Global Markets for Orphan Drugs

Report Highlights

• The global orphan drugs market reached $58.7 billion in 2006, growing by 8% from $54.5 billion in 2005. It is expected to grow at a compounded annual growth rate (CAGR) of 7% to reach $81.8 billion by 2011.
• Regionally, U.S. revenues in the market grew to $32.5 billion accounting for 55% of the market in 2006. The U.S. market is expected to grow at a CAGR of 8% to reach $47.8 billion by 2011.
• Biologic drugs account for over 60% of the orphan drug market with sales of $35.3 billion in 2006, up from $30.2 billion in 2005. The market size of biologic orphan drugs is projected to grow at a 9% CAGR to reach $53.4 billion by 2011.

INTRODUCTION

The orphan drug industry has come a long way since its implementation, leaving many noticeable benchmarks along the way as the U.S. Orphan Drug Act, which was implemented in 1983, entered its 24th year in 2007. The purpose of this report is to analyze the orphan drug industry and provide market, technology, and revenue forecasts for the period 2006 to 2011. The report also analyzes the influence of the orphan drug industry in the development of the biotechnology industry.

This BCC report provides an in-depth look at orphan drugs that had sales of more than $200 million in 2006. Future growth prospects of these drugs as well as the therapeutic areas of these drugs in general have been analyzed based on the market dynamics and regulatory factors. Life stories of blockbuster orphan drugs are tracked and analyzed in detail, recognizing various factors that played key roles in their success. Regional analysis of the industry in terms of current and future trends of the orphan drug market in important regions has been presented in the study. The report also provides revenues of leading orphan products, identifies key market players with significant market shares, analyzes current and future strategies of those companies that will have an impact in the market, and, finally, studies the rare diseases that are being addressed by the industry and the broad therapeutic areas that these diseases represent and their future growth trends.

This report also reviews the current and possible future legislation affecting development and marketing of orphan drugs in the U.S. and other countries and examines the influence of the Orphan Drug Act in the development of the biotech industry. The impact of developments in pharmacogenomics in the orphan drug industry is also analyzed. Finally, technology trends analysis has been presented in the report, identifying how the most prevalent technologies in the market have changed over the past decade with the advent of biotech companies and future growth trends.

SCOPE OF STUDY

This report contains:

• An overview of orphan drug criteria, the history of Orphan Drug Act and its influence and advantages inherent in orphan drug designation and future growth trends
• Detailed discussion of successful orphan products and a discussion of specific rare diseases for which orphan drugs exist
• Analysis of most promising therapeutic areas in the industry and leading orphan dugs in these therapeutic areas
• Global sales projections through 2011 for as many as 50 orphan drugs with sales exceeding $200 million
• Profiles of key players in the market and their market shares
• Technology trends analysis within orphan drugs market

METHODOLOGY

The base year of this study is 2006. Market figures are based on revenues at the manufacturer level and are projected at 2006 dollar values (i.e., inflation is not computed into the projection figures). Forecasts are mainly based on the projections of the marketers. Growth of competing drugs, patient population, patent and market exclusivity status, and lifecycle management strategies adopted by marketers have also been considered for estimating the future growth trends.

Data to prepare this study were derived from regulatory agencies, trade literature, patient support groups, and annual reports of companies and industry-related databases. In addition, discussion with product managers of pharmaceutical companies, research executives, academic researchers, government agency spokespersons, and directors of organizations focused on specific rare diseases have been conducted for gaining insights about the market, strategies, and future trends.

INFORMATION SOURCES

The information and analysis presented in this report are based on an extensive survey of the pharmaceutical industry as well as a detailed examination of published literature and reports obtained from regulatory authorities, medical research institutions, pharmaceutical trade associations, and national and world health organizations. Key information from the literature was used to obtain expert opinion on commercial potential and market sizes from industry professionals.

ANALYST CREDENTIALS

Syamala Ariyanchira was involved in chemical and pharmaceutical research for 7 years in India in companies, such as Chembiotech Research International, as research scientist and ICI as head of the Analytical Department. She has also worked in an academic research institute, and guided students in their Masters and Ph.D. programs at the University Malaya, Malaysia. For the past 4 years, she has been actively involved in industry analysis. She has worked as program manager with Frost & Sullivan, where she conducted many global market analyses of specialized market segments and several due diligence studies for multinational clients. She has also conducted technology foresight studies for government and private investors in the biotechnology sector. She has a Ph.D. in Chemistry from the Indian Institute of Science and post-doctoral experience in biophysics and molecular biology from Bose Institute, India.