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COPD Therapeutics in Asia-Pacific Markets to 2023 - Growth Driven by Rising Prevalence, Growing Awareness and Expected Launch of Novel Therapies

Published By :

GBI Research

Published Date : Dec 2017

Category :

Therapeutic Area

No. of Pages : 120 Pages

Chronic obstructive pulmonary disease (COPD) is a term that refers to a large group of lung diseases characterized by obstruction of air flow that interferes with normal breathing. It occurs most often in older people, but can also affect the middle aged population. COPD is a major cause of chronic morbidity and mortality globally. Many people suffer from the disease for years and eventually die from it or its complications, meaning it constitutes a substantial economic and social burden. Globally, the COPD burden is projected to increase in the coming decades because of continued exposure to disease risk factors, and the increasing number of smokers. Increased smoking will result in a greater number of people living with the condition. The share of mortality attributed to COPD is expected to increase in the coming decades, when compared with other chronic diseases such as heart disease and stroke. The marketed products landscape comprises a wide range of treatment options, including bronchodilator combinations, bronchodilator and inhaled corticosteroid (ICS) combinations, bronchodilator monotherapies and PDE-4 inhibitors. However, the market is undergoing a gradual transition, moving away from bronchodilator and ICS therapies and towards targeted and triple-combination drug treatments. The market is set to be driven by recently launched products, and the approval of novel drugs that will supplement current market leaders and offer broader therapeutic options.

Scope

  • The COPD Asia-Pacific market will be valued at $6.7 billion in 2023, growing from $3.8 billion in 2016 at a CAGR of 8.7%.
  • Bronchodilators and ICS therapies dominate the COPD market, but unmet needs exist in terms of safety and efficacy. Will the drugs under development fulfill the unmet needs?
  • Do branded therapies show continuous growth, and are they facing competition from generics?
  • How will branded therapies be affected by upcoming pipeline therapies?
  • 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?
  • Will the pipeline address unmet needs related to limited targeted therapies for COPD patients?
  • What first-in-class triple combinations are due to enter the COPD market within the forecast period, and how will they compete with the currently marketed products?
  • Various drivers and barriers will influence the market over the forecast period.
  • What barriers will limit the uptake of premium-priced therapeutics in the assessed countries?
  • What factors are most likely to drive the market in these countries?

Reasons to buy

  • Understand the current clinical and commercial landscape by considering disease pathogenesis, diagnosis, prognosis, and the treatment options available at each stage of diagnosis, including a clinical comparison of marketed therapies.
  • Visualize the composition of the COPD market in terms of dominant therapies, with their clinical and commercial standing. Unmet needs are highlighted to allow a competitive understanding of gaps in the market.
  • Analyze the COPD pipeline and stratify pipeline therapies by stage of development, molecule type and molecular target.
  • Understand the potential of late-stage therapies, with extensive profiles of products that could enter the market over the forecast period, highlighting clinical performance, potential commercial positioning, and how they will compete with other therapies.
  • Predict COPD market growth in the five Asia-Pacific markets, with epidemiological and annual cost of therapy forecasts across India, China, Australia, South Korea and Japan, as well as analysis of the contributions of promising late-stage molecules to market growth.
  • Identify commercial opportunities in the COPD deals landscape by analyzing trends in licensing and co-development deals.

Table of Contents

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 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

List of Table

Table 1: COPD Therapeutics Market, Global, Licensing Deals Value, 2006-2017 86
Table 2: COPD Therapeutics Market, Global, Co-development Deals Value, 2006-2017 94
Table 3: COPD Therapeutics Market, Global, All Pipeline Products, Discovery, 2017 95
Table 4: COPD Therapeutics Market, Global, All Pipeline Products, Preclinical, 2016 96
Table 5: COPD Therapeutics Market, Global, All Pipeline Products, Phase I, 2017 99
Table 6: COPD Therapeutics Market, Global, All Pipeline Products, Phase I, 2017 100
Table 7: COPD Therapeutics Market, Global, All Pipeline Products, Phase III, 2017 102
Table 8: COPD Therapeutics Market, Global, All Pipeline Products, Pre-registration, 2016 102
Table 9: COPD Therapeutics Market, Asia-Pacific, Market Forecast, 2016-2023 103
Table 10: COPD Therapeutics Market, India, Market Forecast, 2016-2023 103
Table 11: COPD Therapeutics Market, China, Market Forecast, 2016-2023 104
Table 12: COPD Therapeutics Market, Australia, Market Forecast, 2016-2023 104
Table 13: COPD Therapeutics Market, South Korea, Market Forecast, 2016-2023 105
Table 14: COPD Therapeutics Market, Japan, Market Forecast, 2016-2023 105

