China is rapidly becoming one of the most important countries in the world for the conduct of clinical trials on pharmaceuticals, according to consultancy firm Kline & Co.
The attraction of China as a low-cost manufacturing base is already well-established, with most of the top 10 drugmakers already operating in the country in this capacity. But many of the world’s leading drug makers are also including China in their clinical research plans, attracted by the country’s vast population, ethnic variation, broad disease profile and rich source of scientific expertise.
At the end of 2004, there were already more than 250 trials in progress, all sponsored by multinational companies and representing an increase of about 25% over the number of trials ongoing in 2002.
Leading the way are companies like Roche and AstraZeneca, which are now operating their own clinical trial centres in China, attracted by the expansive 1.3 billion population, as well as the potential for rapid patient recruiting, according to Kline.
For example, AstraZeneca has made no secret of its view that, as the pharmaceutical industry moves away from its blockbuster drug developmental model to one focusing on developing treatments for people with specific genetic profiles, it is invaluable to have access to as wide a human gene pool as possible, China’s ethnic diversity provides just that resource, it believes.
Another major factor behind the readiness of multinationals to conduct studies in China is the country’s fast-improving intellectual property environment, as well as last year’s legislation to streamline the drug development and approval process.
“By 2010, China is predicted to be the fifth-largest pharmaceutical market in the world,” says Li Wang, author of the report and managing director of Kline’s office in Shanghai. “As China improves its clinical resources and regulatory processes, it’s becoming an increasingly competitive market for major clinical trials.”
As with manufacturing, cost is also likely be a factor. In the US and Europe, the investment required for developing a successful new drug has rocketed to around $1 billion, largely due to the high cost of clinical trials as well as high attrition rates.