Pharma and biotech companies are attempting to combat escalating R&D costs and lengthy clinical trial timelines by improving patient recruitment and the efficiency of clinical trial analysis/reporting. The biopharmaceutical market has recognized the opportunities and advantages that exist by conducting clinical trials in emerging markets. Although these markets offer a number of significant benefits over traditional clinical trial settings, there remain a variety of challenges and problems associated with conducting trials in emerging regions.

This report provides a comprehensive examination of the clinical trial landscape in emerging countries, with specific focus on China, India, Central and Eastern Europe and Latin America. It identifies the major drivers and barriers to conducting clinical trials in emerging regions and profiles key issues for consideration when selecting a trial site. For each featured region, this report provides an assessment of pharma market dynamics, the heathcare system and CRO-related infrastructure, leading CROs established within the region and the regulatory and legislative frameworks that govern the conduct of clinical trials.

Key Findings:

Russia is one of the world leaders in patient enrollment - the average patient recruitment rate in 2006 exceeded 4.7 patients per site per month. For some nosologies, this figure is 10 times higher than in Western Europe and the US.

The Chinese Clinical Trial Register (CHiCTR) and The Clinical Trials Registry in India (CTRI) have helped to encourage all clinical trials in these regions to be registered before the enrolment of the first participant, and to disclose the mandatory 20 items of the WHO International Clinical Trials Registry Platform (ICTRP) dataset.

By the end of May 2009, 895 clinical trials were registered in India. By comparison in 2006, 150 clinical trials had been approved by the Drug Controller of India (DCI).

India is able to offer significant cost savings compared with conducting clinical trials in western countries. Phase I trials are approximately 50% cheaper than western equivalents, while Phase II and Phase III are 60% less expensive.

The Chinese CRO market was valued at $250m in 2008. The market is expected to grow at a CAGR of 33% over the next four years to reach $791m in 2012. By that time, Chinese CROs will account for an estimated 2.3% of the global CRO market.

China’s IP protections systems still have a number of serious flaws, despite attempts to conform with international IP protection standards through amendments of the Patent Law and restriction of product approvals by the SFDA.

The number of clinical trials in Brazil has increased from 9 in 2000, to 1177 by 2008. In Argentina the number of trials has risen from 6 to 801 over the same period, while Mexico has witnessed an increase from 63 to 2014.

The costs of conducting clinical trials in Latin America vary from substantially less expensive than the US to slightly more expensive. In recent trials, the cost per patient for Latin America has varied from savings of 50% to relative cost increases against US per patient costs.

The value of the Polish clinical trial market for Phase I to Phase IV clinical trials and bioequivalence studies has been estimated to be worth K167m ($224m) in 2008, having increased in value by 10% from the

Use this report to:

Assess the viability of key emerging clinical trial locations including China, India, Eastern Europe and Latin America by analyzing each region based on:

- Pharma market dynamics
- Drivers of CRO market growth
- Barriers to CRO market growth
- Healthcare systems and hospital resources
- Related regulation and legislation

Examine the phases of the clinical trial process with analysis of clinical trial protocols, related ethical issues, clinical trial study design and planning, patient identification and recruitment, and the influence of regulatory authorities and agencies.

Understand how new technology platforms are enhancing clincial trial effectiveness and identify the issues and challenges associated with these innovations.

Analyze the major market drivers and barriers for clinical trials in emerging markets with analysis of the key benefits and challenges associated with trial sites in emerging countries and the key considerations for site selection.

Table of Contents



287 pages

Publication Date : June 2009