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COPD Therapeutics in Major Developed Markets to 2021 - Emergence of Addition-in-Class and First-in-Class Products Offsets Sales Erosion of Leading Brands

COPD Therapeutics in Major Developed Markets to 2021 - Emergence of Addition-in-Class and First-in-Class Products Offsets Sales Erosion of Leading Brands

Summary

Chronic Obstructive Pulmonary Disease (COPD) is a progressive disorder associated with chronic inflammation of the airways and lungs. Persistent breathing difficulties and repeated exacerbations of COPD symptoms make the disease one of the leading causes of morbidity, and the fifth-leading cause of death in the world. COPD is linked to cumulative exposure to risk factors, primarily tobacco smoke, but also environmental pollutants. The COPD marketed products landscape consists of pharmacological therapies aimed at managing the symptoms associated with COPD, although none of the available therapies have been shown to modify long-term disease progression.

There are currently 203 products in active development, excluding four with an unknown stage of development. Although many of the targets identified in the pipeline are well established in the management of COPD, there are some novel, first-in-class targets. This reflects the growing understanding of the underlying mechanisms that characterize the disease.

Scope

The COPD market has benefited from notable additions over recent years.

  • Which classes of drug dominate the market?
  • What additional benefits have newly approved therapies brought to market?
  • How do the leading marketed therapies compare clinically?
The pipeline contains a range of molecule types and molecular targets, including those that are well established in COPD, and novel, first-in-class therapies.
  • Which molecular targets appear most frequently in the pipeline?
  • How will the new therapies be positioned in the treatment of COPD?
  • How have selected late-stage pipeline therapies performed in clinical trials?
COPD clinical trials have an overall attrition rate of 89.6%.
  • What are the failure rates for individual Phases of clinical development?
  • How do COPD clinical trial characteristics, including failure rate, duration, and size compare against respiratory and industry averages?
The COPD market is forecast to rise from a value of $9.2 billion in 2014 to $11.2 billion in 2021, at a CAGR of 2.9% across the eight major markets assessed.
  • How much of a role will disease prevalence and new product approvals play in market growth?
  • Will generic competition have a significant impact on the market over the forecast period?
There have been 59 licensing deals and 41 co-development deals pertaining to COPD products since 2006.
  • Which territories show the most deal activity?
  • What were the trends in deal completion by product stage of development?
  • What were the conditions of the key licensing or co-development deals to take place in COPD?
Reasons to buy

This report will allow you to -
  • Understand the current clinical and commercial landscape through a comprehensive study of disease pathogenesis, diagnosis, prognosis, and the current treatment algorithm used in COPD.
  • Assess the safety and efficacy of current treatment options, with extensive product profiles on prominent marketed therapies, and a heatmap directly comparing safety and efficacy data.
  • Analyze the COPD pipeline and stratify by stage of development, molecule type, and molecular target. The most promising late-stage therapies are profiled and assessed in terms of clinical performance and competitiveness, alongside a single-product forecast.
  • Predict growth in market size in eight major markets, with in-depth market forecasting from 2014 to 2021. The forecasts will provide an understanding of how epidemiology trends, new drug entries, and patent expirations will influence market value.
  • Identify commercial opportunities in the COPD deals landscape by analyzing trends in licensing and co-development deals, and by profiling the most significant deals that have occurred in this indication in recent years.


