On January 19, 2021, the government presented a draft of the “Bio-Strategy 2020 (Final version of Market Area Measures)” to the Integrated Innovation Strategy Promotion Council, which summarized the policies that the national government should undertake to strengthen the biotechnology field, and the draft was approved. The government aims to double the domestic market for the industries related to biopharmaceuticals, regenerative medicine, cell therapy, and gene therapy to more than 3.3 trillion yen by 2030 compared to 2020.
In June 2019, the government formulated the “Bio-Strategy 2019” with the aim of realizing the world’s most advanced bioeconomy society in 2030. The contents are to be reviewed and updated every year from the need to respond quickly to the domestic and international situations and enhance the strategy.
Last June, the government compiled the 2020 Bio-Strategy (basic measures), based on the contents of the 2019 Bio-Strategy with the addition of measures to deal with the new coronavirus, and it has decided to formulate a final version of the market area measures as a specific package of the measures to show the overall picture.
Among the nine market areas, the goal of the industries related to biopharmaceuticals, regenerative medicine, cell therapy, and gene therapy for 2030 is to achieve full-scale industrialization and create a huge new market through the global development of antibody drugs, and nucleic acid/middle-molecular drugs, as well as regenerative medicine, cell therapy, and gene therapy products originating in Japan. It has stated that Japan will lead the world standard in this field.
In addition, the strategy has stated that Japan will be able to capture a large market when full-scale industrialization of regenerative medicine is realized by using its strengths in manufacturing technology for digitization, AI utilization and mechanization of cell cultivation, transportation, and contract manufacturing, by developing an integrated system from the supply of raw materials such as cells to manufacturing, and by seizing a common related industrial market in the drug discovery field.
It, however, has pointed out that the challenge is to effectively deploy new medical technologies to various diseases through R&D for each modality (method and means of drug discovery) without limiting the diseases. It has proposed that an R&D hub function should be established with a base for substantiation of development and manufacturing at its core, where hospitals, biobanks, and supply chain-related industries can conduct integrated R&D.
Specifically, it mentioned the improvement of an international base for substantiation of development and manufacturing where industry, academia, and government work together to accumulate domestic and foreign related industries, including CROs and CDMOs that support the supply chain for development, manufacturing, etc. The Ministry of Economy, Trade and Industry will consider a system to support and promote the commercialization and entry into new markets of CROs, CMOs/CDMOs and ventures for each modality in the first half of the 2020s.
As for regulatory issues, the Ministry of Health, Labour and Welfare (MHLW) will study appropriate evaluation of innovation, including a drug pricing system to promote the development of innovative pharmaceuticals and medical devices. The MHLW’s policy is to establish rules for using real-world data as evidence in clinical research and trials and in applications for regulatory approval of drugs and medical devices.
Meanwhile, the healthcare for lifestyle improvement, functional foods, and digital health market areas are expected to see expansion of the global health-related market due to the increase in lifestyle-related diseases worldwide. So, the target for the market areas is to realize a society in which diagnosis & treatment and prevention & symbiosis work in tandem to allow social participation over the long term through integration of bio- and digital technologies.
Healthcare services not covered by public health insurance will be increased from 25 trillion yen in 2016 to 33 trillion yen in 2025.
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