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Thomson Reuters Explores the Opportunities and Challenges of Entering the Japanese Generic Drug Market
Date:10/1/2009

PHILADELPHIA and LONDON, Oct. 1 /PRNewswire/ -- Thomson Reuters announced today the publication of a white paper identifying opportunities and challenges facing foreign companies interested in entering the Japanese generic drug market.

The white paper, titled "The Japanese generic drug market: opportunities and strategies for success," notes that a combination of major patent expirations prior to 2012, a rapidly aging population and wide-ranging government initiatives to reduce healthcare spending are making the Japanese generic drugs sector increasingly attractive to foreign manufacturers.

Mark Garlinghouse, senior vice president, Asia-Pacific, at Thomson Reuters, said, "As Japan's generic market is beginning to expand, market growth rates in established generic markets such as Europe and the United States are trending downward sending generic drug companies seeking opportunities to enter new markets. Japan is the world's second largest pharmaceutical market; however, at present generics make up only 6.6 percent of its prescription drug sales."

The white paper explores the probable impact of the recent change in government in Japan on the generic industry. The incoming Democratic Party of Japan has signaled that it intends to continue to support the promotion of generic pharmaceuticals; however, in its July 2009 manifesto, the party claimed that "even though generics are judged to be equivalent to the brand-name drug, the current tests for equivalence are insufficient, and we will promote the collection of additional information to be used in further evaluation of generics."

"We don't know yet what form this 'additional information' and 'further evaluation' will take," Garlinghouse said, "but it will likely mean that generic regulation in Japan could become even tighter. The Japanese market is very focused on quality and only those companies with a proven quality track record can hope to succeed there."


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