Ulcerative colitis (UC) affects approximately 1.75 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 (Celgene) 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 2025. Detailed epidemiological estimates and in-depth coverage of both current and emerging therapies are also included.
Questions Answered:
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 agents?
Patients who fail to respond effectively to corticosteroids and immunosuppressants may be prescribed a tumor necrosis factor-alpha (TNF-α) 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 development 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 is the first non-TNF-α biologic approved for UC in the United States and Europe (2014). Pfizer’s oral Jak inhibitor tofacitinib is in Phase III development for UC in the United States, Europe, and Japan, and Roche/Genentech’s emerging CAM inhibitor etrolizumab and Celgene’s oral S1P-R modulator ozanimod are in Phase III development for UC in the United States and Europe. What are current and future physician perceptions of vedolizumab and these emerging therapies, and how do they envision their use in the UC treatment algorithm? How are these emerging therapies expected to perform during the forecast period?
Biosimilar infliximab, which was available in Europe and Japan in 2015 and launched in the United States in late 2016, will enjoy increased market penetration during our forecast period. Biosimilar adalimumab is expected to enter the market beginning in 2017, and biosimilar versions of golimumab and certolizumab pegol are expected to enter the market beginning in 2024. What will be the commercial impact of less-expensive biosimilar versions on the TNF-α inhibitor class? How will the biosimilar versions fare against the branded drugs in terms of sales and patient share?
Scope:
Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.
Primary research: 26 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: 16 drugs; Phase III: 6 drugs; coverage of 4 select preclinical and Phase I products.