Exports of K-bios reach record $4.5 billion in 1H 2026

Exports up 15.3% year over year…accounting for 86.5% of Korea's total pharmaceutical exports

Switzerland remains the top export destination, fueled by strong CDMO and biosimilar demand… Netherlands and France surge

South Korea's biopharmaceutical industry posted its highest-ever export performance for the first half of the year, once again demonstrating its growing presence in the global market. The expansion was driven primarily by increasing market share in Europe, supported by strong manufacturing competitiveness and growing contract development and manufacturing organization (CDMO) orders.

According to the Ministry of Food and Drug Safety (MFDS, Minister: Yu-Kyoung Oh), Korea's biopharmaceutical exports totaled USD 4.5 billion during the first half of 2026, representing a 15.3% increase from the same period last year. This is the highest first-half export figure on record.

Over the past three years, Korea's biopharmaceutical exports have grown by more than 20% annually on average, nearly doubling in size. During the first half of this year, biopharmaceuticals accounted for 86.5% of Korea's total pharmaceutical exports (USD 5.2 billion), reaffirming their role as the primary driver of Korea’s pharmaceutical exports.

Growth was also evident on a quarterly basis. Exports reached USD 2.0 billion in the first quarter and USD 2.5 billion in the second quarter, representing year-over-year increases of 11.1% and 15.3%, respectively. Monthly exports also set new records throughout the period. In June alone, exports reached USD 1.02 billion, marking the first time monthly biopharmaceutical exports exceeded the USD 1 billion threshold.

Switzerland is the top export destination…Netherlands and France record rapid growth

During the first half of the year, Korean biopharmaceuticals were exported to 163 countries worldwide. By export value, Switzerland ranked first with USD 770 million (17.1%), followed by the United States with USD 610 million (13.6%) and Hungary with USD 600 million (13.3%).

Exports to Switzerland increased 67.4% (US$310 million) compared with the same period last year, allowing the country to maintain the top position for both the first quarter and the first half of the year. The increase was attributed mainly to higher CDMO orders secured by Korean companies from global pharmaceutical firms based in Switzerland, along with growing demand for biosimilars.

Other European markets also posted strong growth. Exports to the Netherlands rose 80% to USD 450 million, making it Korea's fourth-largest export destination, while exports to France reached USD 160 million, allowing the country to enter Korea's top ten export markets for the first time, ranking ninth.

Recombinant biologics account for 88% of exports…toxins and antitoxins also show strong performance

By product category, recombinant biologics led exports with USD 3.97 billion, accounting for 88% of total biopharmaceutical exports. This is an 18.4% year-over-year increase. Exports of recombinant DNA products grew particularly rapidly in major European markets, especially in France (+630%), Belgium(+184%), and Italy(+147%).

Exports of toxins and antitoxins reached USD 280 million, up 47.4% from a year earlier. The United States (USD 70 million) and China (USD 60 million) were the largest export markets, while exports to Southeast Asian countries such as Thailand (+119%) and Vietnam (+112%) more than doubled year on year. In contrast, vaccine exports declined 27.4% year over year to USD 120 million, with shipments primarily exported to Southeast Asia and Africa, including Thailand and Bangladesh.

MFDS to implement ‘CDMO Special Act’ in December…will support the act through regulatory reform

To sustain the current momentum through the second half of the year, the MFDS plans to provide additional regulatory support. ‘The Special Act on Regulatory Support for Biopharmaceutical Contract Development and Manufacturing Organizations (CDMO Special Act),’ enacted last December, will officially take effect this coming December.

Once implemented, the legislation will introduce an ‘Export Manufacturing Registration System,’ allowing CDMO companies manufacturing products exclusively for export to enter global markets without first obtaining a separate pharmaceutical manufacturing license. The MFDS also plans to introduce certification programs aimed at enhancing the credibility of domestically produced biopharmaceutical APIs.

Young-jin Ahn, Director of the Biopharmaceuticals and Herbal Medicines Bureau at the MFDS, said, "We will innovate the review and approval process for new drugs and biosimilars while providing regulatory support throughout the entire product lifecycle so that safe therapies can reach patients around the world as quickly as possible. We will also provide tailored information to support Korean companies' overseas expansion and actively strengthen regulatory cooperation with our major export markets."