Since the beginning of the year, the CDMO sector has entered a new cycle of accelerated capital deployment, reflecting both increased customer demand and improved financial market confidence. The scale of these investments is significant. Investments in sterile injectables, peptides, and advanced therapies are not only reshaping the industrial footprint but are also transforming the financial dynamics of the sector. Furthermore, pharmaceutical companies are continuing in their efforts to geographically align their drug production with their most lucrative markets in terms of sales and revenue, with the United States, the primary end market for the global pharmaceutical industry. CDMOs are contributing to this ongoing geographical relocation of production.

An overview of some key investments made or announced over September 2025

APIs and relocation

Active pharmaceutical ingredients (APIs) remain the foundation of the global pharmaceutical value chain. Growing demand for cancer and metabolic disease treatments, biologics and biosimilars, and outsourced manufacturing models are redefining API development and distribution. Efforts are underway in the US and the EU to bring API production back to the domestic market, but a number of barriers remain. Costs (e.g., labor, energy, environmental compliance etc.) are significantly higher.

AGC Pharma Chemicals inaugurated its new state-of-the-art manufacturing plant in Malgrat de Mar, Barcelona, Spain, representing an investment of over €100 million. The 7,500 m² expansion represents a 30% increase in production capacity and introduces the manufacture of HPAPI (Highly Potent Active Pharmaceutical Ingredients) at OEB5 level, enabling AGC to meet growing demand in a range of areas from clinical development to commercial supply. Designed to handle volumes from grams to tonnes , the plant covers the entire drug development lifecycle: from initial R&D to commercial manufacturing.

Piramal Pharma Limited has committed to a $90 million investment plan towards expanding two of the Company's US facilities. These expansions are in response to ongoing demand from US customers, forming part of the trend towards US onshoring of drug supply, and in line with Piramal Pharma's overall belief in the value and benefits of US-based innovation.

The Riverview site provides comprehensive drug substance development and manufacturing services, including specialized solutions for high potency APIs (HPAPIs). This facility is a vital element of ADCelerate^TM, supplying the payload linkers essential to the overall safety, stability, and efficacy of ADC therapies. The expansion will add a commercial-scale suite specifically designed for the development and manufacturing of payload linkers, which is expected to be operational by the end of 2025.

The strong demand for peptides and oligonucleotides

Demand for peptide active pharmaceutical ingredients continues to grow significantly, driven both by increasing use in diabetes and obesity treatments for large patient groups, and by expansion into new indications. Companies in this sector must meet their customers' capacity needs through new equipment and facilities, as well as increased operational efficiency and innovation in technology and process chemistry.

Bachem has announced a record capital expenditure of $400 million in 2025, with site expansions across Switzerland, Germany, and the US to consolidate its leadership in peptide and oligo APIs. Bachem is pursuing an investment program to expand capacity at all sites. $129.1 million were invested in the first half of 2025 with significant volumes to be invested in the second half of the year. In addition to expansion, the company is also continuously optimizing the utilization of existing buildings and facilities through operational improvements.

Biologics and advanced therapies

The CDMO for biologics is becoming a large and relatively mature segment of the outsourcing ecosystem, and, although riskier, the CDMO segment for advanced therapies is one of the most dynamic.

Fujifilm Biotechnologies celebrated the grand opening of its manufacturing site in Holly Springs, North Carolina. The newest addition to FUJIFILM Biotechnologies' global network represents one of the largest commercial-scale cell culture biomanufacturing sites in North America.

The first phase in the development of the planned $3.2 billion manufacturing site features the addition of eight 20,000 L mammalian cell culture bioreactors encompassing drug product and drug substance manufacturing, with finished goods capabilities to be added in 2026. The second phase expansion (announced in 2024) will double capacity via an additional eight 20,000 L bioreactors, making 16 in total.

Polpharma Biologics is splitting its operations into two independent companies, each with a clear focus and mission. In September 2025, CDMO activities were launched under a new brand: Rezon Bio. Rezon Bio is a European CDMO for biologics combining profitability and digital innovation. While entering the market as a new brand, the CDMO builds on its extensive experience with two Polpharma sites.
The two production sites in Gdansk and Warsaw-Duchnice enable Rezon Bio to offer its customers a comprehensive range of services, from cell line development to GMP compliance and commercial supply. Both sites have similar capabilities, enabling seamless technology transfer and scale-up flexibility. The infrastructure is based on single-use systems, ensuring faster product turnaround and delivery. Development platforms, including AMBR systems, are optimized to shorten early development cycles and minimize scale-up risks.

