Transforming Asia’s Clinical Research – Opportunities and Challenges

pexels-photo-159924 (1)

Asia’s Clinical Research is showing the rapidly transforming in both of market size, investment and transitioning in resources. 

Asia – An emerging market in Clinical Research industry

According to PWC’s report (2012), the global pharmaceutical market is estimated to grow at a compound annual growth rate ( CAGR ) of 5,9%  during 2011 -2020 and reach to 1,6 trillion in 2020. The Analysis from the same source  also forecast that while developed markets such as EU-Big 5 ( including France, Germany, Spain, Italy and the United Kingdom) will grow at a CAGR of -0,6%  from 2011-2020, USA will grow at CAGR of 2,6%, the emerging market (China, Russia, Brazil, Mexico, Turkey, Poland, India, Venezuela, Argentina, South Africa, Indonesia, Thailand, Romania, Egypt, Ukraine, Pakistan and Vietnam will grow at a CAGR of 10%. Developing new medical therapies now is much more competitive so clinical research becomes one of the most concern and more complex. Considering the huge population base in Asian countries,  the region offers huge value propositions for pharmaceutical companies to undertake clinical trials and market their products in Asian countries.

In fact, according to Data monitor ( 22 July 2008), almost 90 percent of clinical trials experience the unexpected delay, with recruitment being the number one reason for the delays. With rapid and easy patient recruitment supported by an enormous pool of potential patients exposed to few or no medications, Asia offers significant cost-effectiveness. Not only the cost for trial-related test and procedures in Asian hospital comparative cheaper than USA and Europe, but the per capital cost (ex the investigator fee) is also lower due to the comparatively low cost of living and base salary. Its process in Asia also brings operational efficiencies including ease of timely regulatory approval, advancement in infrastructure and technology and the ultimate aim of marketing product in the region. Hence, Moving clinical research to Asia could help pharma companies improving speed to market and gaining much more profits. And as a result, Asia is becoming to be the ideal destination and recognized as a hub for clinical trial activities.

Asia is becoming the idealist place for clinical research

Asia is becoming the idealist place for clinical research

Various segmentation in Asia’s clinical research

Due to developing indexes, clinical research market in Asia can be divided into three tiers.

The first tier in the country segmentation analysis is Japan, which is a mature developed pharmaceutical market. Japan is very intensive with respect to research quality, as the medical community is very inclusive and conservative. Clinical research in Japan is approached slightly differently, being more resource-focused and hence more expensive in comparison with the trial in the West. As Japan is a significant pharmaceutical market, more and more companies are now entering the country. The need for global and local trials has increased. Japanese company have started looking at selectively accepting data from other countries with a similar racial profile and have broadened their country-focused clinical trial initiatives to adopt a globalised approach.

The second tier includes India, China, Taiwan and South Korea. India and China offer a great advantage for clinical research due to the sheer size of the population base. Some 37 percent of the global population live in these two countries. Nonetheless, in terms of global industry-sponsored trials, South Korea and Taiwan have performed extremely well in comparison with India and China. Patient recruitment in these countries is quite rapid, which significantly reduces the cost of drug development in comparison with Japan and Western countries. The countries in this tier offer the significant advantage of the resources they provide are rigorously tested and comparatively cheaper. A high level of quality research is performed in these countries, and their economies are growing consistently, making them a highly significant market for the pharmaceutical industry.

The third tier includes Singapore, Malaysia, Hong Kong, Thailand, Vietnam, the Philippines and Thailand. As a central location with very well developed infrastructure and connectivity, Singapore is perceived as another hub of clinical research activities. Many pharma companies and CROs have their Asian headquarters in Singapore. The other countries in this tier are catching up with the other Asian countries with good quality clinical research at a significantly lower cost.

SWOT analysis – Challenges and Opportunities of Clinical Research in Asia

But everything has advantages and disadvantages, Asia market really has many opportunities to be idealist destination for clinical research but it also encounters not little challenges. We can see the SWOT analysis of this market in the table below.

