US FDA Approved Orphan Drugs Clinical Trials Insight

Release Date: 27-Jul-2023

US Orphan Drugs Market and Clinical Trials Insight 2028 Report Highlights:



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The FDA orphan drug designation was introduced in the US pharmaceutical market as part of the Orphan Drug Act passed in 1983. The designation aims to grant special benefits to drugs with the designation to encourage the development of therapeutics for rare and orphan diseases. So far, 6530 compounds have received the designation and 1151 of these have received marketing approval from the FDA, demonstrating the success of the orphan drug designation. Though these a range of diseases and disorders, the only cover a small percentage of all rare disease, which calls for further research and development activities in order to address the unmet medical needs of the growing rare diseases patient population.


This has resulted in increasing overall market value of the orphan drugs market, which was valued at around US$ 100 Billion in 2022, and is expected to grow up to US$ 180 Billion by 2028. Our report provides information about orphan designated-drugs in the US market, along with their prices and sales to give an insight of the ever-growing orphan drugs market of the region, supported by the FDA orphan drug designation.


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