Duration and Cost of Drug Development Fact-finding Survey by Questionnaire
Takashi Yagi (Former Senior Researcher, Pharmaceutical and Industrial Policy Research Institute)
Masami Okubo (Former Researcher, Pharmaceutical and Industrial Policy Research Institute)
(No.59: Published in July 2013)
471 projects obtained from a questionnaire survey of projects for the development of drugs containing new active ingredients for which domestic R&D-oriented pharmaceutical companies conducted non-clinical and clinical trials during the period 2000-2008 were evaluated, and the probability of success and duration of drug development and development costs were compared with those of domestic and overseas The results of the survey were compared with those of previous studies.
The survey revealed that the development cost required to bring one new drug to market in Japan was 48.4 billion yen at 10% capital cost and 2008 prices, and 55.2 billion yen under the same conditions as in the previous survey (9% capital cost and 1995 prices), a significant increase compared to 35 billion yen in the previous survey. The development period was 2.2 years compared to the previous survey. Although the development period was shortened by more than two years compared to the previous survey, the increase in development cost is considered to be mainly due to the increase in the number of subjects. When costs for basic research, post-marketing surveillance and trials, and upfront licensing fees, which were not included in the development costs in the current survey, are taken into account, the development costs required to bring a new drug to market are estimated to be even higher. The development cost required to launch a new drug overseas is 176.4 billion yen at a 10% capital cost, 3.6 times the cost of developing a drug in Japan. In previous surveys of major foreign companies in Europe and the U.S., the development cost required to launch one new drug was reported to be around 100 billion yen, but the overseas development cost obtained in this survey is high.
Comparing the results of this study with those of previous studies, it can be seen that the development cost required to bring a new drug to market, both in Japan and overseas, is rising. As the environment surrounding drug development becomes increasingly severe, pharmaceutical companies must continue their efforts to increase the productivity of drug development in order to provide a continuous supply of drugs needed by patients.