Benchmarking R&D success rates of leading pharmaceutical companies: an empirical analysis of FDA approvals (2006–2022)

• We analyzed the likelihood of first approval (LoA) of 2092 active ingredients and 19 927 clinical trials conducted by 18 leading pharmaceutical companies (2006–2022) • Our study reveals an average LoA rate of 14.3% (median 13.8%) • LoA rates differ across the leading 18 pharmaceutical companies, broadly ranging from 8% to 23% 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%.