South Korean contract development and manufacturing organization (CDMO) Samsung Biologics has embarked on a significant phase of global expansion, marked by its first US manufacturing site acquisition and a major deal to acquire PolyPeptide Group. These strategic moves underscore the company’s ambitious growth trajectory and its commitment to providing a diversified and robust supply chain for its global clientele. The company’s journey, which began with its first license to produce biologic drug substances in 2015, has seen a remarkable ascent, culminating in significant investments aimed at solidifying its position as a leading player in the biopharmaceutical manufacturing landscape.
The foundation for Samsung Biologics’ rapid ascent was laid in 2015 with the attainment of its inaugural license for biologic drug substance production. This pivotal achievement was swiftly followed in 2016 by a Certificate of Good Manufacturing Practice (GMP) compliance from the European Medicines Agency (EMA) for both biologics drug substance and drug product. Today, the company boasts an impressive portfolio of over 450 regulatory approvals worldwide, a testament to its unwavering commitment to quality and compliance. This expanding regulatory footprint is directly mirrored in its financial performance. In 2025, Samsung Biologics reported revenues of $3.1 billion (Won 4,557 billion), representing a substantial 30% increase from the preceding year, indicating robust market demand and successful operational scaling.
Historically, Samsung Biologics’ manufacturing prowess has been concentrated at the Songdo Bio Cluster in Incheon, South Korea. This hub is set to host three distinct campuses, with the recent acquisition of land for Bio Campus III dedicated to future modalities, including cutting-edge work on cell and gene therapies and vaccines. The cluster will also be home to Samsung Biologics’ new open innovation center, slated to open in 2027 and developed in partnership with Lilly Gateway Labs. However, to sustain its exponential growth and meet escalating global demand, the company recognized the imperative to extend its manufacturing capabilities beyond its domestic borders.
A cornerstone of this international expansion strategy was unveiled on July 20, 2026, with Samsung Biologics announcing its intention to acquire PolyPeptide Group for $1.8 billion (SFr 1.46 billion). PolyPeptide Group, a specialized CDMO renowned for its expertise in peptide-based active pharmaceutical ingredients (APIs), currently produces one-third of the world’s commercially approved peptides. This acquisition is poised to significantly broaden Samsung Biologics’ therapeutic repertoire, extending its capabilities beyond antibodies and antibody-drug conjugates (ADCs) into the rapidly growing field of peptide therapeutics, including vital treatments like GLP-1 agonists. Furthermore, the acquisition of the Swiss-based CDMO brings with it an integrated network of manufacturing sites strategically located across Sweden, Belgium, France, the United States, and India. This global footprint is further enhanced by a corporate office in Switzerland and an innovation center in Strasbourg, France, providing Samsung Biologics with immediate access to established infrastructure and diverse talent pools.
The PolyPeptide Group acquisition, expected to be finalized before the end of 2026, builds upon Samsung Biologics’ first major merger and acquisition (M&A) transaction of the year. On March 31, 2026, the South Korean CDMO successfully concluded its $280 million acquisition of GSK’s manufacturing facility in Rockville, Maryland, USA. This landmark deal marked Samsung Biologics’ inaugural manufacturing presence in the United States, injecting an additional 60,000 liters of drug substance capacity into its global network, thereby elevating its total worldwide capacity to an impressive 845,000 liters.
Samsung Biologics’ Strategic Growth Imperatives
James Choi, Executive Vice President, Chief Marketing Officer, and Head of Sales Support, Project Management, and Global Public Affairs at Samsung Biologics, articulated the company’s strategic vision during an interview with Pharmaceutical Technology at the 2026 BIO International Convention (BIO 2026) in San Diego, California, in June 2026. He emphasized the critical need for geographic diversification of its supply chain and detailed how the newly acquired Maryland facility aligns perfectly with these overarching objectives.
