earticle

영어

Analyzing clinical trial success rates is crucial for informing strategic investment and decision-making in drug development. While numerous studies have explored clinical trial outcomes and the associated costs of drug development, research on preclinical success rates, particularly for biologics, remains limited. In this study, we analyzed the preclinical success rates and key success factors of 540 biopharmaceutical candidates that completed private-sector investment agreements—including licensing, acquisition, and financing—from 2016 to 2020. Success rates were evaluated across therapeutic categories and technological platforms. Among the total biopharmaceutical candidates that are subjected to this study, oncology emerged as the most common therapeutic category, while monoclonal antibodies dominated the technological category. The calculated success rate of all biopharmaceutical candidates was 29.8%. Success rates were varied by therapeutic category and technology. The therapeutic categories with the highest success rates were sensory organ and oncology, and the technologies with the highest success rates were Gene-Modified Cell Therapy and Monoclonal antibody. The results of this study are expected to provide strategic investment guidelines for private sector investment in the pharmaceutical industry.