Top Therapeutic Areas In The Asia Pacific Clinical Trial Landscape

The Asia-Pacific region has emerged as a clinical trial hub due to the ease of regulatory compliance, low trial costs, rising patient population, and the availability of top clinical institutions as trial locations. The cost per patient in Asian nations is significantly less than in Western economies across all therapeutic areas and phases. Many experts in the region agree that data management, biostatistics, and laboratory testing, including bioanalytics, are the actual areas where differences can be seen, with the Asia Pacific region being about 40 percent less expensive than the United States and Europe. Asia-Pacific hence offers a lower-cost healthcare ecosystem in addition to the vast patient pool, simplified regulations, increased intellectual property/legal rights and favorable access to cutting-edge technologies.

By streamlining the overall review and approval procedure, for instance, the regulatory bodies in China are aiming to improve the clinical trial process. Conducting trials in China has been fast tracked since the 2016 regulatory reforms. The application procedure, which once took up to two years, is now completed in 10 months. Clinical trial applications are now approved by the China State Food and Drug Administration (SFDA) in half the time to what it did previously. The review and approval of clinical trials have improved because of regulatory reforms. China also modified its IND review process in 2019, which has positive effects on trial efficiency. Additionally, the time it takes for regulatory agencies to approve applications for clinical trials has decreased from 265 days to 65 days on average. The majority of Asia-Pacific authorities now accept data from the US and EU. As a result, applicant companies can avoid repeating studies, register more quickly, maintain extended market exclusivity, and possibly speed up the delivery of treatments to patients.