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1 Table of Contents
1 Table of Contents 5
1.1 List of Tables 8
1.2 List of Figures 8
2 Introduction 10
2.1 Disease Introduction 10
2.2 Epidemiology 10
2.3 Symptoms 11
2.4 Etiology and Pathophysiology 12
2.4.1 Pathophysiology 13
2.5 Diagnosis 13
2.6 Disease Stages 14
2.7 Prognosis 14
2.8 Treatment Options 15
2.8.1 Treatment Algorithm 16
3 Marketed Products 18
3.1 Overview 18
3.2 Bronchodilator Combination Therapy 18
3.2.1 Brimica/Duaklir Genuair (aclidinium/formoterol) - AstraZeneca 18
3.2.2 Spiolto/Stiolto Respimat (tiotropium/olodaterol) - Boehringer Ingelheim 20
3.2.3 Ultibro (glycopyrronium/indacaterol) - Novartis 21
3.2.4 Anoro Ellipta (umeclidinium/vilanterol) - GlaxoSmithKline/Theravance 22
3.2.5 Combivent (ipratropium/albuterol) - Boehringer Ingelheim 22
3.3 Bronchodilator and Inhaled Corticosteroid Combination Therapy 23
3.3.1 Symbicort (budesonide/formoterol) - AstraZeneca 23
3.3.2 Seretide/Advair (salmeterol/fluticasone) - GlaxoSmithKline 24
3.3.3 Relvar/Breo (fluticasone and vilanterol) - GlaxoSmithKline/Theravance 25
3.4 Bronchodilator Monotherapy 26
3.4.1 Spiriva (Tiotropium) - Boehringer Ingelheim 26
3.4.2 Foradil (formoterol) - Novartis 27
3.4.3 Onbrez/Arbeela/Arcapta (indacaterol) - Novartis 27
3.4.4 Seebri /Tovanor (glycopyrronium) - Novartis 28
3.4.5 Striverdi Respimat (Olodaterol) - Boehringer Ingelheim 29
3.5 Alternative therapy 30
3.5.1 Daxas (roflumilast) - Nycomeds 30
3.6 Marketed Products Heat Map 31
4 Pipeline Analysis 36
4.1 Overview 36
4.2 Pipeline Distribution by Stage of Development, Molecule Type, Route of Administration and Program Type 36
4.3 Pipeline Distribution by Molecular Target 38
4.4 Promising Pipeline Candidates 41
4.4.1 Mepolizumab - GlaxoSmithKline 41
4.4.2 Benralizumab - AstraZeneca and MedImmune 42
4.4.3 PT003 - AstraZeneca/Pearl Therapeutics 44
4.4.4 PT010 - AstraZeneca/Pearl Therapeutics 46
4.4.5 Fluticasone Furoate, Umeclidinium Bromide and Vilanterol Trifenatate -GlaxoSmithKline 47
4.5 Heatmap for Pipeline Products 49
4.6 Product Competitiveness Framework 51
5 Clinical Trial Analysis 54
5.1 Failure Rate 54
5.1.1 Overall Failure Rate 54
5.1.2 Failure Rate by Phase and Molecule Type 55
5.1.3 Failure Rate by Phase and Molecular Target 56
5.2 Clinical Trial Duration 57
5.2.1 Clinical Trial Duration by Molecule Type 57
5.2.2 Clinical Trial Duration by Molecular Target 58
5.3 Clinical Trial Size 59
5.3.1 Patient Enrollment per Product by Molecule Type, Molecular Target and Phase 59
5.3.2 Patient Enrollment per Trial by Molecule Type, Molecular Target and Phase 61
5.4 Competitive Clinical Trials Metrics Analysis 63
6 Multi-scenario Forecast 65
6.1 Geographical Markets 65
6.2 Asia-Pacific Market 66
6.3 India 67
6.3.1 Treatment Usage Patterns 67
6.3.2 Annual Cost of Therapy 68
6.3.3 Market Size 70
6.4 China 71
6.4.1 Treatment Usage Patterns 71
6.4.2 Annual Cost of Therapy 72
6.4.3 Market Size 73
6.5 Australia 74
6.5.1 Treatment Usage Patterns 74
6.5.2 Annual Cost of Therapy 74
6.5.3 Market Size 76
6.6 South Korea 77
6.6.1 Treatment Usage Patterns 77
6.6.2 Annual Cost of Therapy 78
6.6.3 Market Size 79
6.7 Japan 80
6.7.1 Treatment Usage Patterns 80
6.7.2 Annual Cost of Therapy 80
6.7.3 Market Size 81
7 Drivers and Barriers 83
7.1 Drivers 83
7.1.1 Active Pipeline 83
7.1.2 Promising Late-Stage Pipeline Products Can Change Treatment Paradigm 83
7.1.3 Increasing Awareness of COPD 83
7.1.4 Ageing Population 84
7.2 Barriers 84
7.2.1 Sales Erosion by Generics 84
7.2.2 Growing Competition 84
7.2.3 Low Diagnosis Rates 84
8 Deals and Strategic Consolidations 85
8.1 Licensing Deals 85
8.1.1 Deals by Region and Value 85
