Strong growth is projected for the injectables drugs market, and CDMOs/CMOS are expanding sterile manufacturing & fill–finish capacity. Which companies are expanding and who is leading the charge?

By Patricia Van Arnum, Editorial Director, DCAT, pvanarnum@dcat.org

Market snapshot
The supply–demand outlook for fill–finish capacity is in a period of flux. The market success of certain blockbuster products, such as the glucagon-1 peptide (GLP-1 agonists) used for treating Type 2 diabetes and obesity, has fueled demand for large-volume fill–finish capacity. This high demand has in part absorbed some of the strongly reduced demand in COVID-19 vaccines and products, which had been a principal driver for fill–finish capacity. At the same time, biologic-based drug development continues to fuel the market, but that has not been without some headwinds, particularly due to a slowdown in biotech funding over the past two years. Now in 2025, supply and demand for fill–finish capacity continues to re-calibrate. Overall demand for fill-finish capacity remains strong, but demand is varied based on evolving product needs, both on a volume and format basis.

Capacity leaving and coming into the market
Top of mind for the fill–finish market on the CDMO/CMO side relates to capacity transitioning out of the market with Novo Holdings’ $16.5-billion acquisition of the CDMO, Catalent, a deal which closed last December (December 2024) and Novo Holding’s subsequent sale of three fill–finish sites to Novo Nordisk for $11 billion to support Novo Nordisk’s blockbuster GLP-1 agonists, Ozempic/Wegovy (semaglutide), respectively for treating Type 2 diabetes and obesity. The deal netted Novo three fill–finish sites and related assets in Anagni, Italy, Bloomington, Indiana, and Brussels, Belgium. The Catalent acquisition is expected to gradually increase Novo Nordisk’s filling capacity from 2026 and onwards.

As that capacity transitions out of the market, more investment is coming. On the CDMO/CMO side, an estimated 12 to 15 major investments totaling $1.5-billion to $2 billion (based on disclosed investments) are coming on line in the 2024–2026 time frame, according to a recent analysis by L.E.K. Consulting. Figure I at the end of the article highlights some recent and near-term investments.

Roundup of recent investments
What are some of these capacity additions by CDMOs/CMOs, including investments for related support functions, as well as other expansions? A roundup is outlined below.

Vetter. Vetter, a Ravensburg, Germany-headquartered CDMO of aseptic filling and packaging, is currently expanding its sites in Ravensburg and Langenargen, Germany as well at its sites in the Austria and the US. The company is expanding its production facility in Langenargen. Additional office spaces and a technical workshop are being created in Rankweil, Austria. In its site outside of Chicago, the company is expanding its development site, which involves construction of a new site in Des Plaines, Illinois, and the relocation and expansion of Vetter Development Services US from the Illinois Science and Technology Park over the next years. Also, the third phase of the expansion of Vetter Center for Visual Inspection and Logistics is underway. The cold-storage facility will also provide additional capacity for manual and automated visual inspection. Construction of the extension began in late 2024, with an eye on a 2028 opening. In addition to housing a larger high-bay warehouse, the 22,500-square-meter facility will be home to a stability chamber, offices, and a data center. The company is investing more than EUR 150 million ($174 million) to add 16,000 pallet positions to the existing 13,000 cold-storage pallet spaces. Upon completion, Vetter will have a total of 68,000 pallet positions for various temperature requirements.

PCI Pharma Services. In May (May 2025),  PCI Pharma Services completed its acquisition of Ajinomoto Althea, a San Diego, California-based sterile fill–finish CDMO and 100% 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 Ajinomoto Group. The acquisition provides 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 ADCs.

The company is also proceeding with the addition of a new 50,000-square-foot sterile fill–finish manufacturing facility at its site in Bedford, New Hampshire, which is scheduled for full-scale GMP production this summer (summer of 2025). Site construction and infrastructure installation is complete (as reported on June 3, 2025), and the company has begun qualification activities. The facility houses an aseptic vial fill–finish line within a fully isolated containment system, equipped with twin 430-square-foot lyophilizers featuring automatic loading and unloading systems. A high-speed integrated filler can produce batches of up to 300,000 vials at speeds up to 400 per minute.

