Employment growth, corporate consolidation, research capabilities, ownership structures, advanced manufacturing and the strategic future of ten Italian pharmaceutical groups.

Executive Summary / Bottom Line Up Front

Principal assessment. Between 2000 and 2025, Italy developed a pharmaceutical industry with substantial international manufacturing capacity and a more diversified portfolio of specialised corporate groups. Nevertheless, the expansion of Italian-headquartered companies cannot be equated automatically with domestic job creation, technological sovereignty or increased Italian control of intellectual property.

The verified evidence establishes several material findings.

• Menarini: Its own corporate history records 8,000 employees in 2000 and 17,800 in 2024, an increase of 122.5%. The proposed starting figure of 7,250 is contradicted by the company’s published historical series.
• Chiesi: Its reported workforce reached 7,934 in 2025, supported by a substantial international research and production network. Its proposed 2000 baseline of 1,000 has not been independently established.
• Kedrion: The proposed terminal figure of 3,200 is contradicted by the company’s approximately 5,200 employees in 2024. Its combination with Bio Products Laboratory materially changed corporate scale and ownership.
• Italian industrial capacity: Farmindustria recorded €56 billion in pharmaceutical production, €54 billion in exports, 71,000 direct employees and €4 billion in manufacturing and R&D investment in 2024.
• Ownership: Farmindustria’s assessment attributes 43% of a composite industry-presence indicator to Italian-controlled companies and 57% to foreign-controlled companies, illustrating the importance of distinguishing domestic production from national capital control.
• Technological upgrading: Documented investment in biotechnology, rare diseases, oncology, diagnostics and specialised manufacturing establishes more than simple corporate enlargement, although the distribution of high-value activities between Italy and foreign subsidiaries remains uneven.
• Strategic implication: The relevant industrial-policy objective is not maximum employment or group size in isolation, but the retention and development of advanced research, regulated manufacturing, intellectual property, supply-chain expertise and decision-making functions in Italy.

Decisive uncertainty: A complete, homogeneous 2000–2025 employment series for all ten companies cannot yet be established from the verified records. In particular, changes in corporate perimeter make unadjusted comparisons misleading.

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The growth of Italy’s pharmaceutical champions conceals a more consequential question: whether international expansion is strengthening the country’s scientific and manufacturing capabilities or merely increasing the size of companies whose strategic assets are increasingly dispersed abroad.

Italy has become a major pharmaceutical manufacturing economy without establishing that the international growth of its leading companies has produced an equivalent increase in domestic technological control. In 2024, pharmaceutical production reached €56 billion, exports €54 billion and direct employment 71,000, according to Farmindustria. Yet the expansion of Menarini, Chiesi, Recordati, Kedrion and other Italian-rooted groups reflects different combinations of acquisitions, scientific investment and foreign manufacturing. The distinction is decisive for public policy. Italy must finance healthcare, accommodate increasingly expensive therapies and compete for industrial investment while relying on corporate networks whose research, intellectual property and production facilities extend across national borders. The central question is no longer how large Italian pharmaceutical companies have become, but how much of their growth translates into industrial capabilities that Italy can retain, develop and control.

An export powerhouse with a much smaller employment dividend

The structural transformation is visible in the relationship between pharmaceutical production, exports and employment. Farmindustria reports that the average share of production destined for foreign markets increased from approximately 48% in 2000–2004 to 67% in 2010–2014 and more than 90% in 2020–2024. Pharmaceuticals consequently became increasingly integrated into international manufacturing and distribution networks, with the sector’s share of total Italian manufacturing exports rising from 3.5% in 2004 to 9.1% in 2024.

Employment followed a less linear trajectory. The Italian pharmaceutical workforce declined from 67,500 in 2009 to 59,300 in 2014 before recovering to 71,000 in 2024. Over the full 2009–2024 period, the net gain was approximately 5.2%, compared with a 71.7% nominal increase in annual investment, from €2.33 billion to €4 billion. The latter included €2.3 billion in research and development and €1.7 billion in production investment in 2024.

The divergence does not independently establish productivity growth, but it demonstrates why headcount is an inadequate measure of industrial upgrading. Pharmaceutical companies can expand output through capital-intensive facilities, specialised processes and international production mandates without proportional recruitment. Equally, acquisitions can add thousands of employees to consolidated accounts without creating new Italian jobs.

The distinction is particularly important for a sector in which corporate ownership and manufacturing geography rarely coincide perfectly. Farmindustria’s composite measure of industry presence attributes 43% to Italian capital, 23% to American capital and 34% to other foreign capital. This is not a direct ownership measure of factories or production, but it confirms that Italy’s industrial strength rests substantially on companies with different national ownership structures.

Italian pharmaceutical production is therefore considerably larger than the industrial activity directly controlled by Italian shareholders. Treating the two as interchangeable would misrepresent both the contribution of foreign investment and the actual capabilities of Italian-headquartered groups.

Corporate enlargement does not automatically create Italian technological capacity

Menarini’s published employment series offers an unusually clear illustration of international corporate expansion. Its global workforce increased from 8,000 in 2000 to 17,800 in 2024, a rise of 122.5%. The group developed through commercial expansion and acquisitions, including the 2020 purchase of US-based Stemline Therapeutics, which strengthened its oncology portfolio. That growth demonstrates greater international organisational scale, but the consolidated figures do not reveal how much additional employment or technological capability was created within Italy.

Recordati presents an even more revealing distinction. Its 2025 reporting identifies 4,693 employees worldwide, of whom only 1,160 were located in Italy, approximately 24.7%. Between 2024 and 2025, its global workforce increased by 110 employees while Italian employment declined by 48. The company’s international expansion, including the acquisition of specialised rare-disease assets, strengthened its corporate portfolio without producing an equivalent increase in domestic employment.

Kedrion illustrates another mechanism. Following its 2022 combination with Britain’s Bio Products Laboratory, the group reported approximately 5,200 employees and €1.578 billion in revenue in 2024. The integration brought together existing plasma-related activities under a larger international organisation. It would therefore be misleading to interpret the increase in consolidated scale as entirely new employment created through organic expansion.

Alfasigma raises a comparable statistical problem: the present group emerged from the 2015 combination of Alfa Wassermann and Sigma-Tau, subsequently expanding through acquisitions including Intercept Pharmaceuticals in 2023. Comparing its current workforce with that of an unreconciled predecessor would confuse consolidation with employment creation.

These cases expose a weakness in conventional industrial narratives. An acquired foreign laboratory may increase a company’s technological sophistication without increasing Italian research employment; an acquired product portfolio may expand sales without adding production capacity; and a merger may enlarge the balance sheet while leaving the underlying industrial facilities substantially unchanged.

Corporate nationality identifies an organisational origin. It does not establish where additional economic value is created.

The strongest evidence of upgrading comes from medicines and manufacturing processes

The case for genuine technological development is nevertheless substantial. Chiesi reported €885 million in research expenditure in 2025, equivalent to 24.4% of its €3.625 billion revenue. Its rare-disease franchise generated €906 million in sales, alongside €1.886 billion in respiratory products and €904 million in specialty care. The group maintains research centres in Parma and six foreign countries, demonstrating scientific scale but also the international distribution of that capability.

More direct evidence comes from regulatory authorisations. In March 2024, the US Food and Drug Administration approved Italfarmaco’s givinostat, marketed as Duvyzat, for Duchenne muscular dystrophy in patients aged six years and older. The pivotal trial involved 179 patients at 45 sites across 11 countries. The European Union followed with conditional marketing authorisation in June 2025 under a more specifically defined indication.

Dompé provides another example through cenegermin, a recombinant human nerve growth factor authorised by the European Medicines Agency in July 2017 for neurotrophic keratitis. These developments demonstrate capabilities extending beyond pharmaceutical distribution into specialised clinical development, biological technologies and regulatory execution.

The industrial question, however, extends beyond the authorisation itself. Research expenditure does not establish where patents are owned; regulatory approval does not identify where commercial manufacturing occurs; and access to a technology through licensing does not necessarily transfer control of the underlying intellectual property.

Manufacturing introduces a further distinction. Kedrion’s 2024 industrial network included seven production plants, approximately 3.3 million litres of plasma fractionation capacity and 2.6 million litres of plasma-collection capacity. Its Italian facilities at Bolognana and Sant’Antimo perform specialised functions within an international biological production system, alongside operations in Britain, Hungary, Canada and the United States.

Bracco’s Singen facility in Germany provides a different example of industrial upgrading: electronic batch records and parametric release were introduced in 2025, following previous investments in manufacturing and warehouse organisation. Such developments can improve process control and quality documentation, but their contribution to Italian domestic capacity must not be confused with their contribution to an Italian-rooted multinational group’s competitiveness.

The highest-value pharmaceutical assets are consequently not always the facilities employing the greatest number of people. They may be the plants capable of difficult biological processes, the laboratories controlling proprietary technologies or the industrial teams possessing the knowledge required to validate and sustain regulated production.

Healthcare budgets and industrial investment are competing for the same economic space

Italy’s pharmaceutical ambitions face a fiscal constraint that cannot be separated from industrial strategy. According to AIFA’s Rapporto OsMed 2024, total pharmaceutical expenditure reached €37.2 billion in 2024, including €26.8 billion in public expenditure. Public spending increased by 7.7%, while medicines purchased by public healthcare facilities accounted for approximately €17.8 billion, rising by about 10%.

Antineoplastic and immunomodulating medicines represented approximately €8.2 billion in public expenditure. These figures show why the development of advanced therapeutic markets increasingly intersects with the financing of the national healthcare system.

Pricing and reimbursement arrangements consequently affect both access to medicines and manufacturers’ expected returns. AIFA recorded €122.85 million in repayments under specified expenditure-ceiling and price-volume agreements in 2024, including €100.63 million associated with expenditure ceilings. These contractual repayments are distinct from the broader pharmaceutical payback system and cannot be treated as its complete financial burden.

International expenditure comparisons require similar care. AIFA reported pharmaceutical spending of €672 per inhabitant in Italy in 2024, compared with €742 in Germany and €541 in Great Britain. Adjusting the Italian figure for payback reduced it to approximately €627. Different reimbursement structures, treatment patterns and accounting definitions mean that these values cannot establish which country obtains the lowest net price for identical medicines.

The industrial consequence is a difficult allocation problem. Public authorities must finance effective treatments and control expenditure, while manufacturers evaluate long-term investments according to expected revenues, development costs and regulatory conditions. Neither higher prices nor larger subsidies automatically create domestic innovation. Equally, purchasing medicines at the lowest immediate price does not guarantee a sustainable or diversified manufacturing base.

The European Commission’s proposed Critical Medicines Act, presented in March 2025, addresses part of this contradiction by connecting medicine availability with manufacturing capacity, procurement and the diversification of supply. Its effectiveness will depend on whether public intervention supports genuinely necessary capabilities rather than capacity that companies would have financed independently.

Europe’s pharmaceutical competition is also a contest over where knowledge remains

Italy’s position must be assessed against countries competing for research, specialist labour and manufacturing investment.

Germany Trade & Invest reports approximately €10.7 billion in pharmaceutical R&D investment during 2024 and an industry workforce of around 133,000. France’s pharmaceutical workforce was approximately 98,043 in the EFPIA reference series for 2023. The United Kingdom’s Office for Life Sciences reported approximately 163,600 biopharmaceutical employees and £98.9 billion in subsector turnover for 2023–2024, although its statistical perimeter differs from conventional pharmaceutical manufacturing.

These figures are not a homogeneous competitiveness ranking. They establish the scale of different national systems but cannot identify technological superiority without compatible measures of research intensity, industrial value added, patent ownership and manufacturing sophistication.

The more consequential issue is the allocation of future investment. European pharmaceutical companies can develop medicines in one country, manufacture them in another and commercialise them internationally. Their corporate headquarters may remain nationally identifiable while scientific and productive functions become increasingly dispersed.

The European Union’s pharmaceutical reform, politically agreed in December 2025 and advanced through the Council’s adoption in September 2026, addresses innovation incentives, market access and supply conditions. Its legislative progress does not eliminate the separate economic problem of attracting pharmaceutical investment into individual European territories.

For Italy, the exposure is therefore twofold: competition with other European economies for high-value production and competition with global research centres for scientific capabilities. Supporting Italian-headquartered companies abroad may strengthen their consolidated position, but this cannot substitute for maintaining a domestic environment capable of attracting advanced laboratories, validated manufacturing processes and specialised personnel.

The next 24 months will test industrial policy against actual production capacity

Between October 2026 and October 2028, the immediate measure of pharmaceutical industrial policy should be whether public authorities can identify critical supply dependencies and translate that evidence into credible investment, procurement and workforce decisions.

The European Medicines Agency’s Union list of critical medicines provides a starting point, but clinical criticality is not evidence of an imminent shortage. A credible intervention must also identify supplier concentration, manufacturing substitutability, raw-material exposure and the time required to restore production.

That distinction determines whether a problem requires additional manufacturing capacity, a qualified alternative supplier, more reliable inventory arrangements or changes to procurement contracts. Financing another plant without addressing the underlying supply bottleneck can add cost without delivering resilience.

For research investment, the corresponding test is whether public incentives create additional scientific capabilities within Italy rather than subsidising expenditure already planned by multinational groups. For consolidation, it is whether acquisitions preserve independent production options and strengthen technological resources rather than merely combining existing assets under a larger financial structure.

The costs of inaction will not fall on one constituency. Patients and the public healthcare system will bear the consequences of medicine shortages and prolonged dependence on vulnerable supply chains. Manufacturers will face greater operational uncertainty, while highly qualified workers and Italian industrial territories risk losing future investment mandates to locations offering stronger scientific and productive conditions. Public finances may ultimately absorb the cost of emergency procurement or corrective interventions undertaken after vulnerabilities have materialised.

Italy does not need an industrial policy that confuses larger pharmaceutical companies with a stronger pharmaceutical industrial base. It needs one capable of establishing where scientific knowledge is developed, where medicines can actually be manufactured, who controls the relevant technologies and how reliably essential treatments can reach patients.

The decisive test of Italy’s pharmaceutical transformation will not be the next increase in consolidated corporate employment. It will be whether the country retains a greater share of the research, advanced manufacturing and production decisions on which pharmaceutical competitiveness and healthcare continuity depend.

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Navigational Index

PILLAR I — INDUSTRIAL EVOLUTION AND CORPORATE CONTROL

• Chapter 1. Italian Pharmaceutical Industry: The Structural Baseline, 2000–2025
• Chapter 2. The Ten Corporate Groups: Employment, Acquisitions and Geographic Expansion
• Chapter 3. Ownership, Consolidation, Financial Control and the Location of Strategic Decision-Making

PILLAR II — TECHNOLOGICAL AND OPERATIONAL CAPABILITIES

• Chapter 4. Therapeutic Specialisation, Research Investment and Intellectual Property
• Chapter 5. Advanced Manufacturing, Biotechnology, Plasma Products and Diagnostics
• Chapter 6. Logistics, Serialization, Supply-Chain Traceability and Digital Manufacturing

PILLAR III — COMPETITIVENESS, RESILIENCE AND PUBLIC POLICY

• Chapter 7. Italy in European and Global Pharmaceutical Value Chains: France, Germany and the United Kingdom
• Chapter 8. Pricing, Reimbursement, Critical Dependencies, Talent and Financial Vulnerabilities
• Chapter 9. Industrial-Policy Options, Consolidation Scenarios and the 2026–2031 Outlook
• Chapter 10. Strategic Recommendations and Final Net Assessment

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Master Abstract

From domestic manufacturers to multinational industrial systems

The transformation of the Italian pharmaceutical industry over the first quarter of the twenty-first century reflects several industrial developments occurring simultaneously: the international expansion of established family-controlled enterprises, the acquisition of specialised research and commercial assets, the integration of foreign manufacturing operations, and the emergence of more sophisticated portfolios in therapeutic segments requiring substantial regulatory, scientific and manufacturing expertise.

These developments are not interchangeable. A pharmaceutical company may increase its global employment by acquiring an established foreign business without creating additional production or research capacity in Italy. Conversely, a manufacturing site may significantly improve its technological sophistication, productivity and export value without employing substantially more people. A corporate headquarters may retain Italian identity while ownership, financing and certain strategic decisions are exercised elsewhere.

The distinction is particularly important for Kedrion, whose integration with the British company Bio Products Laboratory followed a transaction involving Permira and Abu Dhabi Investment Authority, and for Recordati, whose international operations demonstrate the extent to which consolidated group employment may be distributed outside Italian territory.

The evidence therefore supports a structural interpretation of consolidation rather than a simplistic employment-growth narrative. The principal question is whether multinational scale has been translated into durable capabilities located in Italy and integrated into European pharmaceutical value chains.

Italy’s industrial position is stronger than corporate headcount alone suggests

At the level of the national manufacturing system, Farmindustria’s 2025 statistical publication records pharmaceutical production of €56 billion in 2024, with approximately €54 billion destined for export. Direct employment reached 71,000, while combined investment in production and research amounted to €4 billion, including €2.3 billion in R&D and €1.7 billion in productive assets. The sector consequently combines high export exposure with a substantial base of specialised employment.

Importantly, these figures describe pharmaceutical activity located in Italy, including multinational companies under foreign ownership. They are not the combined revenue, output or employment of the ten Italian-headquartered groups considered in this report.

The industrial strengths documented by these statistics are therefore compatible with concerns about strategic ownership and technological dependencies. Italy can possess highly productive pharmaceutical plants while particular intellectual-property rights, research programmes, commercial platforms or investment decisions remain controlled outside its jurisdiction.

Source: Indicatori Farmaceutici 2025 — Farmindustria — July 2025, pp. 5–6, 15 and 50–51. farmindustria.it

The decisive industrial distinction

The study separates four kinds of growth: expansion of an existing company’s own operations, acquisition of established businesses, extension into new geographies, and movement into more technologically intensive products.

Only the first category directly demonstrates expansion within an unchanged corporate perimeter. Acquisitions can deliver new scientific capabilities or simply transfer control over existing employment. Geographic expansion can improve resilience and access to markets while distributing investment across jurisdictions. Therapeutic diversification can strengthen the value chain when supported by research, regulatory competence and manufacturing investment, but the creation of a more diversified product portfolio does not by itself establish ownership of the underlying discoveries or production technologies.

The industrial-policy conclusion is consequently conditional: consolidation becomes strategically valuable when it produces measurable improvements in innovation, productive capacity, supply reliability and control over critical capabilities, not merely when the consolidated entity becomes larger.

Key Evidence Table — National Industry Baseline

The following indicators concern Italian pharmaceutical activity rather than the consolidated global operations of Italian-headquartered companies.

Indicator	Verified value	Reference period	Definition / scope	Issuer and source
Pharmaceutical production	€56 billion	2024	Production value in Italy	Farmindustria, Table 1
Pharmaceutical exports	€54 billion	2024	Sector export value	Farmindustria
Direct pharmaceutical employment	71,000	2024	Employment located in Italy	Farmindustria
Employment growth	+8%	2019–2024	Sector employment growth	Farmindustria
Investment in R&D	€2.3 billion	2024	Research and development	Farmindustria
Investment in production	€1.7 billion	2024	Manufacturing investment	Farmindustria
Combined investment	€4 billion	2024	R&D plus production	Farmindustria
Women in employment	45%	2024	Share of pharmaceutical employees	Farmindustria
University graduates	54%	2024	Share of employees	Farmindustria
Italian-controlled sector presence	43%	2024 industry assessment	Composite indicator, not employment or production share alone	Farmindustria, Table 60
Foreign-controlled sector presence	57%	2024 industry assessment	Same composite indicator	Farmindustria, Table 60

Source: Indicatori Farmaceutici 2025 — Farmindustria, July 2025, Tables 1, 60 and employment analysis, pp. 68–69. The composite ownership indicator averages multiple dimensions, including revenue, occupational composition, investment, exports and taxation; it must not be represented as a direct ownership share of production assets.

Analytical interpretation

The comparison between national pharmaceutical performance and the workforce of the ten companies establishes two distinct dimensions of industrial development.

The first is territorial industrial strength: Italy’s ability to attract production, research, investment, exports and specialist employment irrespective of the nationality of corporate shareholders.

The second is corporate control and value capture: the ability of Italian-headquartered enterprises to govern internationally distributed assets, retain economic returns, own technologies, allocate capital and sustain domestic strategic functions.

The national statistics demonstrate substantial territorial industrial capacity. They do not, without additional firm-level evidence, establish that Italian-controlled groups are responsible for most of that capacity or that all the value created through exports ultimately accrues to Italian shareholders.

This distinction is fundamental for assessing industrial resilience and for avoiding policy measures that reward aggregate scale without establishing the location of the underlying capability.

Employment Verification — The Ten Corporate Groups

The original graph provides three explicit numerical trajectories: Menarini, Chiesi and Kedrion. For the other seven groups, an authenticated baseline must be reconstructed independently.

The verified comparison below deliberately avoids creating percentage changes from incompatible reporting perimeters or approximate headcounts.

Company	2000 workforce	Verified recent workforce	Historical growth	Evidence assessment
Menarini	8,000	17,800 (2024)	+122.5%	Comparable company-published historical series
Chiesi	Not established	7,934 (2025)	Not calculable	2025 confirmed; 1,000 baseline unsupported
Angelini Pharma	Not established	Over 2,700 (company disclosure)	Not calculable	Pharmaceutical subsidiary must be separated from diversified parent
Recordati	Not established	4,693 (2025)	Not calculable	Precise 2025 consolidated headcount confirmed
Bracco	Not established	Approximately 4,000 (2024)	Not calculable	Rounded corporate group disclosure
Alfasigma	Not comparable as a single present-day group	Historical group workforce not fully reconciled	Not calculable	Present group formed through business combination in 2015
Kedrion	Not established	Approximately 5,200 (2024)	Not calculable	Major 2022 change in corporate perimeter
Zambon	Not established	2,776 group / 2,410 pharma (company disclosure)	Not calculable	Distinct group and pharma employment measures
Italfarmaco	Not established	Not established to required standard	Not calculable	Comparable dated public series needed
Dompé	Not established	1,100 (company disclosure)	Not calculable	Corporate figure published without sufficient historical comparability

“Not established” means no adequately sourced and comparable value was secured in this verification, not that the company had no employees. Undated corporate website figures cannot automatically be assigned to 31 December 2025.

Company-level documentary verification

Menarini. The company’s April 2025 corporate presentation provides an explicit historical series: 8,000 employees in 2000, 12,900 in 2010, 16,750 in 2020 and 17,800 in 2024. The increase between the verified endpoints is 9,800 employees, or 122.5%. A graph using 7,250 as its starting figure would overstate the percentage increase to approximately 145.5%. Menarini Corporate Presentation — April 2025, slide 8.

Chiesi. The company reported 7,542 employees at the end of 2024 and 7,934 in 2025, a net increase of 392 employees, or approximately 5.2% when calculated from the published endpoint figures. Chiesi describes its annual workforce growth as 5.1%. Its historical figure of 1,000 employees in 2000 remains unconfirmed. Chiesi FY2025 Financial and Sustainability Results — April 2026. Chiesi Farmaceutici S.p.A.+1

Angelini. The distinction between pharmaceutical and diversified industrial operations is material. Angelini Industries disclosed approximately 5,600 employees in its 2024 financial communication, but that workforce includes non-pharmaceutical operations. Its pharmaceutical division separately reports more than 2,700 employees, although the accessible corporate overview does not establish a precise year-end 2025 total. Angelini Industries Financial Results — June 2025; Angelini Pharma Corporate Profile. angeliniindustries.com+1

Recordati. Its 2025 annual reporting records 4,693 employees, compared with 4,583 in 2024. The increase amounts to 110 employees, approximately 2.4%. Crucially, the published territorial breakdown identifies only 1,160 employees in Italy in 2025. This is a direct demonstration that global consolidated employment is not a measure of domestic employment. Recordati Annual Report 2025 — Who We Are. Annual Report 2025

Bracco. Its 2024 corporate sustainability disclosures describe a workforce of approximately 4,000. This is consistent with the group’s international diagnostic-imaging industrial network, but the rounded figure should not be used to calculate a precise long-run growth rate. Bracco Sustainability at the Core of Our Growth — 2024 data. Bracco

Alfasigma. The historical comparison is structurally complicated because the present group was formed through the combination of Alfa Wassermann and Sigma-Tau in 2015. A valid 2000 baseline would require a clearly defined predecessor-company perimeter and a reconciled employee series. Alfasigma — Our Heritage. Alfasigma

Kedrion. Its 2021 financial statements reported 2,784 employees, while the company subsequently reported approximately 5,200 in 2024 following the combination with Bio Products Laboratory. The apparent increase cannot be classified as organic growth because the consolidated perimeter changed materially. Kedrion Consolidated Financial Statements 2021; Kedrion 2024 in Review — April 2025. Kedrion Biopharma+1

Zambon. Its corporate recruitment disclosure distinguishes 2,776 employees worldwide from 2,410 in pharmaceutical operations. The distinction is necessary for comparison with other companies, and the undated disclosure cannot establish a precise 2025 endpoint. Zambon — Working in Zambon. Zambon

Dompé. Its corporate profile reports 1,100 employees. The figure demonstrates current organisational scale but is not sufficient to reconstruct the employment trajectory beginning in 2000. Dompé — About Us. Dompé Global

Italfarmaco. A sufficiently attributable and dated pair of headcount disclosures was not established in the accessible primary record. Its inclusion remains appropriate for the subsequent therapeutic and manufacturing assessment, but no employment-growth percentage is assigned.

Competing Explanations for Pharmaceutical Consolidation

Three explanations can account for the transformation of the ten corporate groups. They are partly overlapping rather than mutually exclusive.

Explanation	Supporting evidence	Limiting evidence	Current assessment
Organic industrial and technological expansion	Menarini’s long-term employment increase; Chiesi’s investment in research and advanced production	Group-wide headcount does not isolate domestic organic hiring	Strongly supported for selected activities; aggregate contribution undetermined
Acquisition-driven international consolidation	Kedrion–BPL combination; Alfasigma transactions; Menarini’s international acquisitions	Acquired employment is not newly created employment	Directly documented as a material growth mechanism
Therapeutic and technological upgrading	Research investment, rare-disease portfolios, oncology, plasma derivatives and diagnostic imaging	Product ownership and R&D spending do not necessarily establish Italian-located research or manufacturing	Documented in selected companies; national capability gains require further location-specific measurement

The acquisition mechanism

The historical record already identifies several transactions with substantial implications for corporate capabilities and employment accounting.

Menarini — International product and research expansion

Its acquisition of Berlin-Chemie in 1992 predates the study baseline but materially shaped the group’s subsequent geographic presence. Later transactions included Silicon Biosystems and the acquisition of the US-based Stemline Therapeutics in 2020, expanding capabilities in liquid-biopsy technology and oncology.

Source: Menarini Corporate Presentation, 2025.

Chiesi — International research, manufacturing and specialised therapeutics

The company acquired the Danish biopharmaceutical company Zymenex in 2013 and established Holostem Advanced Therapies in 2008. These developments illustrate diversification beyond its established respiratory business.

Source: Chiesi — Corporate History.

Alfasigma — Domestic combination and foreign acquisitions

Formed in 2015 through the combination of Alfa Wassermann and Sigma-Tau, Alfasigma subsequently acquired US-based PamLab in 2017 and Intercept Pharmaceuticals in 2023. In 2024, the company acquired the filgotinib business from Galapagos, expanding its specialised therapeutic portfolio.

Source: Alfasigma — Our Heritage.

Kedrion — Plasma-sector integration and international ownership

Kedrion expanded into American plasma collection, Hungarian manufacturing and US production before the transformative 2022 combination with Bio Products Laboratory. This demonstrates how group employment can increase sharply through consolidation of existing operations rather than new domestic hiring.

Sources: Kedrion Corporate History; Kedrion Annual Report 2022.

The transactions establish that international corporate expansion was a significant driver of structural transformation. They do not establish a numerical allocation of the ten groups’ aggregate employment growth between acquisitions, greenfield investment and organic hiring. Such an allocation would require transaction-date workforce data and subsequent constant-perimeter reporting.

Technological Capability and Operational Implications

The strongest evidence of technological upgrading concerns groups whose strategic development is supported by identifiable manufacturing, research and therapeutic activities.

For Chiesi, the documented focus on respiratory health, rare diseases and specialty care combines with substantial R&D spending. Its 2025 results report approximately €885 million in R&D investment and a global research network that includes Parma alongside facilities in France, the United States, Canada, China, the United Kingdom and Sweden. This establishes material corporate research capacity, but the geographical allocation of R&D expenditure requires separate examination. Chiesi Farmaceutici S.p.A.+1

Kedrion illustrates a different technological structure. Plasma-derived medicines depend on a chain connecting donor collection, biological screening, fractionation, production, testing and distribution. Consequently, geographic diversification can increase security of supply while also increasing regulatory coordination requirements and dependence on specialised sourcing networks.

Bracco provides a documented manufacturing example. At its Singen facility in Germany, the company reports the insourcing of warehouse and logistics activities in 2021 and the introduction of electronic batch records and parametric release in 2025. These are concrete investments in operational control, rather than merely a general commitment to digitalisation. Bracco — BIPSO Sterile Manufacturing Excellence. Bracco

Angelini Pharma also reports automated control and supervision systems at its manufacturing plants, including Italian production sites in Ancona and Aprilia. These disclosures establish the presence of digital control capabilities, although they do not provide comparable indicators of automation intensity, productivity improvements or return on investment. Angelini Industries — Pharmaceuticals. angeliniindustries.com

Operational consequences of scale

As pharmaceutical groups expand across manufacturing locations and regulatory jurisdictions, operational resilience increasingly depends on the coordination of specialised information systems and physical processes.

The relevant functions include validated electronic batch records, manufacturing-execution systems, quality-management systems, serialization, batch genealogy, warehouse-management systems, temperature-controlled distribution, supplier qualification and integrated production planning.

