Clinical Research in Asia

Opportunities and Challenges

U Sahoo

• Publisher: Woodhead Publishing
• Year: 2012
• Print ISBN: 9781907568008
• eBook ISBN: 9781908818133
• Topic: Medicina
• Subtopic: Farmacología

Asia is increasingly taking on a leading role in the fields of Good Clinical Practice (GCP) and ethics, two areas that are central to clinical research practices worldwide. Clinical research in Asia examines the evolution of these key sectors in the Asian countries where the greatest developments are taking place, offering valuable perspectives on a wide range of issues affecting clinical research. Following an introduction that provides an overview of the topic and its strengths and weaknesses, each chapter of the book is devoted to clinical research in a specific country, focusing on issues including the history and evolution of clinical research, clinical trials and regulatory aspects. The chapters also offer a perspective on future trends in clinical research in each country. The book concludes with a discussion of the importance of political, economic, socio-cultural, technological, legal and environmental factors (PESTLE analysis). - Analysis from a leading and highly respected professional in the sector - An overview of country-specific regulatory environments - Discussion of challenges and solutions for clinical research

1

Clinical research in Asia: a brief overview

Abstract:

Starting with a brief background of the drug development cycle, Chapter 1 delves into the global pharmaceutical market and key global pharmaceutical players in terms of market size and their clinical research initiatives. This chapter briefly discusses the clinical research business, the global market and key players and contract research organisations (CROs). It further narrows down to describe the clinical research boom and key players in Asia and undertakes a country segmentation analysis of Asia. This chapter summarises the number of trials undertaken in Asia, inspections and audits performed in Asia and outlines a SWOT analysis.

1.1 Background

Clinical research forms the backbone of new product development in pharmaceutical business. It involves the testing of new drugs or new chemical entities for safety and efficacy in human beings and could pose risks to human life. It is always based on scientific rationale and highly regulated by government bodies. Clinical trials for a drug can cost up to $1 billion and can take as long as 12 years from discovery phase to marketing phase (Figure 1.1).

Figure 1.1 Drug development life-cycle

Until recently, most new pharmaceutical products were due largely to the sincere efforts and investments of the global pharma companies. Most of these companies have invested a lot of time and money to undertake clinical studies in the USA and Western Europe. Their success is due to increased public awareness for research and development, driven by relevant expertise among government bodies to implement regulations to protect the interests of human subjects. These regulations also safeguard the commercial interests of the pharma companies in terms of protecting their intellectual property.

1.2 Global pharmaceutical market

According to IMS Report, the global pharmaceutical market is presently worth $808 billion, and is estimated to grow at a compound annual growth rate (CAGR) of 5–8 per cent during 2009–14. The same analysis also forecasts that while developed markets such as the USA, Europe and Japan will grow at a CAGR of 2–6 per cent, the emerging countries of Asia, Africa, Australia and Latin America will grow at a CAGR of 12–15 per cent (Table 1.1).

Table 1.1

Global pharmaceutical market analysis

Source: IMS Health Market Prognosis, March 2010

Despite the similarity in environmental and disease traits, there are striking differences between the various Asian countries as far as pharmaceutical market size and health expenditure are concerned; this is primarily due to differences in regulatory and business environments. Table 1.2 highlights these differences across the Asian countries. Note that the Japanese and Chinese pharmaceutical markets are huge and hence attract significant investment.

Table 1.2

Pharmaceutical market size in select Asian countries

Country	Market size ($)
Japan	60bn
China	20bn
India	6bn
Taiwan	2.5bn
Hong Kong	1.5bn
Thailand	1.5bn
Singapore	400 m
Indonesia	350 m
Philippines	300 m
Malaysia	210 m

Source: World Bank, World Development Indicators 2006

Again, per capita health expenditure between different countries in Asia varies significantly, from $27 in India to $2,662 in Japan (Table 1.3). 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.

Table 1.3

Health expenditure in select Asian countries

Source: World Bank, World Development Indicators 2006

Global pharmaceutical players contribute significantly in providing healthcare medicine for mankind. From Table 1.4 it is evident that the main multinational pharma companies have a robust product portfolio that yields a huge sales revenue. These companies invest large sums of money in research and development. Their objective is to develop new drugs and devices to fight advanced chronic or rare diseases. In the process, pharmaceutical and biotech companies undertake a number of trials to prove not only that their products are safe, but also that they are more efficacious than what exists in the market already. These trials are undertaken in preclinical and clinical phases from Phase I to IV, which is time-consuming and very cost-intensive. As shown in Table 1.4, these 15 global pharmaceutical players were und...

Table of contents

• Cover image
• Title page
• Table of Contents
• Dedication
• Copyright
• List of figures and table
• Acknowledgments
• List of abbreviations
• Preface
• About the author
• Chapter 1: Clinical research in Asia: a brief overview
• Chapter 2: Clinical research in Japan
• Chapter 3: Clinical research in India
• Chapter 4: Clinical research in China
• Chapter 5: Clinical research in South Korea
• Chapter 6: Clinical research in Taiwan
• Chapter 7: Clinical research in Singapore
• Chapter 8: Clinical research in Thailand
• Chapter 9: Clinical research in Malaysia
• Chapter 10: Clinical research in Hong Kong
• Chapter 11: Clinical research in the Philippines, Indonesia Vietnam
• Chapter 12: Conclusions
• Bibliography
• Index