The CPHI Annual Report predicts expected biologics demand and capacity for 2024-2027.
Overall, demand for biologics is expected reach 4,400KL by 2027 [up from 2,500KL in 2022] – with a growth rate of 11.5% per year and capacity increasing during the same time to 8,400KL [up from 6,550 in 2023]
Tara Dougal, Content Director – Pharma at Informa, commented: “we see this first hand at CPHI Barcelona where demand for bio CMDOs and outsourced biological services continues to grow, and we expect this be one of the fastest areas of growth in the next few years.”
Analysis was provided by CPHI panel of experts from BDO USA – jointly author to Dawn Ecker, Managing Director of bioTRAK Database Services and Patricia Seymour, Managing Director, BioProcess Technology Group – and predicts that, despite surprise blockbuster approvals like Wegovy, capacity at CMOs should be accessible for most biotechs in the year ahead. However, even with CMO capacity rising from 35% of available reactors to 45% by 2027, demand could be constrained in the future as more and more biologics commercialise.
“Resources could well tighten significantly if we see approvals for large population diseases such as Alzheimer’s and diabetes or if cancer checkpoint inhibitors are approved by regulators and reimbursed 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.” commented Ecker.
The report notes, that the majority of cell culture capacity is currently in-house, and the distribution of this capacity is highly concentrated within just ten companies. These account for 54% of capacity in 2023 [see table 1] and this will rise to 57% in 2027 – however, CMOs, Fujifilm Diosynth and Celltrion, based on recent substantial capacity investments, will displace two big pharma companies in the top ten (Novartis and Sanofi).
Significantly, future manufacturing equipment is also evolving and becoming smaller, with nearly three quarters of the recombinant products currently in late phase development (Phase 2, Phase 3) able to be producing using a single 2,000L or 5,000‑L bioreactor [see table 2].
Tara Dougal, added: “Securing capacity and finding the right partner continue to be significant challenges for the market. CPHI Barcelona is such an important event for the manufacturing community because it offers a platform to meet with so many different vendors – both new and existing – in one convenient location.
For more information on the CPHI Annual report findings and to download copy, please vsit:https://www.cphi-online.com/cphi-barcelona-annual-report-illuminates-industry-news122743.html