Owing to the pharmaceutical companies' inadequate interest in this category of drugs, the term "orphan" was coined for drugs targeted to treat rare diseases. Almost 222 orphan designated drugs in US and 132 in Europe are marketed till date. However, in spite of the increased efforts in this market, there is still a shortage in the number of treatments for most rare disease indications. Thus, the market for rare diseases in the United States, Europe and other regions continue to offer significant potential for growth owing to enormous unmet medical need.
Globally, there was a desire to address the unmet treatment needs of orphan diseases, which transformed into the 1983 U.S. Orphan Drug Act, as well as similar Acts in 1991 in Singapore, 1993 in Japan, 1997 in Australia and in 2000 by the European Union.The introduction of these acts, along with high-profile philanthropic funding, has made orphan diseases an attractive segment and encouraged investment in R&D for a number of these destructive conditions.
Historically, the development of 70-75% of orphan drugs was mostly in the realm of smaller biotechnology and specialty pharmaceutical companies, and the remaining 25-30% of the orphan drugs were developed by the pharma giants. However, in the past decade, the share of pharma giants in the orphan drug approvals has increased to close to 40-45%.
The US and European region are the major markets for orphan drugs. It is in these two regions that the popularity of these drugs and diseases is increasing rapidly. The US alone accounts for a dominating share of 55%-60% in the global pie, followed by Europe. As the Asian pharmaceutical markets are still in nascent stage, there opportunities for orphan drugs in Asia are also immense and getting increasingly popular. It is expected that by 2017-18, the Asian orphan drugs market would witness steady growth.
"Global Orphan Drug Pipeline & Regulatory Insight 2015" Report Highlights & Findings:
Global Orphan Drug Market Overview
In-depth Insight on Regulatory Framework & for Orphan Drugs by Region
Orphan Drug Designation Criteria & Reimbursement Policy by Region
Comprehensive Insight on Global Orphan Drug Clinical Pipeline
Europe Orphan Drug Clinical Pipeline: 697 Drugs
Majority Orphan Designated Drugs in Phase-II : 249
Globally Marketed Orphan Drugs: 274
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