More and more Western medical device and diagnostics firms are choosing to conduct clinical trials in Asian countries. This trend is expected to grow over the next decade. Western companies are in particular expanding clinical trial operations to Japan, China, South Korea, and Singapore.
At the same time, a growing number of device trials are also being conducted in Southeast Asia. The Association of Southeast Asian Nations (ASEAN) is composed of 10 countries with a combined population of 620 million and a combined GDP of almost $2.5 trillion. ASEAN nations are currently working to harmonize their medical device and pharmaceutical regulatory frameworks, which should make multi-country clinical trials easier to conduct in Southeast Asia.
There are a variety of reasons why Western medical device firms are choosing to do their clinical trials in Asia. Companies can save up to 50% on trial costs in Asia, when compared with trials in the U.S. or Europe. Asian countries often offer good patient access, high patient retention rates in trials, and a treatment naïve population. Furthermore, many Asian countries are upgrading their regulations to conform to global clinical standards — and regulatory agencies in the U.S. and Europe are increasingly accepting clinical trial data from Asia.
However, Western medical device companies also face challenges when conducting clinical trials in Asia. These challenges include language differences, intellectual property protection, and differing regulatory frameworks and requirements. In addition, this growth in the number of clinical trial operations in Asia does not include India, which has seen clinical trials plummet by 80%.