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.

Questions Answered in This Report:

  • With increasing acceptance of adalimumab (AbbVie/Eisai’s Humira) as an alternative to infliximab (Janssen/Merck & Co./Mitsubishi Tanabe Pharma’s Remicade) for CD, infliximab’s market-leader position is being challenged. When will adalimumab overtake infliximab in patient share and sales? Has the TNF-α inhibitor drug class reached saturation in the CD market?

  • With its recent U.S. and European launches, vedolizumab (Takeda’s Entyvio) joins natalizumab (Biogen’s Tysabri) as the second CAM inhibitor. How much uptake is vedolizumab experiencing in CD? What are physicians’ prescribing behaviors with regard to vedolizumab? How will the availability of vedolizumab impact natalizumab’s place in the treatment algorithm for CD?

  • The IL-12/IL-23 inhibitor ustekinumab is expected to launch for CD during our study period. What is its potential position in the treatment algorithm for CD? How will it perform commercially compared with vedolizumab? How will long-term safety data accumulated for ustekinumab in psoriasis and psoriatic arthritis affect the drug’s potential approval and uptake in CD?

  • Biosimilars for the TNF-α inhibitors have become available in Japan and Europe. How will the availability of biosimilars affect the patient share and market revenue of branded TNF-α inhibitors? How will the availability of biosimilars affect the uptake of emerging biologics in CD?


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.

Author(s): Qinghui Yu, Ph.D.
Brian Nasipak, Ph.D.
Sunali Goonesekera, M.S.

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