"79 Trillion Won Biopharmaceutical Contract Manufacturing Market Opens... Support Needed for Han Companies"

by Park Soyeon

Published 03 Apr.2025 06:50(KST)

Updated 03 Apr.2025 08:36(KST)

Blockbuster Drug Patent Expirations to Create Market Worth Up to 79 Trillion Won
Samsung Bioepis, Celltrion, and Others Begin Global Phase 3 Clinical Trials
US, Japan, and Taiwan Expand Public-Private Partnerships to Secure CDMO Leadership
Institutional Support Needed, Including Extension of Integrated Employment Tax Credit and Streamlining Customs Procedures
“International Regulatory Changes Such as the US Biosecurity Act Should Also Be Closely Monitored to Counter China”

Over the next five years, numerous global blockbuster drug patents are expected to expire consecutively, creating a new contract development and manufacturing organization (CDMO) market worth tens of trillions of won. It has been analyzed that systematic government support is urgently needed for Korean companies to secure competitiveness in this market.

The Korea Economic Association (KEA) stated in its report titled “Global Biopharmaceutical CDMO Market Analysis and Implications,” released on the 3rd, that among the top 20 biopharmaceutical and synthetic drug products by global sales as of last year, patents for 12 items in the U.S. are expected to expire before 2030, opening up a CDMO market potentially worth up to 79 trillion won.

The highest-grossing drug is Merck (MSD) of the U.S.’s immuno-oncology drug “Keytruda,” which recorded sales of $29.5 billion (approximately 43.2 trillion won) last year and is scheduled for patent expiration in 2028. Major companies such as Samsung Bioepis, Celltrion, Amgen (U.S.), and Sandoz (Switzerland) have already entered global Phase 3 clinical trials for biosimilar versions of biopharmaceuticals.

Samsung Biologics 1st Bio Campus view. Provided by Samsung Biologics.

KEA analyzed that major countries such as the U.S., Japan, and Taiwan are striving to secure the CDMO market by leveraging government support or strategic investments from other industries. In the U.S., information technology companies like Google and Nvidia are expanding investments in the bio sector by utilizing AI-based new drug development technologies. The Japanese government is strengthening CDMO support with the goal of “realizing a cutting-edge bioeconomy society by 2030,” allocating a budget of approximately 3.1 trillion won. Taiwan has established a CDMO-specialized public enterprise, “TBMC,” with 57% government ownership in partnership with the U.S. bio manufacturer National Resilience, applying the successful semiconductor industry model of TSMC to the bio industry.

The report pointed out that since the bio CDMO industry typically takes more than five years on average from Phase 1 clinical trials to profit realization, institutional foundations are necessary for securing workforce and long-term business promotion. It proposed extending the integrated employment tax credit, which is scheduled to expire at the end of this year, for at least 10 more years, simplifying import customs procedures for active pharmaceutical ingredients, and allowing manufacturing consignment at facilities approved by the Ministry of Food and Drug Safety, among other measures.

Lee Sang-ho, head of the Economic and Industrial Headquarters at KEA, stated, “The biopharmaceutical CDMO industry can be a core future growth engine for Korea,” adding, “Considering competition with Chinese companies, it is also necessary to closely monitor international regulatory changes such as the passage of the U.S. Biosecurity Act.”