K-Bios acquire US plants to mitigate tariff risks

Samsung BioLogics acquires US plant with KRW 410 billion investment

Celltrion Buys Lilly’s facility for KRW 460 billion

Securing US production bases...responding to tariff risks

Investing cash accumulated through high-purity performance

Korea’s flagship biotech companies, Samsung Biologics and Celltrion, are moving in tandem to acquire manufacturing plants in the United States. Following Celltrion, Samsung Biologics has made a decisive move by acquiring a multinational pharmaceutical manufacturing facility with an investment exceeding KRW 400 billion. These two companies—Korea’s largest biotech exporters to the U.S.—are leveraging strong profitability to pursue large-scale mergers and acquisitions (M&A) as a preemptive strategy to mitigate tariff risks.

Samsung Biologics acquires GSK plant in the U.S. for KRW 410 billion...first overseas investment

According to industry sources on the 22nd, Samsung Biologics signed an agreement with GSK to acquire a biologics manufacturing facility formerly operated by Human Genome Sciences (HGS), located in Rockville, Maryland. Samsung Biologics America, the U.S. subsidiary of Samsung Biologics, will invest $280 million (approximately 410 billion won) to acquire the facility. The asset acquisition process is expected to be completed within the first quarter of 2026.

Human Genome Sciences' biopharmaceutical production facility in Rockville, Maryland, USA

The Rockville production facility is a 60,000-liter API manufacturing plant located in the heart of Maryland's biocluster. It consists of two manufacturing buildings. The facility is equipped with infrastructure capable of supporting antibody drug production at various scales, from clinical development to commercial manufacturing.

This marks Samsung Biologics' first overseas plant acquisition. Samsung Biologics currently operates five plants in Songdo, Incheon. All five plants were constructed using internally sourced funds.

Since its inception, Samsung Biologics has sequentially built Plant 1 (30,000 liters), Plant 2 (155,000 liters), and Plant 3 (180,000 liters). In October 2022, just 23 months after groundbreaking, it launched Plant 4, which boasts the world's largest manufacturing capacity (240,000 liters) for a single plant. With the start of operations at the 180,000-liter Plant 5 last April, Samsung Biologics' total manufacturing capacity expanded to 785,000 liters. Samsung Biologics invested KRW 5.9089 trillion in the construction of Plant 5.

The GSK plant Samsung Biologics is acquiring this time is not large in scale compared to the domestic plants it built itself or the investment amounts involved. Samsung Biologics invested over KRW 2 trillion each in the construction of Plants 4 and 5.

Samsung Biologics explained, “This acquisition establishes a dual-source production system connecting Songdo, Korea, and Rockville, USA, providing flexible and stable production options to global customers.” The company plans to expand its collaboration base with North American customers and enhance its ability to respond to regional supply environment changes, thereby further elevating its CDMO competitiveness.

Samsung Biologics' acquisition of the US plant is analyzed as a strategy to preemptively mitigate tariff risks.

South Korea and the U.S. agreed at the APEC summit in Gyeongju last October to apply Most-Favored-Nation (MFN) treatment in the pharmaceutical sector. This means domestically manufactured drugs in the U.S. will receive MFN treatment, similar to Japan and the EU, with tariffs capped at a maximum rate of 15%.

According to the detailed agreement released last month, the White House announced a Joint Fact Sheet (JFS) from the Korea-U.S. summit stating that tariffs on Korean pharmaceuticals would not exceed 15%. It was confirmed that any tariffs imposed on pharmaceuticals would not exceed a 15% tariff rate. Generic drugs would be subject to zero tariffs. Nevertheless, industry players note that future tariff uncertainties remain.

Celltrion acquires Lilly plant for KRW 460 billion... resolves tariff risk for top two U.S. exporters

From the perspective of domestic pharmaceutical and biotech companies, building factories locally in the U.S. is the most realistic and optimal strategy to eliminate tariff risk.

