Investigating Growth in Clinical Trials (Part 3: Growth by Geography)
Clinical research is a rapidly growing industry. But that growth looks a lot different depending on where you look. In the third and final installment of our eBook series on growth in clinical trials, we explore how regulatory reforms, shifting population profiles, and other factors have transformed certain regions into new global growth leaders in clinical research.
What Makes an Attractive Clinical Trial Destination?
In 2017, SCORR Marketing partnered with Applied Clinical Trials on a survey to understand why certain regions attract organizations conducting clinical trials. The top 4 reasons were:
Clinical trials are less expensive in some regions than others.
Differences in culture and population size can make certain regions more conducive to patient recruitment.
Organizations may conduct clinical trials in a certain country so they can be approved to sell their products in that country.
Organizations are drawn to the regions where they’re best able to conduct
their trials quickly.
The Rise of Asia
We looked at the clinical trial markets of the Asia Pacific (APAC) region, India, and the historical market-leading regions of Western Europe and the United States. Here are the major takeaways:
- The overall number of clinical trials is increasing everywhere as the industry, on the whole, steadily grows.
- That increase, however, is much higher in China, India, and Japan, giving Asia a higher market share at the expense of the Western regions.
Of all the countries we examined, the strongest growth by far has taken place in China. From 2010 to 2017, the number of clinical trials in China skyrocketed.
Total Numbers of Clinical Trials in China
During the same time period, Phase 1 clinical trials came to occupy a larger share of the total trials taking place in China, signalling an increase in the R&D pipeline and a surge of innovation.
Share of Phase 1 Trials
What’s driving China’s growth?
Numerous factors – many of which are aligned with the SCORR Marketing/Applied Clinical Trials analysis – have conspired to make China the clinical trials powerhouse it’s rapidly becoming.
- Social – China’s population of 1.4 billion and high disease incidence make it conducive to patient recruitment. The country has also expanded its insurance coverage, creating an incentive to enroll in clinical trials.
- Governmental – A 5-year extension of patent protection has enabled pharmaceutical organizations to protect their patents for 25 years.
- Economic – China’s recent economic growth has bolstered incomes, making it easier to afford medical treatment. The top 20 global pharmaceutical companies saw Chinese sales grow 18% in the first quarter of 2018 over the previous year.
Perhaps the biggest driver, however, is regulatory. The Chinese government has taken steps to harmonize its life sciences regulatory landscape with that of the global industry.
Green-lighting Phase 1 research
The government has lifted many of its previous restrictions on Phase 1 clinical trials conducted by multinational companies. With newfound access to China, where development expenses are lower, companies can reduce costs on their early-phase research.
Faster application reviews
China has signalled that clinical trial applications will be considered approved if regulators don’t respond to the application within 60 days – a comparable timeline to the US FDA’s 30-day waiting period, and a significant reduction from the previous average approval time of 200 days.
Acceptance of overseas data
Regulators now accept clinical data obtained from clinical trials outside of China, allowing organizations to eliminate the costs associated with obtaining data domestically. Previously, organizations often had to conduct entirely new trials just to obtain domestic data, incurring significant costs.
Growth-driving segments in China
Biotechnology and CART-T immunotherapy have played a major role in China’s growth as a clinical research destination.
Growth in the Chinese biotech sector has been driven by:
- Government initiatives – The government is pushing for increased output from biotech organizations, as well as for more STEM-related educational programs in China, in hopes that biotechnology will exceed 4% of GDP by 2020.
- Increased private and public funding – Investors are increasingly turning to Chinese biotech organizations. These organizations raised almost $40 billion in 2017 and $32 billion in the first half of 2018 – even as venture capital investment in other sectors slowed.
Just in the last few years, CAR-T immunotherapy clinical research – one of the biggest recent
innovations in oncology – has experienced explosive growth in China.
Number of registered CAR-T trials in China
2015: 10 Trials 2018: 120 Trials
This growth has been driven by:
- Disease prevalence – China is home to 40% of the world’s cancer patients, with 10,000 new patients a day. These conditions create great potential for oncology clinical trials.
- Demonstrated success – Immunotherapy clinical trials have yielded some high-profile success stories in utilizing patients’ immune systems to kill cancer cells. This has led to strong government support for further CAR-T research.
- Regulatory favorability – In some ways, China has a less stringent regulatory landscape than other geographies. In fact, the government is even helping to subsidize the development of 10,000 square meters of manufacturing facilities for companies conducting CAR-T trials.
