Despite external uncertainties, including rising tensions in the Middle East, exports of Korea's bio-health industry topped 6 trillion won in the first quarter, maintaining a steady trend.
According to the Korea Biomedicine Industry Association on Apr. 5, exports of the bio-health industry reached $4.16 billion (about 6.3 trillion won) from January to March. By month, March posted $1.5 billion, up 6.3% from a year earlier; February rose 7.1% to $1.31 billion. January also showed growth, up 18.3% to $1.35 billion.
Biosimilars led the results. As demand expanded in key markets such as the United States and the European Union (EU), exports have increased for five consecutive months.
In particular, in the United States, biosimilar development has not been pursued for 106 biologic products—about 90% of those whose patents expire between last year and 2034. The market opportunity is estimated at about $232 billion. Europe likewise has a development gap for 79% of roughly 100 products whose exclusivity ends by 2032, representing a potential market of about $143 billion.
Domestic corporations are actively targeting this opportunity. For two straight years, 2024 and 2025, Korea ranked as the country with the most biosimilar approvals by the U.S. Food and Drug Administration (FDA), and exports have continued to grow, jumping from $980 million in 2021 to $1.47 billion in 2022. Last month as well, exports of biopharmaceuticals reached $920 million, driving overall results.
The association projected this year's bio-health exports will reach $30.4 billion (about 46 trillion won), up about 9% from a year earlier. Diversification of export markets and stronger contract development and manufacturing organization (CDMO) competitiveness were cited as growth drivers. Beyond the United States and Europe, demand is expanding in emerging markets such as the Middle East, Africa and Latin America, and domestic corporations are also moving to increase orders by expanding production capacity.
Notably, Samsung Biologics expanded its total production capacity to 845,000 liters by adding GSK plc's U.S. manufacturing facility to its existing 785,000 liters.