Globally clinical trials are expected to grow at a compound annual growth rate (CAGR) of 12.4 percent to reach USD57 billion in revenue in 2020 from USD31.8 billion in 2015. During 2015-2020, while the CRO market in North America is expected to grow at 10.4 percent CAGR, the Asia Pacific CRO market is forecasted to grow at a CAGR of 19.9 percent. The key drivers for this growth are increased R&D activity and shift toward outsourcing. More than three-quarters of R&D spending by biotechnology and pharmaceutical companies can be potentially outsourced. There is a significant increase in the CRO market, through increased outsourcing alone with penetration expected to increase from 29 percent in 2015 to 43 percent in 2020. Asian growth is expected to be even higher as clinical trial penetration in Asia in 2015 was even lower than the global penetration, at around 15 percent.
Asia is well positioned to become a preferred destination for clinical trials, due to number of attractive traits that include:
- Availability of treatment-naive patients for speedy recruitment: A pool of approximately 4.0 billion people, with more than 2.0 billion in easily accessible urban areas.
- Worldwide accepted data quality: The percentage of EMA critical findings and US FDA official actions taken during inspections are lower in Asia than North America, reflecting high quality of international compliance.
- Attractiveness of trials to patients: Per capita government spending on healthcare in Asian countries is lower than in the US and Western Europe. This creates opportunity for clinical trials to be an effective way for Asian patients to get access to innovative therapies.
- Western disease patterns: Asian countries show similar disease patterns for major diseases to Western nations, providing a comparable environment to conduct clinical trials. Some pockets of high incidence may provide advantages in certain therapeutic areas.
- High quality infrastructure: Numerous specialized clinical trial centers boast state-of-theart equipment and advanced technology. Fast-growing Asian economies are leapfrogging the traditional path of enhancing legacy information technology (IT) systems and are at the forefront of innovation.
- Cost: Asia offers lower costs for clinical trials. For example, costs in China and India are 25% to 40% lower than that of Western countries.
Key Challenges of Conducting Clinical Trials in The United States and Western Europe
Broadly, the primary barriers to conducting clinical trials in the US and Western Europe involve challenges in participant recruitment and retention, resulting in longer lead times and high costs. Finding qualified and experienced investigators and key opinion leaders (KOLs) add to the already lengthy trial times.
Recruiting and Retaining Patients
Failure to meet patient numbers or timelines can delay product launch. A 2013 analysis found that almost 57 percent of trials fail due to low patient accrual rates that could translate into huge financial losses. Racial and ethnic minorities, women, and the elderly often are underrepresented in enrollments. For example, a study found that only 25 percent of elderly cancer patients enroll in trials, although they account for 63 percent of new cancer cases. Low participation has encouraged more biopharmaceutical companies to pursue clinical trials beyond the US and Western Europe. A study of 24 cardiac trials in the US found that 19 trials, with a total of more than 151,000 patients, included international participation. One trial for HIV-associated cryptococcal meningitis recognized low US patient enrollment and subsequently added Thailand as a trial site, where it recruited 99 patients in 5 sites. The trial added an average of 4 patients per site in Thailand over 3 months compared with 1 per site in the United States. According to EMA clinical trial data submitted between January 2005 and December 2011, 62 percent of patients were recruited from outside the European Economic Area and Switzerland.
High Costs
A 2014 study estimated the cost of developing a prescription drug and gaining market approval at USD2.6 billion. The time and costs associated with conducting trials in the European Union have grown significantly due to higher insurance fees and increased admi...
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