APAC’s clinical research momentum: China, Japan and South Korea are emerging as global hubs for innovative, multi-regional clinical trials. Credit: Shutterstock

The global map of clinical research is changing rapidly. Once viewed primarily as an attractive destination for cost-efficient clinical trials, the Asia-Pacific (APAC) region is now driving innovation across the pharmaceutical industry, with governments, regulators and private investors working together to accelerate drug development.

Clinical trial activity illustrates the scale of this transformation. APAC contributes an estimated 43% of the world’s innovative treatment pipeline, with metabolic and cardiovascular disease therapeutic areas in particular experiencing rapid expansion. The APAC market is marked by an estimated cardiovascular drug value reaching USD 12.60 billion, a metabolic therapeutics sector growing at over 8% CAGR.

Clinical understanding in 2026 emphasises that Asian populations develop metabolic and cardiovascular risk factors at a lower body mass index (BMI) than Western populations, accelerating local screening and early intervention protocols. As such, APAC continues to serve as a major hub for early-phase and multi-regional clinical trials (MRCTs), bolstered by modernised regulatory pathways and expansive local patient demographics.

But demand for clinical research across a broad range of therapies is rising in APAC, with key countries strengthening the foundations needed for globally competitive trials, including regulatory reform, protocol standardisation, testing infrastructure, national data systems, skilled talent, and innovation ecosystems.

This article charts three APAC countries’ rise as clinical research hubs: China, Japan and South Korea. Their approaches offer frameworks for other regions aiming to strengthen their clinical research infrastructures.

China: From fast followers to fast innovators

Today, China is recognised as the world’s second-largest pharmaceutical market and one of the fastest-growing major pharmaceutical markets globally, providing both the scale and investment needed to accelerate innovation. Drug reviews and evaluations, for example, are particularly swift; typically, the path from early discovery to IND cycles is 50 to 70% faster than elsewhere in the world.¹ Trial recruitment for later stages of development is also often two to five times faster than in the EU or the US.¹

The country’s supportive policy environment has also evolved considerably. Regulatory reforms now allow overseas clinical trial data to support submissions, while breakthrough therapy and conditional approval pathways have helped reduce time to market for innovative medicines.

Currently, China leads the world in outlicensing deals, accounting for more than 75% of private equity and VC funding in the APAC region since 2019.³This momentum is reflected commercially, too. GlobalData forecasts China-headquartered pharmaceutical sales will increase from US$12.6 billion in 2025 to US$36.8 billion by 2031, driven largely by continued demand for biologics and innovative therapies.

Figure 1: China company sales forecast: Small molecule versus biologic sales, 2025-31 ($bn)

Source: GlobalData, Chinese Company Drug Sales Forecast to Triple to $36.8 Billion Driven by Biologics Demand.

Cardiovascular research in particular benefits from China’s large patient pool and local clinical expertise, with significant real-world study activity across related conditions such as heart disease, atrial fibrillation, and heart failure. This suggests that China is not only a conventional interventional trial market but also an important geography for large-scale cardiovascular evidence generation, safety monitoring, and outcomes research.

Together, these developments have transformed China from a destination for efficient clinical studies into one of the world’s leading sources of pharmaceutical innovation.

Japan: First for first-in-class

Between 2015 and 2023, Japan accounted for the highest number of FDA novel drug approvals in Asia, including 24 new molecular entities (NMEs).¹

As the world’s third-largest pharmaceutical market, valued at more than US$85 billion in 2025, Japan combines commercial scale with a mature research environment, making it an attractive destination for innovation-led clinical development. Japan’s ageing population also contributes to this, creating a distinctive clinical research environment and increasing the importance of therapeutic areas associated with age-related disease, including cardiovascular conditions. GlobalData estimates that Japan’s diagnosed prevalent cases of heart failure, for example, will reach approximately 1.69 million by 2032. The scale and persistence of this disease burden reinforce the need for continued cardiovascular treatment innovation and clinical research.

Figure 2: Diagnosed prevalent cases of heart failure across the 7MM, 2022 and 2032

Source: GlobalData, Heart Failure: Epidemiology Forecast to 2032.

Like China, the country’s success is built on a supportive ecosystem and government funding. The Agency for Medical Research and Development (AMED), for example, provides funding and other practical support for biotech and pharma innovation.

