Oncology clinical trial activity in the Asia-Pacific (APAC) region has been robust over the past decade, increasing 138 percent from 2010 to 2020.¹ In the past, most studies conducted in APAC countries were later studies, but there has recently been an uptick in the number of phase 1 trials. This bustling activity, in combination with the fastest growing global market for pharmaceutical sales, makes the APAC region an attractive target market for clinical trials and commercialization.

In this blog post, we highlight seven factors contributing to oncology clinical trial activity in the APAC region.

1. Large patient population
The APAC region is densely populated, accounting for 60 percent of the people in the world.² The population includes many treatment-naïve patients who may be eligible – and eager – to enroll in clinical trials for access to novel treatments. Further, globalization has contributed to rapid growth of the middle class in the APAC region. This socioeconomic demographic often bears the burden of paying for their own healthcare, potentially making them more open to clinical trial participation.

2. Availability of key opinion leaders and specialized clinical trial centers
In addition to being home to more than 50,000 principal investigators who are actively supporting clinical trials, APAC also boasts many specialized clinical trial centers.³ Several countries have made significant investments to increase clinical trial competitiveness by developing state-of-the-art medical institutions with the latest equipment, technology, and infrastructure. In Japan and South Korea, certain hospitals have even created large, de-identified patient databases that can be leveraged for evaluating study design and feasibility and accelerating recruitment.⁴

3. Increase in skilled personnel and data quality
The APAC contract research organization (CRO) market, which includes both regional and global firms, was valued at $8 billion in 2020 and is projected to exceed $18 billion by 2028.⁵ Overseas expatriates are returning to their home countries in the APAC region, bringing drug development expertise, global study training, and knowledge of ICH good clinical practice.

Coupled with this increase in skilled personnel, stricter regulations and oversight has led to meaningful improvements in data quality. Both the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted data from clinical trials in Asia as part of submissions.⁴ Moreover, the current rate of FDA and EMA inspections is lower in the APAC region than in North America.

4. High incidence of cancer, including some that are less common in Western countries
Of the estimated 19.3 million new cancer cases and nearly 10 million cancer deaths in 2020, at least half occurred in the APAC region.⁶ China alone accounts for approximately one-quarter of all new cancer diagnoses and one-third of cancer deaths globally.⁷

Oncology clinical trial activity in the region has also increased due to the higher prevalence of certain cancers of interest which are less common in Western countries. For instance, four of the top five countries for gastric cancer are in the APAC region and this high prevalence would facilitate enrollment for studies targeting this tumor type.⁸ Oncology studies in APAC may also help to shed new light on how risk factors for cancer vary by geography, adding to the body of knowledge and contributing to target discovery.

5. Regulatory reforms
Many APAC countries have implemented, or are developing, pathways that streamline the review and approval process. As one example, China was historically considered a challenging market due to submission backlogs, long review timeframes, and inconsistencies in the quality of locally manufactured products.⁹ Beginning in 2015, the National Medical Products Administration has instituted numerous reforms to the regulatory framework to increase transparency and enable timely or expedited review of certain innovative drugs. In July 2020, Chinese Drug Registration Regulations also introduced a new breakthrough therapy pathway.⁹

6. Faster enrollment
Studies in the APAC region often enroll more quickly than studies in the U.S., in part due to lower per capita government spending on healthcare.³ For people in APAC countries, oncology clinical trials represent an opportunity to access treatment that may otherwise be out of reach. According to GlobalData, the median number of patients recruited in oncology studies involving APAC sites was more than 40 percent higher than the global median from 2018 to 2019.¹⁰

7. Evolution of the local drug development ecosystem
Over the past decade, the innovation ecosystem in the APAC region has matured, giving rise to a transition from generics-focused to innovative biopharmaceutical development. APAC countries such as Korea and China are actively developing novel oncology molecules, with strong government support, as evidenced by the proliferation in FDA designations for therapies originating from those countries. In 2020, local biotechs accounted for more than half of the new molecules under development in China.¹¹

Key takeaway

The APAC region now leads the world in total number of active oncology studies, with China accounting for more than 50 percent of those trials.¹ Sponsors seeking to globalize their trials to this region may benefit from ease of regulatory compliance and lower cost of study conduct.

To learn more about how Premier Research can help you achieve study success in APAC countries, click here.

[1] Clinical Trials Arena. Asia-Pacific region has seen the largest growth in oncology-related trials over the past decade. Available at https://www.clinicaltrialsarena.com/analysis/asia-pacific-region-has-seen-the-largest-growth-in-oncology-related-trials-over-the-past-decade/.

[2] Frost & Sullivan. Asia: Preferred Destination for Clinical Trials. Available at https://novotech-cro.com/sites/default/files/170217_FrostSullivan_Asia%20white%20paper_full.pdf.

[3] Clinical Trials Arena. Why Asia-Pacific is the next frontier for decentralized clinical trials. Available at https://www.clinicaltrialsarena.com/sponsored/apac-decentralized-clinical-trials/.

[4] Frost & Sullivan. Asia: Preferred Destination for Clinical Trials. Available at https://novotech-cro.com/sites/default/files/170217_FrostSullivan_Asia%20white%20paper_full.pdf.

[5] Business Market Insights. Asia Pacific Contract Research Organization (CRO) Market Forecast to 2028 – COVID-19 Impact and Regional Analysis By Type (Early Phase Development Services, Clinical Research Services, Laboratory Services, and Post-approval Services); End User (Pharmaceutical and Biotechnology Companies and Medical Device Companies) and Geography, April 2021. Available at https://www.businessmarketinsights.com/reports/asia-pacific-contract-research-organization-cro-market.

[6] Sung H, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 countries in 185 countries. CA Cancer J Clin. 2020;71(3):209-249.

[7] UICC. Estimated age-standardized incidence rates (World) in 2020, all cancers, both sexes, all ages. Available at https://www.uicc.org/news/globocan-2020-new-global-cancer-data.

[8] WorldAtlas. Countries with the highest prevalence of stomach cancer in the world Available at https://www.worldatlas.com/articles/countries-with-the-highest-prevalence-of-stomach-cancer-in-the-world.html.

[9] European Pharmaceutical Review. China and the evolving regulatory landscape. Available at https://www.uicc.org/news/globocan-2020-new-global-cancer-datahttps://www.europeanpharmaceuticalreview.com/article/98200/china-and-the-evolving-regulatory-landscape/.

[10] Clinical Trials Arena. The benefit of running clinical trials in Asia-Pacific for biotech companies, December 21, 2020. Available at https://www.clinicaltrialsarena.com/accelerating-clinical-trials/the-benefit-of-running-clinical-trials-in-asia-pacific-for-biotech-companies/.

[11] China Association of Enterprises with Foreign Investment. A Gift to 2021 | “Building China’s Pharmaceutical Innovation Ecosystem – Part One of the Series: 2015 – 2020 Development Review and Future Prospects” is officially released, April 3, 20