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  • jimcasey76 jimcasey76 Oct 6, 2013 9:56 PM Flag

    the advantages of orphan drug development

    Economically Feasible – Shorter Development Timelines

    Investing in orphan drugs is at least as economically feasible as non-orphan pharmaceutical drug development due to the higher rates of approval and the shorter development times. For instance, the chances of approval for orphan drugs is very high, at 82 percent, compared to non-orphan drugs, at just 35 percent. Additionally, the time taken from Phase II to market is often shorter due to both smaller clinical trials and to the FDA Fast Track designation. On average, the timeline for orphan drugs is 3.9 years while traditional drugs typically take 5.4 years to reach the market.

    With new orphan diseases being discovered every week, the potential for pharmaceutical drug development in this area is huge. While initially the market for these drugs may appear small, this is more than counterbalanced by the revenue opportunities and the quick time-to-market.