The biopharma clinical research landscape has undergone significant transformation over the past five years, driven by technological, environmental, societal, regulatory, and geopolitical shifts. According to the IQVIA Institute, these changes have not only reshaped the clinical trial pipeline and introduced new global players but also posed challenges such as execution delays, capacity concerns, and ongoing uncertainty. This evolution has made the prioritization of clinical trial countries a critical focus for stakeholders across the sector.

The IQVIA Institute reports that the duration of clinical trial enrollment has increased by 26% across all phases over the past five years. This extended duration has been accompanied by a decline in clinical trial country utilisation. Simultaneously, key drivers of trial complexity have been rising. Geopolitical, health, and environmental disruptions have exacerbated uncertainties within the clinical trial ecosystem, indicating a pressing need to diversify country utilisation to mitigate timeline and disruption risks.

The distribution of clinical trials by region has experienced dramatic changes. Western Europe’s share of global clinical trials has declined by 21%, falling from 32% to 25% of the global total. Similarly, Eastern Europe’s share has decreased by 33%, from 17% to 11%. In contrast, North America’s share has increased by 17%, from 19% to 23%, and China’s share has surged by 57%, from 10% to 15%.

The IQVIA Institute has introduced a Clinical Trial Readiness Score, which ranks countries by trial type and identifies specific investment and improvement opportunities to increase the utilisation of potentially underutilised countries. This score provides an industry-wide and stakeholder-wide view of readiness for clinical trials.

Country utilisation has become heavily consolidated in the U.S., China, and Western European countries. The top 10 most used countries account for 58% of the total average pipeline country use, with the United States and China responsible for 16% and 13%, respectively, of total country- use for trials started between 2021 and 2023. The next 10 countries represent 19% of the country-use share, the next 30 countries 20%, and the remaining 95 countries account for only 3% of total country-use.

In light of the shifting clinical trial capabilities and capacity, the IQVIA Institute emphasises the necessity of a systematic approach to assess country readiness for clinical trials. A transparent country prioritisation process is essential to inform near- and long-term clinical trial allocation and global investment decisions. This process should address key questions, such as identifying characteristics of successful countries, determining countries with the highest clinical trial readiness, and evaluating opportunities for greater or lesser inclusion in clinical trials.

The analysis by the IQVIA Institute highlights next-tier opportunities by evaluating countries based on patient availability and operational readiness. Smaller Western European countries such as Denmark, Ireland, and Belgium, as well as Central and Eastern European countries including Bulgaria, Romania, and Poland, show potential for increased trial activity. While these countries may not top the Readiness Scores due to lower patient availability or trial saturation concerns, they offer valuable insights for future clinical trial investments.

The evolving biopharma clinical research landscape underscores the necessity for strategic global diversification to enhance trial efficiency and ensure better patient outcomes. As the IQVIA Institute’s findings suggest, a concerted effort to diversify country utilization and adopt a systematic approach to country readiness assessment will be crucial in navigating the complexities of the modern clinical trial ecosystem.