Duration and Cost of Drug Development An Analysis Based on a Survey of New Drug Development
Takeshi Yamada, Associate Professor, Faculty of Commerce and Economics, Chiba University of Commerce and Business Administration
(No. 8: Published in October 2001)
Companies headquartered in Japan that are conducting new drug development were asked to respond to a survey in the form of a questionnaire. Questions included new active ingredient or not, indication, target disease, origin company, development company, progress status, and development costs. The following results were obtained from the analysis based on the collected data. The probability of successfully developing a new active ingredient (so-called new drug) is 13%, and only one project out of 7.7 projects that have started non-clinical studies will receive approval. It takes 11.5 years from the start of non-clinical work to receive approval. And to bring one compound to market as a product, 35 billion yen is needed, including projects that have stopped development in the middle of the project. Although the risks and huge development costs of new drug development have been vaguely discussed in the past, this study is the first in Japan to reveal the actual situation based on detailed data.