Orphan Drug Report 2014-2020

An orphan drug is a pharmaceutical product aimed at rare diseases or disorders. The development of orphan drugs has been financially incentivised through US law via the Orphan Drug Act of 1983. The National Organization for Rare Disorders (NORD), which was instrumental in establishing the Act, currently estimates 30 million Americans suffer from 7,000 rare diseases. Prior to the 1983 Act, 38 orphan drugs were approved. To date, 468 indication designations covering 373 drugs have been approved. 

The success of the original Orphan Drug Act in the US led to it being adopted in other key markets, most notably in Japan in 1993 and in the European Union in 2000

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