Severe allergic rhinitis (AR) is a chronic immunoglobulin E (IgE)-mediated respiratory response to seasonal and/or perennial environmental allergens. Treatment options include intranasal corticosteroids, antihistamines, mast cell stabilizers, decongestants, leukotriene antagonists, and anticholinergics. In addition, allergen immunotherapy (AIT) can target specific environmental allergies and change the patient’s immune system response to the allergen. Off-label biological therapies that target circulating free IgE, such as Roche / Novartis’s Xolair, offer an alternative therapeutic approach to treating the disease. Although most patients, especially those with mild to moderate disease, can control their AR using currently available therapies, individuals with more-severe disease could benefit from additional treatments. AITs in development and biological therapies with novel mechanisms of action will expand physicians’ arsenal of treatment options and fuel competition in the severe AR therapy market.

QUESTIONS ANSWERED

  • What attributes are key influencers, which have limited impact, and which are hidden opportunities?
  • How do current inhaled therapies (e.g., Boehringer Ingelheim’s Atrovent) and allergen immunotherapies (e.g., Merck’s Ragwitek, Stallergenes Greer’s Oralair) perform on key treatment drivers and goals in severe AR?
  • What are the prevailing areas of unmet need and opportunity in severe AR?
  • What trade-offs across different clinical attributes and prices are acceptable to U.S. and European physicians for a hypothetical new drug targeting severe AR?

Geographies– United States, France, Germany, United Kingdom

Primary Research– 30 U.S. allergists, 30 U.S. otolaryngologists, and 30 European pulmonologists / otolaryngologists

Key Metrics Included

  • Target Product Profile (TPP) simulator based on conjoint analysis methodology
  • Stated versus derived importance of product attributes on prescribing behavior
  • Assessment of current drug performance against treatment drivers and goals
  • Physician perceptions of unmet needs in the indication and related indications
  • Analysis of remaining drug development opportunities

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.

