Japan is emerging as a world leader in the development of regenerative medicine, which refers to therapy products that replace or restore cells and tissues lost to disease or aging. A series of reforms have helped sparked a “regen” boom in the country—most significantly a 2014 law that allowed conditional market approval for regenerative drugs so they can be rapidly commercialized with less clinical studies.
Japan’s aging population and large pharmaceutical market have added to its attraction as a center for research and partnerships on regenerative drugs. U.S. company Agilis Biotherapeutics, for example, has partnered with the Gene Therapy Research Institution of Japan to obtain approval for drugs to treat Parkinson’s disease. Foreign companies that want to conduct R&D in Japan for innovative medical products are entitled to a research grant from the Ministry of Economy, Trade and Industry (METI) and can also win grants from local authorities. Some large Japanese companies, including Nikon, Hitachi, and Asahi Glass, have partnered with foreign firms in the regenerative medicine field.
Despite Japan trying to favor regenerate medicine, only five regenerative products have been approved to date, and most contract research organizations and regulatory executives have little experience in this area.