Korea's biopharmaceutical exports reached $4.5 billion in the first half of this year, marking a record high on a half-year basis. With expanded global contract development and manufacturing organization (CDMO) orders and rising demand for biosimilars driving a full-scale push into the European market, domestic biopharmaceuticals are seen as leading the country's overall drug exports.
According to the Ministry of Food and Drug Safety on Monday, biopharmaceutical exports in the first half of this year totaled $4.5 billion (preliminary), up 15.3% from the same period a year earlier. This surpassed the previous record set in the first half of last year.
Biopharmaceuticals accounted for 86.5% of total drug exports ($5.2 billion). Annual biopharmaceutical exports also grew from $4.9 billion in 2023 to $6.5 billion in 2024 and $7.6 billion last year, roughly doubling over the past three years.
This year, both the first and second quarters posted record highs on a quarterly basis. First-quarter exports were $2 billion, up 11.1% year-on-year, while second-quarter exports reached $2.5 billion, up 15.3%. On a monthly basis, each month from January through June set a new record for that month, and June marked the first time monthly exports surpassed $1 billion.
By country, Switzerland was the largest export destination at $770 million, accounting for 17.1% of total exports. It was followed by the United States ($610 million) and Hungary ($600 million). Exports to Switzerland rose 67.4% year-on-year. The ministry attributed this to expanded CDMO supply to global pharmaceutical companies and rising demand for biosimilars.
Expansion in the European market was also notable. Exports to the Netherlands reached $450 million, up 80% from a year earlier, ranking fourth among export destinations, while France recorded $160 million, entering the top 10 for the first time. In terms of recombinant genetic drugs, exports to France rose 630%, Belgium 184% and Italy 147%, showing strong growth across major European countries.
By product type, recombinant genetic drugs accounted for the largest share at $3.97 billion, or 88% of total biopharmaceutical exports. Toxins and antitoxins rose 47.4% to $280 million, while vaccines fell 27.4% to $120 million.
The ministry plans to strengthen support for CDMO companies through the "Special Act on Regulatory Support for Biopharmaceutical Contract Development and Manufacturing Companies," which is scheduled to take effect this December. Under the plan, it will introduce an export manufacturing registration system that allows CDMO companies aiming for exports to enter overseas markets without separate drug manufacturing licenses, and establish a raw material certification system to enhance international competitiveness.
"We will innovate the approval and review process for new drugs and biosimilars and strengthen full-cycle regulatory support so that domestic biopharmaceuticals can secure competitiveness in the global market," said An Young-jin, director general of the Bio and Herbal Medicine Bureau at the Ministry of Food and Drug Safety. "Through regulatory diplomacy with major export destinations and customized support, we will work to sustain this growth momentum in the second half."
