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COPD Therapeutics in Major Developed Markets to 2021

COPD Therapeutics in Major Developed Markets to 2021


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Executive Summary

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

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 USD 9.2 billion in 2014 to USD 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 Table of Contents 5

1.1 List of Tables 7

1.2 List of Figures 7

2 Introduction 9

2.1 Disease Introduction 9

2.2 Symptoms 9

2.3 Etiology 9

2.4 Pathophysiology 10

2.5 Diagnosis 10

2.6 Assessment of Disease Severity 11

2.7 Treatment 12

2.8 Treatment Algorithm 14

2.8.1 Mild COPD 14

2.8.2 Moderate-to-Severe COPD 15

2.8.3 Very Severe COPD 16

2.8.4 Marketed Products Heat Map 17

3 Marketed Products 21

3.1 Product Profiles 22

3.1.1 Bronchodilator and Inhaled Corticosteroid Combination Therapy 22

3.1.2 Bronchodilator Monotherapy 24

3.1.3 Bronchodilator Combination Therapy 28

3.1.4 Alternative Therapy 30

3.1.5 Conclusion 31

3.1.6 Unmet Needs 32

4 COPD Pipeline 33

4.1 Molecular Target Analysis 35

4.2 Clinical Trials 40

4.2.1 Failure Rate 40

4.2.2 Clinical Trial Duration 42

4.2.3 Clinical Trial Size 44

4.2.4 Comparative Clinical Trial Metrics Analysis 48

4.3 Promising Pipeline Molecules 49

4.3.1 Mepolizumab-GSK 49

4.3.2 Vilanterol Trifenatate-GSK/Theravance 50

4.3.3 Fluticasone Furoate + Umeclidinium Bromide + Vilanterol Trifenatate-GSK 51

4.3.4 Budesonide + Formoterol Fumarate + Glycopyrronium (PT010)-AstraZeneca/Pearl Therapeutics 53

4.3.5 Glycopyrronium + Formoterol Fumarate (PT003)-AstraZeneca/Pearl Therapeutics 54

4.3.6 Glycopyrronium + Formoterol Fumarate Forecast 55

4.3.7 Benralizumab-AstraZeneca/MedImmune 56

4.3.8 TD-4208-Theravance 57

4.3.9 Beclomethasone Dipropionate + Formoterol Fumarate + Glycopyrronium-Chiesi Farmaceutici 59

4.3.10 Heat Map for Pipeline Products 61

5 Market Forecast to 2021 63

5.1 Global Market 64

5.2 North America 66

5.2.1 Treatment Usage Patterns 66

5.2.2 Annual Cost of Therapy 67

5.2.3 Market Size 69

5.3 Top Five EU Markets 70

5.3.1 Treatment Usage Patterns 70

5.3.2 Annual Cost of Therapy 72

5.3.3 Market Size 73

5.4 Japan 75

5.4.1 Treatment Usage Patterns 75

5.4.2 Annual Cost of Therapy 75

5.4.3 Market Size 76

5.5 Drivers and Barriers for the COPD market 77

5.5.1 Drivers 77

5.5.2 Barriers 78

6 Deals and Strategic Consolidations 79

6.1 Licensing Deals 79

6.1.1 AstraZeneca Enters into Licensing Agreement with Synairgen for SNG001 84

6.1.2 Evotec Enters into Licensing Agreement with Zhejiang Conba for EVT 401 84

6.1.3 Vectura Enters into Licensing Agreement with International Pharma Company for VR315 85

6.1.4 Almirall Enters into Licensing Agreement with Kyorin for Aclidinium Bromide 85

6.1.5 Pulmagen Therapeutics Enters into Research and Licensing Agreement with AstraZeneca 85

6.2 Co-development Deals 85

6.2.1 Theravance Enters into Development and Commercialization Agreement with Mylan 90

6.2.2 Five Prime Therapeutics Expands Co-Development Agreement with GSK 90

6.2.3 Galapagos Enters into Strategic Alliance with Roche 91

