The leading CDMO (Contract Development and Manufacturing Organization) company in South Korea is Samsung Biologics. ( Image courtesy of Samsung Biologics)
SEOUL, April 4 (Korea Bizwire) — With patents on a wave of blockbuster drugs set to expire over the next five years, South Korea’s biopharmaceutical industry faces a critical window to capture a share of the rapidly expanding global contract development and manufacturing organization (CDMO) market, projected to be worth tens of trillions of won.
A report released Thursday by the Korea Economic Research Institute (KERI) highlights that 12 of the world’s top 20 biologic and synthetic drugs—measured by global sales in 2024—will lose U.S. patent protection before 2030. The expiring patents are expected to open up a CDMO market worth as much as 79 trillion won (approximately $59 billion), the report said.
Among the most notable examples is Merck’s immuno-oncology therapy Keytruda, the world’s best-selling drug with 2024 revenues of $29.5 billion. The drug is expected to lose its U.S. patent in 2028, spurring a race among global players—including South Korea’s Samsung Bioepis and Celltrion, as well as Amgen (U.S.) and Sandoz (Switzerland)—to develop biosimilar versions currently in Phase 3 clinical trials.
KERI warns that as the competition to dominate the biosimilar market intensifies, countries such as the United States, Japan, and Taiwan are accelerating their CDMO initiatives with strong government backing and cross-industry investment.
In the U.S., tech giants like Google and Nvidia are increasing investments in biotech as AI-driven drug discovery shortens development cycles and identifies new therapeutic candidates. Meanwhile, Japan is ramping up its CDMO support as part of its 2030 bioeconomy strategy, allocating over 3.2 trillion yen (roughly 31.5 trillion won) in total project funding.
Taiwan has also entered the CDMO arena aggressively. In 2023, its government partnered with U.S.-based National Resilience to establish TBMC, a joint venture modeled after the success of semiconductor giant TSMC. The government holds a 57% stake in the company.
To ensure Korean firms can compete globally, KERI recommends a multi-pronged approach that includes extending the nation’s integrated employment tax credit—which currently expires at the end of 2025—for at least another decade, to support long-term hiring in a sector where commercialization typically takes over five years.
The report also calls for streamlining customs procedures for importing pharmaceutical ingredients, and revising legislation to allow contract manufacturing in pre-approved facilities, thereby reducing capital expenditures for companies.
“CDMO is one of the key future growth engines for the Korean economy,” said Lee Sang-ho, Head of Economic and Industrial Policy at KERI. “To secure a competitive edge globally, Korean companies need systematic support, while policymakers must closely track international shifts such as the U.S. Biosecurity Act, which could curb China’s growing influence in the sector.”
Lina Jang (linajang@koreabizwire.com)
