Investigating the origins of recent pharmaceutical innovation

Leading pharmaceutical companies have historically been engaged in all stages of the R&D pipeline, from target identification through to drug marketing, and thus have been termed fully integrated pharmaceutical companies (FIPCOs). In the past decade, externally invented assets gained through partnering or mergers and acquisitions (M&As) have become a prominent component of the pipelines of such companies. Given the long development cycles and the increasing level of collaboration between pharma companies and biotech companies, however, the precise origins of innovation are not obvious, in part as regulatory approvals for innovative drugs by agencies such as the FDA are granted to the company filing the applications, which is not necessarily the company that discovered the active pharmaceutical ingredient. Understanding the origins of innovation provides a deeper understanding of the pharma business model and could support strategic improvements. We therefore systematically assessed the origins of innovation for all new molecular entities (NMEs) and new therapeutic biologics (NTBs) approved between 2015 and 2021 by the Center of Drug Evaluation and Research (CDER) of the US Food and Drug Administration (FDA) for the top 20 biopharma companies globally by sales in 2020 (see Supplementary information for details).