In his presentation at China Trials 2008 in Shanghai, “Conducting Global Post-Marketing Surveillance Studies in China—Opportunity and Practical Issues,” Mark Engel, president and chairman of Excel PharmaStudies, a large China-based contract research organization, identified two megatrends that will drive post-marketing surveillance studies to China: the rapid aging of its population and its increasingly insured rural population.

With Congress recently giving approval for the U.S. Food and Drug Administration to enforce post-marketing studies by fining sponsor companies for not doing them, the clinical research environment has become subject to more stringent requirements than expected. Engel described the fallout: Clinical trials are now larger than expected, their duration is longer and their requirements are broader. As an example, he said that any diabetes submission now requires a long-term cardiovascular surveillance study.

“There is a tremendous, rapid rise in surveillance projects in China,” Engel said.

He cited costs that were 30% of the U.S., access to patients and speed as factors in sponsor companies deciding to go to China. But, what will really drive the market in the future is the fact that more of China’s population will be insured in the coming years. More will be seeking medical care and will be able to spend money for it.

“The ruralization of healthcare is the next great driver,” he said.

Engel broke down the patient pool of 1.3 billion in China by insurance coverage: 250 million people have insurance coverage; another 250 million are partially covered by insurance; and 800 million have limited insurance coverage.

The rural population in China is rarely enrolled in a health insurance plan, but this will change, Engel said. In 2015, people living in rural areas of China will receive $150 each from the government to spend on medical care.

Twenty percent of longer-term patients in urban hospitals are already from rural areas, according to Engel.

Engel explained that there are 700 million people in the rural market, served by 1 million rural physicians and that there will be a rapid increase in rural physicians. There are already “significant programs to educate rural physicians” in place, he said.

Envisioning the China of 2015, Engel sees the number of products available increasing and the standard of care available improving. “Treatment regimens will change and the professionalism of physicians will change. Distribution costs to rural areas will drop 14% within the next four years.”

At that time, Engel also believes that “it will be much, much easier to enroll larger numbers of patients.” If clinical research infrastructure keeps up with the pace of ruralization of healthcare, China should continue growing its clinical research market.