Given the challenges in conducting clinical trials, mainly due to increasing cost, patient recruitment and retention, and study timelines, clinical trials growth in the Asia-Pacific, or APAC, region has started outpacing that of North America and Europe. This is particularly true in China and India. The total number of clinical trials conducted in China grew at a compounded annual growth rate (CAGR) of 28% between 2010 and 2017, as compared to a 10% CAGR of the clinical trials worldwide. This growth has been particularly prominent in three segments:
1. Oncology: The number of oncology trials in China grew by 368% from 2010 to 2017, compared to 62% growth in oncology trials worldwide.
2. Immunotherapy-based CAR-T trials: With strong support from the government, CAR-T therapies are developing very rapidly in China. The number of registered CAR-T trials grew multifold from 10 at the end of 2015, to 120 trials up to September 2018, close to the 127 number of registered CAR-T trials in the United States. Most of these trials are in the early stage (Phase I or II) of clinical development. Further, some 30 Chinese companies involved in Car-T trials are building a total of more than 10,000 square meters of dedicated manufacturing facilities, mostly with the help of government subsidies.
3. Biotechnology: Government initiatives, increasing funding and other factors are driving innovation in the biotech industry, which is visible in the surge in patent applications – more than 50,000 biotech patents were submitted in 2017, up from less than 20,000 in 2010.
India is another growth market, where following a raft of regulatory initiatives since 2015, the number of clinical trials registered a year-over-year growth of 66.3% in 2017. These initiatives included the launch of the Online submission of clinical trial applications and monitoring system (OCTAMS), reduced approval timelines for clinical trials, clinical trial results being updated on the online registry, and online availability of minutes of subject expert committee meetings that have led to increased transparency in the system.
At the Root of Growth in APAC
So what’s behind this massive geographic shift? Some of it is surely explained by regulatory considerations, as countries like China have made recent regulatory reforms in an effort to accelerate research and development of new drugs and medical devices. But there’s more to it than that.
SCORR Marketing, in partnership with Applied Clinical Trials, conducted a survey in 2017 to understand the attitudes and beliefs of those in the health sciences industry as they pertain to the globalization of clinical trials. The survey examined key reasons for life sciences companies pursuing global clinical trials and the challenges they face in conducting them. Cost, patient recruitment, and study timelines are key challenges for clinical trials in North America and Western Europe. Those same factors also explained the rise of emerging markets like APAC. Emerging countries also have a greater disease variation compared to the West, where the traditional lifestyle diseases predominantly show growth. The greater disease variation in the emerging markets provides a wider scope for clinical trials.
What Conclusions Should We Draw from All This?
While the numbers paint a clear picture of Asia’s rise, sometimes it takes a real-life example to truly bring home what’s happening. And in December 2018, Chinese regulators gave us just that with their approval of a new anemia drug from AstraZeneca. It represented the first time a Big Pharma product won approval in China ahead of North America or Europe, and visibly demonstrates the increasing regulatory appeal of China as a clinical trial destination.
In light of all this, what can researchers conducting clinical trials in North America or Europe do to make their geographies as attractive as locations for clinical trials? From the regulatory perspective, the FDA has, in fact, taken recent measures to facilitate innovation, especially in medical device clinical research. But a key challenge facing the West is cost, and organizations are reckoning with how to either reduce the costs of locally-conducted clinical trials, or overcome the logistical hurdles involved with setting up shop in more affordable and flexible places like APAC.
At Medrio, we’re always thinking about this from the technological perspective. For example, as the eSource revolution takes off, it’s been fascinating to see how organizations’ ability to cut down on source data verification and other costly monitoring-related processes has led to a comprehensive reevaluation of clinical trial costs and timelines. CROs who have invested in eSource are becoming more competitive with organizations in more cost-friendly geographies as they vie for sponsor business. Those looking to lean into the APAC revolution have taken an interest in eSource for their own reasons: with real-time remote data sharing, the logistical hurdles that have historically hindered organizations in their communications with geographically dispersed sites are melting away.
The extent to which eClinical technology will affect clinical trial growth in North America or Europe, or in Asia remains to be seen. But as clinical trial technology – both in the Clinical space and in non-traditional sectors like wearables and sensors – advances, we’ll be watching the market closely.
1. WHO International Clinical Trials Registry Platform (ICTRP), October 2018
2. GLOBAL TRENDS SURVEY REPORT, SCORR Marketing and Applied Clinical Trials, August 2017.