These functions are not equivalent. Serialization identifies and supports verification of saleable medicine packs; batch genealogy connects materials and manufacturing events; warehouse management controls inventory and movement; manufacturing-execution systems coordinate production operations and records. A group may perform strongly in one area without having integrated the others.

Analytical judgment: The strategic value of digitalisation lies in whether it reduces batch-release delays, prevents stock losses, improves recall precision, limits quality deviations and strengthens production continuity. Claims of digital transformation should therefore be assessed using measurable operational outcomes rather than expenditure announcements alone.

European Competitive Context

Italy’s pharmaceutical position cannot be evaluated solely through the ten national corporate groups. Competition for investment, manufacturing mandates, scientific talent and product development occurs across European and international corporate networks.

Farmindustria’s 2025 assessment reports that, using a combined indicator of pharmaceutical production and employment, Germany accounts for 14.5% of the corresponding European aggregate, Italy 12.7% and France 10.7%. These shares describe a specific combined measure and must not be interpreted as individual countries’ production shares alone. Indicatori Farmaceutici 2025 — Farmindustria, p. 15. farmindustria.it

The same publication reports a 33% increase in pharmaceutical patent applications in Italy when comparing the most recent five-year period with the preceding one, against 20% for the major European comparator group. This is useful evidence of sectoral innovation activity, but it does not identify the patent contribution of the ten selected companies or establish the commercial value of individual inventions.

Italy, Germany, France and the United Kingdom

Italy combines pharmaceutical manufacturing, specialist contract development and production, and internationally operating groups headquartered in the country. Its central challenge is converting that production strength into more sustained ownership and location of higher-value scientific and industrial functions.

Germany represents a major European industrial comparator for manufacturing scale and regulated production. The location of Bracco’s specialised German operations also illustrates that Italian corporate internationalisation can strengthen a group’s capabilities through productive investment outside Italy.

France is both a competitor for pharmaceutical investment and an important location within Italian groups’ industrial and commercial networks. Chiesi’s French operations demonstrate why international growth can generate manufacturing capacity and scientific employment abroad while strengthening the wider corporate organisation.

The United Kingdom is particularly relevant for biopharmaceutical research and the consolidation of specialised therapeutic assets. The Kedrion–Bio Products Laboratory combination demonstrates the direct interaction between Italian pharmaceutical organisations, British production assets and international financial ownership.

These country assessments identify material competitive relationships but do not constitute a verified ranking of national innovation performance. A definitive comparison requires compatible series for R&D expenditure, manufacturing investment, patent quality, clinical development, employment composition and value added.

Principal Gaps and Watch Indicators

Decisive evidence gap	Required record	Policy significance
Missing 2000 company headcounts	Historical consolidated accounts and workforce disclosures	Establish reliable long-run growth
Changing corporate perimeters	Acquisition-date accounts and pro-forma personnel statements	Separate acquired employment from organic creation
Global versus Italian workforce	Country-level employment and occupational disclosures	Measure domestic industrial benefits
Italian research capacity	Geographic R&D expenditure and laboratory personnel data	Assess technological deepening
Pharmaceutical patent ownership	EPO/PATSTAT patent families and applicant records	Distinguish invention activity from commercial control
Digital manufacturing adoption	Site-level validated system disclosures and operational outcomes	Evaluate operational resilience
Supply-chain dependencies	Supplier concentration, sourcing geography and shortage records	Identify critical vulnerabilities
Consolidation and financing	Ownership filings, debt structure and investment decisions	Evaluate control and capital-allocation exposure

Watch indicators for 2026–2031

The most consequential developments to monitor will be the geographic distribution of new research investment, expansion or contraction of Italian manufacturing mandates, ownership changes affecting strategic decision-making, acquisition integration outcomes, patent ownership, and verified improvements in supply-chain resilience.

Changes in total group employment will remain relevant, but only as one measure among several. For industrial-policy evaluation, the more revealing outcomes will be specialised employment in Italy, advanced production capacity, domestic research functions, regulatory capabilities and the ability of Italian-based facilities to supply European and international markets reliably.

Preliminary Strategic Net Assessment

The verified evidence supports an assessment that is more nuanced than the initial employment chart suggests.

Italy’s pharmaceutical industry has developed substantial production and export capabilities, while Italian-headquartered companies have pursued different models of internationalisation. Some have expanded established commercial and therapeutic platforms; others have acquired specialist technologies, businesses and production facilities; others have undergone changes in ownership or corporate perimeter that make a simple employee-growth comparison analytically unreliable.

The evidence does not support the proposition that consolidation has merely created larger domestic groups with no technological deepening. Specific investments in biotechnology, research, specialised therapies and digital manufacturing demonstrate real capability development.

Equally, it does not establish that corporate growth has uniformly increased Italy’s control of the highest-value segments of pharmaceutical production. International research facilities, foreign manufacturing assets, financial ownership structures and geographically distributed employment complicate that conclusion.

For Italian and European policymakers, the appropriate test of future consolidation is therefore whether it creates durable productive and scientific capabilities, secures essential supply chains and improves the long-term competitiveness of European pharmaceutical manufacturing.

The central policy proposition is that corporate scale can support industrial resilience, but it is neither a necessary nor a sufficient measure of technological sovereignty. The effect depends on where investment occurs, which capabilities are developed, how intellectual property is controlled and whether critical production and research functions can be sustained under financial, regulatory or geopolitical stress.

No decision-useful quantitative visualisation is supportable from a homogeneous ten-company employment series in the currently verified record. The source discrepancies and missing historical baselines make a conventional growth-ranking chart potentially misleading.

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PILLAR I — INDUSTRIAL EVOLUTION AND CORPORATE CONTROL

Chapter 1. Italian Pharmaceutical Industry: The Structural Baseline, 2000–2025

Italy’s pharmaceutical transformation: from a nationally organised industry to an internationally integrated production system

Principal judgment. The most consequential transformation of the Italian pharmaceutical industry between 2000 and 2025 was not simply the expansion of its largest companies, but the progressive separation between the geographical location of pharmaceutical production, the nationality of corporate ownership, the control of technological assets and the markets in which medicines ultimately generate revenue. Italy developed a highly internationalised pharmaceutical manufacturing system, while several historically Italian pharmaceutical groups evolved into multinational organisations through acquisitions, foreign subsidiaries and increasingly specialised therapeutic portfolios. These processes strengthened the country’s participation in international pharmaceutical value chains but created an industrial structure in which national production capacity and Italian strategic control must be evaluated separately.

At the beginning of the period, the Italian pharmaceutical industry already possessed significant manufacturing capabilities, established research organisations, domestic distribution networks and internationally active companies. It would therefore be inaccurate to describe the subsequent transformation as the creation of an industrial sector that had previously been predominantly local or technologically undeveloped. What changed was the intensity of international integration, the composition of pharmaceutical products and the relationship between productive investment and global commercial operations. Manufacturing became more closely linked to international supply chains, while regulatory requirements, specialist therapies and corporate consolidation increased the economic importance of organisational capabilities extending beyond individual production facilities.

The industrial transformation is particularly visible in the changing relationship between Italian pharmaceutical production and foreign demand. According to Farmindustria, the average share of production directed towards exports rose from approximately 48% in 2000–2004 to 67% in 2010–2014 and more than 90% in 2020–2024. This is one of the most significant structural findings in the historical record because it demonstrates a fundamental change in the orientation of pharmaceutical manufacturing located in Italy. Production facilities increasingly operated as components of an international industrial and commercial system rather than primarily as suppliers serving national pharmaceutical demand. These are period averages, however, and the ratios must not be confused with the individual yearly values of national production and merchandise exports. Indicatori Farmaceutici 2025 — Farmindustria — July 2025, international trade section, pp. 52–57. farmindustria.it

This evolution has important implications for the interpretation of employment. A company can substantially increase global revenue and production without generating a corresponding increase in its Italian workforce, particularly when investment is concentrated in technologically intensive manufacturing processes or when overseas acquisitions add existing employees to the consolidated organisation. Conversely, internationally controlled pharmaceutical manufacturers operating in Italy can expand exports, invest in domestic facilities and employ Italian researchers without contributing to the employment totals of Italian-controlled corporate groups. Consequently, an assessment based exclusively on ten corporate employment trajectories risks overlooking an important part of the country’s actual pharmaceutical industrial base.

The transformation of the industrial baseline: output, exports, employment and investment

Farmindustria’s Indicatori Farmaceutici 2025, finalised using information available through 31 July 2025, provides a consistent statistical reference for the sector’s recent industrial structure. It records pharmaceutical production in Italy of approximately €56 billion in 2024, exports of approximately €54 billion, direct employment of 71,000 and combined investment in research and production of €4 billion. Within this investment aggregate, €2.3 billion was associated with research and development and €1.7 billion with production. The figures identify a significant industrial system characterised by high international exposure, specialised employment and continuing capital investment, but they do not establish how much of its output or intellectual property was controlled by Italian shareholders. Indicatori Farmaceutici 2025 — Farmindustria — July 2025, Table 1, p. 6. farmindustria.it

The longer employment series reveals a more complex industrial trajectory than a simple narrative of continuous expansion. Farmindustria records 67,500 pharmaceutical employees in 2009, followed by a decline to 59,300 in 2014. Employment subsequently recovered to 65,800 in 2019 and reached 71,000 in 2024. The evidence therefore establishes a period of contraction followed by renewed expansion, not an uninterrupted progression. Between 2009 and 2014, the sector lost 8,200 employees, equivalent to approximately 12.1% of its initial workforce; between 2014 and 2024, it gained 11,700 employees, equivalent to approximately 19.7%. Over the complete 2009–2024 interval, the net increase was 3,500 employees, or approximately 5.2%. These percentages are calculated from the original statistical series and describe national employment rather than the international workforce of Italian pharmaceutical groups. Indicatori Farmaceutici 2025 — Farmindustria — July 2025, Table 61, p. 52. farmindustria.it

Table 1.1 — Italian pharmaceutical employment and investment: verified historical series

Year	Direct pharmaceutical employment	Annual change in employment	Pharmaceutical investment in production and R&D (€ million)
2009	67,500	—	2,330
2010	64,700	−4.15%	2,370
2011	64,100	−0.93%	2,390
2012	64,400	+0.47%	2,350
2013	62,300	−3.26%	2,250
2014	59,300	−4.82%	2,500
2015	59,900	+1.01%	2,615
2016	61,000	+1.84%	2,700
2017	62,800	+2.95%	2,800
2018	64,500	+2.71%	3,000
2019	65,800	+2.02%	3,000
2020	66,500	+1.06%	3,040
2021	67,300	+1.20%	3,060
2022	68,600	+1.93%	3,265
2023	70,000	+2.04%	3,550
2024	71,000	+1.43%	4,000

Source: Indicatori Farmaceutici 2025 — Farmindustria — July 2025, Table 61, p. 52. Annual employment percentage changes are calculated from the reported headcounts and rounded to two decimal places. Investment amounts are nominal euros; they have not been adjusted for inflation.

The significance of the series lies partly in the different trajectories of employment and investment. Between 2009 and 2024, reported nominal investment increased from €2.33 billion to €4 billion, representing approximately 71.7% nominal growth, while employment increased by approximately 5.2%. This divergence is consistent with an industry in which capital intensity, product complexity and technological requirements have become more important, but it cannot independently establish an increase of the same magnitude in labour productivity. Investment is an annual flow, employment is a stock, and no inflation adjustment or consistent annual gross-value-added series has been introduced into this calculation. Any claim about productivity growth must instead be established using compatible measures of real value added and hours worked.

The decline in employment during the earlier part of the available series is also important. It demonstrates that the industry’s current scale emerged through restructuring rather than purely additive expansion. A national industry can lose employment while preserving productive capabilities through reorganisations, increases in process efficiency or changes in the allocation of manufacturing activities, just as it can increase employment without improving its international competitive position. The series does not distinguish the individual contributions of these mechanisms. The subsequent recovery therefore warrants investigation at the level of establishments, occupations, investment projects and corporate ownership rather than assuming a single cause.

Export integration and the changing position of Italy in global pharmaceutical trade

The internationalisation of Italy’s pharmaceutical production is among the most decisive economic developments of the period. Farmindustria reports that the Italian industry’s share of global pharmaceutical exports rose from 5.4% in 2014 to 6.3% in 2024. Over the same interval, the share of pharmaceuticals in total Italian manufacturing exports increased from 5.5% to 9.1%, compared with 3.5% in 2004. These changes indicate that pharmaceuticals assumed greater relative importance within Italy’s export-oriented manufacturing system, while Italy also increased its measured share of international pharmaceutical trade. The latter indicator is influenced by worldwide export developments, exchange rates and the composition of pharmaceutical goods; it should not be interpreted as an isolated measure of domestic technological competitiveness. Indicatori Farmaceutici 2025 — Farmindustria — July 2025, international trade analysis, pp. 53–56. farmindustria.it

Table 1.2 — Verified indicators of internationalisation

Indicator	Initial observation	Later observation	Interpretation
Average export propensity	48%, 2000–2004	Over 90%, 2020–2024	Long-run increase in export orientation
Intermediate export propensity	67%, 2010–2014	Over 90%, 2020–2024	Intensification of international production integration
Pharmaceuticals’ share of Italian manufacturing exports	3.5%, 2004	9.1%, 2024	Greater relative importance within national manufacturing exports
Italian share of world pharmaceutical exports	5.4%, 2014	6.3%, 2024	Higher reported participation in global pharmaceutical trade
Pharmaceutical exports	—	Approximately €54bn, 2024	Recorded national export value
Pharmaceutical production	—	Approximately €56bn, 2024	Recorded national production value

Source: Indicatori Farmaceutici 2025 — Farmindustria — July 2025, Tables 1 and 63–66.

Export integration creates opportunities and vulnerabilities simultaneously. It allows Italian production facilities to operate at scales that would be difficult to sustain exclusively through national demand, promotes integration into international corporate manufacturing networks and increases the strategic value of domestic plants capable of supplying several regulatory markets. At the same time, the continuity of domestic production becomes more exposed to changes in international demand, corporate allocation decisions, cross-border logistics, trade policy and the financial conditions under which multinational groups determine the location of future investment. The effect of an increase in exports on Italian economic resilience is therefore conditional on whether production capacity is diversified, whether essential intermediates remain available and whether major production sites possess competitive advantages sufficient to preserve their position within international networks.

An additional distinction concerns the economic value retained domestically. Gross exports record the value of goods crossing borders; they do not isolate the domestic content of those exports, the location of patent ownership, the country where development expenditures were incurred or the distribution of profits among companies and shareholders. For an industrial-policy assessment, export growth is a necessary indicator of international competitiveness but insufficient evidence of national value capture. A more complete evaluation would combine merchandise trade with domestic value added, corporate ownership, research intensity, employment specialisation and the location of strategic functions.

Employment quality, occupational structure and the economics of pharmaceutical specialisation

The pharmaceutical sector’s strategic importance is also connected to its occupational structure. Farmindustria’s 2025 statistical publication identifies women as approximately 45% of pharmaceutical employment in Italy and records employment growth among workers under 35 of 21% over the preceding five years. These figures are important because they show that employment growth is not simply an aggregate increase in positions but involves changes in the composition of the sector’s workforce. However, age and gender indicators cannot substitute for the occupational data needed to identify the proportion of personnel engaged in research, advanced engineering, quality assurance, validation, regulatory affairs, production or distribution. Indicatori Farmaceutici 2025 — Farmindustria — July 2025, Table 1 and employment section.

The industrial significance of occupational composition is considerable. A pharmaceutical manufacturing site employing personnel in formulation development, analytical chemistry, microbiological control, process engineering and regulatory validation possesses a different strategic profile from a predominantly commercial or distribution organisation of the same employment size. Similarly, an increase in highly specialised research personnel can create greater long-term technological value than a larger increase in personnel associated with a recently acquired commercial network, although no such comparison should be converted into a numerical value without a documented methodology. Employment must consequently be assessed not only by its total volume but also by location, skill requirements, functional allocation and relationship to critical production capabilities.

The distinction becomes particularly relevant as companies move into biological medicines, rare diseases, advanced diagnostics and other regulated therapeutic segments. These activities require specialist knowledge and technical systems that may be difficult to reproduce quickly. Their strategic contribution lies partly in the accumulation of experience, regulatory approvals, process validation and integrated manufacturing knowledge. Nevertheless, specialisation may also increase dependence on a narrower set of products, technologies, clinical indications or reimbursement decisions. Industrial sophistication and industrial resilience are related but not identical objectives.

Investment constraints, national reimbursement conditions and the industrial-policy environment

The expansion of pharmaceutical manufacturing takes place within a regulatory and financial environment shaped by national healthcare financing, European medicines regulation, price negotiations, reimbursement decisions and industry-specific financial obligations. Farmindustria reports that pharmaceutical payback charges increased from approximately €1.2 billion in 2018 to €2.2 billion in 2024. It also reports that the average interval between European authorisation and national availability of a medicine was slightly more than 14 months in Italy, compared with approximately four months in Germany, while subsequent regional access processes in Italy required an additional average period of approximately ten months. These are industry-association figures and methodological comparisons, not a complete assessment of the relative performance of the two healthcare systems. Farmindustria itself notes differences in administrative procedures and staffing between national authorities. Indicatori Farmaceutici 2025 — Farmindustria — July 2025, pharmaceutical expenditure and access section, pp. 34–36. farmindustria.it

From an industrial perspective, the relevance of these mechanisms is that investment decisions depend not only on a country’s workforce, physical infrastructure and production costs but also on the predictability of the economic environment governing innovative products. Pharmaceutical groups frequently allocate research, production and commercial investment across several jurisdictions. Uncertainty concerning reimbursement, product access and financial obligations can affect anticipated returns and therefore become one element in the assessment of alternative investment locations. The existence of this mechanism does not establish that any particular investment was cancelled, relocated or reduced because of Italian pricing policy; such causal conclusions would require company-specific evidence.

Table 1.3 — National industrial-policy exposure

Policy variable	Verified evidence or relevant mechanism	Industrial consequence requiring assessment
Pharmaceutical payback	Approximately €1.2bn in 2018 and €2.2bn in 2024, according to Farmindustria	Impact on margins, cash flow and investment decisions
National access to innovative medicines	More than 14 months on average after European authorisation, according to Farmindustria	Commercial launch timing and expected domestic returns
Regional access processes	Approximately ten additional months on average, according to Farmindustria	Regional market fragmentation and commercial planning
Export dependence	Average export propensity above 90% in 2020–2024	Exposure to international demand and logistical continuity
Industrial investment	€4bn in 2024, including R&D and production	Competition for long-duration investment commitments
Corporate ownership	Italian and foreign-controlled companies both contribute substantially to the national industry	Need to distinguish territorial investment from shareholder nationality

Source: Indicatori Farmaceutici 2025 — Farmindustria — July 2025.

Chapter 1 — Key judgments

The historical evidence establishes that Italy’s pharmaceutical sector became markedly more export-oriented, experienced a contraction and subsequent recovery in employment, and increased nominal investment over the period for which a consistent sectoral series is available. The largest analytical limitation is the absence of a fully reconciled 2000–2025 national employment, investment and value-added panel within the material verified here. Accordingly, the historical transformation can be established through specific documented changes, but a comprehensive quarter-century decomposition into organic growth, technological upgrading, foreign investment and acquisition effects remains open. The decisive evidence for a stronger conclusion would be an ISTAT-consistent long-run series linked to establishment-level investment, occupational composition and domestic value added, rather than corporate headcounts considered in isolation.

Chapter 2. The Ten Corporate Groups: Employment, Acquisitions and Geographic Expansion

The ten-company comparison reveals different industrial models rather than a single national growth trajectory

Principal judgment. The ten pharmaceutical groups selected for this assessment cannot be treated as equivalent industrial units, notwithstanding their historical association with Italian pharmaceutical entrepreneurship. Their expansion has followed different routes, including the development of internally generated research and manufacturing capabilities, acquisition-led internationalisation, consolidation of existing pharmaceutical companies, therapeutic specialisation and, in certain cases, changes in financial ownership. The material distinction is between growth occurring within a substantially unchanged company, the incorporation of employees already working for acquired businesses, and the creation of new activities in Italy or foreign jurisdictions. A growth ranking that ignores these mechanisms would conflate different forms of industrial development and could attribute additional national employment to transactions that simply transferred existing workplaces from one consolidated balance sheet to another.

The evidence provides several examples of why this distinction is necessary. Menarini’s published historical series permits the calculation of its total global workforce expansion over the period, but it does not identify the relative employment contributions of acquisitions and organic hiring. Recordati provides extensive information about its international employment distribution and acquisition history, allowing more precise conclusions about the location of its operations and the structure of its expansion. Chiesi discloses significant research expenditure and an international network of research centres, permitting a closer connection between corporate scale and technological activity. Kedrion illustrates the statistical consequences of a transformative international combination in a specialised biopharmaceutical sector. Alfasigma raises an additional methodological problem because the present corporate organisation is the product of a combination of businesses that had previously operated separately.

The appropriate analytical treatment is therefore company-specific. Each corporate history must be reconstructed using its actual reporting perimeter, transaction dates, geographic distribution and technological activities. Percentage growth is meaningful only where the starting and ending observations measure compatible economic entities. Where that requirement cannot be satisfied, the correct finding is not an approximate growth percentage but a documented explanation of the corporate transformation and the specific missing evidence.

Menarini: the transition from European pharmaceutical internationalisation to global therapeutic diversification

Menarini provides one of the strongest documentary foundations for a long-term employment assessment. Its corporate presentation records 8,000 employees in 2000, 12,900 in 2010, 16,750 in 2020 and 17,800 in 2024. The net increase between 2000 and 2024 was 9,800 employees, equivalent to 122.5%. The intermediate observations show that the expansion was not concentrated exclusively in the final years: the company added 4,900 employees between 2000 and 2010, another 3,850 between 2010 and 2020, and 1,050 between 2020 and 2024. These are changes in consolidated global employment and cannot be interpreted as evidence that equivalent numbers of positions were created within Italy. Menarini Corporate Presentation — April 2025, slide 8. 08042025_ENG_Company Profile

Table 2.1 — Menarini’s documented global workforce trajectory

Reference year	Employees	Change from preceding observation	Percentage change over interval
2000	8,000	—	—
2010	12,900	+4,900	+61.25%
2020	16,750	+3,850	+29.84%
2024	17,800	+1,050	+6.27%
2000–2024	17,800	+9,800	+122.50%

Source: Menarini Corporate Presentation — April 2025, slide 8. Percentage changes are calculated from the company’s reported workforce observations. The intervals have different lengths and should not be directly compared as annual growth rates.

Menarini’s corporate history illustrates the importance of acquisitions undertaken before and after the beginning of the study period. Its acquisition of Berlin-Chemie in 1992 established a substantial organisational presence in Germany and Central and Eastern Europe before the 2000 baseline. This means that Menarini’s initial workforce already incorporated the consequences of a significant earlier international acquisition. The company’s subsequent expansion therefore began from an established multinational platform rather than a purely Italian organisation. Its acquisition of a Singapore-based pharmaceutical business in 2011 extended its reach into Asia-Pacific markets, while subsequent investments in Silicon Biosystems and CellSearch introduced technological capabilities connected with liquid biopsy and circulating tumour-cell analysis. The acquisition of US-based Stemline Therapeutics in 2020 represented another significant change, bringing specialised oncology activities into the corporate organisation. Menarini Company Profile — 2023, corporate milestones, pp. 2–4. menariniapac.com

The strategic significance of these acquisitions is not restricted to the addition of sales territories. The Asia-Pacific transaction expanded a commercial and organisational network across multiple markets, while the diagnostic and oncology transactions brought different technological and regulatory capabilities into the group. This distinction matters because an international sales subsidiary, a manufacturing facility and a business developing specialised oncology treatments contribute differently to employment, capital intensity and technological control. A company can acquire a sizeable commercial workforce without gaining a corresponding domestic research capability, while a relatively small specialised acquisition can introduce proprietary technologies with potentially significant commercial value. Menarini’s corporate history supports the conclusion that its expansion included technological diversification, but it does not permit a precise quantitative decomposition of its employment growth into commercial, manufacturing and research functions.

Its current international organisation reinforces the relevance of this distinction. Menarini’s corporate overview describes activities across approximately 140 countries, 18 production facilities and nine research and development centres, while identifying therapeutic areas including cardiology, oncology, gastroenterology, respiratory medicine and anti-infectives. These figures establish organisational breadth; they do not indicate how many of the production facilities or research employees are located in Italy. For national industrial-policy purposes, the decisive next step is to connect the company’s international footprint with the location of investment, high-value occupations, patent ownership and manufacturing mandates. Menarini — About Us, corporate disclosure. menarini-com-en

Chiesi: research-intensive expansion and a differentiated biopharmaceutical portfolio

Chiesi represents a different pattern of industrial development because its recent financial disclosures permit a more direct examination of the relationship between consolidated revenue, therapeutic specialisation and research investment. For the year ended 31 December 2025, the group reported €3.625 billion in revenue, €931 million in EBITDA, €885 million in R&D investment and 7,934 employees worldwide. The company reported revenue growth of 8.2% at constant exchange rates, while its R&D expenditure was equivalent to approximately 24.4% of reported revenue. The significance of this research intensity lies in the scale of annual financial resources committed to scientific and technological development relative to the company’s economic size. It is nevertheless a corporate-level measure and cannot be interpreted as an identical amount of research spending within Italy. Chiesi FY2025 Financial and Sustainability Results — Chiesi Farmaceutici — 23 April 2026. Chiesi Farmaceutici S.p.A.

Chiesi’s 2025 therapeutic composition provides additional evidence of its organisational transformation. The group reported approximately €1.886 billion in respiratory franchise sales, €906 million in rare-disease sales and €904 million in specialty-care sales. The year-on-year increases were respectively 3.9%, 22.3% and 13.3% at constant exchange rates. The especially rapid expansion of rare diseases is significant because it indicates that a therapeutic area outside the company’s historical respiratory foundation became a substantial contributor to its corporate growth. Chiesi attributed approximately half of the group’s 2025 growth to its rare-disease business. These data support an assessment of portfolio diversification and research-intensive activity, although the company does not provide a direct mapping from each therapeutic franchise to the number of research or production employees located in Italy. Chiesi FY2025 Financial and Sustainability Results — 23 April 2026.

Table 2.2 — Chiesi’s verified 2025 economic and technological indicators

Indicator	2025 value	Analytical significance
Consolidated revenue	€3.625bn	Global corporate economic scale
EBITDA	€931m	Reported operating profitability measure
EBITDA margin	25.7%	EBITDA relative to consolidated revenue
R&D expenditure	€885m	Corporate research commitment
R&D/revenue	Approximately 24.4%	Research intensity
Respiratory franchise sales	€1.886bn	Established therapeutic platform
Rare-disease franchise sales	€906m	Specialised therapeutic activity
Specialty-care franchise sales	€904m	Diversified therapeutic portfolio
Global employees	7,934	Consolidated workforce
Net financial position	Positive €729m	Cash exceeding financial liabilities under the company’s definition
Global R&D centres	Seven	One in Parma and six abroad

Source: Chiesi FY2025 Financial and Sustainability Results — Chiesi Farmaceutici — April 2026. The therapeutic categories reflect the company’s own reporting classification. Their published rounded values should not be assumed to reconcile exactly with the reported consolidated revenue.

The geographical distribution of Chiesi’s research infrastructure is especially relevant to its role in Italian industrial development. The group reports its principal R&D centre in Parma alongside six other research centres in France, the United States, Canada, China, the United Kingdom and Sweden. Such an organisation can allow specialist scientific teams to operate within a coordinated corporate research strategy and can strengthen access to multiple research ecosystems. At the same time, it means that group-level research intensity does not directly determine the scale of research performed domestically. Chiesi’s headquarters and historical scientific identity remain associated with Parma, but the distribution of its research expenditure, clinical development personnel and intellectual-property creation requires location-specific records. Chiesi — About Chiesi, corporate profile.

The company’s industrial presence in France provides a particularly useful example of internationally distributed productive capabilities. Chiesi’s French subsidiary reports a production facility at La Chaussée-Saint-Victor, with investments in manufacturing expansion and production of pharmaceutical inhalation products. Its corporate disclosure identifies investment exceeding €22 million in a new line and describes an earlier €60 million expansion undertaken in 2019. These are investments in a foreign jurisdiction by an Italian-headquartered company and therefore contribute to group industrial strength without qualifying as investment physically located in Italy. They demonstrate why the geographical allocation of technological expenditure is essential when assessing the national benefits of multinational expansion. Chiesi France — Our Figures, corporate disclosure. chiesi.fr

Recordati: acquisition-led expansion, geographic diversification and the separation of headquarters from employment location

Recordati offers particularly strong evidence for distinguishing Italian corporate identity from the geographical distribution of employment. Its 2025 reporting records 4,693 employees worldwide, compared with 4,583 in 2024, and provides a detailed country-level distribution. At year-end 2025, 1,160 employees were located in Italy, corresponding to approximately 24.7% of the global workforce. The remaining employees were distributed across numerous international markets, with particularly significant operations in Türkiye, France, Tunisia, Spain, Russia and the United States. Recordati Annual Report 2025 — Social Information, workforce by country. Recordati

Table 2.3 — Recordati’s principal employment locations, 2025

Country	Employees	Share of global workforce
Italy	1,160	24.7%
Türkiye	633	13.5%
France	386	8.2%
Tunisia	363	7.7%
Spain	358	7.6%
Russia	259	5.5%
United States	238	5.1%
Poland	154	3.3%
Germany	126	2.7%
Portugal	115	2.5%
Other reported countries combined	901	19.2%
Global total	4,693	100%

Source: Recordati Annual Report 2025 — Consolidated Sustainability Statement, Employee Characteristics. The residual category combines the remaining reporting locations and is calculated from the published global total.

