Europe is at a critical juncture in its biomanufacturing landscape, facing a significant production gap compared to the US and China. Industry advocates are calling for a second Biotech Act to address these shortcomings and strengthen Europe’s position in the global market.
The Current State of European Biotech
In December 2025, the European Commission (EC) unveiled Biotech Act I, a regulatory framework aimed at streamlining clinical trial approvals and enhancing biomanufacturing capacity. This initial legislation is geared towards health biotechnology and is designed to facilitate easier access to funding within the European Union (EU). However, there is a pressing need for a follow-up act that encompasses a broader range of industrial biotechnologies, anticipated to be proposed by the end of 2026.
A recent competitiveness report highlighted the stark contrast in investment and regulatory environments between Europe and its global counterparts. From 2015 to mid-2025, US biopharma startups attracted approximately €219 billion in venture capital, while European firms garnered a mere €25 billion. Furthermore, the time taken for clinical trial approvals is significantly longer in Europe—averaging 113 days compared to just 60 days in the US and China.
The Implications of the Biotech Act
The European Biotech Act introduced an Investment Pilot aimed at mobilizing €10 billion over two years, partnering with the European Investment Bank Group (EIBG). It also streamlined clinical trial pathways and provided a 12-month supplementary protection certificate (SPC) extension for innovative biotech medicines produced in Europe.
Despite these advancements, the Act has been criticized for overlooking the vital area of industrial biomanufacturing, where Europe is lagging behind its competitors. Miriam Monge, head of market strategy and advocacy at Sartorius, emphasizes the need for a policy framework that recognizes manufacturing capacity as a strategic asset. She asserts that while Act I is a positive step for health biotech, the industrial component is crucial for strengthening supply chain resilience.
Global Competition and Strategic Priorities
The competitive landscape is further complicated by aggressive initiatives from other regions. China’s five-year plan identifies biomanufacturing as a strategic priority alongside cutting-edge technologies like 6G and quantum computing, with specific targets for pharmaceutical production. In contrast, the US launched its National Biotechnology and Biomanufacturing Initiative in 2022, committing $2 billion to bolster domestic biomanufacturing infrastructure. Although recent political changes have curtailed some of these initiatives, earlier tariff strategies from the Trump administration spurred substantial investments in domestic biomanufacturing.
Europe, despite its bioeconomy and biopharma sectors contributing over €3 trillion to the EU economy in recent years, finds itself struggling to keep pace with global manufacturing trends. The continent’s share of global active pharmaceutical ingredient (API) drug master files has plummeted from 49% in 2000 to just 7% in 2021. Concerns have escalated, with pharmaceutical CEOs warning that a planned investment of €16.5 billion could be redirected to the US unless Europe implements swift regulatory reforms.
The Call for Act II
In light of these challenges, nearly 40 European industry organizations recently united to advocate for a dedicated Biomanufacturing Act II. This coalition includes leading entities such as EuropaBio, the European Federation of Pharmaceutical Industries and Associations (EFPIA), CropLife Europe, and the Bio-based Industries Consortium (BIC). Claire Skentelbery, director general of EuropaBio, describes Act II as “the missing piece of the puzzle” for enhancing the EU’s global competitiveness.
The specifics of what Act II will entail remain uncertain, as the Commission has not yet released a formal proposal. Optimistically, stakeholders hope for more clarity by 2027, but the joint statement underscores the urgent need to foster an advanced manufacturing ecosystem within Europe. As Skentelbery notes, the goal is to take charge of Europe’s biomanufacturing destiny rather than passively allowing it to be shaped by external forces.
The Road Ahead
The implications of the European Biotech Act for the biotech sector will be a focal point during the upcoming BPI Europe keynote. This event promises to shed light on the future of biomanufacturing in Europe and its potential to reclaim its competitive edge.
As Europe navigates this complex landscape, the call for a comprehensive biomanufacturing strategy becomes increasingly urgent. The potential for innovation and growth within the continent’s biotech sector is immense, but only with the right policies and investments can it hope to thrive.
Key Takeaways
- Europe is significantly behind the US and China in biomanufacturing investment and regulatory efficiency.
- The initial Biotech Act focuses on health biotech but largely neglects industrial biomanufacturing.
-
Industry leaders advocate for a second Biotech Act to address the gaps and enhance Europe’s competitiveness.
-
Swift action is necessary to prevent a redirection of investments away from Europe.
-
A unified voice from industry organizations emphasizes the importance of a strategic approach to biomanufacturing.
In conclusion, Europe’s biomanufacturing challenge is a pivotal issue that requires immediate attention. The proposed second Biotech Act could be a game-changer, enabling Europe to harness its strengths and secure a leadership position in the global biotechnology arena. The time for decisive action is now.
Read more → www.bioprocessintl.com