The move is part of an industry push to avoid the nation’s regulatory delays and higher costs - many Japanese hospitals are unable to test dozens of people, making it faster and cheaper to recruit patients elsewhere in Asia, according to Akihisa Harada, who heads clinical research at Pfizer’s unit in Tokyo, Bloomberg News reports.

Slower regulatory review in Japan means products typically enter the $65 billion market four years after release in the US or Europe, delaying profits. Pfizer last year tested 30 meds in Japan, compared with 99 worldwide, but studies in Japan can cost twice as much as in the US and Europe, according to Harada. “Japan is an extremely large market, but there is no growth,” Harada told a Kitasato University-Harvard School of Public Health Symposium in Tokyo this week. “The markets in China and Korea are relatively small, but companies can expect growth from their investments.”

The pharmaceutical market is forecast to expand 2 percent this year in Japan, where government-mandated price cuts on medications every two years erode growth, according to IMS Health, which also predicts 12 to 13 percent growth in China and Korea, Bloomberg writes. You may recall that both Glaxo and Novartis are leaving Japan for China.

Last June, Pfizer announced plans to spend $300 million on R&D in South Korea, five months after saying its research center in Japan will close. “It’s somewhat natural to pick South Korea as an alternative R&D center in Asia because it costs less, while Korean doctors have relatively good medical expertise,” Bae Ki Dal, an analyst with Good Morning Shinhan Securities in Seoul, tells Bloomberg. “It’s likely South Korea will see more companies following Pfizer.”

Japanese approval is also slower than in the US or Europe because of regulatory hurdles. In most cases, Japan’s drug agency requires that experimental medicines be studied in at least some Japanese patients to prove efficacy and safety. The proportion differs according to the therapeutic category and consideration is given for data from other East Asian nations, Bloomberg notes.

Japan wants docs to undertake as many clinical studies as other Asian countries by 2012, according to a five-year plan released by the health ministry in 2007. The country aims to supply at least a quarter of new drugs developed globally, Toshihiko Takeda, director of the health ministry’s economic affairs division, told participants at the conference. The health ministry, he added, wants Japan included in international trials so local regulators can review the research data at the same time as their counterparts overseas.

More than 236 drug reviewers are being hired to reduce approval time by 30 months, according to the Pharmaceuticals and Medical Devices Agency in Tokyo. Last year, 40 hospitals were selected for research upgrading so they can handle bigger patient groups, Bloomberg notes. Hospitals undertaking clinical research in Europe enroll 3.5 times more patients than Japanese facilities and US hospitals recruit 18 times more patients, the Office of Pharmaceutical Industry Research in Tokyo said in a 2006 report. About 100 patient studies are now being run in Japan, Takeda said. The number fell to 56 in 2004 from 95 in 1996, according to health ministry data.

Glaxo plans to shut its drug research base in Japan and is spending an initial $40 million on its first Chinese site, with plans to hire as many as 50 scientists at its Shanghai facility. And Novartis will close a research center in Japan and is building a $100 million center in Shanghai that will employ 400 people by 2010.

Source: Bloomberg News