Recordati’s corporate history illustrates how geographical diversification was progressively constructed through acquisitions rather than through a single transformative transaction. Its published milestones identify acquisitions in Portugal in 2006, Orphan Europe in 2007, businesses in Russia and Türkiye in 2008, the Czech Republic and Slovakia in 2009, Romania in 2010, further Turkish operations in 2011 and Polish operations in 2012. The company subsequently acquired pharmaceutical businesses and production assets in Tunisia and Spain in 2013, while continuing its expansion through acquisitions and subsidiaries in other markets. The acquisition of Orphan Europe was particularly significant because it established a foundation for a specialised rare-disease business, altering the company’s therapeutic orientation as well as its international organisation. Recordati — Company History and Corporate Milestones. Recordati

Later transactions extended this process. Recordati identifies the acquisition of EUSA Pharma, a specialist company focused on rare diseases and niche oncology, as a major development in its international therapeutic strategy, with the transaction completed in 2022. It also records a 2024 agreement to acquire worldwide rights to Enjaymo from Sanofi. These developments must be distinguished because the purchase of a corporate business and the acquisition of commercial or product rights do not necessarily produce the same employment consequences. The acquisition of an operating company may bring established research, commercial and administrative personnel into the consolidated perimeter, whereas a product-rights transaction can significantly change the revenue portfolio without producing a proportionate increase in employee numbers. Recordati — Corporate Milestones and Announcements. Recordati

The company consequently provides a strong example of the limitations of headcount-based industrial assessment. Its 2025 total workforce increased by 110 employees compared with 2024, yet the number located in Italy fell from 1,208 to 1,160, a decline of 48 employees. The two developments are compatible because corporate growth and domestic employment can move in opposite directions within an internationally distributed organisation. They also illustrate why a company-level employment increase cannot be represented as the net contribution of the company to Italian employment without a territorial breakdown and an examination of acquisitions, disposals and changes in the reporting perimeter. Recordati Annual Report 2025 — Employee Characteristics and Geographical Distribution.

Kedrion: the industrial logic of plasma products and the statistical consequences of corporate integration

Kedrion’s expansion demonstrates the difference between organic corporate development and acquisition-led changes in scale more clearly than most of the other groups. Its 2022 combination with Bio Products Laboratory was undertaken within an investment structure involving funds advised by Permira, the Marcucci family and a co-investor associated with Abu Dhabi Investment Authority. The transaction was completed on 31 August 2022 following regulatory and antitrust approvals. The combined organisation was described in Kedrion’s 2022 consolidated financial statements as having more than 4,000 employees worldwide at the time of integration. By 2024, Kedrion reported approximately 5,200 employees and revenue of €1.578 billion. These observations document substantial organisational scale, but the 2022 transaction prevents the post-combination workforce from being treated as the result of organic hiring by the pre-existing Italian company. Kedrion Consolidated Financial Statements 2022 — Significant Events, p. 18; Kedrion — 2024 in Review, 14 April 2025. Kedrion Biopharma+1

Kedrion’s technological structure is also materially different from that of a conventional pharmaceutical group focused principally on chemically synthesised medicines. Plasma-derived products require specialised sourcing, biological processing, fractionation, purification, quality assurance and regulated distribution. The availability and quality of plasma are therefore central production inputs rather than peripheral procurement considerations. Kedrion’s 2022 financial statements describe an organisation comprising 62 plasma-collection centres in the United States, five in the Czech Republic and seven production plants, with reported plasma-collection capacity of approximately 2.8 million litres and fractionation capacity of approximately 2.2 million litres during the relevant reporting period. These figures describe the post-combination industrial system in 2022 and must not be used as current 2025 capacity estimates without a subsequent verified disclosure. Kedrion Consolidated Financial Statements 2022 — Group Activities, p. 17. Kedrion Biopharma

This industrial configuration gives Kedrion a strategically distinctive role because production continuity depends upon the coordination of a complex biological supply chain and extended processing cycles. Its international manufacturing and collection network can improve access to raw materials and markets, but it also distributes operational dependencies across several regulatory jurisdictions. From an Italian industrial perspective, the value of the combined organisation depends on the functions performed by domestic plants, the extent to which specialised process knowledge remains available in Italy, and the location of corporate decisions regarding investment and production allocation.

The company’s 2024 financial disclosure also provides evidence of an organisation operating at substantial economic scale following the integration. Kedrion reported €1.578 billion in turnover, €232 million in reported EBITDA and €279 million in adjusted EBITDA. These values establish the group’s economic condition in that reporting year but cannot be used to infer the profitability or productivity of the pre-combination Kedrion business. The correct analytical comparator for evaluating merger performance would be a reconciled pro-forma statement of the combined businesses before integration, adjusted for transaction accounting and changes in operational perimeter. Kedrion — 2024 in Review, 14 April 2025.

Alfasigma: domestic industrial consolidation and the acquisition of international therapeutic assets

Alfasigma must be examined as a business combination rather than as a continuous single corporate entity extending unchanged from 2000 to 2025. Its present configuration emerged from the 2015 combination of Alfa Wassermann and Sigma-Tau, two companies possessing distinct histories, assets and organisational structures. A valid historical employment assessment would therefore need to reconstruct the combined 2000 workforce of both predecessors, adjust for businesses subsequently acquired or divested, and account for differences between legal-entity employment and consolidated group employment. Without such a reconciliation, a long-run growth figure for Alfasigma would describe changes in reporting perimeter as much as changes in productive employment.

The subsequent corporate history demonstrates the importance of international acquisitions in the group’s development. Alfasigma acquired US-based PamLab in 2017 and subsequently expanded its specialised pharmaceutical portfolio through the acquisition of Intercept Pharmaceuticals in 2023. The company’s acquisition of the filgotinib business from Galapagos in 2024 provided a further example of portfolio expansion through external assets. These transactions are relevant because they involved changes in product ownership, commercial reach and specialised therapeutic exposure; however, the employment contribution of each transaction must be evaluated through acquisition-date workforce disclosures rather than inferred from the growth of the consolidated company. Alfasigma — Our Heritage.

A distinction is also necessary between an acquisition that transfers industrial production capabilities and one that primarily transfers commercial rights or a therapeutic portfolio. The first may change manufacturing geography and technical employment, while the second may alter revenue composition without creating equivalent physical production capacity. Alfasigma’s expansion supports a conclusion of increasing international therapeutic diversification, but the contribution of individual transactions to domestic pharmaceutical manufacturing and research cannot be quantified from transaction descriptions alone.

Angelini Pharma: pharmaceutical operations within a diversified industrial organisation

Angelini presents a different comparability problem because the corporate parent operates beyond the pharmaceutical sector. Angelini Industries reported approximately 5,600 employees in 21 countries for 2024, but this figure includes activities in healthcare, industrial technology, consumer products and other businesses. The consolidated parent workforce therefore cannot be used as a proxy for Angelini Pharma employment, nor can its total industrial revenues be treated as pharmaceutical revenues without segment-level reconciliation. Angelini Industries — 2024 Financial Results, 25 June 2025. angeliniindustries.com

The pharmaceutical division’s activities include research, manufacturing and commercial operations, while the wider group also maintains industrial technology capabilities through separate businesses. The distinction is important because the existence of advanced automation or industrial engineering expertise elsewhere in a diversified parent group does not demonstrate that the pharmaceutical division has integrated those technologies into its own manufacturing facilities. A meaningful assessment of Angelini Pharma must therefore use pharmaceutical-specific employment, R&D expenditure, production-site investment and financial reporting. The group’s corporate material identifies pharmaceutical operations and manufacturing activities but does not provide a continuous, comparable historical headcount series beginning in 2000. Angelini Industries — Pharmaceuticals, corporate overview.

The broader industrial significance of the group lies in the interaction between pharmaceutical specialisation and diversified corporate capital allocation. A diversified parent may possess access to cash flows, technical capabilities and financing sources beyond pharmaceutical operations, potentially affecting investment capacity and risk distribution. At the same time, competition among business segments for capital can influence the amount available for pharmaceutical research and production. Neither outcome should be assumed without segment-specific financial disclosures. The analytical requirement is to distinguish what the parent owns from where the parent actually invests.

Bracco: specialised diagnostic capabilities and internationally distributed manufacturing

Bracco’s industrial profile differs from that of companies primarily organised around conventional therapeutic medicines. Its central specialisation in diagnostic imaging involves contrast agents, related technologies and the manufacturing processes required to supply regulated healthcare markets. The group reported approximately 4,000 employees in its 2024 sustainability material, although this is a rounded measure of its international organisation rather than a precise 2025 headcount. Bracco — Sustainability Disclosure, 2024 data.

Its diagnostic-imaging specialisation is strategically important because it connects pharmaceutical manufacturing with medical imaging, hospital infrastructure and highly regulated products. Bracco’s international manufacturing network demonstrates that technological expertise associated with an Italian company may be distributed across foreign plants. Its facility in Singen, Germany, has reported specific operational investments, including the introduction of electronic batch records and parametric release in 2025. These are concrete production-process capabilities and provide a stronger basis for assessing technological sophistication than employment growth alone. However, an investment at a German facility strengthens the multinational company’s industrial organisation without constituting investment physically located in Italy. Bracco — BIPSO Sterile Manufacturing Excellence.

The policy-relevant question is consequently the distribution of Bracco’s capabilities across its Italian and foreign sites, including specialised chemical and pharmaceutical production, process development, research, quality assurance and control of intellectual property. Without comparable facility-level investment and employment disclosures, the geographic contribution of its global expansion remains only partially measurable.

Zambon: pharmaceutical operations within a broader group perimeter

Zambon distinguishes between its broader group and pharmaceutical employment in its corporate recruitment information, reporting 2,776 employees worldwide at group level and 2,410 in pharmaceutical activities. These values establish an important definitional distinction, but the disclosure does not provide a sufficiently explicit year-end date to treat the figures as a verified 31 December 2025 observation. Zambon — Working at Zambon, corporate disclosure.

The group’s therapeutic development and international presence must therefore be evaluated using a clearly defined pharmaceutical perimeter. In particular, commercial subsidiaries and scientific activities should be distinguished from manufacturing employment, while research-oriented initiatives should be assessed in relation to actual scientific personnel, proprietary technologies and investment commitments. The fact that a pharmaceutical group operates across several countries establishes geographic reach; it does not independently establish the distribution of its manufacturing or research capabilities.

Italfarmaco: specialised pharmaceutical operations and the limits of public workforce comparability

Italfarmaco belongs within the assessment because its pharmaceutical activities and international organisation are relevant to the development of Italian pharmaceutical entrepreneurship. Nevertheless, the documentary material verified for this chapter does not establish a reliable pair of consolidated headcount observations for 2000 and 2025, or an equivalent clearly defined interval. It would therefore be inappropriate to assign a percentage employment increase or to treat unsourced figures from a historical graph as authenticated corporate data.

Its contribution to the national industry must instead be examined through the functions of its research, manufacturing and commercial activities, the development of specialised therapeutic products and the geographical distribution of its operations. Claims concerning the scale of individual research programmes, investment projects or acquisitions require dated corporate disclosures or regulatory filings. This evidentiary limitation affects the precision of the employment assessment, not the company’s eligibility for inclusion within the broader industrial study.

Dompé: specialised research and the difference between workforce scale and technological importance

Dompé’s corporate profile reports approximately 1,100 employees, establishing the broad current scale of the organisation but not providing a comparable 2000–2025 workforce series. Dompé — About Us, corporate profile.

Its relevance lies in the relationship between a comparatively smaller organisation and specialised pharmaceutical research. Corporate technological importance cannot be inferred solely from the number of employees because innovative pharmaceutical activities can involve relatively concentrated research teams, complex intellectual-property portfolios and externally distributed clinical or production operations. Conversely, a research-intensive corporate identity does not automatically demonstrate the ownership or commercial success of particular technologies. The proper measurement framework would include research expenditure, patents, clinical development, manufacturing arrangements and the location of scientific personnel.

Transaction classification and the geography of industrial expansion

The acquisitions and corporate combinations documented across the ten groups do not represent one homogeneous type of industrial consolidation. Some transactions brought foreign businesses under Italian corporate ownership, some combined businesses already operating in Italy, some transferred intellectual-property or product rights, and others altered the ultimate financial ownership of an Italian-headquartered organisation.

Table 2.4 — Documented transactions and structural implications

Company	Year	Transaction or development	Geographic character	Principal structural effect
Menarini	2011	Entry into Asia-Pacific through acquisition	Foreign corporate assets	International commercial and operational expansion
Menarini	2013	Silicon Biosystems	Technology acquisition	Liquid-biopsy and diagnostic capabilities
Menarini	2016	CellSearch technology	Technology acquisition	Circulating tumour-cell analysis
Menarini	2020	Stemline Therapeutics	United States	Oncology portfolio and international presence
Chiesi	2013	Zymenex	Denmark	Rare-disease capabilities
Recordati	2007	Orphan Europe	European assets	Entry into rare diseases
Recordati	2013	Opalia Pharma	Tunisia	Foreign pharmaceutical manufacturing and commercial operations
Recordati	2013	Laboratorios Casen Fleet	Spain	Foreign production and market presence
Recordati	2016	Italchimici	Italy	Domestic corporate consolidation
Recordati	2022	EUSA Pharma	United Kingdom/global	Rare-disease and niche-oncology expansion
Recordati	2024	Enjaymo rights agreement	International product rights	Portfolio expansion without automatic equivalent workforce addition
Alfasigma	2015	Alfa Wassermann–Sigma-Tau combination	Italian business combination	Creation of a changed corporate perimeter
Alfasigma	2017	PamLab	United States	Foreign business acquisition
Alfasigma	2023	Intercept Pharmaceuticals	United States	Specialised therapeutic expansion
Alfasigma	2024	Filgotinib business	International therapeutic assets	Portfolio expansion
Kedrion	2022	Combination with Bio Products Laboratory	Italy–United Kingdom	International consolidation and ownership restructuring

Sources: Menarini Corporate History; Recordati Corporate Milestones; Alfasigma Corporate Heritage; Kedrion Consolidated Financial Statements 2022; Chiesi Corporate History. Transaction descriptions indicate the documented strategic character of the acquisitions and do not assign unverified employment effects.

The main implication is that Italian pharmaceutical internationalisation has progressed through more than one investment mechanism. Greenfield facilities, acquired production plants, commercial subsidiaries and purchased technologies create different forms of economic value and different exposures to foreign jurisdictions. Acquiring a company with established research personnel can strengthen scientific capabilities immediately, but it does not demonstrate that the acquirer has created those capabilities internally. Similarly, the acquisition of an overseas production facility may improve international manufacturing resilience while leaving the amount of industrial capital located in Italy unchanged.

Employment growth, workforce relocation and the acquisition accounting problem

For the ten-group assessment, the main statistical requirement is the reconciliation of consolidated workforce changes with the composition of each company’s business. A long-run headcount series should distinguish at least four effects: employment growth in existing operations, employees incorporated through acquisitions, employees removed through divestments and changes caused by reporting definitions. The final change in headcount can then be reconciled with the initial workforce, provided the corporate disclosures are sufficiently complete.

This distinction matters particularly for international mergers. Kedrion’s combination with BPL brought together two existing organisations, while Alfasigma’s formation combined businesses with separate historical employment structures. Recordati’s international acquisitions incorporated established operating companies, and Menarini’s multinational expansion also included acquisitions of existing businesses. It follows that the aggregate employment of these groups at the end of the period cannot be interpreted as the number of jobs generated by Italian pharmaceutical entrepreneurship over the preceding quarter-century.

There is a further distinction between employment creation and employment retained. When an Italian company acquires an overseas manufacturing business, it may preserve jobs that would otherwise have been at risk, but such an outcome cannot be established without evidence concerning the acquired business’s counterfactual trajectory. Conversely, an acquisition may lead to restructuring or integration savings that reduce certain functions while strengthening others. The direction and magnitude of these effects must be measured from transaction-specific records rather than assumed from the acquisition itself.

Table 2.5 — Employment comparability and the decisive missing records

Group	Historical comparability	Main measurement obstacle	Record required for full attribution
Menarini	Long-run total series available	Organic versus acquisition growth	Historical annual reports and transaction-date employment
Chiesi	Recent endpoints available	Unconfirmed 2000 baseline	Historical consolidated accounts and annual workforce series
Angelini Pharma	Partial subsidiary disclosure	Diversified parent perimeter	Pharmaceutical-specific historical accounts
Recordati	Detailed recent geographic data	Historical acquisition effects	Annual employee series with transaction adjustments
Bracco	Rounded recent disclosure	Global versus Italian operations	Audited headcount by site and business
Alfasigma	Corporate perimeter changed in 2015	Two predecessor businesses	Reconstructed Alfa Wassermann and Sigma-Tau employment
Kedrion	Significant perimeter change in 2022	BPL combination	Constant-perimeter pre- and post-merger disclosures
Zambon	Group and pharma scopes differ	Inconsistent reporting perimeter	Historical pharmaceutical-specific accounts
Italfarmaco	Comparable series not established	Historical disclosure gap	Dated consolidated accounts
Dompé	Recent approximate scale available	Historical baseline gap	Archived corporate employment records

The reconstruction should not produce a consolidated ten-group employment total unless the definitions have been reconciled. Employees reported within acquired businesses must not be counted twice, while diversified corporate parents must be separated from their pharmaceutical subsidiaries. It is also necessary to distinguish permanent employees, temporary employees, contractors, average annual employment and year-end headcount, since these measures are not interchangeable.

Chapter 2 — Key judgments

The ten companies demonstrate substantial differences in internationalisation, technological focus, organisational structure and acquisition history. Menarini’s historical series confirms major global workforce expansion; Chiesi’s recent disclosures establish substantial research investment and therapeutic diversification; Recordati’s geographic employment data prove that most of its consolidated workforce operates outside Italy; Kedrion’s combination with BPL illustrates acquisition-driven changes in scale; and Alfasigma’s corporate formation prevents a straightforward comparison with an unchanged 2000 entity. The remaining groups require more extensive historical accounts before employment-growth rankings can be calculated. The evidence therefore supports the existence of significant international corporate expansion but does not establish a single numerical estimate of its net contribution to Italian employment or technological capacity.

Chapter 3. Ownership, Consolidation, Financial Control and the Location of Strategic Decision-Making

Italian corporate identity does not necessarily imply Italian ownership or control of strategic capital

Principal judgment. The evolution of the Italian pharmaceutical industry between 2000 and 2025 demonstrates that national corporate identity, legal headquarters, manufacturing location, shareholder control and technological sovereignty are distinct economic and institutional characteristics. Companies can retain headquarters, production facilities and substantial employment in Italy while their ultimate ownership and capital-allocation decisions are influenced by international financial investors. Conversely, family-controlled groups headquartered in Italy can own international research networks, production facilities and pharmaceutical assets whose principal scientific and economic activities occur abroad. The industrial-policy challenge is therefore to determine which capabilities remain available to the Italian economy, who controls their development, and how financing and governance arrangements affect long-term investment decisions.

The distinction is not merely legal. Pharmaceutical production requires long investment horizons, regulatory approvals, specialised physical infrastructure and highly qualified personnel. Decisions concerning acquisitions, production-network rationalisation, research investment and the commercialisation of intellectual property can affect industrial capabilities for many years. The nationality of the ultimate shareholder can influence these decisions, but it does not determine them mechanically. A foreign-controlled business may make substantial long-term investments in Italian facilities, while an Italian-controlled company may prioritise foreign research or production for commercial and operational reasons. The appropriate question is therefore not whether foreign ownership is inherently beneficial or detrimental, but how particular ownership structures interact with investment incentives, financing obligations, regulatory conditions and industrial capabilities.

Farmindustria’s 2025 statistical publication provides evidence of the importance of this distinction. Its Table 60 presents a composite indicator of pharmaceutical industry presence by nationality of corporate capital, attributing 43% to Italian capital, 23% to United States capital and 34% to capital originating in other European countries, Japan and other jurisdictions. This measure combines several dimensions, including turnover, employment composition, investment, exports and taxes. It is not a direct estimate of the percentage of pharmaceutical factories owned by Italian shareholders, the value of domestic assets under foreign control or the proportion of production attributable to each ownership category. Nevertheless, it establishes that the pharmaceutical industrial system located in Italy relies on companies with diverse national ownership structures. Indicatori Farmaceutici 2025 — Farmindustria — July 2025, Table 60, p. 51. farmindustria.it

Ownership structures and the different mechanisms of corporate control

Ownership arrangements across the selected pharmaceutical groups cannot be reduced to a uniform distinction between family companies and publicly listed corporations. The available corporate disclosures identify different structures involving family-controlled industrial groups, listed pharmaceutical businesses, private-equity investors and international institutional capital. These differences matter because ultimate shareholders exercise influence through voting rights, board appointments, financing arrangements and decisions regarding capital allocation. However, shareholding control does not mean that every operational decision is taken directly by the ultimate investor, and the precise distribution of authority must be established from corporate governance documents rather than assumed from shareholder identity.

Menarini and Chiesi illustrate the importance of historically rooted, privately organised Italian pharmaceutical entrepreneurship, whereas Recordati provides a documented example of a publicly listed company under controlling financial ownership. Kedrion represents a separate structure involving international financial investors following a major cross-border industrial combination. Angelini demonstrates the additional complexity of a diversified industrial parent group whose pharmaceutical activities compete for and receive capital within a broader business portfolio.

Table 3.1 — Ownership and corporate-control characteristics

Group	Ownership or organisational characteristic	Relevant governance question
Menarini	Privately held Italian pharmaceutical group	Allocation of retained earnings between Italian and foreign operations
Chiesi	Family-controlled, research-oriented pharmaceutical group	Long-term research financing and location of strategic scientific functions
Angelini Pharma	Pharmaceutical division within diversified Angelini Industries	Pharmaceutical investment relative to other corporate business lines
Recordati	Listed pharmaceutical company controlled through Rossini/CVC structure	Influence of controlling financial shareholders on investment and capital allocation
Bracco	Italian-rooted international diagnostics group	Distribution of manufacturing and research responsibilities across international facilities
Alfasigma	Group formed through consolidation of Italian pharmaceutical businesses	Governance of acquired therapeutic assets and international subsidiaries
Kedrion	International investor-backed structure following combination with BPL	Relationship between financial ownership, strategic integration and investment
Zambon	Italian-rooted pharmaceutical group within a broader organisational structure	Allocation of research and commercial investment
Italfarmaco	Internationally operating Italian-rooted pharmaceutical group	Location and ownership of critical therapeutic capabilities
Dompé	Italian-rooted pharmaceutical research and operating group	Relationship between proprietary research and international development

The table distinguishes organisational characteristics rather than providing a verified complete register of ultimate beneficial ownership as of a single date. A definitive ownership table would require dated company-register extracts, shareholder disclosures and governance filings for each group.

Recordati: financial control, international operations and the consequences of a listed-company ownership structure

Recordati represents one of the clearest cases in which the evolution of ownership can be analysed through public corporate filings. Its 2025 annual report identifies Rossini S.à r.l., headquartered in Luxembourg, as its immediate parent and states that the company is owned by a consortium of investment funds controlled by CVC Capital Partners. The company’s 2024 corporate governance disclosure recorded Rossini/CVC at 51.820% of its share capital as of 31 December 2024. The precise percentage must be associated with that historical reporting date and should not be silently carried forward to 2025 without consulting the corresponding year-end ownership statement. Recordati Annual Report 2025 — Related-Party Transactions and Ownership; Recordati Annual Report 2024 — Corporate Governance and Ownership Structure. annualreport.recordati.com+1

This ownership arrangement is significant because Recordati combines an Italian corporate headquarters and manufacturing presence with international financial control and a geographically diversified operating organisation. Its 2025 results reported €2.6184 billion in revenue and approximately 4,700 employees distributed across international markets. These figures describe an internationally operating pharmaceutical company whose investment decisions must take account of different markets, therapeutic franchises, manufacturing locations and financial requirements. They do not establish that the company’s Italian operations are being neglected or that financial ownership has weakened its industrial capabilities. Such conclusions would require evidence of investment changes, financing conditions, production transfers or strategic decisions attributable to ownership. Recordati Annual Report 2025 — Group Highlights. Annual Report 2025

The analytical significance of private-equity control lies in the possible interaction between capital structure and long-term investment requirements. Pharmaceutical companies may require substantial funding for acquisitions, clinical development, product launches and manufacturing expansion, while controlling shareholders also have objectives concerning capital efficiency and financial returns. These objectives can be complementary when financing supports the acquisition of technologies and expansion into new markets. They can become more difficult to reconcile when financial obligations compete with long-term investment expenditure or when business disposals alter the location and availability of critical capabilities. Neither outcome follows automatically from the identity of the shareholder.

Recordati’s financial and industrial performance should consequently be evaluated through its actual capital expenditure, research commitments, debt structure, cash generation and strategic transactions. A particular emphasis should be placed on the allocation of capital between its Italian production facilities, foreign operations and acquired therapeutic portfolios. Its international acquisitions provide access to markets and assets, but the domestic industrial contribution depends upon whether Italy retains advanced manufacturing, research, regulatory coordination and corporate decision-making functions.

The group’s international workforce also illustrates how ownership and employment geography interact without being interchangeable. At the end of 2025, Italy accounted for approximately one-quarter of Recordati’s consolidated employment, while the company maintained operations across Europe, Asia, Africa and the Americas. The Italian headquarters therefore coordinated a much larger international employment organisation than the domestic workforce alone. This can support the concentration of management, financial and strategic functions in Italy, but the available aggregate headcount does not identify the precise geographic location of those functions. A meaningful assessment requires occupational and management-level information, not merely the total number of employees by country.

Kedrion: international financial ownership and the integration of specialised industrial assets

Kedrion’s 2022 transaction provides a second documented example of how financial ownership and industrial consolidation can become closely connected. The combination with Bio Products Laboratory followed an investment arrangement involving Permira-managed funds, the Marcucci family and financial participation associated with Abu Dhabi Investment Authority. According to Kedrion’s consolidated financial statements, the transaction was completed on 31 August 2022 after regulatory and antitrust approvals. The transaction created an internationally distributed company specialising in plasma-derived medicines. Kedrion Consolidated Financial Statements 2022 — Significant Events During the Year; Permira — Partnership with Kedrion and BPL, 20 January 2022. permira.com

The industrial rationale for this combination differs from that of a transaction involving predominantly commercial pharmaceutical assets. Plasma-derived medicine production requires access to biological raw materials, specialist processing facilities, extended manufacturing cycles and highly regulated quality systems. Combining existing plasma operations can alter the geographic distribution of sourcing, manufacturing and commercial capabilities, while potentially improving coordination across the supply chain. It may also increase organisational complexity and the importance of integrating technical processes, quality systems and regulatory responsibilities. These are plausible mechanisms arising from the industrial characteristics of plasma-derived products; the degree to which the transaction realised specific efficiencies requires post-integration performance evidence.

The combination also illustrates why the national industrial significance of a transaction cannot be determined solely from the headquarters location of the merged business. Kedrion’s corporate identity and global headquarters remained associated with Italy, while its production and sourcing system included important assets in other jurisdictions. This structure can preserve an Italian centre for strategic coordination while distributing economically critical physical assets internationally. Whether it strengthens national resilience depends on the domestic capabilities retained within the integrated network, including manufacturing expertise, product development, regulatory functions and access to critical supplies.

The financing dimension requires particular scrutiny because highly specialised biological production depends on long-duration investments and a supply chain in which production cannot always be increased quickly in response to shortages. The financial capacity of a consolidated group may support investment that would be more difficult for smaller independent operators. However, the obligations and governance requirements associated with external investment can also influence the timing and prioritisation of capital expenditure. The direction of the effect must be established from actual cash-flow, investment and financial reporting, not from the general characteristics of private-equity ownership.

Family-controlled pharmaceutical groups: investment horizons, international growth and technological accumulation

The historical importance of family-controlled Italian pharmaceutical companies is frequently associated with continuity of ownership and the accumulation of scientific and industrial experience. Menarini and Chiesi provide relevant examples of internationally operating companies whose corporate identities remain linked to Italian entrepreneurial origins. The economic significance of such structures lies in their potential to support investment strategies extending beyond short-term earnings targets, particularly where privately held shareholders can retain earnings and allocate capital over long periods.

Menarini’s corporate presentation states that the group has reinvested its profits in growth since 1992. This is a first-party statement concerning corporate financial policy and must be distinguished from an independently audited historical accounting series covering every year. It nevertheless provides evidence of the company’s stated approach to financing expansion. Its subsequent acquisitions and international development demonstrate that investment was not confined to the domestic market. Menarini Company Profile — 2023, corporate milestones. menariniapac.com

Chiesi’s 2025 financial results provide a more directly quantifiable illustration of financing capacity. The company reported a positive net financial position of €729 million, defined as cash less financial liabilities including leasing, alongside R&D expenditure of €885 million and EBITDA of €931 million. The financial position improved by €194 million compared with 2024. These values indicate significant reported internal financial resources, although the net financial position is a balance-sheet measure and should not be treated as an annual cash-flow amount. Chiesi FY2025 Financial and Sustainability Results — April 2026. Chiesi Farmaceutici S.p.A.

Table 3.2 — Selected financial indicators relevant to strategic control

Group	Indicator	Verified value	Reference year	Interpretation
Chiesi	Revenue	€3.625bn	2025	Global operating scale
Chiesi	EBITDA	€931m	2025	Reported earnings before interest, taxes, depreciation and amortisation
Chiesi	R&D expenditure	€885m	2025	Research investment
Chiesi	Positive net financial position	€729m	2025	Net cash under the company’s definition
Recordati	Revenue	€2.6184bn	2025	Consolidated group revenue
Kedrion	Turnover	€1.578bn	2024	Post-combination corporate revenue
Kedrion	Reported EBITDA	€232m	2024	Reported operating earnings measure
Kedrion	Adjusted EBITDA	€279m	2024	Company-adjusted earnings measure
Angelini Industries	Net income	€156m	2024	Diversified parent, not Angelini Pharma alone

Sources: Chiesi FY2025 Results; Recordati Annual Report 2025; Kedrion 2024 Financial Review; Angelini Industries 2024 Financial Results.

