During the first half (H1) of 2024, the global contract development and manufacturing organization (CDMO) landscape was driven by the escalating demand for complex drug development and manufacturing.With the industry grappling
with constantly evolving therapeutic modalities, CDMOs are racing to invest in
cutting-edge technologies and infrastructure to meet the growing needs of
pharmaceutical and biotech companies.Some of the key players in
the CDMO space are Catalent, EUROAPI, Lonza, Axplora, Thermo Fisher, SEQENS, Samsung Biologics, Fujifilm Diosynth Biotechnologies, Quotient Sciences, Famar, LGM Pharma, Veranova, and Evonik. View CDMO Activity Tracker for H1 2024 (Free Excel Available)Novo’s parent buys Catalent for US$ 16.5 bn; Bora, Lonza, Siegfried expand US footprintDuring H1 2024, several
European and Asian drugmakers expanded their footprints in the US. In February,
Novo Nordisk’s parent company, the Novo Nordisk Foundation, announced the acquisition of Catalent through its
investment arm Novo Holdings for US$ 16.5 billion. Novo Holdings plans to sell three of Catalent’s “fill-finish” sites to Novo Nordisk for US$ 11 billion. The deal is expected to allow the Danish drugmaker “to serve significantly more people living with diabetes and obesity,” a company statement said.Taiwan-headquartered Bora Pharmaceuticals forged
ahead with its expansion plans in the US market by acquiring Minnesota-based generics
manufacturer Upsher-Smith Laboratories. Emergent BioSolutions said it is selling its Maryland facility to an affiliate of Bora. This site
in Camden is part of its
CDMO, Emergent Bioservices, and offers clinical and commercial non-viral
aseptic fill/finish services on four fill lines, including lyophilization,
formulation development, and support services.Swiss drugmaker Lonza has
agreed to acquire Genentech’s manufacturing facility in California, US, from Roche for US$ 1.2 billion in cash. The site,
located in the city of Vacaville, is one of the largest biologics manufacturing
facilities in the world by volume.Lonza also launched an artificial intelligence-driven route design technology for choosing the optimal synthetic pathway to manufacture novel APIs.Switzerland’s Siegfried is acquiring a Wisconsin (US)-based CDMO that specializes in early-phase development and
manufacturing services from Curia Global to strengthen its capabilities in
North America. Siegfried will further develop the site into its North American
Siegfried Acceleration Hub for early-phase CDMO services. View CDMO Activity Tracker for H1 2024 (Free Excel Available) Merck
Millipore, SK Bioscience lead CGT boom; Fujifilm,
Axplora, expand CDMO capabilitiesThe burgeoning field of cell
and gene therapies (CGTs) is driving significant investments in CDMOs. CGTs saw
considerable deal-making too. Merck KGaA agreed
to buy Wisconsin-based Mirus Bio for US$ 600 million. Mirus Bio is a specialist in the development and
commercialization of transfection reagents that are used to help introduce
genetic material into cells. These reagents play a key role in the production of viral vectors for CGTs.Similarly, South Korea’s SK
Bioscience acquired a 60
percent stake in IDT
Biologika GmbH for KRW 339
billion (US$ 244 million). IDT Biologika is a
104-year-old German company that ranks among the top 10 vaccine producers in
the world.CDMOs are also expanding their capabilities in order
to lead innovation for their pharmaceutical partners. Fujifilm Diosynth Biotechnologies is
investing US$ 1.2
billion in its large-scale cell culture
CDMO business to further expand its end-to-end bio-manufacturing facility
in North Carolina, bringing the total investment in the facility to over US$
3.2 billion. Similarly, Merck
KGaA owned MilliporeSigma made its biggest investment in the Asia-Pacific
region in March when it invested € 300 million (US$ 327 million) in a new bioprocessing production center in Daejeon, South Korea.German CDMO giant Axplora is investing € 8 million (US$ 8.73 million) to expand
capacity for antibody drug conjugate (ADC) payload
manufacturing at its Le Mans site in France. Catalent completed
upgrades to its capsule filling capabilities of dry
powders for inhalation to handle potent drugs at its Boston facility. This now
positions Catalent as the CDMO with the largest GMP capacity for capsule
spray-dried and carrier-based inhaled powders.LGM
Pharma increased its Analytical Testing Services
(ATS) by 50 percent with a US$ 2
million investment and introduced new suppository
manufacturing capabilities to its CDMO portfolio. Minakem has invested
in a new production unit in Montreal, Canada, for steroid APIs. View CDMO Activity Tracker for H1 2024 (Free Excel Available) EUROAPI kicks off four-year sweeping plan; LegoChem
partners Samsung Biologics for ADC programSanofi’s spinoff EUROAPI marked 2024 as a “transition year”, setting in motion its Focus-27 plan for profitable growth in the
future. The sweeping four-year plan includes a streamlined value-added
portfolio focused on highly differentiated and profitable APIs, and a CDMO
focused on late-stage and high-value complex small molecules and tides supported
by unique technological platforms. The leading
French small molecules player signed a five-year
collaboration with Ireland’s Priothera wherein EUROAPI will develop and industrialize the manufacturing process of an innovative, complex molecule for blood cancers – mocravimod. The project will be carried out at EUROAPI’s site in Budapest, which is its center of excellence for complex chemistry.South Korea’s CDMO powerhouse Samsung
Biologics has partnered LegoChem
Biosciences and will
provide antibody development and drug substance manufacturing services as a part of LegoChem’s ADC program designed to treat solid tumors. LegoChem aims to submit an investigational new drug application to the US Food and Drug Administration (FDA) in the first half of 2025. Aurigene and Vipergen have joined
forces to offer DNA-encoded library (DEL) screening for drug discovery. By combining Aurigene’s drug discovery capabilities with Vipergen’s DEL screening technologies, they seek to create a powerful tool that can quickly test over a billion small-molecule compounds against different disease targets. Dr. Reddy’s Laboratories’ company Aurigene also inaugurated its biologics facility spread across 70,000 square feet.Chinese biotech startup Pleryon is collaborating with France’s SEQENS, a leader in specialty ingredients, to develop and manufacture the former’s lead candidate, an innovative polymer to treat osteoarthritis. Famar is collaborating with Lavipharm and will serve as the contract manufacturer for the latter’s recently added analgesic pharmaceutical products — Lonarid N and Lonalgal. View CDMO Activity Tracker for H1 2024 (Free Excel Available) Our view Key
trends observed in H1 2024 include a surge in investments for fill-finish
facilities, a growing emphasis on cell and gene therapies, and advancements in
ADC manufacturing. With the proliferation of these new classes of drugs, the
CDMO space has been rapidly changing in recent years. In the future, the
integration of digital technologies, such as AI and automation, will be a key
differentiator for CDMOs looking to optimize their operations and accelerate
drug development timelines.
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