South Korean biotech firms boost CDMO, biosimilar efforts ahead of Trump return

South Korea’s biotech sector eyes growth as U.S. targets China, drug costs

Samsung Biologics has reached a historic milestone, surpassing 5 trillion won ($3.7 billion) in annual contract orders for the first time since its establishment in 2011, driven by a series of major deals with global pharmaceutical companies. On Nov. 20, the company announced a $668.4 million (930.4 billion won) contract with a European pharmaceutical firm for contract manufacturing. This follows earlier agreements, including a 1.46 trillion won deal with a U.S. company in July and a record-breaking 1.7 trillion won contract with an Asian firm in October. These deals have brought Samsung Biologics’ total orders for the year to 5.2922 trillion won, a more than 50% increase from last year’s 3.5009 trillion won.

The company’s record-breaking performance underscores its leadership in South Korea’s pharmaceutical and biotech sectors, particularly in contract development and manufacturing (CDMO) and biosimilar development. These areas are gaining momentum as the incoming Trump administration is expected to implement measures targeting China and reducing drug prices, creating favorable conditions for South Korean companies.

A Samsung Biologics researcher inspects biopharmaceutical equipment at the company's production facility in Songdo, Incheon./Samsung Biologics

As of the third quarter, Samsung Biologics reported revenue of 3.2909 trillion won, a 26% increase from the same period last year, positioning it to become the first domestic pharmaceutical and biotech firm to achieve annual revenue of 4 trillion won. A key factor in this growth is its production capacity. The company operates four plants with a combined capacity of 604,000 liters, which will expand to 784,000 liters upon the completion of its fifth plant in April 2025, matching the scale of industry leader Lonza. “We have secured 17 of the world’s top 20 pharmaceutical companies as clients and achieved record-breaking contract wins with 11 agreements this year,” a company representative said.

Samsung Biologics also stands to benefit from U.S.-China tensions. The proposed “Biosecure Act,” which aims to restrict transactions between U.S. entities and Chinese biotech firms, is expected to gain momentum under the Trump administration. If enacted, the legislation could force WuXi Biologics, the world’s second-largest CDMO player, out of the U.S. market by 2032, opening opportunities for Samsung Biologics. CEO John Rim said in June, “Since discussions on the Biosecure Act began, inquiries about our services have roughly doubled.”

Other South Korean companies are advancing in the CDMO market as well. Daewoong Bio recently completed a bio-manufacturing plant, signaling its entry into the sector. Yuhan, Hanmi Pharm, and Boryung are also increasing their investments, while Huons has acquired Pangen, a biosimilar-focused firm, to bolster its CDMO capabilities. SK Bioscience has entered the vaccine CDMO market by acquiring shares in a German manufacturing company.

South Korean biosimilar manufacturers are positioned to benefit from Trump’s return to office, with his administration likely to continue promoting biosimilars as a cost-saving alternative to pricier original drugs. South Korea has developed 14 of the 61 biosimilars approved by the U.S. Food and Drug Administration (FDA), the second-highest number after the U.S. Celltrion has received FDA approval for five biosimilars, while Samsung Bioepis has eight. Dong-A ST recently secured FDA approval for “IMULDOSA,” a biosimilar of Stelara, and is preparing for a global launch.

Celltrion said, “The industrial environment is expected to shift toward encouraging biosimilar use, creating opportunities for expanded sales during Trump’s second term.” The company plans to establish its own CDMO facilities as a subsidiary by the end of the year.

[Park Ji-min]

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