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CPhI has launched the first part of its Annual Report.
CPhI has launched the first part of its Annual Report, forecasting large growth of monoclonal antibody (mAb) production in China, cell and gene therapy capacity shortages in the United States, and widespread adoption of single-use technologies, but limited continuous bioprocessing.
The first part of the report, which has been published ahead of the CPhI Festival of Pharma, includes analysis from three experts from BioPlan Associates—Vicky Qing Xia, Leo Cai Yang, and Eric Langer. The experts focus on the global biologics market, implications for contract outsourcing, and the use of China as a hub for bio innovation and contract services.
One of the predictions, announced in the report, is the fact that bio growth rates in China are expected to continue to be rapid. It is forecasted that there will be more than 10 mAbs launched each year in the country by 2025. “As most early-stage biotech in China lack manufacturing facilities, the need for contract manufacturing services is rising quickly, and has been accelerated further by the 2016 MAH reforms,” said Xia, senior project manager at BioPlan Associates, in a Sept. 16, 2020 press release announcing the launch of the report.
Additionally, it is expected that the number of domestic bioprocessing contract development and manufacturing organizations (CDMOs) in China at tier one level will increase from one to six by 2025. The pending regulatory changes for contract vaccine production are predicted to incite more growth amongst the existing tier one CDMOs, which include a number of international companies.
Growth in the use of single-use systems (SUS) is forecasted to continue, there are doubts that continuous bioprocessing will be mainstream by 2025. “Because preclinical and clinical pipeline products require flexible manufacturing, SUS lends itself to these scales, but many of these will fail as they progress through the pipeline,” explained Langer, president and managing partner of BioPlan Associates, in the press release. “This means that while more commercial-scale biologics are going to be made in SUS platforms, or hybrid systems, over the next two years or more, stainless platforms are, and will remain, critical to bioprocessing as well.”
Furthermore, the report has suggested there will be shortages in cell and gene therapy capacity in the US and Europe by 2025. However, this issue will not be the only one to affect the field, as there is also a shortage of specialized platforms and trained personnel to operate them, that will impact cell and gene therapies.
“This first part of the CPhI Annual Report arrives at a very poignant moment as the CPhI Festival of Pharma launches in October 2020. The cell and gene therapy space is hugely fast-moving and we will run a session on the potential for M&As as both manufacturers and CDMOs try to buy-in expertise rather than build,” added Tara Dougal, head of content at CPhI Festival of Pharma, in the press release.