Biopharmaceutical Exports Hit Record High of $4.5 Billion in First Half

CDMO Orders from Global Pharmaceutical Companies on the Rise
Growing Biosimilar Demand Drives Higher Market Share in Europe

South Korea's biopharmaceutical exports reached a record high of USD 4.5 billion in the first half of this year. Expansion of contract development and manufacturing organization (CDMO) orders from global pharmaceutical companies, coupled with rising demand for biosimilars, has broadened the export base, especially in Europe.

According to the Ministry of Food and Drug Safety on July 8, the country's biopharmaceutical exports amounted to USD 4.5 billion in the first half of this year, a 15.3% increase from the same period last year (USD 3.9 billion). This surpasses the previous record set in the first half of last year. Exports in the first and second quarters amounted to USD 2.0 billion and USD 2.5 billion, respectively, up 11.1% and 15.3% year-on-year. On a monthly basis, exports set new records for each respective month, with last month's exports exceeding USD 1.0 billion.

By country, Switzerland topped the list with exports amounting to USD 770 million, accounting for 17.1% of the total and up 67.4% from the same period last year. This is attributed to an increase in domestic CDMO orders for global pharmaceutical companies based in Switzerland and growing demand for biosimilars. The Ministry of Food and Drug Safety explained, "In the first half of this year, Korean biopharmaceuticals expanded their market share in Europe based on manufacturing competitiveness, and CDMO orders increased."

The United States (USD 610 million) and Hungary (USD 600 million) followed Switzerland as the top export destinations. The Netherlands ranked fourth, recording USD 450 million in exports for the first half, an 80% increase year-on-year. France entered the top 10 export destinations for the first time with USD 160 million.

By product type, recombinant biopharmaceuticals accounted for USD 3.97 billion, representing 88% of total exports. Exports to the Netherlands reached USD 440 million (+76%), while exports to Italy, Belgium, and France were USD 250 million (+147%), USD 170 million (+184%), and USD 160 million (+630%) respectively, indicating a significant expansion of exports to Europe.

In line with the growth of the biopharmaceutical CDMO market, the Ministry of Food and Drug Safety has enacted the "Special Act on Regulatory Support for Biopharmaceutical Contract Development and Manufacturing Organizations," introducing an export manufacturing registration system that allows CDMO companies to enter global markets for export purposes without a pharmaceutical manufacturing license. The ministry also plans to promote the certification of domestic biopharmaceutical raw materials to enhance trust in the manufacturing and quality of raw materials and to strengthen international competitiveness.

Ahn Youngjin, Director of the Biopharmaceuticals and Herbal Medicines Bureau at the Ministry of Food and Drug Safety, stated, "To facilitate the overseas expansion of Korean biopharmaceuticals, we will provide rational regulatory innovation and tailored information, actively promote regulatory diplomacy with key export countries, and continue to support sustained growth in the second half of the year."

This content was produced with the assistance of AI translation services.