1 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 Introduction
2.1 Disease Introduction
2.2 Symptoms
2.3 Etiology
2.4 Pathophysiology
2.5 Diagnosis
2.6 Assessment of Disease Severity
2.7 Treatment
2.8 Treatment Algorithm
2.8.1 Mild COPD
2.8.2 Moderate-to-Severe COPD
2.8.3 Very Severe COPD
2.8.4 Marketed Products Heat Map
3 Marketed Products
3.1 Product Profiles
3.1.1 Bronchodilator and Inhaled Corticosteroid Combination Therapy
3.1.2 Bronchodilator Monotherapy
3.1.3 Bronchodilator Combination Therapy
3.1.4 Alternative Therapy
3.1.5 Conclusion
3.1.6 Unmet Needs
4 COPD Pipeline
4.1 Molecular Target Analysis
4.2 Clinical Trials
4.2.1 Failure Rate
4.2.2 Clinical Trial Duration
4.2.3 Clinical Trial Size
4.2.4 Comparative Clinical Trial Metrics Analysis
4.3 Promising Pipeline Molecules
4.3.1 Mepolizumab - GSK
4.3.2 Vilanterol Trifenatate - GSK/Theravance
4.3.3 Fluticasone Furoate + Umeclidinium Bromide + Vilanterol Trifenatate - GSK
4.3.4 Budesonide + Formoterol Fumarate + Glycopyrronium (PT010) - AstraZeneca/Pearl Therapeutics
4.3.5 Glycopyrronium + Formoterol Fumarate (PT003) - AstraZeneca/Pearl Therapeutics
4.3.6 Glycopyrronium + Formoterol Fumarate Forecast
4.3.7 Benralizumab - AstraZeneca/MedImmune
4.3.8 TD-4208 - Theravance
4.3.9 Beclomethasone Dipropionate + Formoterol Fumarate + Glycopyrronium - Chiesi Farmaceutici
4.3.10 Heat Map for Pipeline Products
5 Market Forecast to 2021
5.1 Global Market
5.2 North America
5.2.1 Treatment Usage Patterns
5.2.2 Annual Cost of Therapy
5.2.3 Market Size
5.3 Top Five EU Markets
5.3.1 Treatment Usage Patterns
5.3.2 Annual Cost of Therapy
5.3.3 Market Size
5.4 Japan
5.4.1 Treatment Usage Patterns
5.4.2 Annual Cost of Therapy
5.4.3 Market Size
5.5 Drivers and Barriers for the COPD market
5.5.1 Drivers
5.5.2 Barriers
6 Deals and Strategic Consolidations
6.1 Licensing Deals
6.1.1 AstraZeneca Enters into Licensing Agreement with Synairgen for SNG001
6.1.2 Evotec Enters into Licensing Agreement with Zhejiang Conba for EVT 401
6.1.3 Vectura Enters into Licensing Agreement with International Pharma Company for VR315
6.1.4 Almirall Enters into Licensing Agreement with Kyorin for Aclidinium Bromide
6.1.5 Pulmagen Therapeutics Enters into Research and Licensing Agreement with AstraZeneca
6.2 Co-development Deals
6.2.1 Theravance Enters into Development and Commercialization Agreement with Mylan
6.2.2 Five Prime Therapeutics Expands Co-Development Agreement with GSK
6.2.3 Galapagos Enters into Strategic Alliance with Roche
6.2.4 Forest Laboratories Enters into Agreement with Almirall
6.2.5 Forest Laboratories Enters into Co-Development Agreement with Nycomed
7 Appendix
7.1 All Pipeline Drugs by Phase
7.1.1 Discovery
7.1.2 Preclinical
7.1.3 Phase I
7.1.4 Phase II
7.1.5 Phase III
7.1.6 Filed
7.2 Market Forecasts to 2021
7.2.1 Global
7.2.2 US
7.2.3 Canada
7.2.4 UK
7.2.5 France
7.2.6 Germany
7.2.7 Italy
7.2.8 Spain
7.2.9 Japan
7.3 Bibiography
7.4 Abbreviations
7.5 Research Methodology
7.5.1 Secondary Research
7.5.2 Marketed Product Profiles
7.5.3 Late-Stage Pipeline Candidates
7.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products
7.5.5 Forecasting Model
7.5.6 Deals Data Analysis
7.6 Expert Panel Validation
7.7 Contact Us
7.8 Disclaimer
1.2 List of Figures
Figure 1: COPD Market, Global, Marketed Products Heat Map, Moderate to Severe, Efficacy, 2015
Figure 2: COPD Market, Global, Marketed Products Heat Map, Moderate to Severe, Safety, 2015
Figure 3: COPD Market, Global, Marketed Products Heat Map, Very Severe, Efficacy, 2015
Figure 4: COPD Market, Global, Marketed Products Heat Map, Very Severe, Safety, 2015
Figure 5: COPD Market, Global, Pipeline, 2015
Figure 6: COPD Market, Global, Pipeline, Molecular Target, 2015
Figure 7: COPD Market, Global, Pipeline, Molecular Target Tier 2 , 2015
Figure 8: COPD Market, Global, Clinical Trial Failure Rate, 2015
Figure 9: COPD Market, Global, Clinical Trial Failure Rate by Molecular Target, 2015
