Challenges for the Biopharmaceutical Industry and Recommendations for Further Development
Hirotomo Akahane ( The Office of Pharmaceutical Industry Research Senior Researcher)
(No. 71: Published in March 2018)
With the development of biotechnology and novel analytical techniques, the production and supply capacity of biopharmaceuticals, which have advantages over conventional therapeutics in terms of efficacy and safety, has dramatically increased, resulting in global sales of US$201.2 billion in 2016, and its share of the pharmaceutical market has grown to 31.5% of the total (in the Japanese market, that share is 13.6%).
Against this backdrop, the biopharmaceutical industry is expected to be a growth industry on a global scale and to play a role in the development of the pharmaceutical industry. On the other hand, Japan is said to have been late in entering the biopharmaceutical business, especially the antibody drug business, and the problem of expensive drugs has also been cited as the country faces a super-aged society and medical costs are getting tighter. At the same time, there are issues in Japan's domestic industry regarding the ability to create new drugs, manufacturing capacity, and development of biosimilars in the biotech field, and there are concerns about future development. This is a concern for the future development of Japan's biotechnology industry.
Therefore, this paper will conduct a detailed study of the actual conditions of the market and industry for the development of the biopharmaceutical industry in Japan, and discuss the "challenges of the biopharmaceutical industry and recommendations for further development".