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 15
2.8 Treatment Options 15
2.8.1 Treatment Algorithm 17
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 23
3.3 Bronchodilator and Inhaled Corticosteroid Combination Therapy 24
3.3.1 Symbicort (budesonide/formoterol) – AstraZeneca 24
3.3.2 Seretide/Advair/Adoair (salmeterol/fluticasone) – GlaxoSmithKline 25
3.3.3 Relvar/Breo (fluticasone and vilanterol) – GlaxoSmithKline/Theravance 26
3.4 Bronchodilator Monotherapy 27
3.4.1 Spiriva (tiotropium) – Boehringer Ingelheim 27
3.4.2 Foradil (formoterol) – Novartis 28
3.4.3 Onbrez/Arbeela/Arcapta (indacaterol) – Novartis 28
3.4.4 Seebri /Tovanor (glycopyrronium) – Novartis 29
3.4.5 Striverdi Respimat (olodaterol) – Boehringer Ingelheim 30
3.5 Alternative therapy 30
3.5.1 Daxas/Daliresp (roflumilast) – Nycomeds 30
3.5.2 Marketed Products Heatmap 31
4 Pipeline Analysis 35
4.1 Overview 35
4.2 Pipeline Distribution by Stage of Development, Molecule Type, Route of Administration and Program Type 35
4.3 Pipeline Distribution by Molecular Target 37
4.4 Promising Pipeline Candidates 39
4.4.1 Mepolizumab – GlaxoSmithKline 39
4.4.2 Benralizumab – AstraZeneca and MedImmune 41
4.4.3 PT003 – AstraZeneca/Pearl Therapeutics 43
4.4.4 PT010 – AstraZeneca/Pearl Therapeutics 45
4.4.5 Fluticasone Furoate, Umeclidinium Bromide and Vilanterol Trifenatate –GlaxoSmithKline 46
4.4.6 CHF-5993 (beclometasone dipropionate/formoterol fumarate/glycopyrronium bromide) – Chiesi Farmaceutici S.p.A. 47
4.5 Heatmap for Pipeline Products 49
4.6 Product Competitiveness Framework 51
5 Clinical Trial Analysis 52
5.1 Failure Rate 52
5.1.1 Overall Failure Rate 52
5.1.2 Failure Rate by Phase and Molecule Type 54
5.1.3 Failure Rate by Phase and Molecular Target 55
5.2 Clinical Trial Size 56
5.2.1 Patient Enrollment per Product by Molecule Type, Molecular Target and Phase 56
5.2.2 Patient Enrollment per Trial by Molecule Type, Molecular Target and Phase 58
5.3 Clinical Trial Duration 59
5.3.1 Clinical Trial Duration by Molecule Type 59
5.3.2 Clinical Trial Duration by Molecular Target 61
5.4 Competitive Clinical Trials Metrics Analysis 62
6 Multi-scenario Forecast 63
6.1 Geographical Markets 63
6.2 Asia-Pacific Market 64
6.3 India 65
6.3.1 Treatment Usage Patterns 65
6.3.2 Annual Cost of Therapy 66
6.3.3 Market Size 67
6.4 China 68
6.4.1 Treatment Usage Patterns 68
6.4.2 Annual Cost of Therapy 69
6.4.3 Market Size 70
6.5 Australia 70
6.5.1 Treatment Usage Patterns 70
6.5.2 Annual Cost of Therapy 71
6.5.3 Market Size 73
6.6 South Korea 74
6.6.1 Treatment Usage Patterns 74
6.6.2 Annual Cost of Therapy 74
6.6.3 Market Size 75
6.7 Japan 76
6.7.1 Treatment Usage Patterns 76
6.7.2 Annual Cost of Therapy 77
6.7.3 Market Size 78
7 Drivers and Barriers 79
7.1 Drivers 79
7.1.1 Active Pipeline 79
7.1.2 Promising Late-Stage Pipeline Products Can Change Treatment Paradigm 79
7.1.3 Increasing Awareness of COPD 79
7.1.4 Aging Population 80
7.2 Barriers 80
7.2.1 Sales Erosion by Generics 80
7.2.2 Growing Competition 80
7.2.3 Low Diagnosis Rates 80
8 Deals and Strategic Consolidations 81
8.1 Licensing Deals 81
8.1.1 Deals by Region and Value 81
8.1.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 82
8.1.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 83
8.1.4 Key Licensing Deals 85
8.2 Co-development Deals 88
8.2.1 Deals by Region and Value 88
8.2.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 89
8.2.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 90
8.2.4 Key Co-development Deals 92
9 Appendix 95
9.1 All Pipeline Drugs by Stage of Development 95
9.1.1 Discovery 95
9.1.2 Preclinical 96
9.1.3 Phase I 99
9.1.4 Phase II 100
9.1.5 Phase III 102
9.1.6 Pre-registration 102
9.2 Market Forecasts to 2023 103
9.2.1 Asia-Pacific 103
9.2.2 India 103
9.2.3 China 104
9.2.4 Australia 104
9.2.5 South Korea 105
9.2.6 Japan 105
9.3 Bibliography 106
9.4 Abbreviations 114
9.5 Research Methodology 115
9.5.1 Secondary Research 116
9.5.2 Marketed Product Profiles 116
9.5.3 Late-Stage Pipeline Candidates 117
9.5.4 Comparative Efficacy and Safety Heatmap for Marketed and Pipeline Products 117
9.5.5 Product Competitiveness Framework 117
9.5.6 Pipeline Analysis 117
9.5.7 Forecasting Model 118
9.5.8 Deals Data Analysis 119
9.6 Contact Us 119
9.7 Disclaimer 120