ArticleHealth affairs scholar2025
Research and development investments for biologics independently developed by US biotechnology startups, 2017-2023.
Article in Health affairs scholar, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Introduction: Despite policy interest in pharmaceutical innovation, little is known about the investment needed for venture capital-backed startups to develop innovative biologics, a growing segment of the pharmaceutical marketplace. Methods: In a cross-sectional analysis of Food and Drug Administration (FDA) drug approval data, investment deal records, and clinical trials data, we estimated the investment needed for a biotechnology startup company to independently develop a biologic approved by the US FDA with priority review, an indicator of innovation. To isolate a homogenous set of cases, the sample focused on independent drug development of 13 drugs by 9 biotechnology startup companies that retained ownership of the drug from the start of development to FDA approval without being acquired or licensing the product. Results: We found that the median investment per FDA-approved biologic was $304.1 million (IQR: $289.9-$790.3 million) in uncapitalized costs, accounting for the cost of failures. Conclusion: This estimate represents the direct drug R&D investment needed for independent development of innovative biologic products by biotechnology startup companies.
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