Are new drug classes expected to address the considerable unmet need?
Crohn’s disease (CD) is a chronic gastrointestinal inflammatory disorder affecting over 1 million people in the major markets in our study, with a sizable market opportunity. TNF-α inhibitors infliximab (Janssen/Merck/Mitsubishi Tanabe’s Remicade) and adalimumab (AbbVie/Eisai’s Humira) dominate the biologics market space; however, this market will be increasingly competitive, starting with the recent launch of a new agent, vedolizumab (Takeda’s Entyvio). Significant opportunity exists for emerging therapies to differentiate themselves by addressing important unmet needs such as increased benefit to induction of remission and maintenance of clinical remission (without corticosteroids), achieving mucosal healing, and/or providing a more-convenient delivery formulation (i.e., oral). Several compounds in new drug classes currently in clinical development show promise in some of these areas but will also need to demonstrate safety profiles comparable to or better than TNF-α inhibitors to experience significant uptake.