CDMOs Roll Out Expansions for Parenteral Drugs
The global injectables drugs market is projected for strong growth, driven by demand in biologics and specialty therapeutics. In response, CDMOs/CMOS are expanding production capacity. What are the latest expansions?
By Patricia Van Arnum, Editorial Director, DCAT, pvanarnum@dcat.org
Capacity: a 360-degree view
In taking a 360-degree view of the CDMO market for injectables, macro issues impacting the industry as whole that emerged last year continue to loom large in 2026. A fluid tariff/trade scheme, a policy push for US-based manufacturing, and the potential margin pressure from US drug pricing reforms if most-favored-nation drug pricing were to come into full play are large-ticket issues facing the industry as a whole. How these issues may factor in the calculus of in-sourced/outsourced decision-making is the focus of the latest episode of the DCAT Value Chain Insights podcast, Production to Prescription, which gained perspectives on what be in store for both bio/pharma companies and CDMOs of injectables.
As these issues unfold, however, the business of biopharmaceutical development and manufacturing continues. Driven by demand for biologics, specialty therapeutics, and other complex drugs, the global injectable drug market is projected for strong growth, with the CDMO market for injectables following pace with near-term growth in the high single digits, according to industry estimates. Several CDMOs are proceeding with capacity additions, and a roundup of key expansions announced in 2025 and 2026 to date are highlighted below.
The CDMOs making the moves
Last month (January 2026), Vetter, a CDMO of aseptic filling and packaging, announced plans to build a EUR 480-million ($574-million) production facility in the Saarland region of southwest Germany. Construction is scheduled to begin in the second quarter of 2026, and operations are expected to commence in 2031. In addition, the company recently began construction on a new $285-million clinical manufacturing site in Des Plaines, Illinois. The facility is expected to be ready for media fill by the end of 2029. The expansion provides additional capacity for small-batch production and includes space for warehouses, laboratories, and administrative offices. The 860,000-square-foot site has the capacity to accommodate future expansion. The new location supplements Vetter’s existing clinical network in Skokie, Illinois, and Rankweil, Austria.
At its site in Bloomington, Indiana, Simtra BioPharma Solutions added a flexible clinical line for prefilled syringes and liquid and lyophilized vials and is building a new production facility that will house three isolator commercial-scale sterile filling lines. The company also acquired a 65-acre property nearby with more than 300,000 square feet of available space for future development. Plans for this campus include the installation of at least six additional isolator filling lines. The first new line will be a highspeed isolator vial filling line equipped with three lyophilizers dedicated to highly potent molecules, such as antibody-drug conjugates (ADCs) and is scheduled to be operational in 2027. Outside the US, the company recently added an conjugation and purification suite for ADCs at its site in Halle/Westfalen, Germany, and inaugurated a new building with two new high-speed isolator lines, one for syringes and one for liquid and lyophilized vials.
To increase its US drug-product manufacturing capacity in the US, last September (September 2025), Thermo Fisher Scientific acquired Sanofi’s sterile manufacturing site in Ridgefield, New Jersey. Thermo Fisher’s global sterile fill–finish manufacturing network includes US sites in Greenville, North Carolina, and Plainville, Massachusetts. In 2025, Thermo Fisher added multiple new drug-product service lines, including high-speed prefilled syringe lines at its site in Greenville, North Carolina, and one new line in Swindon, UK. That is in addition to expanding pharmaceutical development service lines to support sterile fill–finish at sites across Europe and the US.
Incog BioPharma Services announced last month (January 2026) an investment of approximately $200 million in its manufacturing facility in Fishers, Indiana. The expansion is scheduled to begin in early 2026, establishing the 21‑acre campus as a global manufacturing hub for injectable biopharmaceuticals, with 300,000 square feet of space. By 2030, Incog expects to employ nearly 1,000 people at its Fishers campus.
As part of a global investment strategy, in Europe, Sharp Services is increasing GMP production capacity to accommodate new vial labeling, syringe assembly and injectables packaging at its site in the Netherlands, which is due to come online in 2026. In the US, the company is investing $28 million to increase capacity at its sterile manufacturing facility in Lee, Massachusetts, recently invested $20 million to expand its autoinjector and pen assembly, labeling and packaging lines across various therapeutic areas at its facility in Macungie, Pennsylvania, and at its site in Allentown, Pennsylvania, the company is adding a new pre-filled syringe assembly, labeling and packaging line.
Last May (May 2025), PCI Pharma Services completed its acquisition of Ajinomoto Althea, a San Diego, California-based sterile fill–finish CDMO and subsidiary of the Japanese multinational conglomerate, Ajinomoto Co. Althea provides aseptic fill–finish services at clinical and commercial scales and was part of Ajinomoto Bio-Pharma Services, a CDMO of drug substances and sterile drug-product manufacturing. Under the deal, Althea was separated from Ajinomoto Bio-Pharma Services, and all other Ajinomoto Bio-Pharma Services continue to operate globally as part of the Ajinomoto Group. The acquisition provided PCI with its first-ever North American manufacturing location for prefilled syringes and cartridges, including isolator technology for these formats, as well as high-potent manufacturing suitable for antibody drug conjugates. In addition, in 2024, PCI announced investments exceeding $365 million to support the clinical – and commercial-scale final assembly and packaging of drug-device combination products, with an emphasis on injectable formats.
Also building US capacity is Grand River Aseptic Manufacturing (GRAM), a Grand Rapids, Michigan-based CDMO of injectables, which through the addition of a new 150,000-square-foot syringe and cartridge filling center designed to hold up to four syringe/cartridge filling and inspection lines. The new center is adjacent to GRAM’s existing 200,000-square-foot finishing and warehouse center. It brings the company to five manufacturing facilities and more than 450,000 square feet. of production space. Building construction was slated for completion in 2025, with new filling and inspection equipment installed in 2026.
Outside the US, Lonza is investing CHF 500 million ($547 million) in a large-scale, commercial drug-product fill–finish facility in Stein, Switzerland, scheduled to be operational in 2027.
In other expansions, Delpharm is investing $220 million to upgrade and add a new sterile filling line at its site in Boucherville, Quebec. In late 2025, Alcami, a CDMO of drug products and provider of analytical testing services, launched a third sterile fill-finish line at its Research Triangle Park, North Carolina, campus. It represented the company’s fifth sterile fill–finish line that is qualified for GMP clinical and commercial manufacturing within Alcami’s drug-product manufacturing network. Also in 2025, Aenova announces a investment in its sterile manufacturing capabilities with the installation of another fill–finish line at its site in Latina, Italy. Also in 2025, Famar, an Athens, Greece-based CDMO, acquired a sterile production site from MiP Pharma, a Homburg, Germany-based bio/pharmaceutical company. In late 2025, Symbiosis, a CDMO of injectables, manufactured its first 10,000-vial batch at the company’s new facility in Stirling, UK.
