Microbiome-Based Medicinal Products: Poised for Progress Despite Uncertain Regulatory Environment

Microbiome-Based Medicinal Products: Poised for Progress Despite Uncertain Regulatory Environment

Summary

Following on from the US FDA's approval of Ferring's (Switzerland) microbiome-based medicinal product (MBMP) Rebyota (fecal microbiota, live) in November 2022, only three other MBMPs have been approved in developed markets around the world. However, this bare statistic belies the intensive R&D activity that has been taking place beneath the surface, with more than a dozen MBMP candidates currently undergoing late-stage clinical trials. Moreover, while the four approved products are all indicated for preventing the recurrence of Clostridioides difficile (C. difficile) infection (CDI), the late-stage candidates span a wide range of potential indications, including ulcerative colitis, lung cancer, and graft versus host disease (GVHD). In this Strategic Report, the analyst tracks the progress that has been made in the MBMP field up to now, and looks ahead at the key challenges, which include an uncertain regulatory environment.