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Legislative Benefits and Unmet Needs to Drive the Market for Orphan Drugs, According to a New Report by Global Industry Analysts, Inc.
Date:9/4/2013

environment for drug development. With austerity emerging as the buzzword, orphan drugs which command high prices and also full reimbursement owing to lack of alternate therapies, are expected to come under pressure as reimbursement policies are reviewed and revised. Orphan drugs with some kind of alternatives, and/or prevalent off-label use are expected to be among the first to face the prospects of revision of reimbursement rates.

Breakthroughs in the field of biotechnology are expected to improve understanding of rare diseases and assist development of novel therapies. Further, the numerous collaborative research programs across the US and Europe, intended to improve patient access to appropriate medical care and support provide manufacturers, healthcare experts and patients with epidemiological research data on the disease. This trend will result in greater awareness among patients over available treatment options. Improved awareness of rare diseases and therapies available is expected to drive demand for orphan drugs. Biological Orphan Drugs represents the largest market segment with growth led by high prices of biological drugs and the ability of such drugs to target specific sites. Moreover, with about 80% orphan diseases being genetic in nature, these drugs are best suited for targeted therapies.

As stated by the new market research report on Orphan Drugs, the United States and Europe, which have well established regulatory as well as reimbursement frameworks, represent the largest markets worldwide. The rise in interest of major pharmaceutical companies driven by the incentives offered by the US Food and Drug Administration (FDA) as well as the European Medicines Evaluation Agency (EMA), and European Commission,
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