Why Europe is Becoming a Global Hub for Biologics Manufacturing

• Europe is rapidly positioning itself as the global leader in biologics manufacturing, fueled by strategic investment, a unified regulatory framework, and a surge in biopharma innovation. 
• With over €55 billion invested in R&D and a growing network of advanced CDMOs, the region offers unmatched end-to-end capabilities for biologic drug production. 
• Biopharma companies seeking scalable, high-quality, and regulatory-aligned manufacturing solutions increasingly turn to Europe as the ideal launchpad for global success. 

Europe’s emergence as a global hub for biologics manufacturing is a multi-faceted success story. Driven by strong market growth, strategic investment, a collaborative pan-EU approach, and unparalleled regulatory expertise, Europe has built a thriving biopharma industry that is contributing profoundly to global health. From innovative monoclonal antibodies to lifesaving biosimilars, European science and industry are delivering results. The EMA’s high standards ensure these therapies set benchmarks for quality worldwide, while EU-wide initiatives continue to future-proof the sector through 2030 and beyond. The region’s biotech sector generated nearly $480 billion in revenue in 2023 and is forecast to grow at double-digit rates (~13% CAGR) through 2030. 

As biologics and biosimilars become ever more central to healthcare, Europe’s leadership not only bolsters its own economy but also benefits patients around the globe. By proving that cutting-edge innovation and cost-effective production can go hand in hand, Europe is charting a path for sustainable growth in the biopharmaceutical arena – truly becoming the global center of gravity for biologics manufacturing in the years ahead. 

The Rise of Biologics Manufacturing in Europe 

Biologics (large-molecule drugs produced via biotechnology, such as therapeutic proteins and antibodies) have become a cornerstone of Europe’s pharmaceutical landscape. Biologic medicines now account for roughly 41% of all prescription drug spending in Europe, reflecting their growing importance in treating diseases from cancer to autoimmune disorders. In 2024, EU countries spent an estimated €228 billion on medicines at list prices, of which about €95 billion was on biologics [1].  

This marks a dramatic rise over the past decade, as biologics’ share of the market continues to expand. The economic impact of life sciences in Europe is enormous – the sector contributes nearly €1.5 trillion in value to the EU’s economy and supports 29 million jobs across member states [2]. Not only is Europe a major consumer market for biologic therapies, but it is also a major producer: European companies (and European sites of multinational pharma companies) manufacture many of the world’s top biologic drugs. 

Several European countries host state-of-the-art biologics production facilities. Ireland, for example, has become a global biologics manufacturing hub with numerous large-scale vaccine and antibody production plants. Germany, France, Switzerland, the Netherlands, and emerging players in Eastern Europe (like Poland) all contribute to a robust production capacity across the continent. This collective capacity is reflected in Europe’s significant share of the global biotech industry – about 30.9% of the worldwide biotechnology market in 2023, second only to North America [3]. 

Fig. 1. Summary of the European biotech market in 2025. 

Moreover, Europe’s biotech sector is growing faster than many other regions, thanks to strong private and public investment. The European Federation of Pharmaceutical Industries and Associations (EFPIA) reports that the biopharmaceutical industry invested €55 billion in R&D in Europe in 2024, supporting 2.6 million jobs in the region [4]. Such investment in innovation further cements Europe’s capacity to develop and produce high-value biologic drugs. 

Key Factors Driving Europe’s Leadership in Biologics Production 

Europe boasts a rich life sciences heritage, with world-class universities, research institutes, and a history of breakthrough discoveries. The monoclonal antibody technology itself was co-pioneered by European scientists, and many Nobel prizes in medicine originate from European labs. This strong knowledge base produces a highly skilled workforce for biotech R&D and biomanufacturing. It also means a steady pipeline of innovation – from academic spin-offs to mature biotech companies – driving new biologics development. 

Europe’s regulatory environment for biologics is considered gold-standard globally. The European Medicines Agency (EMA), through its centralized approval process, ensures that biologic drugs meet rigorous safety, quality, and efficacy criteria for all EU markets. Notably, Europe pioneered biosimilar regulation, establishing a framework in 2004 and approving the world’s first biosimilar in 2006. Since then, EMA’s guidelines for biologics (including complex products like gene therapies and vaccines) have often set benchmarks adopted by other regulators. The EMA’s proactive approach – e.g. continually updating scientific guidelines and promoting international harmonization – gives companies in Europe a clear pathway to develop advanced biologics. This regulatory clarity and high standard bolster global trust in biologics “Made in Europe” and accelerate their adoption worldwide. 

