Orphan drugs are specific pharmaceutical agents which are developed for treatment of orphan or rare diseases. Orphan disease, according to laws of various countries, may include medical conditions which have low prevalence, i.e. affects less than 200,000 persons (U.S.), or 50,000 (Japan). Expiring patents of blockbuster drugs, drying pipelines, stringent regulations across the globe, has encouraged the pharmaceutical industries to shift the focus to a new business model that includes niche busters or orphan drugs.
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Currently, around 7,000 diseases are recognized as orphan and around 250 new diseases are added to the list every year. Orphan drug laws introduced and implemented in countries such as the U.S., Japan, Singapore, Australia, and the European Union, have stimulated the orphan drug market and shifted the focus of pharmaceutical companies towards incentives on developing orphan drugs. The orphan drugs market currently forms around six percent of the total pharmaceutical market. However, this market is expected to register double digit growth to outshine the mainstream drugs market in the near future.
Orphan drugs market will be driven by the R&D benefits or grants availed, FDA fee waiver benefits, and shorter development timelines along with favorable reimbursement, prolonged exclusivity, premium pricing and fewer hurdles for getting approval of the drug. However, the market confronts the challenge of locating or recruiting patient for trials. Nevertheless, the orphan drug market is expected to maintain a competitive edge over the traditional drug model.
Some of the major players in the orphan drug market include Pfizer, Genentech, Abbott Laboratories, Amgen, Inc., Sanofi Aventis, Janssen Biotech, Inc. among others.
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