South Korea’s biopharmaceutical sector achieved its highest-ever quarterly export value in Q1 2026, reaching $2 billion, an 11.1% increase from the previous year. The Food and Drug Safety Ministry attributes this growth to expanded global market share and strengthened contract development and manufacturing (CDMO) competitiveness. Biopharmaceuticals now account for 71% of Korea’s total pharmaceutical exports, reflecting their central role in the industry. The government’s ongoing regulatory reforms aim to further enhance international competitiveness and ensure safe, rapid access to new therapies.
The primary beneficiaries of these policies are biopharmaceutical manufacturers, CDMO firms, and global partners. Switzerland emerged as the top export destination, accounting for $340 million or 17% of total exports, followed by the United States, Hungary, Germany, and the Netherlands. The top five countries collectively represent 68.4% of Korea’s biopharmaceutical exports. Notably, exports to Switzerland surged by over 70% year-on-year, while U.S. exports declined by $40 million. European market expansion is attributed to increased collaboration with global pharmaceutical companies and favorable conditions for biosimilars.
The export growth has been consistent, with Q1 figures rising from $1.5 billion in 2024 to $1.8 billion in 2025, and $2 billion in 2026. Regulatory changes include the enactment of a special law supporting CDMO firms, allowing export manufacturers to operate without separate manufacturing permits. The Ministry has streamlined GMP evaluation requirements from 11 to 4 documents and launched pilot programs for ingredient manufacturing certification. Additionally, the ‘Click! Global Biopharmaceutical Information’ service provides regulatory updates and guidelines for 24 countries, supporting industry compliance and market entry.
Frequently asked questions include: What are the main drivers of export growth? The answer is regulatory innovation and increased global partnerships. How are companies supported for overseas expansion? The Ministry offers tailored regulatory assistance, streamlined approval processes, and access to international guidelines. What is the outlook for the sector? Continued regulatory improvements and technical support are expected to sustain export growth and strengthen safety management. For further information, contact the Biopharmaceutical Quality Management Division or the Biopharmaceutical Policy Division at the Ministry.
South Korea’s record biopharmaceutical exports in Q1 2026 reflect successful regulatory innovation and strategic industry support. The rise of Switzerland as the top export destination signals a shift toward European markets, driven by favorable conditions for biosimilars and increased collaboration with global pharmaceutical companies. Streamlined approval processes and the new CDMO law have reduced operational barriers, enabling faster international expansion. Sustained regulatory improvements and technical support will be key to maintaining growth and ensuring product safety.