Small and mid-size biopharma companies in the U.S. and Europe are under intense pressure to find more efficient and cost-effective ways to commercialize their products. In an increasingly competitive clinical trial environment, sponsors have begun to shift their focus to the Asia-Pacific (APAC) region for their studies. In fact, the number of clinical trials in the U.S. has been on a gradual decline since 2014, while Asia has seen a steady increase.
Here are five reasons why the APAC region may be a good fit for your global clinical trial:1
1. Access to a large pool of treatment-naïve patients
The APAC region offers a genetically diverse population of over 4 billion people, and in countries such as India and China, many of these people may be treatment-naïve. Consequently, recruitment of patients who meet eligibility criteria may be easier than it is in Western countries. In addition, APAC countries often have a large affluent sub-population that manifests lifestyle-related health conditions which were historically more common in the West. For example, India has a growing incidence of hypertension and heart disease.
In some cases — such as stroke, hepatitis, and lung cancer — the incidences of disease may even be significantly higher than in Western countries. According to data from the Korea National Statistics Office, major health problems among the geriatric population in Korea include hypertension; stroke; coronary heart disease; diabetes; dementia; and cancer of the stomach, liver, cervix or breast. In China, with rising income, urbanization, and longevity, the burden of disease is now dominated by conditions such as cardiovascular disease, lung cancer, chronic obstructive pulmonary disease, and mental and musculoskeletal disorders.
To date, clinical trial penetration in the APAC region is still low compared with the U.S., limiting competition and simplifying recruitment. Moreover, lower per capita healthcare spending in these countries positions clinical trials as an attractive opportunity for patients to gain access to novel therapies that would otherwise be out of reach.1
2. A favorable and harmonized regulatory environment
There have been several initiatives to harmonize clinical trial conduct among International Conference on Harmonization (ICH) member countries and non-ICH member countries. In addition, fast-track regulations have been adopted in several APAC countries. For example, Australia has developed a Clinical Trial Notification (CTN) scheme which offers a straightforward, efficient, and reliable regulatory process.
China is also investing in improving its regulatory environment, leading to reductions in startup time. In February 2016, the China Food and Drug Administration (CFDA) announced a priority review process for innovative drugs. In March 2017, the CFDA announced its decision to change the requirement on import drug registration with the aim of encouraging foreign-developed new drugs to undergo clinical trials in and outside of China in parallel to shorten drug lag. On May 12, 2017, the CFDA also announced new guidelines that would reform clinical trial management, accelerate the review process, enhance lifecycle management, and strengthen intellectual property protection.
3. A strong intellectual property and clinical trial infrastructure
Intellectual property protections in Singapore and Japan are the strongest in the world, and other APAC countries are also focusing on protecting innovator’s rights. Singapore also has a sophisticated transportation and communication infrastructure, regulatory framework, and educated workforce, which supports both clinical operations and supply chain.2 In addition, the percentage of European Medicines Agency (EMA) critical findings and U.S. Food and Drug Administration (FDA) official actions taken during audits is lower in Asia than in North America, reflecting high data quality.1
4. Availability of skilled talent
The Asia-Pacific region is also home to a plethora of skilled workers who have experience with global regulations, as well as numerous large-scale, advanced clinical trial centers and specialized disease centers with therapeutic area expertise. For example, Wooridul Spine Hospital in South Korea is one of the leading state-of-the-art spinal treatment hubs in the world with more than 1,130 neurospinal specialists. The APAC region is also home to renowned centers of excellence for oncology and pediatrics, including Samsung Comprehensive Cancer Center at the Samsung Medical Center (Korea), Peter MacCullum Cancer Center (Australia), and Royal Children’s Hospital (Australia).
5. Access to the fastest-growing clinical trial and pharmaceutical market in the world
The contract research organization (CRO) market in the APAC region is the fastest-growing in the world, with revenue expected to increase at a 20 percent compound annual growth rate (CAGR) from 2016 to 2021 compared with 11.4 percent for the rest of the world.1
The pharmaceutical market in the APAC region is also the fastest-growing, with a 7.7 percent CAGR from 2015 to 2020 compared with 4.6 percent in the U.S. Moreover, the APAC pharma market is expected to capture a 30 percent revenue share by 2020.1
As it becomes more and more challenging to recruit patients — as well as investigators and key opinion leaders — in the U.S. and Europe, the APAC region may soon become a preferred destination for clinical trials. The increasing globalization of drug development has also led to well-developed ethical and regulatory frameworks in these countries and increased harmonization of clinical trial and commercialization standards, offering sponsors a faster, more efficient pathway to market.
If you’re planning a clinical trial in the APAC region, choose a CRO with proven experience and a strong local presence. Small and mid-size biotech sponsors may benefit from partnering with a nimble, biotech-focused CRO who can understand their unique needs and give them the attention they deserve. Contact us to learn more about our capabilities and how we can help you realize your clinical development goals.
 Frost & Sullivan. Asia: Preferred Destination for Clinical Trials. March 2017.
 PharmaWisdom. Challenges in conducting clinical trials in Asia. Available at http://www.pharmawisdom.com/Challenges-Clinical-Trials-in-Asia.html.
 Health and Health Care of Korean American Older Adults. Available at http://geriatrics.stanford.edu/wp-content/uploads/downloads/ethnomed/korean/downloads/korean_american.pdf.
 Yang G, et al. Rapid health transition in China, 1990-2010: findings from the Global Burden of Disease Study 2010. Lancet 2013;381(9882):1987-2015.
 An overview of major reforms in China’s regulatory environment. Regulatory Rapporteur July/August 2017. Available at https://embed.topra.org/sites/default/files/regrapart/1/6559/2_focus_-_overview_of_major_reforms.pdf.