AbbVie announced the start of construction of a $70 million expansion at its AbbVie Bioresearch Center (ABC) in Worcester, Massachusetts, which serves as a center of excellence for biologics research and development and manufacturing. This expansion is part of the company's previously announced commitment to invest more than $10 billion in the US to support innovation and expand critical biologics manufacturing capabilities and capacity.

This investment will further expand AbbVie's domestic biologics manufacturing capacity to meet increased global demand and facilitate US production of current and next-generation oncology and immunology medicines. It will include construction of additional biologics manufacturing areas and a three-story building housing laboratory, warehouse and office space. Construction will enable the expedited transfer of select oncology products from Europe to the US.

Sterile injectables and fill-finish

The sterile injectables segment continues to attract the lion's share of investment projects, highlighting both the high level of demand for sterile injectables (driven by biologics, oncology drugs, and GLP-1s) and regulatory pressure with regard to isolator technology.

At its Pau site in France, FAREVA is continuing its commitment to pharmaceutical innovation with the opening of a new GMP pilot unit dedicated to the production of liquid and lyophilized injectable forms. With its new isolator, FAREVA offers a development service for the formulation and aseptic dispensing stages of liquid or lyophilized forms.

This equipment meets the latest requirements of the new Annex 1 for sterile products. It enables the production of biotechnology-derived drugs, such as monoclonal antibodies, mRNA in LNP form, proteins, peptides, recombinant proteins, and ADCs, supporting Phase 1 to 3 studies through to commercialization, using Fareva's industrial capacity (five sterile sites).

Delpharm announced a key step in the modernization of its Boucherville facilities in Quebec, thanks to government aid amounting to $60 million. This financial aid is in addition to an already confirmed investment of $60 million from the federal government, announced last March, as well as $100 million in private capital, making a total of $220 million. This investment will transform the Delpharm Boucherville site into a world-class pharmaceutical facility by 2031. This modernization, made possible thanks to the support of the Government of Quebec, aims to expand the plant and install a new sterile filling line, and will also enable the renewal of 95% of the current equipment, while significantly increasing production capacity, in response to the growing demand for injectable drugs.

PCI Pharma Services expanded its aseptic footprint with the acquisition of Ajinomoto Althea's San Diego facility, adding flexible clinical-to-commercial fill-finish capacity. In addition, with construction of the Bedford site and infrastructure installation now complete, PCI has launched qualification activities for the plant's sophisticated Annex 1 sterile filling and finishing technologies. Highlights include an aseptic vial filling and finishing line, integrated into a fully isolated containment system, equipped with two 40 m² (430 square feet) freeze dryers with automatic loading and unloading systems. Providing additional capacity to accommodate recent planned growth, this robust, high-speed integrated filler can produce batches of up to 300,000 vials at speeds of up to 400 per minute. Other state-of-the-art production facilities at the new site include Smart Fill modules that optimize product usage and prevent underfilling, SKANFOG® decontamination technology, and comprehensive quality control systems such as 100% checkweighing and inline camera inspection.

The site constitutes the third high-throughput, isolator-based commercial sterile fill-finish facility that PCI have built in the last four years. As it comes online, the new facility further bolsters capacity and capabilities for the sterile fill-finish of late-phase clinical and large-scale commercial small molecule and biologic drugs - including life-changing, high-value drug products such as monoclonal antibodies (mAbs), fusion proteins and peptides.

Sharp Services announced, a $20 million investment in its autoinjector and pen assembly, labeling and packaging lines across various therapeutic areas at its facility in Macungie, Pennsylvania. The announcement follows recent market reports indicating that the autoinjector market is projected to reach $20.6 billion globally by 2030, with a CAGR of 15.1%, due in part to high levels of convenience and usability for both patients and healthcare providers. Sharp's Macungie facility will feature two autoinjector assembly lines to support both clinical and commercial needs. Investments include a low-speed semi-manual, 2 devices-per- minute line, to support the assembly of custom and non-custom pens and autoinjectors. The second line will offer mid-speed assembly of 50-70 devices per minute with inline labeling and cartoning and will support both Ypsomed's YpsoMate® and SHL Medical's Molly® autoinjectors.

The new production lines in Macungie that will support the specific requirements of these devices and therapies are expected to be fully operational in the first half of 2027.

Symbiosis successfully completed qualification of its new FPD 50 Flexicon automated fill/finish line at its new commercial production facility in Stirling, Scotland.

The fully integrated sterile liquid fill/finish system operates under a Grade A Restricted Access Barrier System (RABS). Designed to deliver with both precision and efficiency, it incorporates rapid transfer ports for aseptic handling and high-accuracy vial filling with Flexicon pump technology. Symbiosis will commence commercial production at their new facility in Q4 2025, manufacturing batches of up to 15,000 vials, and representing the latest in a series of recent milestones for the company.