CDMOs/CMOs: The Movers and Shakers of 2024
As 2024 comes to a close, what were the key developments—expansions and M&A—from CDMOs/CMOs this year? DCAT Value Chain Insights looks at which companies topped the headlines this year and their moves.
By Patricia Van Arnum, Editorial Director, DCAT, pvanarnum@dcat.org
Key moves in 2024
A look back at 2024 reveals key moves across the bio/pharma manufacturing value chain: from active pharmaceutical ingredients (small molecules and biologics) and drug products (sterile manufacturing aseptic fill-finish). Some of the larger moves, both on a company and market segment basis, in the CDMO/CMO market in 2024 are highlighted below.
Novo’s $16.5-billion pending acquisition of Catalent. The largest move in the CDMO/CMO sector in 2024 was also the largest deal in the bio/pharma industry as a whole in 2024: Novo Holdings’ $16.5-billion acquisition of the CDMO, Catalent. In February (February 2024), Novo Holdings, the parent company of Novo Nordisk, announced plans to acquire Catalent for $16.5 billion as a means for Novo to add manufacturing capacity for its blockbuster glucagon-like peptide 1 (GLP-1) agonists for treating Type 2 diabetes and obesity, Ozempic/Wegovy/Rybelsus (semaglutide). The deal, which is expected to close later this year (2024), will net Novo three fill–finish sites and related assets in Anagni, Italy, Bloomington, Indiana, and Brussels, Belgium. After closing, Novo Holdings plans to sell the three fill–finish sites to Novo Nordisk for $11 billion. The Catalent acquisition is expected to gradually increase Novo Nordisk’s filling capacity from 2026 and onwards. The deal moved further to closing when earlier this month (December 6, 2024), the European Commission approved Novo Holdings’ acquisition of Catalent well as Novo Nordisk’s subsequent acquisition of the three manufacturing sites from Novo Holdings. The completion of the acquisition remains subject to the fulfilment of further customary closing conditions, including regulatory approvals in other jurisdictions, but Novo Nordisk says it still expects the acquisition to be completed toward the end of 2024.
Billion-dollar-plus moves in biomanufacturing: Several of the large CDMOs specializing in biomanfacturing are proceeding with billion-dollar-plus expansions. Samsung Biologics is proceeding with a KRW 7.5 trillion (approximately $6 billion) expansion plan to add a second biomanufacturing campus in South Korea. The plan first includes the addition of a fifth biomanufacturing plant for the company with a capacity of 180,000 liters, scheduled for completion in April 2025, contributing to a significant increase in the company’s overall biomanufacturing capacity, which will reach a total of 784,000 liters upon the plant’s completion. The full development of the company’s second biomanufacturing campus, which will entail future Plants 5-8 and an open innovation center, represents an investment of KRW 7.5 trillion (approximately $6 billion).
Fujifilm Diosynth Biotechnologies is also proceeding with a multi-billion-dollar biomanufacturing expansion. In April (April 2024), the company announced an additional investment of $1.2 billion in its large-scale cell-culture biomanufacturing facility in Holly Springs, North Carolina, bringing the total investment in the facility to over $3.2 billion. The company is also proceeding with a $1.6-billion capital investment to expand large-scale cell-culture capacity in its Denmark facility, with the first drug-substance expansion set to come on line later this year (2024) and a second drug-substance expansion slated for online activation in 2026.
Lonza also made a significant move with its $1.2-billlion acquisition of a large-scale biologics manufacturing site in Vacaville, California, from Roche’s Genentech. Lonza plans to invest an additional CHF 500 million ($554 million) to upgrade the facility.
Lotte Biologics, a Seoul, South Korea-based CDMO of biologics, is proceeding with a $3-billion biomanufacturing expansion plan, which involves the construction of three new biomanufacturing plants in South Korea., with construction of the first plant beginning in 2024.
CordenPharma’s $981-million peptide manufacturing expansion. In July (July 2024), CordenPharma, a CDMO of drug substances and drug products, announced an investment of more than EUR 900 million ($981 million) over the next three years to expand peptide manufacturing at its sites in Colorado and in Europe. The expansions cover both existing facilities and new construction. The investment represents the single largest investment by the company to date. The Colorado site’s expansion will target additional large-scale peptide manufacturing capacity to meet increasing demand of glucagon-like peptide-1 (GLP-1) peptides, resulting from multiple long-term manufacturing contracts totaling approximately EUR 3 billion ($3.3 billion), with potential upsides. In Europe, CordenPharma will construct a greenfield site for small- to large-scale peptide development and manufacturing, integrated within its global facility network.
