The headquarters of the Ministry of Food and Drug Safety. / Courtesy of the Ministry of Food and Drug Safety

Driven by the growth of the contract development and manufacturing organization (CDMO) market, biopharmaceutical exports reached a record high in the first half of this year.

According to the Ministry of Food and Drug Safety on July 8, the preliminary figure for biopharmaceutical exports in the first half of 2026 stood at $4.5 billion, representing a 15.3% increase compared to the same period last year. While the first half of last year had already set a record high, that milestone was surpassed just one year later.

By quarter, exports in the first and second quarters reached $2 billion and $25 billion, up 11.1% and 15.3% year-on-year, respectively. Amid a consistent streak of monthly record-high performances, exports for the single month of June alone surpassed $1 billion.

By destination, Switzerland accounted for the largest share of biopharmaceutical exports in the first half of the year at $770 million, or 17.1% of the total. This performance is attributed to expanded CDMO supplies from South Korean companies to global Swiss pharmaceutical firms, coupled with growing demand for biosimilars.

Switzerland was followed by the United States at $610 million (13.6% of the total) and Hungary at $600 million (13.3%).

By product category, recombinant protein drugs led the sector at $3.97 billion, followed by toxins and antitoxins at $280 million, and vaccines at $120 million.

The Ministry of Food and Drug Safety plans to extend institutional support to ensure that the robust export performance continues into the second half. In response to the rapid expansion of the biopharmaceutical CDMO market, the ministry enacted the Special Act on Regulatory Support for Biopharmaceutical Contract Development and Manufacturing Companies at the end of last year. This legislation introduced an export manufacturer registration system, enabling export-oriented CDMO firms to enter global markets without being required to hold a standard pharmaceutical manufacturing license.

"By innovating the approval and review processes for new drugs and biosimilars and offering life-cycle regulatory support, we will help safe therapeutics launch globally at the fastest possible pace," said Ahn Young-jin, director general of the Biopharmaceuticals and Herbal Medicines Bureau at the ministry. "We will provide rational regulatory innovation and tailored insights to facilitate the global expansion of domestic biopharmaceuticals, while actively engaging in regulatory diplomacy with major importing nations to maintain this upward growth trajectory throughout the second half of the year."

                                                                                                           Seo Byung-joo