Korean biotech companies are tightening their grip on the contract development and manufacturing (CDMO) market, reinforcing South Korea’s standing as an Asian bio hub. As global drugmakers expand outsourcing, Korean firms are moving beyond basic production into higher-value work that includes process development and regulatory support.
BioPlan, a biopharmaceutical market research firm, said on the 7th that Samsung Biologics’ Songdo Bio Campus in Incheon was selected as the world’s largest single facility by production capacity. It held the No. 1 spot again after a 2022 survey, a result seen as validating the company’s “super-gap” strategy.
Celltrion also gained ground. Operating Plants 1, 2 and 3 in Incheon, Celltrion ranked seventh in the survey, joining the global top 10. China’s CL Biologics’ Shenzhen facility ranked second, and a Genentech facility in the United States acquired by Switzerland’s Lonza in 2024 ranked third.
In revenue, Korean companies are also closing in on global leaders. Jefferies said Samsung Biologics ranked fourth in global CDMO sales in 2024, posting $3.27 billion (about 4.9458 trillion won), behind Lonza, Thermo Fisher and Catalent. The report cited surging demand as CDMOs shift from small-molecule drugs toward more complex products such as cell and gene therapies.
The shift is reflected in business models. Samsung Biologics is expanding modalities such as antibody-drug conjugates, while extending into contract research through “Samsung Organoid,” building an integrated service system that spans research and development.
It has also strengthened its production base. After securing 17 of the world’s top 20 pharmaceutical companies as clients, it completed the acquisition of a biopharmaceutical manufacturing facility in Rockville, Maryland, on March 31 local time. With a 60,000-liter drug substance plant capable of supporting clinical through commercial production, its total capacity expanded to 845,000 liters.
Celltrion is also upgrading its structure on the back of growing orders. After signing a contract manufacturing (CMO) deal worth about 678.7 billion won with Eli Lilly early this year, it added further contracts, pushing its cumulative CMO order backlog past 1 trillion won within the first quarter.
The company is also shifting weight toward higher-value services. It is pursuing a CMO strategy aimed at boosting clients’ competitiveness through formulation changes, seeking differentiation with its own subcutaneous (SC) formulation conversion technology. A key example is its “formulation-change CMO” business, applying know-how built through products such as Remsima SC and Herzuma SC to external clients.
Celltrion is accelerating its overseas footprint as well. It recently completed the relocation of a biopharmaceutical production facility in Branchburg, New Jersey, and set its expansion scale at 75,000 liters. That would raise its drug substance capacity from 316,000 liters to 571,000 liters. The company aims to secure CMO revenue through local production while broadening into CDMO and cutting costs to expand supply to the U.S. market.
Lotte Biologics said it signed a CDMO contract on the 1st with a U.S. oncology-focused biotech company to produce antibody drug substance and develop processes. It plans to produce late-stage clinical samples and optimize processes at its Syracuse, New York, campus, while linking with its Songdo campus to strengthen integrated CDMO capabilities.
As companies broaden their scope, the basis of competition is changing. A production-only model is showing limits, and integrated capabilities that include clinical support and regulatory approvals are emerging as a key factor. Jung Yoon-taek, head of the Korea Pharmaceutical Industry Strategy Research Institute, said, “The market is being reshaped from CMO to CDMO and to CRDMO,” referring to contract research, development and manufacturing organizations. “Competition is shifting toward companies that can provide customized, integrated services,” he said.
The trend is also feeding into expanded investment by global drugmakers in South Korea. Roche signed a memorandum of understanding with the Ministry of Health and Welfare last month on strengthening global competitiveness in the biohealth industry and agreed to pursue $500 million (about 750 billion won) in investment over five years. Eli Lilly also announced a plan this year to invest a total of $500 million over five years.
Even as South Korea emerges as a new hub, companies still face the task of proving both capacity and technology. Lee Seung-gyu, vice chairman of the Korea Bio Association, said the CDMO market requires not only scale but also quality control, skilled operating staff and the ability to respond to regulatory approvals to win sustained orders. “The key is building global competitiveness that matches market demand,” he said.
* This article has been translated by AI.
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