6.2.4 Forest Laboratories Enters into Agreement with Almirall 91

6.2.5 Forest Laboratories Enters into Co-Development Agreement with Nycomed 91

7 Appendix 92

7.1 All Pipeline Drugs by Phase 92

7.1.1 Discovery 92

7.1.2 Preclinical 94

7.1.3 Phase I 99

7.1.4 Phase II 101

7.1.5 Phase III 104

7.1.6 Filed 106

7.2 Market Forecasts to 2021 106

7.2.1 Global 106

7.2.2 US 106

7.2.3 Canada 107

7.2.4 UK 107

7.2.5 France 108

7.2.6 Germany 108

7.2.7 Italy 109

7.2.8 Spain 109

7.2.9 Japan 110

7.3 Bibiography 110

7.4 Abbreviations 117

7.5 Research Methodology 118

7.5.1 Secondary Research 119

7.5.2 Marketed Product Profiles 119

7.5.3 Late-Stage Pipeline Candidates 119

7.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 119

7.5.5 Forecasting Model 120

7.5.6 Deals Data Analysis 121

7.6 Expert Panel Validation 122

7.7 Contact Us 122

7.8 Disclaimer 122

1.1 List of Tables

Table 1: COPD Market, Disease Severity, 2015 11

Table 2: COPD Market, Patient Risk Categories, 2015 12

Table 3: COPD Market, Treatment Algorithm, 2015 14

Table 4: COPD Market, Global, Pipeline Products, Discovery, 2015 92

Table 5: COPD Market, Global, Pipeline Products, Preclinical, 2015 94

Table 6: COPD Market, Global, Pipeline Products, Phase I, 2015 99

Table 7: COPD Market, Global, Pipeline Products, Phase II, 2015 101

Table 8: COPD Market, Global, Pipeline Products, Phase III, 2015 104

Table 9: COPD Market, Global, Pipeline Products, Filed, 2015 106

Table 10: COPD Market, Global, Market Forecast, 2014-2021 106

Table 11: COPD Market, US, Market Forecast, 2014-2021 106

Table 12: COPD Market, Canada, Market Forecast, 2014-2021 107

Table 13: COPD Market, UK, Market Forecast, 2014-2021 107

Table 14: COPD Market, France, Market Forecast, 2014-2021 108

Table 15: COPD Market, Germany, Market Forecast, 2014-2021 108

Table 16: COPD Market, Italy, Market Forecast, 2014-2021 109

Table 17: COPD Market, Spain, Market Forecast, 2014-2021 109

Table 18: COPD Market, Japan, Market Forecast, 2014-2021 110

1.2 List of Figures

Figure 1: COPD Market, Global, Marketed Products Heat Map, Moderate to Severe, Efficacy, 2015 17

Figure 2: COPD Market, Global, Marketed Products Heat Map, Moderate to Severe, Safety, 2015 18

Figure 3: COPD Market, Global, Marketed Products Heat Map, Very Severe, Efficacy, 2015 19

Figure 4: COPD Market, Global, Marketed Products Heat Map, Very Severe, Safety, 2015 20

Figure 5: COPD Market, Global, Pipeline, 2015 34

Figure 6: COPD Market, Global, Pipeline, Molecular Target, 2015 36

Figure 7: COPD Market, Global, Pipeline, Molecular Target Tier 2 , 2015 39

Figure 8: COPD Market, Global, Clinical Trial Failure Rate, 2015 40

Figure 9: COPD Market, Global, Clinical Trial Failure Rate by Molecular Target, 2015 41

Figure 10: COPD Market, Global, Clinical Trial Duration by Stage of Development, 2015 42

Figure 11: COPD Market, Global, Clinical Trial Duration by Stage of Development and Molecule Target, 2006-2015 43

Figure 12: COPD Market, Global, Clinical Trial Size by Product, 2015 44

Figure 13: COPD Market, Global, Clinical Trial Size by Individual Clinical Trial, 2015 45

Figure 14: COPD Market, Global, Clinical Trial Size by Individual Clinical Trial, 2015 46

