Dr Aimee Tharaldson: Orphan Drugs Will Remain A Lucrative, Growing Business

Orphan drugs are a very lucrative business, and Aimee Tharaldson, PharmD, senior clinical consultant of emerging therapies at Express Scripts, expects to see more orphan drugs reach market as manufacturers focus their development efforts in these areas.

Transcript (slightly modified)

In 2015, the majority of specialty drugs were approved for orphan indications. Do you see that trend continuing?

In 2015, two-thirds of the specialty drugs approved were for orphan conditions. I think that’s high. I think, going forward, we’ll maybe see that closer to half, but yes, orphan medications is really where many manufacturers are focusing their development efforts.

These medications have 7 years of patent exclusivity and other financial incentives. Obviously, they’re very expensive; they cost about $300,000 per year or more depending. So they’re very expensive medications, and actually about 30% of all orphan medications become blockbuster medications with annual sales greater than $1 billion.

It’s very lucrative for manufacturers to develop orphan drugs so yes, I think that’s going to be a continuing trend that we’ll see more and more orphan drugs reaching the market.