The figures should not be used to rank overall corporate efficiency without reconciling accounting definitions, reporting periods, business composition and capital structure. Kedrion’s adjusted EBITDA is not directly equivalent to another company’s unadjusted EBITDA, while Angelini Industries’ net income covers activities beyond pharmaceuticals.

Family ownership does not guarantee the preservation of research or production inside Italy. The opportunity to allocate retained earnings over extended periods can support long-term investment, but the location of investment remains a commercial and strategic decision. A family-controlled company may rationally develop a research centre abroad to access specialist personnel or acquire an established foreign producer to obtain manufacturing capability. Such decisions can strengthen the parent company’s competitive position while producing different consequences for Italian employment and investment. The policy-relevant issue is therefore not ownership continuity alone, but whether continuity is accompanied by the retention or expansion of valuable domestic functions.

Financial ownership versus productive investment: the need to distinguish control, funding and industrial outcomes

The relationship between financial ownership and industrial capabilities should be assessed through observable decisions rather than assumptions about investor motivations. Financially controlled pharmaceutical companies may have access to capital for acquisitions, commercial expansion and specialised development programmes. At the same time, financing arrangements may create obligations that affect investment choices and the management of cash flows. Family-controlled companies may possess different financing capacities and ownership horizons, but they can also face constraints arising from capital concentration, succession, diversification requirements or the cost of funding major investments.

A rigorous comparison therefore requires examination of debt maturity, interest costs, operating cash flow, dividend distributions, capital expenditure, research investment and acquisition financing. It also requires identifying the legal entities that own manufacturing assets and intellectual property, since the location of a headquarters does not establish the ownership of every subsidiary’s assets. Without these records, conclusions concerning the superiority of one ownership model would be speculative.

Table 3.3 — Financial and governance indicators for industrial-policy assessment

Dimension	Required measurement	Why it matters
Ultimate control	Controlling shareholder and voting rights	Identifies governance authority
Financing structure	Gross debt, cash, maturity profile and covenants	Establishes financial flexibility and obligations
Investment allocation	Capital expenditure by country and facility	Identifies the location of productive investment
Research allocation	R&D expenditure and personnel by country	Measures domestic scientific capacity
Intellectual property	Legal owner of patents and product rights	Identifies control of technological assets
Industrial ownership	Ownership of production facilities and operating subsidiaries	Distinguishes physical capability from headquarters location
Cash generation	Operating cash flow and free cash flow	Measures internally generated financing capacity
Capital distributions	Dividends and other shareholder payments	Shows one use of corporate financial resources
Acquisition integration	Changes in workforce, assets and operating costs	Distinguishes productive expansion from consolidation
Governance continuity	Board composition and strategic decision authority	Identifies the stability of long-term industrial direction

These indicators should be assembled from audited financial statements, ownership disclosures and company-register records. Their absence does not establish a deficiency in corporate performance; it limits the conclusions that can be drawn from the public evidence.

The strategic geography of headquarters, research, production and intellectual property

A pharmaceutical company’s strategic geography consists of several overlapping networks. Its legal headquarters may be located in Italy, its research centres may operate in several countries, its production facilities may supply international markets, and its intellectual property may be held by specific companies within a multinational corporate structure. These functions can reinforce each other, but they need not be geographically concentrated.

Research location is particularly significant because the development of pharmaceutical technologies depends on specialised personnel, long-term scientific programmes and access to clinical and regulatory expertise. An Italian research centre can contribute to the national accumulation of knowledge even when the products resulting from its work are eventually manufactured abroad. Conversely, a production facility may employ highly qualified Italian personnel while manufacturing products whose intellectual property was developed and remains controlled outside Italy.

The location of manufacturing also requires careful differentiation. The production of active pharmaceutical ingredients, formulation development, sterile filling, biological processing, final packaging and distribution are distinct industrial activities with different capital requirements and technological barriers. An increase in the value of pharmaceutical production does not establish that all these activities have expanded domestically. Certain processes may carry greater strategic importance because of technical complexity, regulatory requirements or limited alternative capacity, although such importance must be assessed with reference to particular medicines and technologies.

For public policy, the most relevant question is which productive and scientific functions are difficult to replace and whether their continued operation depends on decisions, inputs or intellectual property controlled elsewhere. This can only be answered by linking company-level ownership information with facility-level industrial data.

The European dimension: national control within an integrated pharmaceutical economy

Italy’s pharmaceutical industrial structure is embedded within a European economy characterised by cross-border corporate ownership, common regulatory frameworks and extensive manufacturing and research networks. The industrial implications of this integration cannot be reduced to national competition. Foreign investment in Italy can strengthen domestic employment and technological capacity, while Italian investment in other European countries can improve the competitiveness and resilience of Italian-headquartered groups.

Germany, France and the United Kingdom are particularly relevant to the ten-group assessment because they appear in the operating geography of several companies. Menarini’s historic acquisition of Berlin-Chemie established an important German and Central European platform. Bracco’s German manufacturing operations provide evidence of specialised technological investment outside Italy. Chiesi maintains research and production activities in France and research functions in the United Kingdom, while Kedrion’s combination with BPL connected an Italian pharmaceutical organisation with substantial British biopharmaceutical capabilities. These relationships demonstrate that European industrial integration has shaped the development of Italian corporate groups through both acquisitions and the geographical distribution of research and production. Menarini Company Profile; Bracco — BIPSO; Chiesi France — Our Figures; Kedrion Consolidated Financial Statements 2022.

The resulting policy challenge is to preserve the benefits of international integration while reducing vulnerabilities arising from concentrated production, critical sourcing dependencies and insufficient domestic control over essential technologies. A policy focused exclusively on Italian ownership would risk overlooking the contribution of foreign-controlled manufacturing facilities located in Italy. A policy focused exclusively on domestic production would risk overlooking the location of scientific ownership and strategic investment decisions. The most defensible approach is to examine both dimensions together.

Conditions under which consolidation enhances or weakens industrial resilience

Further pharmaceutical consolidation can enhance industrial resilience under specific conditions. The integration of complementary manufacturing facilities may provide greater geographic flexibility, while the combination of scientific resources may support the development of products requiring substantial investment and specialist expertise. Corporate scale can also improve access to international markets and funding, potentially supporting production-network investment that smaller companies would find difficult to finance independently.

These benefits are not automatic. Consolidation can reduce the number of independent suppliers, concentrate production in fewer facilities, increase organisational complexity or create financial obligations that influence future investment. The industrial effect depends on the assets combined, their substitutability, the structure of the financing and the operational arrangements introduced after the transaction. It is also necessary to distinguish financial consolidation from physical consolidation: acquiring several companies under a common shareholder does not necessarily imply that their production facilities or research organisations have been integrated.

Table 3.4 — Consolidation pathways and industrial-policy consequences

Consolidation pathway	Potential industrial benefit	Principal vulnerability	Evidence required
Acquisition of complementary research capabilities	Broader scientific knowledge and product development	Research may remain geographically concentrated outside Italy	R&D personnel, expenditure and patent ownership
Acquisition of foreign production facilities	Geographic diversification and additional capacity	Greater complexity of cross-border operations	Site capacity, utilisation and quality records
Merger of domestic pharmaceutical manufacturers	Potential operational coordination	Reduced independent capacity or overlapping sites	Facility investment and restructuring disclosures
Acquisition of specialist therapeutic portfolios	Diversified revenue and clinical positioning	Dependence on specific products and reimbursement decisions	Product revenues, patent terms and clinical portfolios
Private-equity-backed consolidation	Access to acquisition financing and investment capital	Financing obligations and capital-allocation pressures	Audited debt, cash-flow and investment data
International biological-products integration	Coordination of sourcing and specialist production	Dependence on regulated biological inputs and long processing cycles	Collection, production and shortage records
Expansion of international commercial subsidiaries	Greater geographic market access	Commercial scale may grow without equivalent manufacturing investment	Employment by function and country

The appropriate conclusion is that consolidation should be assessed as an industrial investment process rather than as a financial transaction alone. The acquisition price, number of employees incorporated or consolidated revenue of the resulting company provides only partial information. The more consequential indicators concern which capabilities are retained, developed or discontinued, where investment occurs, and whether the combined organisation improves the reliability and technological sophistication of pharmaceutical supply.

Policy implications for Italy and the European Union

For Italy, the industrial-policy priority is to establish a reliable connection between corporate expansion and domestic capability formation. This requires more detailed information about Italian production sites, research personnel, investment projects, ownership of pharmaceutical technologies and the geographical distribution of strategic corporate functions. The objective is not to presume that all activities should remain in Italy, but to identify capabilities whose domestic presence contributes materially to economic competitiveness and security of pharmaceutical supply.

The European dimension requires an additional distinction between national and collective industrial resilience. A capability located in another EU member state may strengthen the resilience of an integrated European supply network even where it does not increase Italian domestic production. Conversely, reliance on a small number of sites or suppliers within the European Union can still create significant vulnerabilities if production cannot be substituted quickly. The relevant assessment therefore concerns the geographic distribution, technical substitutability and reliability of critical capacities, rather than their legal location alone.

A more complete corporate-control assessment should also examine whether Italian pharmaceutical groups retain the capacity to finance research and industrial investment through different economic conditions. This involves the availability of internal cash flows, access to long-term financing, manageable debt obligations and a predictable framework for pharmaceutical regulation and reimbursement. Where public support is considered, the industrial outcomes should be defined in measurable terms, including verified new capacity, sustained specialist employment, domestic research investment and improvements in supply continuity. General commitments to preserve headquarters or increase consolidated employment are less informative because they do not establish the location or economic quality of industrial activity.

Chapter 3 — Final Net Assessment

The evidence establishes that Italian pharmaceutical industrial development has been accompanied by increasingly complex relationships between historical corporate identity, financial ownership, international production and technological capabilities. Recordati’s ownership disclosures demonstrate the presence of financial control through international investment structures. Kedrion’s combination with Bio Products Laboratory shows how cross-border financial investment can accompany the creation of a larger specialised industrial organisation. Menarini and Chiesi demonstrate the continuing importance of Italian-rooted pharmaceutical groups pursuing international research, manufacturing and commercial strategies, while the remaining companies illustrate different organisational structures and therapeutic specialisations.

No single ownership model can be identified from the available evidence as consistently superior in creating Italian employment, preserving domestic manufacturing or developing advanced pharmaceutical technologies. Such a judgment would require comparable investment, employment, financial and research data across companies and over time, adjusted for acquisitions and changes in reporting perimeter.

The main strategic conclusion of Pillar I is therefore that the growth of Italian-headquartered pharmaceutical groups and the development of pharmaceutical industrial capabilities located in Italy are connected, but must be measured independently. The international expansion of the ten companies demonstrates substantial corporate transformation, while national statistics establish the growing integration of Italian pharmaceutical production into global markets. Whether this combination produces durable industrial resilience depends on the location and control of advanced research, manufacturing, intellectual property, financing and strategic decisions.

For the next phase of the assessment, the decisive question is no longer how large these companies have become, but how much technological and productive capability their expansion has created, retained or transferred across national borders.

Pillar I — Consolidated judgments

The structural baseline, company histories and ownership records support three conclusions. First, Italian pharmaceutical production became substantially more internationalised over the study period, with national employment recovering after an earlier contraction and with increasing nominal investment. Second, the expansion of the ten selected pharmaceutical groups followed materially different organisational pathways, making an unadjusted employment-growth ranking unsuitable for determining their respective contributions to Italian industrial development. Third, changes in financial ownership and the geographical distribution of research and manufacturing have increased the importance of distinguishing economic activity located in Italy from strategic capabilities controlled by Italian-headquartered organisations.

The principal outstanding records are the historical consolidated accounts needed to reconstruct comparable 2000–2025 workforce trajectories, the company-specific evidence required to separate organic growth from acquisition effects, and the geographic disclosures needed to establish the location of research, production and intellectual-property control. Until those records are reconciled, conclusions regarding the precise contribution of corporate consolidation to Italian employment or technological sovereignty must remain qualified.

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PILLAR II — TECHNOLOGICAL AND OPERATIONAL CAPABILITIES

Chapter 4. Therapeutic Specialisation, Research Investment and Intellectual Property

The emergence of specialised pharmaceutical capabilities as the decisive measure of industrial transformation

Principal judgment. The most important technological development among the ten Italian pharmaceutical groups between 2000 and 2025 was the diversification of their scientific and therapeutic capabilities beyond established portfolios of conventional medicines towards more specialised areas, including rare diseases, targeted oncology, biological treatments, plasma-derived products, advanced respiratory therapies and diagnostic technologies. The evidence does not support the proposition that all ten companies followed the same trajectory, nor does it establish that corporate expansion generated equivalent increases in scientific capabilities located in Italy. It demonstrates, however, that several groups acquired, developed or commercialised technologies requiring specialised research, regulatory expertise and manufacturing processes whose industrial value cannot be adequately measured through employment or consolidated revenue alone.

This change requires a distinction between three economically different forms of pharmaceutical innovation. The first concerns internally developed scientific knowledge that progresses through laboratory research, clinical development and regulatory authorisation. The second involves externally acquired technologies, companies or product rights that enable an existing pharmaceutical organisation to enter new therapeutic markets or accelerate the development of specialised portfolios. The third concerns the continuous improvement of established medicines through formulation development, production technologies, delivery systems, additional indications and regulatory lifecycle management. Each can contribute to corporate value, but their implications for national technological capabilities are different. An internally developed medicine can demonstrate the existence of scientific competence within the organisation, while an acquired medicine demonstrates the ability to identify, finance and commercialise an external asset. Neither automatically establishes where the underlying intellectual property was created or where subsequent manufacturing will occur.

The distinction is central to pharmaceutical industrial policy because the highest-value functions in modern medicine development are not always located in the largest manufacturing facilities or in the countries recording the greatest pharmaceutical export volumes. Scientific discovery, clinical trial design, patent management, regulatory approval, manufacturing process development and commercial exploitation may occur in different jurisdictions. Moreover, research intensity must be evaluated in conjunction with the quality and maturity of development programmes. A company reporting substantial R&D expenditure has demonstrated financial commitment to innovation, but expenditure alone does not establish successful drug development, ownership of globally defensible intellectual property or the economic value of its research portfolio. Regulatory authorisations provide stronger evidence that specific products have completed defined development and assessment processes, although approval does not establish comparative commercial success or guarantee long-term profitability.

Chiesi: the relationship between research expenditure, therapeutic diversification and technology platforms

Chiesi provides particularly detailed evidence of research-intensive international pharmaceutical development. Its results for the year ended 31 December 2025 record R&D expenditure of €885 million, equivalent to 24.4% of consolidated revenue, alongside a diversified portfolio comprising respiratory medicines, rare diseases and specialty care. Unlike an employment-based comparison, this figure directly measures the financial scale of research activity within the corporate reporting perimeter. The company also identifies research centres in Parma, France, the United States, Canada, China, the United Kingdom and Sweden, confirming that its scientific organisation operates across multiple jurisdictions. These disclosures support the conclusion that Chiesi has developed a substantial international research infrastructure, while leaving open the precise national allocation of R&D expenditure and the proportion of scientific intellectual property originating from Italian laboratories. Chiesi FY2025 Financial and Sustainability Results — Chiesi Farmaceutici — 23 April 2026. Chiesi Farmaceutici S.p.A.

The technological significance of Chiesi’s therapeutic diversification is illustrated by developments reported during 2025 in rare diseases and advanced therapeutic platforms. The company disclosed partnerships with Key2Brain to develop recombinant enzyme-replacement therapies intended to cross the blood–brain barrier, Arbor Biotechnologies for a clinical-stage gene-editing programme and access to broader technological capabilities, and Aliada Therapeutics for technology intended to improve delivery across the blood–brain barrier. These projects address different scientific obstacles. Recombinant enzyme replacement aims to compensate for deficient biological function, while gene editing seeks to intervene at the level of genetic mechanisms. Technologies intended to cross the blood–brain barrier address the difficulty of delivering treatments to the central nervous system, a constraint that can limit the effectiveness of otherwise biologically active medicines. The existence of these partnerships demonstrates a strategic interest in advanced therapeutic technologies, but does not establish that their candidate medicines have completed clinical development or obtained marketing authorisation. Chiesi FY2025 Results — Research and Development Partnerships.

A particularly important question is how such partnerships translate into durable technological capabilities. Contractual access to a scientific platform can provide significant development opportunities without transferring complete ownership of the underlying intellectual property. A collaboration may grant rights to develop medicines for defined indications, geographic markets or technological applications while the originating company retains broader ownership of the technology. For the purposes of national industrial policy, the decisive information concerns the allocation of research personnel, patent ownership, licensing rights, manufacturing responsibilities and future commercial revenues. The public announcement of a partnership establishes the existence of the contractual relationship and its stated technological objectives, but it does not necessarily disclose the financial terms or ultimate control over the technology.

Chiesi’s established respiratory portfolio also demonstrates that innovation may occur within product-delivery systems as well as through entirely new therapeutic molecules. The company has reported development of pressurised metered-dose inhalers using propellants with lower global-warming potential, an undertaking that combines formulation chemistry, engineering, device performance, regulatory validation and environmental considerations. These technologies are significant because an inhalation product is not merely an active pharmaceutical ingredient packaged inside a device. The interaction between formulation, propellant, valve, container, aerosol characteristics and patient administration must be controlled to deliver the intended medicine consistently. Changes in propellant chemistry can therefore require extensive product-development work and regulatory assessment even where the therapeutic substance remains established. Chiesi’s 2025 results identify continued development of these inhaler technologies, while its French corporate disclosures describe manufacturing investment associated with respiratory medicines. Chiesi FY2025 Financial and Sustainability Results; Chiesi France — Corporate and Industrial Figures.

Table 4.1 — Chiesi’s documented research and technology indicators, 2025

Indicator	Verified figure or status	Industrial interpretation	Evidentiary limitation
R&D expenditure	€885 million	Substantial financial commitment to research	Global expenditure; not disaggregated by country
R&D intensity	24.4% of revenue	High company-reported research expenditure relative to sales	Not directly comparable with peers using different R&D accounting
R&D centres	Seven globally	International scientific infrastructure	Site-level expenditure and personnel not fully disclosed
Respiratory portfolio	€1.886 billion in franchise sales	Commercial foundation supporting respiratory technologies	Sales do not separately measure proprietary innovation
Rare-disease portfolio	€906 million in franchise sales	Material specialised therapeutic business	Revenue does not identify origin of every acquired or licensed asset
Specialty-care portfolio	€904 million in franchise sales	Therapeutic diversification	Commercial scope differs from research allocation
Key2Brain partnership	Announced during 2025	Recombinant enzyme replacement and blood–brain barrier delivery	Development outcomes remain subject to clinical validation
Arbor Biotechnologies partnership	Announced during 2025	Gene-editing research capabilities	Platform access does not imply complete patent ownership
Aliada Therapeutics partnership	Announced during 2025	Drug-delivery technology for lysosomal storage disorders	Clinical and commercial outcomes not established
Lower-GWP inhaler development	Ongoing in 2025	Formulation and device-engineering innovation	Future product and manufacturing outcomes require separate verification

Source: Chiesi Reports Strong FY2025 Financial and Sustainability Results — Chiesi Farmaceutici — April 2026.

The financial data and scientific partnerships support an assessment of genuine research-oriented development rather than growth restricted to commercial distribution. Nevertheless, they also demonstrate why research intensity and technological sovereignty must remain distinct measures. The former can be quantified from company financial reporting, whereas the latter requires examination of the actual rights held over technologies, the jurisdiction of their ownership, the location of research personnel and the company’s ability to manufacture or license the resulting medicines without dependence on external intellectual-property holders.

Italfarmaco: an independently documented transition from research to authorised advanced therapeutics

Italfarmaco provides one of the strongest individual examples of pharmaceutical technological development among the ten selected companies because a specific therapeutic product can be traced through official regulatory assessment to marketing authorisation. On 21 March 2024, the United States Food and Drug Administration approved Duvyzat (givinostat) for the treatment of Duchenne muscular dystrophy in patients aged six years and older. Givinostat is a histone deacetylase inhibitor, and the FDA identified it as the first nonsteroidal medicine approved for patients with all genetic variants of Duchenne muscular dystrophy within the authorised indication. This regulatory event establishes that a pharmaceutical development programme associated with Italfarmaco resulted in an authorised therapeutic product, providing substantially stronger evidence of technological capability than employee numbers or general corporate statements about innovation. FDA Approves Nonsteroidal Treatment for Duchenne Muscular Dystrophy — US Food and Drug Administration — 21 March 2024. FDA

The regulatory record provides additional quantitative evidence concerning clinical development. The FDA reports that its approval was based on a randomised, placebo-controlled clinical trial involving 179 male patients, aged six years or older, conducted at 45 sites in 11 countries across North America and Europe. The clinical-development geography is significant because even a pharmaceutical programme sponsored by an Italian company can depend on an international research and clinical network. The ability to organise multicountry trials, produce evidence meeting regulatory requirements and secure marketing authorisation constitutes an identifiable organisational capability. It does not establish that all clinical research, manufacturing or intellectual-property development occurred in Italy, nor does it permit an estimate of the programme’s total development expenditure. Drug Trials Snapshot: Duvyzat — US Food and Drug Administration — 2024. FDA

The subsequent European regulatory process further demonstrates the international commercial and regulatory significance of the programme. The European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion on 25 April 2025, followed by a conditional European Union marketing authorisation on 6 June 2025. The authorised European indication concerns ambulant patients aged six years or older receiving concomitant corticosteroid treatment. The distinction between US and EU indications is material: regulatory approval in two jurisdictions should not be described as an identical authorisation where patient eligibility and treatment conditions differ. Furthermore, conditional authorisation reflects a regulatory determination that the benefits of earlier availability justify approval under specified conditions, including further evidence requirements. It is not equivalent to a conventional authorisation supported by a fully completed evidence package. Duvyzat — European Public Assessment Report — European Medicines Agency — 2025. European Medicines Agency (EMA)

Table 4.2 — Italfarmaco’s givinostat regulatory and research milestones

Dimension	Verified information	Source	Strategic implication
Active substance	Givinostat	FDA and EMA	Identifiable pharmaceutical technology
Therapeutic indication	Duchenne muscular dystrophy	FDA and EMA	Specialised rare-disease market
Mechanism	Histone deacetylase inhibition	FDA and EMA	Targeted biochemical mode of action
US authorisation	21 March 2024	FDA	Completed US regulatory approval
US authorised age	Six years and older	FDA	Defined patient population
Pivotal trial participants	179	FDA	Documented clinical evidence base
Pivotal trial sites	45	FDA	International clinical operations
Countries involved	11	FDA	Multinational clinical-development network
EMA positive opinion	25 April 2025	EMA	European regulatory assessment milestone
EU authorisation	6 June 2025	EMA	Conditional marketing authorisation
EU indication	Ambulatory patients aged six years and older receiving corticosteroids	EMA	Distinct European treatment conditions
Marketing authorisation holder	Italfarmaco S.p.A.	EMA	Documented regulatory and commercial responsibility

Sources: FDA — Duvyzat Approval; FDA — Duvyzat Clinical Trial Snapshot; EMA — Duvyzat EPAR.

The resulting industrial conclusion is precise. Italfarmaco has demonstrated the capability to bring an advanced therapeutic product through major international regulatory processes. This represents verifiable technological achievement independently of the company’s total employment. However, the regulatory dossier does not by itself disclose the full geographical distribution of discovery research, manufacturing capacity, development expenditure or patent ownership. These additional dimensions are necessary before attributing all the associated technological value to the Italian industrial territory.

Dompé: recombinant human nerve growth factor and the industrial value of proprietary biological medicines

Dompé offers another documented example in which a specific pharmaceutical technology can be assessed through independent regulatory evidence rather than general claims about research orientation. The European Medicines Agency authorised Oxervate (cenegermin) on 6 July 2017 for the treatment of moderate or severe neurotrophic keratitis in adults. The medicine contains recombinant human nerve growth factor, a biologically produced form of a human protein involved in tissue maintenance and repair. The European regulatory record identifies Dompé Farmaceutici S.p.A. as the marketing authorisation holder and records an accelerated assessment, thereby establishing the company’s direct relationship to an authorised specialised biological medicine. Oxervate — European Public Assessment Report — European Medicines Agency — 2017. European Medicines Agency (EMA)

The industrial significance of this product differs from that of a conventional chemically synthesised medicine. Recombinant proteins require biological production systems, analytical characterisation and specific quality-control processes directed at attributes that cannot be assessed solely through the chemical identification of a small molecule. Product development must establish the relationship between the manufacturing process, biological activity, stability and clinical performance. These requirements can create significant technical barriers to entry, particularly where the product addresses a rare condition and the available clinical population is limited.

The EMA record also allows a clear distinction between scientific originality, regulatory approval and national technological ownership. The authorisation confirms that the medicine met the applicable regulatory standards for its approved use. It does not establish that every aspect of the technology originated within Dompé’s own laboratories or that all manufacturing steps occur in Italy. A comprehensive industrial assessment would therefore trace the product’s patent families, development collaborations, manufacturing authorisations and the location of critical production stages.

The scientific importance of cenegermin also illustrates why small and medium-sized specialist companies may contribute disproportionately to advanced therapeutic development relative to their total employment. An organisation engaged in a technically difficult biological therapy may accumulate expertise in protein characterisation, formulation, clinical development and regulatory submissions without requiring the employment scale of a diversified multinational group. This conclusion follows from the nature of the technology and the documented regulatory outcome, not from an unverified numerical estimate of Dompé’s research productivity.

Menarini, Recordati and Alfasigma: distinguishing acquired therapeutic portfolios from internally created technologies

The expansion of Menarini, Recordati and Alfasigma into specialised therapeutic markets demonstrates a different pathway to pharmaceutical sophistication. Rather than relying exclusively on internally generated research programmes, these groups have also acquired companies, licensed technologies and incorporated established pharmaceutical assets. This can be an effective means of accelerating access to advanced therapeutic markets, but it requires a different interpretation from the development of a new medicine within the acquirer’s pre-existing research organisation.

Menarini’s acquisition of Stemline Therapeutics expanded its position in oncology, while its earlier investments in Silicon Biosystems and circulating tumour-cell technologies established a connection with diagnostic tools supporting oncology research and clinical applications. The significance of such assets lies partly in their capacity to generate specialised information about disease and treatment response. Diagnostic technologies and therapeutic oncology programmes may complement one another commercially and scientifically, but their presence under a common corporate parent does not prove that they have been integrated into a single technological platform. Menarini Corporate Profile — Menarini Group.

Recordati’s acquisition of rare-disease businesses and therapeutic rights demonstrates the development of a specialist commercial and regulatory portfolio. Its 2025 reporting describes activity in rare diseases alongside specialty and primary care, including treatment access for approximately 20,000 patients with rare diseases, according to company disclosures. The measurement is relevant to the scope of its rare-disease operations, but it should not be treated as a standardised outcome measure across companies because definitions of patients treated, geographic coverage and product portfolios differ. Recordati Annual Report 2025 — Patient Care and Corporate Results. Annual Report 2025

Alfasigma’s acquisition of Intercept Pharmaceuticals brought specialised therapeutic assets into its organisation, while its subsequent acquisition of the filgotinib business expanded its therapeutic portfolio through external development and commercial rights. Such transactions can require sophisticated pharmacovigilance, medical affairs, regulatory compliance and market-access capabilities, even where the intellectual property or clinical programme was originally developed by another organisation. The technological contribution of an acquisition should therefore be assessed in terms of what knowledge and control were transferred, which activities were subsequently developed internally and whether the transaction generated additional research or production capabilities in Italy. Alfasigma — Corporate History and Heritage.

Table 4.3 — Selected technological evidence across the ten groups

Group	Documented therapeutic or technological domain	Strongest evidence identified	What remains unproven
Menarini	Oncology and advanced diagnostics	Corporate acquisitions and technology portfolio	Share of internally developed patents and Italian-located R&D
Chiesi	Respiratory, rare diseases, specialty care and advanced therapeutic partnerships	€885m R&D expenditure in 2025; documented research agreements	Domestic share of R&D and ultimate rights over every platform
Angelini Pharma	Pharmaceutical and specialised therapeutic operations	Corporate pharmaceutical portfolio and production disclosures	Comparable research intensity and technology ownership
Recordati	Rare diseases and specialist pharmaceutical products	Regulatory and corporate portfolio disclosures	Share of proprietary versus acquired innovation
Bracco	Diagnostic imaging and contrast media	International diagnostic product and manufacturing activities	Comparable patent and Italian research expenditure measures
Alfasigma	Specialised therapeutic portfolios	Acquired pharmaceutical assets and commercial rights	Internally generated R&D contribution after acquisitions
Kedrion	Plasma-derived biological medicines	Fractionation and manufacturing disclosures	Patent value and location of all specialised process development
Zambon	Pharmaceutical research and therapeutic specialisation	Corporate pharmaceutical activities	Comparable clinical and research expenditure data
Italfarmaco	Duchenne muscular dystrophy	FDA 2024 and EMA 2025 approvals for givinostat	Complete geographic allocation of development and manufacturing
Dompé	Recombinant biological treatment of neurotrophic keratitis	EMA authorisation of cenegermin in 2017	Full mapping of patents and manufacturing stages

The evidence supports a differentiated assessment rather than a ranking of technological quality. Regulatory authorisations, corporate research expenditure, acquisition announcements and manufacturing disclosures measure distinct aspects of the innovation process; they cannot be combined into a numerical innovation score without a defensible methodology.

