Japan continues to be the third pharmaceutical market in the world. According to the Ministry of Health, Labor and Welfare (MHLW)’s Annual Pharmaceutical Production Statistics, the Japanese market for pharmaceuticals in 2020 was $107 billion.
Oncology therapies, drugs for diabetes and immunosuppressive agents are all growing, same as biologics, with the Japanese biotech-based economy growing up to around $30 billion and interesting opportunities for biosimilars given government’s focus on cost control.
Besides from the market size and potential, it is also interesting that there are government incentives to priority review such as Sakigake (forerunner designation) for development and NDA in Japan being world’s first or simultaneous with other countries, or Conditional Early Approval, which was initially only for regenerative medical products but has been expanded to other therapies and allows the NDA submission based on the exploratory efficacy and safety clinical data from a limited number of patients and in a shorter time compared with the basic review process.
Despite these favourable scenario, to leverage potential business opportunities in Japan it is essential to team up with experts able to provide the right guidance and network to optimize timing and costs and also to properly face challenges related to medical needs (Japanese population singularities need to be considered), regulatory (PMDA still requires secondary analyses of Japanese-specific data), pricing (new drug prices are decided solely by the government shortly after approval) or financing (Corporate Venture Capital is the primary source of capital).
In summary, although cost-containment measures will strike a note of caution among investors, the Japanese pharma market remains large, reliable, and full of potential, but it is crucial to understand it singularities for designing a successful market access strategy.
Linical supports Biotech venture/pharmaceutical companies interested in entering Japanese market but unfamiliar with its regulations and/or those who are seeking for strategic partners to distribute and commercialize their products in Japan. Our services include market analysis, medical writing and regulatory (including PMDA consultation) and support related to strategic partnerships and licensing.
Our team have been involved with research, clinical development, medical writing, regulatory affairs, project management, licensing or business development for many years in the Japanese pharmaceutical or CRO industry.
SOURCES:
1. “Japan – Country Commercial Guide”. United States International Trade Administration. https://www.trade.gov/country-commercial-guides/japan-pharmaceuticals
2. “Japan Market Entry: Opportunities & Challenges” https://pharmaboardroom.com/articles/insider-tips-for-life-science-companies-looking-to-enter-the-japanese-market/
3. Japan pharma market review. https://www.thepharmaletter.com/article/japan-pharma-market-review