Cited by 3,566Pharmaceutical Economics and PolicyComputational Drug Discovery MethodsPharmaceutical industry and healthcare

How to improve R&D productivity: the pharmaceutical industry's grand challenge

Paul, Steven M., Mytelka, Daniel S., Dunwiddie, Christopher T., Persinger, Charles C., Munos, Bernard H., Lindborg, Stacy R., Schacht, Aaron L.·2010·Nature Reviews Drug Discovery

Abstract

The pharmaceutical industry is under growing pressure from a range of environmental issues, including major losses of revenue owing to patent expirations, increasingly cost-constrained healthcare systems and more demanding regulatory requirements. In our view, the key to tackling the challenges such issues pose to both the future viability of the pharmaceutical industry and advances in healthcare is to substantially increase the number and quality of innovative, cost-effective new medicines, without incurring unsustainable R&D costs. However, it is widely acknowledged that trends in industry R&D productivity have been moving in the opposite direction for a number of years. Here, we present a detailed analysis based on comprehensive, recent, industry-wide data to identify the relative contributions of each of the steps in the drug discovery and development process to overall R&D productivity. We then propose specific strategies that could have the most substantial impact in improving R&D productivity.

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Crossref · 10.1038/nrd3078

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  • Approximately 75% of the cost in research and development is the cost of failure, meaning money spent on projects whose candidate drug was deemed efficacious and safe by early testing but later revealed to be ineffective, unsafe, or otherwise of limited commercial value during human clinical trials.

    “Approximately 75% of the cost in research and development is the cost of failure5—that is, money spent on projects in which the candidate drug was deemed efficacious and safe by early testing but was later revealed to be ineffective, unsafe, or otherwise of limited commercial value during human clinical trials.”

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Authors
Paul, S. M., Mytelka, D. S., Dunwiddie, C. T., Persinger, C. C., Munos, B. H., Lindborg, S. R., & Schacht, A. L.
Affiliations
Eli Lilly (United States) (US)
Corresponding author
Paul, Steven M.
Venue
Nature Reviews Drug Discovery
Published
2010-02-19
Volume
9
Issue
3
Pages
203-214
ISSN
  • 1474-1776 (ISSN-L)
  • 1474-1784
OpenAlex
W2166550586
Cited by
3,566
References
1
Citations by year
2026: 240 · 2025: 237 · 2024: 226 · 2023: 205 · 2022: 214 · 2021: 229 · 2020: 236 · 2019: 200 · 2018: 231 · 2017: 214 · 2016: 223 · 2015: 235 · 2014: 257 · 2013: 230 · 2012: 205
FWCI
51.49
Type
journal article
Language
en
Open access
closed
Locations
  • Nature Reviews Drug Discovery (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
  • Physical Sciences › Computer Science › Computational Theory and Mathematics › Computational Drug Discovery Methods
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
Keywords
R&D productivity, pharmaceutical industry, drug discovery, drug development, research and development costs, patent expiry, regulatory requirements, innovation strategy
MeSH terms
Clinical Trials as Topic, Drug Industry, Efficiency, Humans, Research, Research Design, Time Factors, Models, Economic, Drug Discovery

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