Abstract
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 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.
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