Last Updated 29 September 2014

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.

With the recent launch of the cell adhesion molecule (CAM) inhibitor vedolizumab (Takeda’s Entyvio), physicians have a welcome alternative for TNF-α inhibitor-refractory patients. An emerging therapy with a different mechanism of action, the interleukin (IL)-12/IL-23 inhibitor ustekinumab (Janssen’s Stelara), remains in clinical development for moderate to severe CD. However, in the absence of data demonstrating superior efficacy, interviewed thought leaders do not expect these drugs to displace the TNF-α inhibitors as the dominant drug class for moderate to severe CD. The estimated high pricing of ustekinumab, which is already marketed for psoriasis and psoriatic arthritis, and concerns about the risk of progressive multifocal leukoencephalopathy (PML) for vedolizumab will likely limit their 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/Mitsubishi Tanabe’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 Idec’s Tysabri) as the second CAM inhibitor. How will natalizumab’s history of PML and lingering concerns related to vedolizumab impact uptake of the newer agent? How will the availability of vedolizumab impact natalizumab’s place in the treatment algorithm for CD?

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

  • Biosimilars for the TNF-α inhibitors are expected to start entering major CD markets near the end of 2014. How will the availability of biologics affect brand patient share and sales? How will the availability of biosimilars affect the uptake of emerging biologics in CD?

Scope:

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 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: 4 drugs.

Market forecast features: We forecast drug sales for acute and maintenance therapies though 2023.

Author(s): Alexandra Makarova, M.D., Ph.D.
Courtney Walls, M.P.H.