Foreign contract manufacturing organisations (CMOs) are accelerating investment in US manufacturing as pharmaceutical companies prioritize supply-chain resilience, regional capacity and greater control over production. The recent site upgrades, acquisitions and new partnerships signal a shift from cost-driven outsourcing toward integrated, locally anchored models, giving sponsors broader access to end-to-end capabilities while reducing exposure to geopolitical, tariff and technology-transfer risks, according to GlobalData, a leading intelligence and productivity platform.
The latest edition of GlobalData’s monthly Bio/Pharmaceutical Outsourcing report explores how foreign-headquartered CMOs are responding to the growing pressure to bring manufacturing back to the US.
Edita Hamzic, Healthcare Analyst at GlobalData, says: “Companies are rethinking how pharmaceutical supply chains are structured. They are localizing production in the US while also making new facilities more integrated than older plants.”
In July, Germany-based Evonik announced a $100 million, five-year investment to modernize its Indiana drug substance site with new reactors, automation and energy-efficiency upgrades.
Taiwan-based Bora Biologics completed its $122.5 million acquisition of MacroGenics’ GMP biologics operations in Indiana, gaining a 20,000-liter single-use bioreactor platform spanning early development to commercial manufacturing and adding domestically anchored capacity.
South Korea’s Samsung Biologics completed its $280 million acquisition of GSK’s Maryland biologics plant, retaining GSK production while pursuing new CMO orders.
Meanwhile, the FDA selected Kyowa Kirin’s North Carolina biologics facility for its PreCheck Pilot Program in June, offering earlier regulatory engagement and greater timeline predictability as the Japanese pharma company expands US manufacturing.
Alongside physical expansion, CMOs are also expanding their services through partnerships. In July, AGC Biologics partnered with Pyramid Laboratories to combine drug-substance development and manufacturing with fill-finish, device assembly, labeling and packaging. The partnership was framed to give US-based developers a fully integrated domestic pipeline. Argonaut and Ensera have similarly joined capabilities across fill-finish and final assembly for drug delivery systems. The goal is to simplify supply chains and accelerate time-to-market for combination products.
The trend extends beyond biologics. Earlier in the year, Corealis Pharma and Rottendorf Pharma have divided responsibilities for early development, clinical supply, scale-up and commercial manufacturing, while Piramal Pharma Solutions and Ajinomoto Bio-Pharma Services have combined ADC technology with development and GMP manufacturing.
Sponsors are now looking for CMOs that can support their products across different stages of development, rather than providing individual services.
Hamzic continues: “Companies are looking for partners that can connect early development, clinical supply and commercial manufacturing into a single program. For sponsors, working with a CMO that can provide services across multiple stages of manufacturing can reduce the need for technology transfers between companies, save time and make the supply chain more reliable.”
Overall, the industry is moving away from a traditional, cost-driven global outsourcing model to a more regionalized and integrated approach to manufacturing. Expanding US capacity can help companies manage tariff and geopolitical risks, while closer partnerships can streamline operations and reduce fragmentation across the manufacturing process.
Hamzic concludes: “This does not mean the end of European and Asian manufacturing. Rather, companies are likely to maintain a more diversified global footprint, building capacity in the US while using established overseas expertise. CMOs that can provide local manufacturing capabilities with end-to-end services may be better positioned to support sponsors as they seek greater supply chain resilience and a more efficient route to market.”