Figure 10: COPD Market, Global, Clinical Trial Duration by Stage of Development, 2015
Figure 11: COPD Market, Global, Clinical Trial Duration by Stage of Development and Molecule Target, 2006-2015
Figure 12: COPD Market, Global, Clinical Trial Size by Product, 2015
Figure 13: COPD Market, Global, Clinical Trial Size by Individual Clinical Trial, 2015
Figure 14: COPD Market, Global, Clinical Trial Size by Individual Clinical Trial, 2015
Figure 15: COPD Market, Global, Clinical Trial Size by Individual Clinical Trial, 2015
Figure 16: COPD Market, Global, Comparison by Average Trial Metrics by Phase and Molecular Target, 2015
Figure 17: COPD Market, Global, Mepolizumab Market Forecast, 2017-2021
Figure 18: COPD Market, Global, Vilanterol Trifenatate Market Forecast, 2017-2021
Figure 19: COPD Market, Global, Fluticasone Furoate + Umeclidinium Bromide + Vilanterol Trifenatate Market Forecast, 2017-2021
Figure 20: COPD Market, Global, Budesonide + Formoterol Fumarate + Glycopyrronium Market Forecast, 2018-2021
Figure 21: COPD Market, Global, Glycopyrronium + Formoterol Fumarate Market Forecast, 2016-2021
Figure 22: COPD Market, Global, Benralizumab Forecast, 2018-2021
Figure 23: COPD Market, Global, TD-4208 Forecast, 2017-2021
Figure 24: COPD Market, Global, Beclomethasone Dipropionate + Formoterol Fumarate + Glycopyrronium Forecast, 2018-2021
Figure 25: COPD Market, Global, Pipeline Heat map, Efficacy, 2015
Figure 26: COPD Market, Global, Pipeline Heat map, Safety, 2015
Figure 27: COPD Market, Global, Treatment Patterns, Market Size, 2014-2021
Figure 28: COPD Market, North America, Treatment Usage Patterns, 2014-2021
Figure 29: COPD Market, North America, Annual Cost of Therapy ($), 2014-2021
Figure 30: COPD Market, North America, Market Size, 2014-2021
Figure 31: COPD Market, Top Five EU Markets, Treatment Usage Patterns, 2014-2021
Figure 32: COPD Market, Top Five EU Markets, Annual Cost of Therapy, 2014-2021
Figure 33: COPD Market, Top Five EU Markets, Market Size, 2014-2021
Figure 34: COPD Market, Japan, Treatment Usage Patterns, 2014-2021
Figure 35: COPD Market, Japan, Annual Cost of Therapy, 2014-2021
Figure 36: COPD Market, Japan, Market Size, 2014-2021
Figure 37: COPD Market, Global, Licensing Deals by Region, 2006-2015
Figure 38: COPD Market, Global, Licensing Deals by Value, 2006-2015
Figure 39: COPD Market, Global, Number of Disclosed and Undisclosed Licensing Deals by Year, Aggregate Deal Value ($m) and Aggregate Upfront Value ($m), 2006-2015
Figure 40: COPD Market, Global, Licensing Deals by Stage of Development, Deal Value ($m) and Upfront Payment Value ($m), 2006-2015
Figure 41: COPD Market, Global, Licensing Deals by Molecule Type, Stage of Development and Aggregate Deal Value ($m), 2006-2015
Figure 42: COPD Market, Global, Licensing Deals by Mechanism of Action and Aggregate Deal Value ($m), 2006-2015
Figure 43: COPD Market, Global, Co-development Deals by Region, 2006-2015
Figure 44: COPD Market, Global, Co-development Deals by Value, 2006-2015
Figure 45: COPD Market, Global, Number of Disclosed and Undisclosed Co-development Deals by Year, Aggregate Deal Value ($m) and Aggregate Upfront Value ($m), 2006-2015
Figure 46: COPD Market, Global, Co-development Deals by Stage of Development, Deal Value ($m) and Upfront Payment Value ($m), 2006-2015
Figure 47: COPD Market, Global, Co-development Deals by Molecule Type, Stage of Development and Aggregate Deal Value ($m), 2006-2015
Figure 48: COPD Market, Global, Co-development Deals by Mechanism of Action and Aggregate Deal Value ($m), 2006-2015
1.2 List of Figures
Figure 1: COPD Market, Global, Marketed Products Heat Map, Moderate to Severe, Efficacy, 2015
Figure 2: COPD Market, Global, Marketed Products Heat Map, Moderate to Severe, Safety, 2015
Figure 3: COPD Market, Global, Marketed Products Heat Map, Very Severe, Efficacy, 2015
Figure 4: COPD Market, Global, Marketed Products Heat Map, Very Severe, Safety, 2015
