Biomanufacturing Capacity Facing Huge Pressure, Notes CPhI Annual Report

October 22, 2020
Pharmaceutical Technology Editors

The third part of the CPhI annual report has predicted a significant amount of pressure will be placed on bioprocessing networks should COVID-19 biologics gain approval.

The third part of the CPhI annual report, which was released during the Festival of Pharma virtual event, has predicted a significant amount of pressure will be placed on bioprocessing networks should COVID-19 biologics gain approval.

According to an Oct. 19, 2020 press release, Dawn M. Ecker, managing director of bioTRAK Database Services at BDO, provided her expertise in the report and specified that although short-term capacity issues for biologics have been eased, there may be challenges encountered beyond 2024. Primarily, future commercial capacity may be impacted by the progress of Alzheimer’s drugs, PDL/PDL-1 checkpoint inhibitors, and COVID-19 therapeutics currently in late stage development.

“Should indications, such as treatments for Alzheimer’s disease or broad cancers obtain regulatory approval, a significant increase in demand for manufacturing capacity could occur, potentially leading to a serious capacity shortage,” Ecker said in the press release. “We also face an additional challenge of incorporating demand for recombinant proteins to combat COVID-19. We conservatively estimate that the demand for these products could require approximately 30 metric tonnes per year—so this potential demand will add significant pressure to manufacturing networks with large-scale capacity.”

In the report, Ecker has highlighted that the global capacity for biomanufacturing is expected to increase to 6500 kL by 2024, yet the demand for capacity will increase at a faster compound annual growth rate of approximately 12% by 2024. Additionally, in her analysis of manufacturing trends, Ecker reports that capacity is moving from big pharma to contract manufacturing organizations and hybrids.

“Over the last five years there has been modest capacity growth in North America and Europe, with significantly greater growth in Asia. The next few years, however, will see significant growth rates projected in both Asia (~7%) and Europe (~12%), and by 2024 Europe will have equivalent capacity to the US for the first time,” added Ecker, in the press release. “Looking deeper at the country level, particularly Korea, Singapore, and Ireland, we see that growth here reflects government incentives and tax advantages, amongst other factors.”

Source: CPhI