CPHI Annual Survey Suggests 54% of Biologics Capacity in 2028 to be Held by CMOs and Hybrid Companies

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Editor's note: this story was originally published on PharmTech.com.

The 2024 CPHI Annual Report suggests that contract manufacturing organizations (CMOs) and hybrid companies—companies having both their own pipelines and contract services for using spare capacity—will hold over half of global biologics capacity within the next three years. The results of the annual survey predict a dramatic shift from current (2024) global totals.

In 2024, total global biologics capacity is allocated as follows: nearly 60% controlled in-house, 28% held by CMOs, and 15% held by hybrid companies, according to the annual report. The report predicts that CMO capacity, which is rising fast, will account for 40% of total global biologics capacity by 2028, 45% of which will be located in Asia. The results suggest that capacity for new clinical products entering development may not be easily accessible in the United States, despite capacity being available. Europe and Asia combined are expected to account for approximately three-quarters of all available CMO resources in 2028, according to the report.

“Our Bioproduction Zone at CPHI Milan mirrors these findings. We are seeing a rapid increase in the numbers of bio CDMOs [contract development and manufacturing organizations] at our event, and we expect this be one of the fastest areas of growth in the next few years,” said Tara Dougal, Brand & Content director—Pharma, Informa, in a press release. “Particularly notable [in the report] is the rising capacity in Asia and among newer CDMOs.Many attendees visit specifically to start building their networks with these new partners.”

Over the past two decades, overall biologics capacity rapidly expanded from nearly 600 kL in 2000 to just above 6700 kL today; capacity is projected to grow to nearly 9000 kL by 2028, according to analysis provided by Dawn Ecker, managing director of bioTRAK Database Services at BDO. Insight from this analysis shows that, for the first time, CMOs will hold four of the top five capacities in 2028. Ranked in order from largest-to-smallest capacity holder, these CMOs are: Lonza, Samsung Biologics, FujiFilm Diosynth Biotechnologies, and WuXiBiologics. These four CMOs are estimated to control 34% of capacity between them. By 2028, CMOs will account for nearly 60% of global biologics capacity within the top 10 capacity holders, according to the annual report.

“The era of CMO production dominance is clearly arriving and is much needed, with many smaller companies now developing new biologics—especially mAbs [monoclonal antibodies]. This is significant for CPHI, where we see many more biotechs and early stage companies now attending to find suitable capacity—particularly for small production runs where they are more likely to partner with one of the hundreds of smaller CDMO partners. Helping find these ‘perfect fits’ is vital, and CPHI Milan is integral as a platform for meeting many different vendors, customers, and bioprocessing firms in one convenient location,” Dougalsaid in the press release.

CPHI Milan, held Oct. 8–10, 2024 in Milan, Italy, will host a panel on “Global Trends in Bio-Manufacturing” in addition to a number of important bio sessions and seminars as well as insights on “Optimizing Biologics Production with Single-Use Technologies” and lowering production costs with “cell line development” and “continuous bioprocessing”, according to the press release.

The full CPHI Annual Report will be released at CPHI Milan and will be made available for download at www.cphi.com.

Source: CPHI