Korea’s position as a clinical trials hub did not happen overnight. The country has treated clinical development as a matter of deliberate government policy for the better part of two decades, with Korea ranking among the world’s leading trial destinations as far back as 2018; years before China’s biotech ambitions fully took off. That sustained investment in investigators, hospital infrastructure, and regulatory support has produced one of the most efficient clinical trial ecosystems anywhere in the world. It is this depth that will determine how well Korea holds its ground as competition for global sponsors intensifies.
Compelling Fundamentals
The statistics are compelling. Korea ranks among the world’s leading countries in the global clinical development pipeline, accounting for 14.2 percent of the international total in 2024 with an astonishing 3,386 drugs in development, according to Citeline’s Pharma R&D Annual Review 2025.
Moreover, a full 3.46 percent of all clinical trials conducted in 2025 took place in Korea, putting the East Asian nation of just 51.7 million in sixth place globally, ahead of heavyweights like the UK, Canada, Japan, Italy, and France. On a city level, the data is even more striking, with Korea’s capital Seoul ranked as the second most active city globally for industry-sponsored clinical trials.
“Over the past two decades, Korea has rapidly emerged as a trusted and strategically important destination for global clinical trials,” says Hyejin Kim, president of KoNECT (Korea National Enterprise for Clinical Trials). Clinical trial numbers in Korea have more than doubled since KoNECT was established by the Korean Ministry of Health and Welfare in 2007 to better coordinate sites, investigators, infrastructure, and policy support in the country.
“Our competitiveness has been continuously strengthened by a synergistic combination of world-class medical institutions, highly skilled investigators, exceptional healthcare accessibility, an efficient patient recruitment environment, and state-of-the-art IT infrastructure,” adds Kim. There are more than 200 qualified clinical trial institutions in Korea and it sits among the world’s top ten countries for operational readiness and patient availability.
On the regulatory front, the Ministry of Food and Drug Safety (MFDS) offers fast-track approval processes for medicines that tackle serious public health threats as well as pre-submission consultation and a ‘navigator’ programme for certain innovative medicines.
Costs are low too. Jinhak Kim, executive director and US president at local contract research organisation C&R Research, estimates that Korean clinical trial expenditure is 60 percent or less than the equivalent US cost, a potential attraction point for capital-constrained US biotechs looking to conduct early-stage trials.
Then there is Korea’s population, which is ageing rapidly with disease patterns closely aligned with those of Western countries (including a preponderance of cancer, which accounted for 41.9 percent of deaths among the top ten causes in 2023), making clinical research conducted in Korea extremely relevant globally. Koreans have a high level of accessibility to medical services, with virtually the entire population covered by National Health Insurance (NHI), and there is a good level of public understanding of the value of participation in clinical research.
C&R Research’s Kim adds that beyond cost, Korea’s high-density population concentrated around major hospital centres, combined with the fact that only accredited institutions can conduct clinical trials, means that “a single large hospital can provide access to a very significant patient pool.”
Professor Do-Youn Oh, an oncology specialist based at Seoul National University Hospital, agrees that the density of the patient population and concentration of expertise in Korea bolsters its credentials as a clinical trials hub. “Korea is a genuinely small country; even Jeju, our furthest region from Seoul, is just an hour’s flight away,” she explains.
“In oncology specifically, most cancer patients gravitate toward Seoul, where several major hospitals are concentrated, which means a single centre here can achieve patient volumes that would be far harder to replicate in a country like the US. Patients travel back and forth to Seoul for both clinical trials and routine treatment, creating a genuinely concentrated, efficient environment for rapid trial recruitment.”
Slipping Status
Given these credentials, why then has Korea’s share of global clinical trials been slipping? Its share of worldwide industry-sponsored clinical trials fell from 4.04 percent and fourth place in 2023 to 3.46 percent and sixth in 2024, while although Seoul is still the second most active trial city in the planet, for years it was number one, before being displaced by Beijing in 2024.
For Youngshin Lee, CEO of KRPIA, the Korean Research-based Pharmaceutical Industry Association representing 51 multinational members, the sluggish growth of Korean biotech – especially compared to its supercharged contemporaries across the Yellow Sea in China – is an unignorable factor.
“Domestic Korean company trials are declining here while China is seeing large increases in both domestic and foreign trials,” says Lee. “China has more biotech companies, more funding availability, and more companies actively pursuing global blockbusters. Korea, with some notable exceptions, has been slower to make that transition. Funding availability for Korean domestic companies has been particularly difficult.”
