Increased contribution of small companies to late-entry drugs: a changing trend in FDA-approved drugs during the 2020s

Abstract

Small- and medium-sized enterprises (SMEs) have significantly boosted innovative drug discovery, whereas large pharmaceutical companies have focused on incremental drug innovation. I explored the evolving role of SMEs in late-entry drug discovery. A comparative analysis of new drugs approved by the US Food and Drug Administration (FDA) during the 2020s with those approved previously revealed that SMEs have expanded their role to late-entry drug discovery while maintaining their contribution to first-in-target drug discovery. I analyzed the characteristics of SMEs responsible for the discovery of late-entry drugs approved during the 2020s, and the modality, market entry timing, and differentiation points of the drugs. I also discuss encompassing opportunities for SMEs, pharmaceutical industry future alliance strategies, and the importance of startup promotion measures.