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

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Tác giả: Elazar Brief, Oliver Gassmann, Dominik Hartl, Markus Hinder, Alexander Schuhmacher

Ngôn ngữ: eng

Ký hiệu phân loại: 943.022 Period of Conrad I and House of Saxony, 911-1024

Thông tin xuất bản: England : Drug discovery today , 2025

Mô tả vật lý:

Bộ sưu tập: NCBI

ID: 254104

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%.
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