Figure 15: COPD Market, Global, Clinical Trial Size by Individual Clinical Trial, 2015 47

Figure 16: COPD Market, Global, Comparison by Average Trial Metrics by Phase and Molecular Target, 2015 48

Figure 17: COPD Market, Global, Mepolizumab Market Forecast, 2017-2021 50

Figure 18: COPD Market, Global, Vilanterol Trifenatate Market Forecast, 2017-2021 51

Figure 19: COPD Market, Global, Fluticasone Furoate + Umeclidinium Bromide + Vilanterol Trifenatate Market Forecast, 2017-2021 52

Figure 20: COPD Market, Global, Budesonide + Formoterol Fumarate + Glycopyrronium Market Forecast, 2018-2021 54

Figure 21: COPD Market, Global, Glycopyrronium + Formoterol Fumarate Market Forecast, 2016-2021 55

Figure 22: COPD Market, Global, Benralizumab Forecast, 2018-2021 57

Figure 23: COPD Market, Global, TD-4208 Forecast, 2017-2021 58

Figure 24: COPD Market, Global, Beclomethasone Dipropionate + Formoterol Fumarate + Glycopyrronium Forecast, 2018-2021 60

Figure 25: COPD Market, Global, Pipeline Heat map, Efficacy, 2015 61

Figure 26: COPD Market, Global, Pipeline Heat map, Safety, 2015 61

Figure 27: COPD Market, Global, Treatment Patterns, Market Size, 2014-2021 64

Figure 28: COPD Market, North America, Treatment Usage Patterns, 2014-2021 66

Figure 29: COPD Market, North America, Annual Cost of Therapy (USD ), 2014-2021 68

Figure 30: COPD Market, North America, Market Size, 2014-2021 69

Figure 31: COPD Market, Top Five EU Markets, Treatment Usage Patterns, 2014-2021 71

Figure 32: COPD Market, Top Five EU Markets, Annual Cost of Therapy, 2014-2021 72

Figure 33: COPD Market, Top Five EU Markets, Market Size, 2014-2021 74

Figure 34: COPD Market, Japan, Treatment Usage Patterns, 2014-2021 75

Figure 35: COPD Market, Japan, Annual Cost of Therapy, 2014-2021 76

Figure 36: COPD Market, Japan, Market Size, 2014-2021 76

Figure 37: COPD Market, Global, Licensing Deals by Region, 2006-2015 80

Figure 38: COPD Market, Global, Licensing Deals by Value, 2006-2015 81

Figure 39: COPD Market, Global, Number of Disclosed and Undisclosed Licensing Deals by Year, Aggregate Deal Value (USD m) and Aggregate Upfront Value (USD m), 2006-2015 81

Figure 40: COPD Market, Global, Licensing Deals by Stage of Development, Deal Value (USD m) and Upfront Payment Value (USD m), 2006-2015 82

Figure 41: COPD Market, Global, Licensing Deals by Molecule Type, Stage of Development and Aggregate Deal Value (USD m), 2006-2015 83

Figure 42: COPD Market, Global, Licensing Deals by Mechanism of Action and Aggregate Deal Value (USD m), 2006-2015 84

Figure 43: COPD Market, Global, Co-development Deals by Region, 2006-2015 86

Figure 44: COPD Market, Global, Co-development Deals by Value, 2006-2015 87

Figure 45: COPD Market, Global, Number of Disclosed and Undisclosed Co-development Deals by Year, Aggregate Deal Value (USD m) and Aggregate Upfront Value (USD m), 2006-2015 87

Figure 46: COPD Market, Global, Co-development Deals by Stage of Development, Deal Value (USD m) and Upfront Payment Value (USD m), 2006-2015 88

Figure 47: COPD Market, Global, Co-development Deals by Molecule Type, Stage of Development and Aggregate Deal Value (USD m), 2006-2015 89

Figure 48: COPD Market, Global, Co-development Deals by Mechanism of Action and Aggregate Deal Value (USD m), 2006-2015 90

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