@article{SchuhmacherHinderBriefetal.2025, author = {Schuhmacher, Alexander and Hinder, Markus and Brief, Elazar and Gassmann, Oliver and Hartl, Dominik}, title = {Benchmarking R\&D success rates of leading pharmaceutical companies: an empirical analysis of FDA approvals (2006-2022)}, volume = {30}, pages = {104291}, journal = {Drug Discovery Today}, number = {2}, publisher = {Elsevier}, address = {Amsterdam}, issn = {1878-5832}, doi = {https://doi.org/10.1016/j.drudis.2025.104291}, year = {2025}, abstract = {Previous analyses provide an industry benchmark of ∼10\% for the success rate in clinical development. However, prior analyses were limited by a narrow timeframe, a diverse research focus, biases in phase-to-phase transition methodology or a focus on specific use cases. We calculated unbiased input:output ratios (Phase I to FDA new drug approval) to analyze the likelihood of first approval using data from clinicaltrials.gov, encompassing a total of 2092 active ingredients, 19 927 clinical trials conducted by 18 leading pharmaceutical companies (2006-2022) and 274 new drug approvals. Our study reveals an average likelihood of first approval rate of 14.3\% across leading research-based pharmaceutical companies, broadly ranging from 8\% to 23\%.}, language = {en} }