Agilent’s $925-million acquisition of BioVectra. In September (September 2024), Agilent Technologies, a Santa Clara, California-based technology company and CDMO of active pharmaceutical ingredients (APIs), completed its $925-million acquisition of BioVectra, a Charlottetown, Prince Edward Island, Canada-based CDMO of drug substances and drug products. The deal was announced in July 2024. BioVectra provides clinical-to-commercial scale production of biologics, small molecules (including highly potent APIs), bioreagents, lipids, plasmid DNA (pDNA), mRNA and lipid nanoparticles (LPNs), and fill–finish services for drug products. The acquisition builds on Agilent’s CDMO specialization in oligonucleotides and CRISPR therapeutics and expands its portfolio of services and adds new modalities, such as highly potent APIs. The acquisition included all of BioVectra employees and sites in Prince Edward Island and Nova Scotia, Canada. BioVectra recently made a $240-million investment to expand its operational footprint in both Prince Edward Island and Nova Scotia. Earlier this year (2024), the company completed an expansion of its capabilities in mRNA, pDNA, LPNs, and fill–finish.
The acquisition builds on Agilient’s recent expansions. Last year (2023), Agilent announced an investment of $725 million to double manufacturing capacity of therapeutic nucleic acids at its facility in Frederick, Colorado, by adding two new manufacturing lines. The new investment is in addition to a previously announced $150-million investment to add 25,000 square feet of manufacturing capacity to the Frederick facility. Agilent’s manufacturing facilities in Colorado produce siRNA, antisense molecules, and CRISPR-guided RNA molecules. The expansion is expected to be completed by the end of 2026.
Sterile manufacturing and aseptic fill-finish expansions. Novo’s pending acquisition of Catalent is the largest move in the contract sterile manufacturing and aseptic fill-finish sector, but other CDMOs/CMOs are proceeding with expansions. Simtra BioPharma Solutions is investing $250-million-plus to expand its sterile fill-finish manufacturing campus in Bloomington, Indiana. Simtra BioPharma Solutions is the former CDMO, Baxter BioPharma Solutions, spun off from Baxter Healthcare and acquired for $4.25 billion by the private equity firm, Advent International, and growth investment firm, Warburg Pincus, last October (October 2023). The company is also proceeding with a $100-plus million investment in its Halle/Westfalen, Germany, site for the construction of a new building housing a high-speed syringe line and a vial line equipped with four lyophilizers, with GMP readiness is anticipated by the end of 2024.
Lonza is investing CHF 500 million ($547 million) in a large-scale, commercial drug-product fill–finish facility in Stein, Switzerland. The new facility follows the company’s previous investment in formulation and clinical drug-product manufacturing and is slated to be completed in 2026. Vetter, a CDMO of aseptic filling and packaging, is investing EUR 230 million ($252 million) in a new production building, which is currently under construction at its global corporate headquarters site in Ravensburg, Germany.
High-potency manufacturing expansions. High-potency manufacturing continued to be an active area of investment for CDMOs/CMOs in 2024, both on the API and drug product side. Among the companies making moves is Lonza, which is increasing bioconjugation capacity by adding two new bioconjugation suites at its site in Visp, Switzerland. This expansion is expected to be one of the largest bioconjugation facilities globally (1,500 m²) when operational in 2026. The expansion builds on other recent investments for antibody drug conjugates (ADCs). Last year (2023), Lonza acquired Synaffix B.V., a company with a technology platform for ADCs, bispecific antibodies, and other targeted therapeutics. The companies are advancing their Center of Excellence for Bioconjugate Technology Development. On the drug product side, Lonza is adding a dedicated commercial-scale aseptic cGMP filling line at its site in Stein, Switerland, to be operational by 2027. This new filling line will handle and fill bioconjugates for the commercial supply of ADCs.
BSP Pharmaceuticals, a CDMO of drug substances and drug products, announced a multi-year investment totaling EUR 530 million ($576 million) to expand its site in Latina, Italy, designed for the manufacturing of cytotoxic and non-cytotoxic innovative products. The investments began in 2024 and will be completed by the end of 2028.
Among smaller-scale investments, MilliporeSigma announced in October (October 2024) a $76-million expansion of its ADC manufacturing capabilities and capacity at its Bioconjugation Center of Excellence in St. Louis, Missouri. The investment will triple existing capacity and upgrade 34,000 square feet to support process and analytical development, quality control, research and development, manufacturing, and logistics. In June (June 2024), Veranova initiated a $30-million expansion of its ADC and highly potent compound development and manufacturing capabilities at its Devens, Massachusetts, facility. In November (November 2024), Olon announced the schedule for the construction of a new EUR-25-million ($27-million) facility in Rodano (Milan), Italy, dedicated to ultra-potent compounds. Olon is also adding a GMP high-potency API suite at the company’s site in Concord, Ohio, which is the company’s Center of Excellence for early development of APIs. As part of a plan to increase early-stage CDMO services in the US, in July (July 2024), Siegfried acquired an early-phase drug-substance manufacturing site in Grafton, Wisconsin, from Curia. Siegfried plans to develop the site into a hub for early-phase CDMO services, including services for projects for highly potent APIs, the company said at the time of the announced acquisition in June (June 2024).