During the 2017-2025 forecast period, the global orphan drugs market is expected to display a healthy growth rate, backed by a number of factors such as high return on investments for the development of orphan drugs, strong research and development initiatives for orphan drugs in developed countries, and increasing number of rare diseases related to genetic mutations that are treated using orphan drugs.

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In matters of competition, players in the moderately fragmented global orphan drugs market are focused on strategic acquisitions, and are focused to leverage incentives offered by governments for efforts for R&D of orphan drugs.

A report by Transparency Market Research estimates the global orphan drugs market will expand at a healthy 12.1% CAGR between 2017 and 2025, for the market to be valued at US$318.5 bn by the end of 2025.

The report studies the global orphan drugs market on the basis of disease type, product type, distribution channel, and geography. The segments of this market depending upon disease type are oncology, gastrointestinal, pulmonary, neurology, hematology, cardiovascular, metabolic disorders, endocrinology, infectious diseases, and others. Of them, in 2016, oncology led the market vis-à-vis revenue, and the segment is expected to hold on to its dominant position until the end of 2025. The strong growth of oncology disease type segment is mainly because of increasing drug approvals for treatment of rare cancers. In the European Union, for instance, the burden of cancer has been growing significantly, with 22% of all diagnosed cancer cases identified as rare cancers. The segment of metabolic disorders is expected to expand at a significant CAGR over the forecast period. The increasing number of urea cycle disorders that form a significant part of metabolic disorders account for the high growth of metabolic disorders segment.

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In terms of product type, the report divides the global orphan drugs market into biologic and non-biologic products. Vis-à-vis revenue, biologic products led the market in 2016 and is anticipated to stay dominant over the report’s forecast period. Further, the segment of biologic products is expected to display a significant CAGR over the forecast period mainly because of high efficacy of biologic products for treatment of diseases, fewer side effects, and difficulty to develop generic versions of these drugs.

On the basis of distribution channel, the global orphan drugs market has been segmented into hospital pharmacies, retail pharmacies, specialty pharmacies, and others. Hospital pharmacies led the overall market in 2016 on the basis of revenue, and the trend is anticipated to continue over the forecast period. Moreover, increasing hospitalization for the treatment of rare diseases, ease of availability of products in hospital pharmacies, and increasing referrals from physicians for hospitalization are aiding growth of the hospital distribution channel.

Geography-wise, the global orphan drugs market is segregated into North America, Europe, and Rest of the World. In 2016, North America held the leading share of the market due to various factors that include a well-established healthcare infrastructure, favorable regulations for the approval of drugs for rare diseases, drug exclusivity status received by orphan drugs, and initiatives by governmental and non-governmental agencies to raise awareness about use of orphan drugs for treatment of rare diseases. Within North America, the U.S. contributes substantially to the orphan drugs market as more than 30 million people are reported to suffer from rare diseases in the country. This calls for strong R&D for development of orphan drugs.

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Prominent names in the orphan drugs market include Novartis AG, Celgene Corporation, Pfizer Inc., Alexion Pharmaceuticals Inc., Novo Nordisk A/S, Eisai Co. Ltd., Bayer AG, Merck & Co. Inc., Biogen Inc., Amgen Inc., Bristol-Myers Squibb Company, F. Hoffmann-La Roche Ltd., Sanofi S.A., Eli Lilly and Company, AstraZeneca plc., Daiichi Sankyo Company Limited, GlaxoSmithKline plc., Johnson & Johnson, and Shire plc. among others.

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