Why ASIA-PACIFIC Leads The World In Clinical Trials?

The Asia-Pacific region, with over half of the global population, is becoming a growing popular spot for conducting clinical trials by offering lower trial costs, access to large patient pools, and a friendly regulatory environment. These distinguishing traits are increasing interest in medical device, pharmaceutical, and healthcare companies to shift their clinical trial locations to Asia-Pacific countries.

In 2020, the Asia-Pacific clinical trials market grossed USD 7.1 billion, with an anticipation to reach $19.8 billion at a CAGR of 8.7% between 2022 and 2032.

To make the most of Asia’s opportunities for timely, outstanding, affordable clinical development in a minimum-risk way, sponsors need to have access to the following capabilities: an understanding of local regulatory processes, connections with local physicians and healthcare providers, an understanding of international regulatory authority requirements, and the application of international standards to local clinical research settings.

Let’s explore various reasons why you should consider conducting your clinical trials in the Asia-Pacific region.

Top 5 reasons to choose the Asia-Pacific region for clinical trials

Here is a list of the top 5 reasons to choose the APAC region for your clinical trials:

Accessibility to a diverse spectrum of patient populations
Budget-friendly & cost-saving
Simplified regulatory process
Access to high-quality data
The availability of skilled personnel

Let’s discuss each reason in detail to understand the advantages of preferring the APAC region for clinical trials.

1. Accessibility to a diverse spectrum of patient populations in Asia-Pacific

The major challenge in clinical trials is subject recruitment, which directly affects the duration and expense of the study. Achieving the estimated recruitment count is directly proportional to the epidemiology of diseases.

Most populous countries like China and India offer a genetically diverse population, and many of these people may be treatment-naïve. Overall, patient recruitment is generally easier and faster in the Asia-Pacific countries.

Below is a table listing a few Asia-Pacific (APAC) countries with the highest disease burden.

Country	Disease Burden
South Korea	Diabetes; dementia; hypertension; stroke; coronary heart disease; stomach cancer, liver cancer, cervical cancer, and breast cancer
Thailand	Ischemic heart disease; stroke; lower respiratory infections; chronic kidney disease; liver cancer; tracheal cancer; lung cancer, alzheimer’s disease and other dementias;
Malaysia	Heart disease; pneumonia; cerebrovascular diseases; cancer; heart attack; stroke
Singapore	Colorectal cancer, lung cancer, prostate cancer, breast cancer; heart attacks; strokes; high blood pressure; diabetes
Australia	Coronary heart disease, back pain & problems; anxiety and depressive disorders; COPD
Japan	Stroke; low back pain; Alzheimer’s disease; ischemic heart disease; lung cancer;
New Zealand	Ischemic heart disease; stroke; COPD Alzheimer’s disease; lung cancer; colorectal cancer; chronic kidney disease lower respiratory infection; prostate cancer breast cancer
China	Cardiovascular disease, lung cancer, chronic obstructive pulmonary disease, and mental and musculoskeletal disorders.
India	Hypertension and heart disease

2. Budget-friendly & cost-saving

Another extremely valid reason that limits conducting clinical trials is cost, especially for small and medium-sized biopharma businesses.

This cost variation is frequently the consequence of lower expenses for surgeries, medical procedures, and visits, as well as a tendency toward quicker patient recruitment and a growing interest in joining studies.

The following are some examples of the economic advantages of choosing the APAC region.

Australia has implemented the Research and Development Tax Incentive (R&DTI), which gives tax reductions for R&D activities. As a result, the total cost of performing clinical studies in Australia may be up to 40% less than in the United States.
The Malaysian government established Clinical Research Malaysia (CRM) to boost the number of clinical trials in Malaysia, as the current Malaysian Economic Transformation Programme (ETP) has recognized clinical research as one of the primary drivers of economic growth.
Countries like Japan, India, South Korea, and China provide numerous economic advantages, offering incentives for the development of orphan drugs. Click on the respective countries to learn about the advantages offered by regulators in these countries.

Clinical trials may be a cost-effective way for patients to gain access to novel treatment options in APAC countries, where government healthcare funds are often lower than in other regions.

Not sure which countries to choose for your clinical trial in the Asia-Pacific region? Enter the details in the form below to connect with us.

3. Simplified regulatory process in Asia-Pacific

Many APAC countries have simplified regulatory review processes to expedite the regulatory process.

