Ulcerative Colitis | Unmet Need | US/EU | 2020

The moderate to severe ulcerative colitis (UC) drug market still offers substantial opportunity for companies that can address the remaining unmet needs in this patient population. The TNF-α inhibitors (e.g., Janssen’s Remicade, AbbVie’s Humira, biosimilars of both drugs, where available) are the mainstay of biological treatment for moderate to severe UC. However, these agents carry safety risks and have efficacy limitations. Takeda’s Entyvio (a CAM inhibitor), Pfizer’s Xeljanz / Xeljanz XR (an oral Jak inhibitor), and Janssen’s Stelara (an IL-12/23 inhibitor) have expanded the treatment options for moderate to severe UC, but despite the number of currently available agents, significant unmet need exists, especially for patients refractory to these therapies. Although several agents in late-phase development, including additional Jak agents, are poised to enter the moderate to severe UC market over the next several years, their ability to fulfill these areas of unmet need is unknown at this time.


  • What are the treatment drivers and goals for moderate to severe UC?
  • In addition to efficacy, what other drug attributes influence physician prescribing behavior the most, and which attributes have limited impact?
  • How do TNF-α inhibitors (branded and biosimilars), Entyvio, and novel agents (i.e., Xeljanz / Xeljanz XR, Stelara) perform on treatment drivers and goals?
  • What are the prevailing areas of high unmet need and hidden opportunity in moderate to severe UC?
  • What trade-offs across different clinical attributes and prices are acceptable to U.S. and European gastroenterologists for a hypothetical new UC drug?


Unmet Need supports clinical development decisions by identifying key attributes and assessing areas of unmet need for a specific disease or subpopulation. Based on surveys with U.S. and European physicians, this report provides insight into key treatment drivers and goals, the performance of current therapies, and the remaining commercial opportunities. One market scenario is profiled in detail by DRG experts, and additional customized market scenarios can be evaluated with the corresponding TPP simulator.

Markets covered: United States, United Kingdom, France, Germany

Primary research: Survey of 60 U.S. and 30 European gastroenterologists fielded in February – March 2020

Key companies: AbbVie, Janssen, Takeda, Pfizer

Key drugs: Remicade and infliximab biosimilars, Humira and adalimumab biosimilars, Simponi, Entyvio, Xeljanz / Xeljanz XR, Stelara

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