List of Chart

Figure 1: COPD Therapeutics Market, Treatment Algorithm of COPD 17
Figure 2: COPD Market, Global, Moderate-to-Severe COPD Marketed Products Heatmap, Efficacy and Safety, 2017 33
Figure 3: COPD Market, Global, Very Severe COPD Marketed Products Heatmap, Efficacy and Safety, 2017 34
Figure 4: COPD Therapeutics Market, Global, Pipeline, 2017 36
Figure 5: COPD Therapeutics Market, Global, Pipeline by Molecular Target, 2017 37
Figure 6: Pipeline for COPD Therapeutics by Molecular Target and Stage of Development, Global, 2017 39
Figure 7: COPD Therapeutics Market, APAC, Mepolizumab Market ($m), 2019-2023 41
Figure 8: COPD Therapeutics Market, APAC, Benralizumab Market ($m), 2020-2023 43
Figure 9: COPD Therapeutics Market, APAC, PT003 Market ($m), 2018-2023 44
Figure 10: COPD Therapeutics Market, APAC, PT010 Market ($m), 2019-2023 46
Figure 11: COPD Therapeutics Market, APAC, FF/UMEC/VI Market ($m), 2018-2023 47
Figure 12: COPD Therapeutics Market, APAC, CHF-5993 Market ($m), 2020-2023 49
Figure 13: COPD Market, Global, Pipeline Heatmap, Efficacy, 2017 49
Figure 14: COPD Therapeutics Market, Global, Competitor Matrix for Efficacy and Safety of Marketed and Pipeline Products, 2017 51
Figure 15: COPD Therapeutics, Global, Average Clinical Trial Failure Rate (%), 2006-2016 53
Figure 16: COPD Therapeutics, Global, Clinical Trial Failure Rates by Molecule Type (%), 2006-2016 54
Figure 17: COPD Therapeutics, Global, Clinical Trial Failure Rates by Molecular Target (%), 2006-2016 55
Figure 18: COPD Therapeutics, Global, Clinical Trial Size per Product by Molecule Type (participants), 2006-2016 56
Figure 19: COPD Therapeutics, Global, Clinical Trial Size per Product by Molecular Target (participants), 2006-2016 57
Figure 20: COPD Therapeutics, Global, Clinical Trial Size per Trial by Molecule Type (participants), 2006-2016 58
Figure 21: COPD Therapeutics, Global, Clinical Trial Size per Trial by Molecular Target (participants), 2006-2016 59
Figure 22: COPD Therapeutics, Global, Clinical Trial Duration by Molecule Type (months), 2006-2016 60
Figure 23: COPD Therapeutics, Global, Clinical Trial Duration by Molecular Target (months), 2006-2016 61
Figure 24: COPD Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecule Type 62
Figure 25: COPD Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecular Target 62
Figure 26: COPD Therapeutics Market, Asia-Pacific, Treatment Patterns (million) and Market Size ($bn), 2016-2023 64
Figure 27: COPD Therapeutics Market, India, Treatment Patterns (million), 2016-2023 65
Figure 28: COPD Therapeutics Market, India, Annual Cost of Therapy ($), 2016-2023 66
Figure 29: COPD Therapeutics Market, India, Market Size ($m), 2016-2023 67
Figure 30: COPD Therapeutics Market, China, Treatment Patterns (million), 2016-2023 68
Figure 31: COPD Therapeutics Market, China, Annual Cost of Therapy ($), 2016-2023 69
Figure 32: COPD Therapeutics Market, China, Market Size ($bn), 2016-2023 70
Figure 33: COPD Therapeutics Market, Australia, Treatment Patterns (million), 2016-2023 71
Figure 34: COPD Therapeutics Market, Australia, Annual Cost of Therapy ($), 2016-2023 72
Figure 35: COPD Therapeutics Market, Australia, Market Size ($m), 2016-2023 73
Figure 36: COPD Therapeutics Market, South Korea, Treatment Patterns (million), 2016-2023 74
Figure 37: COPD Therapeutics Market, South Korea, Annual Cost of Therapy ($), 2016-2023 75
Figure 38: COPD Therapeutics Market, South Korea, Market Size ($m), 2016-2023 75
Figure 39: COPD Therapeutics Market, Japan, Treatment Patterns (million), 2016-2023 76
Figure 40: COPD Therapeutics Market, Japan, Annual Cost of Therapy ($), 2016-2023 77
Figure 41: COPD Therapeutics Market, Japan, Market Size ($m), 2016-2023 78
Figure 42: COPD Therapeutics Market, Global, Licensing Deals by Region and Value, 2006-2017 81
Figure 43: COPD Therapeutics Market, Global, Number of Disclosed and Undisclosed Licensing Deals by Year, Aggregate Deal Value and Aggregate Upfront Payment Value, 2006-2017 82
Figure 44: COPD Therapeutics Market, Global, Licensing Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006-2017 83
Figure 45: COPD Therapeutics Market, Global, Licensing Deals by Molecule Type and Stage of Development, 2006-2017 84
Figure 46: COPD Therapeutics, Global, Licensing Deals by Molecular Targets and Aggregate Deal Value ($), 2006-2017 85
Figure 47: COPD Therapeutics Market, Global, Co-development Deals by Region and Deal Value, 2006-2017 88
Figure 48: COPD Therapeutics Market, Global, Number of Disclosed and Undisclosed Co-development Deals by Year, Aggregate Deal Value and Aggregate Upfront Payment Value, 2006-2017 89
Figure 49: COPD Therapeutics Market, Global, Co-development Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006-2017 90
Figure 50: COPD Therapeutics Market, Global, Co-development Deals by Molecule type and Stage of Development, 2006-2017 91
Figure 51: COPD Therapeutics Market, Global, Co-development Deals by Molecular Target, 2006-2017 92

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