Asia is no doubt the current healthcare hub of the world, with a share of 41.8% in global research and development (R&D) spending in 2016. Since we can all anticipate the major player in this sector is Japan, whose cost of clinical trials is even more expensive than those in the West, this time we are shifting our gear to the second tier in this continent, namely South Korea, Taiwan, India, and China. Though less mature than the mighty nation of sushi, these four countries have made significant progress and are promising candidates for increased expenditure in the upcoming decade.
According to a market research done by UNESCO, South Korea comes first in R&D spending with regard to gross domestic products (GDP) at 4.3% of GDP. Marked for its high level of technological and social development, South Korea is attracting more Phase I trials with a growth rate of 8.22% from 2011 to 2013. Since early-phase trials are only allowed in countries where the medicine is originally developed, this upward trend means that this country is making remarkable progress in researching on new drugs and therapies.
This achievement stems largely from the investment of South Korean government in an attempt to facilitate health care. Established in 1987, The Korean Drug Development Fund (KDDF) has spent approximately $2 billion on new drug research until 2010. Funds were poured in to build 15 clinical trial centers (CTCs) at teaching hospitals, with modern facilities to provide highly controlled conditions necessary to perform early-phase research. These centers are under supervision by the Korea National Enterprises for Clinical Trials (KoNECT), who is also running a training academy for professionals involved in clinical trials and a technology development fund supported by the Korean Ministry of Health and Welfare.
The country focuses its trials on treatments for cancer. From 2007 to 2013, there was a 50% increase in the number of sponsor-initiated oncology trials, while investigator-initiated ones rocketed by 640%. In 2015, Korea Herald reported that the number of approved drugs for Phase III trials was highest at 255.
Clinical trials in Taiwan are showing positive signs with a constant growth trend from 2011. Similar to South Korea, Taiwan also experienced a significant increase in the number of early-phase trials, specifically from 11 Phase I approved investigational new drugs (IND) in 2011 to 53 in 2016. As of now, 27 contract research organizations (CROs) have been present in this country, including global market players such as Parexel, Covance, and QuintilesIMS.
The government is paying serious attention to clinical research, with 134 hospitals throughout the country approved by Taiwan Food and Drug Administration (TFDA) to conduct trials. In 2005, the National Center of Excellence for Clinical Trial and Research (NCECTR) was established in answer to the growing demand for international-standard facilities. NCECTR is currently handling 600 clinical trials for new drug every year, of which more than 40 are Phase I trials. With complaints about a lengthy approval process, TFDA has shortened mean review time for INDs to 29.4 days, giving incentive to researchers to work on a wider range of drugs.
From 2004 to 2014, Taiwan has carried out 71 first-in-human trials including chemical drug (30%), biologics (17%), vaccine (14%) and cell therapy (25%). With high-quality infrastructures and skilled human resources, as well as intensive support from the government, it will come as no surprise for Taiwan to emerge as a desirable destination for both global and national early-phase trials. As a result of the 2010 agreement between TFDA and its Chinese counterpart, Taiwan is gaining considerable benefits to extend its trials’ diversity and the pharmaceutical market as well.
Accounting for 16% of the world population and 20% of global disease burden, India is now considered one of the most robust hubs for late-phase clinical trials due to its large patient pool and low cost of conducting research. What’s more, India now has the largest number of FDA-approved pharmaceutical manufacturing facilities outside the U.S, specifically 119 units.
Despite its relatively low level of technical development, its market size always guarantees its position in the second-tier in Asia. From 0.9% of the global quantity of trials in 2008, the ratio has risen to 4.9% in 2013. With a long history of medical education and medical practice, the Indian pharmaceutical market is expected to finish at $74 billion in 2020, according to reports by McKinsey and PwC.
However, 2016 witnessed a decrease in the number of drugs approved due to some concerns about quality and ethics in conducting clinical trials. It was revealed that a Human Papilloma Virus (HPV) vaccination trial in 2009 that enrolled 24,000 girls contained untransparent issues related to informed consent. Also, the Indian government testified that between 2005 and 2012, approximately 2,800 patients have died during the course of clinical trials that did not meet international standards. These alarming figures have captured special attention from the public and raised heated debate all over the world.
It is believed that the problem partly results from the complicated and unclear regulations from the government. Thus, after repeated allegations, the Indian government has reviewed and made changes to its regulations so that uncertainty and ambiguity can be cleared out.
The most populated country in the world ranked 13th globally with 5,628 commercial clinical trial sites in 2016. Its pharmaceutical market reached $108 billion in 2016, with patented drugs accounting for 22% at $23 billion. The percentage of clinical trials conducted in China has also risen from 2.2% in 2008 to 5.0% in 2013.
In a survey conducted in 2016 by Applied Clinical Trial on companies that carry out clinical trials, 41% were conducting research in China and 33% pointed to the increase in the number of trials in China in the past two years. 68% anticipated growth in this market in the foreseeable future.
Most clinical trials here are late-phase trials, with Phase III accounting for 56% while the percentage of Phase I trials is only 9%. The reason can be traced back to large and diverse patient pool with a high demand for new drugs and low cost of manufacturing and conducting trials in China. However, the remarkably small number of early-phase trials poses a challenge to the development level of expertise and facilities, as well as worries about procedure transparency and lengthy approval process. In response to the approval delays, the China Food and Drug Administration (CFDA) managed to increase review efficiency by recruiting more staff and cutting on substandard drugs, increasing the number of completed reviews in 2015 to 9,600 applications, compared with 5,260 in the previous year.
Together with North American and European markets, Asia’s pharmaceutical market in general and clinical trial market, in particular, is on the rise, with South Korea, Taiwan, India and China being the major contributors. Since governments in these countries are all paying much more attention to optimizing regulations to create the most favorable environment for clinical trials, we can look forward to even more flourish in the next ten years.
- 2016 Global R&D Spending Forecast
- Asia-Pacific Analysis: R&D spending boosts development
- Planning successful clinical trials in the APAC region
- South Korea: Sprinting Clinical Trial Development
- South Korea approved more clinical trials in 2015
- Current Status and Challenges of Cancer Clinical Trials in Korea
- Highlights of Taiwan
Sahoo, Umakanta. Clinical Research in Asia: Opportunities and Challenges. Woodhead Publishing, 2012.