COVID-19 manufacturing requirements are lucrative for CMOs, says GlobalData
A new report shows half the drugs and all the vaccines approved for emergency use in 2020 had an associated contract manufacturing agreement.
According to a new report, the market conditions imposed by the COVID-19 pandemic have brought about significant opportunities for contract manufacturing organisations (CMOs), as even the largest biopharma companies require extra capacity to supply billions of doses. In a statement, GlobalData said that the compressed timelines and manufacturing scale challenges for COVID-19 vaccines and medicines had resulted in CMOs signed contract manufacturing service agreements at an unprecedented rate in 2020.
Adam Bradbury, PharmSource Analyst at GlobalData, commented: “These contracts were for pipeline vaccines and therapies with emergency approvals in 2020, but many of these molecules will achieve full market approvals in 2021. Findings show 50 percent of all emergency use authorization (EUA) drugs in 2020 had an associated contract manufacturing agreement and this rises to 100 percent of EUAs for just vaccines, where there have been rapid development timelines, highly innovative products (mRNA vaccines) and a global requirement for production scale.”
According to the new report, in 2020 the US Food and Drug Administration (FDA) approved 121 New Drug Applications (NDAs) and Biologics License Applications (BLAs), including New Molecular Entities (NMEs), biologics approved as BLAs through the Center for Biologics Evaluation and Research and new formulations of older drugs.
Bradbury continued: “This represents a 2.4 percent increase over the 2015–2019 period average of 118. Despite the disruptive effects of the pandemic on the FDA, the overall number of approvals increased from 2019’s total of 119. The total numbers of innovative small molecule and biologic NMEs have risen since last year, with biologic NME approvals at the highest level over the last decade.”
NDA approvals for small cap companies (market cap <$2bn) were also relatively high in 2020, compared to approvals from 2011–2020, and the number of drugs sponsored by small cap sponsors increased from 2019. Bradbury stated: “This trend is potentially advantageous to CMOs, given that historically their clients are more likely to be smaller companies that are unable to invest in their own facilities or enhance their own capabilities.”