According to a recent survey in Japan, based on published documents and press releases as well as discussions with drug companies and the Japan Pharmaceutical Manufacturing Association, 43 novel drugs will be approved and receive NHI pricing in 2025. This will be a significant increase over prior years as Japan tries to correct its drug lag problem. Innovative drugs with new mechanisms of action will include very expensive orphan drugs, gene therapies, antibody-drug conjugates (ADCs), oncology products, etc.
Of the 43 novel new drugs, 15 have already been approved and expect to receive NHI pricing by March. The remaining 28 drugs are still in the review process. Overseas companies with novel innovative drugs include Pfizer, MSD, Jansen (JNJ), and Santen Pharmaceuticals. Pfizer and Chugai have AAA vector-based products, which are very expensive one-time treatments. Prices in the West are expected to be in the millions of dollars. While Japan’s reimbursement agency Chuikyo has historically been decent for drug reimbursement and pricing, whether it is open to very high prices for novel treatments is still an outstanding question. As mentioned in an earlier news brief, in 2025 Japan will increase the number of approval and pricing rounds from 4 to 7 times a year which will also expedite new drugs entering the market.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.