Why China Matters to the Future of Clinical Development
Sungin Hong
Sungin Hong
VP, Asia Pacific, SSD

As the demand for clinical trials continues to grow around the world, geographic expansion into Asia is increasing and for good reason. Drug development is complicated, time consuming, and expensive particularly in the US and Western Europe. Recruiting and retaining patients is also challenging resulting in longer lead times and higher costs. Asia, with a regional population of over 4 billion, offers attractive resources such as numerous clinical trial centers, a vast patient pool, and comparable incidence and prevalence of Western diseases.

While globally clinical trials are expected to grow at a compound annual growth rate (CAGR) of 12.4% from 2015 to 2020, topping out at $57 billion in revenue, North American expected growth is only at 10.4% CAGR, while Asia is forecasted to grow at a CAGR of 19.9% over the same time period. (Frost & Sullivan, Asia: Preferred Destination for Clinical Trials, 2016).

As regulatory uncertainty in India made it nearly impossible for sponsors and CROs to run clinical trials, they looked to shift clinical trial activity to other Asian markets. China is now the second largest pharmaceutical market in the world and PRA Health Sciences is making a significant commitment to the region as it continues to strategically expand operations and local expertise.

Sponsors want relevant clinical study experience and capabilities across all phases, language proficiency, and technological expertise. PRA’s innovative operational models, such as its dynamic partnership and joint venture with Takeda in Japan, allows the company to expand its full-service presence in the region and globally.

PRA has been delivering innovative drug development solutions in China for nearly a decade offering specialized operational and therapeutic expertise through a broad spectrum of full-service clinical development and integrated outsourced operating models. With more than 200 clinical studies conducted in APAC in the past 5 years, and 130 currently underway, PRA has an experienced team on the ground.

PRA currently has over 400 employees in China and is looking to add another 100 positions. New offices are opening in Dalian and Shanghai, in addition to existing offices in Shanghai and Beijing. In building out infrastructure with key resources, the goal is to establish the most comprehensive and flexible offering in the region to support clients with global and China specific trials, embedded teams, and in-house biometrics.

While China is quickly becoming a preferred clinical research destination, navigating the complexity of treatment paradigms, local laws and regulatory requirements can be challenging. Due to China’s massive cabinet restructuring within the State Health Committee there is some uncertainty about what the new Clinical Trial Application process will look like. As the regulatory environment improves, China is poised to become an even bigger clinical research powerhouse and PRA is making the necessary investment in the best talent and infrastructure to help support this growth.

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PRA operates in Australia, China, Hong Kong, India, Indonesia, Japan, Malaysia, New Zealand, the Philippines, Singapore, South Korea, Taiwan, Thailand, and Vietnam