8.1.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 86
8.1.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 86
8.1.4 Key Licensing Deals 89
8.2 Co-development Deals 91
8.2.1 Deals by Region and Value 91
8.2.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 92
8.2.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 93
8.2.4 Key Co-development Deals 95
9 Appendix 98
9.1 All Pipeline Drugs by Stage of Development 98
9.1.1 Discovery 98
9.1.2 Preclinical 100
9.1.3 Phase I 103
9.1.4 Phase II 104
9.1.5 Phase III 105
9.1.6 Pre-registration 106
9.2 Market Forecasts to 2021 106
9.2.1 Asia-Pacific 106
9.2.2 India 106
9.2.3 China 107
9.2.4 Australia 107
9.2.5 South Korea 108
9.2.6 Japan 108
9.3 Bibliography 109
9.4 Abbreviations 116
9.5 Research Methodology 118
9.5.1 Secondary Research 119
9.5.2 Marketed Product Profiles 119
9.5.3 Late-Stage Pipeline Candidates 119
9.5.4 Comparative Efficacy and Safety Heatmap for Marketed and Pipeline Products 119
9.5.5 Product Competitiveness Framework 120
9.5.6 Pipeline Analysis 120
9.5.7 Forecasting Model 121
9.5.8 Deals Data Analysis 122
9.6 Contact Us 122
9.7 Disclaimer 122
1.1 List of Tables
Table 1: COPD Therapeutics Market, Global, All Pipeline Products, Discovery, 2016 98
Table 2: COPD Therapeutics Market, Global, All Pipeline Products, Preclinical, 2016 100
Table 3: COPD Therapeutics Market, Global, All Pipeline Products, Phase I, 2016 103
Table 4: COPD Therapeutics Market, Global, All Pipeline Products, Phase II, 2016 104
Table 5: COPD Therapeutics Market, Global, All Pipeline Products, Phase III, 2016 105
Table 6: COPD Therapeutics Market, Global, All Pipeline Products, Pre-registration, 2016 106
Table 7: COPD Therapeutics Market, Asia-Pacific, Market Forecast, 2015-2022 106
Table 8: COPD Therapeutics Market, India, Market Forecast, 2015-2022 106
Table 9: COPD Therapeutics Market, China, Market Forecast, 2015-2022 107
Table 10: COPD Therapeutics Market, Australia, Market Forecast, 2015-2022 107
Table 11: COPD Therapeutics Market, South Korea, Market Forecast, 2015-2022 108
Table 12: COPD Therapeutics Market, Japan, Market Forecast, 2015-2022 108
1.2 List of Figures
Figure 1: COPD Therapeutics Market, Treatment Algorithm of COPD 17
Figure 2: COPD Market, Global, Moderate-to-Severe COPD Marketed Products Heat Map, Efficacy, 2016 32
Figure 3: COPD Market, Global, Moderate-to-Severe COPD Marketed Products Heat Map, Safety, 2016 33
Figure 4: COPD Market, Global, Very Severe COPD Marketed Products Heat Map, Efficacy, 2016 34
Figure 5: COPD Market, Global, Very Severe COPD Marketed Products Heat Map, Safety, 2016 35
Figure 6: COPD Therapeutics Market, Global, Pipeline, 2016 37
Figure 7: COPD Therapeutics Market, Global, Pipeline by Molecular Target, 2016 39
Figure 8: Pipeline for COPD Therapeutics by Molecular Target and Stage of Development, Global, 2016 41
Figure 9: COPD Therapeutics Market, APAC, Mepolizumab Market ($m), 2019-2022 42
Figure 10: COPD Therapeutics Market, APAC, Benralizumab Market ($m), 2021-2022 44
Figure 11: COPD Therapeutics Market, APAC, PT003 Market ($m), 2018-2022 46
Figure 12: COPD Therapeutics Market, APAC, PT010 Market ($m), 2020-2022 47
Figure 13: COPD Therapeutics Market, APAC, FF/UMEC/VI Market ($m), 2020-2022 48
Figure 14: COPD Market, Global, Pipeline Heatmap, Efficacy, 2016 49
Figure 15: COPD Market, Global, Pipeline Heatmap, Safety, 2016 49
Figure 16: COPD Therapeutics Market, Global, Competitor Matrix for Efficacy of Marketed and Pipeline Products, 2016 52
Figure 17: COPD Therapeutics Market, Global, Competitor Matrix for Safety of Marketed and Pipeline Products, 2016 53
Figure 18: COPD Therapeutics, Global, Average Clinical Trial Failure Rate (%), 2006-2016 55