The following are some regulatory revisions made by some regulatory authorities that reduced the approval timeline from years to months:

Australia
- Australia has implemented a Clinical Trial Notification (CTN) system that provides a simple, quick, and reliable regulatory strategy.
Japan
- Japan is the second-fastest country to approve clinical trials, having simpler rules and strong ethical standards that are comparable to those in the United States and Europe.
- It generally requires four to eight weeks for institutional review board (IRB) approval as per the Clinical Trials Act of 2018. The Pharmaceuticals and Medical Devices Agency (PMDA) responds within 30 days after they apply.
China
- Submitting a Clinical Trial Application (CTA) in China must demonstrate that the study will adhere to all drug regulations and rules, as well as the Country’s standards of ethics.
- The National Medical Products Administration (NMPA) responds within 60 business days of filing its CTA.
- The application will be automatically granted if the company does not receive a response within the required time frame, with the restriction that it will lose approval if it is unable to recruit volunteers and does not complete the study within three years after it is approved.
- In 2016 and 2017, the China Food and Drug Administration (CFDA) adopted the following measures to expedite the regulatory process:
  - Introduced a priority review process for novel drugs.
  - To facilitate the conduct of clinical studies on foreign-developed innovative pharmaceuticals in and outside of China while simultaneously easing the import drug registration process.
Malaysia
- Malaysia also has quicker regulatory and ethics approval processes for Industry Sponsored Research (ISR), which are comparable to countries like Hong Kong, Japan, Singapore, Taiwan, and South Korea.

Regulators from other countries in the APAC region offer similar kinds of advantages.

4. Access to high-quality data

One of the key factors that position the Asia-Pacific (APAC) region as a leader in clinical trials is its ability to generate high-quality data.

APAC boasts a robust infrastructure for clinical research, coupled with stringent regulatory standards, which ensure the integrity and reliability of the data produced.

In APAC countries such as Japan, Australia, and South Korea, there exists a well-established framework for clinical trials, with guidelines and protocols designed to uphold the highest standards of data quality and patient safety.
Regulatory bodies such as the PMDA in Japan and the TGA in Australia enforce strict regulations to ensure compliance with Good Clinical Practice (GCP) guidelines.
In the APAC region, certain countries, like Japan, Korea, and China, require local data for drug approvals, and the data from these trials is known to be of high quality, so it’s simpler to seek approval in other markets.
Many APAC countries offer excellent data quality standards at a competitive cost than the United States and Europe, which apply efficiently to other markets.

A few examples of High-quality data in APAC

As per the 2015 h-Index, Japan was among the top 10 global countries.
Numerous Korean institutions are using sophisticated digital data collection techniques that go further than what companies typically collect in clinical trials.

5. The availability of skilled personnel in the Asia-Pacific region

One of the key factors contributing to the Asia-Pacific region’s leadership in clinical trials is the abundant availability of skilled personnel. Across the APAC countries, there is a wealth of highly trained professionals in various fields related to clinical research, including medical professionals, researchers, clinical trial coordinators, and support staff.

In countries like Singapore, South Korea, India, and China renowned academic institutions and research organizations produce a large pool of talented individuals equipped with the necessary knowledge and skills to conduct clinical trials effectively.
Additionally, many professionals in the APAC region have received training and education from prestigious international institutions, further enhancing their expertise in clinical research.

Advantages of having skilled personnel

The availability of skilled personnel in the APAC region offers several advantages for conducting clinical trials. Firstly, it ensures that trials are conducted with the highest standards of professionalism and adherence to regulatory requirements.
Skilled personnel are well-versed in Good Clinical Practice (GCP) guidelines and are capable of managing all aspects of the trial process, from protocol development to data analysis.
Another benefit of the availability of skilled personnel is the efficiency and speed at which clinical trials can be conducted.
With experienced professionals overseeing the trial operations, tasks such as patient recruitment, data collection, and monitoring can be carried out swiftly and accurately, accelerating the overall timeline of the trial.

Conclusion

The APAC region is at the cutting edge of the highly competitive global drug development market. Because of the above-mentioned advantages of the APAC region in executing clinical trials, sponsors can choose Asia-Pacific countries for the clinical development of their drugs with a small probability of failure.

Many of the world’s largest CROs are setting up operations in Asia to accommodate this demand. Clinical trials in the region have risen considerably in the recent decade, surpassing those in the United States and Europe.

Do you have any additional questions or concerns regarding conducting your clinical trials in the Asia-Pacific region?

Do you have any questions about conducting clinical trials, or uncertain about choosing countries for your clinical trials? Please provide your detailed requirements in the form below and connect with us to discuss your clinical trial needs.