Last Updated 3 November 2014
Approximately 1.2 million people in the major pharmaceutical markets under study (United States, France, Germany, Italy, Spain, United Kingdom, and Japan) are diagnosed with ulcerative colitis (UC). The conventional therapies, including aminosalicylates and corticosteroids, are often successfully used to treat mild to moderate UC, but new pharmacotherapies are needed that more effectively treat moderate to severe disease and maintain disease remission better than existing drugs (immunosuppressants and the tumor necrosis factor-alpha [TNF-α] inhibitors). The cell adhesion molecule (CAM) inhibitor vedolizumab (Takeda’s Entyvio) recently launched for moderate to severe UC, and the oral Janus-activated kinase (Jak) inhibitor tofacitinib (Pfizer’s Xeljanz) is in late-stage development. This report provides a detailed analysis and an annualized ten-year forecast of the UC therapy market extending into 2023. Included are epidemiological estimates and in-depth coverage of current treatments and emerging therapies.

Questions Answered in This Report:

  • Therapies to treat UC are many and come from a variety of drug classes. 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 (Cosmo Pharmaceuticals/Santarus/Ferring’s Uceris/Cortiment) 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 (Salix 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 TNF-α inhibitor. Three such drugs are approved for UC: infliximab (Janssen/Merck/Mitsubishi Tanabe’s Remicade), adalimumab (AbbVie/Eisai’s Humira), and golimumab (Janssen/Merck/Mitsubishi Tanabe’s Simponi; approved in the U.S. 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. What barriers do the two drugs face in terms of gastroenterologists’ prescribing habits and the UC treatment paradigm in achieving early-line use ahead of the TNF-α inhibitors? Which of these emerging therapies is likely to supersede the other during the forecast period?

  • Biosimilar infliximab is expected to enter the UC market starting in November 2014 in Japan and 2015 in Europe. 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 play 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, maintenance therapy.

Emerging therapies: Phase II: 21 drugs; Phase III: 3 drugs; Coverage of 4 select preclinical and Phase I products.

Author(s): Adi Reske, Ph.D.
Courtney Walls, M.P.H.

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