Tufts Researchers Find Difficulties of First-in-Class Drugmakers to Establish Themselves

It is well-known that pharmaceuticals and biologics are tough, competitive fields. New analysis from the Tufts Center for the Study of Drug Development demonstrates just how competitive those fields are.

According to Tufts researchers, companies developing first-in-class drugs have very little time to establish themselves once they are ready to hit the market, as nearly all subsequent entrants either have begun clinical testing or have their products under FDA review.

The analysis finds that 83 percent of all later-in-class drugs had at least initiated Phase 2 clinical testing somewhere in the world prior to U.S. marketing approval for the first-in-class drug. In addition, all later-in-class drugs had a patent filed somewhere in the world before the pioneer product’s approval.