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As CMOs continue to invest in cell culture capacity, some are expected to surpass top in-house companies.
On Oct 26, 2023 a report was released from CPHI Barcelona on the discussion around the growth of contract manufacturing organizations (CMOs) in the biologics sphere. The biologics demand is anticipated to reach 4400KL by 2027 (2500KL more than in 2022), which accounts for a growth rate of 11.5% each year and a capacity increase to 8400KL. Tara Dougal, Content Director–Pharma at Informa said, “we see this first hand at CPHI Barcelona where demand for bio CMDOs [contract development and manufacturing organizations] and outsourced biological services continue to grow, and we expect this to be one of the fastest areas of growth in the next few years.”
A CPHI panel of experts—chiefly Dawn Ecker, managing director of bioTRAK Database Services and Patricia Seymour, managing director, BioProcess Technology Group—provided analysis. The panel predicted that even with surprise blockbuster approvals like Wegovy, CMO capacity should be accessible for most biotechs in the coming year. But with CMO capacity growing from 35% of available reactors to 45% by 2027, demand could become constrained in the future as more and more biologics commercialize. Ecker noted that resources could tighten considerably if approvals pass for large population diseases such as Alzheimer’s and diabetes, or if cancer checkpoint inhibitors receive approval from regulators and reimbursement by most insurers. “In this instance, demand for capacity could be much higher resulting in capacity constraints particularly for smaller and early-stage biotech innovators,” Ecker commented.
As of the publication of this article, the majority of cell culture capacity is in-house, primarily concentrated within just 10 companies. This capacity, at 54% in 2023, is expected to rise to 57% in 2027. But as CMOs Fujifilm Diosynth and Celltrion make substantial capacity investments, they are predicted to displace two Big Pharma companies in that top 10 (Novartis and Sanofi). Future manufacturing equipment is also changing and becoming smaller—nearly three quarters of recombinant products in late-phase development can currently be produced using a single 2000L or 5000L bioreactor.
Source: CPHI Annual Report