Study: Europe’s share of clinical trials is declining amid shift toward Asia
The number of clinical trials authorized in the EU and European Economic Area (EEA) has decreased by 13.5% from pre-pandemic levels as Asia has captured a growing share of clinical research.
According to a recent analysis published in The Lancet Regional Health, the number of trials dropped from an average of 1,989 between 2013 to 2019 to 1,721 from 2022 to 2025.
The most significant reductions were observed in non-commercial and Phase IV trials, while the clinical trials landscape in Europe is increasingly focused on multi-phase, multinational, and biologics research.
The study, authored by Tiago Machado from Portugal’s National Authority of Medicines and Health Products (INFARMED), along with co-authors from the European Medicines Agency (EMA) and INFARMED, emphasizes the need for targeted policy support and regulatory guidance, especially for research led by academic sponsors.
For the analysis, the authors reviewed 25,320 trials authorized in at least one EU member state from 2013 through 2025. The work relied on public data from the European Union Drug Regulating Authorities Clinical Trials (EudraCT) and the Clinical Trials Information System (CTIS). The study excludes Phase I trials and trials conducted exclusively in the United Kingdom.
“Adoption of multi-phase designs increased. The proportion of trials involving biologic medicinal products rose to nearly half (49.1% in 2025), accompanied by growth in advanced therapy medicinal products. Multinational trials showed a modest rise, with non-commercial trials remaining predominantly mononational,” the authors wrote.
The authors noted that the global clinical trial landscape is experiencing significant changes. While Europe and the United States have traditionally been the leaders in registered trials, Asia has recently increased its share. At the same time, the regulatory environment in the EU/EEA has transformed considerably due to the introduction of the Clinical Trials Regulation and the launch of the CTIS.
They further noted that the ongoing revision of the Pharmaceutical Legislation, which is nearing final approval, along with the recently published EU Biotech Act, aims to create an environment that supports innovation in the EU from development to market.
The authors wrote that “the EU clinical trials landscape has recently adopted a new regulatory paradigm and is currently adapting to an increasingly competitive global research environment. To preserve a competitive EU/ EEA environment for clinical research, ongoing policy efforts should ensure the regulatory framework remains agile enough to support innovation in study designs and therapeutic modalities, while further facilitating clinical research, including for academic sponsors addressing matters with limited commercial attractiveness. Notably, the transparency mandates introduced by the CTR offer new opportunities for public accountability and oversight.”