The European Union provides a single, consolidated market of 27 countries with a combined population of ~450 million. A biologic drug approved by EMA gains access to all member states, simplifying market entry and scaling up production. Furthermore, EU initiatives foster collaboration across borders – from research consortia to manufacturing networks. This integration mitigates the fragmentation that could otherwise hinder innovation. It also means that expertise and technology diffuse quickly across Europe: for example, a cell therapy technique developed in France can be trialed in Germany and manufactured in Belgium with relative ease. Unlike the U.S. model of a few geographic hotbeds, Europe’s approach creates multiple centers of excellence – in effect linking diverse regional hubs into one giant innovation ecosystem. Biotech clusters in the UK–Oxford/Cambridge (even outside the EU), Germany’s Rhineland, France’s BioValley, Denmark-Sweden’s Medicon Valley, Poland’s emerging biotech scene, and others collectively form a distributed yet cooperative network. This broad base spreads know-how and production capacity widely, making the EU as a whole a more resilient and comprehensive biomanufacturing hub. 

Last but not least, Europe has invested heavily in high-end biomanufacturing infrastructure – from fermentation and cell culture facilities to fill-finish and cold chain logistics. Many global pharma companies maintain their flagship biologics plants in Europe due to the skilled workforce and reliable quality systems. European contract development and manufacturing organizations (CDMOs) likewise offer state-of-the-art facilities for hire. Importantly, Europe is relatively self-sufficient in key inputs for biologics. For instance, 77% of the active ingredients for innovative biologic medicines produced in the EU are sourced within Europe itself, indicating a high degree of supply chain autonomy [5]. This internal supply of critical raw materials (cell lines, cultures, reagents, etc.) reduces dependency on external markets and enhances Europe’s competitiveness. 

Investment, Innovation, and Infrastructure Behind Europe’s Growth 

Europe’s ascent in biologics manufacturing is not happenstance; it is being actively propelled by strategic investments and policy initiatives. Recognizing the critical role of life sciences in economic and public health, the European Union has launched a comprehensive strategy to boost biotechnology and biomanufacturing across the bloc. A prime example is the EU’s Strategy to Boost Biotechnology and Biomanufacturing, unveiled in 2024 and now under implementation, which marshals significant funding and regulatory reforms to supercharge the sector. 

The EU is funding international R&D collaboration – for example, dedicating €170 million under Horizon Europe to a flagship action aligning research funders worldwide on climate and health challenges. Under the Horizon Europe research program, the Commission will mobilize up to €100 million (in 2026–27 work programs) to develop and deploy microbiome-based solutions. An additional €250 million is earmarked for cross-sector life science technologies, including novel methodologies, advanced materials, and more efficient biomanufacturing processes. Europe’s strategy also looks outward, recognizing that being a global hub means engaging in global partnerships. These investments aim to ensure Europe remains at the forefront of scientific innovation and can translate discoveries into manufacturable products. 

To speed up the path from lab to market, the European Commission is proposing an “EU Biotech Act” that will create a more innovation-friendly regulatory framework across biotech sectors [2]. 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. Additionally, the EMA and national regulators are experimenting with tools like “regulatory sandboxes” for emerging technologies, giving developers space to innovate under supervision. 

The EU is launching platforms to connect startups, investors, and industry partners – effectively matchmaking innovators with the resources they need. One such initiative is a new Biotech and Biomanufacturing Hub (hosted on the “Your Europe” portal), which serves as a one-stop shop for companies seeking information on funding opportunities, research infrastructure, intellectual property guidance, and regulatory requirements [6]. By centralizing these supports, the Hub lowers barriers for small biotech firms to scale up in Europe. It also leverages networks like the Enterprise Europe Network to provide mentorship and access to broader EU programs. The goal is to foster a vibrant ecosystem where even SMEs can plug into continental value chains and succeed in bringing biologic products to market. 

