Global Markets for Orphan Drugs
- Worldwide, the orphan drug market reached $84.9 billion in 2009. The market is expected to grow at a compound annual growth rate (CAGR) of nearly 6% to reach $112.1 billion by 2014. The U.S. accounted for 51% of the market in 2009 and is expected to grow at a CAGR of 8.9% to reach $65.9 billion by 2014.
Biologic drugs accounted for a major share (64.3%) of the orphan drug market with sales of $54.6 billion in 2009, up from $51.4 billion in 2008. The size of the biologic orphan drug market is projected to grow at a 6.9% CAGR to reach $76.2 billion by 2014.
- Orphan drugs for the cancer sector generated the largest amount of revenues, $30.6 billion in 2009, accounting for 36% of the market. Revenues for cancer-related orphan drugs are expected to grow at a CAGR of 10% to reach $49.7 billion in 2014.
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 (ODA), which was implemented in 1983, entered its 26th year in 2009. The purpose of this report is to analyze the orphan drug industry and provide market, technology, and revenue forecasts for the period 2009 to 2014. 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 2009. 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. The report also provides revenues of leading orphan products, identifies key market players with significant market shares, analyzes current and future strategies of these companies that will have an impact in the market, and, finally, analyzes the rare diseases that are being addressed by the industry and the broad therapeutic areas that these diseases represent and their future growth trends.
- An overview of orphan drug criteria, the history of the Orphan Drug Act and its influence and advantages inherent in orphan drug designation and future growth trends
- Detailed discussion of successful orphan products
- Global sales projections through 2014 for as many as 57 orphan drugs with sales exceeding $200 million
- Key players in the market and their market shares
- Detailed analysis of blockbuster orphan drugs
- Analysis of the Orphan Drug Act and its influence in the growth of the biotech industry
- The rising influence of pharmacogenomics in the orphan drug market
- A discussion of specific rare diseases for which orphan drugs exist
- Analysis of the most promising therapeutic areas in the industry and leading orphan drugs in these therapeutic areas
- An outline of legislation and regulation, including public and private agencies involved in support and development
- Technology trends analysis within the orphan drug market
- In-depth analysis of leading companies and their successful strategies within the orphan drug market segment.
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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.
The total worldwide market for orphan drugs, including sales for nonorphan applications, exceeded $28 billion in 2003.
This market is expected to rise at an AAGR (average annual growth rate) of 9.1% to reach $43.6 billion in 2008.
As a percentage of overall global drug sales, orphans are expected to increase their share from 7.0% in 2003 to 7.5% in 2008, as growth of the orphan market outpaces that of the total market.
As of mid-2003, 221 orphan drugs had been developed for the treatment of rare diseases affecting about 11 million patients.
Some orphan products have sales in excess of $1 billion annually.