The site constitutes the third high-throughput, isolator-based commercial sterile fill–finish facility that the company has built in the last four years. The company is also expanding its pharmaceutical development capabilities at its Bedford campus, which includes repurposing an existing building into a dedicated Development Center of Excellence providing formulation, analytical and process development, as well as stability testing. The center is expected to be operational in early 2026.

In addition, last September (September 2024), the company announced it is investing more than $365 million in infrastructure supporting the clinical and commercial-scale final assembly and packaging of drug-device combination products, with an emphasis on injectable formats. This includes a 545,000-square-foot expansion at its campus in Rockford, Illinois, dedicated to advanced drug delivery and drug-device combination assembly and packaging. In Europe, the company acquired a pharmaceutical packaging and device assembly facility near Dublin, Ireland, providing large-scale temperature-controlled storage capabilities, with the facility providing commercial-scale packaging and assembly operations for injectables as well as oral solid dose drug products. The company is also proceeding with a new packaging and device assembly services facility at its CityNorth campus in Dublin, Ireland. Slated to begin operations in the third quarter of 2025, the plant will provide increased capacity for the final assembly, labeling and packaging of injectable drug products, including vials, prefilled syringes, and drug-device combination products such as autoinjectors. The facility also will include cold chain packaging for injectable and biologic products, as well as associated temperature-controlled storage.

Simtra BioPharma Solutions. 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, in 2023. A clinical line was slated to be ready to onboard new projects by summer 2025. Construction of the new building began and is anticipated to take two years to complete, allowing for GMP readiness in late 2026. The company also invested $100-plus million in its Halle/Westfalen, Germany, site for a new building housing a high-speed syringe line and a vial line equipped with four lyophilizers, with GMP readiness achieved for the end of 2024.

Lonza. 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.

Thermo Fisher Scientific. Thermo Fisher is adding multiple new drug-product service lines in 2025, including four 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 seven pharmaceutical development service lines to support sterile fill–finish at sites across Europe and the US (Ferentino, Italy, Greenville, North Carolina, Monza, Italy, and Plainville, Massachusetts).

Grand River Aseptic Manufacturing. Grand River Aseptic Manufacturing (GRAM) is adding 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 is expected to be complete in 2025, with new filling and inspection equipment installed in 2026.

Piramal Pharma Solutions. Piramal Pharma Solutions, a CDMO of active pharmaceutical ingredients and drug products, is investing $80 million to expand its site in Lexington, Kentucky, which specializes in sterile compounding, liquid filling, and lyophilization for sterile injectable drug products. The  Lexington site can manufacture 104 product batches per year (utilization at peak levels). Upon completion of the expansion in the first quarter of 2027, this capacity will increase to over 240 annual batches. The expansion will equip the Lexington site with an additional 24,000 square feet of manufacturing space, a new laboratory, and machinery.

Other expansions
Famar. In May (May 2025), Famar Group, an Athens, Greece-based CDMO of drug products, agreed to acquire a sterile production site in Homburg (Saar), Germany, from MiP Pharma, a mid-sized bio/pharmaceutical company. With the closing of the acquisition, Famar will operate seven facilities across Europe. The site will be developed into a multi-customer CDMO platform under Famar ownership.

Bora. Bora Pharmaceuticals is adding a new fill–finish vial, syringe, and cartridge line at its site in Baltimore, Maryland. The installation will take place over the course of the next year (as reported in May 2025). The new line will operate under full isolator conditions and is suited for clinical and small-scale commercial supply.

