Benchmarking R&D success rates of leading pharmaceutical companies: an empirical analysis of FDA approvals (2006–2022)
Journal
Drug Discovery Today
Type
journal article
Date Issued
2025-02
Author(s)
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
English (United States)
HSG Classification
contribution to scientific community
Refereed
yes
Publisher
Elsevier
Volume
30
Number
2
Start page
91
End page
97
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25 DDT benchmarking R&D.pdf
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Format
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