Figure 5: COPD Market, Global, Pipeline, 2015
Figure 6: COPD Market, Global, Pipeline, Molecular Target, 2015
Figure 7: COPD Market, Global, Pipeline, Molecular Target Tier 2 , 2015
Figure 8: COPD Market, Global, Clinical Trial Failure Rate, 2015
Figure 9: COPD Market, Global, Clinical Trial Failure Rate by Molecular Target, 2015
Figure 10: COPD Market, Global, Clinical Trial Duration by Stage of Development, 2015
Figure 11: COPD Market, Global, Clinical Trial Duration by Stage of Development and Molecule Target, 2006-2015
Figure 12: COPD Market, Global, Clinical Trial Size by Product, 2015
Figure 13: COPD Market, Global, Clinical Trial Size by Individual Clinical Trial, 2015
Figure 14: COPD Market, Global, Clinical Trial Size by Individual Clinical Trial, 2015
Figure 15: COPD Market, Global, Clinical Trial Size by Individual Clinical Trial, 2015
Figure 16: COPD Market, Global, Comparison by Average Trial Metrics by Phase and Molecular Target, 2015
Figure 17: COPD Market, Global, Mepolizumab Market Forecast, 2017-2021
Figure 18: COPD Market, Global, Vilanterol Trifenatate Market Forecast, 2017-2021
Figure 19: COPD Market, Global, Fluticasone Furoate + Umeclidinium Bromide + Vilanterol Trifenatate Market Forecast, 2017-2021
Figure 20: COPD Market, Global, Budesonide + Formoterol Fumarate + Glycopyrronium Market Forecast, 2018-2021
Figure 21: COPD Market, Global, Glycopyrronium + Formoterol Fumarate Market Forecast, 2016-2021
Figure 22: COPD Market, Global, Benralizumab Forecast, 2018-2021
Figure 23: COPD Market, Global, TD-4208 Forecast, 2017-2021
Figure 24: COPD Market, Global, Beclomethasone Dipropionate + Formoterol Fumarate + Glycopyrronium Forecast, 2018-2021
Figure 25: COPD Market, Global, Pipeline Heat map, Efficacy, 2015
Figure 26: COPD Market, Global, Pipeline Heat map, Safety, 2015
Figure 27: COPD Market, Global, Treatment Patterns, Market Size, 2014-2021
Figure 28: COPD Market, North America, Treatment Usage Patterns, 2014-2021
Figure 29: COPD Market, North America, Annual Cost of Therapy ($), 2014-2021
Figure 30: COPD Market, North America, Market Size, 2014-2021
Figure 31: COPD Market, Top Five EU Markets, Treatment Usage Patterns, 2014-2021
Figure 32: COPD Market, Top Five EU Markets, Annual Cost of Therapy, 2014-2021
Figure 33: COPD Market, Top Five EU Markets, Market Size, 2014-2021
Figure 34: COPD Market, Japan, Treatment Usage Patterns, 2014-2021
Figure 35: COPD Market, Japan, Annual Cost of Therapy, 2014-2021
Figure 36: COPD Market, Japan, Market Size, 2014-2021
Figure 37: COPD Market, Global, Licensing Deals by Region, 2006-2015
Figure 38: COPD Market, Global, Licensing Deals by Value, 2006-2015
Figure 39: COPD Market, Global, Number of Disclosed and Undisclosed Licensing Deals by Year, Aggregate Deal Value ($m) and Aggregate Upfront Value ($m), 2006-2015
Figure 40: COPD Market, Global, Licensing Deals by Stage of Development, Deal Value ($m) and Upfront Payment Value ($m), 2006-2015
Figure 41: COPD Market, Global, Licensing Deals by Molecule Type, Stage of Development and Aggregate Deal Value ($m), 2006-2015
Figure 42: COPD Market, Global, Licensing Deals by Mechanism of Action and Aggregate Deal Value ($m), 2006-2015
Figure 43: COPD Market, Global, Co-development Deals by Region, 2006-2015
Figure 44: COPD Market, Global, Co-development Deals by Value, 2006-2015
Figure 45: COPD Market, Global, Number of Disclosed and Undisclosed Co-development Deals by Year, Aggregate Deal Value ($m) and Aggregate Upfront Value ($m), 2006-2015
Figure 46: COPD Market, Global, Co-development Deals by Stage of Development, Deal Value ($m) and Upfront Payment Value ($m), 2006-2015
Figure 47: COPD Market, Global, Co-development Deals by Molecule Type, Stage of Development and Aggregate Deal Value ($m), 2006-2015
Figure 48: COPD Market, Global, Co-development Deals by Mechanism of Action and Aggregate Deal Value ($m), 2006-2015

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