MARKET OUTLOOK

Treatment of moderate to severe Crohn’s disease (CD) typically begins with safe, albeit often less-efficacious, conventional agents (e.g., 5-ASAs) and progresses to more-potent drugs, such as immunosuppressants and/or biologics. The TNF-α inhibitors (e.g., Janssen’s Remicade, AbbVie’s Humira) are the mainstay of biological treatment for moderate to severe CD. However, these agents have safety risks and efficacy limitations. Two additional biological agents with novel mechanisms of action (i.e., Takeda’s Entyvio, a CAM inhibitor approved in 2014, and Janssen’s Stelara, an IL-12/23 inhibitor approved in 2016) have expanded the treatment options for moderate to severe CD; however, significant need remains, especially for patients refractory to currently available therapies.

QUESTIONS ANSWERED

  • What are the treatment drivers and goals for moderate to severe CD?
  • In addition to efficacy, what other drug attributes influence physician prescribing behavior the most, and which attributes have limited impact?
  • How do TNF-α inhibitors (branded and biosimilars) and novel biologics (i.e., Entyvio and Stelara) perform on treatment drivers and goals?
  • What are the prevailing areas of high unmet need and hidden opportunity in moderate to severe CD?
  • What trade-offs across different clinical attributes and prices are acceptable to U.S. and European gastroenterologists for a hypothetical new CD drug?

PRODUCT DESCRIPTION

Unmet Need supports clinical development decisions by identifying key attributes and assessing areas of unmet need for a specific disease or subpopulation. Based on surveys with U.S. and European physicians, this report provides insight into key treatment drivers and goals, the performance of current therapies, and the remaining commercial opportunities. Two market scenarios are profiled in detail by DRG experts, and additional customized market scenarios can be evaluated with the corresponding TPP simulator.

Markets covered: United States, United Kingdom, France, Germany

Primary research: Survey of 60 U.S. and 31 European gastroenterologists fielded in January2019.

Key companies:  AbbVie, Galapagos NV, Gilead, Janssen, Merck & Co., Takeda, TiGenix,  Boehringer Ingelheim, Allergan,  Celgene, Roche

Key drugs: Humira, Remicade, Entyvio, Stelara, Cimzia, infliximab biosimilars, adalimumab biosimilars

Table of contents

  • Detailed, Expanded Analysis (US & EU)
    • Introduction
      • Overview
      • Methodology
      • Rationale for Treatment Drivers and Goals Selection
        • Efficacy
        • Safety and Tolerability
        • Convenience of Administration
        • Nonclinical Factors
      • Rationale for Drug Selection
    • Treatment Drivers and Goals
      • Key Findings: Attribute Importance
      • Key Findings: Stated vs. Derived Importance
    • Product Performance Against Treatment Drivers and Goals
      • Key Findings
    • Assessment of Unmet Need
      • Key Findings: Unmet Need in Moderate to Severe CD
      • Key Findings: Unmet Need in Moderate to Severe CD and Related Indications
    • Opportunity Analysis
      • Areas of Opportunity in the Moderate to Severe CD Market and Emerging Therapy Insights
        • Opportunity: A Novel Therapy Able to Demonstrate Improved Efficacy in Long-Term Maintenance of Remission
        • Opportunity: A Novel Agent with Greater Efficacy in Mucosal Healing
        • Opportunity: A Novel Oral Agent with Efficacy Comparable or Superior to That of Biologics
        • Opportunity: A Novel Therapy with a Lower Risk of Serious Adverse Events Compared with Approved Biologics
    • Target Product Profiles
      • Assessing Drug Development Opportunities
      • Target Product Profile Methodology
      • Attribute Importance and Part-Worth Utilities
        • Moderate to Severe CD Target Product Profile: Attribute-Level Part-Worth Utilities
      • Conjoint Analysis-Based Simulations of Market Scenarios
        • Scenario 1
        • Scenario 2
    • Appendix
      • Experts Interviewed
      • Bibliography

Author(s): Ritesh Gupta, PhD

Ritesh Gupta is a Lead Analyst on the immune and inflammatory disorders team at Decision Resources Group, whose work focuses primarily on Psoriatic Arthritis, Ulcerative Colitis and Crohn’s Disease. He holds a degree in Cell Biology from Max Delbrück Center for Molecular Medicine, Berlin, where he worked on development of novel inhibitors for HGF/MET signaling pathways. Prior to joining DRG, Ritesh has worked as an assistant manager with BioXcel corporation and provided insights on various consulting projects. He was also associated with GVK Biosciences and worked on drug repurposing projects.


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