Cell and gene manufacturers benefit from surge in FDA drug approvals

2023 marked a significant upsurge in US Food and Drug Administration (FDA) approvals, particularly for ground-breaking treatments such as cell and gene therapies.

This surge highlights not just advancements in medical technology but also provides substantial opportunities for manufacturers specializing in these cutting-edge therapies. Looking ahead to 2024-25, the pharmaceutical industry braces for challenges marked by increasing drug approvals, innovative medication developments, and persistent challenges with drug shortages, all while contract manufacturing organizations (CMOs) stand poised to capitalize on the expanding market demand, says pharma analytics company GlobalData.

“Pharmaceutical companies have a high tendency to outsource the finished dose manufacture of new molecular entities, the most innovative type of drug. Even larger pharma companies will find difficulty in developing and producing cell and gene therapies solely in-house. These innovative products have a limited pool of production staff and qualified facilities; large CMOs have been acquiring these capabilities in recent years and even larger sponsors will require these production services,” commented pharma analyst Adam Bradbury.