To drive demand for innovative biologics (and other life science breakthroughs), the EU is putting money on the table via public procurement. The Commission will mobilize €300 million to stimulate the purchase of life science innovations in areas such as next-generation vaccines, advanced therapies for cancer, and climate-resilient healthcare solutions [7]. By acting as an early buyer (or co-funder) of novel biologics and related technologies, public authorities can help new products gain traction, benefiting patients while de-risking innovators. Europe is also encouraging member states to adapt procurement and reimbursement systems to reward innovation – for instance, valuing the long-term health and cost benefits of a new biologic, not just the upfront price. Such measures aim to boost the uptake of home-grown innovations and ensure that regulatory approval is followed by real-world access for patients. 

All these efforts are part of a broader vision. The European Commission explicitly aims to make Europe the most attractive place in the world for life sciences by 2030. The coordinated life sciences strategy spans the entire value chain – from research funding and clinical trial networks to skill development and market access – ensuring that innovation can be born, grown, and retained in Europe. Backed by over €10 billion per year from the EU budget, this roadmap addresses current gaps (e.g. fragmented innovation ecosystems, need for better AI/data use in biotech, faster market uptake of new drugs) and leverages Europe’s strengths (scientific excellence, universal healthcare systems, etc.). 

End-to-End Biologics Manufacturing Expertise – Europe’s Competitive Edge 

One of Europe’s distinctive advantages in the biologics arena is its end-to-end manufacturing expertise. The continent offers the full spectrum of capabilities needed to bring a biologic from concept to delivered product, often within an integrated framework. European CDMOs and biotech firms pride themselves on providing “one-stop-shop” services: everything from cell line development, process optimization, and clinical-scale manufacturing to large-scale commercial production, fill-finish, and even distribution can be handled by experienced players within Europe. This end-to-end model is highly attractive to biopharma companies that want to streamline supply chains and ensure quality control at every step. 

Europe’s edge is further evident in logistics and distribution – an often overlooked but critical part of biologics manufacturing, given many of these medicines are temperature-sensitive or have short shelf lives. The EU’s single-market logistics framework (with no customs barriers among member states) means that once a biologic drug product is made, it can be swiftly transported to clinics and pharmacies across Europe. Specialized cold-chain logistics providers abound, and some CDMOs even have in-house logistics units to handle the transport of drug substances and clinical trial samples under controlled conditions. 

Finally, Europe’s end-to-end strength is reinforced by an emphasis on partnerships and consortia. European stakeholders frequently collaborate through initiatives that bring together academia, biotech, CDMOs, and pharma companies to solve manufacturing challenges or develop platform technologies. EU-funded projects (under programs like Innovative Health Initiative or Horizon Europe) often focus on bioprocess innovation, training biomanufacturing talent, or creating shared facilities – all of which enhance the collective capability. This culture of collaboration means knowledge is shared and best practices are adopted widely, keeping Europe at the cutting edge of manufacturing science. When combined with individual companies’ vertical integration, it creates an ecosystem where a drug can go from DNA to delivered dose with world-class efficiency. This end-to-end prowess is a compelling reason why more biologics are being made in Europe – the region can deliver the full package of development, production, and distribution better than many others. 

Among Europe’s many CDMOs, Mabion stands out as a prime example of this end-to-end excellence. Based in the heart of Europe (Poland), Mabion offers fully integrated biologics development and manufacturing services. The company’s capabilities span from cell line and process development through upstream and downstream processing, analytical testing, GMP manufacturing in commercial scale, and regulatory support. Uniquely, Mabion also operates an in-house logistics department – a rarity in the CDMO space – which allows it to transport drug substances, final drug products, and clinical samples across Europe under controlled conditions. This means clients can rely on one partner for the entire journey of their product. By choosing a truly end-to-end European CDMO like Mabion, biopharma companies can focus on their core science, confident that every step from bench to bedside is expertly managed. It is this kind of comprehensive service offering – rooted in Europe’s talent, infrastructure, and unified market – that underpins the continent’s growing reputation as the place to develop and manufacture biologics. 

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. As the first region to embrace biosimilars, Europe has accumulated over 15 years of real-world experience with these medicines, demonstrating that they can safely expand patient access and reduce costs. The impact has been substantial: biosimilar competition in Europe has delivered an estimated €56 billion in healthcare cost savings from 2013 to 2024, allowing health systems to reallocate resources to other innovations and treat more patients. Dozens of high-cost biologics – for conditions like rheumatoid arthritis, oncology, diabetes – now face biosimilar competitors in the EU, often driving prices down by 20-50% or more over time. Patients have benefited through broadened access to effective biologic therapies that were previously budget-restricted. This European success story has not gone unnoticed globally; it arguably paved the way for markets like the US, Canada, and Japan to adopt biosimilars in recent years. 