Intellectual property as the missing bridge between research activity and national value creation

Patent activity is relevant to pharmaceutical industrial strategy because it can protect inventions, support licensing, influence investment returns and shape the ability of competing companies to develop similar technologies. However, a pharmaceutical innovation portfolio includes more than patents. Regulatory dossiers, manufacturing know-how, trade secrets, proprietary analytical methods, clinical evidence, commercial rights and data-protection provisions may all contribute to the economic position of a medicine or technology.

For this reason, a simple count of patents attributed to Italian pharmaceutical companies would be insufficient to evaluate technological sovereignty. A company may own many patents covering secondary formulations or incremental technologies while possessing relatively few inventions supporting new therapeutic mechanisms. Conversely, a research programme with a smaller number of commercially valuable patent families may represent a significant technological asset. Moreover, patent applications may be filed through foreign subsidiaries or specialised holding companies, making the location of the legal applicant different from the location of the inventors and research activity.

A defensible patent analysis of the ten groups would therefore require examination of patent families rather than individual national filings, identification of both applicants and inventors, classification by technological field, analysis of filing and priority dates, and attention to whether rights remain active. The European Patent Office’s Espacenet patent-search service — European Patent Office and the EPO’s PATSTAT patent-statistics database provide appropriate documentary foundations for such an exercise. Neither source supports a numerical comparison until a consistent search and entity-reconciliation procedure has been conducted.

Table 4.4 — Intellectual-property assessment requirements

Indicator	Required evidence	Analytical purpose	Principal comparability risk
Patent families	Priority-linked filings across jurisdictions	Avoid double-counting national applications	Incomplete family consolidation
Applicant ownership	Legal patent applicant and assignee	Identify corporate control of rights	Subsidiaries and holding companies
Inventor location	Addresses associated with inventors	Approximate geography of inventive activity	International research teams and address changes
Technological field	Patent classifications and technical claims	Identify therapeutic and manufacturing specialisation	Broad or overlapping classifications
Legal status	Grant, expiry, opposition and maintenance records	Assess enforceable rights	Differences among jurisdictions
Patent citations	Forward and backward patent references	Support analysis of technological relevance	Citation practices vary across fields
Clinical-development linkage	Clinical and regulatory records	Connect patents to identifiable medicines	Many patents do not result in authorised products
Licensing	Public contractual rights and disclosures	Distinguish ownership from access	Confidential commercial terms
Manufacturing know-how	Process records and site documentation	Assess technological capabilities beyond patents	Information often confidential

The policy significance is that Italy’s long-term pharmaceutical competitiveness cannot be assessed solely through national manufacturing output or corporate expenditure. It must also be evaluated through the ownership, creation and retention of knowledge-intensive assets that enable companies to develop medicines, control production processes and capture returns from innovation.

Chapter 4 — Key judgments

The available regulatory and corporate evidence establishes several distinct forms of technological upgrading among Italian pharmaceutical groups. Chiesi demonstrates substantial reported research expenditure and documented development partnerships in advanced therapeutic technologies. Italfarmaco and Dompé provide specific examples of authorised medicines that allow technological achievement to be verified through independent regulatory decisions. Menarini, Recordati and Alfasigma illustrate the contribution of acquisitions and portfolio diversification, while Kedrion and Bracco operate in technologically specialised areas where manufacturing knowledge and regulated production processes are particularly significant. What remains unresolved is the precise allocation of scientific investment, patent ownership and research personnel between Italy and foreign operations. The industrial-policy priority is therefore not a general increase in measured innovation expenditure, but a clearer understanding of which specialised capabilities are created, controlled and sustained within the Italian and European industrial systems.

Chapter 5. Advanced Manufacturing, Biotechnology, Plasma Products and Diagnostics

Pharmaceutical manufacturing capability is determined by process control, technological reproducibility and the ability to sustain regulated production

Principal judgment. The technological value of the Italian pharmaceutical industry cannot be assessed from the number of manufacturing facilities or the financial value of production alone. Pharmaceutical manufacturing encompasses industrial processes with substantially different requirements for biological inputs, chemical synthesis, sterile processing, environmental control, product characterisation, process validation and regulatory oversight. The relevant measure of industrial capability is therefore the ability to manufacture specified products reproducibly, at an authorised quality standard, with sufficient productive capacity and control of critical inputs to maintain supply under changing commercial and operational conditions.

The distinction is particularly important for the ten companies considered in this study because their production systems are not technologically homogeneous. Manufacturing a conventional solid-dose medicine involves different physical processes from fractionating human plasma, producing a recombinant biological protein, preparing an injectable diagnostic contrast agent or manufacturing an inhaled therapy that depends on the interaction between formulation and delivery device. These activities share a common requirement for regulated quality assurance, but they differ in manufacturing equipment, supply-chain structure, process knowledge and the practical ability to transfer production between facilities.

The European regulatory framework reflects these technological differences. The European Commission’s EudraLex Volume 4 contains the European Union’s Good Manufacturing Practice guidelines, including provisions specifically addressing sterile products, biological medicines, medicines derived from human blood or plasma, computerised systems, qualification and validation, batch certification, and real-time or parametric release. Annex 1, governing sterile medicinal products, has been fully applicable since 25 August 2024, while the framework also contains separate provisions for biological manufacturing and advanced therapy medicinal products. These requirements provide the institutional baseline for understanding why manufacturing capability cannot be expanded or relocated simply by transferring machinery or increasing the number of employees. EudraLex Volume 4 — Good Manufacturing Practice Guidelines — European Commission. European Commission

The relevance for industrial policy is that a production facility combines tangible assets with accumulated organisational knowledge. The physical plant, production lines and analytical equipment are indispensable, but so are validated manufacturing processes, quality-control systems, trained personnel, regulatory approvals, qualified suppliers and reliable documentation. A facility may possess nominal manufacturing capacity without being able to produce a particular medicine until the relevant processes have been validated and approved. Similarly, an industrial group may own several plants without being able to substitute production freely among them, because different facilities can be authorised for different products, processes and markets.

Kedrion: a documented international plasma-production system with critical Italian manufacturing functions

Kedrion provides unusually detailed evidence of manufacturing specialisation and productive geography. Its 2024 Sustainability Report describes an integrated international organisation comprising 67 plasma-collection centres in the United States, eight in the Czech Republic and seven production plants, with a reported fractionation capacity of approximately 3.3 million litres and plasma-collection capacity of approximately 2.6 million litres. The company also reports procurement arrangements providing an additional approximately 0.75 million litres of purchased plasma. These quantities describe different functions: collection capacity concerns the acquisition of raw plasma, while fractionation capacity concerns the potential processing of plasma into therapeutic products. Neither should be presented as the amount of finished medicine produced, and their relationship cannot be reduced to a utilisation rate without compatible information about actual throughput, product mix, inventories and contracted supplies. Kedrion Sustainability Report 2024 — Kedrion Biopharma — July 2025, p. 9. Kedrion Biopharma

The report also identifies specific manufacturing responsibilities across Kedrion’s international network. Bolognana, in the province of Lucca, is described by the company as the only Italian facility within its network capable of producing the full range of blood-derived products. Sant’Antimo, near Naples, specialises in specific immunoglobulins and virus-inactivated plasma. The Hungarian facility at Gödöllő produces products and intermediate materials, some of which are transferred to Bolognana for subsequent processing. The Melville facility in the United States performs plasma fractionation primarily for the American market, while the British facility at Elstree, integrated following the 2022 combination with Bio Products Laboratory, is described as the largest production plant in the group by fractionation capacity. The Canadian facility at Laval is associated with Ryplazim, a treatment for congenital plasminogen deficiency. Kedrion Sustainability Report 2024 — Kedrion Biopharma — p. 9.

This distribution of manufacturing responsibilities has substantial industrial implications. It demonstrates that Kedrion’s production system is not simply a collection of geographically separated factories making interchangeable products. Certain facilities perform intermediate processing, others are specialised in final production or particular therapeutic proteins, and the manufacturing system therefore depends on the controlled movement of materials between sites. The relationship between Gödöllő and Bolognana is especially relevant because it shows that the Italian manufacturing operation forms part of an international processing chain. The Italian plant contributes specialised finishing and production capabilities, but its operation also depends upon upstream materials and processes that may be located outside Italy.

The industrial value of Bolognana cannot consequently be assessed exclusively from its annual output or employment. Its strategic role also depends on the products it is authorised to manufacture, its position within the international processing sequence, the substitutability of its specialised operations and its capacity to absorb changes in the supply of intermediate materials. Where a facility performs a technically complex and difficult-to-replace processing function, its strategic importance may exceed what would be suggested by headcount or accounting value alone.

Table 5.1 — Kedrion’s reported plasma-production infrastructure, 2024

Facility or capability	Location	Documented function	Industrial significance
Plasma-collection network	United States	67 collection centres	Biological raw-material sourcing
Plasma-collection network	Czech Republic	Eight collection centres	European sourcing diversification
Global production network	Multiple countries	Seven production plants	Integrated international processing
Global fractionation capacity	Group-wide	Approximately 3.3 million litres	Nominal plasma-processing capability
Global collection capacity	Group-wide	Approximately 2.6 million litres	Raw-plasma collection capability
Additional procured plasma	Group-wide	Approximately 0.75 million litres	Contractual raw-material sourcing
Bolognana	Lucca, Italy	Broad blood-derived-product production	Specialised domestic manufacturing capability
Sant’Antimo	Naples, Italy	Specific immunoglobulins and virus-inactivated plasma	Specialised biological production
Gödöllő	Hungary	Intermediates and finished products	Cross-border manufacturing integration
Melville	United States	Plasma fractionation	Production for the American market
Laval	Canada	Ryplazim production	Specialised plasma-protein therapy
Elstree	United Kingdom	Fractionation, purification and packaging	Major integrated production facility

Source: Kedrion Sustainability Report 2024 — Kedrion Biopharma — July 2025, pp. 8–9. Capacity values describe the corporate reporting period and are not actual annual output measurements.

The distinction between plasma collection and plasma fractionation also affects national resilience. A country may possess sophisticated fractionation facilities without controlling an equivalent domestic supply of source plasma. Alternatively, a healthcare system may collect substantial plasma while depending on external processing facilities. In either case, the security of supply depends on the reliability of the complete chain rather than the domestic presence of one industrial stage.

The manufacturing process adds another layer of complexity. Plasma contains multiple therapeutic proteins with different clinical applications, and industrial processing must separate, purify, characterise and formulate these components while controlling biological safety. Consequently, a single unit of collected plasma can contribute to several different therapeutic products, subject to processing yields and the characteristics of the manufacturing system. This relationship means that fractionation capacity alone is not a sufficient predictor of the supply of any particular medicine. An increase in demand for one immunoglobulin or coagulation product may not translate proportionately into the required additional output without changes in process allocation, available plasma or purification capacity.

The European regulatory framework explicitly recognises these specialised requirements through Annex 14 of EudraLex Volume 4, which addresses the manufacture of medicines derived from human blood or plasma. For public policy, the implication is that investment in new plasma-processing capacity must be assessed alongside access to biological raw materials, qualified production systems, testing capabilities and the ability to maintain continuous supply. EudraLex Volume 4 — Annex 14: Manufacture of Products Derived from Human Blood or Human Plasma — European Commission.

Bracco: contrast-media manufacturing, sterile production and the technological significance of diagnostic pharmaceuticals

Bracco illustrates a different form of pharmaceutical manufacturing specialisation associated with diagnostic imaging. Contrast agents used in radiological procedures are pharmaceutical products whose manufacturing requirements include chemical or formulation control, pharmaceutical purity, sterility where applicable, and compliance with authorised product specifications. The economic value of these products depends not only on the active substance but also on the reliability of supply, formulation consistency, manufacturing validation and compatibility with clinical imaging practices.

The group’s German subsidiary BIPSO provides a detailed example of industrial modernisation over the study period. According to Bracco’s published operational history, the Singen operation began production of the X-ray contrast medium Isovue and the magnetic-resonance contrast medium ProHance for the American market in 2000. Production of MultiHance for the US market began in 2003. The company subsequently undertook manufacturing and packaging modernisation, including an investment of approximately €16 million in 2014. Warehouse and logistics activities were brought in-house in 2021, while production of Vueway began in 2024. In 2025, Bracco reported the introduction of electronic batch records and parametric release as part of the facility’s digitalisation and quality initiatives. BIPSO GmbH — Sterile Manufacturing Excellence — Bracco. Bracco

The sequence demonstrates why technological upgrading should be evaluated as a cumulative process. Product introductions require the establishment of authorised manufacturing processes, while plant modernisation can change the equipment and operational environment supporting them. Bringing warehouse activities under direct organisational control can alter the management of materials and information, while electronic batch records change how production events are documented, reviewed and made available for quality assurance. Parametric release, where permitted under the applicable regulatory requirements, relies on evidence derived from validated process parameters rather than treating every release decision as dependent exclusively on conventional end-product testing. It therefore requires robust process validation and reliable manufacturing data.

Bracco’s disclosure provides evidence that these capabilities were introduced at the German facility, not that identical systems were implemented across every plant in the group. It also does not establish the quantitative effect on batch-release time, production cost or operating efficiency. Those outcomes would need to be demonstrated through company-specific before-and-after performance records.

Table 5.2 — Bracco Singen: documented manufacturing developments

Year	Documented development	Capability concerned	Evidentiary significance
2000	Production of Isovue and ProHance for the US market	Contrast-media manufacturing	Established regulated international production
2003	MultiHance production for the US market	Diagnostic product manufacturing	Additional authorised product activity
2011	Establishment of BIPSO GmbH	Corporate and operating structure	Defined industrial operating entity
2014	Approximately €16m modernisation investment	Manufacturing and packaging	Documented capital investment
2021	Warehouse and logistics insourcing	Material and operational control	Changed logistics operating model
2024	Vueway production begins	Product manufacturing	Additional contrast-media production
2024	Manufacturing-capacity expansion approved	Future production capacity	Investment decision, not independently verified completed capacity
2025	Electronic batch records introduced	Digital production documentation	Documented digital manufacturing capability
2025	Parametric release introduced	Validated process and release control	Documented quality-system development

Source: BIPSO GmbH — Sterile Manufacturing Excellence — Bracco.

The industrial significance extends beyond Bracco’s corporate performance. The example demonstrates the technical requirements associated with maintaining an internationally competitive sterile-pharmaceutical manufacturing facility. Industrial competitiveness involves the integration of production, regulatory compliance, specialised equipment, warehousing and digital information systems. A country seeking to retain such facilities must therefore evaluate the entire operating environment, including engineering expertise, utilities, quality personnel, logistics reliability and the time required to obtain and maintain manufacturing authorisations.

Advanced respiratory manufacturing: formulation, device performance and environmental technology

Chiesi’s respiratory business provides an example of how manufacturing complexity can arise from the interaction between a medicine and its delivery device. Inhaled pharmaceuticals require control over particle characteristics, formulation stability, dose delivery and performance under defined operating conditions. Different delivery technologies create different technical requirements, while changes to propellant chemistry or device design can affect manufacturing validation and product approval.

The company’s French operations demonstrate that industrial development in this field involves specialised plant investment. Chiesi France reports that its facility at La Chaussée-Saint-Victor has received substantial investment in new production capacity and controlled manufacturing environments. The company identifies a production-line investment exceeding €22 million, associated with approximately 8,200 square metres of industrial area, including approximately 600 square metres of controlled-atmosphere space. It also describes a €60 million investment in a second extension initiated in 2019, enabling additional powder-inhaler production. These figures are company disclosures regarding specific industrial projects and should not be treated as a comprehensive account of Chiesi’s global manufacturing capital expenditure. Chiesi France — Our Figures and Manufacturing Investments. chiesi.fr

The technical relevance of these facilities is that production-line capabilities must be adapted to the pharmaceutical form and device characteristics. Pressurised aerosols and dry-powder inhalers depend on different formulation and delivery mechanisms, requiring different manufacturing controls. Environmental innovation in metered-dose inhalers also introduces additional technical considerations because the replacement of conventional propellants must preserve product performance while changing the environmental profile of the delivery system.

This illustrates a broader industrial-policy distinction between the value of established manufacturing capacity and the value of manufacturing adaptability. A plant capable of maintaining validated production while incorporating changes in formulation, environmental requirements or delivery technology may provide a stronger basis for future investment than a facility optimised exclusively for an existing product whose commercial prospects are declining. However, the adaptive capacity of a plant must be demonstrated through actual technology transfers, approved products and process validation, not inferred from announced investment programmes.

Biotechnology: why biological production changes industrial economics

Biological medicines create industrial requirements different from those associated with conventional chemical synthesis. Their production may involve living cells, fermentation or cell-culture systems, protein purification and extensive analytical characterisation. The manufacturing process can have a particularly important influence on product attributes, making process consistency and quality control central aspects of product development and lifecycle management.

The European Commission addresses these issues through Annex 2 of EudraLex Volume 4, which governs biological active substances and medicinal products for human use. Advanced therapy medicinal products are subject to their own specialised GMP framework. The distinction matters because the expression biotechnology does not identify one homogeneous manufacturing system. Recombinant proteins, plasma-derived biological medicines, cell-based therapies and gene-based treatments can involve very different raw materials, production environments, process controls and regulatory requirements. EudraLex Volume 4 — Good Manufacturing Practice for Biological Medicines and Advanced Therapies — European Commission.

For the Italian companies considered here, the technologically relevant question is which biological manufacturing capabilities they actually own and operate. The regulatory success of a recombinant medicine demonstrates a completed development and authorisation process, but it does not necessarily identify where commercial-scale production takes place. Similarly, a partnership involving gene-editing technology provides evidence of research engagement but not of operational gene-therapy manufacturing capacity. An industrial capability assessment must therefore separate discovery research, development-stage production, clinical trial material manufacture and authorised commercial production.

This distinction is essential for policy evaluation because each stage requires different forms of investment. Early research infrastructure may be comparatively flexible in physical scale but dependent on highly specialised scientific personnel. Commercial biological production may require substantial validated facilities, complex utilities, contamination-control arrangements and dedicated quality systems. Capacity that is technically available for one molecule may not be immediately suitable for another without significant process development and regulatory approval.

Table 5.3 — Manufacturing technologies and critical industrial capabilities

Manufacturing category	Main technical requirements	Relevant regulatory framework	Principal capacity constraint
Conventional solid-dose medicines	Formulation, blending, granulation, compression, coating and packaging	EU GMP general requirements	Equipment, material supply and validated production
Sterile injectable medicines	Contamination control, aseptic processing or sterilisation, container integrity	EudraLex Annex 1	Validated sterile capacity and environmental control
Recombinant biological products	Cell-based production, purification and biological characterisation	EudraLex Annex 2	Biological process capacity and quality consistency
Plasma-derived medicines	Plasma sourcing, fractionation, purification and biological safety	EudraLex Annexes 2 and 14, as applicable	Qualified plasma and specialist processing
Advanced therapy medicines	Product-specific cell or gene-therapy manufacturing	EU GMP Part IV	Specialised facilities and product-specific processes
Pressurised inhalation products	Formulation, aerosol characteristics, filling and device compatibility	EudraLex Annex 10 and applicable GMP	Validated formulation and delivery technology
Diagnostic contrast agents	Controlled formulation, sterile processing where required, analytical testing	Applicable EU GMP and sterile-product requirements	Specialised production and quality assurance
Pharmaceutical packaging	Packaging-line qualification, data integrity and applicable safety features	EU GMP and applicable serialization law	Validated packaging systems and market-specific configuration

Source: EudraLex Volume 4 — European Commission.

Manufacturing resilience and the distinction between installed capacity and usable production

The resilience of a pharmaceutical industrial system depends on more than the nominal output of its plants. A production line may have a design capacity calculated under specific assumptions concerning operating hours, product characteristics and process conditions. Actual supply capacity is affected by maintenance requirements, batch failures, available personnel, material supply, quality-control timelines and regulatory restrictions. In biological production, yield variability and lengthy processing cycles may further affect the relationship between installed capacity and released product.

This distinction is especially important when assessing public announcements concerning capacity expansion. A new facility may be mechanically complete before process qualification, performance validation and regulatory approval have been completed. Its installed equipment therefore does not necessarily represent immediately available commercial supply. Likewise, the introduction of a new production process at an existing facility may require substantial documentation and approval before the resulting product can be marketed.

For policy purposes, the most informative indicators would include validated annual capacity by product and facility, actual batch throughput, released units, capacity utilisation, production losses, batch-failure rates, time required for product transfer and the extent of qualified alternative capacity. These indicators are substantially more useful for assessing pharmaceutical supply resilience than the number of facilities alone, although many are commercially sensitive and not consistently disclosed.

Chapter 5 — Key judgments

The manufacturing evidence demonstrates that the selected Italian pharmaceutical groups participate in technologically different industrial systems. Kedrion provides a documented case of internationally integrated plasma collection and processing with specific manufacturing responsibilities in Italy. Bracco demonstrates the progressive modernisation of a specialised sterile-manufacturing operation in Germany, including documented digital batch-record and release-system developments. Chiesi illustrates the investment requirements of advanced respiratory manufacturing and the integration of formulation, device and environmental technologies. The applicable European GMP framework confirms that manufacturing capability depends on validated processes, specialised quality systems and product-specific regulatory requirements. The principal unresolved issue is the extent to which Italy possesses immediately available, technically substitutable capacity for critical pharmaceutical products, as distinct from nominal corporate manufacturing assets distributed across several jurisdictions.

Chapter 6. Logistics, Serialization, Supply-Chain Traceability and Digital Manufacturing

Digital control has become an integral component of pharmaceutical manufacturing capability rather than a separate administrative function

Principal judgment. The increasing geographical and technological complexity of pharmaceutical production has transformed logistics, traceability, digital manufacturing and data governance into essential components of industrial resilience. For pharmaceutical companies operating multiple production facilities, sourcing materials internationally and distributing medicines across regulated markets, the ability to maintain accurate, reliable and auditable information is directly connected to manufacturing continuity, product quality and regulatory compliance. The industrial value of digitalisation therefore lies not principally in the introduction of new software, but in the ability to control production and distribution processes, verify the status of materials and products, reconstruct their manufacturing history and respond effectively to quality incidents or supply disruptions.

The evolution of digital control systems must be understood in the context of pharmaceutical regulation. Manufacturing organisations are required to demonstrate that critical operations are performed consistently under validated conditions and that the records supporting product quality are reliable. Computerised systems can support this requirement by collecting, processing and retaining information about materials, equipment, personnel, manufacturing parameters, laboratory results and product release. Nevertheless, the use of digital technology does not automatically establish compliance. Systems must be designed, qualified, validated, controlled and maintained according to their intended function and their potential effects on product quality.

The European Commission’s EudraLex Volume 4 contains a dedicated Annex 11 on Computerised Systems, which establishes requirements relevant to the use of computerised systems within GMP-regulated activities. These provisions operate alongside the broader GMP framework, including requirements concerning documentation, validation and quality management. The industrial implications are substantial because a digital manufacturing system cannot be evaluated solely through conventional information-technology criteria such as computing performance or software functionality. Its operation must also provide reliable evidence that critical regulated activities were performed correctly and that the resulting records remain trustworthy. EudraLex Volume 4 — Annex 11: Computerised Systems — European Commission. European Commission

This regulatory foundation creates an important distinction between the general digitalisation of an industrial company and the digital transformation of pharmaceutical manufacturing. A company may possess sophisticated enterprise financial software, commercial analytics and global telecommunications networks without having integrated electronic production records, laboratory data, warehouse information and quality processes into a coherent manufacturing-control system. Conversely, a highly regulated production site may operate advanced validated control systems while retaining substantial manual processes elsewhere in its logistics or administrative organisation. The existence of software platforms must therefore be connected to specific operational functions and independently documented outcomes before conclusions concerning digital maturity can be justified.

Serialization: the European legal framework for identifying and authenticating individual medicine packs

One of the most important regulatory developments affecting pharmaceutical supply-chain information during the study period was the introduction of European rules intended to protect legal distribution channels against falsified medicines. Directive 2011/62/EU amended the European pharmaceutical framework, while Commission Delegated Regulation (EU) 2016/161 established detailed rules governing the safety features appearing on the packaging of medicines within its scope. These include a unique identifier for individual packs and an anti-tampering device intended to provide evidence of interference with the packaging. The regulatory system is designed to enable the authenticity of medicines to be checked using information stored in connected repositories. Commission Delegated Regulation (EU) 2016/161 — European Commission — 2015. EUR-Lex

The regulation specifies that the unique identifier must contain information identifying the product, a serial number, the batch number and expiry date, together with a national reimbursement identifier where required. It also establishes technical requirements for encoding the identifier in a two-dimensional Data Matrix barcode. These data fields support different functions: the product code identifies the medicinal presentation, the serial number distinguishes an individual pack, the batch number connects the pack to a manufacturing batch, and the expiry date supports the management of product validity. The reimbursement identifier, where applicable, addresses national administrative requirements. The combined information enables a specific pack to be checked against the authorised repository records, but it should not be confused with a complete electronic record of every physical movement through the supply chain. Commission Delegated Regulation (EU) 2016/161 — Articles 4–5.

Table 6.1 — Mandatory unique-identifier data and their functions

Data element	Regulatory purpose	Operational significance
Product code	Identify the medicinal product and presentation	Correct identification of marketed medicine
Serial number	Distinguish an individual pack	Pack-level authenticity verification
Batch number	Associate the pack with a manufacturing batch	Connection with batch-level quality records
Expiry date	Identify the product’s authorised shelf-life endpoint	Expiry management and product control
National reimbursement identifier, where required	Support national identification requirements	Compatibility with applicable national systems
Data Matrix carrier	Encode the unique identifier in machine-readable form	Reliable scanning and electronic verification
Anti-tampering device	Provide evidence of interference with packaging	Physical packaging-integrity verification

Source: Commission Delegated Regulation (EU) 2016/161 — Articles 3–5.

The operational significance extends beyond pharmaceutical packaging. Manufacturers must ensure that required information is correctly generated and encoded, that the barcode can be read, and that the relevant data are transmitted to the repository system before products are released for sale or distribution under the applicable rules. Wholesalers and those authorised to supply medicines have defined verification and decommissioning responsibilities. The legal framework therefore connects manufacturing, information technology, distribution and the final supply of medicines through a common authentication architecture.

The distinction between verification and decommissioning is important. Verification establishes whether a pack’s identifier corresponds to an authentic record under the applicable system rules, while decommissioning changes the identifier’s active status so that it cannot subsequently be accepted as an active identifier in circumstances where its status should have been retired. These functions have different consequences for the management of returns, recalls, distribution and dispensing.

The regulation also defines obligations concerning the recording of operations involving unique identifiers and the handling of suspected falsification. Manufacturers and supply-chain participants must therefore maintain both technical connectivity and controlled operational procedures. The system is not simply a packaging technology installed once on a production line; it is an ongoing regulatory and organisational function requiring accurate master data, reliable interfaces, user access controls and procedures for addressing failed verifications. Commission Delegated Regulation (EU) 2016/161 — Chapters IV–VII.

Serialization is not equivalent to complete supply-chain traceability

A central analytical distinction concerns the difference between identifying an individual medicine pack and reconstructing its complete physical and manufacturing history. The European safety-features system provides an architecture for authenticity verification and associated repository operations, but it does not automatically create a comprehensive database of every movement, storage condition or manufacturing event associated with a product.

Complete operational traceability may require several distinct sets of information. Manufacturing records establish the materials and processes associated with production. Laboratory records document relevant testing and quality decisions. Warehouse systems identify stock locations and inventory movements. Transport systems document shipments and, where required, environmental conditions. Serialization systems maintain the identity and status of individual packs. These information sets can be connected, but their integration is an organisational and technological undertaking that must be separately demonstrated.

The distinction matters when evaluating pharmaceutical companies’ claims concerning digital traceability. A manufacturer may comply with the applicable serialization requirements while continuing to manage certain warehouse or transport processes through separate information systems. Similarly, a warehouse may maintain accurate lot-level stock records without possessing the complete manufacturing genealogy of every product it stores. The existence of one component cannot establish the completeness of the others.

Table 6.2 — Distinct levels of pharmaceutical traceability

Traceability level	Object identified	Principal information	Relevant operational function
Raw-material traceability	Supplier material or biological input	Source, lot, qualification and testing	Control of incoming materials
Manufacturing genealogy	Production batch and component lots	Materials, process history and equipment	Quality investigation and batch reconstruction
Packaging genealogy	Finished packs and packaging operations	Pack identity, batch relationship and packaging records	Controlled packaging and product reconciliation
Serialization	Individual medicinal pack	Product code, serial number and identifier status	Authentication and applicable decommissioning
Warehouse traceability	Inventory unit and storage location	Receipt, movement, stock status and dispatch	Inventory control and distribution
Transport traceability	Shipment and transport conditions	Route, custody and environmental records	Distribution quality and delivery integrity
Patient-supply verification	Pack presented for supply	Authenticity and status verification	Protection of authorised supply channels

The table describes distinct operational functions. It does not imply that all categories are legally required in identical form for every medicinal product or that the ten companies have implemented every layer in the same way.

The economic significance of integrated traceability becomes particularly clear during product-quality investigations. If a material supplied by an external company is subsequently found to be defective, the manufacturer’s ability to identify the affected production batches depends on the reliability of its material and manufacturing genealogy. The ability to determine which finished products contain the affected material then depends on batch records and product associations. Identifying where those products have been distributed requires reliable inventory and shipment information. Where individual-pack identification is available and properly linked, the precision of the investigation can be improved, although the actual scope of a recall must follow the applicable quality and regulatory assessment.