Celltrion has taken the most proactive steps in preparation for U.S. tariffs. In September, Celltrion USA, a subsidiary of Celltrion, signed a definitive agreement to acquire a biopharmaceutical manufacturing facility located in Branchburg, New Jersey,  from ImClone Systems Holdings, a subsidiary of Eli Lilly. The acquisition price is approximately USD 330 million (about KRW 460 billion). In addition to the plant acquisition cost, Celltrion plans to invest a total of KRW 700 billion, including initial operating expenses.

Celltrion received approval from Ireland's competition authorities last October and completed the final review by the U.S. Federal Trade Commission (FTC) in November. These two reviews are key procedures where regulatory agencies assess whether combining corporate assets could harm market competition, representing the final hurdle determining the deal's success.

With these acquisitions, Korea’s leading biotech exporters have invested over KRW 1 trillion to secure U.S. production bases, effectively insulating themselves from tariff risks.

According to the Ministry of Food and Drug Safety (MFDS), Korean pharmaceutical exports to the U.S. reached USD 1.49 billion (approx. KRW 2 trillion) last year, accounting for 16.1% of Korea’s total USD 9.28987 billion pharmaceutical exports. Finished pharmaceutical products accounted for USD 1,298.99 million (87.1%), while active pharmaceutical ingredients (APIs) amounted to just USD 192.19 million (16.9%. Samsung Biologics and Celltrion dominate this export volume.

Samsung Biologics recorded US regional sales of KRW 1.1741 trillion out of its total sales of KRW 4.5473 trillion last year, representing 25.8%. The proportion of Samsung Biologics' sales to the US was 28.5% in 2022 and 26.3% in 2023. Samsung Biologics calculates regional sales based on the location of its CDMO clients. Its cumulative third-quarter U.S. sales reached KRW 1.6482 trillion, already surpassing last year's total exports. U.S. sales accounted for 38.8% of Samsung Biologics' cumulative third-quarter revenue of KRW 4.2484 trillion.

Celltrion Regional Sales (Unit: KRW 1 billion, Source: Celltrion)

Celltrion has secured 11 FDA approvals in the U.S. Its North American biologics revenue reached KRW 1.045 trillion last year. While Celltrion's North American sales decreased by 11.3% from KRW 709.5 billion in 2022 to KRW 629.2 billion in 2023, they surged 66.1% year-on-year last year, surpassing KRW 1 trillion for the first time. In Q3 alone this year, North American exports surged to KRW 265 billion, more than three times the figure from the same period last year, driven by biosimilar expansion and preemptive shipments ahead of tariff risks.

Securing new revenue streams through U.S. manufacturing bases... Generous investments with cash accumulated from high-purity performance

Both Samsung Biologics and Celltrion avoided tariff risks while securing new revenue streams by establishing U.S. manufacturing bases.

Samsung Biologics acquired the Rockville production facility, inheriting contracts for existing products manufactured there and securing a stable supply of large-scale contract manufacturing (CMO) volumes. The company explained that by retaining all 500+ local employees with operational experience and expertise, it established a system that preserves manufacturing continuity and operational stability post-acquisition.

Celltrion secured a stable revenue base from the outset by acquiring Lilly's plant and taking over the existing CMO volume of active pharmaceutical ingredients (APIs) previously produced by Lilly. Celltrion anticipates that once the manufacturing line conversion is completed, following post-acquisition validation and re-approval procedures, full-scale production of its own products and CMO volume supply to Lilly will commence next year. This is expected to yield tangible results, structurally mitigating U.S. tariff risks while improving manufacturing efficiency and expanding profitability.

Samsung Biologics and Celltrion were able to flexibly secure U.S. manufacturing bases thanks to cash reserves accumulated through high performance.

Samsung Biologics recorded cumulative sales of KRW 4.2484 trillion and operating profit of KRW 1.6911 trillion during the first three quarters of this year. Its operating profit margin reached 39.8% relative to sales. Samsung Biologics held KRW 922.1 billion in cash and cash equivalents as of the end of the third quarter.

Celltrion posted cumulative sales of KRW 2.8323 trillion and operating profit of KRW 693.3 billion for the first three quarters of this year. This represents an operating profit margin of 24.5%. Celltrion's cash and cash equivalents totaled KRW 810 billion as of the end of the third quarter.