South Korean biopharma exports hit record $6.6bn in Jan-Sep as Europe offsets US decline

South Korea's Ministry of Food and Drug Safety said on 8 October that the country's biopharmaceutical exports for January to September were provisionally tallied at $6.6 billion, up 15.8% from the same period last year and the highest total on record for the first three quarters. Chosun Ilbo put the figure at $6.604 billion, against $5.702 billion a year earlier. Biopharmaceuticals accounted for 73.4% of the country's $9 billion in total pharmaceutical exports over the period. [ 1 , 2 , 3 , 4 , 7 ]

Third-quarter exports were $2.07 billion, up 15.6% year on year, following $1.99 billion in the first quarter (up 11.8%) and $2.54 billion in the second (up 20.9%). Seoul Economic Daily reported that July exports rose 54.3% to $710 million and August exports 25.5% to $690 million. Asia Economy and Seoul Economic Daily said September exports fell 14.1% to $670 million, citing factors including fewer working days. [ 1 , 2 , 4 , 7 ]

The United States remained the largest destination at $1.07 billion, but exports there fell 23.7% and its share of the total dropped from 24.7% to 16.3%. Asia Economy said the decline appeared largely due to a $400 million fall in exports of recombinant medicines and other products. Newsis reported that toxin and antitoxin exports to the US partly increased while recombinant medicine exports fell. [ 1 , 2 , 4 , 7 ]

European markets drove the growth. Exports to Switzerland rose 27.3% to $1.01 billion and to Hungary 28.0% to $920 million, keeping them second and third. The Netherlands rose 42.4% to $630 million, Italy 59.6% to $300 million, Belgium 209.7% to $290 million and France 269.1% to $200 million. Seven of the top 10 destinations were European; Chosun Ilbo named the United States, Japan and Türkiye as the exceptions. The ministry attributed the increase to expanded CDMO supply to global drugmakers in Europe and rising biosimilar demand. [ 1 , 2 , 4 , 7 ]

By product, recombinant medicines reached $5.71 billion, up 16.8% and 86.5% of the total. Toxin and antitoxin exports, which include botulinum toxin, rose 43.3% to $433 million; Chosun Ilbo reported that those to the US rose 95.5% to $131 million. Vaccine exports fell 21.7% to $182 million, going mainly to countries such as Bangladesh, Nigeria, Thailand and Colombia, according to Chosun Ilbo. [ 1 , 4 , 7 ]

The ministry said it had eased requirements for Phase 3 clinical trial and animal study data in biosimilar approvals, within the bounds of safety, and that it would pursue raw material certification and other support under the special act on regulatory support for biopharmaceutical CDMO companies, which takes effect in December. "We will continue to pursue rational regulatory improvement and institutional and technical support to strengthen the global competitiveness of domestic biopharmaceuticals," the ministry said, according to Newsis. [ 1 , 2 , 4 , 7 ]