The Sakigake designation system, broadly akin to the FDA’s Breakthrough Therapy Designation, is administered by the Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Device Agency. The scheme offers prioritised consultations and accelerated reviews and, depending on the product and assessment outcome, may support premium pricing at reimbursement. Seven new medicines achieved first-in-world approvals under Sakigake between April 2015 and August 2020.⁵

Alongside its established regulatory framework, Japan is also experiencing renewed momentum in clinical research. Recent GlobalData analysis ranked the country among the world’s top five for clinical trial growth between Q2 2024 and Q2 2025, supported by continued government incentives to encourage research investment.

Increased funding for regenerative medicine and advanced biomanufacturing is further strengthening Japan’s position, helping to expand capacity for cell and gene therapies while supporting the next generation of innovative treatments.

South Korea: A reputation for innovation

South Korea has a nationalised healthcare system covering 97% of the population under a single payer. This enables access to expansive healthcare data and a trial participant population of both healthy people and those with medical conditions. Like its APAC neighbours, South Korea faces a significant cardiometabolic disease burden. GlobalData estimates that the diagnosed prevalence of Type 2 diabetes in South Korea was 6.98% in 2025, highlighting the importance of metabolic disease research alongside the country’s strengths in innovative drug development.

Its strong healthcare infrastructure has helped position South Korea as one of Asia’s fastest-growing biopharmaceutical innovation hubs. Government and industry investment, coupled with efficient regulatory processes, continue to attract both domestic and international sponsors.

As such, the country is emerging as a leader in drug development focused on antibody drug conjugates (ADCs) and CGT. South Korea has a high proportion of first-in-class medicines, 36% from 2023 to the end of the first half of 2025.

Innovation is also translating into commercial success. GlobalData analysis shows the value of innovator drug licensing agreements reached US$7.86 billion in the first half of 2025, representing a 113% increase on 2024 and highlighting growing international confidence in South Korean drug development.

Figure 3: Total licensing agreement deal value involving South Korean innovator drug in-licensing to domestic versus international biopharmaceutical companies (2021-25 YTD)

GlobalData: South Korea Emerges as 2025 Licensing Hub with 113% Growth and Billion-Dollar Deals.

Government support remains a key differentiator. In 2025, the National Bio Committee was established with the ambition of making South Korea one of the world’s top five bio-industry leaders by 2035, backed by plans for a ₩1 trillion fund to stimulate private investment in biopharmaceuticals and vaccines.

This commitment is being reinforced by multinational investment, with companies continuing to expand clinical research and manufacturing activities in South Korea as the country’s reputation for innovation grows.

How APAC’s growth is reshaping global clinical research

The evidence suggests an APAC landscape in evolution and, with clinical trial activity rising two to three times faster than in Europe – a trend which is expected to accelerate over the next decade – a range of new opportunities are emerging for sponsors.

But increased trial activity in the region is also revealing a number of operational pressures, including fragmented regulatory pathways, budgetary changes, and delays to start-up times and recruitment.

The experiences of China, Japan and South Korea demonstrate how sustained investment, supportive regulation and long-term commitment can create internationally competitive clinical research ecosystems. As APAC plays a larger role in global drug development, sponsors are increasingly looking to the region for innovation, scientific expertise and access to diverse patient populations.

For sponsors, addressing those challenges and realising opportunities largely depends on working with partners who understand the regulatory, operational and cultural complexities of conducting studies across APAC. With more than 30 years of experience in APAC and operations spanning 13 countries, ICON helps sponsors unlock the region’s potential through comprehensive clinical development services. From study design and regulatory strategy to patient recruitment, clinical operations, data management and decentralised trial delivery, ICON combines local expertise with global capabilities to help sponsors accelerate development, improve study quality and bring innovative therapies to patients faster.

Whether supporting early-phase research, large multinational programmes, or the development of advanced therapies, ICON works alongside sponsors to overcome regional complexities and deliver successful clinical trials across one of the world’s fastest-growing research environments.

To learn more about how ICON supports clinical development across APAC, download the free whitepaper below.

References

  1. Anirudh Roy Popli, Fangning Zhang, Jay Park, Leu FD. The emerging epicentre: Asia’s role in biopharma’s future. McKinsey & Company. January 2026.
  2. Badarch M. By The Numbers: Phase III Trials In China Skyrocket While Phase I Falls To Earth. In Vivo: Citeline Commercial. 2025.
  3. La Mola F, Chang K, Kapur V, Rodriguez B, Ang A. Empowering Biotech Innovation in Asia-Pacific. July 2025.
  4. Beaney A. China takes lead in CGT trials amid Western funding challenges. Clinical Trials Arena. 2025.
  5. Tanaka M, Idei M, Sakaguchi H, et al. Achievements and challenges of the Sakigake designation system in Japan. British Journal of Clinical Pharmacology. 2021.

Additional market intelligence incorporated