Delpharm. Delpharm is modernizing its injectable manufacturing facility in Boucherville, Quebec, Canada. The facility manufactures 65 million units primarily for North America and specializes in the production of sterile drugs packaged in vials and ampoules. The modernization plan represents a total investment exceeding CAD$200 million (US$140 million) and is scheduled to run until 2031. The plan includes expanding the site, installing a new filling line, and upgrading existing equipment to comply with new Health Canada standards. Ultimately, 95% of the equipment will be replaced.

Recipharm. In February (February 2025), Recipharm announced a new modular sterile filling system for process development and pilot-scale and clinical supply, became fully operational at its facility in Wasserburg, Germany. The system supports various product types, such as syringes and vials. The line can deliver 500 to 50,000 units per batch, covering all the development phases of a product. An additional pre-filled syringe module is being added to the installation.

Adragos Pharma. Adragos Pharma, a Munich, Germany-based CDMO of drug products, announced last November (November 2024), the launch of a new ampoule filling line at its facility in Livron, France. The new line increases the company’s production capacity to over 160 million ampoules per year, with flexible fill volumes ranging from 1 mL to 20 mL. The new line marks the fourth line by the company and increases its capacity by 30%

Pace Life Sciences. In January (January 2025), Pace Life Sciences announced expansions to the company’s facilities in Salem, New Hampshire, to add sterile fill–finish capacity, which includes the addition of an isolated vial filling line Upon completion, the Salem, New Hampshire facility will be classified as a Center of Excellence for sterile fill–finish processing.

Afton Scientific, a CDMO of small-batch filling of injectables, plans to invest over $200 million to expand its manufacturing facility in Albemarle County, Virginia. The company provides aseptic fill-finish services for preclinical to commercial-scale manufacturing.

Ten23health. Ten23 health, a Basel, Switzerland-based CDMO, opened in 2024 a new fill-finish facility in Visp, Switzerland. The new facility will provide capacity for clinical and commercial fill-finish of vials, syringes, and cartridges, in combination with quality control microbiology labs and related office space. The two additional sterile manufacturing lines include a large-scale commercial and clinical filling line for ready-to-use primary packaging for syringes, cartridges, and vials as well as a clinical-to-commercial bulk vial filling facility, including two larger-scale lyophilizers. The combined output is estimated to be 30 million to 70 million units.

Boston Oncology. Boston Oncology is is investing $70 million to increase capacity for biologics and complex injectables in Saudi Arabia. The expansion will add 355,000 square feet of production space and increase manufacturing capacity by 75 million units per year. The expansion is in line with Saudi Arabia’s goal to enhance its position as a biopharmaceutical hub for the regions of the Gulf Cooperation Council (GCC) and MENA (Middle East and North Africa).

The expanded facility will feature seven high-speed sterile injectable production lines, using aseptic manufacturing technology. The facility will support the production of prefilled syringes autoinjector pens, and vials, using advanced GMP fill-finish capabilities. Construction of the expanded facility was slated to begin in the first quarter 2025, with cGMP certification and batch manufacturing expected in the second quarter 2027.

Upperton Pharma Solutions. Upperton Pharma Solutions recentlyc ompleted the build of a new 7,000-square-foot sterile manufacturing facility in Nottingham, UK. The new facility is in addition to the company’s existing 50,000-square-foot facility and will support the manufacturing of aseptic and terminally sterilized small volume liquids and powders for parenteral, nasal and pulmonary delivery.

JGL. JGL, is investing $64 million to expand its sterile production capabilities at its site in Rijeka, Croatia. The expansion, which began in 2020 and is expected to conclude by 2026, involves adding new production lines and infrastructure to the existing site, which has a focus on sterile filling technology for products in ophthalmology, cold and flu, and dermatology.

RV Group. RV Group, a Southeast Asian company, is moving forward with a sterile injectables expansion in Vietnam. The company is investing $20 million to set up an EU/WHO- GMP compliant sterile injectable (aseptic) facility for monoclonal antibodies and peptides for prefilled syringes, vials, and cartridges. The expansion project is ongoing, and operations are slated to begin in the first quarter of 2026.