South Korean contract development and manufacturing organisation (CDMO) Samsung Biologics has maintained consistent growth since obtaining its first biologic drug substance production license in 2015.
The company secured FDA approval followed in 2016 by EMA’s GMP compliance certification for biologics. With over 450 global regulatory approvals, Samsung’s expansion activities have driven revenues to $3.1bn (Won4,557bn) in 2025, reflecting a 30% year-over-year increase.
Headquartered in Incheon’s Songdo Bio Cluster, Samsung operates three campuses, including recently acquired land for Bio Campus III focused on cell/gene therapies and vaccines. The company’s global growth strategy includes plans for an open innovation centre in partnership with Lilly Gateway Labs, scheduled to open in 2027.
On July 20, 2026, Samsung announced its $1.8bn (SFr1.46bn) acquisition of Swiss peptide API specialist PolyPeptide Group. This acquisition expands Samsung’s capabilities into peptide therapeutics and grants access to PolyPeptide’s network across Sweden, Belgium, France, the US, and India, along with strategic facilities in Switzerland and Strasbourg, France. The deal is projected to close before year-end 2026.
Samsung Biologics’ Growth Strategy
At the 2026 BIO International Convention in San Diego, James Choi, Samsung’s executive vice president and head of sales support, emphasized the company’s geographically diverse approach. He stated, “We’ve always prioritized expansion, particularly in the US market where approximately half of our clients are based.”
The Rockville, Maryland facility acquisition addressed multiple requirements: locating in an established biotech hub with talent access, leveraging existing GSK-manufactured expertise, and satisfying security-focused client requirements. Samsung will maintain GSK’s contract supply relationship while expanding to serve additional clients at the site.
Expansion at Rockville, Maryland
Samsung’s Maryland facility currently supports clinical and commercial biologic production across multiple scales through two cGMP plants. Future expansions will focus on adding capabilities while maintaining operational continuity through the ‘ExellenS’ process equivalency approach.
The company plans to increase bioreactor capacity and upgrade equipment as needed. Choi noted, “We’re evaluating various configurations to modernize capabilities while ensuring process equivalence with our South Korean facilities for seamless transfers.”
Manufacturing and Supply Chain Diversity
The Rockville acquisition provides Samsung’s first US manufacturing presence. The PolyPeptide deal will further diversify operations across Europe and India, aligning with regulatory initiatives like the EU’s Critical Medicines Act.
Choi emphasized the importance of geographic diversification: “No company can rely on a single production location. Geographic diversification remains essential for risk mitigation, particularly for critical products.” He concluded, “Our experience confirms that geographic diversification is a sound business strategy.”