EU Biotech Act Aims to Close Widening Global Competitiveness Gap

Industry Insights from Next Move Strategy Consulting

A stark warning has been issued by the European Commission regarding Europe's weakening position in the global biotechnology sector, highlighting a widening gap with competitors like China and the United States. The urgency to act was underscored during a parliamentary hearing on the newly introduced EU Biotech Act, which aims to establish a more forward-looking regulatory environment for the critical sector.

A Deepening Competitiveness Crisis

Presenting the data to the European Parliament's research and industry committee, Rainer Becker, director for medical products and innovation at the Commission, stated plainly: "We have, unfortunately, a competitiveness gap, and that gap is widening." The figures reveal a clear trend of Europe falling behind in key areas of clinical development and investment.

While Europe maintains an excellent scientific base, particularly in health biotechnology, its ability to translate that research into commercial and therapeutic success is faltering. Becker pointed to China's rapid rise as an illustration of the shifting global landscape, noting its share of global clinical trials has surged from less than 10% to nearly 30% over the past decade. In contrast, Europe's share has halved from around 20% to roughly 10%.

The investment disparity with the United States is even more pronounced. US investment in biotech start-ups is more than nine times that of the EU. This capital market gap is further evidenced by the fact that 66 out of 67 highly promising European biotech start-ups that went public in the last six years chose to list on the US Nasdaq rather than on European exchanges.

The EU Biotech Act: A Response to Urgency

This sense of a growing crisis was a primary motivation for the accelerated publication of the European Biotech Act. The legislative package is intended to create a regulatory framework that can better support the sector's growth within Europe. The first part, focusing on health biotechnology, was released on November 16, 2025. A second part concentrating on industrial policy is anticipated in the third quarter of 2026.

"We are facing an immediate urgency to act in the sector," Becker emphasized, stressing the need to ensure biotech innovators not only originate in the EU but also choose to remain and scale their technologies there. Despite the high stakes, the parliamentary discussion on the Act attracted notably little interest, with the chamber nearly empty—a fact that did not go unnoticed by attendees.

Morten Løkkegaard of the Renew Europe Group commented on the sparse attendance, stating, "The fact that we are only eight or ten people together in this room that we need to broaden communication in order to show just how important is."

Strategic Outlook from Next Move Strategy Consulting

According to analysis by Next Move Strategy Consulting, the data presented by the Commission signals a critical inflection point for Europe's bioeconomy. The widening gap in clinical trial activity, venture investment, and capital market participation is not merely a statistical trend but a direct threat to the region's long-term health security, economic resilience, and scientific sovereignty. The success or failure of the EU Biotech Act in reversing these trends will have profound implications, potentially redirecting the global flow of life sciences talent and capital for decades. This legislative initiative represents a decisive test of Europe's ability to translate regulatory ambition into a competitive, innovation-friendly ecosystem that can retain its homegrown scientific champions.

A Call for Action and Engagement

The European Commission's warning presents a clear challenge: Europe possesses the foundational science but is losing the race in translation, scale, and market creation. The proposed Biotech Act is a direct response to this challenge, aiming to build a more supportive environment. Its ultimate impact, however, will depend on broader political engagement and a concerted effort to make Europe a more attractive home for biotech innovation from lab to listing.

Source: Science Business

Prepared By: Next Move Strategy Consulting