EU Biopharma Strategy: Scaling Up to Tackle Funding Gaps and Drive Innovation

On Day 2 of CPHI Frankfurt 2025, we caught the tail end of the keynote presentation “State of Biopharma — Rethinking Innovation Amid a Shifting Landscape,” moderated by Montserrat Daban, director of Strategic Foresight & International Relations at Biocat and featuring Daniel Fleischanderl, head of Upstream Development, Development Operations Austria at Boehringer Ingelheim RCV; Emma West, CEO & co-founder at Digital Biology; Lisa Peng, director at Kline Group; and Thomas Halfmann, COO at consigliere tom gmbh. The speakers provided an overview of the challenges and strategic responses facing the European biopharma sector, emphasizing the need for increased competitiveness against other global regions like the US and China.

The current dialogue surrounding European biopharma strategy and regulation underscores a vital moment for the continent’s biopharmaceutical sector, which finds itself at a critical inflection point demanding accelerated adaptation and scaled capabilities to maintain global competitiveness, according to the panel. They note that the overarching strategic imperative is clear: Europe must successfully convert its complex regulatory and financial challenges into tangible opportunities to secure a leading position against global rivals. Their discussion identified major legislative overhauls and strategic activations that are set to redefine the industry’s operational landscape over the next five to seven years.

What is driving Europe’s regulatory and strategic shift in biopharma?

The catalyst for this sweeping strategic overhaul stemmed from a "wake up call" delivered through three influential reports—the Draghi Report, the Letta Report, and European Life Sciences Strategy—which collectively serve as the foundational guidance for current European Commission policy, noted the speakers. These reports highlighted significant structural issues within Europe’s single market, suggesting that it might be based on industries that are "too little complex" compared with international counterparts. Crucially, the analysis revealed that private pharmaceutical investment in Europe has stagnated and is falling behind the US and China. This situation created an urgent need to accelerate, scale, and "flex" activities across the sector, while increasing focus and funding for research hubs to effectively compete globally. Draghi's analysis, specifically focusing on pharma, stressed that private pharmaceutical investment must grow relative to other regions.

The discussion turned to a response from the European Commission in the form of a flurry of "activations." Key strategies include the Biotech Act, the Clean Industrial Deal, and a new life sciences strategy to “make Europe the most attractive place in the world for life sciences by 2030,” the latter of which features flagships dedicated to clinical trials and advanced therapies. Other related initiatives include the single market strategy, the EU Stockpiling Strategy linked to the Health Emergency Preparedness and Response Authority, and efforts within the new multi-annual financial framework post-2027 to address funding gaps and optimize ecosystems through the European competitiveness plan. The goal of these initiatives is to ensure faster market access and uptake of innovation.

How must the biopharma industry adapt to the new regulatory environment?

The immediate future is dominated by numerous legislative proposals that impact the bio economy, pharma, and biotech industries, requiring industry participants to be closely involved in their formation, the panel discussion noted. The proposed Pharma Package, for example, was viewed positively for promoting a faster and more digital industry structure. However, concerns remain regarding potential negative impacts, such as reduced intellectual property protection and diminished competitiveness. Similarly, while the Biotech Act signals Europe’s strategic commitment to the sector, delays in drafting the legislation are causing industry "nervousness," necessitating alignment with the Commission to ensure a favorable outcome.

The speakers note that technological preparedness is also crucial. The industry faces a key deadline in 2026 for the implementing acts of the European Health Data Space Regulation, which will fundamentally change how industry accesses and utilizes data. Furthermore, the requirements of the EU Artificial Intelligence Act, with its varying risk levels, must be carefully considered. The industry must engage with the numerous channels available—including communications with the Council, Parliament, and Commission—to ensure these regulations are feasible and act as enablers rather than barriers to innovation, the panel states.

The speakers stress that while companies must adapt to these forthcoming changes, they must simultaneously contribute to shaping them: "At the same time, we need to adapt... and also be able to give back our thoughts through the channels we have at our level to make sure that it also is activated as a driver and enabler and not a barrier for that." Competition is intensifying, particularly from regions like China, which is the panel described as "rushing and really going fast forward" in development, especially in manufacturing and value chain evolution. The overarching lesson from the panel is that Europe must learn these lessons and embrace innovation rapidly to avoid falling further behind. The ability of the European biopharma sector to seize this critical moment and manage risks will determine its momentum and future global success.