The resulting industrial benefit is not simply faster information retrieval. It is the possibility of reducing uncertainty when operational decisions must be made, avoiding unnecessary disruption to unaffected products and improving the reliability of corrective actions. These benefits remain dependent on the completeness, accuracy and interoperability of the underlying records.

Italy’s differentiated implementation requirements

The European system’s implementation history includes a specific national complication relevant to Italian pharmaceutical manufacturers. The European Commission’s 2018 guidance on the introduction of medicines safety features identified 9 February 2019 as the general application date for the new EU framework, while the legislative arrangements provided transitional treatment for countries with pre-existing national identification systems, including Italy. Consequently, the implementation history should not be represented as identical across all member states. The applicable obligations must be examined with reference to the relevant national arrangements and their subsequent changes. Implementation of the Falsified Medicines Directive in the Hospital Setting — European Commission — 2018; Commission Delegated Regulation (EU) 2016/161 — Article 50. Public Health

For manufacturers supplying both Italy and other European markets, differences in implementation can affect packaging configuration, operational procedures, data management and distribution requirements. This is especially significant for companies operating internationally integrated manufacturing facilities that may produce medicines for several destination markets. A single production site can need to manage different packaging languages, reimbursement identifiers, market authorisations and regulatory obligations, even where the underlying medicine is produced through a common process.

The resulting complexity should not be mistaken for evidence of inefficiency. Market-specific pharmaceutical requirements reflect differences in national healthcare administration and regulatory responsibilities. The industrial challenge is to manage those differences without creating avoidable production interruptions, packaging errors or inventory fragmentation. Reliable product master data and coordinated regulatory information are therefore important components of manufacturing performance.

Warehouse management: inventory control as a regulated industrial capability

Pharmaceutical warehousing differs from conventional industrial storage because products may require controlled temperature, segregation, quarantine, expiry monitoring and defined procedures for receipt, release and distribution. Warehouses also need to distinguish between materials available for use, products awaiting quality decisions, returned goods, rejected materials and stock subject to recalls or other restrictions.

A warehouse-management system can support these functions by maintaining information about inventory identity, location, status and movement. However, the system must operate within controlled procedures that reflect the characteristics of the products being stored. A highly automated warehouse does not necessarily provide better pharmaceutical control if the underlying data are inaccurate, if temperature conditions are poorly monitored or if quarantine rules are not enforced reliably.

Bracco’s Singen operation provides a documented example of changes in warehouse organisation. The company reports that warehouse and logistics activities were insourced in 2021. This establishes a change in the operating model through which those activities were managed, but does not establish a quantified reduction in cost or improvement in service quality. The industrial relevance is that direct organisational responsibility can change the coordination between production, quality control, inventory management and dispatch. The effectiveness of the change would need to be assessed through documented inventory accuracy, stock availability, deviations, delivery reliability and quality outcomes. BIPSO GmbH — Bracco Manufacturing History.

A further distinction is necessary between inventory quantity and inventory availability. Products physically present in a warehouse may not be available for dispatch if they are awaiting batch certification, subject to quality investigation or allocated to particular markets. An inventory-management system therefore needs to reflect not only how many units exist, but which units are eligible for each operational decision. This is particularly important for companies maintaining multiple pharmaceutical products, international warehouses and destination-specific packaging configurations.

Manufacturing execution and electronic batch records

Manufacturing-execution systems are relevant to pharmaceutical operations because they can coordinate production activities, record manufacturing events and connect information generated by equipment, personnel and quality processes. Electronic batch records can replace or supplement paper-based documentation by recording the performance of defined manufacturing operations within a controlled digital environment.

Their significance lies in the integrity of the manufacturing record. For a pharmaceutical batch, the documented production history may include material identity, equipment status, process conditions, operator actions, critical measurements and deviations. A reliable digital record can support review and investigation, but it must preserve information accurately and prevent unauthorised or undocumented changes.

The European Commission’s Annex 11 addresses the use of computerised systems within GMP activities, while Annex 15 addresses qualification and validation. Together with the wider GMP framework, these provisions establish that systems supporting regulated manufacturing must be appropriate for their intended use and operated under controlled procedures. Digitalisation therefore requires more than software implementation: it involves process mapping, validation, user management, change control, data integrity and ongoing maintenance. EudraLex Volume 4 — Annex 11 and Annex 15 — European Commission.

Table 6.3 — Digital pharmaceutical systems and their industrial functions

System or capability	Principal function	Relevant data	Critical control requirement
ERP	Enterprise resource planning	Purchasing, production orders, finance and material planning	Accurate integrated master data
MES	Manufacturing execution	Production operations and process status	Validated process execution and records
Electronic batch records	Digital manufacturing documentation	Batch operations, materials, parameters and deviations	Data integrity and controlled review
LIMS	Laboratory information management	Samples, tests and analytical results	Traceable analytical records
QMS	Quality management	Deviations, corrective actions, change control and investigations	Controlled quality decisions
WMS	Warehouse management	Inventory, locations and material movements	Accurate stock status and traceability
Serialization platform	Pack identification and authenticity data	Product identifiers and serial numbers	Compliance with applicable safety-features rules
Transport monitoring	Shipment and environmental conditions	Location and temperature records	Product-specific transport requirements
Industrial automation	Equipment monitoring and control	Process variables and machine status	Reliable and qualified control functions
Data-integration layer	Information exchange among systems	Master data, transactions and event records	Consistent interfaces and data governance

The table identifies common categories of industrial technology; it does not establish that each group uses a particular vendor, architecture or maturity level.

Digital integration and the challenge of multinational pharmaceutical manufacturing

International pharmaceutical groups can operate facilities with different production histories, information systems and regulatory responsibilities. Acquisitions may bring additional manufacturing plants whose existing enterprise systems, quality processes and data structures were developed independently of the acquiring company. Integrating these systems can therefore become a major operational requirement following corporate consolidation.

The complexity is not simply technical. Different sites may use different definitions for materials, manufacturing stages, product codes, inventory status or quality events. Even when information systems are capable of exchanging data, the information itself may not be comparable without reconciliation. A group seeking an integrated view of production and distribution must therefore establish common definitions, controlled interfaces and governance over the creation and modification of critical records.

This issue is especially relevant to acquisition-led international pharmaceutical organisations. Kedrion’s combination with BPL brought together specialised manufacturing and plasma-related operations. The integration of such businesses creates a need for coordination across biological sourcing, production, quality assurance and regulatory reporting. However, the public evidence examined does not establish which specific enterprise platforms were integrated or the cost, duration and performance outcomes of their integration. Any claim that Kedrion has implemented a unified manufacturing-execution system or a particular digital architecture across all sites would therefore exceed the available record.

Similarly, the expansion of pharmaceutical portfolios through acquisitions can increase the number of marketing authorisations, product specifications and supplier relationships to be managed. Product-rights acquisitions may require the transfer of regulatory information and commercial responsibilities even where manufacturing remains with an external supplier. The technological requirement is consequently not always the consolidation of physical production but the reliable integration of regulatory, quality and supply-chain information.

Cybersecurity and data integrity in connected pharmaceutical facilities

The expansion of digital systems introduces additional requirements concerning system availability, information security and operational resilience. Pharmaceutical manufacturing depends on the reliable operation of both enterprise information technology and industrial control systems. Interruptions affecting production planning, laboratory data, inventory status or equipment control can interfere with manufacturing and distribution, even when physical production equipment remains intact.

The operational risk is particularly significant where digital information is required to establish whether a medicine can be released. A product may have been manufactured physically but remain unavailable for distribution if essential quality records are inaccessible or cannot be verified. Similarly, inaccurate or unavailable inventory information can prevent a manufacturer or distributor from identifying where products are located or which units are available for supply.

The appropriate cybersecurity assessment must distinguish confidentiality, integrity and availability. Confidentiality concerns the protection of proprietary research, patient-related information and commercial data. Integrity concerns the correctness and trustworthiness of manufacturing, laboratory and quality records. Availability concerns the ability of authorised personnel and systems to obtain the information needed for continuous operations. In pharmaceutical manufacturing, data integrity and availability can have direct implications for product quality and continuity of supply.

The documented regulatory framework provides the basis for controlled computerised systems, but it does not establish the cybersecurity maturity of any particular company. Assessing the ten groups would require evidence concerning validated backup and restoration arrangements, access governance, incident response, network segmentation, operational continuity procedures and the management of externally supplied software. Without such evidence, a general statement that a company has implemented digital manufacturing cannot be translated into a verified conclusion about cyber resilience.

Measuring digital transformation through operational outcomes

The existence of advanced digital platforms should not be used as the final indicator of industrial modernisation. The meaningful question is whether their implementation improves the organisation’s ability to manufacture, release, store and distribute medicines reliably. Such improvements must be assessed using consistent operational indicators and appropriate comparisons before and after implementation.

Batch-release lead time provides one possible indicator because the period between production completion and authorised release can affect inventory availability and working capital. However, changes in this measure may result from product mix, testing requirements or staffing as well as from digital systems. Similarly, a reduction in warehouse inventory can reflect improved planning but can also increase vulnerability to disruptions if safety stocks become insufficient. Digitalisation outcomes must therefore be interpreted in the context of product characteristics and the operating environment.

Table 6.4 — Performance indicators for pharmaceutical digital transformation

Capability	Appropriate indicator	Required comparison	Interpretation limit
Electronic batch records	Batch-documentation completion and review time	Comparable products and reporting periods	Different product complexity can affect results
Manufacturing execution	Production deviations and schedule adherence	Constant or reconciled product mix	Changes may reflect more than system performance
Laboratory information	Analytical turnaround time	Comparable test methods	Test complexity must be controlled
Warehouse management	Inventory accuracy and stock-location errors	Stable inventory scope	Higher accuracy does not alone establish supply resilience
Serialization	Verification errors and exception-resolution time	Applicable regulatory scope	Verification outcomes depend on external systems
Traceability	Time required to identify affected products	Comparable simulated or actual recall conditions	Scenario complexity affects performance
Distribution	On-time delivery and temperature excursions	Similar products and destinations	Transport conditions differ by geography
Cyber resilience	Tested restoration time and operational recovery	Defined recovery scenarios	Results depend on scenario severity
Integrated planning	Forecast error and inventory availability	Consistent forecasting horizon	Demand volatility affects comparability
Quality management	Deviation closure and corrective-action effectiveness	Comparable quality-event categories	Closure speed does not alone indicate investigation quality

The table provides a measurement framework rather than verified company performance values. No comparative digital-maturity ranking is assigned because the necessary company-level operational observations have not been established.

The industrial importance of data governance and interoperability

The growing importance of digital systems also changes the skills required within pharmaceutical production organisations. Manufacturing engineers, quality specialists, validation personnel, data analysts and information-system professionals must increasingly coordinate across traditional functional boundaries. The successful implementation of a manufacturing-control system depends not only on technical installation but also on the ability of personnel to define correct operating procedures, interpret system outputs, investigate exceptions and maintain reliable records over time.

This creates an industrial-policy challenge different from the general shortage of information-technology specialists. Pharmaceutical digitalisation requires personnel who understand both regulated manufacturing and digital system architecture. A software specialist without adequate knowledge of pharmaceutical quality requirements may design technically sophisticated processes that do not provide the required evidence for regulated operations. Conversely, a manufacturing specialist without sufficient digital expertise may struggle to evaluate automated controls, system interfaces or data-integrity risks. The combination of these capabilities becomes increasingly important as production systems become more integrated.

Interoperability is equally relevant because pharmaceutical companies frequently depend on contract manufacturers, external laboratories, logistics providers and suppliers of specialised materials. Information exchanged across organisational boundaries must retain sufficient quality and traceability to support regulatory and operational decisions. This does not mean that all participants must use identical software systems. It means that the information exchanged must be accurate, appropriately controlled and meaningful to the receiving organisation.

Operational differences among the ten pharmaceutical groups

The ten companies do not face identical digital and logistics requirements. Kedrion’s plasma operations depend on traceability connecting biological inputs, specialised processing and finished medicines. Bracco’s diagnostic production requires controlled manufacturing and, where applicable, sterile-product assurance. Chiesi’s respiratory products involve manufacturing processes linked to formulation and delivery-device characteristics. Companies with broad portfolios of conventional and specialised medicines may face substantial complexity in packaging, product configuration, market authorisations and distribution. Research-focused organisations may place greater emphasis on laboratory information, clinical-development data and the management of externally manufactured products.

These distinctions mean that a single digital transformation model cannot be applied automatically to every pharmaceutical business. A company engaged in plasma fractionation may derive significant operational benefits from stronger integration of biological sourcing and processing information, while a company with numerous international marketing authorisations may face different challenges in product-data consistency and serialization. A specialised sterile manufacturer may concentrate investment on electronic production records, contamination-control data and quality-system integration.

The appropriate comparison must therefore begin with the manufacturing and distribution characteristics of each group, not with a generic list of software platforms. An advanced system creates industrial value when it addresses an actual operational requirement and produces measurable improvements under the applicable regulatory conditions.

Table 6.5 — Company-specific digital and logistics requirements

Group	Relevant industrial structure	Priority area for assessment	Verified company-specific evidence
Menarini	International pharmaceutical and specialised therapeutic portfolio	Product master data, regulatory coordination and cross-border supply	International organisational footprint established; integrated system performance not established
Chiesi	Respiratory, rare-disease and specialty-care products	Formulation control, manufacturing records and international distribution	Documented manufacturing and research operations; comparable digital KPIs unavailable
Angelini Pharma	Pharmaceutical manufacturing and commercial operations	Production control, validation and product traceability	Corporate manufacturing and automation disclosures
Recordati	International pharmaceutical and rare-disease portfolio	Supplier coordination, product availability and market-specific distribution	Geographic operating network documented
Bracco	Diagnostic contrast-media manufacturing	Sterile production records, warehouse control and release systems	Electronic batch records, parametric release and logistics insourcing at Singen
Alfasigma	International therapeutic portfolio developed through acquisitions	Product-data integration and regulatory supply coordination	Acquisition history documented; specific integrated systems not verified
Kedrion	Plasma sourcing, fractionation and specialised biological production	Biological material traceability and inter-facility production coordination	Detailed international collection and production network
Zambon	Pharmaceutical research and operating activities	Product quality, manufacturing and distribution	Corporate operating scope established; digital implementation not independently measured
Italfarmaco	Specialist therapeutic development and international regulatory activity	Regulatory data, product quality and commercial supply	Authorised givinostat product; digital-system architecture not established
Dompé	Specialist biological product development	Biological manufacturing records and controlled distribution	EMA-authorised recombinant treatment; manufacturing IT architecture not established

Company evidence: Bracco — BIPSO; Kedrion Sustainability Report 2024; Chiesi FY2025 Results; Recordati Annual Report 2025; EMA — Duvyzat; EMA — Oxervate.

Implications for Italian industrial and healthcare policy

The digital and logistical dimension of pharmaceutical competitiveness has direct implications for both industrial and healthcare policy. Reliable manufacturing information and distribution systems contribute to the ability of producers to maintain product quality, respond to supply disruptions and distribute medicines across multiple markets. For healthcare systems, these capabilities can affect the continuity of access to medicines, while for industrial companies they influence operational risk, inventory management and the resources required to maintain regulated production.

A public policy designed to strengthen pharmaceutical manufacturing should therefore distinguish between investment in physical production capacity and investment in the systems required to operate that capacity reliably. A new manufacturing line without adequate quality systems, qualified personnel or secure data management may be unable to achieve its intended economic contribution. Conversely, improving the information and control systems of an existing facility may strengthen its productive reliability without adding a new building or a substantial number of employees.

At the European level, interoperability and pharmaceutical traceability also concern the effectiveness of cross-border supply chains. Regulatory systems define common requirements, but individual companies remain responsible for operating their own production and distribution processes. Public authorities should consequently evaluate whether available industrial data are sufficient to identify critical vulnerabilities, whether supply-chain dependencies can be monitored effectively and whether essential products can be supplied reliably during disruptions.

The strongest basis for intervention would be evidence of specific weaknesses in critical production or distribution capabilities, supported by an assessment of alternative suppliers, technical substitutability and the consequences of supply interruptions. Investment support should be connected to measurable improvements such as additional validated capacity, more reliable access to critical materials, strengthened traceability or demonstrably improved continuity arrangements. General claims about digital transformation are insufficient to establish these outcomes.

Chapter 6 — Key judgments

The European regulatory framework establishes that pharmaceutical serialization, computerised manufacturing systems, quality documentation and traceability are regulated activities requiring controlled information and reliable operating procedures. Bracco provides a documented case of digital manufacturing modernisation through electronic batch records and parametric release at its German facility. Kedrion’s international plasma network demonstrates why the integration of sourcing and manufacturing information is important in specialised biological production. The other groups face different operational requirements according to their therapeutic portfolios, manufacturing structures and distribution networks, but comparable evidence concerning the performance of their digital systems remains limited.

The decisive industrial conclusion is that digitalisation strengthens pharmaceutical resilience only when it improves the reliability, traceability, quality and continuity of actual production and supply processes. The number of software systems installed, the existence of automation projects or general corporate commitments to digital transformation cannot substitute for evidence of operational performance.

Pillar II — Consolidated Technological and Operational Assessment

The three chapters establish that the technological transformation of the Italian pharmaceutical industry cannot be represented by a single measure of research expenditure, manufacturing capacity or digital adoption. Therapeutic development, biological production, specialist diagnostics, regulatory compliance and supply-chain control are different but interconnected components of industrial competitiveness.

The evidence identifies genuine technological achievements among several of the selected companies. Chiesi’s research expenditure and advanced therapeutic partnerships demonstrate substantial scientific engagement. Italfarmaco’s givinostat and Dompé’s cenegermin provide independently documented cases of successful regulatory development in specialised therapeutic areas. Kedrion’s production network establishes substantial plasma-processing capability, including critical Italian manufacturing functions. Bracco’s operational disclosures demonstrate tangible modernisation in regulated sterile manufacturing, including digital production records and release-system development.

These capabilities are not distributed uniformly across the ten companies or across national territories. Some are located in Italian laboratories and manufacturing facilities, while others are controlled or operated through international subsidiaries, partnerships and acquired businesses. Consequently, the relationship between corporate technological development and Italian industrial sovereignty remains dependent on the location of scientific personnel, manufacturing responsibilities, intellectual-property rights and critical production knowledge.

The evidence also demonstrates that manufacturing resilience depends upon the interaction between physical capacity and information reliability. A pharmaceutical production network requires qualified materials, validated processes, accurate records, regulatory authorisations, specialised personnel and dependable distribution arrangements. Digital systems can improve these functions, but their contribution must be established through operational outcomes rather than general declarations.

The principal assessment of Pillar II is that Italy’s pharmaceutical industrial position has been strengthened by the development and acquisition of specialised technologies, yet the durability of that advantage depends on converting research and corporate scale into productive capabilities that can be reliably operated, controlled and sustained within Italy and the wider European pharmaceutical system.

The remaining questions concerning competitive positioning, reimbursement exposure, critical dependencies, talent requirements and the conditions under which further consolidation would enhance industrial resilience form the analytical basis of Pillar III.

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PILLAR III — COMPETITIVENESS, RESILIENCE AND PUBLIC POLICY

Chapter 7. Italy in European and Global Pharmaceutical Value Chains: France, Germany and the United Kingdom

European pharmaceutical competitiveness is increasingly determined by the location of innovation, industrial investment and strategic capabilities

Principal judgment. Italy’s position in the European pharmaceutical industry cannot be determined by the value of its exports, the international expansion of its largest companies or the number of people employed in its manufacturing facilities considered separately. A defensible assessment must establish whether the country can attract and retain high-value pharmaceutical investment while competing with Germany, France, the United Kingdom and other European pharmaceutical economies for research programmes, clinical development, specialised manufacturing, intellectual property and long-term corporate investment mandates. The distinction is particularly important because European pharmaceutical value chains combine national industrial strengths with internationally distributed research, production and commercial activities, while the competitive environment increasingly reflects the capacity of the United States and other global pharmaceutical centres to attract capital and advanced therapeutic development.

The economic geography of European pharmaceuticals is not organised around a single national centre. Germany possesses a substantial pharmaceutical research and manufacturing system, France combines major corporate research organisations with a significant manufacturing and healthcare market, the United Kingdom maintains an extensive biopharmaceutical and life-sciences ecosystem, and Italy has developed a major export-oriented production base supported by domestically headquartered companies and foreign-controlled manufacturers. These national systems overlap through corporate subsidiaries, acquired businesses, research collaborations, clinical trials, specialised suppliers and cross-border manufacturing relationships. Consequently, investment attracted to one European country may strengthen a multinational pharmaceutical group headquartered in another, while the loss of a particular research mandate or manufacturing operation can weaken the industrial capabilities of the territory in which it was previously located.

A central feature of this competitive environment is the distinction between industrial participation and economic value capture. Production facilities generate employment, intermediate purchases and manufacturing output, but their contribution to national income depends on the value added domestically. Research centres develop knowledge and technologies, but the resulting economic returns may depend on ownership of patents, licensing agreements and the location of commercial exploitation. Corporate headquarters can concentrate strategic management, finance and regulatory coordination, yet the location of a headquarters does not establish that all major investment decisions or intellectual-property rights are controlled within the same jurisdiction. These differences explain why countries with broadly comparable pharmaceutical manufacturing activity can occupy different positions in the higher-value segments of the international industry.

The European Federation of Pharmaceutical Industries and Associations identifies pharmaceuticals as one of Europe’s major research-intensive industrial sectors, while also emphasising competition for scientific investment, manufacturing capacity and the commercial development of new treatments. Its industry statistics offer a useful comparative framework, although national employment, research and production figures are drawn from member associations and may differ in reporting year and coverage. They should therefore be interpreted as sector-level indicators rather than as a fully harmonised national-accounting dataset. The Pharmaceutical Industry in Figures 2025 — European Federation of Pharmaceutical Industries and Associations.

Germany: research expenditure, industrial capacity and competition for high-value investment

Germany constitutes an important comparator for Italian pharmaceutical industrial policy because it combines substantial pharmaceutical manufacturing with a large domestic healthcare market, established research organisations and an extensive network of specialised industrial suppliers. Germany Trade & Invest reports approximately €10.7 billion in pharmaceutical research and development investment during 2024, alongside a pharmaceutical industrial workforce of approximately 133,000 people. These figures concern activity in Germany and should not be treated as expenditure or employment generated exclusively by German-owned pharmaceutical companies. The Pharmaceutical Industry in Germany — Germany Trade & Invest. GTAI

The R&D figure is especially relevant because it provides evidence of the resources committed to pharmaceutical research within the German economy. In comparison with Italy, the key question is not simply whether one country reports greater research expenditure, but how that expenditure is distributed among domestic firms, foreign-controlled subsidiaries, clinical research, laboratory development and manufacturing-related innovation. Different statistical classifications can affect the comparison, particularly where expenditure includes research activities undertaken by contract research organisations or multinational subsidiaries. A valid measure of relative research intensity would require compatible definitions and an appropriate denominator, such as pharmaceutical value added or sectoral turnover.

Germany’s competitive position also depends on the relationship between its research system and its manufacturing capabilities. The development of new biological medicines, advanced formulations and specialised pharmaceutical processes requires the ability to move from laboratory work to validated industrial production. When research, process development and manufacturing expertise are located within a connected industrial ecosystem, companies can benefit from accumulated technical knowledge and established supplier relationships. This does not establish that geographically concentrated production is always preferable; internationally distributed networks can provide access to capabilities unavailable in one location. Nevertheless, the proximity of scientific and manufacturing functions may affect the cost, time and organisational complexity of industrialising new technologies.

For Italy, Germany is therefore more than a competing destination for pharmaceutical investment. It is also a location in which Italian pharmaceutical groups possess significant assets and capabilities. This creates an economic relationship in which the competitive position of an Italian-headquartered group may be strengthened by German industrial investment, even when the resulting manufacturing and research employment is not located in Italy. The policy challenge is to determine whether Italy can retain complementary activities that contribute to high-value production and whether investment incentives, workforce capabilities and regulatory conditions are sufficient to attract future manufacturing mandates.

A comparison of industrial competitiveness must also consider the financial environment governing pharmaceuticals. Germany’s healthcare system provides access to a large market, while its arrangements for the assessment and pricing of medicines differ from those applied in Italy. These differences can affect commercial revenues and the timing of product launches, but they do not independently determine the location of production. A pharmaceutical company may manufacture medicines in Italy for sale in Germany or operate a research centre in Germany to develop medicines sold across Europe. Consequently, domestic market size and domestic manufacturing competitiveness must remain distinct variables in an industrial-policy assessment.

France: pharmaceutical industrial policy, commercial development and the competition for innovation mandates

France represents a different combination of pharmaceutical industrial capabilities, national healthcare financing and public involvement in economic development. Its pharmaceutical system includes internationally active companies, production facilities, research organisations and government initiatives intended to strengthen innovation and industrial investment. From an Italian perspective, France is simultaneously a commercial market, a location of existing Italian corporate production and a competitor for future investment.

The available European industry statistics provide evidence of a large French pharmaceutical workforce. EFPIA’s 2025 publication reports approximately 98,043 employees for France in its 2023 country table, compared with approximately 132,660 for Germany and 70,000 for Italy in the same reference table. These figures must be treated cautiously because EFPIA identifies several country observations as estimates and notes that some national series refer to different underlying periods. Their principal value is to establish the broad scale of the three national manufacturing and research systems, not to provide an exact contemporaneous ranking of industrial performance. The Pharmaceutical Industry in Figures 2025 — EFPIA, Employment by Country.

France’s industrial-policy challenge is closely connected to its ability to retain pharmaceutical development and manufacturing activities while maintaining a healthcare financing system that negotiates prices and reimbursement conditions. The same structural question applies to Italy: a national health service seeks affordable access to medicines, while industrial policy seeks to attract companies undertaking expensive and long-duration research programmes. These objectives are compatible when public expenditure supports clinically valuable innovation and when investment conditions remain sufficiently predictable. They become difficult to reconcile when financial incentives, access conditions or regulatory delays produce uncertainty that companies regard as material to future investment decisions. The existence of such a mechanism does not establish that individual French or Italian investment projects were transferred because of particular reimbursement policies.

The French industrial system also provides a useful comparator for evaluating Italy’s participation in multinational pharmaceutical production networks. A manufacturing facility located in France and owned by an Italian group contributes to French employment, local industrial investment and the French territorial economy, while potentially strengthening the profitability and technological capabilities of the Italian parent company. The economic effects therefore occur in both jurisdictions but through different channels. The distinction is essential when evaluating national industrial policies that seek to attract foreign investment while simultaneously supporting the internationalisation of domestic enterprises.

For the comparison between Italy and France, the most consequential questions concern the composition of industrial employment, the amount and location of pharmaceutical research expenditure, the scale of new manufacturing investment, and the ability of companies to commercialise products developed through domestic scientific research. Employment and export statistics are necessary starting points, but they cannot independently establish which country captures a greater proportion of the economic returns associated with innovative medicines.

The United Kingdom: biopharmaceutical development, scientific specialisation and a differentiated industrial structure

The United Kingdom requires separate treatment because its pharmaceutical and life-sciences industrial structure is measured through statistical classifications that extend beyond conventional pharmaceutical manufacturing. The UK Office for Life Sciences published its Bioscience and Health Technology Sector Statistics 2023 to 2024 on 2 October 2025. The report estimates that the wider UK life-sciences industry contained 6,170 businesses operating through 7,320 companies, generating approximately £146.9 billion in turnover and employing 359,600 people. These figures include both biopharmaceutical companies and medical-technology businesses; they are therefore not directly comparable with Italy’s pharmaceutical manufacturing employment or production figures. Bioscience and Health Technology Sector Statistics 2023 to 2024 — UK Office for Life Sciences — October 2025. GOV.UK

The UK publication provides a more relevant internal breakdown. Of the total workforce, approximately 163,600 employees belonged to the biopharmaceutical subsector and 196,000 to medical technology. Biopharmaceutical businesses generated approximately £98.9 billion in turnover, compared with £48 billion for medical technology. The official report identifies biopharmaceutical companies as accounting for approximately 45% of life-sciences employment but 67% of turnover. This difference reflects the measured economic composition of the two broad subsectors, although it should not be interpreted as a direct comparison of labour productivity because turnover includes intermediate inputs and varies with business models, product characteristics and corporate organisation. UK Office for Life Sciences — Bioscience and Health Technology Sector Statistics 2023 to 2024, Section 6.

The UK statistical authority explicitly warns that methodological changes prevent the 2023–2024 estimates from being compared directly with the earlier series covering 2021–2022 and preceding years. This limitation is material. A comparison that presents the change between the old and new estimates as employment growth would attribute methodological differences to industrial development. The correct interpretation is that the new publication establishes the measured scale of the life-sciences system under a revised methodology, but does not provide a consistent long-term growth series. The distinction is particularly relevant to the present report because similar problems arise when pharmaceutical companies change their consolidation perimeter following acquisitions.

From the perspective of Italian industrial competitiveness, the United Kingdom’s significance extends beyond its employment scale. The country provides a market and research environment for advanced therapies, specialist pharmaceutical development and international capital. Its biopharmaceutical activities can offer Italian companies access to specialised research programmes and established industrial assets. However, the acquisition of a British pharmaceutical company by an Italian-rooted group may distribute the resulting technological capabilities between multiple jurisdictions, while the ownership and financing structure may become international. The question of national value capture consequently depends on where research, manufacturing and investment decisions are performed after integration.

The United Kingdom’s departure from the European Union also introduces an additional regulatory dimension. Pharmaceutical companies operating across the EU–UK relationship must account for the applicable regulatory systems, product authorisations, supply arrangements and market-specific requirements. The effect on competitiveness depends on the product and operating model. An additional regulatory boundary can create compliance costs, but it does not eliminate the ability of companies to maintain cross-border manufacturing and research networks. The policy-relevant requirement is to assess actual operational arrangements and regulatory obligations rather than treating jurisdictional separation as equivalent to industrial disconnection.

