Page 174 - CW E-Magazine (4-6-2024)

Special Report

What’s trending inside the CDMO/CMO market?

hat are key trends shaping the turing facility in Holly Springs, North PATRICIA VAN ARNUM
market for bio/pharmaceutical Carolina, bringing the total invest- Editorial Director
Woutsourcing? DCAT Value ment in the facility to over $3.2-bn. Drug, Chemical & Associated
Chain Insights takes an inside look The company is also proceeding with Technologies Association,Inc. (DCAT)
into the market drivers, trends, and key a $1.6-bn capital investment to expand
activity shaping the CDMO/CMO sector large-scale cell-culture capacity in its Novo Holdings, the parent company of
in small-molecules, biologics, and drug Denmark facility, with the fi rst drug- Novo Nordisk, which upon closing of
products. substance expansion set to come on the acquisition will net Novo three fi ll-
line later this year (2024) and a second fi nish sites and related assets in Anagni,
Biologics drug-substance expansion slated for Italy; Bloomington, Indiana; and Brus-
The global contract biologics market online activation in 2026. sels, Belgium. The merger is expected
(biologic drug substance) was valued at to close toward the end of 2024, subject
over $19-bn in 2023 and is expected to Lonza is making a large capital in- to customary closing conditions, includ-
grow at a compound annual growth rate vestment through its pending $1.2-bn ing approval by Catalent stockholders
(CAGR) of approximately 9% between acquisition of a large-scale biologics and receipt of required regulatory ap-
2023 and 2035 to $55.97-bn, according manufacturing site in Vacaville, Cali- provals. After closing, Novo Holdings
to a recent report by Research And fornia, from Roche’s Genentech. Lonza plans to sell the three fi ll-fi nish sites to
Markets, a Dublin, Ireland-based mar- plans to invest an additional CHF 500-mn Novo Nordisk for $11-bn. The Catalent
ket research company. ($554-mn) to upgrade the Vacaville faci- acquisition is expected to gradually in-
lity. Lotte Biologics, a Seoul, South crease Novo Nordisk’s fi lling capacity
Refl ecting that strong growth are Korea-based CDMO of biologics, is from 2026 and onwards.
large capacity expansions by several of proceeding with a $3-bn biomanufactur-
the large CDMOs. Samsung Biologics ing expansion plan, which involves the Several key expansions among CD-
is proceeding with a KRW 7.5-trillion construction of three new biomanufac- MOs, however, will add capacity to the
(approximately $6-bn) expansion plan to turing plants in South Korea. The fi rst market. For example, Simtra BioPharma
add a second biomanufacturing campus biomanufacturing plant is set to com- Solutions is investing $250-mn-plus to
in South Korea. The plan fi rst includes mence construction this year (2024) with expand its sterile fi ll-fi nish manufactur-
the addition of a fi fth biomanufactur- a production capacity of 120,000-litres. ing campus in Bloomington, Indiana.
ing plant for the company with a capa- Simtra BioPharma Solutions is the for-
city of 180,000 litres, scheduled for Drug products (sterile injectables) mer CDMO, Baxter BioPharma Solu-
completion in April 2025, contributing The contract sterile injectables market tions, spun off from Baxter Healthcare
to a signifi cant increase in the company’s is also a high-growth sector, marked by and acquired for $4.25-bn by the pri-
overall biomanufacturing capacity, which several large recent moves by CDMOs. vate equity fi rm, Advent International,
will reach a total of 784,000-litres The global sterile injectable contract and growth investment fi rm, Warburg
upon the plant’s completion. The full manufacturing market was estimated at Pincus, last October. The company is
development of the company’s second $12.89-bn in 2022 and is projected to also proceeding with a $100-plus-mn
biomanufacturing campus, which will grow at a CAGR of 12.1% from 2023 investment in its Halle/Westfalen, Ger-
entail future Plants 5-8 and an open to 2030 to reach nearly $32-bn in 2030, many, site for the construction of a new
innovation centre, represents an invest- according to a recent analysis by Grand building housing a high-speed syringe
ment of KRW 7.5-trillion (approximately Review Research, a San Francisco, Califor- line and a vial line equipped with four
$6-bn). nia-headquartered market research fi rm. lyophilizers, with GMP readiness is
anticipated by the end of 2024.
Fujifi lm Diosynth Biotechnologies One of the largest moves in the
is also proceeding with a multi-billion- CDMO/CMO market is the pending Lonza is investing CHF 500-mn
dollar biomanufacturing expansion. In mega acquisition that will move manu- ($547-mn) in a large-scale, commercial
April 2024, the company announced facturing capacity out of the CDMO/ drug-product fi ll-fi nish facility in Stein,
an additional investment of $1.2-bn in CMO market: the pending $16.5-bn Switzerland. The new facility follows the
its large-scale cell-culture biomanufac- acquisition of the CDMO, Catalent, by company’s previous investment in for-

174 Chemical Weekly June 4, 2024

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