Strengths

  • Huge treatment-naïve patient population across all disease profiles
  • High enrolment rates (2–5 times higher than the USA and Western Europe)
  • Predominantly clinical research hub for extended Phase II and Phase III programs for new chemical entities and volunteer studies (bio-analytical and bioequivalence studies) for marketed generic drugs
  • Large, well-qualified, young and English-speaking resource base
  • Highly-qualified and Western-educated doctors practicing modern advanced medicines who are inclined to work in global clinical trials
  • Cost-effectiveness – low per patient cost due to comparatively low investigator fees and cheaper tests and procedures
  • Most Asian countries have brought their national good clinical practice recommendations in line with global standards, namely the International Conference on Harmonisation Guidelines for Good Clinical Practice (ICH-GCP)
  • Government initiatives have helped to improve good clinical practice awareness; for example the Chinese government helped establish good clinical practice centers to provide training to investigators and staff, while the Indian government offered similar training programs to site staff and ethics committee members
  • Recently adopted intellectual property protection and patent laws to win the confidence of global sponsors with respect to confidentiality and data exclusivity
  • Strong IT background, secured leased line and VPN connectivity facilitate easy data transfer
  • Committed and cost-effective workforce Substantial presence of pharma multinationals in major Asian countries
  • Initial positive feedback on data quality during US FDA inspections

Weakths

  • Cultural factors such as illiteracy, differences in the practice of medicine and socio-economic conditions pose inherent weakness in the system
  • Regulatory differences across countries may impact timing and cost of clinical trials
  • Regulatory systems across Asian countries are not harmonized
  • Hospital infrastructure is not standardized
  • Multiple countries and the large number of languages form a critical operational barrier – data often recorded in local languages need translation into English and vice versa
  • Mandatory toxicology tests after Phase II completion require six-month delay before start of Phase III
  • Coordination with local physicians and hospitals is mandatory as some hospitals and investigators are very capable but do not have enough experience
  • Investigators are less experienced with ICH-GCP and global standards and hence site operations are not efficiency
  • Phase I tests/first-in-man studies are not allowed for drugs that have not originated in India
  • Asian countries are not ready to undertake Phase 0/Phase I programs due to lack of expertise and infrastructure
  • Clinical research is limited to large cities and large hospitals
  • Lack of central institutional review board; some areas have no organized institutional review board process
  • Each country has its own process for systems and permits, which are very difficult to standardize; this requires substantial resources for pharma companies/CROs/vendors
  • Cost advantage eroding due to competition increased investigator expectations and rising salary costs
  • Higher attrition rates; poaching leads to loss of knowledge and quality outcome
  • Unrealistic career expectations regarding rapid promotions and salary growth

Opportunities

  • Some Asian countries are expected to be significant players in the global commercial pharma market in the next five years
  • The growing drug market is also a reason for conducting clinical trials in China and India
  • Strong overall economic growth will lead to improvements in general and healthcare infrastructure
  • The increased number of CROs and other service providers will help pharma companies increase manufacturing and testing in India
  • Expanding private health insurance services is also a consideration for conducting clinical trials in many countries in Asia
  • Expansion in early-phase capabilities (Phase 0 and Phase I) with the growth of the business
  • More and more late-phase (Phase IV studies) will be conducted as new drugs become affordable for the Asian public at large and pharmacovigilance resources and capabilities are in place
  • Opportunities for high-end CRO services, consulting and business solutions, new areas of research possible based on increased domain knowledge over time

Challenges

  • Limited enforcement of intellectual property protection and the legacy of reverse engineering is a dragging force, being watched globally
  • Bureaucracy and government regulations require trials to be approved, with drug import licenses required for every shipment
  • Ethnicity in Asia may impact trial results due to different metabolic rates and other genetic effects
  • Differences in the practice of medicine may impact trial results or affect trial execution
  • Perception of political instability and other geopolitical risks may jeopardize investments in clinical research
  • Limited local R&D initiatives by local pharma companies
  • Overdependence on US pharma companies for clinical trial outsourcing
  • Growing resistance to outsourcing from the USA
  • Talent availability not in sync with growth potential, leading to growth of low-end labor-intensive work
  • Media sensitivity and misleading messages
  • Exchange rate fluctuation
  • Competition from IT/IT-enabled services in the life-science domain acts as a potential threat for the CRO industry in As

References:

  • Clinical research in Asia Opportunities and challenges – Umakanta Sahoo – Published by Woodhead Publishing Limited, 2012
  • Pwc Report – From vision to decision Pharma 2020 – Published by Pwc 2012