Biologics demand soars with predicted growth in capacity, says CPHI report

The biologics market is set for a substantial expansion, with demand expected to reach 4,400 kiloliters (KL) by 2027, up from 2,500KL in 2022, stated an analysis at the Convention on Pharmaceutical Ingredients (CPHI) that concluded on Thursday.

This significant growth comes with a yearly rate of increase of 11.5%, and concurrent capacity expansion to 8,400KL by 2027, up from 6,550KL in 2023, said the experts.

The analysis was provided by a panel of experts from CPHI and BDO USA, jointly authored by Dawn Ecker, Managing Director of bioTRAK Database Services, and Patricia Seymour, Managing Director of BioProcess Technology Group.

The predictions suggest that despite unexpected blockbuster approvals like Wegovy, capacity at Contract Manufacturing Organizations (CMOs) should be accessible for most biotech companies in the year ahead. However, even with CMO capacity set to rise from 35% of available reactors to 45% by 2027, there are concerns about potential constraints in the future as more biologics enter the commercial market.

"Resources could tighten significantly if we see approvals for large population diseases such as Alzheimer’s and diabetes or if cancer checkpoint inhibitors gain approval and reimbursement from insurers. In this scenario, demand for capacity could surge, leading to potential constraints, especially for smaller and early-stage biotech innovators,” said Ecker.

The report highlighted that the majority of cell culture capacity remains in-house, with distribution highly concentrated among just ten companies. These companies account for 54% of capacity in 2023 and are projected to increase to 57% by 2027. However, Contract Manufacturing Organizations (CMOs) like Fujifilm Diosynth and Celltrion, which have made substantial capacity investments, are expected to displace two major pharmaceutical companies in the top ten, specifically Novartis and Sanofi, noted the report.

Furthermore, future manufacturing equipment is evolving to become smaller, with almost three-quarters of recombinant products in late-phase development capable of being produced using a single 2,000L or 5,000 L bioreactor.

"We witness this firsthand at CPHI Barcelona, where demand for bio CDMOs and outsourced biological services continues to surge. We anticipate this to be one of the fastest-growing areas in the coming years,” Tara Dougal, Content Director for Pharma at Informa, a market and trade platform for industries.

CPHI Barcelona, this week, hosted vital discussions on topics including 'sterile tech transfer,' 'building collaborative supply chains,' and the evaluation of 'future CDMO capacity and capabilities' during a dedicated Next-Generation Manufacturing segment.