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Last Updated 18 December 2015
Treatment options for Crohn’s disease (CD) include conventional, largely generic small molecules and more-potent biological agents, including tumor necrosis factor-alpha (TNF-α) inhibitors. Despite the clinical and commercial success of the TNF-α inhibitors, opportunity remains for agents that can safely and effectively induce and maintain remission in a significant number of patients with moderate to severe CD, especially those refractory to TNF-α inhibitors. Indeed, with the launch of vedolizumab (Takeda’s Entyvio) in 2014, physicians have a welcome alternative for TNF-α inhibitor-refractory patients. Additional agents in late-stage development include therapies offering a variety of mechanisms of action; prominent candidates include the IL-12/IL-23 inhibitor ustekinumab (Janssen’s Stelara), the CAM inhibitor etrolizumab (Roche), and oral SMAD7 antisense oligonucleotide mongersen (Celgene’s GED-0301). The IL-12/IL-23 inhibitor ustekinumab, pending the release of additional Phase III data, has demonstrated efficacy in both TNF-α inhibitor-refractory and -naive patients. However, interviewed thought leaders do not expect any of these drugs to displace the TNF-α inhibitors as the dominant drug class for moderate to severe CD. The entry of less-expensive biosimilar TNF-α inhibitors and the increasingly difficult pricing and reimbursement environment will likely limit emerging agents’ market potential in the CD market.
Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.
Primary research: 34 country-specific interviews with thought-leading gastroenterologists.
Epidemiology: Diagnosed prevalence of CD, segmented by disease activity: remission, low activity, and high activity.
Population segments in market forecast: Acute therapy, maintenance therapy.
Emerging therapies: Phase II: 19 drugs; Phase III: 5 drugs; preregistration: 1 drug. Coverage of 6 select preclinical and Phase I products.
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