K-Bio Q1 sales hit record high…tops $2 billion

11.1% increase in export value year-over-year…Exports to Swiss ranked No.1, recording $340 million

Exports of Korean biopharmaceuticals in the first quarter of this year were at a record high. In particular, exports of biosimilars to Europe increased significantly.

The Ministry of Food and Drug Safety (MFDS, Minister Yu-kyoung Oh) announced on the 10th that the export volume of South Korea's biopharmaceuticals in the first quarter of 2026 reached an unprecedented record of $2 billion (estimated), an 11.1% increase compared to the export value of the first quarter of last year.

The MFDS explained that this is driven by an increase in the market share of K-biopharmaceuticals and by the expansion of competitiveness among biopharmaceutical Contract Development and Manufacturing Organizations (CDMOs).

According to export value by year for the first quarter, it recorded $1.5 billion in 2024, followed by $1.8 billion in 2025 (a 20% increase from the previous year), and $2 billion this year (an 11.1% increase). Biopharmaceuticals accounted for 71% of the total pharmaceutical export value of $2.8 billion in the first quarter of this year.

"Export value by year for Q1": $1.5 billion in 2024, followed by $1.8 billion in 2025 (a 20% increase from the previous year), and $2 billion this year (an 11.1% increase). ​"Top 5 countries for exports in Q1": The country with the largest exported value in the first quarter of 2026 was Switzerland, recording $340 million (17.0% of total exports). Source: Korea Customs Service HS code and Korea Trade Statistics Promotion Institute

By month, exports in January and February increased by 11.9% and 25.4% year-on-year to $660 million and $690 million, respectively. March exports were similar to the same period last year at $650 million, showing steady export figures from January through March.

The country with the largest exported value in the first quarter of 2026 was Switzerland, recording $340 million (17.0% of total exports). The United States followed this at $330 million (16.5%) and Hungary at $300 million (15.0%). Exports to the top five countries accounted for 68.4% of the total.

Exports to Switzerland increased by 70% (+$140 million) compared to the same period last year, rising from the 4th largest export destination in the first quarter of last year to 1st place this year.

Exports to the United States decreased by $40 million (-12.6%) year-over-year, accounting for 16.5% of the first quarter export value. Exports to Hungary increased by $50 million (+20.2%) year-over-year.

Analysis suggests that the increase in exports to Europe is due to a combination of cooperation with global pharmaceutical companies, technology exports, and a favorable environment for biosimilars.

The MFDS explained that it is strengthening the global competitiveness of domestic biopharmaceuticals and helping them enter overseas markets by advancing rational regulatory innovation and providing customized information, as well as by actively pursuing regulatory diplomacy with major exporting countries.

Aligning with the rapid growth of the biopharmaceutical CDMO market, the 'Special Act on Regulatory Support for Biopharmaceutical CDMO Companies' was enacted. By introducing a registration system for export manufacturing, an institutional foundation was established, enabling CDMO companies for export purposes to enter the global market without a pharmaceutical manufacturing license.

Furthermore, the MFDS is advancing innovations in the biopharmaceutical approval and review process and in full-cycle regulatory support, enabling safe treatments to be launched faster than anywhere else in the world.

To enable domestic biotech companies to enter the international market quickly, the MFDS has simplified the documents required for a preliminary GMP evaluation (from 11 to 4). It has preemptively promoted the 'Raw Material Manufacturing Site Certification Pilot Project' to support the entry of domestic biopharmaceutical raw materials into the global market.

In addition, to respond to varying licensing systems and regulatory environments by country, the "Click! Global Biopharmaceutical Information Service" is operated to systematically provide regulatory information for 24 major countries, including the U.S., Europe, and Southeast Asia, along with the latest guidelines and translations to address local regulatory changes.

An official from the MFDS stated, "We will continue to strengthen the international competitiveness of our biopharmaceuticals through rational regulatory improvement and institutional and technical support. We will also create an environment where the public can use them with safety management of biopharmaceuticals."