The moderate to severe ulcerative colitis (UC) drug market still offers substantial opportunity for companies that can address the remaining unmet needs in this patient population. The TNF-α inhibitors (e.g., Janssen’s Remicade, AbbVie’s Humira, biosimilars of both drugs, where available) are the mainstay of biological treatment for moderate to severe UC. However, these agents carry safety risks and have efficacy limitations. Takeda’s Entyvio (a CAM inhibitor), Pfizer’s Xeljanz / Xeljanz XR (an oral Jak inhibitor), and Janssen’s Stelara (an IL-12/23 inhibitor) have expanded the treatment options for moderate to severe UC, but despite the number of currently available agents, significant unmet need exists, especially for patients refractory to these therapies. Although several agents in late-phase development, including additional Jak agents, are poised to enter the moderate to severe UC market over the next several years, their ability to fulfill these areas of unmet need is unknown at this time.

QUESTIONS ANSWERED

  • What are the treatment drivers and goals for moderate to severe UC?
  • 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), Entyvio, and novel agents (i.e., Xeljanz / Xeljanz XR, Stelara) perform on treatment drivers and goals?
  • What are the prevailing areas of high unmet need and hidden opportunity in moderate to severe UC?
  • What trade-offs across different clinical attributes and prices are acceptable to U.S. and European gastroenterologists for a hypothetical new UC 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. One market scenario is 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 30 European gastroenterologists fielded in February – March 2020

Key companies: AbbVie, Janssen, Takeda, Pfizer

Key drugs: Remicade and infliximab biosimilars, Humira and adalimumab biosimilars, Simponi, Entyvio, Xeljanz / Xeljanz XR, Stelara

