Economics of New Oncology Drug Development
Open accessAbstract
Purpose: Review existing studies and provide new results on the development, regulatory, and market aspects of new oncology drug development. Methods: We utilized data from the US Food and Drug Administration (FDA), company surveys, and publicly available commercial business intelligence databases on new oncology drugs approved in the United States and on investigational oncology drugs to estimate average development and regulatory approval times, clinical approval success rates, first-in-class status, and global market diffusion. Results: We found that approved new oncology drugs to have a disproportionately high share of FDA priority review ratings, of orphan drug designations at approval, and of drugs that were granted inclusion in at least one of the FDA's expedited access programs. US regulatory approval times were shorter, on average, for oncology drugs (0.5 years), but US clinical development times were longer on average (1.5 years). Clinical approval success rates were similar for oncology and other drugs, but proportionately more of the oncology failures reached expensive late-stage clinical testing before being abandoned. In relation to other drugs, new oncology drug approvals were more often first-in-class and diffused more widely across important international markets. Conclusion: The market success of oncology drugs has induced a substantial amount of investment in oncology drug development in the last decade or so. However, given the great need for further progress, the extent to which efforts to develop new oncology drugs will grow depends on future public-sector investment in basic research, developments in translational medicine, and regulatory reforms that advance drug-development science.
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Many drugs fail during clinical trials, especially phase III, largely due to lack of clinical efficacy and/or unacceptable toxicity.
“Many of the drugs fail during clinical trials, especially during phase III, which is the most expensive phase of clinical development, 4,5 largely due to the lack of clinical efficacy and/or unacceptable toxicity. 6,7”
From Three-dimensional cell culture systems and their applications in drug discovery and cell-based biosensors (2014) · cites this paper as [4]
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- Authors
- DiMasi, J. A., & Grabowski, H. G.
- Affiliations
- Tufts University (US)
- ORCID
- DiMasi, Joseph A.
- Venue
- Journal of Clinical Oncology
- Published
- 2007-01-10
- Volume
- 25
- Issue
- 2
- Pages
- 209-216
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2104505549
- Cited by
- 348
- References
- 17
- Citations by year
- 2026: 3 · 2025: 7 · 2024: 11 · 2023: 11 · 2022: 7 · 2021: 8 · 2020: 11 · 2019: 15 · 2018: 17 · 2017: 14 · 2016: 24 · 2015: 27 · 2014: 25 · 2013: 33 · 2012: 30
- FWCI
- 64.56
- Type
- journal article
- Language
- en
- Open access
- green
- hdl.handle.net
- Licence
- cc-by-nc-nd
- Locations
- Journal of Clinical Oncology (publishedVersion)
- PubMed (publishedVersion)
- DukeSpace (Duke University) (submittedVersion, cc-by-nc-nd)
- Topics
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Economic and Financial Impacts of Cancer
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Health Systems, Economic Evaluations, Quality of Life
- Keywords
- anticancer drug development, drug development costs, regulatory approval time, first-in-class drugs, orphan drug designation, FDA priority review, market diffusion, drug development investment, translational medicine, regulatory reform
- MeSH terms
- Antineoplastic Agents, Drug Industry, Humans, Neoplasms, Drug Design, Drug Costs, Drug Approval, Economics, Pharmaceutical
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