Rise of the recombinants: Global mammalian capacity to reach 8,400kL by 2027

Demand for mammalian biomanufacturing capacity is growing at nearly 11.5% per year and will increasingly be fed by CDMOs, says a report published ahead of CPHI Barcelona.

The biomanufacturing sector is set to continue its upward trajectory, according to a report looking at supply and demand trends for mammalian capacity from BioProcess Technology Group BDO.

The findings seen by this publication form part of this year’s CPHI annual report, ahead of what is the world’s largest pharma event happening in Barcelona later this month. 

DepositPhotos/artursz

Last year, annual volumetric requirements stood at just over 2,500 kL, said authors Dawn Ecker and Patricia Seymour – MD of bioTRAK Database Services at BDO USA and MD of BDO USA, respectively – but by 2027 this is projected to be close 4,400 kL. This represents a 5-year growth rate of nearly 11.5% but could be higher if large population indications such as Alzheimer’s, diabetes, and cancer checkpoint inhibitors are approved.

From a weight perspective, this represents a jump from around 37 metric tons of all product types produced using mammalian production systems last year to an estimated 64 metric tons in 2025 and 87 metric tons in 2027.

“To understand how the industry is positioned to meet these product demands, we estimated the 2023 mammalian cell culture supply to be nearly 6,500 kL and predict it to grow to just over 8,400 kL by 2027, with a 5-year growth rate of nearly 6.5% per year,” the report said.

“Currently, 54% of the capacity is controlled by ten companies shifting slightly to 57% in 2027.”

The authors noted the makeup of capacity has been dominated by end-users that, unsurprisingly, have invested in their inhouse manufacturing networks to support their product portfolios.

The likes of Roche, Novartis, Sanofi, and Biogen have traditionally held the bulk of the global manufacturing capacity, but the impact of contract development and manufacturing organizations (CDMOs) is shifting the dynamic.

“As of 2023, product companies, defined as companies focused solely on product development, control nearly 65% of the installed mammalian cell culture capacity. CDMOs (strict fee for service manufacturers) and hybrid companies (those companies that are not only developing products but are also selling or making available any excess manufacturing capacity) control significantly less capacity.”

Yet forecasts show this distribution will change by 2027, with end-users set to hold just over half the installed capacity. With hybrid companies (e.g. Boehringer Ingelheim) remaining stable, the authors expect CDMO capacity to increases 12%.

Lonza and Samsung Biologics have long contributed to the bulk of the CDMO-owned capacity – Lonza offers mammalian manufacturing at sites in Hayward (California), Portsmouth (New Hampshire), Porrino (Spain), Slough (UK), Visp (Switzerland), Guangzhou (China), and Singapore, while Samsung Biologics has four plants in Songdo, Korea with further expansions planned.

But through heavy CAPEX, WuXi Biologics and Fujifilm Diosynth Biotechnologies are making their marks on the landscape. WuXi’s rapid growth means it now offers more than 430,000 L of mammalian capacity, while Fujifilm currently boasts 240,000 L. However, 8 x 20,000 L stainless-steel bioreactors are planned to be installed by 2026 at its Denmark site and a ¥200 billion ($1.4 billion) investment in North Carolina will bring 160,000+ L online in the coming two years.

While WuXi already features on the top ten capacity holders in 2023, Fujifilm is set to displace Pharma giant Novartis.

“While the majority of capacity is product‑based, rather than CMO‑based, contract manufacturers are significantly expanding their capacities which, in the coming years, may lessen the difficulties companies without capacity may have experienced accessing capacity at the right time and under the right terms.”

Control of manufacturing capacity