Over the past decade, the European Economic Area (EEA) has seen a marked decline in its role as a hub for clinical trials.
In 2013, approximately 22% of global industry-sponsored clinical trials were conducted within the EEA. By 2023, that figure had dropped to 12%, even as the global clinical trials market grew by nearly 40% over the same period (Ref: EFPIA Annual Report 2024).
Multiple structural factors contributed to this erosion such as: regulatory heterogeneity, protracted ethical review procedures and inconsistent national implementation of EU-level reforms. However, the landscape is shifting. As the United States, historically dominant in this sector, contends with abrupt funding reversals and workforce cuts, a policy window may be opening for Europe to reassert itself.
Recent political developments in the United States have introduced significant uncertainty for clinical researchers and sponsors. Following the 2025 presidential inauguration, the Department of Health and Human Services (HHS) announced workforce reductions exceeding 10,000 positions. The National Institutes of Health (NIH) has reportedly cancelled over 300 vaccine-related grants, including those focused on mRNA platforms and emerging infectious disease surveillance.
Simultaneously, the U.S. Food and Drug Administration (FDA) has lost approximately 3,500 staff, raising concerns over regulatory bottlenecks and longer investigational timelines. Industry groups have expressed alarm, and several biotech firms are reportedly re-evaluating U.S.-centric development strategies in favour of more stable jurisdictions.
According to the European Federation of Pharmaceutical Industries and Associations (EFPIA), the U.S. continues to outperform Europe across key trial metrics, including time to first patient enrolment. In 2020, median time from application to first dose was 155 days in the U.S., compared with 226 days in Germany, 253 days in the U.K. and 266 days in France (Ref: EFPIA 2023 Regulatory Performance Data).
Meanwhile, China now hosts 18% of global commercial trials, benefiting from centralised regulatory oversight and consistent trial funding, particularly for Phase I studies. Patient recruitment costs remain substantially lower than in both Europe and the U.S. (Ref: McKinsey & Co., 2023 China Clinical Research Outlook).
Europe is not standing still. Recent years have seen coordinated efforts to enhance trial attractiveness across the bloc. The EU Clinical Trials Regulation (CTR 536/2014), fully implemented in 2022, replaced the older Directive (2001/20/EC) and introduced the Clinical Trials Information System (CTIS), enabling single-entry, multi-country applications and centralised assessment for multinational trials.
At the national level, several member states have introduced reform packages:
- Germany’s National Pharma Strategy (2023–2027) prioritises digital clinical data infrastructure, regulatory simplification and pricing innovation to attract investment
- France’s Innovation Santé 2030 allocates €500 million to streamline trial approvals and bolster drug development pathways.
- Spain has emerged as a European leader, combining streamlined approvals with generous tax incentives for Research & Development (R&D). AstraZeneca, Roche and Novartis have announced major R&D expansions in the region, citing public-private alignment.
The United Kingdom, despite its post-Brexit divergence, has made significant pledges. A £400 million initiative will support new Clinical Research Delivery Centres across under-served regions and policymakers are targeting a reduction in trial setup times from 250 to 150 days.
Notwithstanding these reforms, external risks remain. U.S. policy volatility may boost Europe’s relative appeal, but protectionist trade measures could reverse some gains. President Trump’s 2025 tariff proposals, while not yet applied to pharmaceuticals, have included speculative discussions of 25% levies on foreign drugs. Such measures could significantly reduce the competitiveness of European-developed therapies in the U.S. market.
In addition, renewed interest in Most Favoured Nation (MFN) pricing—which links U.S. drug reimbursement to the lowest global reference price—could deter companies from launching in lower-price markets first, further complicating European HTA strategies.
A March 2025 EFPIA survey of pharmaceutical CEOs estimated that €16.5 billion in planned EU research investments could be at risk if trade tensions escalate. EFPIA has formally warned the European Commission that, absent meaningful structural reforms, biopharma innovation may drift permanently toward North America.
The way forward must include:
- Further harmonisation of ethics and regulatory reviews within the CTR framework;
- Real-time trial infrastructure investment across all member states, not just historical leaders;
- Incentivisation of manufacturing localisation, reducing exposure to cross-border tariff regimes;
- Formal talent pipelines to attract displaced U.S. researchers, as envisioned in the EU’s proposed “Union of Skills” initiative.
Europe’s re-entry into global clinical trial leadership is not a foregone conclusion. While the U.S. faces considerable internal challenges, and China continues its rise, Europe must urgently translate policy intent into operational capability. The opportunity is real, but so is the risk of further decline if coordination and consistency falter.
To compete effectively, Europe must offer not just an alternative to U.S. instability, but a demonstrably superior environment for high-quality, ethically sound, cost-effective clinical research. If it can do so, the EEA, and associated partners such as the UK, could see their role in shaping future therapeutic innovation meaningfully restored.