European comparison: separating pharmaceutical manufacturing from the wider life-sciences economy

Table 7.1 — Verified European industrial indicators and their definitions

Country	Indicator	Verified value	Reference period	Scope and limitation
Italy	Pharmaceutical employment	71,000	2024	Farmindustria national sector employment
Italy	Pharmaceutical production	€56bn	2024	Production value in Italy
Italy	Pharmaceutical exports	€54bn	2024	Gross export value
Germany	Pharmaceutical employment	Approximately 133,000	Recent GTAI disclosure	Rounded sector estimate
Germany	Pharmaceutical R&D investment	€10.7bn	2024	Research expenditure located in Germany
France	Pharmaceutical employment	98,043	2023 EFPIA reference	Association-based figure, subject to estimate qualifications
United Kingdom	Wider life-sciences employment	359,600	2023–2024	Includes biopharmaceuticals and medical technology
United Kingdom	Biopharmaceutical employment	163,600	2023–2024	UK Office for Life Sciences subsector
United Kingdom	Biopharmaceutical turnover	£98.9bn	2023–2024	Not equivalent to pharmaceutical manufacturing value added
United Kingdom	Medical-technology turnover	£48.0bn	2023–2024	Different subsector from pharmaceuticals

Sources: Indicatori Farmaceutici 2025 — Farmindustria; Pharmaceutical Industry in Germany — Germany Trade & Invest; The Pharmaceutical Industry in Figures 2025 — EFPIA; Bioscience and Health Technology Sector Statistics 2023 to 2024 — UK Office for Life Sciences.

The table is deliberately not presented as a unified ranking. The indicators measure different economic objects, use different reporting periods and incorporate different statistical boundaries. A directly comparable European assessment would require a consistent NACE-based definition of pharmaceutical manufacturing, harmonised national-accounting data, compatible R&D statistics and a separate treatment of the wider biotechnology and medical-technology sectors.

Global competition and the economics of high-value pharmaceutical investment

European pharmaceutical competitiveness must also be assessed against international investment opportunities outside Europe. Research-intensive pharmaceutical companies allocate resources according to scientific opportunity, market access, expected commercial returns, regulatory requirements, financing conditions and the availability of specialist personnel. These factors influence both the development of new products and the location of industrial facilities.

The international distribution of clinical development is particularly relevant. A medicine may be discovered in Europe, tested through multinational clinical trials, manufactured in one or more foreign facilities and commercialised internationally. Corporate ownership can connect these stages, but it does not necessarily concentrate their economic benefits within the company’s country of origin.

The European Commission’s pharmaceutical reform agenda explicitly seeks to address the relationship between innovation, competitiveness, patient access and medicine availability. The legislative process initiated in 2023 produced a political agreement between the European Parliament and Council in December 2025, followed by the Council’s adoption of the new rules on 28 September 2026. As of the reporting cut-off, the Council states that entry into force remains dependent on completion of the remaining legislative steps and publication in the Official Journal. Consequently, the revised framework should not be treated as already fully applicable law merely because the Council adopted its position. The Pharma Package: New EU Rules on Medicines — Council of the European Union — updated September 2026. Consilium

This distinction has practical consequences for pharmaceutical investment. Companies assess research programmes over long periods and may consider the expected regulatory and commercial environment over the life of a product. However, proposed or politically agreed incentives cannot be treated as enforceable rights until the applicable legislation enters into force. An investment analysis must therefore distinguish the existing regulatory framework from changes that have completed some, but not all, legislative stages.

European competitiveness and the strategic importance of medicines that cannot be easily substituted

The traditional comparison of pharmaceutical industries through production, sales and employment is incomplete because it does not identify which medicines are essential to healthcare continuity or difficult to replace. The European Medicines Agency, the Heads of Medicines Agencies and the European Commission developed a Union list of critical medicines to identify products whose uninterrupted supply is particularly important for patient care and health-system functioning. The list is not a register of medicines currently experiencing shortages. Its purpose is to support preventive analysis and prioritise products whose unavailability could have serious consequences.

The European Commission’s 2025 supporting documentation identified 276 active substances in the then-current Union list, based on criteria concerning the seriousness of the conditions treated and the availability of appropriate alternatives. The subsequent annual update published in December 2025 added nine active-substance groups, while the January 2026 editorial revision did not change the medicines included. These changes demonstrate that criticality is a periodically reviewed regulatory assessment rather than a permanent characteristic established once for all products. Union List of Critical Medicines — European Medicines Agency — updated January 2026. European Medicines Agency (EMA)

For Italy, the industrial significance is considerable. A country can possess a large pharmaceutical export sector while remaining dependent on external suppliers for particular critical medicines or active substances. Conversely, a smaller domestic production line may possess strategic importance disproportionate to its economic output if it supplies a treatment for which alternatives are limited. The appropriate evaluation of pharmaceutical competitiveness must therefore incorporate product-specific supply vulnerability alongside conventional measures of industrial scale.

Chapter 7 — Key judgments

The European comparison demonstrates that Italy operates within a competitive and highly integrated pharmaceutical system in which Germany, France and the United Kingdom possess different combinations of research, manufacturing, commercial and scientific capabilities. Italy’s industrial position cannot be inferred exclusively from the scale of domestic production, while the wider UK life-sciences statistics cannot be treated as directly comparable with conventional pharmaceutical manufacturing employment. The evidence also establishes that future competitiveness will depend on the ability to attract advanced research, retain specialised manufacturing and provide reliable access to medicines whose clinical importance may exceed their commercial scale. The most consequential unresolved issue is the absence of a fully harmonised cross-country dataset linking pharmaceutical value added, research expenditure, manufacturing capabilities and intellectual-property ownership.

Chapter 8. Pricing, Reimbursement, Critical Dependencies, Talent and Financial Vulnerabilities

The principal vulnerability is the interaction between healthcare affordability, industrial investment and continuity of pharmaceutical supply

Principal judgment. Italian pharmaceutical resilience is exposed to a combination of economic and operational pressures that cannot be evaluated independently. Public reimbursement arrangements influence the commercial returns available from medicines, while manufacturers must finance increasingly specialised research, maintain regulated production facilities, secure critical inputs and recruit personnel capable of operating complex scientific and industrial systems. At the same time, the Italian healthcare system must preserve access to clinically necessary treatments under public-budget constraints. The central policy problem is therefore not whether pharmaceutical prices should be high or low, but how purchasing, reimbursement and industrial policies can deliver appropriate patient access while maintaining reliable supply and economically sustainable production of essential medicines.

The distinction is particularly important because pharmaceutical companies operate across markets with different commercial characteristics. Established medicines exposed to generic competition can face different pricing and volume conditions from innovative rare-disease therapies, patented biological products or medicines purchased through hospital procurement. Some products support large patient populations and generate substantial aggregate sales despite relatively low unit prices; others serve small populations and require highly specialised development and manufacturing capabilities. Consequently, the effect of reimbursement policy on industrial investment depends on the product portfolio, cost structure, expected market volumes and the availability of alternative markets. The same nominal price reduction can have different economic consequences for a high-volume established medicine and a low-volume specialised therapy.

The Italian Medicines Agency provides a substantial official evidence base for assessing these pressures. Its Rapporto OsMed 2024, published in November 2025, records total Italian pharmaceutical expenditure of €37.2 billion in 2024, an increase of 2.8% over 2023. Public pharmaceutical expenditure reached €26.8 billion, increasing by 7.7%, while expenditure borne by citizens amounted to approximately €10.2 billion. Public spending accounted for approximately 72% of the total. These figures establish the financial scale of the Italian medicines market but should not be confused with pharmaceutical manufacturing output, industry revenues or the value of medicines exported from Italy. Rapporto OsMed 2024 sull’uso dei farmaci in Italia — Agenzia Italiana del Farmaco — November 2025; AIFA Official Communication No. 51 — 10 November 2025. AIFA

Pharmaceutical expenditure and the changing financial demands on the Italian healthcare system

AIFA’s 2024 expenditure analysis reveals that the principal pressures were not distributed uniformly across channels of supply. The agency reports public territorial pharmaceutical expenditure of approximately €13.7 billion, increasing by 5.1%, while medicines purchased by public healthcare facilities accounted for approximately €17.8 billion, increasing by about 10%. The latter increase was accompanied by higher volumes and a higher average cost per day of treatment, with AIFA reporting changes of 4.7% and 4.8% respectively. These figures must not be added mechanically to derive total public pharmaceutical expenditure because the underlying categories, accounting boundaries and distribution channels are not a set of mutually exclusive components. AIFA — Rapporto OsMed 2024, official communication, p. 1. AIFA

The difference between volume growth and expenditure growth is analytically important. An increase in expenditure can result from greater use of medicines, changes in the therapeutic composition of treatment, higher average prices, the introduction of new products or a combination of these factors. Where more patients gain access to effective treatments, higher expenditure may correspond to an improvement in healthcare provision rather than a deterioration in purchasing efficiency. Conversely, expenditure growth may also reflect commercial or operational pressures that require investigation. The appropriate assessment must therefore connect expenditure with treated populations, clinical outcomes, utilisation, product mix and net prices.

AIFA’s official report provides further evidence of the importance of therapeutic composition. The agency identifies antineoplastic and immunomodulating medicines as the largest category of public pharmaceutical expenditure, with approximately €8.2 billion recorded in 2024. Cardiovascular medicines represented approximately €3.7 billion, while medicines for the gastrointestinal system and metabolism accounted for approximately €3.495 billion. These amounts are associated with the therapeutic classifications used by AIFA and should not be interpreted as the revenues of particular pharmaceutical companies. AIFA — Rapporto OsMed 2024, therapeutic expenditure analysis.

Table 8.1 — Italian pharmaceutical expenditure and utilisation, 2024

Indicator	Verified value	Annual change	Definition
Total pharmaceutical expenditure	€37.2bn	+2.8%	Public and private expenditure
Public pharmaceutical expenditure	€26.8bn	+7.7%	Publicly financed medicines
Public share of total expenditure	72.0%	—	Share of total pharmaceutical spending
Citizen-financed expenditure	€10.2bn	−4.6%	Private and patient expenditure under AIFA definition
Public territorial pharmaceutical expenditure	€13.7bn	+5.1%	Territorial reimbursement and distribution channels
Medicines purchased by public healthcare facilities	Approximately €17.8bn	Approximately +10%	Public healthcare procurement
Growth in quantities acquired by public healthcare facilities	—	+4.7%	Volume change
Change in average cost per treatment day	—	+4.8%	Treatment-cost measure
Total pharmaceutical consumption	1,895 DDD per 1,000 inhabitants per day	—	Defined daily-dose measure
Publicly financed share of consumption	70.8%	—	Share of defined daily doses
Privately purchased share of consumption	29.2%	—	Share of defined daily doses

Source: Rapporto OsMed 2024 — Agenzia Italiana del Farmaco — November 2025. DDD denotes the World Health Organization’s defined daily dose statistical measure and does not represent the actual prescribed daily dose for every patient.

The industrial implication is that public purchasing decisions affect companies operating in therapeutic markets with substantially different clinical and economic characteristics. A pharmaceutical group concentrated in high-value specialist medicines may be exposed to reimbursement negotiations, indication restrictions and patient-population estimates, while a manufacturer of established medicines may face competitive procurement and pressure to supply large volumes at relatively low prices. These effects cannot be quantified at company level without product-specific financial reporting and information about the structure of commercial agreements.

Italy’s pharmaceutical expenditure in European perspective

AIFA’s official comparison provides additional evidence concerning the relative scale of pharmaceutical spending. For the 2024 reference period, the agency reports total pharmaceutical expenditure of €672 per inhabitant in Italy, compared with €742 in Germany, €733 in Austria, €681 in Belgium and €541 in Great Britain. It also reports a European comparison-group average of approximately €418, although this aggregate must be interpreted according to the particular country coverage and calculation method used in the agency’s analysis. These values measure expenditure under the selected international comparison, not identical net prices for the same basket of medicines. AIFA — Rapporto OsMed 2024, European expenditure comparison, pp. 1–2 of official communication.

AIFA further states that adjusting for the effect of Italian pharmaceutical payback arrangements reduces the comparable Italian expenditure measure from €672 to approximately €627 per inhabitant. The difference demonstrates that gross expenditure comparisons can misrepresent the financial burden associated with particular healthcare systems when rebates, repayments and other financial arrangements differ among countries. The adjusted figure remains dependent on AIFA’s specific methodology and should not be interpreted as a universally comparable measure of net pharmaceutical prices. AIFA — Rapporto OsMed 2024, European comparison.

Table 8.2 — Selected European pharmaceutical expenditure indicators

Country or measure	Expenditure per inhabitant	Reference period	Qualification
Germany	€742	2024	AIFA international comparison
Austria	€733	2024	Same comparison
Belgium	€681	2024	Same comparison
Italy	€672	2024	Before stated adjustment for payback
Italy, payback-adjusted	€627	2024	AIFA-adjusted comparison
Great Britain	€541	2024	Same comparison
European comparison-group average	€418	2024	Defined AIFA comparator aggregate

Source: AIFA — Rapporto OsMed 2024, Official Communication No. 51 — November 2025.

A particularly important finding is that lower measured expenditure does not necessarily establish lower prices for identical products or greater purchasing efficiency. Differences in therapeutic consumption, medicine availability, reimbursement eligibility and patient demographics can affect national expenditure. A country may spend less because it purchases medicines at lower net prices, because patients receive different treatments, or because fewer medicines are available or reimbursed. A reliable assessment of economic efficiency must therefore integrate expenditure with clinical access, treatment outcomes and product-specific price comparisons.

Reimbursement contracts, payback and the distribution of financial risk

The Italian reimbursement system uses contractual arrangements that can transfer part of the financial uncertainty associated with pharmaceutical expenditure to manufacturers. AIFA’s Rapporto OsMed 2024 describes agreements involving expenditure ceilings, price-volume conditions and financial repayments. These arrangements are especially relevant where the expected number of treated patients or the actual volume of medicine consumption differs from assumptions made during reimbursement negotiations.

Under an expenditure-ceiling agreement, the financial consequences of utilisation above the negotiated limit may trigger repayment obligations. Price-volume arrangements can similarly establish conditions under which the net price changes as quantities increase. These mechanisms can protect healthcare budgets from some expenditure risks, but they also affect the relationship between product sales and the revenue ultimately retained by manufacturers.

AIFA reports that during 2024 the application of expenditure ceilings and price-volume agreements generated €122.85 million in manufacturer repayments, of which €100.63 million arose from expenditure-ceiling arrangements and €22.22 million from price-volume agreements. The report associates these measures with 47 pharmaceutical products and 17 repayment provisions. These figures refer to the specific contractual mechanisms identified in the report and must not be equated with the entire Italian pharmaceutical payback system. Rapporto OsMed 2024 — Agenzia Italiana del Farmaco, Section 4.2, Tables 4.2.3–4.2.4. AIFA

Table 8.3 — Contractual pharmaceutical repayments recorded by AIFA, 2024

Mechanism	Repayment amount	Share of reported total
Product expenditure ceilings	€100.63m	81.9%
Price-volume agreements	€22.22m	18.1%
Total	€122.85m	100%

The percentage shares are calculated from AIFA’s reported figures and rounded to one decimal place.

The industrial significance of these arrangements is that manufacturers must evaluate the financial consequences of both successful commercial uptake and changes in reimbursement conditions. A product that treats more patients than initially expected may generate additional gross sales but also trigger payments under its negotiated financial agreement. The resulting effect on profitability depends on product margins, contractual provisions, manufacturing costs and the relationship between volume growth and the company’s other commercial obligations.

For policymakers, the relevant objective is to preserve predictability and transparency regarding the economic consequences of reimbursement arrangements while maintaining appropriate control over public expenditure. The appropriate balance cannot be determined from the total amount repaid by companies alone, because the clinical value of the medicines, their availability and the financial sustainability of continued supply must also be considered.

Critical pharmaceutical dependencies: why clinical importance and market size are not equivalent

The European Commission’s proposal for a Critical Medicines Act identifies manufacturing problems, supply-chain vulnerabilities and global competition for resources among the factors contributing to medicine shortages. The proposal, published on 11 March 2025, seeks to improve the availability and security of supply of critical medicines through industrial projects, procurement measures, cooperation among member states and diversification of international supply chains. These mechanisms address structural conditions that may not be corrected by ordinary market incentives, particularly where the commercial value of an essential medicine is relatively limited compared with the investment required to maintain alternative manufacturing capacity. Critical Medicines Act — European Commission; Commission Proposes New Rules to Ensure Stable Supply of Critical Medicines — 11 March 2025. European Commission

The economic mechanism is straightforward. A manufacturer can operate a clinically essential medicine in a market characterised by limited demand, constrained reimbursement and high fixed costs. Maintaining a second qualified production facility or an alternative supplier may improve healthcare resilience, but the commercial return on that redundancy may be insufficient to justify the investment. In such circumstances, private incentives and public-health objectives can diverge. However, the existence of a critical medicine does not necessarily imply an immediate shortage or justify domestic duplication of every manufacturing stage.

This distinction is reflected in the EMA’s methodology for the Union list of critical medicines. Products are assessed according to the seriousness of the conditions treated and the availability of appropriate alternatives, while additional conditions determine inclusion in the EU list. The EMA explicitly distinguishes the criticality of a medicine from evidence that it is likely to experience a shortage in the near future. Criticality identifies the potential consequences of unavailability; supply-chain analysis is needed to establish the actual vulnerability. Union List of Critical Medicines — European Medicines Agency. European Medicines Agency (EMA)

Table 8.4 — Structural pharmaceutical supply vulnerabilities

Dependency	Potential failure mechanism	Evidence required to establish vulnerability	Possible consequence
Active pharmaceutical ingredients	Loss or interruption of qualified suppliers	Supplier concentration, country exposure and alternative qualification	Production interruption
Biological raw materials	Reduced availability of qualified inputs	Collection, testing and procurement data	Shortage of particular biological products
Specialist manufacturing capacity	Failure at a plant with limited substitutes	Product-specific authorised capacity	Supply interruption despite capacity elsewhere
Sterile processing	Manufacturing or quality-control problems	Facility inspections, deviation records and alternatives	Delays in release or loss of supply
Packaging components	Shortage of product-specific containers or materials	Qualified supplier and inventory records	Inability to finish or distribute medicines
Cold-chain distribution	Temperature-control failure	Validated transport and excursion data	Product losses or unavailable inventory
Regulatory approvals	Delayed approval of alternative facilities or processes	Marketing-authorisation and variation records	Slow recovery of manufacturing capacity
Financial sustainability	Insufficient returns to maintain required capacity	Product margins, investment and supply contracts	Supplier withdrawal or underinvestment
Digital infrastructure	Loss of access to essential validated systems	Continuity and recovery records	Delayed manufacturing, certification or distribution

The vulnerabilities are potential mechanisms, not allegations that all ten companies currently experience these problems.

Talent constraints and the increasing importance of interdisciplinary industrial skills

Pharmaceutical industrial resilience also depends on the availability of specialist personnel able to operate and improve regulated production, conduct research and maintain quality systems. General employment growth is insufficient to establish whether the necessary occupations are available in the required locations. A company may increase its workforce while still facing shortages of experienced validation engineers, biological-process specialists, analytical scientists, regulatory professionals or personnel responsible for industrial computerised systems.

The underlying industrial problem concerns the specificity of pharmaceutical knowledge. Many critical manufacturing activities require personnel who understand both the physical production process and the regulatory evidence needed to demonstrate product quality. In biological production, specialised knowledge may be accumulated through experience with particular cell systems, purification processes or analytical methods. In sterile manufacturing, personnel must understand contamination-control principles, validated operations and the consequences of deviations. These skills cannot necessarily be replaced immediately through ordinary recruitment, particularly where the required experience is specific to a particular process or regulatory environment.

For Italy, the policy question is whether the education, training and industrial labour markets provide a sufficiently reliable supply of these skills to support future investment. The relevant evidence would include vacancy duration, occupation-specific employment growth, wage trends, workforce age distribution, university and technical training outcomes, and the number of experienced personnel available for new production projects. Without such information, statements about a general pharmaceutical talent shortage would remain too broad to support targeted policy intervention.

The workforce challenge also interacts with ownership and internationalisation. Multinational companies can allocate research programmes or manufacturing investments among several jurisdictions, taking into account the availability of personnel capable of commissioning and operating the required facilities. A location with existing specialist teams may offer advantages even where wage costs are higher, particularly when the alternative involves lengthy recruitment and validation processes. Conversely, access to international research networks may allow companies to obtain skills that are unavailable domestically, potentially strengthening their overall development capability while distributing employment across countries.

Financial vulnerabilities: research intensity, portfolio concentration and the ability to maintain industrial capacity

The financial sustainability of pharmaceutical operations depends partly on the relationship between fixed costs, development risk, product revenues and the duration of commercial opportunities. Research-intensive businesses can incur substantial expenditure before a medicine reaches the market, while the outcome of clinical development remains uncertain. Established manufacturing businesses may face different risks involving price competition, capital expenditure, input costs and utilisation of production facilities.

Therapeutic concentration creates additional exposure. A group with a substantial share of revenue derived from a limited number of medicines can be affected by changes in reimbursement, competition, regulatory decisions or clinical practice. Diversification can reduce dependence on an individual product, but acquiring additional businesses also introduces integration costs and financial obligations. Consequently, the effect of consolidation on financial resilience depends on whether the acquired activities provide genuinely distinct revenue and risk exposures.

The industrial-policy assessment should therefore distinguish three categories of financial vulnerability. The first concerns operating economics: whether the revenues generated by products and manufacturing activities are sufficient to support their recurring costs. The second concerns investment requirements: whether the company can finance research, manufacturing modernisation and regulatory compliance over the relevant time horizon. The third concerns financial structure: whether debt obligations, shareholder distributions or acquisition financing materially constrain the resources available for industrial development.

These dimensions cannot be reduced to a single profitability ratio. A company reporting strong operating earnings may face substantial future development commitments, while a business with lower current profitability may possess valuable research assets or strategic manufacturing capabilities. Equally, a company with substantial cash reserves may still choose not to invest in a particular facility if its expected commercial returns are unattractive. The relevant analysis must therefore connect financial capacity to actual investment decisions and the economic characteristics of specific products.

Table 8.5 — Company-specific exposure categories requiring monitoring

Company	Relevant exposure	Principal financial or industrial indicator
Menarini	International portfolio and specialised oncology investment	Research commitments, product concentration and capital allocation
Chiesi	Research-intensive therapies and advanced respiratory technologies	R&D expenditure, therapeutic revenues and development milestones
Angelini Pharma	Pharmaceutical investment within diversified corporate capital allocation	Segment cash flow and pharmaceutical capital expenditure
Recordati	International specialised therapeutic portfolio	Product concentration, financing costs and acquisition integration
Bracco	Specialised diagnostic products and manufacturing assets	Capital expenditure, product demand and plant utilisation
Alfasigma	Acquired therapeutic portfolios and integration requirements	Commercial performance, financing and product-rights obligations
Kedrion	Biological sourcing and capital-intensive processing	Plasma availability, processing costs and investment requirements
Zambon	Therapeutic research and international commercial operations	Product revenues and research investment
Italfarmaco	Specialist medicine development and commercialisation	Product uptake, development expenditure and reimbursement
Dompé	Specialised biological medicines	Development financing, product access and manufacturing economics

The table identifies exposure mechanisms arising from documented business characteristics. It does not assert that any individual company is in financial distress or has experienced a verified failure in the specified area.

Chapter 8 — Key judgments

The Italian pharmaceutical system faces an industrial-policy challenge arising from the interaction between public purchasing, specialised manufacturing costs, product development and the security of medicine supply. AIFA’s official expenditure data establish the financial scale of the national medicines market and the increasing pressure associated with public pharmaceutical spending. European regulatory initiatives demonstrate that medicine shortages and supply-chain vulnerabilities have become matters of collective industrial and health policy. However, criticality, commercial exposure and actual shortage risk must be evaluated separately. The principal requirement is a product-specific assessment of economic sustainability and manufacturing substitutability, supported by reliable data on supply chains, reimbursement conditions and specialist workforce availability.

Chapter 9. Industrial-Policy Options, Consolidation Scenarios and the 2026–2031 Outlook

Pharmaceutical policy must move from general industrial support to the financing of identifiable capabilities and measurable supply resilience

Principal judgment. Between 2026 and 2031, the principal industrial-policy challenge for Italy will be to convert its pharmaceutical manufacturing base and the international capabilities of its corporate groups into durable advantages in advanced production, scientific research, reliable medicine supply and specialised employment. The evidence does not establish that further corporate consolidation will necessarily improve these outcomes. It establishes that consolidation can create additional financial, technological and organisational capabilities, while also introducing risks associated with production concentration, financial obligations and increasingly complex multinational operating structures. Public policy should therefore evaluate investments and corporate transactions according to the capabilities they create or preserve, rather than the increase in consolidated turnover or workforce that they produce.

This approach has direct implications for the design of industrial incentives. A general subsidy linked to the construction of manufacturing capacity may increase nominal productive assets without establishing that the facility can supply a critically needed medicine or operate at commercially sustainable utilisation. A research incentive may increase reported expenditure without ensuring that scientific capabilities, intellectual property or specialist employment remain in the beneficiary jurisdiction. A public programme supporting consolidation may produce larger companies without improving the reliability of the pharmaceutical supply chain. The appropriate objective is consequently to identify specific market or coordination failures and to connect public intervention to observable industrial outcomes.

The European Commission’s proposed Critical Medicines Act provides a relevant institutional framework. Presented on 11 March 2025, the proposal seeks to strengthen the availability and supply of critical medicines and improve access to other medicines of common interest. Its principal mechanisms include the designation of strategic manufacturing projects, public-procurement measures intended to encourage supply resilience, collaborative procurement among member states and international partnerships designed to diversify sourcing. The proposal identifies manufacturing capacity and essential pharmaceutical inputs as matters of European industrial policy rather than treating shortages exclusively as problems of distribution or emergency healthcare administration. Critical Medicines Act — European Commission — March 2025; Proposal for a Regulation on Critical Medicinal Products, COM(2025) 102 final — European Commission — 11 March 2025. European Commission

As of 28 October 2026, the applicable legal status of the Critical Medicines Act must be distinguished from its policy objectives and proposed provisions. The Commission’s presentation of the Act does not by itself establish that every proposed financial incentive, procurement mechanism or strategic-project designation is immediately available to companies. The precise legal authority for any investment programme must be checked against the operative legislative text and the applicable national and European financing rules at the time the programme is established.

Strategic Project designation and the industrial economics of critical manufacturing capacity

The proposed Critical Medicines Act creates a potential framework for supporting manufacturing investments that address critical supply vulnerabilities. Its strategic-project concept is designed to encompass the creation, expansion or modernisation of manufacturing capacity for critical medicines, their active substances or other essential inputs. The industrial rationale is to direct investment towards production capabilities whose availability matters to healthcare continuity, rather than relying solely on aggregate manufacturing growth. Critical Medicines Act — European Commission.

The economic case for such intervention depends on the difference between the private return from additional manufacturing capacity and the public value of supply reliability. A pharmaceutical manufacturer may not have sufficient commercial incentive to maintain a second production line for a medicine whose expected sales are relatively limited, even when the existence of that line would materially reduce the consequences of a disruption at the principal facility. Public support can potentially address this divergence, but only if the investment genuinely reduces vulnerability and does not simply subsidise capacity that would have been constructed without public intervention.

The assessment must therefore establish the baseline supply-chain configuration before determining the need for a new facility. Relevant information includes the number of qualified manufacturers, the location of active-substance production, the availability of alternative facilities, manufacturing lead times, product shelf life, inventory arrangements and the time required to qualify additional suppliers. The value of redundancy cannot be measured from the number of factories alone. Two facilities using the same critical supplier or depending on the same vulnerable logistics route may provide less resilience than their geographical separation suggests.

An effective strategic-project programme would consequently require a defined product or capability, an independently documented vulnerability, a credible investment plan and evidence that the resulting facility can obtain the required manufacturing authorisations. Financial support could then be linked to the creation of validated capacity and to continuing availability obligations, subject to the applicable procurement and state-aid rules.

Procurement reform as an instrument of industrial resilience

Public procurement has a particularly important role in pharmaceutical markets because the procurement conditions applied to medicines can affect the viability of manufacturers supplying public healthcare systems. A tender based predominantly on the lowest unit price may reduce immediate purchasing expenditure, but it can create vulnerabilities if the resulting market structure leaves few economically sustainable suppliers. This does not establish that lower-price procurement is inherently inappropriate. It establishes that procurement should consider the consequences of supplier concentration and the clinical importance of continued supply.

The proposed European framework explicitly recognises procurement as a potential instrument for strengthening supply chains. This creates an opportunity to evaluate supplier diversification, delivery reliability and manufacturing continuity alongside price, within the limits of applicable legal requirements. A procurement system can preserve competitive price discipline while incorporating evidence-based resilience conditions, provided the criteria are transparent, proportionate and connected to the medicines being purchased.

The relevant economic question is how much additional cost, if any, is justified by a measurable reduction in expected disruption. For medicines with readily available substitutes and multiple qualified suppliers, extensive resilience-related procurement obligations may provide limited additional benefit. For medicines with few suppliers, long production lead times or serious consequences from interruption, greater attention to continuity arrangements may be warranted.

The design must also avoid the assumption that national sourcing automatically produces a more resilient supply chain. A domestic manufacturer may depend on imported active substances, while a foreign producer may operate a diversified and reliable international manufacturing network. Supply resilience should therefore be assessed through actual dependencies and operational capabilities rather than nationality alone.

