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Chronic Obstructive Pulmonary Disease Forecast and Market Analysis to 2026

  • Drug Pipelines

  • 64 Pages
  • April 2021
  • Region: Global
  • Citeline
  • ID: 3797418
Disease Overview

Chronic obstructive pulmonary disease (COPD) is defined by persistent airflow limitation (reduction in the ability to exhale at a normal rate and volume). While chronic and progressive dyspnea (shortness of breath) is a key symptom, patients may also present with productive cough. Significant exposure to noxious particles or gases, namely tobacco smoke, is the primary cause of the underlying alveolar and airway abnormalities that result in the airflow limitation and respiratory symptoms that characterize the disease. However, other environmental and occupational exposures or genetic abnormalities may also contribute to symptoms.

Latest Key Takeaways

  • The publisher estimates that in 2018, there were approximately 307.0 million prevalent cases of chronic obstructive pulmonary disease (COPD) worldwide, and forecasts that number to increase to 328.9 million prevalent cases by 2027.
  • The “ABCD” GOLD treatment guidelines focus on exacerbation risk and patient-reported outcomes to determine pharmacological treatment strategies, independent of spirometric value.
  • Dual bronchodilator combinations are being considered as the new gold standard over long-acting muscarinic antagonist (LAMA) Spiriva in the treatment of more severe COPD.
  • Triple inhaled corticosteroid/long-acting beta 2 agonist/long-acting muscarinic antagonist (ICS/LABA/LAMA) fixed-dose combination therapies delivered through a single inhaler bring convenience to more severe patients. For Breztri Aerosphere’s FDA submission, AstraZeneca included data from the KRONOS study, but the ETHOS trial did not complete primary endpoints until mid-2019. As such, the FDA issued a complete response letter to AstraZeneca, benefitting rival GlaxoSmithKline’s marketed Trelegy Ellipta as the only triplet on the US market. More recently, Breztri has gained approval in the US and Europe.
  • IL-5 inhibitors have disappointed in the broader population of more severe COPD patients. However, ongoing studies are evaluating AstraZeneca’s Fasenra and GlaxoSmithKline's Nucala in individuals with high eosinophils. Topline results from Fasenra’s RESOLUTE and Nucala’s MATINEE trials are expected in the coming years, while Phase III results from Sanofi and Regeneron’s dual IL-4 and IL-13 inhibitor Dupixent are expected in 2023.
  • Nebulizers are limited by convenience and often are being developed by smaller companies that lack the commercial resources of large pharma.

Table of Contents

OVERVIEW
  • Latest key takeaways

DISEASE BACKGROUND
  • Disease definition
  • Diagnosis
  • Patient segmentation
  • GOLD treatment recommendations

TREATMENT
  • Maintenance treatment
  • Oral therapies for maintenance treatment
  • Non-pharmacological management of COPD

EPIDEMIOLOGY
  • Prevalence methodology

MARKETED DRUGSPIPELINE DRUGS
KEY REGULATORY EVENTS
  • Hikma Launches Long-Awaited US Advair Rival
  • Trixeo Aerosphere Wins EMA Thumbs Up
  • US FDA Panel Rejects Trelegy Ellipta COPD Mortality Claim; Worries Include Potential Overuse
  • Cipla Files ANDA For Advair Rival; FDA Will Now Consider Indian Firm’s Version Alongside Hikma
  • Can Glenmark’s Triple Therapy Combo Move COPD Treatment Needle?
  • String Of Positives For Lupin Lifts Outlook
  • Cipla Granted Approval For First US Proventil Rival
  • Mylan Launches Advair Rival In Canada

PROBABILITY OF SUCCESS
LICENSING AND ASSET ACQUISITION DEALS
  • Iconovo And Amneal Collaborate On Symbicort Rival
  • Circassia Ends AZ Deal To Dig Itself Out Of Debt Hole

CLINICAL TRIAL LANDSCAPE
  • Sponsors by status
  • Sponsors by phase
  • Recent events

DRUG ASSESSMENT MODEL
  • LAMAs
  • LABAs
  • LABA/LAMAs
  • ICS/LABAs
  • ICS/LABA/LAMAs
  • Biologics
  • PDE3/4 inhibitor

MARKET DYNAMICS
FUTURE TRENDS
  • Triple therapies will drive modest growth of the COPD market
  • The impact of nebulized treatment is limited
  • Biologics present an opportunity that is limited to certain patient subsets

CONSENSUS FORECASTS
RECENT EVENTS AND ANALYST OPINION
  • Trelegy Ellipta for COPD (August 31, 2020)
  • Trelegy Ellipta for COPD (August 28, 2020)
  • Breztri Aerosphere for COPD (June 24, 2020)
  • RPL554 (Inhaled) for COPD (March 31, 2020)
  • Breztri Aerosphere for COPD (October 1, 2019)

KEY UPCOMING EVENTS
UNMET NEEDS
  • Characterizing patient subpopulations
  • Developing more effective means of managing exacerbations
  • Improving inhaler technique and compliance

BIBLIOGRAPHY
  • Prescription information

APPENDIX
LIST OF FIGURES
Figure 1: Trends in prevalent cases of COPD, 2018–27
Figure 2: Overview of pipeline drugs for COPD in the US
Figure 3: Pipeline drugs for COPD, by company
Figure 4: Pipeline drugs for COPD, by drug type
Figure 5: Pipeline drugs for COPD, by classification
Figure 6: Probability of success in the COPD pipeline
Figure 7: Clinical trials in COPD
Figure 8: Top 10 drugs for clinical trials in COPD
Figure 9: Top 10 companies for clinical trials in COPD
Figure 10: Trial locations in COPD
Figure 11: COPD trials status
Figure 12: COPD trials sponsors, by phase
Figure 13: The publisher’s drug assessment summary for COPD
Figure 14: Market dynamics in COPD
Figure 15: Future trends in COPD
Figure 16: Breztri Aerosphere for COPD (June 24, 2020): Phase III - ETHOS
Figure 17: RPL554 (Inhaled) for COPD (March 31, 2020): Phase II - Metered-Dose Inhaler (MDI) Formulation
Figure 18: Key upcoming events in COPD
LIST OF TABLES
Table 1: Modified British Medical Research Council (mMRC) Questionnaire
Table 2: COPD Assessment Test (CAT)
Table 3: COPD assessment, by spirometric grade
Table 4: The “ABCD” assessment tool
Table 5: Inhaled bronchodilators for COPD, by class
Table 6: Combination therapies for COPD, by class
Table 7: Prevalent cases of COPD, 2018–27
Table 8: Marketed drugs for COPD
Table 9: Pipeline drugs for COPD in the US
Table 10: Historical global sales, by drug ($m), 2015–19
Table 11: Forecasted global sales, by drug ($m), 2021–25
Table 12: Trelegy Ellipta for COPD (August 31, 2020)
Table 13: Trelegy Ellipta for COPD (August 28, 2020)
Table 14: Breztri Aerosphere for COPD (June 24, 2020)
Table 15: RPL554 (Inhaled) for COPD (March 31, 2020)
Table 16: Breztri Aerosphere for COPD (October 1, 2019)