visiongain predicts by 2009 Orphan drugs will grow to be worth almost $65 billion
According to the latest visiongain report "Orphan Drugs: Future Directions for a High Growth Market 2004-2009", in 1983 there were just 10 orphan drugs available to treat rare diseases. However in the space of 20 years there are now 210 different drugs resulting in a market that is worth more than $27 billion today. The high cost of orphan drugs and lack of competition in the market means that the industry is extremely profitable for many drugs.
PR9.NET December 03, 2004 - San Francisco, CA and London, UK; visiongain According to the latest visiongain report "Orphan Drugs: Future Directions for a High Growth Market 2004-2009", in 1983 there were just 10 orphan drugs available to treat rare diseases. However in the space of 20 years there are now 210 different drugs resulting in a market that is worth more than $27 billion today. The high cost of orphan drugs and lack of competition in the market means that the industry is extremely profitable for many drugs.
In 2003, there were 9 orphan drugs that had reached Blockbuster status, but these highly successful products typically have additional indications for non-orphan diseases as well. The introduction of the Orphan Drug Act in the US has provided financial incentives for companies to develop and market drugs to target these rare diseases that affect less than 200,000 sufferers.
In terms of revenue, in 2003, this market was dominated by blood disorder, cancer and hormonal treatments, with the blood disorder treatment category alone worth more than $5.6 billion.
When the U.S. Orphan Drug Regulation was passed in 1982, the funding budget for orphan drug clinical trials was just $0.5 million. In 1983, when the Act was passed, the budget increased to $4 million. In the 21 years to 2004, this more than tripled to $13.2 million. By 2006, the total budget is expected to increase further to $25 million.
According to the FDA, as of July-end 2004, there were a total of 210 orphan drugs with active approval on the market (branded and generic), with 253 indications. Of these drugs, 49 generated significant revenue in 2003 (of $43 million each or above), appearing on the top 400 list of prescription drugs by sales. Those 49 drugs collectively carried 71 orphan indications and together generated revenue of $27149m in 2003. This represents a 14.8% increase on the sales made by the same drugs in 2002.
The visiongain report “Orphan Drugs: Future Directions for a High Growth Market 2004-2009” provides analysis on the current industry, the top ten best selling drugs in this market sector and the performance potential of newly released products. The report also analyses the profile of the key factors for success in this market area. By 2009, visiongain believes that this industry opportunity will grow to be worth almost $65 billion from the $27 billion it was worth in 2003.
To encourage more companies to develop treatments for rare diseases, the U.S. Orphan Drug Regulation was passed by Congress in 1982, and was signed into law by President Ronald Reagan on January 4, 1983. This legislation amended the U.S. Federal Food, Drug, and Cosmetic Act, and has been one of the most successful U.S. legislative actions in recent history. Although it took seven years to get the first drug to market under the scheme, by May 2004 a total of 210 drugs were available in the U.S. for rare diseases, improving the lives of an estimated 6.5m Americans. Europe launched its own orphan drug regulations in April 2000, mirroring the aims of its U.S. counterpart. In this respect, the EU was late compared to the U.S., due mainly to the partition of the European area (size of each country too small) and the dispersion of healthcare competencies. However since January 1995, with the new system of marketing authorisation by centralised procedure, the EU can be considered as one entity.
# # #
Visiongain is one of the fastest growing and most innovative independent media companies in Europe today. visiongain produce a host of business-2-business conferences, newsletters, management reports and e-zines focusing on the Financial markets, the Pharmaceutical, Telecoms industries and the Defence sector.
|Recent News Headlines
|Industry Category of Current Press Release