Last Updated 15 September 2015
Ulcerative colitis (UC) affects approximately 1.25 million people across the major markets. Aminosalicylates and corticosteroids are routinely prescribed for mild and moderate patients; however, substantial opportunity exists for new treatment options that can more effectively induce or maintain remission in moderate to severe patients than existing therapies. Vedolizumab (Takeda’s Entyvio) is a recently approved cell adhesion molecule inhibitor that offers a novel mechanism of action. Tofacitinib (Pfizer’s Xeljanz), etrolizumab (Roche/Genentech), and ozanimod (Receptos) are emerging therapies in late-stage development for moderate to severe UC. This report provides a detailed analysis and an annualized ten-year forecast of the UC market extending into 2024. Detailed epidemiological estimates and in-depth coverage of both current and emerging therapies are also included.

Questions Answered in This Report:

  • Numerous therapies are used to treat UC, and treatment decisions are most often based on the severity of the disease. In addition, most of the therapies are used to treat the acute phase, the maintenance phase, or both. What do expert gastroenterologists think of the currently available therapies for UC, and how are they used in current medical practice across the major markets?

  • Budesonide MMX is a reformulation of oral budesonide featuring Cosmo’s MMX technology; it delivers the drug to the colon and seeks to improve on the safety of older, oral corticosteroids. MMX delayed-release mesalamine (Cosmo/Shire/Takeda/Giuliani/Mochida Pharmaceuticals’ Lialda/Mezavant/Mesavancol) and the extended-release granule formulation of mesalamine (Valeant Pharmaceuticals’ Apriso), offer patients the potential for once-daily dosing. What is the market potential for innovative reformulations of current therapies developed for mild to moderate UC in the face of stiff competition from entrenched and often less-expensive therapies?

  • Patients who fail to respond effectively to corticosteroids and immunosuppressants may be prescribed a tumor necrosis factor-alpha (TNF-?) inhibitor. Three such drugs are approved for UC: infliximab (Janssen/Merck & Co./Mitsubishi Tanabe Pharma’s Remicade), adalimumab (AbbVie/Eisai’s Humira), and golimumab (Janssen/Merck & Co./Mitsubishi Tanabe Pharma’s Simponi) (approved in the United States and Europe; in Phase III in Japan). How will the subcutaneous TNF-α inhibitors golimumab and adalimumab perform over the forecast period compared with the market leader, infliximab?

  • The CAM inhibitor vedolizumab (Takeda’s Entyvio) is the first non-TNF-α biologic approved for UC in the United States and Europe (2014). Pfizer’s oral Jak inhibitor tofacitinib (Xeljanz) is in Phase III development for UC in the United States, Europe, and Japan and Roche/Genentech’s emerging CAM inhibitor etrolizumab and Receptos’ oral S1P-R modulator ozanimod are in Phase III development for UC in the United States and Europe. What are current physician perceptions of vedolizumab and what hurdles do the emerging therapies face in terms of gastroenterologists’ prescribing habits and the UC treatment paradigm if they are to achieve early-line use ahead of the TNF-? inhibitors? Which of these emerging therapies is likely to supersede the other during the forecast period?

  • Biosimilar infliximab has already launched in many European markets as of February 2015 and entered the Japanese UC market in November 2014. It is expected to enter the U.S. market in 2018. Biosimilar adalimumab is expected to enter the market starting in 2017. What will be the commercial impact of less-expensive biosimilar versions of key TNF-α inhibitors on the moderate to severe UC market? How will the biosimilar versions fare against the branded drugs in terms of sales and patient share?


Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.

Primary research: 30 country-specific interviews with thought-leading gastroenterologists.

Epidemiology: Diagnosed prevalence of UC.

Population segments in market forecast: Acute therapy and maintenance therapy.

Emerging therapies: Phase II: 19 drugs; Phase III: 5 drugs; coverage of 3 select preclinical and Phase I products.

Author(s): Michael Darcy, Ph.D.
Catherine Vasilakis-Scaramozza, Ph.D., M.P.H.

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