Cell and gene manufacturers benefit from surge in FDA drug approvals: GlobalData

According to the statement released by GlobalData, 2023 marked a significant upsurge in FDA approvals, particularly for groundbreaking treatments such as cell and gene therapies. This surge highlights not just advancements in medical technology but also provides substantial opportunities for manufacturers specialising in these cutting-edge therapies. 

Looking ahead to 2024-25, the pharmaceutical industry braces for challenges marked by increasing drug approvals, medication developments, and persistent challenges with drug shortages, all while contract manufacturing organisations (CMOs) stand poised to capitalise on the expanding market demand, says GlobalData.

Adam Bradbury, Pharma Analyst at GlobalData, comments: “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.”

GlobalData’s report, “New Drug Approvals and Their Contract Manufacture – 2024 Edition,” reveals that the number of NME approvals increased substantially in 2023, to a record high, leading to more commercial-scale production contracts than in recent years. Small molecule NME approvals dramatically reversed their decline in 2023. NMEs have a tendency for greater finished dose outsourcing, and a greater quantity of commercial-scale production contracts will directly increase business opportunities for larger CMOs.

GlobalData’s analysis of the FDA’s drug approvals over the last decade found that 2023 was a record year for cell and gene therapy approvals. There were seven cell or gene therapies that gained FDA approval: two cell therapies, three gene therapies, and two gene-modified cell therapies. There have been sustained strong levels of approvals for these advanced biologics in recent years.

“Some of 2023’s approvals were highly innovative: Casgevy is the first FDA-approved treatment to use a type of novel genome editing technology and Vyjuvek is the first FDA-approved topical gene therapy. While some gene therapies work by adding functional copies of modified genes to correct a defect, gene editing via CRISPR, or Clustered Regularly Interspaced Short Palindromic Repeats, can target and modify specific DNA sequences,”concludes Bradbury.