Foreign contract manufacturing organizations are pouring capital into US pharmaceutical production facilities, responding to drugmakers’ demands for supply chains anchored closer to home.
Major investments reshape domestic capacity
Germany-based Evonik announced a $100 million, five-year plan to modernize its Indiana drug substance site, adding new reactors, automation systems and energy-efficiency upgrades. The investment targets production capabilities that can support everything from early development through commercial launch.
Taiwan-based Bora Biologics completed a $122.5 million acquisition of MacroGenics’ GMP biologics operations in Indiana, acquiring a 20,000-liter single-use bioreactor platform that spans early development to commercial manufacturing. The deal brought domestically based capacity under Asian ownership.
South Korea’s Samsung Biologics closed its $280 million purchase of GSK’s Maryland biologics plant, keeping existing GSK production running while pursuing new contract manufacturing work. The acquisition added scale without requiring greenfield construction.
Companies are rethinking how pharmaceutical supply chains are structured, localizing production in the US while building facilities that are more integrated than older plants, said Edita Hamzic, Healthcare Analyst at GlobalData.
Regulatory flexibility and partnership models
The FDA selected Kyowa Kirin’s North Carolina biologics facility for its PreCheck Pilot Program in June, giving the Japanese pharma company earlier regulatory engagement and greater predictability on approval timelines as it expands physical capacity in the US. The program is designed to streamline oversight for facilities meeting high standards consistently.
Beyond acquiring facilities, CMOs are expanding through partnerships. In July, AGC Biologics teamed with Pyramid Laboratories to combine drug-substance development with fill-finish, device assembly, labeling and packaging. The arrangement aims to give US-based developers a single domestic source for the full production pipeline. Argonaut and Ensera linked their capabilities across fill-finish and final assembly for drug delivery systems, while Corealis Pharma and Rottendorf Pharma divided responsibilities for early development, clinical supply, scale-up and commercial manufacturing. Piramal Pharma Solutions and Ajinomoto Bio-Pharma Services brought together antibody-drug conjugate technology with broader development and GMP manufacturing capacity.
