Global Orphan Drug Pipeline & Regulatory Insight 2015

Rare diseases are also known as Orphan diseases. These diseases are generally categorized as chronic, degenerative, life threatening in nature and normally include certain cancers, metabolic conditions, diseases of the nervous system and musculoskeletal disorders. As per the official definition, rare diseases are classified as those that affect fewer than 200,000 in the United States and less than 5 in 10,000 in the EU. These two regions form a dominant portion of the global market for orphan drugs.

In Japan, any disease with less than 50,000 prevalent cases is defined as a rare disease. In Australia, the perspective is different. The Therapeutic Substances Regulations in Australia defines rare drugs as those which should not be intended for use in more than 2000 patients annually. In Taiwan, the official definition of rare diseases is that these diseases would be termed “rare” if the prevalence rate is 1:10,000 people. For drugs to get an orphan designation in Korea, less than 20,000 people in Korea should suffer from the disease/condition, or no other alternative treatment should be available for the disease in the country.

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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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PNS Pharma is a pioneer in offering exclusive research reports for the pharmaceuticals industry. PNS Pharma offers Syndicated Research Reports on Drug Pipeline and Company Pipeline Analysis. These reports include comprehensive information related to the development of various drugs across clinical pipeline. Further, the reports include details on the originator, Owner, License, Chemical Formula, Patent Information, Phase of development, and Phase of development by country for each specific drug. The reports on company pipeline include all the drugs developed by particular companies across different therapeutic segments and phases and in different countries.

Rajesh Arora
rajesh@pnspharma.com
PNS Pharma
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