Comprehending Generic Drug Registration and Approval Requirements in Japan

The Japan generic drug market size reached USD 10.7 Billion in 2022 and is further expected to reach USD 16.9 Billion by 2028, exhibiting a growth rate (CAGR) of 7.8% during 2023-2028. Japan represents the world’s eighth-biggest market for generic drugs in terms of value. Generic drugs, however, have traditionally enjoyed a relatively lower penetration in Japan compared to other developed markets such as the United States and Europe, because of the lack of generic substitution rights by Japanese pharmacists, slower review timelines in the drug approval process, etc.

However, the landscape of the Japanese generic drug market has changed noticeably over the last decade. The Japanese government has identified the growth of the country’s generic drug market as imperative to Japan’s long-term economic health. The Japanese government, recognizing the country’s increasingly aging population as well as the rising costs of branded drugs has begun instituting healthcare policy changes. Driven by these initiatives, the penetration of generics has grown robustly over the past few years. This is expected to create huge opportunities for both domestic and foreign generic manufacturers in Japan.

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