According to a report by Frost and Sullivan, global clinical trials are expected to develop at a compound annual growth rate (CAGR) of 12.4%. Its revenue is forecast to reach $57 billion by 2020, increasing from $31.8 in 2015. In the period 2015-2020, while the CRO market in North America is only expected to grow at a CAGR of 10.4%, the market in the Asia-Pacific region is forecast to flourish at 19.9%. Beside an increase in R&D activities, the crucial reason for this rapid development is a shift from Western markets to Asian ones.
Challenges in conducting clinical trials in the U.S and Europe
The U.S and European countries are nations that have the most developed clinical trials in the world, especially the U.S. Among 10 largest pharmaceutical enterprises over the world, there are 6 American companies, 2 Swiss, 1 French and 1 British agencies. However, lately, leading companies are having to deal with various challenges including patient recruitment and retention, high costs and long study duration.
An analytic report in 2013 showed that 57% trials failed due to low patient accrual rates which lead to huge financial losses. Low participation rates are one of the reasons why biopharmaceutical companies are working on the strategy to move research out of the U.S and Western Europe. A trial on Cryptococcus meningitis drug conducted on HIV patients able to recruit too few subjects in the U.S had to move to Thailand immediately to recruit more participants. Here, the research enrolled 99 patients over 5 sites. On average, that study recruited 4 patients per 1 site in Thailand while the rate was only 1 patient per 1 site in the U.S
Nowadays, the majority of European clinical trials are seeking patient resources all over the world. According to clinical data submitted to EMA from January 2005 to December 2011, 62% of subjects are enrolled outside European Economic Area and Switzerland.
A 2014 report estimated the cost of inventing a drug and getting approval to market it was $2.6 billion. Study duration and expenditure boosted up in European Union (EU) owing to a rise in insurance costs as well as increasingly pricey administrative and other resources costs. Companies need to be able to take control of cost-effectiveness and strictly measure profit potentials in each research. Conducting clinical trials at low-cost locations is one of the ways to cut down manufacturing expenditure of biopharmaceutical companies.
Long study duration
A clinical trial is a time-consuming process. Average duration from when the drug is tested to when it finally comes out to the market is about 7-8 years, whereas the whole research process can last up to 11-15 years. Meanwhile, the approval process of FDA and EMA accounts for a lot of time, even though they have put forward a priority procedure to minimize delays in carrying out clinical trials.
Another problem faced by clinical trials is that the study operation has to comply with highly complicated regulations. In the U.S and EU, apart from general standards, companies are also obliged to state and local regulations.
Such context together with increasing competition has encouraged companies to prioritize the strategy to explore new markets. The current desirable destination is Asia.
Asia – An ideal destination for clinical trials
Following the robust global commercialization that took place last decade, pharmaceutical companies expanded their business into Asian countries. Their initial goals were purely doing business: entering the market and marketing their products. However, during that time, pharmaceutical and biotechnological enterprises realized the potential patient pools that matched with Western diseases. Then, they also saw that if doctors could experience using their drugs in various clinical trial stages, the drug’s chance of success in this market could be raised.
Things started to change. Pharmaceutical companies tend to conduct trials in North America and Western Europe less since creating additional data according to requests by authorized entities will lead to a slowdown in the patient recruitment process along with a jump in spendings. Based on pharmaceutical companies’ experience, trials in Asia can generate high-quality clinical data that can answer well to the strictest regulations, while the environment here openly welcomes global clinical studies.
Asia becomes the most popular outsourcing location due to three factors: resources and capabilities, globally accepted data and cost efficiency.
Resources and capabilities
Asia has a large patient pool concentrated in crucial sites. Urban population in Asia rose from 746 million in 1950 to 3.9 billion in 2015 and is expected to reach 5 billion by 2030. Asian population accounts for 53% of global population, and by 2030, approximately 58% of urban residents will locate in this area. Besides, the increase of middle class is also highly noticeable. In 2009, the middle class in Asia accounted for 23% globally. This number is forecast to reach 59% in 2030.
Also by 2030, 4 out of 5 leading emerging markets in the world will be in Asia: China, India, Indonesia, and the Philippines. With a sharp rise in after-tax incomes and medical awareness, Asia has become a crucial consumer market, promising to bring in numerous potentials for clinical trials done by pharmaceutical companies. At the same time, large patient pools are ideal for rapid subject recruitment in clinical studies.
Government budgets for health care in Asian countries are relatively lower than those in North America and Europe (excluding Japan). Thus, the clinical trial is quite an effective way for patients to get access to new treatments and therapies.
Common disease incidence rates in Asian countries are starting to be equal or higher than those in Western countries, creating a competitive environment for trial conduct. Asia becomes a desirable destination for clinical trials, especially those from countries that are in serious shortage of patients like the U.S and Western Europe.
A lot of countries in Asia are global leaders in several treatments and therapies. Taiwan National Hospital has outstanding expertise in dealing with cardiovascular diseases. Singapore, Japan, China and South Korea are pioneers in stem cell therapies thanks to favorable regulations from governments and huge investments. Moreover, Asia has quite a lot key opinion leaders (KOLs) in various therapeutical fields, among whom are global experts in Technical Advisory Board of World Health Organization (WHO).
Globally accepted data
In Asia, the rate of EMA’s important investigations is lower than those of other regions. Critical inspections are also among the lowest. The same goes for FDA; the number of investigations in Asia is smaller than in North America. This proves high compliance level with global quality standards. In a research by one biopharmaceutical company in collaboration with Novotech, data quality in Asia-Pacific region was better than other areas by 155%. This is also the first and only region to have 100% clean data, 100% data entry without any query throughout the duration of the study.
Low administrative costs help position Asia as a desirable destination for clinical trials compared to the U.S and Western Europe. According to a research provided by Medidata Grant Managers, doctor visits, medical treatments, and procedures have the tendency to be cheaper in Asian countries.
Aside from the advantages to become an attractive destination, clinical trials in Asia also have to deal with difficulties such as complicated regulations, infrastructure, and law issues as well as linguistic and cultural barriers. Yet these challenges are being gradually handled with the attention that governments and residents are paying to health care. Asia is expected to become a robust medical research hub, with a high density of groundbreaking and large-scale clinical studies.