Chronic Obstructive Pulmonary Disease – Unmet Need – Detailed, Expanded Analysis: (US/EU)

The severe to very severe chronic obstructive pulmonary disease (COPD) drug market is becoming increasingly crowded as several LAMAs, LABA/ICSs, LABA/LAMAs, and, most recently, LABA/LAMA/ICSs compete for a share of the maintenance space. Unfortunately, none of these agents can reverse the disease’s progression or repair lung tissue; instead, these treatments focus on improving breathing and reducing inflammation. Although inhaled medications are effective in reducing the burden of COPD by easing its symptoms, patients’ quality of life still suffers, and the disease remains one of the leading causes of death worldwide. Thus, significant unmet need remains for more-effective therapies, especially for those patients whose symptoms are not adequately controlled with available therapies.

QUESTIONS ANSWERED

  • What are the key drivers and goals of treatment of severe to very severe COPD? How do current therapies such as Boehringer Ingelheim’s Spiriva, GlaxoSmithKline’s Anoro and Trelegy, and AstraZeneca’s Symbicort perform on these measures?
  • What drug attributes are key influencers on pulmonologists’ prescribing decisions, which have limited impact, and which are hidden opportunities?
  • What are the prevailing areas of unmet need and opportunity in the treatment of severe to very severe COPD?
  • What trade-offs across different clinical / nonclinical attributes and prices are acceptable to U.S. and European pulmonologists for a hypothetical new COPD 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 Clarivate 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 pulmonologists fielded in February 2021

Key companies: AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline

Key drugs: Advair / Seretide, Anoro, Spiriva, Stiolto / Spiolto, Symbicort, Trelegy, Yupelri

