Page 192 - CW E-Magazine (14-11-2023)

Special Report

regulatory and reimbursement issues,
and competitive landscapes.

To understand how the industry is
positioned to meet these product de-
mands, we estimated the 2023 mamma-
lian 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
(Figure 4). However, not all capacity
is equally available throughout the in-
dustry. As of 2023, product companies,
defined as companies focused solely on
product development, control nearly
Fig. 3: Estimated Volumetric capacity Needed to Meet Product Demand 65% of the installed mammalian cell
culture capacity. CMOs (strict fee for
service manufacturers) and hybrid com-
panies (those companies that are not
only developing products but are also
selling or making available any excess
manufacturing capacity) control signifi-
cantly less capacity. This distribution
of capacity changes in 2027, with Pro
duct companies controlling just over half
of the installed capacity, while CMO
capacity increases 12%, with Hybrid
companies remaining stable.
While Product companies control
the majority of cell culture capacity, the
Fig. 4: Mammalian Manufacturing capacity distribution of this capacity is highly
checkpoint inhibitors. Should several these are the industry’s increased focus concentrated within ten companies, as
of these large-demand products obtain on small population and orphan indi- shown in Table 1. Capacity for com-
regulatory approval and adequate re- cations, a shift from full length naked panies not ranked in the top ten is dis-
imbursement by healthcare oversight antibodies to alternative antibody for- tributed among 131 companies in 2023,
organizations (e.g., US Pharmacy Bene- mats, many of which can be manufac- and 140 companies in 2027. Currently,
fit Managers, the UK’s National In- ture in microbial systems, as well as the 54% of the capacity is controlled by ten
stitute for Healthcare and Excellence interest in more potent products (e.g., companies shifting slightly to 57% in
(NICE)) or become part of a managed antibody drug conjugates (ADCs) or 2027. Most of the top ten capacity hol-
entry agreement between a company bispecific antibodies) which often re- ders in 2023 are also present on the 2027
and public payer of a social or national quire lower doses and therefore less list, however, based on substantial capa-
health insurance system, a significant manufacturing capacity. Given the pro- city investments, FujiFilm Diosynth
increase in demand for manufacturing jected increase in volumetric demand Biotechnologies and Celltrion will dis-
capacity could occur, potentially lead- over the next five years, the industry is place Novartis and Sanofi from the top
ing to a capacity shortage. cognizant of the inherent volatility of ten.
production capacity forecasts. There is
Conversely, there are other manu- always a degree of uncertainty in bala- Figure 5 illustrates the geographic
facturing trends which could result in ncing the demand and supply equation distribution of the manufacturing facili-
a decrease in demand for biopharma- due to production problems, market de- ties. In 2022, nearly 40% of all mamma-
ceutical manufacturing capacity. Among mand fluctuations over time as well as lian capacity is in North America,

192 Chemical Weekly November 14, 2023

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