Page 190 - CW E-Magazine (14-11-2023)

Special Report

Mammalian biomanufacturing industry overview

Trends Overview 2022-2027 and biopharmaceutical companies, and DAWN M. ECKER
emand for biologics manu- these companies face key issues such Managing Director
facturing capacity by volume as the current and future state of bio- bioTRAK Database Services
Dis projected to reach nearly manufacturing capacity, the availabi-
4,400-kL, a 5-year growth rate of nearly lity of that capacity, and technologies PATRICIA SEYMOUR
11.5% per year (just over 2,500-kL in impacting upstream and downstream Managing Director
2022). bioprocessing. This article provides a BioProcess Technology Group
high-level overview of the current state BDO USA
If certain high-dosage and frequently of the supply of and demand for mamma-
dosed products for large-population lian-based biopharmaceuticals and market, BDO’s proprietary bioTRAK
®
indications such as Alzheimer’s, diabe- details a forecast of where the industry database of biopharmaceutical products
tes and cancer checkpoint inhibitors are is heading and how manufacturers are and manufacturing capacity estimates
approved by regulators and reimbursed keeping pace. that there are over 1,600 biopharma-
by most insurers, demand for capacity ceutical products in some stage of clini-
could be much higher resulting in Mammalian-based biopharmaceu- cal development in the US or Europe.
capacity constraints. tical product sales have continually
increased over the past three decades The majority, approximately 88%,
Global biologics manufacturing and represent a thriving sector in the are produced in mammalian cell culture
capacity will increase to nearly 8,400-kL overall growth of pharmaceutical com- systems. We evaluated the distribution
by 2027, from nearly 6,500-kL in 2023. pany revenue. In 2022, the top five of mammalian products by product
CMO and hybrid companies are pro- selling recombinant proteins generated type and phase of development to fur-
jected to increase their control of capa- nearly $71-bn in sales, four of which ther refine the biopharmaceutical manu-
city from just over 35% in 2023 to were antibody-based products (Humira, facturing market. Figure 1 shows the
just over 45% in 2027, with capacity Keytruda, Stelara, Eylea) with sales distribution of product types, including
growth rates in Asia exceeding 10%. totaling nearly $62-bn. The fifth antibody products, blood proteins, cyto-
Nearly three quarters of the recombi- product, the microbially-expressed glu- kines, enzymes, fusion proteins, hor-
nant products currently in late phase cagon-like peptide-1 (GLP-1) receptor mones, and other recombinant proteins,
development (Phase 2, Phase 3) can be agonist Ozempic/Wegovy, posted just by phase of development. Antibody
met by a single 2,000 or 5,000-L bio- over $9-bn in sales. For antibody pro- products are the dominant commer-
reactor. duct revenue, a group which includes cially marketed product type at nearly
naked monoclonal antibodies, Fc-fusion 70% and the largest product type for
In the short term, BPTG predicts proteins, antibody fragments, bispecific all phases of development, including
manufacturing capacity will not be antibodies, antibody conjugates, and the early-stage pipeline, which con-
constrained, but may tighten after other antibody related products, the sists of nearly all antibody products.
2027. While the majority of capacity compound annual growth rate was It is important to note that many of the
currently remains in-house, companies 16.9% from 2005 to 2015. early commercial biopharmaceutical
performing contract manufacturing are products, such as growth hormones,
expanding their capacities which, in the Although this growth has remained insulins, and interferons, are produced
coming years, may lessen the difficul- in the low teens in recent years due to the in microbial systems, and are not
ties companies without capacity may maturation of many products and emerg- included in this analysis.
have experienced in accessing capa- ing alternative therapeutic modalities, it
city at the right time and under the right far exceeds the 4.5% growth rate of Whether commercially approved
terms. traditional pharmaceutical (i.e., small or in development, the manufacture
molecule) sales from 2005 to 2015 or of each of these products requires
AbsTrAcT the low single digits in recent years. access to mammalian production capa-
Biologic-based drugs continue to city. For current commercially approved
be an important part of the portfolio To provide context around this biopharmaceutical products, future
growth strategies for pharmaceutical growing segment of the pharmaceutical demand is estimated from each pro-

190 Chemical Weekly November 14, 2023

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