TNF-alpha inhibitors (e.g., Janssen’s Remicade, AbbVie’s Humira) are the mainstay of biological treatment for moderate to severe Crohn’s disease (CD), while newer biologics (i.e., Takeda’s Entyvio, a CAM inhibitor, and Janssen’s Stelara, an IL-12/23 inhibitor) are mostly used as later-line therapies, following anti-TNF failure. These agents all have safety risks and efficacy limitations, and the launch of biosimilar alternatives has only increased the complexity of CD treatment. Significant need remains, especially in the treatment of patients refractory to available therapies and patients with fistulizing disease.

QUESTIONS ANSWERED

  • What are the treatment drivers and goals for moderate to severe CD?
  • What drug attributes are key influencers, which have limited impact, and which are hidden opportunities?
  • How do current therapies perform on key treatment drivers and goals for moderate to severe CD?
  • What are the prevailing areas of unmet need and opportunity in moderate to severe CD?
  • What trade-offs across different clinical attributes and price are acceptable to U.S. and European gastroenterologists for a hypothetical new moderate to severe CD drug?

PRODUCT DESCRIPTION

Unmet Need provides quantitative insight into U.S. and European physician perceptions of key treatment drivers and goals and the current level of unmet need for a specific disease. Commercial opportunities are analyzed, and the extent to which emerging therapies may capitalize on these opportunities is evaluated.

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

Primary research: Survey of 60 U.S. and 31 European gastroenterologists fielded in January 2020

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

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

Table of contents

  • Crohn's Disease - Unmet Need - Detailed, Expanded Analysis (US & EU)
    • Executive Summary
      • Unmet Need - Moderate to Severe CD - Executive Summary - April 2020
    • Introduction
      • Overview
      • Methodology
      • Rationale for Treatment Drivers and Goals Selection
        • Rationale for Drug Selection
          • Products for Moderate to Severe CD and Rationale for Drug Selection
      • Treatment Drivers and Goals
        • Key Findings: Attribute Importance
        • Relative Importance of Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Surveyed Gastroenterologists' Prescribing Decisions in Moderate to Severe CD
        • Importance of Efficacy Attributes to Prescribing Decisions in Moderate to Severe CD: United States
        • Importance of Efficacy Attributes to Prescribing Decisions in Moderate to Severe CD: Europe
        • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Moderate to Severe CD: United States
        • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Moderate to Severe CD: Europe
        • Importance of Convenience of Administration Attributes to Prescribing Decisions in Moderate to Severe CD: United States
        • Importance of Convenience of Administration Attributes to Prescribing Decisions in Moderate to Severe CD: Europe
        • Importance of Nonclinical Factors to Prescribing Decisions in Moderate to Severe CD: United States
        • Importance of Nonclinical Factors to Prescribing Decisions in Moderate to Severe CD: Europe
        • Key Findings: Stated vs. Derived Importance
        • Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in Moderate to Severe CD: United States
        • Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in Moderate to Severe CD: Europe
      • Product Performance Against Treatment Drivers and Goals
        • Key Findings
        • Overall Performance of Key Therapies for Moderate to Severe CD: United States
        • Overall Performance of Key Therapies for Moderate to Severe CD: Europe
        • Mean Overall Performance of Key Therapies for Moderate to Severe CD: United States and Europe
        • Relative Performance of Key Therapies for Moderate to Severe CD Across Select Efficacy Attributes: United States
        • Relative Performance of Key Therapies for Moderate to Severe CD Across Select Efficacy Attributes: Europe
        • Relative Performance of Key Therapies for Moderate to Severe CD Across Select Safety and Tolerability Attributes: United States
        • Relative Performance of Key Therapies for Moderate to Severe CD Across Select Safety and Tolerability Attributes: Europe
        • Relative Performance of Key Therapies for Moderate to Severe CD Across Select Convenience of Administration Attributes: United States
        • Relative Performance of Key Therapies for Moderate to Severe CD Across Select Convenience of Administration Attributes: Europe
        • Relative Performance of Key Therapies for Moderate to Severe CD Across Select Nonclinical Attributes: United States
        • Relative Performance of Key Therapies for Moderate to Severe CD Across Select Nonclinical Attributes: Europe
      • Assessment of Unmet Need
        • Key Findings: Unmet Need in Moderate to Severe Crohn's Disease
        • Surveyed Gastroenterologists’ Satisfaction with the Performance of Key Therapies for Moderate to Severe CD on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: United States
        • Surveyed Gastroenterologists’ Satisfaction with the Performance of Key Therapies for Moderate to Severe CD on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: Europe
        • Surveyed Gastroenterologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Moderate to Severe CD: United States
        • Surveyed Gastroenterologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Moderate to Severe CD: Europe
        • Surveyed Gastroenterologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Moderate to Severe CD: United States
        • Surveyed Gastroenterologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Moderate to Severe CD: Europe
        • Surveyed Gastroenterologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Moderate to Severe CD: United States
        • Surveyed Gastroenterologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Moderate to Severe CD: Europe
        • Surveyed Gastroenterologists' Ascribed Level of Unmet Need Across Key Nonclinical Factors in Moderate to Severe CD: United States
        • Surveyed Gastroenterologists' Ascribed Level of Unmet Need Across Key Nonclinical Factors in Moderate to Severe CD: Europe
        • Key Findings: Unmet Need in Moderate to Severe Crohn's Disease and Related Indications
        • Surveyed Gastroenterologists' Ascribed Level of Unmet Need in Moderate to Severe CD and Related Indications: United States
        • Surveyed Gastroenterologists' Ascribed Level of Unmet Need in Moderate to Severe CD and Related Indications: Europe
      • 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 Therapy with a Lower Risk of Serious Adverse Events Compared with Approved Biologics
          • Opportunity: A Novel Oral Agent with Efficacy Comparable or Superior to That of Biologics
      • Target Product Profiles
        • Assessing Drug Development Opportunities
        • Target Product Profile Methodology
          • Attributes and Attribute Levels
          • Attributes of Key Current Therapies for Moderate to Severe Crohn's Disease
        • Attribute Importance and Part-Worth Utilities
          • Moderate to Severe CD Target Product Profile: Attribute Importance
          • Induction of Remission at 8 Weeks (% of Patients)
          • Maintenance of Remission at 52 Weeks (% of Patients)
          • Mucosal Healing at 52 Weeks (% of Patients)
          • Corticosteroid-Free Remission at 52 Weeks (% of Patients)
          • Rate of Serious Adverse Events (% of Patients)
          • Delivery Burden (Dosing Formulation and Frequency, Maintenance Setting)
          • Price/Day (Crohn's Disease Maintenance Setting)
        • Conjoint Analysis-Based Simulation of a Market Scenario
          • Moderate to Severe CD Market Simulation: Share of Preference of Target Product Profiles Included in the Market Scenario
          • Moderate to Severe CD Market Simulation: Likelihood to Prescribe Target Product Profiles Included in the Market Scenario
          • Moderate to Severe CD Market Simulation: Target Product Profiles Included in the Market Scenario
      • Appendix
        • Key Abbreviations
        • 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 Ph.D. 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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