An increasing number of approvals and Emergency Use Authorisations (EUAs) by the Food and Drug Administration (FDA) for Covid-19 vaccines and drugs, as well as cell and gene therapies, is helping provide manufacturing opportunities for contract manufacturing organisations (CMOs).
This is according to GlobalData’s latest report – New Drug Approvals and Their Contract Manufacture – 2022 Edition1. The report details that over the last two years the FDA has awarded numerous EUAs to Covid-19 products, such as Pfizer’s Comirnaty vaccine. More so, the report signifies that 2021 was a record year for cell and gene therapy approvals.
In 2021, the FDA approved 122 NDAs and Biologics License Applications (BLAs), according to GlobalData. This represents a 2.4% increase over the 2016–2020 period average. The overall number of approvals is similar to 2020; however, the total number of innovative NME cell/gene therapies and non-NME NDAs has risen since 2020.
Speaking about the report, Adam Bradbury, Pharma Analyst at GlobalData said: “In 2021, the FDA shifted its focus as it granted EUA to fewer vaccines than the previous year and instead prioritised Covid-19 drugs. Most therapies approved in this way were monoclonal antibodies, which have high manufacturing outsourcing rates. Some EUA therapies were small molecules – such as Pfizer’s Paxlovid and Merck & Co’s Molnupiravir – providing business to numerous CMOs, even those with traditional small molecule active pharmaceutical ingredient (API) manufacturing facilities.”
“Despite the disruptive effects of the Covid-19 pandemic, there has been a static but strong number of approvals yearly since 2019. The FDA approved four cell/gene therapies in 2021, the highest over the last decade. These included two cell therapies and two gene-modified cell therapies. Only a small amount of pharma companies will possess the manufacturing capabilities to produce cell therapies, and many outsource their products’ manufacture to a third party.”
This rise in approvals means that CMOs without the capabilities to cope with the production of novel and sophisticated drugs will miss out on business opportunities, according to GlobalData. Now, the US is planning to invest billions of dollars in Covid-19 vaccine manufacturing, with the goal of adding an extra one billion doses a year in domestic capacity beginning in H2 2022.
The report also highlights that the pandemic has caused the FDA to postpone some clinical studies and facility inspections for new drug applications. This drove drug approval numbers lower than they might have been otherwise.
“When it comes to New Drug Applications (NDAs), the FDA’s approval route for innovative drugs, the largest CMOs won contracts to manufacture the finished dose form of a disproportionately large number of drugs approved between 2012 and 2021,” Bradbury added.