Japan’s Rising Demand for Protein Drug Manufacturing and Regenerative Medicine Boom Capture Attention of Major Biotech Companies, Says TrendForce

Japan has enormous influence over the development of the global biotech industry. The country is the world’s third-largest pharmaceutical and biotech market after the U.S. and China. It is also ranked second globally in terms of R&D spending in pharmaceutical and biotech industry. One of the major trade exhibitions in Japan, Life Science World 2016, was held in Tokyo earlier this May. Sean Liu, TrendForce biotechnology analyst, offers his insights to the event. Japanese pharmaceutical industry will be a new market for the competing contract manufacturing organizations (CMOs) that specializes in protein drugs. Japan will become the global R&D center of regenerative medicine. Many large international regenerative medicine companies will take the Japanese market as the priority in their overseas expansion plans.

Major international protein drug companies compete for the growing demand from the Japanese CMO market

The Japanese pharmaceutical industry is following the global shift trend from chemical drugs to protein drugs. As the domestic capacity of protein drugs production is insufficient, Japanese drug companies are actively searching for CMO partners. According to Liu’s observation, Samsung Biologic has been the most aggressive among contract manufacturers worldwide in expanding protein drug production, achieving an overall capacity of 180,000 liters. Other leading CMOs of protein drugs, such as Fujifilm Diosynth and Beohringer Ingelheim, also sought for trading opportunities in the exhibition.

Liu expects that the increase of new protein drugs, the indication expansion of existed protein drugs, and the developments of biosimilars will boost the demand of protein drug manufacturing. According to TrendForce’s latest analysis, the overall utilization rate of global capacity of protein drug production will increase from around 50% to 70% in 2019.

Promising future for Japanese regenerative medicine market as the loosening of regulations accelerates the momentum of the country’s biotech industry

Japanese government passed the Pharmaceutical and Medical Device Act (PMD Act) in 2014 that loosened the domestic drug regulations. Under the PMD Act, a new cell therapy product can be conditionally approved by regulatory authorities if its safety and predictability of efficacy have been proven. The approval not only lowers the financial cost of regenerative medicine companies but also shortens the time between the development and market launch of new products. The PMD Act is a powerful driving force behind the growth of the regenerative medicine market in Japan. The positive effect of the new regulatory framework is reflected in the Life Science World 2016, which has attracted a large number of cell CMOs and companies specializing, cell culture materials and experiment equipment related companies. The abundance of exhibitions indicate the bright prospect of Japan’s regenerative medicine market.