Table of contents

  • Chronic Obstructive Pulmonary Disease - Unmet Need - Detailed, Expanded Analysis: (US/EU)
    • Executive Summary
      • Unmet Need - Severe to Very Severe COPD - Executive Summary - May 2021
    • Introduction
      • Overview
      • Methodology
      • Rationale for Treatment Drivers and Goals Selection
        • Rationale for Drug Selection
          • Products for Severe to Very Severe COPD 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 Pulmonologists' Prescribing Decisions in Severe to Very Severe COPD
        • Importance of Efficacy Attributes to Prescribing Decisions in Severe to Very Severe COPD: United States
        • Importance of Efficacy Attributes to Prescribing Decisions in Severe to Very Severe COPD: Europe
        • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Severe to Very Severe COPD: United States
        • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Severe to Very Severe COPD: Europe
        • Importance of Convenience of Administration Attributes to Prescribing Decisions in Severe to Very Severe COPD: United States
        • Importance of Convenience of Administration Attributes to Prescribing Decisions in Severe to Very Severe COPD: Europe
        • Importance of Nonclinical Factors to Prescribing Decisions in Severe to Very Severe COPD: United States
        • Importance of Nonclinical Factors to Prescribing Decisions in Severe to Very Severe COPD: 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 to Very Severe COPD: United States
        • Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in Severe to Very Severe COPD: Europe
      • Product Performance Against Treatment Drivers and Goals
        • Key Findings
        • Overall Performance of Key Therapies for Severe to Very Severe COPD: United States
        • Overall Performance of Key Therapies for Severe to Very Severe COPD: Europe
        • Mean Overall Performance of Key Therapies for Severe to Very Severe COPD: United States and Europe
        • Relative Performance of Key Therapies for Severe to Very Severe COPD Across Select Efficacy Attributes: United States
        • Relative Performance of Key Therapies for Severe to Very Severe COPD Across Select Efficacy Attributes: Europe
        • Relative Performance of Key Therapies for Severe to Very Severe COPD Across Select Safety and Tolerability Attributes: United States
        • Relative Performance of Key Therapies for Severe to Very Severe COPD Across Select Safety and Tolerability Attributes: Europe
        • Relative Performance of Key Therapies for Severe to Very Severe COPD Across Select Convenience of Administration Attributes: United States
        • Relative Performance of Key Therapies for Severe to Very Severe COPD Across Select Convenience of Administration Attributes: Europe
        • Relative Performance of Key Therapies for Severe to Very Severe COPD Across Select Nonclinical Attributes: United States
        • Relative Performance of Key Therapies for Severe to Very Severe COPD Across Select Nonclinical Attributes: Europe
      • Assessment of Unmet Need
        • Key Findings: Unmet Need in Severe to Very Severe COPD
        • Surveyed Pulmonologistsu2019 Satisfaction with the Performance of Key Therapies for Severe to Very Severe COPD on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: United States
        • Surveyed Pulmonologistsu2019 Satisfaction with the Performance of Key Therapies for Severe to Very Severe COPD on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: Europe
        • Surveyed Pulmonologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Severe to Very Severe COPD: United States
        • Surveyed Pulmonologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Severe to Very Severe COPD: Europe
        • Surveyed Pulmonologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Severe to Very Severe COPD: United States
        • Surveyed Pulmonologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Severe to Very Severe COPD: Europe
        • Surveyed Pulmonologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Severe to Very Severe COPD: United States
        • Surveyed Pulmonologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Severe to Very Severe COPD: Europe
        • Surveyed Pulmonologists' Ascribed Level of Unmet Need Across Key Nonclinical Factors in Severe to Very Severe COPD: United States
        • Surveyed Pulmonologists' Ascribed Level of Unmet Need Across Key Nonclinical Factors in Severe to Very Severe COPD: Europe
        • Key Findings: Unmet Need in Severe to Very Severe COPD and Related Indications
        • Surveyed Pulmonologists' Ascribed Level of Unmet Need in Severe to Very Severe COPD and Related Indications: United States
        • Surveyed Pulmonologists' Ascribed Level of Unmet Need in Severe to Very Severe COPD and Related Indications: Europe
      • Opportunity Analysis
        • Areas of Opportunity in the Severe to Very Severe COPD Market and Emerging Therapy Insights
          • Opportunity: Therapies That Can Lead to a Greater Reduction in the Exacerbation Rate
          • Opportunity: Therapies That Can Reduce Daily Symptoms and Thus Improve Quality of Life
          • Opportunity: Therapies Demonstrating Greater Improvement in Lung Function Compared with Current Therapy
          • Opportunity: Disease-Modifying Therapies
      • Target Product Profiles
        • Assessing Drug Development Opportunities
        • Target Product Profile Methodology
          • Attributes and Attribute Levels
          • Attributes of Key Current Therapies for Severe to Very Severe COPD
        • Attribute Importance and Part-Worth Utilities
          • Severe to Very Severe COPD Target Product Profile: Attribute Importance
          • Improvement in Trough FEV1 at 52 Weeks (Placebo-Adjusted)
          • Reduction in Frequency of Exacerbations over 52 Weeks (% Reduction, Placebo-Adjusted)
          • QOL Improvement at 12 Weeks (% Patients with SGQR Score Gain of 4+, Placebo-Adjusted)
          • Improvement in Exercise Endurance at Six Weeks (%, Placebo-Adjusted)
          • Rate of Severe Adverse Events over 52 Weeks (% of Patients, Placebo-Adjusted)
          • Delivery Burden (Formulation and Frequency)
          • Price per Day
          • Note
        • Conjoint Analysis-Based Simulation of a Market Scenario
          • Market Scenario
          • Severe to Very Severe COPD Market Simulation: Share of Preference of Target Product Profiles Included in the Market Scenario
          • Severe to Very Severe COPD Market Simulation: Likelihood to Prescribe Target Product Profiles Included in the Market Scenario
          • Severe to Very Severe COPD Market Simulation: Target Product Profiles Included in the Market Scenario
      • Appendix
        • Key Abbreviations
        • Bibliography