The Asian clinical trial market is expanding rapidly and has now become the main go-to destination for pharmaceutical companies, who are looking to outsource their clinical trials. A large treatment naïve population, together with friendly market reforms and as a region with a high disease burden, it has made Asia a preferred choice today, than the Western nations. As the clinical trial penetration in the region is lower compared to the United States, the process of recruitment is much faster here. 

The revenue for contract research organisations is expected to seek a hike of 20% compound annual growth rate (CAGR) till 2021 in the Asian region, while the rest of the world lies at 11.4% CAGR. The pharmaceutical giants are facing stiff competition in the USA market, with high product pricing and slow recruitment. These factors have sent waves of uncertainty in the US clinical research industry. The pharma companies are eyeing on the Asian nations now, like China, India, Malaysia, Taiwan and Thailand to progress in their ventures. 

Why Asia is so Popular?

• Large pool of treatment naïve patients : Asia has a large, easily accessible population who are treatment naïve, a good example is China with the largest global population crossing 1.3 billion people with 15 megacities crossing 10 million people. It is a country with a high aged population and the Chinese population is expected to be burdened with chronic related diseases due to changes in their lifestyle. The other Asian nations such as Malaysia, Korea and Taiwan have great opportunities for conducting clinical trials too. The incidence of disease is similar or higher in certain therapeutic areas, in Asian populations compared to the West. Stroke , lung cancer and hepatitis is higher in this region, making it hard to ignore when conducting clinical trials. The patient population in these countries have limited health insurance, the facilities at the government hospitals too are limited as well. Thus, clinical trials are, a great way to avail the latest novel therapies for the people in these nations. 

• Harmonised and Favourable Regulatory Framework : To streamline the regulatory processes, the ICH and non-ICH member countries have collectively streamlined the clinical trial processes, which have helped in harmonising the clinical trials in the Asian region. With the increase in multi-regional clinical trials, many processes have been put in place to fast – track regulatory processes. Japan is a top choice to release new drugs offering a conducive atmosphere for regenerative medicine and specialised orphan diseases. 
• A Rapidly Growing Pharmaceutical Market : The pharmaceutical market of Asia is growing on a rapid scale. A growing middle income level population, aging individuals and friendly market reforms make it a great choice to invest in. The pharmaceutical sales is expected to reach 30% of the global sales, making it an important source of revenue generation. A pharmaceutical industry shift is seen, as the business model is evolving to survive in the tightly regulated competitive market. 

The development in infrastructure with specialised clinical trial centres using modern equipment and well documented data of individuals has helped the growth of clinical trial industry in Asia. Advancement in information technology and electronic systems have played a role in the growth of clinical trial sites. Asia offers a lower cost too, with China offering rates 25% less than the Western Nations. A WHO organisation database study has shown, that the number of registered clinical trials in Asia has increased in the decade 2008 to 2017. This period recorded a total of 125,918 registered trials, which is a 7 fold increase. Japan had a 30.8% increase in registration of clinical trials while China too had recorded a 21.3% registration increase (Ali, Egunsola, Babar & Hasan, 2019).

The pharmaceutical companies have been forced to look into new options due to the low subject participation in saturated USA sites, costing them immensely. A good example was the low participation in USA sites, for a trial conducted for the treatment of HIV associated Crypto-coccal meningitis. This trial was conducted as an international collaboration between the USA and Thailand. The trial gained steeper recruitment when Thailand opened new 5 sites which was able to recruit 4 patients on average per site over a period of 3 months successfully, compared to just 1 patient in USA. A total of 99 patients were recruited from Thailand for the study. Thus, this multicentre study allowed rapid recruitment with reduced costs. Thailand maintained quality metrics which were similar or better to those of USA. 

Asia is evolving fast, but there are also challenges to come over in their journey to success. Certain Asian countries will take a while before they keep pace with the industry’s global standards especially in good laboratory practices. To sustain growth on the long term, it is important to have qualified and well trained researchers and technicians who could support the success in the industry. The doctors working in the clinical trial industry might not always have adequate knowledge on biological sample handling and transport to meet IATA requirements in this region. Inaccurate packaging could delay samples and make them invalid for testing. Asia needs to be watchful of these factors. 

The dynamic pharmaceutical industry is now taking a new shape and Asia is making a mark on the global map as the go-to destination for clinical trial conduct. Facilitated by a large pool of patients with similar disease burden than West and lower operational costs, Asia has become a destination which is hard to ignore. 

To Know more about Clinical Trial in Asia, please reach out to imran@3h-ms.co.jp