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"Innovation in Pieces": A study of the externalization process of FDA approved drugs from 2010-2020

Author

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  • Jimmy Schüler

    (COSTECH - Connaissance Organisation et Systèmes TECHniques - UTC - Université de Technologie de Compiègne, UTC - Université de Technologie de Compiègne)

  • Leonhard Kersten

    (ACT - Analyse des Crises et Transitions - LABEX ICCA - UP13 - Université Paris 13 - Université Sorbonne Nouvelle - Paris 3 - CNRS - Centre National de la Recherche Scientifique - UPCité - Université Paris Cité - Université Sorbonne Paris Nord - Université Sorbonne Paris Nord, Université Sorbonne Paris Nord, Bentley University)

Abstract

This study investigates the role of large biopharmaceutical companies in the development and commercialization of new drugs approved by the U.S. Food and Drug Administration (FDA) between 2010 and 2020. It combines drug-level data on clinical development with firm-level data on ownership and collaborations to trace the sourcing trajectories of 371 novel drugs. We find that large biopharmaceutical companies were affiliated with 289 drugs, or 77% of the 371 FDA-approved drugs from 2010 to 2020. Notably, these companies produced 45 in-house (originated, developed, and marketed internally) drugs (12%) and, through collaborations and external sourcing, were able to secure partial or full ownership of a total of 228 drugs (61%). This is study is among the first to model the innovation nexus across distinct phases of the R&D and commercialization process and is systematically mapping firm involvement throughout the drug life cycle. The results confirm the existence of a fragmented innovation nexus and highlight various innovation trajectories for drugs ultimately marketed by large biopharmaceutical firms.

Suggested Citation

  • Jimmy Schüler & Leonhard Kersten, 2025. ""Innovation in Pieces": A study of the externalization process of FDA approved drugs from 2010-2020," Working Papers hal-05128215, HAL.
    • Handle: RePEc:hal:wpaper:hal-05128215
    Note: View the original document on HAL open archive server: https://hal.science/hal-05128215v1
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