In the last 15 years, TNF-α inhibitors (AbbVie’s Humira, Amgen / Pfizer’s Enbrel, Janssen’s Remicade and Simponi, UCB’s Cimzia) have transformed the treatment of ankylosing spondylitis (AS) and brought new attention to this autoimmune disease. Today, a second wave of biological therapies, the IL-17 inhibitors (Novartis’s Cosentyx and Eli Lilly’s Taltz), have been approved for AS; these agents’ success will be shaped by the remaining unmet needs in the treatment of this population. In this report, with quantitative insight into U.S. and European rheumatologists’ assessment of the unmet need in AS, we discuss the commercial opportunities for this enigmatic indication and how emerging therapies may capitalize on these opportunities.

QUESTIONS ANSWERED

  • What are the treatment drivers and goals for AS?
  • What drug attributes are key influences, which have limited impact, and which are hidden opportunities?
  • How do current therapies perform on key treatment drivers and goals for AS?
  • What are the prevailing areas of unmet need and opportunity in AS?
  • What trade-offs across different clinical attributes and price are acceptable to U.S. and European rheumatologists for a hypothetical new AS 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 31 European rheumatologists fielded in April 2020.

Key companies: AbbVie, Amgen, Eli Lilly, Pfizer, Janssen, UCB, Novartis.

Key drugs: Humira, Enbrel, Remicade, Cimzia, Cosentyx, Taltz.

Table of contents

  • Axial Spondyloarthritis - Unmet Need - Detailed, Expanded Analysis: Ankylosing Spondylitis (US & EU)
    • Executive Summary
      • Unmet Need - Ankylosing Spondylitis - Executive Summary - June 2020
    • Introduction
      • Overview
      • Methodology
      • Rationale for Treatment Drivers and Goals Selection
        • Rationale for Drug Selection
          • Products for Ankylosing Spondylitis 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 Rheumatologists' Prescribing Decisions in Ankylosing Spondylitis
        • Importance of Efficacy Attributes to Prescribing Decisions in Ankylosing Spondylitis: United States
        • Importance of Efficacy Attributes to Prescribing Decisions in Ankylosing Spondylitis: Europe
        • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Ankylosing Spondylitis: United States
        • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Ankylosing Spondylitis: Europe
        • Importance of Convenience of Administration Attributes to Prescribing Decisions in Ankylosing Spondylitis: United States
        • Importance of Convenience of Administration Attributes to Prescribing Decisions in Ankylosing Spondylitis: Europe
        • Importance of Nonclinical Factors to Prescribing Decisions in Ankylosing Spondylitis: United States
        • Importance of Nonclinical Factors to Prescribing Decisions in Ankylosing Spondylitis: 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 Ankylosing Spondylitis: United States
        • Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in Ankylosing Spondylitis: Europe
      • Product Performance Against Treatment Drivers and Goals
        • Key Findings
        • Overall Performance of Key Therapies for Ankylosing Spondylitis: United States
        • Overall Performance of Key Therapies for Ankylosing Spondylitis: Europe
        • Mean Overall Performance of Key Therapies for Ankylosing Spondylitis: United States and Europe
        • Relative Performance of Key Therapies for Ankylosing Spondylitis Across Select Efficacy Attributes: United States
        • Relative Performance of Key Therapies for Ankylosing Spondylitis Across Select Efficacy Attributes: Europe
        • Relative Performance of Key Therapies for Ankylosing Spondylitis Across Select Safety and Tolerability Attributes: United States
        • Relative Performance of Key Therapies for Ankylosing Spondylitis Across Select Safety and Tolerability Attributes: Europe
        • Relative Performance of Key Therapies for Ankylosing Spondylitis Across Select Convenience of Administration Attributes: United States
        • Relative Performance of Key Therapies for Ankylosing Spondylitis Across Select Convenience of Administration Attributes: Europe
        • Relative Performance of Key Therapies for Ankylosing Spondylitis Across Select Nonclinical Attributes: United States
        • Relative Performance of Key Therapies for Ankylosing Spondylitis Across Select Nonclinical Attributes: Europe
      • Assessment of Unmet Need
        • Key Findings: Unmet Need in Ankylosing Spondylitis
        • Surveyed Rheumatologists’ Satisfaction with the Performance of Key Therapies for Ankylosing Spondylitis on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: United States
        • Surveyed Rheumatologists’ Satisfaction with the Performance of Key Therapies for Ankylosing Spondylitis on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: Europe
        • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Ankylosing Spondylitis: United States
        • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Ankylosing Spondylitis: Europe
        • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Ankylosing Spondylitis: United States
        • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Ankylosing Spondylitis: Europe
        • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Ankylosing Spondylitis: United States
        • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Ankylosing Spondylitis: Europe
        • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Nonclinical Factors in Ankylosing Spondylitis: United States
        • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Nonclinical Factors in Ankylosing Spondylitis: Europe
        • Key Findings: Unmet Need in Ankylosing Spondylitis and Related Indications
        • Surveyed Rheumatologists' Ascribed Level of Unmet Need in Ankylosing Spondylitis and Related Indications: United States
        • Surveyed Rheumatologists' Ascribed Level of Unmet Need in Ankylosing Spondylitis and Related Indications: Europe
      • Opportunity Analysis
        • Areas of Opportunity in the Ankylosing Spondylitis Market and Emerging Therapy Insights
          • Opportunity: An Agent with Demonstrated Efficacy in Slowing Radiographic Progression
          • Opportunity: Treatments with Sustained Efficacy
          • Opportunity: Treatment with Alternative Mechanism of Action
      • Target Product Profiles
        • Assessing Drug Development Opportunities
        • Target Product Profile Methodology
          • Attributes and Attribute Levels
          • Attributes of Key Current and Late-Phase Emerging Therapies for Ankylosing Spondylitis
        • Attribute Importance and Part-Worth Utilities
          • Ankylosing Spondylitis Target Product Profile: Attribute Importance
          • % of Patients Achieving ASAS20 at 12-24 Weeks
          • % of Patients with a Worsening Radiographic mSASSS Score After 2 Years
          • Average Improvement in the ASQoL Questionnaire from Baseline at 16-24 Weeks
          • Mechanism of Action
          • Placebo-Adjusted Incidence of Serious Infections per 100 Patient Years
          • Route and Frequency of Administration
          • Price per Day (relative to Humira)
        • Conjoint Analysis-Based Simulation of a Market Scenario
          • Ankylosing Spondylitis Market Simulation: Share of Preference of Target Product Profiles Included in the Market Scenario
          • Ankylosing Spondylitis Market Simulation: Likelihood to Prescribe Target Product Profiles Included in the Market Scenario
          • Ankylosing Spondylitis Market Simulation: Target Product Profiles Included in the Market Scenario
      • Appendix
        • Key Abbreviations
        • Experts Interviewed
        • Bibliography

    Author(s): Swati Kinger, M.B.A

    Swati Kinger, M.B.A., is an associate analyst on the immune and inflammatory disorders team at Decision Resources Group. Prior to joining DRG, she was an associate consultant for a life sciences consulting firm, where she worked on syndicated offerings and ad-hoc requests involving patient journeys, market assessment and competitive intelligence. She holds a bachelor’s degree in pharmacy and an M.B.A. in Pharma from the National Institute of Pharmaceutical Education and Research, India.


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