Chronic Obstructive Pulmonary Disease

Published by: Decision Resources

Published: Mar. 12, 2012 - 219 Pages


Table of Contents

Executive Summary
What are the key parameters of the COPD market?
What factors are driving the market for COPD therapies?
What factors are constraining the market for COPD therapies?
What are the drug development activities of note in COPD?
What do the experts say?
What key challenges and opportunities remain?
1. Etiology and Pathophysiology
Overview
Disease Definition According to Current Guidelines
Spirometric Measurement and Disease Severity
Differentiating COPD and Asthma
Anatomy
Etiology
Exposure to Noxious Particles
Smoking
Other Exposure Risks
Impaired Lung Development
Genetic Factors
Alpha1-Antitrypsin
Other Potential Genetic Factors
Other Risk Factors
Age
Nutrition
Socioeconomic Status
Pathophysiology
Causes of Airflow Limitation
Small Airway Diseases
Lung Parenchyma Destruction
Systemic Manifestations
Role of Inflammatory Cells
Macrophages
Neutrophils
T Lymphocytes
Other Implicated Inflammatory Cells
Receptors and Proteins Implicated in Inflammation
Protease-Antiprotease Imbalance
Oxidative Stress
COPD Progression
Airway Remodeling
COPD Comorbidities
Biomarkers of COPD
2. Epidemiology and Patient Populations
Overview
Disease Definition
Methods
Subpopulations
Severity
Comorbidity
Diagnosed and Drug-Treated Populations
Percentage Diagnosed
Percentage Drug-Treated
3. Current Therapies and Medical Practice
Treatment Providers
Goals of Treatment
Formulations and Devices for Respiratory Drug Delivery
Currently Marketed Products
4. Unmet Needs
Overview
Disease-Modifying Pharmacotherapies
Improvements in Diagnosis
More-Effective Smoking Cessation Therapies
Effective Anti-Inflammatory Drugs
Greater Understanding of Systemic Manifestations of COPD
Improved Convenience and Drug Delivery
5. Emerging Therapies
Overview
Future Positioning of Key Competitors
Early-Stage Therapies
Disease-Modifying Therapies
Protease Inhibitors
Retinoic Acid Receptor Agonists
Anti-Inflammatory Drugs
Oral Small-Molecule Inhibitors of Inflammatory Mediators
Inhaled Small-Molecule Inhibitors of Inflammatory Mediators
Biological Immunomodulators and Stem Cells
Drug Development and Regulatory Hurdles
Long-Acting Beta2 Agonists
Overview
Mechanism of Action
Olodaterol
Vilanterol
Chronic Obstructive Pulmonary Disease
Long-Acting Muscarinic Antagonists
Overview
Mechanism of Action
Glycopyrronium
Aclidinium
GSK-573719
Long-Acting Beta2 Agonist/Inhaled Corticosteroid Combinations
Overview
Mechanism of Action
Vilanterol/Fluticasone Furoate
Indacaterol/Mometasone
Formoterol/Mometasone
Formoterol/Fluticasone Propionate
Long-Acting Beta2 Agonist/Long-Acting Muscarinic Antagonist Combinations
Overview
Mechanism of Action
Olodaterol/Tiotropium
Indacaterol/Glycopyrronium
Vilanterol/GSK-573719
Formoterol/Aclidinium
Formoterol/Glycopyrrolate
Nonpharmacological Approaches
6. Market Outlook
Overview
Drug-Class-Specific Trends
Long-Acting Beta2 Agonist/Inhaled Corticosteroid Combinations
Long-Acting and Short-Acting Muscarinic Antagonists
Long-Acting Beta2 Agonist/Long-Acting Muscarinic Antagonist Combinations
Short-Acting Beta2 Agonists
Inhaled Corticosteroids
Long-Acting Beta2 Agonists
Short-Acting Beta2 Agonist/Short-Acting Muscarinic Antagonist Combinations
Methylxanthines
Phosphodiesterase IV Inhibitors
Appendix A. Bibliography—Chronic Obstructive Pulmonary Disease
Appendix B. Market Forecast Methodology
Bottom-Up Market Forecasting Overview
Patient Populations
Drug-Specific Assumptions
General Sources of Data
Pricing, Dosing, Days of Therapy, and Compliance Assumptions
General Statements About Pricing
Dosing, Days of Therapy, and Compliance
Long-Acting Beta2 Agonist/Inhaled Corticosteroid Combinations
Long-Acting Muscarinic Antagonists
Short-Acting Beta2 Agonists
Inhaled Corticosteroids
Long-Acting Beta2 Agonists
Short-Acting Beta2 Agonist/Short-Acting Muscarinic Antagonist Combinations
Short-Acting Muscarinic Antagonists
Phosphodiesterase 4 Inhibitors
Methylxanthines
Generic Erosion
Emerging Therapy Prices
Long-Acting Beta2 Agonist/Inhaled Corticosteroid Combinations
Long-Acting Muscarinic Antagonists
Long-Acting Beta2 Agonist/Long-Acting Muscarinic Antagonists
Inhaled Corticosteroids
Long-Acting Beta2 Agonists
Appendix C. Experts Interviewed—Chronic Obstructive Pulmonary Disease
Appendix D. Supplemental Epidemiology Bibliography
Tables and Figures
