Korea's pharmaceutical and biotech industry is entering a new phase of growth.
In the first half of this year, domestic pharmaceutical and biotech stocks were sluggish due to market volatility and weaker investor sentiment. In contrast, the industry's competitiveness is seen as strengthening.
In fact, the results achieved by domestic corporations in the global biosimilar and contract development and manufacturing organization (CDMO) markets are bearing fruit as export growth. Biopharmaceutical exports have set all-time highs for three consecutive years.
According to the Ministery of Food and Drug Safety, domestic pharmaceutical production last year reached 33.8466 trillion won, the highest on record. Exports of pharmaceuticals totaled $10.438 billion, surpassing $10 billion for the first time, and the trade balance posted a record surplus of $1.50581 billion. Biopharmaceuticals in particular led the growth. Last year, biopharmaceutical exports were $7.64 billion, accounting for about 73% of total pharmaceutical exports.
Growth is continuing this year. In the first half, biopharmaceutical exports were $4.5 billion, the highest ever for a half-year period, up about 15% from a year earlier. Rising demand for biosimilars and increased CDMO orders by domestic corporations drove exports. Export markets also expanded quickly, centered on Europe. Switzerland, Hungary, the Netherlands and Germany have emerged as major destinations, widening K-bio's global supply chain.
As global commercialization of homegrown new drugs, investment in production facilities and technology exports align, the competitiveness of K-pharma and bio is also rising a notch. The outlook is that competitiveness will become clearer for corporations generating tangible results in the global market.
◇ Biosimilars and CDMOs power K-bio's growth
At the center of the domestic biopharmaceutical industry's growth are biosimilars and CDMOs.
Samsung Biologics(207940) and Celltrion(068270) both surpassed 4 trillion won in revenue last year, marking record results. They are seen as not only driving growth in Korea's bio industry but also contributing to better treatment environments for global patients and to stable drug supplies.
Of the 18 biosimilars approved by the U.S. Food and Drug Administration (FDA) last year, five were Korean, ranking No. 1 by country.
Celltrion is focusing on expanding its biosimilar portfolio and strengthening global direct sales. It plans to increase its biosimilar lineup from 11 now to 18 by 2030 and 41 by 2038.
The company acquired the Branchburg, New Jersey, manufacturing site previously operated by U.S. drugmaker Eli Lilly and Company and began full-scale operations in January, then acquired French healthcare company Gifrer in May. Its strategy is to boost both global supply chain stability and competitiveness in the European market by securing production bases and reinforcing local distribution networks.
Samsung Biologics is also expanding capacity to strengthen global CDMO competitiveness. This year it completed the acquisition of a biopharmaceutical manufacturing site in Rockville, Maryland, securing its first production base in the United States, and added a 60,000-liter (L) facility, expanding global capacity from 785,000 L to 845,000 L.
It also moved to acquire global peptide CDMO company PolyPeptide Group. The deal is about 2.7 trillion won, the largest ever in Korea's pharmaceutical and biotech sector. By extending beyond its antibody-drug–centered business into peptides, it aims at the next-generation drug manufacturing market, including obesity and diabetes treatments.
◇ Leclaza and Alglotra… era of global commercialization for homegrown new drugs
Global sales of homegrown new drugs and large-scale technology export results are also continuing.
According to the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), disclosed technology export contracts by domestic corporations in the first half of this year totaled about 13 trillion won. There is also hope of surpassing last year's annual tally of 20 trillion won.
Yuhan's lung cancer drug Leclaza (ingredient name Lazertinib) is cited as a representative success case of an open innovation strategy and global technology transfer.
The Leclaza–Rybrevant combination therapy, transferred to Johnson & Johnson (J&J), recorded $289 million (about 430 billion won) in global sales in the second quarter of this year, up 60.8% from a year earlier. First-half cumulative sales were $546 million (about 810 billion won), up 70.4% year over year.
GCBiopharma's immunoglobulin blood product "Alglotra" is also maintaining growth after entering the U.S. market. Alglotra sales rose from about $50 million in 2024 (about 48.6 billion won at the exchange rate at the time) to about $106 million last year (about 151.1 billion won), more than doubling. In the first quarter of this year, sales were 34.9 billion won, up about 306% from a year earlier.
GC Biopharma will invest 140 billion won in its Ochang plant by 2030 to build a next-generation subcutaneous immunoglobulin (SCIG) production line to meet expanding demand in the U.S. market.
Hanmi Pharmaceutical(128940) proved its global competitiveness this year by transferring its short bowel syndrome treatment candidate sonepeglutide to U.S.-based Eli Lilly and Company in a deal worth up to $1.26 billion.
Aribio is continuing its global push in Alzheimer's treatment. In May, the company signed a global licensing deal worth up to 7 trillion won for its oral Alzheimer's disease candidate "AR1001."
◇ ADCs, obesity, MASH, dementia… race to secure next-generation growth engines
Domestic corporations are accelerating next-generation new drug development alongside growth of existing products.
Hanmi Pharmaceutical is proceeding with approvals to launch Efpeglenatide, Korea's first obesity drug. In tandem, it is developing next-generation obesity pipelines, including the triple-agonist (GLP-1, GIP and glucagon) obesity candidate "HM15275" and muscle-enhancing obesity candidates "HM17321" and "HM500197."
Results from the phase 2b trial of the MASH (metabolic dysfunction–associated steatohepatitis) candidate epinopegdutide are also forthcoming.
Chong Kun Dang pharmaceutical(185750) has moved to develop anticancer drugs based on antibody-drug conjugates (ADC) and to expand global open innovation. ADC candidate "CKD-703" began enrolling its first patients in a global phase 1/2a trial in the United States, entering the development stage. At the same time, it is partnering with the Boston biotech cluster to scout promising biotechs.
The Dong-A Socio Group is also strengthening both new drug development and CDMO capabilities.
Dong-A ST(170900) is seeking global technology export opportunities based on pipelines for innovative drugs in oncology, immuno-inflammation and neurodegenerative diseases. ST Pharm(237690) is bolstering CDMO competitiveness in oligonucleotide therapeutics and mRNA. By operating its second oligo plant, it has secured capacity to handle everything from early clinical to commercial production, and it aims to penetrate the RNA therapeutics market with its proprietary 5' capping technology and LNP platform.
K-medical aesthetics is also establishing itself as a global growth pillar. Daewoong Pharmaceutical(069620) is expanding in the U.S. market with its botulinum toxin "Nabota." Along with broader North American sales through its U.S. partner Evolus, it is targeting Latin America and Southeast Asia. Hugel(145020), PharmaResearch(214450), Medytox(086900), L&C BIO(290650), JETEMA(216080) and CLASSYS(214150) are also emerging as new export drivers as they continue to grow overseas sales in toxins, fillers and aesthetic medical devices.