Europe is rapidly emerging as a global leader in biologics manufacturing, driven by strategic investments, regulatory excellence, and a robust biopharma ecosystem.
With €55 billion in annual R&D spending and a unified market of 450 million people, the EU offers unmatched potential for biopharma innovation and production.
Biologics now make up 41% of prescription drug spending in Europe, reflecting their central role in healthcare.
The European Medicines Agency (EMA) sets global regulatory benchmarks, while the continent’s distributed innovation model provides a powerful alternative to the US biopharma hub system.
The Rise of Biologics Manufacturing in Europe
Biologic medicines – including monoclonal antibodies, biosimilars, and therapeutic proteins – have transformed Europe’s pharma landscape and significantly increased demand for biologics manufacturing capacity across the region.
In 2024, EU countries spent €95 billion on biologics out of €228 billion total pharma spending. Europe accounts for nearly 31% of the global biotech market, with major production hubs in Germany, France, Ireland, Italy, Poland, and Switzerland.
The vast majority of European biotech companies are private SMEs, with only a minority being publicly traded on stock exchanges. For instance, Belgium’s biotech sector has 300+ companies with biotech activities, yet only a handful are listed.
Across Europe as a whole, publicly listed biotech firms likely number in the few hundreds, whereas private biotech companies number in the many thousands.
The life sciences sector adds €1.5 trillion in economic value and supports 29 million jobs across Europe. Moreover, Europe’s biotech sector is growing faster than many other regions, thanks to strong private and public investment.
Key Factors Driving Europe’s Leadership in Biologics Production
Europe boasts a rich heritage in the life sciences, with world-class universities, research institutes, and a history of groundbreaking discoveries. The European regulatory environment for biologics is considered the gold standard worldwide.
Through a centralized approval process, the European Medicines Agency (EMA) ensures that biologics meet stringent criteria for safety, quality, and efficacy across all EU markets.
Notably, Europe pioneered the regulation of biosimilars, establishing a regulatory framework in 2004 and approving the world’s first biosimilar in 2006.
The EU’s single market allows seamless scaling of biologics across member states, with robust cross-border collaboration between academic and industrial players.
Unlike the U.S., where innovation is regionally clustered, Europe hosts a distributed network of biotech hubs—from Oxford and Medicon Valley to Central and Eastern Europe.
Investment, Innovation, and Infrastructure Behind Europe’s Growth
In 2025, the European Commission launched a Biotech and Biomanufacturing Hub to support SMEs and startups with funding and regulatory access.
Horizon Europe is allocating €100M for microbiome solutions, €250M for advanced life sciences technologies, and €300M for public procurement of next-gen biologics.
The EU also proposes an “EU Biotech Act” to streamline regulatory approval, promote cross-border cooperation, and encourage public-private partnerships.
This could involve streamlined approval processes, adaptive regulatory pathways for novel therapies, and better alignment of rules across member states.
By reducing red tape and uncertainty, Europe hopes to encourage companies (especially startups) to develop new biologics in the EU.
End-to-End Biologics Manufacturing Expertise – Europe’s Competitive Edge
In Europe, all major CDMOs operating in the biopharmaceutical sector have a significant presence. As of 2025, Europe’s pharmaceutical outsourcing sector is supported by about 337 CDMO companies, which collectively operate over 550 manufacturing facilities on the continent.
These CDMOs provide services ranging from drug substance production to finished dosage manufacturing for biotech and pharma clients.
Europe’s integrated CDMO ecosystem offers complete services from cell line development to distribution, forming one of the most advanced biologics manufacturing support infrastructures worldwide.
The region is self-reliant for 77% of biologic ingredients, enhancing supply chain security. Logistics infrastructure and single-market access support timely delivery across the continent.
Mabion, a Poland-based CDMO, exemplifies this model. Offering upstream and downstream processing, fill-finish, and in-house logistics, Mabion delivers end-to-end solutions with regulatory support across Europe.
Its ability to transport clinical and commercial products across EU borders highlights the operational efficiency of European biologics CDMOs.
Future Outlook for Biosimilars in Global Healthcare
Biosimilars represent one of the most significant contributions of Europe to global healthcare, and their future outlook is closely tied to Europe’s ongoing leadership. Europe pioneered biosimilar regulation and remains a global leader, accounting for 40% of global biosimilar value in 2025.
These drugs have saved €56 billion across EU health systems from 2013 to 2024. As 100+ biologics lose exclusivity by 2030, biosimilar uptake will continue to rise.
With EMA’s streamlined approval and growing market trust, Europe is positioned to lead the next wave of biosimilar innovation, shaping global access to biologic therapies.
