Cost and Duration of Clinical Trials in Drug Development by Japanese Pharmaceutical Companies.

Background: Understanding parameters such as cost and duration, which reflect the scale of clinical trials, is essential for government agencies to formulate pharmaceutical policies and for pharmaceutical companies to strategically allocate resources. As most studies on clinical trial costs and durations have primarily focused on pharmaceutical companies developing drugs in the USA, understanding actual trial costs and durations for Japanese pharmaceutical companies engaged in global development or development within their own countries remains challenging.

Objectives: This study aimed to clarify the actual phase-specific costs and durations of clinical trials conducted by leading Japanese pharmaceutical companies and to identify the factors influencing these parameters.

Methods: We conducted a questionnaire-based survey among 22 pharmaceutical companies headquartered in Japan. Respondents from each company retrospectively identified clinical trials for new drug applications or for expanding approved disease indications, conducted between 2012 and 2022, providing cost and duration data of each clinical trial. We calculated summary statistics for costs and durations by phase and conducted an exploratory analysis of the variables influencing these parameters.

Results: In total, 631 projects with clinical trials conducted by these companies were analyzed. The median costs in the analysis population were 859 million Japanese yen (JPY) for Phase 1, 1,739 million JPY for Phase 2, and 4,183 million JPY for Phase 3. For reference, the median annual average exchange rates during the study period were 109 JPY per US dollar (USD) and 130 JPY per euro (EUR). The median durations were 20 months for Phase 1, 29 months for Phase 2, and 31 months for Phase 3. For projects targeting approval only in Japan, the median Phase 3 cost was 3,050 million JPY, while for projects targeting approval involving the USA or Europe, it was 8,083 million JPY.

Conclusions: This study quantifies the costs and durations incurred by Japanese pharmaceutical companies in conducting clinical trials, revealing the high costs associated with projects targeting approval involving the USA or Europe. The findings highlight the substantial investments required by the Japanese pharmaceutical industry to bring new drugs to the global market.