India is currently surging back from a slowdown in clinical trials that started in 2013, when the country’s Health Ministry made changes that resulted in higher regulatory burdens for researchers. These changes had the following effects:
- Clinical trial approvals slowed down.
- Study sponsors faced a higher burden of subject compensation.
- The National Institutes of Health cancelled several dozen ongoing clinical trials in India, citing an unstable regulatory environment.
These factors conspired to discourage clinical researchers, both domestically and internationally, from setting up shop in India. The Indian clinical trials market, which had been growing steadily year after year, began to slow down, even experiencing negative growth starting in 2013.
In 2015, the Central Drugs Standard Control Organization introduced a number of regulatory reforms that began to reverse the slowdown and inject new life into India’s clinical trials market. These reforms had several positive effects such as:
- Permission for clinical trials to be submitted online
- Reduced timeline for approval of clinical trials
- Increased transparency through publication of clinical trial results and subject expert committee meeting minutes
Regulators also lifted some restrictions that had previously stifled the market:
- Investigators were no longer restricted to conducting a maximum of 3 simultaneous trials.
- Researchers could now conduct trials at sites of all sizes, rather than only at sites with over 50 hospital beds.
- Clinical trials no longer needed approval from the Drug Controller General of India to add new trial sites or investigators.
In the wake of these changes, India’s clinical trials market has grown significantly:
What else makes India a good trial destination?
Aside from these regulatory reforms, numerous other factors attract researchers to India. Again, these factors are largely aligned with those outlined in the SCORR Marketing/Applied Clinical Trials study:
1. Patient recruitment
India is one of the world’s most populous countries, with much of the population concentrated in urban centers and therefore easier to recruit for clinical trial participation.
2. Population profile
India has 17.7% of the world’s population, but 20% of the global disease burden. These conditions create great potential for a wide variety of clinical trials.
3. Life sciences activity
India is one of the world’s largest drug producers and has the most FDA-approved manufacturing plants outside the US. Clinical trials are about 50% less costly than in the US, and the country has a lot of talent in healthcare, IT, and data science.
It’s important not to misconstrue the explosive growth in Asia as an indication that the clinical trials market is shrinking everywhere else. Europe, for instance, continues to host some attractive clinical trial destinations, with a 19% increase in the total number of clinical trials from 2010 to 2017.
European clinical trial growth
From 2010 to 2017, France and Poland showed the strongest growth in clinical trials.
What’s driving growth in these countries?
The growth in France and Poland owes to numerous factors, including, but not limited to:
- France’s Research Tax Credit has done a lot to stoke research and development.
- France boasts significant technology expertise and many healthcare-related innovations, including in up-and-coming sectors like AI and wearables.
- France has a strong pharmaceutical industry, with tens of billions of dollars in exports each year.
- Poland has a large population, with many residents viewing clinical trial participation as an avenue for medical treatment.
- Clinical trial costs are lower in Poland than in other European countries.
- Recent regulatory changes have made it easier for pharma companies to conduct clinical trials in Poland.
An eClinical Route to Success
The globalization of the clinical research industry has changed the calculus for organizations evaluating eClinical technology. The rise of Asia, as well as the mandate for other reasons to respond to that rise, place new urgency on the adoption of certain technologies.
Taking advantage of the Asia revolution
As organizations around the globe increasingly set up clinical operations in Asia, the physical distance between site and CRO has widened. Without the right resources to bridge the gap, communications between these parties can slow down and take on new logistical hurdles. With this in mind, more organizations are investing in eSource, for example, and overcoming a number of the challenges associated with international clinical trials:
- With the ability to share data remotely in real time, it’s easier to conduct clinical trials across oceans and continents.
- By reducing the monitoring burden, eSource helps to address the common struggle to find qualified clinical trial monitors in up-and-coming regions.
How other regions respond
With cost relief as one of the strongest incentives for organizations to choose one country over another for their clinical operations, researchers in Western countries are well-positioned to make their regions more competitive by investing in cost-reducing technology. This could mean reducing study timelines and, therefore, expenses with electronic data capture, or cutting down on costly source data verification processes by investing in eSource.
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Whether by industry, therapeutic area, or geography, clinical research is changing rapidly. Adoption of the wealth of cutting-edge eClinical technology available today is the key to keeping up.