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Orphan drugs are intended for the prevention and treatment of very seriousrare diseases such as chronic myeloid leukaemia, pulmonary arterialhypertension, gaucher disease and adrenal cortical carcinoma. Frost & Sullivan(http://www.pharma.frost.com) estimates that the current global market for"niche busters" is around $26.2 billion.
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"There are currently 6000-8000 known rare diseases, however treatment isavailable for only 200-300 of them," says Frost & Sullivan Programme Leader A.Shabeer Hussain. "80% of rare diseases are of genetic origin and 20% resultdue to cancer, infections and other mutations. Rare diseases often affectchildren under the age of five."
The term 'orphan drug' was originally coined because the pharmaceuticalindustry took little or no interest in discovery, development and marketing ofdrugs for rare diseases. This was mainly due to the small population ofpatients they affect, making it difficult for companies to gain a return ontheir investment. It takes more than ten years to develop and market a newdrug and it is discouraging to market orphan drugs with no significantprofits.
However, in 2000, the EU regulation act encouraged companies to enhancetheir R&D for developing drugs for rare diseases. This encouragement broughtgreat success to the orphan drugs market and more than 800 applications fororphan drugs were made. 30 companies eventually received approval to marketmore than 40 orphan drugs in the EU.
"Companies that market orphan drugs look for government benefits as wellas exclusivity rights to market the drugs," explains Hussain. "The regulationon orphan medicinal products approved 10 year market exclusivity in additionto normal patent protection. The European niche buster market is now estimatedto be around 22.0-24.0 per cent of the global market."
Rare diseases generally suffer from a lack of proper diagnosis andtreatment. However, EURODIS and other organisations are creating awareness onrare diseases and are also influencing governments to legislate for betterquality of life for sufferers.
"The EU parliament should provide more benefits like tax incentives,special status and reimbursements for these orphan drugs," Hussain says. "Thisencouragement could create a revolution amongst the pharmaceutical andbiotechnology companies for developing and marketing these drugs."
If you are interested in more information on Frost & Sullivan's upcominganalysis of European orphan drugs markets due to be published later this year,then send an e-mail to Patrick Cairns, Corporate Communications, [email protected], with your full name, company name, title, telephonenumber, company e-mail address, company website, city, state and country.Further information will be provided upon receipt of the above details.
Frost & Sullivan, the Growth Partnership Company, partners with clients toaccelerate their growth. The company's TEAM Research, Growth Consulting andGrowth Team Membership(TM) empower clients to create a growth-focused culturethat generates, evaluates and implements effective growth strategies. Frost &Sullivan employs over 45 years of experience in partnering with Global 1000companies, emerging businesses and the investment community from more than 30offices on six continents. For more information about Frost & Sullivan'sGrowth Partnerships, visit http://www.frost.com.Contact: Patrick Cairns Corporate Communications - Europe & Africa P: +27 18 468 2315 E: [email protected]
SOURCE Frost & Sullivan