"Geographically, we’ve always been looking at expanding, starting with the US, because about half of our clients are US-based," Choi explained. He clarified that the pursuit of a US manufacturing presence predated the heightened political pressure seen throughout 2025 and 2026 on pharmaceutical companies to onshore their manufacturing operations. "It began many, many years before that, and we looked at other plants, existing plants, we looked at greenfield opportunities, different locations, different biotech corridors where we could build out and scale out. For one reason or another, not everything checked off, but this location came up, and it addressed all of our needs."
Choi highlighted the key advantages of the Rockville site. "Number one, it was in an existing kind of biotech hub, where we have access to talent, and in an area that has a strong technology/biotechnology ecosystem. And we also acquired it from one of our clients, GSK, so the talent there, roughly about 500 people, are well-seasoned, and they have all the know-how and expertise in bio manufacturing, specifically the type of mAbs [monoclonal antibodies] that we create."
The symbiotic relationship with GSK is a crucial element of the acquisition agreement. Under the terms, GSK will continue to leverage the Rockville facility for its ongoing manufacturing needs, with Samsung Biologics acting as a supplier for the products previously produced there. Simultaneously, as GSK’s reliance on the site for certain production lines diminishes, Samsung Biologics is positioned to undertake additional contract manufacturing projects, further optimizing the facility’s utilization and expanding its client base.
Expansion and Integration at Rockville, Maryland
The newly acquired US facility in Rockville, Maryland, is already equipped to support both clinical and commercial biologics production across multiple scales, boasting two current Good Manufacturing Practice (cGMP) manufacturing plants. Future expansion plans are focused on augmenting the facility’s capabilities and fortifying its long-term operational efficiency. A core objective for Samsung Biologics is to ensure a seamless service offering across its diverse global campuses. To achieve this, the company is implementing its proprietary "ExellenS" approach, which standardizes plant-to-plant processes and equipment equivalency. This methodology is designed to accelerate regulatory approvals and streamline technology transfers, thereby reducing time-to-market for its clients. In parallel, Samsung Biologics is conducting a comprehensive feasibility study to determine the optimal strategy for further expanding the Rockville site.
"We do know that the site has potential to add more bioreactors," Choi elaborated. "We’re looking at the different configurations, additional equipment that we would add, or in some cases, maybe even replace to allow the site to be more up to date, and also that equivalency with our existing campus in South Korea, so that it’s seamless in terms of process transfers and stuff like that." This focus on standardization and integration is critical for maintaining the high levels of quality and efficiency that clients expect from a leading CDMO.
Enhancing Manufacturing and Supply Chain Diversity
The acquisition of the former GSK site in Maryland represents Samsung Biologics’ initial foothold in the US market. However, this will be rapidly complemented by further geographic diversification across the US, Europe, and India, contingent on the successful completion of the PolyPeptide Group acquisition. The global trend towards bolstering domestic biopharmaceutical manufacturing capabilities is not confined to the United States. The European Union’s Critical Medicines Act, finalized in January 2026, is another significant policy initiative aimed at enhancing the region’s production capacity for APIs and essential drugs, thereby reducing reliance on imports.
"There’s always going to be a balance," Choi remarked when discussing the optimal distribution of manufacturing operations. "Nobody fully puts all their eggs in one basket. You’re always going to want to diversify your supply chain to reduce risk, so clients will always have a need for a secondary supply for that diversification of the risk portfolio, especially for their flagship products." This strategic imperative for risk mitigation is a primary driver for pharmaceutical companies seeking reliable and geographically distributed manufacturing partners.
Choi concluded by underscoring the strategic foresight behind Samsung Biologics’ expansion: "Time and time again, geographic diversification has proven to be a sound business decision." This philosophy not only benefits Samsung Biologics by broadening its market reach and operational resilience but also provides crucial reassurance to its clients, who depend on a stable and secure supply chain for their life-saving medicines. The company’s proactive approach to global expansion, driven by meticulous planning and significant investment, positions it to navigate the evolving demands of the biopharmaceutical industry and to capitalize on emerging opportunities worldwide. The integration of the Rockville facility and the forthcoming acquisition of PolyPeptide Group are pivotal steps in this ongoing journey, solidifying Samsung Biologics’ commitment to innovation, quality, and global accessibility in biopharmaceutical manufacturing.
