Chronic Obstructive Pulmonary Disease – Unmet Need – Chronic Obstructive Pulmonary Disease | Unmet Need | Severe | US/EU | 2022

MARKET OUTLOOK

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 shares of the maintenance drug space. Unfortunately, none of these agents can reverse disease progression or repair lung tissue; instead, current drug treatment focuses 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 or disease-modifying therapies, especially for patients with more-severe COPD whose symptoms are not adequately controlled with available therapies.

QUESTIONS ANSWERED

  • What are the key treatment drivers and goals for severe to very severe COPD?
  • What drug attributes are key influencers to pulmonologists’ prescribing decisions, which have limited impact, and which are hidden opportunities?
  • How do current therapies, such as BI’s Spiriva, GSK’s Anoro and Trelegy, and AstraZeneca’s Symbicort, perform on these measures? What is pulmonologists’ perception of the performance of Advair compared with its generic, Mylan’s Wixela, on these measures?
  • What are the prevailing areas of unmet need and opportunity in severe to very severe COPD?
  • What trade-offs across different clinical / nonclinical attributes and price are acceptable to U.S. and European pulmonologists for a hypothetical new COPD 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 62 U.S. and 32 European pulmonologists fielded in February 2022

Key companies: GSK, Boehringer Ingelheim, AstraZeneca, Mylan

Key drugs: Advair / Seretide, Anoro, Spiriva, Stiolto / Spiolto, Symbicort, Trelegy, Wixela (generic)

Table of contents

  • Chronic Obstructive Pulmonary Disease - Unmet Need - Chronic Obstructive Pulmonary Disease | Unmet Need | Severe | US/EU | 2022
    • Executive summary
      • Unmet Need - severe to very severe COPD - Executive Summary - April 2022 Updated
    • 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 COPD-related symptoms and thus improve quality of life
          • Opportunity: therapies that can reduce all-cause mortality rate
          • 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 (% of patients with SGRQ score gain of 4+, placebo-adjusted)
          • Improvement in total E-RS score at 24 weeks (compared with SOC)
          • Rate of severe adverse events over 52 weeks (% of patients, placebo-adjusted)
          • Delivery burden (formulation and frequency)
          • Price per day
        • Conjoint Analysis-Based Simulation of a 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
        • Bibliography

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