In the first quarter of this year, Korea's biopharmaceutical exports reached $2.0 billion (about 2.96 trillion won), setting a record for the largest first-quarter exports ever. The surge is seen as the result of expanded exports centered on Europe and strengthened competitiveness in contract development and manufacturing (CDMO).
The Ministery of Food and Drug Safety said on Apr. 10 that first-quarter 2026 biopharmaceutical exports reached $2.0 billion, up 11.1% from the same period a year earlier ($1.8 billion). This is the largest first-quarter performance on record. Biopharmaceuticals accounted for 71% of total pharmaceutical exports of $2.8 billion.
By year, first-quarter biopharmaceutical exports rose from $1.5 billion in 2024 to $1.8 billion in 2025 and $2.0 billion in 2026. By month, they totaled $660 million in January (up 11.9% year over year), $690 million in February (up 25.4%), and $650 million in March (up 2%), showing steady momentum within the quarter.
Switzerland, at $340 million, accounted for the largest share by destination with 17% of the total. It was followed by the United States ($330 million), Hungary ($300 million), Germany ($200 million), and the Netherlands ($190 million). The top five countries accounted for 68.4% of total exports.
In particular, exports to Switzerland jumped 70% from a year earlier, rising from fourth to first. Exports to Hungary increased 20.2% year over year. By contrast, exports to the United States fell 12.6% over the same period.
The expansion in European exports is seen as the result of a combination of cooperation with global pharmaceutical companies, technology out-licensing, and a favorable market environment for biosimilars.
Samsung Biologics, which ranks among the leaders in the global biopharmaceutical CDMO market, Celltrion, which leads the biosimilar (biosimilar) market, and Samsung Bioepis are among the key players.
Alteogen sealed a technology out-licensing deal with Biogen on the 3rd. The exclusive license aims to develop and commercialize two biopharmaceutical products in subcutaneous (SC) form by applying Alteogen's formulation-change platform technology, ALT-B4.
Under the deal, Alteogen will receive an upfront payment of $20 million (about 29.6 billion won). It will receive an additional $10 million when development of the second product begins. On top of that, the company can receive up to $549 million upon achieving key milestones related to development, approval, and sales of the two products, and royalties based on sales after commercialization.
The Ministery of Food and Drug Safety enacted the Special Act on Regulatory Support for Biopharmaceutical CDMO corporations in Dec. 2025, with implementation slated for Dec. 2026. The core of the law is to allow CDMO corporations for export purposes to enter the global market without a separate manufacturing business license.
The agency also innovated approval and review procedures to support faster product launches and eased regulatory burdens by reducing the number of required documents for prior GMP assessment from 11 to 4. It is simultaneously pushing a pilot program for certifying raw material manufacturing sites and a global regulatory information service.
An official at the Ministery of Food and Drug Safety said, "We will continue to enhance the international competitiveness of domestic biopharmaceuticals through reasonable regulatory improvements and technical support, and steadily expand entry into the global market."