The Japanese pharmaceutical market has been an ideal environment for the industry thanks to minimal regulatory delays, favourable pricing, and high reimbursement rates.
Development of the drug and medical device industries, which are knowledge-intensive and high value-added industries, and in particular regenerative medicine technologies, for which Japan has the most advanced technologies, are some of the major pillars of growth strategies.
New drugs are reaching the Japanese market faster and in larger numbers than ever before. The last decade has seen an increasing volume of new drugs entering Japan’s market, resulting in Japan’s healthcare system beginning to implement elements of a value-based healthcare system (VBH). In April 2019 Japan incorporated a new HTA process based on cost-effectiveness evaluation into the medical drugs and devices system, following a successful pilot project begun in April 2016.
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There has been a large increase in the number of new products launched in Japan, rising from 52 in 2007-11 to 82 in 2012-16, ranking Japan fourth in terms of the number of new products launched globally.
In 2015 a Ministry of Health, Labour and Welfare (MHLW) advisory panel published “Japan Vision: Healthcare 2035” (an executive summary of which can be accessed here), in which it identified VBH as one of the three central components of its vision. The paper committed to a “paradigm shift” in the country’s healthcare principles, emphasising quality over quantity, autonomy over government regulation, care over cure, and a shift from fragmentation to integration. In particular, the MHLW’s panel underlined that its view for the future of the Japanese healthcare system envisioned “a healthcare system that evaluated health care on the value it provides to patients and society, not on the inputs it demands”.
Japan is a major pharmaceutical market which cannot be ignored by any serious multinational company. Prescription drug turnover at NHI prices in calendar 2015 was JPY 10,958 billion ($104.6 billion), up 6.2% from the previous year in local currency terms1.