Catalent is a global contract development and manufacturing organization that develops, manufactures, and supplies products for pharma, biotech, and consumer health customers. Its platform spans oral, biologics, and advanced modality services across a global network of sites.
The large molecule drug substance CDMO market is expected to grow at approximately 9% CAGR through 2031, driven by rising demand for biologics and biosimilars, streamlined regulatory approval pathways, and increasing FDA and EMA approvals for biologic therapies.
Scholar Rock plans to resubmit its biologics license application for apitegromab in spinal muscular atrophy following FDA reinspection of the Catalent Indiana fill-finish facility, with a U.S. launch anticipated in 2026.