Table 1-1. Comparison of the Clinical and Pathological Characteristics of Chronic Obstructive Pulmonary Disease and Asthma
Table 1-2. Potential Biomarkers of Chronic Obstructive Pulmonary Disease
Table 2-1. Number of Total Prevalent Cases of Chronic Obstructive Pulmonary Disease in the Major Pharmaceutical Markets by Severity, 2010-2020
Table 2-2. Number of Total, Diagnosed, and Drug-Treated Prevalent Cases of Chronic Obstructive Pulmonary Disease in the Major Pharmaceutical Markets, 2010-2020
Table 2-3. Key Sources for Chronic Obstructive Pulmonary Disease Epidemiology and Model Parameters
Table 3-1. Chronic Obstructive Pulmonary Disease Treatment Providers and Referral Patterns by Market
Table 3-2. End Points Used in Clinical Trials for Chronic Obstructive Pulmonary Disease
Table 3-3. Inhaler Devices for Chronic Obstructive Pulmonary Disease
Table 3-4. Current Classes Used for Chronic Obstructive Pulmonary Disease—Mechanism of Action
Table 3-5. Current Therapies Used for Chronic Obstructive Pulmonary Disease
Table 3-6. Comparison of Current Drug Classes for Chronic Obstructive Pulmonary Disease
Table 3-7. Comparison of Clinical Efficacy of Select Chronic Obstructive Pulmonary Disease Therapies—Lung Function
Table 3-8. Comparison of Clinical Efficacy of Select Chronic Obstructive Pulmonary Disease Therapies—Health-Related Quality of Life
Table 3-9. Comparison of Clinical Efficacy of Select Chronic Obstructive Pulmonary Disease Therapies—Reduction in Exacerbations
Table 3-10. Comparison of Clinical Efficacy of Select Chronic Obstructive Pulmonary Disease Therapies—Changes in Dyspnea
Table 3-11. Expert Insight: Leading Therapies in Chronic Obstructive Pulmonary Disease
Table 3-12. Differentiating Features of New and Leading Drugs in Chronic Obstructive Pulmonary Disease
Table 3-13. Chronic Obstructive Pulmonary Disease Treatment Guidelines by Market
Table 3-14. Factors Influencing Drug Selection in Chronic Obstructive Pulmonary Disease
Table 3-15. Factors Influencing Selection of a Generic Drug over a Branded Drug for Chronic Obstructive Pulmonary Disease, by Market
Table 3-16. Expert Insight on Prescribing Practices by Market
Table 3-17 . Reimbursement Environment by Market
Table 5-1. Emerging Therapies in Development for Chronic Obstructive Pulmonary Disease
Table 5-2. Estimated Launch Dates for Key Emerging Therapies for the Treatment of Chronic Obstructive Pulmonary Disease
Table 5-3. Early-Stage Emerging Therapies in Development for Chronic Obstructive Pulmonary Disease
Table 6-1. Sales of Drugs to Treat Chronic Obstructive Pulmonary Disease (all populations) in the Major Pharmaceutical Markets, 2010-2020
Table 6-2. Timeline of Key Market Events for Chronic Obstructive Pulmonary Disease
Table B-1 . Sources for Drug Prices
Figure 1-1. Lung Anatomy and Pathogenic Processes in Chronic Obstructive Pulmonary Disease
Figure 1-2. Inflammatory Mechanisms of Chronic Obstructive Pulmonary Disease
Figure 2-1. Total Prevalent Cases and Prevalence of Chronic Obstructive Pulmonary Disease in the Major Pharmaceutical Markets, 2010
Figure 3-1. Current Treatment Algorithm for Stable Chronic Obstructive Pulmonary Disease in the Major Pharmaceutical Markets
Figure 4-1. Unmet Needs: Attainment and Remaining Opportunity in Chronic Obstructive Pulmonary Disease
Figure 6-1. Chronic Obstructive Pulmonary Disease Therapies, 2010-2020: Market Share
Figure 6-2. Timeline of Near-Term Events in Chronic Obstructive Pulmonary Disease

Abstract

The sizeable therapeutic market for chronic obstructive pulmonary disease (COPD), a disease that is closely affiliated with smoking, continues to expand. More patients are diagnosed with COPD every year as populations age, efforts to promote awareness of the disease continue, and the use of spirometry to diagnose COPD becomes more widespread. The expanding COPD patient population has great unmet need because truly disease-modifying pharmacotherapies are lacking; current treatments merely alleviate symptoms and do not slow or reverse the progression of COPD. However, large gains are possible in the COPD market for therapies that offer incremental improvements in existing treatment modalities. For example, improving COPD patients’ compliance with their medications by offering more convenient dosing will lead to better treatment outcomes as well as market growth. Major-market COPD sales will grow substantially over our forecast period owing to the uptake of once-daily, fixed-dose combinations.

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