By 2020, orphan-drugs sales are expected to total $176 billion, growing 10.5% annually from 2014, compared with 5.3% for the overall prescription drug market. Orphan drugs are forecast to account for 19% of prescription sales worldwide, excluding generics, up from 6.3% in 2000. In 2013, their sales totaled $90 billion, increasing 6.8% from 2012. Approval time by the US FDA for orphan drugs was 10.2 months, with a Phase III clinical-trial cost of $99 million. The Orphan Drug Act could provide a US tax credit, lowering the cost to $49 million. Median Phase III trial length was 2.89 years. Currently, the value of pipeline Phase III/filed orphan drugs is $86 billion, and the expected Phase III costs of bringing all orphan drugs to market is $5.8 billion. The expected return on investment is 14.9 times the investment. In 2013, orphan-drug designations increased 38% in the US, decreased 17% in Europe and decreased 17% in Japan, to 290, 124 and 30, respectively.

Source: EvaluatePharma