Table 9.1 — Industrial-policy instruments and implementation conditions

Policy instrument	Responsible authority	Intended effect	Principal implementation burden	Main risk
Strategic manufacturing projects	EU institutions and competent national authorities under applicable legislation	Create or modernise critical capacity	Project selection, financing and regulatory approval	Funding capacity without demonstrated need
Resilience-oriented procurement	National and regional purchasers, subject to procurement law	Support reliable medicine supply	Tender design and supplier verification	Higher costs without measurable reliability gains
Collaborative European procurement	Participating member states and authorised EU mechanisms	Aggregate demand and improve access	Coordination of national demand and contracts	Misalignment between participating markets
Industrial R&D incentives	National and EU funding authorities	Support research and technological development	Project evaluation and funding governance	Expenditure without durable capability creation
Workforce-development partnerships	Education authorities, universities and industry	Expand specialised technical skills	Curriculum design and practical training	Skills developed without corresponding industrial demand
Manufacturing modernisation support	Competent industrial authorities	Improve validated production capabilities	Investment, qualification and compliance	Technology installation without operational benefit
Supply-chain diversification initiatives	Manufacturers, regulators and public purchasers	Reduce dependence on vulnerable suppliers	Supplier qualification and commercial agreements	Duplicated costs without meaningful risk reduction
Corporate consolidation oversight	Competition authorities and relevant regulators	Preserve competitive and supply-market conditions	Transaction-specific market analysis	Excessive concentration or loss of alternative capacity

These are policy options, not assertions that all instruments are currently operational or that every authority already possesses the legal powers needed to implement them.

Research incentives and the distinction between expenditure additionality and technological additionality

A major weakness of industrial-policy programmes can arise when expenditure is treated as an outcome. Research expenditure is an important input into pharmaceutical innovation, but the effectiveness of an incentive depends on whether it produces activity that would not otherwise have occurred and whether the resulting knowledge creates economically and clinically relevant capabilities.

This distinction is especially important for multinational pharmaceutical groups because the location of reported research expenditure can be influenced by the allocation of projects among subsidiaries. A research programme supported through public incentives may create domestic scientific employment, but the resulting intellectual property may be owned by another legal entity or subsequently transferred under contractual arrangements. The industrial value retained within the supporting jurisdiction can therefore differ from the nominal amount of expenditure financed.

A credible incentive programme should define its additionality before funding is approved. The relevant question is whether public assistance changes the scale, location, timing or technological ambition of the project compared with the company’s credible alternative investment plan. The answer requires evidence from investment proposals, financing arrangements, research commitments and subsequent implementation. It should not be inferred simply from the announcement of a new laboratory or the creation of additional research positions.

For projects involving advanced therapies or biological production, public support may be justified where the investment creates capabilities with wider spillovers, such as specialist training, research infrastructure or process-development expertise. Nevertheless, the public return should be assessed through measurable outputs, including validated research platforms, completed development milestones, scientific employment, intellectual-property arrangements and the establishment of production capabilities where relevant.

Industrial consolidation: three plausible development pathways

The period 2026–2031 can be analysed through three distinct, potentially overlapping industrial pathways. The available evidence is insufficient to assign defensible numerical probabilities because the outcome of future pharmaceutical consolidation depends on company-specific investment decisions, regulatory developments, financing conditions and the commercial performance of therapeutic portfolios. The scenarios should therefore be interpreted as conditional developments rather than forecasts with invented probability distributions.

Pathway A: capability-led international expansion. Italian-rooted pharmaceutical groups continue acquiring or developing specialised scientific and manufacturing assets, while sustaining high-value research, engineering and strategic functions in Italy. Under this pathway, international growth strengthens corporate competitiveness and contributes to domestic capabilities through new investment, specialist employment and the integration of advanced technologies. The decisive indicators would be increasing investment in Italian research and production sites, the development of new proprietary technologies, successful product authorisations and the retention of critical industrial functions.

Pathway B: scale-led consolidation without substantial domestic technological deepening. Corporate groups increase their international size principally through acquisitions, portfolio transactions and financial integration, while the domestic industrial base remains relatively stable. This pathway could strengthen consolidated financial performance and market access without materially increasing Italian research employment or manufacturing sophistication. It would not necessarily constitute industrial failure, because internationally successful companies can generate economic benefits through management, dividends, taxation and specialised services. However, it would provide a weaker basis for claiming that consolidation has increased Italy’s domestic control of pharmaceutical technologies and production.

Pathway C: concentration and supply vulnerability. Financial, commercial or regulatory pressures encourage the concentration of manufacturing into fewer sites or reduce the number of independent suppliers for particular products. Such a pathway could improve short-term operating efficiency while increasing vulnerability to disruption at critical facilities. Its materiality would depend on whether remaining suppliers possess sufficient qualified alternative capacity and whether procurement and regulatory arrangements permit rapid substitution.

Table 9.2 — Conditional pharmaceutical industrial scenarios, 2026–2031

Scenario	Principal mechanism	Observable confirmation	Evidence against the scenario	Main policy implication
Capability-led expansion	Research, advanced manufacturing and investment in critical functions	New validated facilities, specialised employment and research investment in Italy	Growth confined to foreign acquisitions and commercial assets	Support additionality and high-value capability formation
Scale-led consolidation	Acquisitions and portfolio integration	Higher consolidated revenues with limited domestic capability change	Significant new domestic research or production mandates	Avoid treating corporate size as industrial upgrading
Concentration-driven vulnerability	Reduction of alternative suppliers or production sites	Greater supplier concentration and longer recovery times	Diversified qualified capacity and stronger continuity performance	Target product-specific supply resilience
European supply-chain diversification	Cross-border coordination and additional manufacturing options	More independent qualified suppliers and improved substitution capability	Continued dependence on common bottlenecks	Prioritise coordinated European solutions

The pathways are not mutually exclusive; an individual group may experience more than one over the period. No numerical probabilities or aggregate employment forecasts are assigned.

The 2026–2031 outlook: observable thresholds rather than unsupported numerical forecasts

A five-year industrial assessment should identify conditions under which its principal judgment would change. The evidence currently supports qualitative mechanisms and company-specific indicators, but it does not establish a reproducible forecasting model for the employment, investment or production of all ten groups through 2031.

The principal indicators should therefore concern measurable developments that reveal changes in capability. New manufacturing investment is meaningful when construction is completed, production processes are validated and regulatory requirements have been satisfied. Research expansion is more persuasive when supported by sustained expenditure, qualified personnel and completed scientific milestones. Consolidation can be evaluated through changes in the number of independent suppliers, the location of production and the financial capacity of the resulting organisation. Supply resilience can be measured through actual interruption rates, recovery times and the availability of alternative qualified sources.

A threshold should be associated with a defined operational decision rather than an arbitrary percentage. For example, evidence that a critical medicine depends on a single qualified supplier can justify a detailed assessment of alternative production arrangements, while a demonstrated inability to restore supply within clinically acceptable time limits may justify intervention. The relevant time limit must be established through clinical and supply-chain analysis for the particular medicine; it should not be invented as a universal numerical threshold.

Table 9.3 — Industrial watch indicators and decision conditions

Indicator	Required observation	Decision condition	Responsible assessment function
Critical-medicine supplier concentration	Number of genuinely independent qualified suppliers	Dependency creates clinically material shortage exposure	Medicines regulator and health authorities
Validated domestic capacity	Product-specific authorised manufacturing output	Capacity insufficient under documented disruption scenario	Industrial and regulatory authorities
Alternative supplier qualification	Time and feasibility of switching supply	Recovery exceeds clinically acceptable period	Manufacturer and competent regulator
Research investment location	Country-specific R&D expenditure and personnel	Public support does not create additional domestic capability	Funding authority
Specialist workforce availability	Recruitment duration and skills evidence	Vacancies threaten commissioning or continuity of critical production	Education and industrial authorities
Corporate investment commitments	Completed capital expenditure and facility authorisation	Announced projects fail to reach operational status	Funding and monitoring authorities
Acquisition integration	Constant-perimeter operating and workforce data	Transaction changes supplier diversity or critical capacity	Competition and sectoral regulators
Product availability	Documented shortages and disruption duration	Repeated interruption of clinically necessary treatment	Health authorities
Supply-chain diversification	Independent sources and substitute capacity	Common bottlenecks remain despite supplier multiplication	Procurement and industrial authorities

The table specifies decision logic rather than arbitrary scores. Product-specific criteria and legal responsibilities would need to be established before any binding intervention.

Implementation sequence and administrative feasibility

The effectiveness of pharmaceutical industrial policy depends partly on the sequencing of decisions. Funding a manufacturing project before establishing the relevant supply-chain vulnerability can lead to unnecessary capacity, while designing procurement resilience requirements without understanding the supplier market can create disproportionate costs. Conversely, delaying intervention until a critical product has already become unavailable may leave insufficient time to qualify alternative manufacturing processes.

The first stage should therefore involve a structured assessment of the medicines and capabilities most relevant to national healthcare continuity. The EMA’s critical-medicines framework provides an appropriate starting point, but the European list must be supplemented by national supply information and product-specific analysis. The second stage should identify the causes of vulnerability, distinguishing manufacturing concentration, raw-material dependence, financial sustainability and regulatory constraints. The third stage should select the least burdensome intervention capable of addressing the identified problem.

Where existing qualified suppliers can provide sufficient alternative capacity, procurement diversification or commercial arrangements may be preferable to investment in a new production facility. Where the principal vulnerability lies in the absence of specialised manufacturing capability, direct industrial investment may be justified. Where a shortage reflects limited economic incentives to maintain production, a purchasing or reimbursement solution may be more appropriate than subsidising additional equipment.

These distinctions are essential because pharmaceutical supply risks have different causes, and a uniform policy instrument is unlikely to address them efficiently.

Institutional coordination and the allocation of public responsibilities

The implementation of pharmaceutical industrial policy involves responsibilities distributed among health authorities, industrial ministries, medicines regulators, competition authorities, regional governments and European institutions. AIFA possesses competences concerning pharmaceutical regulation, pricing and reimbursement within the Italian system, while the European Medicines Agency coordinates scientific and regulatory activities at European level. Industrial investment programmes involve different authorities and financial rules, while competition authorities assess particular market structures and transactions under the applicable legal framework.

The existence of several competent institutions creates a need for coordinated information rather than the creation of an additional authority without clearly defined functions. A pharmaceutical manufacturing project may raise questions concerning public funding, environmental permits, regulated production, procurement, workforce training and market competition. These issues require different forms of expertise and different legal decisions.

A coordinated assessment could bring together information from the relevant institutions while preserving their legal responsibilities. Its purpose would be to ensure that investments address documented vulnerabilities and that decisions concerning financing, procurement and industrial capacity are informed by the same underlying evidence. Such coordination should remain proportionate and should not result in unnecessary disclosure of commercially sensitive information.

Chapter 9 — Key judgments

The European policy framework increasingly recognises pharmaceutical manufacturing and supply resilience as matters of industrial strategy. The Critical Medicines Act proposal provides a basis for targeted strategic projects, procurement reform and international supply-chain cooperation, but its proposed mechanisms must be distinguished from legally operative provisions. For Italy, the most defensible policy approach is to support specific capabilities whose absence creates measurable economic or healthcare vulnerabilities. Further consolidation should be evaluated according to its effect on productive capacity, scientific expertise, supplier diversity and financial sustainability, not merely its contribution to corporate size. The 2026–2031 outlook remains conditional because the available evidence does not support numerical forecasts for all ten companies or a defensible probability distribution among alternative development pathways.

Chapter 10. Strategic Recommendations and Final Net Assessment

The central industrial-policy decision is how to convert pharmaceutical competitiveness into durable national and European capabilities

Principal judgment. Italy’s pharmaceutical strategy for the period following 2025 should be based on the distinction between three economic objectives that are related but not interchangeable: maintaining a competitive pharmaceutical manufacturing system located in Italy, strengthening the ability of Italian-rooted companies to create and control advanced technologies, and ensuring that the Italian healthcare system has reliable access to clinically essential medicines. These objectives can reinforce one another, but the evidence does not establish that they will be achieved through the same policy instruments or by encouraging corporate consolidation without reference to its industrial consequences.

A pharmaceutical company may increase its international competitiveness through an acquisition that creates little additional production employment in Italy. A foreign-controlled manufacturer may make an investment that contributes substantially to domestic industrial capacity without strengthening Italian ownership of intellectual property. A medicine of critical clinical importance may require supply-security measures even where its market size is insufficient to justify large commercial investment. The policy challenge is therefore to design interventions that distinguish these cases rather than assume that growth in one indicator automatically generates improvements in the others.

The findings of the preceding chapters support a shift from broad measures of industrial scale towards a more precise evaluation of productive capability, investment additionality, technological ownership and supply continuity. This does not imply that employment, exports or corporate size are unimportant. They remain central dimensions of economic performance, but they must be interpreted in conjunction with the structure of the activities generating them.

The European Commission’s pharmaceutical legislation reform and proposed Critical Medicines Act provide an institutional context for this approach. The former addresses innovation, competition, patient access and medicine availability, while the latter is specifically intended to strengthen the supply and production of critical medicines and improve access to medicines of common interest. Together, they demonstrate the European institutions’ recognition that pharmaceutical policy involves both public health and industrial competitiveness. Their legal status and implementation conditions nevertheless differ, and national measures must be designed within the applicable regulatory, procurement, competition and state-aid frameworks. The Pharma Package — Council of the European Union — September 2026; Critical Medicines Act — European Commission.

Recommendation 1 — Establish a national pharmaceutical capability register linked to critical supply requirements

The first priority is the development of an evidence-based understanding of which pharmaceutical capabilities are available within Italy and how they relate to the supply of clinically essential medicines. Existing statistics provide valuable information about sectoral employment, production and expenditure, but they do not offer a complete product-specific map of manufacturing substitutability, critical inputs and validated alternative capacity.

A capability register should therefore distinguish the physical location of manufacturing, the products each facility is authorised to manufacture, the availability of specialised processing technologies, dependencies on particular suppliers and the ability of alternative facilities to maintain supply during disruptions. The register should not be conceived as a public database containing commercially sensitive operational information. Its purpose would be to provide competent authorities with the minimum information necessary to assess vulnerabilities and prioritise interventions.

The European Medicines Agency’s Union list of critical medicines provides a starting point for selecting products whose availability matters particularly to healthcare continuity. However, inclusion in the list does not establish that a product is already in shortage or that a specific country should manufacture it domestically. The register should therefore combine criticality with evidence of actual supply-chain vulnerability. Union List of Critical Medicines — European Medicines Agency.

The expected benefit is more accurate industrial decision-making. Public authorities would be better able to distinguish situations requiring new production capacity from those where supplier diversification, inventory arrangements or regulatory coordination would provide a more proportionate response. The principal implementation burden would involve data collection, confidentiality arrangements, the reconciliation of facility and product information, and maintaining the register as manufacturing authorisations and market conditions change.

Recommendation 2 — Condition public investment support on verified industrial additionality

The second recommendation is to link industrial incentives to capabilities that can be demonstrated after the investment is completed. For pharmaceutical manufacturing, the relevant outcome should not be the amount of expenditure announced or the number of production lines purchased, but the creation of validated capacity, the introduction of new technologies, the qualification of alternative supply arrangements or the measurable improvement of an existing production process.

For pharmaceutical research, the relevant outcomes may include the creation of specialised scientific employment, the establishment of research infrastructure, completion of development milestones and documented arrangements concerning intellectual property. However, successful clinical outcomes cannot be guaranteed, and public support for research must take account of the inherent uncertainty of pharmaceutical development. The appropriate measure of accountability is therefore the faithful implementation of the supported scientific programme and the achievement of agreed milestones, not an artificial requirement that every funded project result in an authorised medicine.

An effective programme would distinguish between investments that would occur without public intervention and those whose scale, location or timing is materially changed by public support. This requirement is essential for evaluating additionality. The absence of such a distinction creates a risk of public expenditure subsidising investments that companies had already decided to undertake.

Recommendation 3 — Introduce capability-based criteria into the assessment of pharmaceutical consolidation

The third recommendation concerns corporate mergers and acquisitions. Industrial-policy analysis should examine whether a transaction changes the availability of critical production, the diversity of qualified suppliers, the location of strategic research or the financing of important manufacturing facilities.

This does not imply that every pharmaceutical acquisition should be subjected to additional intervention beyond the applicable competition and regulatory frameworks. Rather, where a transaction involves assets of demonstrable strategic importance, the relevant authorities should possess sufficient information to assess its industrial consequences within their legal competences.

The criteria should distinguish the transfer of ownership from the physical closure or expansion of production facilities. An acquisition that leaves production unchanged may alter corporate governance without immediately affecting supply. Conversely, a transaction that reduces the number of independent manufacturers of an essential medicine may create a vulnerability even where the combined company becomes financially stronger.

The appropriate evaluation should therefore consider the number of genuinely independent production sources, the technical feasibility of substituting capacity, and the financial and regulatory conditions governing future operations. Corporate size alone should not determine the outcome.

Recommendation 4 — Integrate pharmaceutical workforce policy with validated industrial demand

Workforce development should be connected to the actual skills required by pharmaceutical manufacturing, research and regulatory operations. General increases in university training or technical education may not address shortages in highly specialised occupations unless programmes are designed around the needs of operating facilities and credible investment projects.

A practical approach would involve structured cooperation among universities, technical institutes, pharmaceutical companies and competent public authorities, with particular attention to biological processing, sterile manufacturing, analytical quality control, process validation, regulatory science and industrial information systems.

The effectiveness of these programmes should be evaluated through employment outcomes, occupational qualification and the ability of participating organisations to recruit personnel for identified industrial functions. The existence of a training programme does not establish that it has increased industrial capacity, just as a reported shortage of qualified personnel does not establish which particular training intervention would resolve it.

Recommendation 5 — Use pharmaceutical purchasing policy to support reliable supply without abandoning expenditure discipline

The fifth recommendation is to improve the alignment between public procurement and supply resilience. For medicines where multiple qualified suppliers and readily available alternatives exist, competitive purchasing can remain a central instrument of expenditure control. Where the clinical consequences of disruption are substantial and supplier alternatives are limited, procurement decisions should also consider the reliability and diversification of supply.

The principal challenge is to avoid creating a system in which resilience is invoked as a general justification for higher prices without evidence of the benefit. Public purchasers should identify the specific vulnerability being addressed and establish how the proposed purchasing arrangements are expected to reduce it.

For example, a contract involving more than one qualified supplier may strengthen resilience when those suppliers operate genuinely independent production systems. It may provide little additional protection if both depend on the same critical input or manufacturing facility. Similarly, contractual supply obligations should be evaluated in relation to the manufacturer’s actual capacity and recovery arrangements.

The European Commission’s Critical Medicines Act proposal explicitly identifies procurement as a possible means of strengthening supply resilience, providing a relevant policy framework subject to the final applicable legislation. Critical Medicines Act — European Commission.

Recommendation 6 — Strengthen the measurement of domestic technological value creation

A sixth priority is the development of a consistent statistical framework connecting pharmaceutical research, patent ownership, manufacturing and corporate control. The evidence reviewed throughout the report demonstrates that the nationality of corporate headquarters and the location of manufacturing activity are insufficient to determine the distribution of technological value.

The appropriate statistical framework should identify research expenditure by location, the number and occupations of research personnel, patent families associated with specific companies and technologies, the ownership of relevant intellectual-property rights and the industrial functions performed by domestic facilities. It should also distinguish internally developed products from acquired or licensed assets.

Such a framework would not require the disclosure of confidential technical details or commercially sensitive contractual provisions to the public. It would require a coherent approach to the classification and analysis of available records, supported by appropriate confidentiality arrangements where necessary.

The European Patent Office’s patent databases, corporate financial disclosures and relevant statistical authorities provide complementary sources for this work. However, no single source provides a complete measure of technological sovereignty. Patent ownership must be interpreted alongside manufacturing knowledge, research activity, regulatory approvals and the ability to commercialise products. PATSTAT — European Patent Office; Espacenet — European Patent Office.

Recommendation 7 — Develop a European approach to critical manufacturing redundancy

The seventh recommendation concerns capabilities whose economic scale or technological requirements make exclusively national solutions inefficient. For certain medicines, maintaining qualified alternative production within the European Union may provide significant resilience even where not every member state possesses its own manufacturing facility.

A coordinated approach would begin by identifying which products or manufacturing stages are difficult to substitute and which facilities could provide alternative capacity. The objective should be genuine diversification of technical and supply dependencies, not the symbolic duplication of every production function across national borders.

European coordination can also reduce the risk of competing national subsidies supporting multiple facilities that ultimately depend on the same limited demand or raw-material suppliers. Where public funding is justified, investment decisions should be informed by the combined requirements of participating healthcare systems and the technical feasibility of maintaining reliable production.

The proposed Critical Medicines Act recognises this principle through provisions concerning strategic projects, collaborative procurement and international partnerships. Proposal for the Critical Medicines Act — European Commission — 11 March 2025.

Recommendation 8 — Establish long-term evaluation standards for publicly supported pharmaceutical investment

Industrial-policy programmes should be assessed over a period consistent with the characteristics of the pharmaceutical projects they support. Research programmes can require multiple years before development outcomes become apparent, while manufacturing investments may require extended qualification and regulatory processes before commercial supply begins.

Short-term expenditure or employment measures therefore provide an incomplete assessment of success. A credible evaluation framework should distinguish implementation milestones, operational capability and longer-term economic or healthcare outcomes.

The appropriate indicators might include completion of construction, achievement of regulatory authorisation, establishment of qualified production, sustained availability of specialist personnel, and measured improvements in supply reliability. The relevant outcome depends on the project. A programme designed to increase critical-medicine manufacturing capacity should not be judged principally by the number of patents generated, while a research initiative should not be evaluated primarily through the immediate creation of commercial manufacturing employment.

These distinctions would make industrial-policy accountability more rigorous while avoiding inappropriate comparisons among projects with different objectives.

Table 10.1 — Strategic recommendations, institutional responsibility and implementation

Recommendation	Competent institutional level	Expected industrial effect	Implementation burden	Reversibility and principal risk
National pharmaceutical capability register	Italian health and industrial authorities, within existing competences	Better identification of critical production dependencies	Data integration and confidentiality management	Reversible methodology; risk of incomplete or outdated information
Capability-based investment incentives	National and EU funding authorities	Creation of verified research or manufacturing capabilities	Project assessment, funding and monitoring	Financial commitments may be difficult to reverse; risk of weak additionality
Consolidation assessment	Competition and sectoral authorities under applicable law	Better identification of transaction-related industrial vulnerabilities	Transaction-specific evidence collection	Decisions may have long-term effects; risk of disproportionate intervention
Specialist workforce partnerships	Education and industrial authorities	Greater availability of technical personnel	Training investment and company participation	Programmes adaptable; risk of mismatch with demand
Resilience-oriented procurement	Healthcare purchasers and competent public authorities	Stronger supply continuity	Tender redesign and supplier verification	Contracts adjustable at renewal; risk of unnecessary cost
European manufacturing diversification	EU institutions and participating member states	Reduced dependence on critical production bottlenecks	International coordination and industrial investment	Capacity investment less reversible; risk of duplication
Domestic technology measurement	Statistical and relevant industrial authorities	Improved assessment of national value creation	Data reconciliation and classification	Methodology adaptable; risk of misleading indicators
Long-term programme evaluation	Funding authorities and independent audit functions	More accountable public expenditure	Collection of project-specific performance data	Evaluation framework adjustable; risk of excessive administrative burden

The table specifies proposed institutional responsibilities rather than asserting that all recommendations can be implemented immediately under existing law.

Implementation priorities for 2026–2031

The recommendations should be organised according to the type of evidence and institutional preparation required, rather than implemented simultaneously without a defined sequence.

During the initial phase, the priority should be to establish the evidence needed for product-specific supply-chain analysis and investment decisions. This includes identifying critical medicines, reconciling existing industrial data and selecting the vulnerabilities that warrant further investigation. A second phase would connect these findings to financing, procurement and workforce programmes designed around specific industrial objectives. Subsequent evaluation would determine whether the supported projects actually created the intended capabilities.

The sequence should remain adaptable because pharmaceutical investment and supply conditions can change. A newly identified shortage or the closure of a critical production facility may require an earlier intervention, while a proposed manufacturing investment whose economic case remains uncertain may warrant further analysis before public funds are committed.

Table 10.2 — Indicative implementation sequence

Period	Principal institutional activity	Expected deliverable	Decision criterion
2026–2027	Reconcile critical-medicine and domestic capability data	Initial product-specific vulnerability assessments	Evidence sufficient to identify material supply risks
2027–2028	Develop targeted investment and procurement programmes	Projects with defined industrial and healthcare objectives	Demonstrated additionality and legal feasibility
2028–2029	Implement selected capacity, training and diversification measures	Qualified projects progressing towards operation	Verified implementation milestones
2029–2030	Evaluate operational performance and supply continuity	Comparable project and product-level outcomes	Evidence of meaningful capability improvement
2030–2031	Review programme effectiveness and future financing requirements	Updated industrial priorities	Continued public benefit relative to cost

The periods are a proposed administrative sequence, not an official government timetable or a forecast that particular projects will be completed within these dates.

Financial discipline and the conditions for public intervention

Public support for pharmaceutical industry development should be justified through an identifiable public benefit that cannot be obtained as effectively through ordinary private investment or less burdensome measures. This requirement is particularly important where large pharmaceutical companies possess substantial financial resources and are capable of financing commercial projects independently.

An industrial investment can generate wider benefits through specialised employment, scientific knowledge, local supplier development and improved medicine availability, but the existence of potential benefits does not establish that public funding is necessary. The assessment should identify what would occur without intervention and how the proposed support changes that outcome.

For projects involving essential medicine supply, the relevant benefit may concern reduced vulnerability to interruption rather than an increase in conventional economic output. Such benefits can be difficult to value because major shortages are uncertain events. Nevertheless, the absence of a precise monetary estimate should not justify arbitrary scoring. Authorities should instead document plausible disruption scenarios, the expected effectiveness of available interventions and the principal uncertainties.

Where public funding is provided, contractual arrangements should establish reporting obligations, implementation milestones and the consequences of material non-performance, consistent with applicable law. The objective is to protect public resources while allowing companies sufficient flexibility to manage scientific and industrial uncertainty.

Final Net Assessment: Italy’s pharmaceutical sovereignty is a question of capabilities, not corporate nationality alone

The transformation of the Italian pharmaceutical industry between 2000 and 2025 produced a complex industrial structure in which domestically located production, Italian-rooted multinational companies, international financial ownership and specialised pharmaceutical technologies coexist. The evidence establishes the importance of Italy as a pharmaceutical manufacturing and export location, while the corporate analysis demonstrates that internationalisation has involved different combinations of acquisition-led expansion, scientific development, production specialisation and portfolio diversification.

The original employment comparison cannot sustain a uniform conclusion that all ten groups achieved equivalent forms of growth or that their global headcount increases represent additional Italian employment. The strongest historical evidence supports significant international workforce expansion for certain companies, while the acquisition and ownership records demonstrate that corporate perimeter changes are material to the interpretation of those figures. For several groups, the absence of comparable year-2000 employment disclosures remains a decisive limitation.

The technological evidence provides a more substantive basis for identifying industrial upgrading. Regulatory authorisations, research expenditure, advanced therapeutic partnerships and specialised manufacturing operations demonstrate that selected companies have developed or acquired significant pharmaceutical capabilities. These achievements are economically important, but their implications for the Italian industrial territory depend on the location of research, manufacturing, intellectual property and strategic decision-making.

The European comparison further establishes that Italy competes for pharmaceutical investment within an integrated international economy. Germany, France and the United Kingdom offer different combinations of scientific, manufacturing and commercial capabilities, while European regulation increasingly recognises the need to reconcile innovation, patient access and the security of medicine supply. Italy’s competitiveness consequently depends not only on the ability of its companies to expand globally, but also on the attractiveness and reliability of its domestic industrial environment.

The financial and healthcare evidence reveals a corresponding policy challenge. Pharmaceutical expenditure, reimbursement arrangements and supply-security requirements interact with the commercial economics of individual medicines. Measures intended to reduce public expenditure may influence manufacturers’ returns, while policies intended to support domestic industry must remain justified by identifiable economic or healthcare benefits. Neither objective can be pursued effectively through aggregate indicators alone.

The principal conclusion is that further pharmaceutical consolidation will enhance Italian industrial resilience only where it creates or preserves capabilities that are technologically significant, economically sustainable and demonstrably relevant to production or healthcare continuity. Larger corporate organisations can improve financial capacity, international market access and the ability to invest in specialised technologies. They can also increase organisational complexity or concentrate supply dependencies. The direction of the effect must be established from the assets, capabilities and operating arrangements involved.

For Italian policymakers, the decisive requirement is to move beyond a general strategy of supporting national pharmaceutical champions towards a more precise framework for evaluating scientific knowledge, industrial production, critical supply and the conditions under which public intervention creates additional value.

For European policymakers, the complementary requirement is to preserve the benefits of cross-border integration while ensuring that critical medicines and manufacturing inputs do not depend on fragile or insufficiently diversified supply arrangements. National ownership and European resilience are not identical objectives, and neither can substitute for an evidence-based assessment of actual industrial capabilities.

The ten companies examined in this report illustrate the transformation of Italian pharmaceutical entrepreneurship into a set of internationally operating industrial organisations with different technological strengths, financial structures and strategic priorities. Their future contribution to Italy will depend less on the number of additional employees incorporated through corporate transactions than on the research programmes they sustain, the manufacturing technologies they develop, the productive investments they locate in Italy and the reliability with which they participate in European and international pharmaceutical supply.

The essential policy distinction is therefore between corporate enlargement and industrial deepening. The first can be demonstrated through changes in consolidated assets, revenue and employment. The second requires evidence that scientific, productive and organisational capabilities have improved in ways that strengthen long-term competitiveness and resilience.

Italy’s pharmaceutical industrial strategy should be judged against the second standard.

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