Table of contents

  • Allergic Rhinitis - Unmet Need - Detailed, Expanded Analysis: Severe Allergic Rhinitis (US/EU)
    • Executive Summary
      • Unmet Need - Severe Allergic Rhinitis - Executive Summary - June 2020
    • Introduction
      • Overview
      • Methodology
      • Rationale for Treatment Drivers and Goals Selection
        • Rationale for Drug Selection
          • Products / Regimens for Severe Allergic Rhinitis 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 Allergists', Otolaryngologists', and Pulmonologists' Prescribing Decisions in Severe Allergic Rhinitis
        • Importance of Efficacy Attributes to Prescribing Decisions in Severe Allergic Rhinitis in the United States: Otolaryngologists
        • Importance of Efficacy Attributes to Prescribing Decisions in Severe Allergic Rhinitis in the United States: Allergists
        • Importance of Efficacy Attributes to Prescribing Decisions in Severe Allergic Rhinitis: Europe
        • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Severe Allergic Rhinitis in the United States: Otolaryngologists
        • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Severe Allergic Rhinitis in the United States: Allergists
        • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Severe Allergic Rhinitis: Europe
        • Importance of Convenience of Administration Attributes to Prescribing Decisions in Severe Allergic Rhinitis in the United States: Otolaryngologists
        • Importance of Convenience of Administration Attributes to Prescribing Decisions in Severe Allergic Rhinitis in the United States: Allergists
        • Importance of Convenience of Administration Attributes to Prescribing Decisions in Severe Allergic Rhinitis: Europe
        • Importance of Nonclinical Factors to Prescribing Decisions in Severe Allergic Rhinitis in the United States: Otolaryngologists
        • Importance of Nonclinical Factors to Prescribing Decisions in Severe Allergic Rhinitis in the United States: Allergists
        • Importance of Nonclinical Factors to Prescribing Decisions in Severe Allergic Rhinitis: 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 Severe Allergic Rhinitis in the United States: Otolaryngologists
        • Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in Severe Allergic Rhinitis in the United States: Allergists
        • Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in Severe Allergic Rhinitis: Europe
      • Product Performance Against Treatment Drivers and Goals
        • Key Findings
        • Overall Performance of Key Therapies for Severe Allergic Rhinitis in the United States: Otolaryngologists
        • Overall Performance of Key Therapies for Severe Allergic Rhinitis in the United States: Allergists
        • Overall Performance of Key Therapies for Severe Allergic Rhinitis: Europe
        • Mean Overall Performance of Key Therapies for Severe Allergic Rhinitis: United States and Europe
        • Relative Performance of Key Therapies for Severe Allergic Rhinitis Across Select Efficacy Attributes in the United States: Otolaryngologists
        • Relative Performance of Key Therapies for Severe Allergic Rhinitis Across Select Efficacy Attributes in the United States: Allergists
        • Relative Performance of Key Therapies for Severe Allergic Rhinitis Across Select Efficacy Attributes: Europe
        • Relative Performance of Key Therapies for Severe Allergic Rhinitis Across Select Safety and Tolerability Attributes in the United States: Otolaryngologists
        • Relative Performance of Key Therapies for Severe Allergic Rhinitis Across Select Safety and Tolerability Attributes in the United States: Allergists
        • Relative Performance of Key Therapies for Severe Allergic Rhinitis Across Select Safety and Tolerability Attributes: Europe
        • Relative Performance of Key Therapies for Severe Allergic Rhinitis Across Select Convenience of Administration Attributes in the United States: Otolaryngologists
        • Relative Performance of Key Therapies for Severe Allergic Rhinitis Across Select Convenience of Administration Attributes in the United States: Allergists
        • Relative Performance of Key Therapies for Severe Allergic Rhinitis Across Select Convenience of Administration Attributes: Europe
        • Relative Performance of Key Therapies for Severe Allergic Rhinitis Across Select Nonclinical Attributes in the United States: Otolaryngologists
        • Relative Performance of Key Therapies for Severe Allergic Rhinitis Across Select Nonclinical Attributes in the United States: Allergists
        • Relative Performance of Key Therapies for Severe Allergic Rhinitis Across Select Nonclinical Attributes: Europe
      • Assessment of Unmet Need
        • Key Findings: Unmet Need in Severe Allergic Rhinitis
        • Surveyed Otolaryngologists' Satisfaction with the Performance of Key Therapies for Severe Allergic Rhinitis on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: United States
        • Surveyed Allergists' Satisfaction with the Performance of Key Therapies for Severe Allergic Rhinitis on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: United States
        • Surveyed Pulmonologists' / Otolaryngologists' Satisfaction with the Performance of Key Therapies for Severe Allergic Rhinitis on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: Europe
        • Surveyed Otolaryngologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Severe Allergic Rhinitis: United States
        • Surveyed Allergists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Severe Allergic Rhinitis: United States
        • Surveyed Pulmonologists' / Otolaryngologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Severe Allergic Rhinitis: Europe
        • Surveyed Otolaryngologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Severe Allergic Rhinitis: United States
        • Surveyed Allergists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Severe Allergic Rhinitis: United States
        • Surveyed Pulmonologists' / Otolaryngologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Severe Allergic Rhinitis: Europe
        • Surveyed Otolaryngologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Severe Allergic Rhinitis: United States
        • Surveyed Allergists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Severe Allergic Rhinitis: United States
        • Surveyed Pulmonologists' / Otolaryngologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Severe Allergic Rhinitis: Europe
        • Surveyed Otolaryngologists' Ascribed Level of Unmet Need Across Key Nonclinical Factors in Severe Allergic Rhinitis: United States
        • Surveyed Allergists' Ascribed Level of Unmet Need Across Key Nonclinical Factors in Severe Allergic Rhinitis: United States
        • Surveyed Pulmonologists' / Otolaryngologists' Ascribed Level of Unmet Need Across Key Nonclinical Factors in Severe Allergic Rhinitis: Europe
        • Key Findings: Unmet Need in Severe Allergic Rhinitis and Related Indications
        • Surveyed Otolaryngologists' Ascribed Level of Unmet Need in Severe Allergic Rhinitis and Related Indications: United States
        • Surveyed Allergists' Ascribed Level of Unmet Need in Severe Allergic Rhinitis and Related Indications: United States
        • Surveyed Pulmonologists' / Otolaryngologists' Ascribed Level of Unmet Need in Severe Allergic Rhinitis and Related Indications: Europe
      • Opportunity Analysis
        • Areas of Opportunity in the Severe Allergic Rhinitis Market and Emerging Therapy Insights
          • Opportunity: Treatments Offering Less-Burdensome Administration
      • 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 Severe Allergic Rhinitis
        • Attribute Importance and Part-Worth Utilities
          • Severe Allergic Rhinitis Target Product Profile: Attribute Importance
          • Improvement in TNSS [Range 0-12] at 16 Weeks; Absolute Units, Baseline- and Placebo-Adjusted
          • Improvement in TOSS [Range 0-9] at 16 Weeks; Absolute Units, Baseline- and Placebo-Adjusted
          • Improvement in RQLQ Score [Range 0-6] at 16 Weeks; Absolute Units, Placebo-Adjusted
          • Improvement in Medication Score [Range 0-36]; Absolute Units, Baseline- and Placebo-Adjusted
          • Rate of Most Common Nonserious AE (% of Patients, Placebo-Adjusted; e.g., Oral Pruritus, Headache)
          • Dosing Burden (Drug Formulation and Frequency)
          • Price per Day (USD)
          • Note
        • Conjoint Analysis-Based Simulation of a Market Scenario
          • Severe Allergic Rhinitis Market Simulation: Share of Preference of Target Product Profiles Included in the Market Scenario
          • Severe Allergic Rhinitis Market Simulation: Likelihood to Prescribe Target Product Profiles Included in the Market Scenario
          • Severe Allergic Rhinitis Market Simulation: Target Product Profiles Included in the Market Scenario
      • Appendix
        • Key Abbreviations
        • Experts Interviewed
        • Bibliography

    Author(s): Shubhendu Ghosh, PhD

    Shubhendu Ghosh, Ph.D., is a Business Insights Analyst on the Immune and Inflammatory Disorders team at Decision Resources Group, with a primary focus on asthma.

    Prior to joining DRG, Shubhendu was an Associate Editor at Nature Structural & Molecular Biology and a Copy Editor at Nature Medicine. He was also a Scientific and Developmental Editor at Nature Research Editing Service. Shubhendu received his Ph.D. in Biomedical Sciences from the University of Massachusetts Medical School after completing a B. Sc. in Microbiology from Delhi University and an M. Sc. In Biotechnology from Madurai Kamaraj University.