Figure 19: COPD Therapeutics, Global, Clinical Trial Failure Rates by Molecule Type (%), 2006-2016 56
Figure 20: COPD Therapeutics, Global, Clinical Trial Failure Rates by Molecular Target (%), 2006-2016 57
Figure 21: COPD Therapeutics, Global, Clinical Trial Duration by Molecule Type (months), 2006-2016 58
Figure 22: COPD Therapeutics, Global, Clinical Trial Duration by Molecular Target (months), 2006-2016 59
Figure 23: COPD Therapeutics, Global, Clinical Trial Size per Product by Molecule Type (participants), 2006-2016 60
Figure 24: COPD Therapeutics, Global, Clinical Trial Size per Product by Molecular Target (participants), 2006-2016 61
Figure 25: COPD Therapeutics, Global, Clinical Trial Size per Trial by Molecule Type (participants), 2006-2016 62
Figure 26: COPD Therapeutics, Global, Clinical Trial Size per Trial by Molecular Target (participants), 2006-2016 63
Figure 27: COPD Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecule Type 63
Figure 28: COPD Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecular Target 64
Figure 29: COPD Therapeutics Market, Asia-Pacific, Treatment Patterns (million) and Market Size ($bn), 2015-2022 66
Figure 30: COPD Therapeutics Market, India, Treatment Patterns (million), 2015-2022 68
Figure 31: COPD Therapeutics Market, India, Annual Cost of Therapy ($), 2015-2022 69
Figure 32: COPD Therapeutics Market, India, Market Size ($m), 2015-2022 70
Figure 33: COPD Therapeutics Market, China, Treatment Patterns (million), 2015-2022 71
Figure 34: COPD Therapeutics Market, China, Annual Cost of Therapy ($), 2015-2022 72
Figure 35: COPD Therapeutics Market, China, Market Size ($bn), 2015-2022 73
Figure 36: COPD Therapeutics Market, Australia, Treatment Patterns (million), 2015-2022 74
Figure 37: COPD Therapeutics Market, Australia, Annual Cost of Therapy ($), 2015-2022 75
Figure 38: COPD Therapeutics Market, Australia, Market Size ($m), 2015-2022 76
Figure 39: COPD Therapeutics Market, South Korea, Treatment Patterns (million), 2015-2022 77
Figure 40: COPD Therapeutics Market, South Korea, Annual Cost of Therapy ($), 2015-2022 78
Figure 41: COPD Therapeutics Market, South Korea, Market Size ($m), 2015-2022 79
Figure 42: COPD Therapeutics Market, Japan, Treatment Patterns (million), 2015-2022 80
Figure 43: COPD Therapeutics Market, Japan, Annual Cost of Therapy ($), 2015-2022 81
Figure 44: COPD Therapeutics Market, Japan, Market Size ($bn), 2015-2022 81
Figure 45: COPD Therapeutics Market, Global, Licensing Deals by Region and Value, 2006-2016 85
Figure 46: COPD Therapeutics Market, Global, Number of Disclosed and Undisclosed Licensing Deals by Year, Aggregate Deal Value and Aggregate Upfront Payment Value, 2006-2016 86
Figure 47: COPD Therapeutics Market, Global, Licensing Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006-2016 87
Figure 48: COPD Therapeutics Market, Global, Licensing Deals by Molecule Type and Stage of Development, 2006-2016 88
Figure 49: COPD Therapeutics, Global, Licensing Deals by Molecular Targets and Aggregate Deal Value ($), 2006-2016 89
Figure 50: COPD Therapeutics Market, Global, Co-development Deals by Region and Deal Value, 2006-2016 91
Figure 51: COPD Therapeutics Market, Global, Number of Disclosed and Undisclosed Co-development Deals by Year, Aggregate Deal Value and Aggregate Upfront Payment Value, 2006-2016 92
Figure 52: COPD Therapeutics Market, Global, Co-development Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006-2016 93
Figure 53: COPD Therapeutics Market, Global, Co-development Deals by Molecule type and Stage of Development, 2006-2016 94
Figure 54: COPD Therapeutics Market, Global, Co-development Deals by Molecular Target, 2006-2016 95