Table of contents

  • Ulcerative Colitis - Unmet Need - Detailed, Expanded Analysis (US & EU)
    • Executive Summary
      • Unmet Need - Moderate to Severe Ulcerative Colitis - Executive Summary - April 2020
    • Introduction
      • Overview
      • Methodology
      • Rationale for Treatment Drivers and Goals Selection
        • Rationale for Drug Selection
          • Products for Moderate to Severe Ulcerative Colitis 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 Ulcerative Colitis
        • Importance of Efficacy Attributes to Prescribing Decisions in Moderate to Severe Ulcerative Colitis: United States
        • Importance of Efficacy Attributes to Prescribing Decisions in Moderate to Severe Ulcerative Colitis: Europe
        • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Moderate to Severe Ulcerative Colitis: United States
        • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Moderate to Severe Ulcerative Colitis: Europe
        • Importance of Convenience of Administration Attributes to Prescribing Decisions in Moderate to Severe Ulcerative Colitis: United States
        • Importance of Convenience of Administration Attributes to Prescribing Decisions in Moderate to Severe Ulcerative Colitis: Europe
        • Importance of Nonclinical Factors to Prescribing Decisions in Moderate to Severe Ulcerative Colitis: United States
        • Importance of Nonclinical Factors to Prescribing Decisions in Moderate to Severe Ulcerative Colitis: 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 Ulcerative Colitis: 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 Ulcerative Colitis: Europe
      • Product Performance Against Treatment Drivers and Goals
        • Key Findings
        • Overall Performance of Key Therapies for Moderate to Severe Ulcerative Colitis: United States
        • Overall Performance of Key Therapies for Moderate to Severe Ulcerative Colitis: Europe
        • Mean Overall Performance of Key Therapies for Moderate to Severe Ulcerative Colitis: United States and Europe
        • Relative Performance of Key Therapies for Moderate to Severe Ulcerative Colitis Across Select Efficacy Attributes: United States
        • Relative Performance of Key Therapies for Moderate to Severe Ulcerative Colitis Across Select Efficacy Attributes: Europe
        • Relative Performance of Key Therapies for Moderate to Severe Ulcerative Colitis Across Select Safety and Tolerability Attributes: United States
        • Relative Performance of Key Therapies for Moderate to Severe Ulcerative Colitis Across Select Safety and Tolerability Attributes: Europe
        • Relative Performance of Key Therapies for Moderate to Severe Ulcerative Colitis Across Select Convenience of Administration Attributes: United States
        • Relative Performance of Key Therapies for Moderate to Severe Ulcerative Colitis Across Select Convenience of Administration Attributes: Europe
        • Relative Performance of Key Therapies for Moderate to Severe Ulcerative Colitis Across Select Nonclinical Attributes: United States
        • Relative Performance of Key Therapies for Moderate to Severe Ulcerative Colitis Across Select Nonclinical Attributes: Europe
      • Assessment of Unmet Need
        • Key Findings: Unmet Need in Moderate to Severe Ulcerative Colitis
        • Surveyed Gastroenterologists’ Satisfaction with the Performance of Key Therapies for Moderate to Severe Ulcerative Colitis 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 Ulcerative Colitis 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 Ulcerative Colitis: United States
        • Surveyed Gastroenterologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Moderate to Severe Ulcerative Colitis: Europe
        • Surveyed Gastroenterologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Moderate to Severe Ulcerative Colitis: United States
        • Surveyed Gastroenterologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Moderate to Severe Ulcerative Colitis: Europe
        • Surveyed Gastroenterologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Moderate to Severe Ulcerative Colitis: United States
        • Surveyed Gastroenterologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Moderate to Severe Ulcerative Colitis: Europe
        • Surveyed Gastroenterologists' Ascribed Level of Unmet Need Across Key Nonclinical Factors in Moderate to Severe Ulcerative Colitis: United States
        • Surveyed Gastroenterologists' Ascribed Level of Unmet Need Across Key Nonclinical Factors in Moderate to Severe Ulcerative Colitis: Europe
        • Key Findings: Unmet Need in Moderate to Severe Ulcerative Colitis and Related Indications
        • Surveyed Gastroenterologists' Ascribed Level of Unmet Need in Moderate to Severe Ulcerative Colitis and Related Indications: United States
        • Surveyed Gastroenterologists' Ascribed Level of Unmet Need in Moderate to Severe Ulcerative Colitis and Related Indications: Europe
      • Opportunity Analysis
        • Areas of Opportunity in the Moderate to Severe Ulcerative Colitis Market and Emerging Therapy Insights
          • Opportunity: A Novel Therapy Demonstrating Greater Effect on Long-Term Maintenance of Remission
          • Opportunity: A Novel Therapy Demonstrating Improved Mucosal Healing Rates
          • Opportunity: A Novel Therapy Demonstrating Improved Corticosteroid-Free Remission Rates
          • Opportunity: A Novel Oral Therapy Demonstrating Improved Safety
      • Target Product Profiles
        • Assessing Drug Development Opportunities
        • Target Product Profile Methodology
          • Attributes and Attribute Levels
        • Attribute Importance and Part-Worth Utilities
          • Moderate to Severe Ulcerative Colitis Target Product Profile: Attribute Importance
          • Induction of Remission at Eight Weeks (% of Patients, Placebo-Adjusted)
          • Maintenance of Remission at 54 Weeks (% of Patients, Placebo-Adjusted)
          • Mucosal Healing at 54 Weeks (% of Patients, Placebo-Adjusted)
          • Corticosteroid-Free Remission at 54 Weeks (% of Patients, Placebo-Adjusted)
          • Incidence of Serious Adverse Events (% of Patients, Placebo-Adjusted)
          • Delivery Burden (Dosing Formulation and Frequency, UC Maintenance Setting)
          • Price per Treated Day (UC Maintenance Setting)
        • Conjoint Analysis-Based Simulation of a Market Scenario
          • Moderate to Severe Ulcerative Colitis Market Simulation: Share of Preference of Target Product Profiles Included in the Market Scenario
          • Moderate to Severe Ulcerative Colitis Market Simulation: Likelihood to Prescribe Target Product Profiles Included in the Market Scenario
          • Moderate to Severe Ulcerative Colitis Market Simulation: Target Product Profiles Included in the Market Scenario
      • Appendix
        • Key Abbreviations
        • Experts Interviewed
        • Bibliography

    Author(s): Andrea Buurma Kravit

    Andrea Kravit is a director in Decision Resources Group’s Immune and Inflammatory division, where she manages, and supports, a team of therapeutically-aligned analysts who conduct extensive primary and secondary market research in the gastrointestinal and respiratory space. Prior to this role, she was a principal analyst for Decision Resources Group's Central Nervous Systems and Ophthalmology division, where she provided expert insight into the commercial aspects of drug development and market sizing across Pain indications. Her project experience includes patient-based market forecasting, market opportunity assessments, early to late-stage pipeline analyses, and competitive analytics for the life-science industry. 


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