A Substantial Financial Benefit of an Orphan Designated Product
In many cases, developing a product for a rare disease means developing a product for fewer than 1000 people worldwide and in some cases, less than 100. These products are clearly not being developed for the masses, they do not expect to be “blockbuster” drugs like Humira (with sales of just over $14B in 2015) and the development is certainly not expected to be (nor will it be) a walk in the park. Getting an orphan product to the market may be done in a shorter timeframe, but the challenges of developing such therapies are often abundant and costly. Under normal market conditions, developing products intended to treat such a small number of patients would prove little interest to the industry and quite certainly would rarely happen due to low ROI.