The pharmaceutical market and drug development prognosis in Japan: Current and future perspectives according to pharmacological classes

Japan is now the second largest pharmaceutical market in the world. As a unique population, it provides many opportunities for pharmaceutical companies to develop their businesses. However, the market is strictly regulated by the government, and drug prices are determined according to the rules in Japan. Nevertheless, no detailed empirical analyses have been conducted to clarify what opportunities may exist for pharmaceutical companies in the future. In the present article, we reviewed the pros and cons of the Japanese pharmaceutical market including related regulations, discussed our analyses of economic and regulatory science, and provided future perspectives on drug development and the pharmaceutical market in Japan. Specifically, we first clarified the Japanese pharmaceutical market profile using the publically available market database. Second, we reviewed the Japanese pharmaceutical pricing system, and found inconsistencies between the “pricing premium for the promotion of new drug development and the elimination/resolution of off-label use” and “repricing for market expansion” based on our literature review. Finally, we provided future perspectives on the pharmaceutical markets in Japan, as well as the direction of the research and development of new drugs