Looking ahead, Europe’s role in the biosimilar arena will remain pivotal. Many more biologics are coming off patent in the next decade, opening the door to new biosimilars that can further revolutionize treatment affordability. It is projected that by 2030, around 100–110 biologic medicines (worth nearly €30 billion in annual sales) will lose exclusivity in Europe [1]. These include blockbuster antibodies and enzyme therapies as well as smaller-market biologics. Each such loss of exclusivity is an opportunity for multiple biosimilar versions to be developed and brought to patients. If even a portion of these upcoming biologics see successful biosimilar launches, the savings to European healthcare systems could be enormous – potentially another €10–15 billion over the subsequent years, and even greater patient access gains. Indeed, biosimilars are becoming integral to the sustainability of healthcare: without them, many health systems would struggle to afford cutting-edge biologic treatments for all who need them. 

Globally, Europe’s leadership in biosimilars sets a template for other regions. As of 2025, Europe still accounts for about 40% of the global biosimilars market by value (down from 75% a decade ago as other countries catch up) [1]. European manufacturers and joint ventures are increasingly supplying biosimilars beyond Europe – for instance, to emerging markets that are building biologics access programs. The EMA’s standards often serve as a benchmark for WHO guidelines and national regulators when approving biosimilars elsewhere. In this sense, Europe’s experience is being exported to benefit patients worldwide. By 2030, one can envision a more balanced global biosimilar landscape, but Europe will likely remain a center of excellence, continually developing next-generation biosimilars 

Conclusion

Realizing this future requires continued commitment to innovation and favorable policies. Europe faces some challenges, such as ensuring there are enough incentives for companies to invest in developing biosimilars for smaller patient populations or very complex molecules. The development costs for biosimilars can be significant, and as the easiest targets (like insulin and simple antibodies) get covered, the remaining ones may be more scientifically and economically challenging. The European Commission and organizations like Medicines for Europe are aware of this “biosimilar void” risk and are discussing measures to address it – for example, optimizing regulatory pathways (to avoid unnecessary duplication of trials), aligning pricing/reimbursement to reward sustained competition, and encouraging physicians and patients to embrace switching to biosimilars where appropriate. The EMA is also doing its part by exploring ways to streamline biosimilar approvals (such as accepting more sophisticated analytics in lieu of some clinical studies when appropriate). Given Europe’s proactive approach historically, it is likely the region will adapt and continue to foster a healthy biosimilar market. 

FAQ

Prepared by:

Jakub Knurek

Marketing Specialist

j.knurek@mabion.eu

Jakub Knurek

Marketing Specialist

Jakub Knurek is a marketing and business development expert specializing in CDMO operations with scientific and biopharmaceutical background. During the COVID-19 pandemic, he contributed to the development of the Novavax protein vaccine. As a side project, he runs his own pharma company.

As the author of numerous articles, he is recognized as an important voice of the younger generation of scientists. He is a member of Mabion’s representation at industry trade shows, including BIO International Convention 2025 in Boston, 2nd Global Biologics India 2025 in Hydrabad, CPHI 2024 in Milan, CPHI 2023 in Barcelona, Life Sciences Baltics 2023 in Vilnius. He actively participates in academic, business and industry discussions, such as the “Building the Future Pharma Workforce” panel at CPHI Milan 2024.

References

1. IQVIA, Impact of Biosimilar Competition Report 2024. 8th Biosimilar Multistakeholder Event. Brussels, 2024. 
2. European Commission, Commission launches new strategy to make Europe a global leader in life sciences by 2030. Brussels, 2025.  
3. Grand View Horizon, Europe Biotechnology Market Size & Outlook Report, 2023-2030. San Francisco, 2025. 
4. European Federation of Pharmaceutical Industries and Associations, Europe’s choice -Europe has the potential to be a leader in the research, development and production of new medicines. Brussels, 2024. 
5. EuropaBio, Biomanufacturing: Europe’s Industrial Future. Brussels, 2025. 
6. European Commission, Commission launches new Biotech and Biomanufacturing Hub to support innovative companies. Brussels, 2025. 
7. European Commission, European Commission expected to earmark around €300 million to acquire innovations in life sciences. Brussels, 2025.