Byline Craig Morgan NZCS, MBA (Hons), PMP, goBalto, Inc.
The Japanese pharmaceutical market is the world’s second largest behind the US, representing 9.7% of the world pharma market in 2013, with sales estimated at $115 billion. According to Deloitte, the industry’s annual average growth rate of 2.2 percent is expected through to 2018, with revenues totaling $128 billion. Though a highly attractive market, historically Japan has been insular – a consequence of a number of factors, such as medical culture and the complexity of the underlying regulatory context. One of the nuances of this environment was the so-called “drug-lag,” where new drug approvals could lag up to six years behind U.S. and EU approval. Because of these delays companies often didn’t bother to pursue drug development. The end result was that Japanese patients had to wait years, or sometimes decades, to get the same drugs that were available in the U.S., Europe and elsewhere. With the advance of modern communication and open access to information, problems associated with drug lag became apparent in Japanese society and change soon followed. In 2007, the Japanese Ministry of Health, Labor and Welfare (MHLW) reversed some key policies, which in turn, led to markedly reduced regulatory review periods and a friendlier environment for global trials. In many ways, the Japanese clinical research landscape has shifted. Once viewed as unique and difficult to work with, Japan is increasingly a region where opportunities for global registration studies abound, supported by government policies as well as the medical community and its local population.