Innovation and Harmonization on the Rise
As R&D costs continue to hit new heights and domestic participation in clinical trials wane, more and more biopharmaceutical companies are seeking ways to mitigate costs and access new patient populations. Over the past decade, these driving market forces have contributed to a sharp rise in R&D activities, pharmaceutical market size, and the number of clinical trials conducted in Asia.
Historically, large biopharmaceutical companies have maintained their operational infrastructure in Europe and the US while they accessed the new patient population in Asia via global trials. However, recent trends mark a noticeable uptick in the number of these biopharmaceutical companies and supporting service providers moving R&D functions and commercial operations to Asia as well as growth in the number of domestic Asian drug development companies.
The continued maturation of Asia's drug development market is largely being fueled by growing innovation, harmonization of regulations and a growing talent pool.
Asian governments, including Korea and China, are fostering increased innovation in novel drug development. Beijing for example, has made faster development of research-based pharmaceuticals a national priority, even identifying the segment as one of seven “pillar” industries to promote in its 2011, 5 year plan. Similarly, this past decade, Japan's Pharmaceuticals and Medical Devices Agency (PMDA) has seen success in reducing almost by half, the time to review and approve drugs.
In a continuing effort to accelerate and enable more efficient drug development, Asia-based regulatory agencies are collaborating across multi-regional clinical trials (MRCT) and harmonizing regulations. In fact, several initiatives are underway to increase cooperation between countries including the Association of Southeast Asian Nations (AEAN) harmonization, the “Comprehensive Economic Cooperation Agreement (CECA)” between India and Singapore, and the “Cross-Straits Economic Cooperation Framework Agreement (ECFA)” between Taiwan and mainland China. Additionally, alignment with ICH Guidelines remains on a track towards eventual fruition.
Once a major obstacle, R&D talent in China has seen large growth over the last decade and this new trend is being reflected across other countries in Asia. Highly skilled executives are returning to their native Asian countries and new scientists are graduating at greater numbers from University fueling a skills job market. In Malaysia for example, major initiatives are underway to attract a further number of Malaysian-born skilled talent back from abroad.
As Asia's Drug Development market continues to mature, international pharmaceutical and drug development service organizations will continue to see opportunities in countries central to its growth, including China, Korea, Japan, India and Singapore. These opportunities will allow for access to fresh patient populations, faster enrollment and increased number of clinical trials with potential to reduce drug development times and associated costs.