Kwunho Jeong, CEO of local CRO JNPMEDI, argues that good innovation exists in Korea, and that local biotechs have the potential to do more in-country trials, but that Korea’s capital markets are a major constraint. Jeong notes that Korean biotechs are selling assets to global pharma before Phase I trials are complete because the local stock exchange KOSDAQ requires them to demonstrate a global licensing deal before they can list. “It is forcing companies to sign deals too early, at terrible terms, just to access the capital markets,” he says.
For its part, JNPMEDI is attempting to bridge this gap by investing directly in Korean biotechs, helping them complete Phase I, and then supporting them in negotiating with global pharmaceutical companies from a position of actual data rather than promise.
Although domestic Korean company trials are declining, a KRPIA survey found that the multinational base in Korea is holding. Moreover, KRPIA member company trial expenditure has actually risen 18.8 percent year on year. “The number of trials is slightly down, but the expense is significantly up,” says Lee. “That tells me the trials are becoming more complex and sophisticated – biologics, advanced therapies, late-stage confirmatory studies. That is not a negative signal for Korea as a clinical destination. It is a signal that Korea is being selected for the most demanding work.”
However, continued multinational investment in all types of trials – including early-stage work – is under threat, says Kyong Hwa Park, associate professor of medical oncology at the Korea University College of Medicine.
“What concerns me is that more and more global pharmaceutical companies are reducing their support for investigator-initiated research with Korean researchers,” says Park, who feels that Korea’s potential contribution to drug development programmes is underappreciated.
“We need more of that kind of support, not less,” she adds. “Sponsor-initiated phase III trials can generate practice-changing evidence, but investigator-initiated and real-world-driven research is also extremely valuable for patient care, and that kind of research can only be generated by the investigators themselves.”
Opportunity & Optimism
Korea’s slight clinical trial decline does not, though, seem to be terminal. Several new governmental initiatives have the potential to move the needle, including KoNECT’s new K-CThub. This model, broadly equivalent to ‘Trial Nation’ in Denmark (Europe’s leading country for clinical trials on a per capita basis) and the NIHR Research Delivery Network in the UK, aims to smooth the information gathering process for sponsors and increase the efficiency and ease of conducting clinical research in Korea.
KoNECT President Hyejin Kim underlines the importance of ensuring that Korean clinical trials meet the most rigorous global standards (and can therefore be accepted by global regulators like the FDA and EMA). With the FDA increasingly sceptical of single-country data, Kim is hoping that sponsors looking beyond China will head to Korea first.
“We firmly believe that for Korean clinical data to be effectively utilised in the global arena, securing data quality and integrity that strictly adheres to international regulatory standards is paramount,” says Kim. “To ensure that the domestic clinical trial environment consistently meets these rigorous global benchmarks, KoNECT actively shares the latest regulatory trends and standards with local stakeholders. Furthermore, we are continuously expanding our collaborative channels with overseas regulatory bodies, the global industry, and allied organisations.”
She continues, “Ultimately, our primary objective is to cultivate an ecosystem where the clinical trials conducted in Korea – and the data generated from them – are universally recognised as highly reliable, not only for multi-region clinical trials but also throughout the global drug development and regulatory approval processes.”
More money is flowing into Korean biotechs too, after a tricky couple of years. C&R’s Jinhak Kim saw many firms go into a “holding pattern” in 2023 and 2024, waiting for conditions to improve before committing to new studies.
However, “from late 2025, the funding environment has been recovering, and our pipeline of enquiries reflects that,” he states. “What is also notable is how the nature of the work is shifting: the traditional small molecule programmes that defined the CRO business for decades are increasingly giving way to advanced modalities – ADCs, CAR-T and other cell and gene therapies, and other complex biologics.” Many of the companies now emerging are the result of a decade-long focus on genomics and precision medicine from the Korean government under the K-MASTER banner.
There are genuine, unpolished diamonds in the Korean biotech scene too, often outdazzled by their contemporaries in China, but with huge potential provided the global investor base gets wise to their value. “The innovation quality in Korea is real – there are first-in-class and best-in-class assets there – and the valuations are considerably more attractive than what you are seeing in mainland China precisely because Korea does not command the same level of global attention,” says Ken Lee, managing director and region head for clinical development in Asia Pacific at Syneos Health.
“We have been making that point to some of our investor clients: there are assets in Korea that are worth examining, and you may be able to acquire them at a price that reflects their merit rather than a premium driven by competitive frenzy.”
