Summary
Heart failure (HF) is a life-threatening syndrome with substantial morbidity and mortality. There are more than 26 million people with HF globally and this is increasing because of the rapidly aging population. HF is a major global healthcare problem as the number of HF patients is increasing. It has the greatest negative impact on quality of life compared with other major chronic disease, such as diabetes, arthritis, and hypertension.
HF has been gradually rising in the Asia-Pacific region, with the growing elderly population and increasingly Westernized lifestyles. Increasing risk factors will result in an increased number of people living with the condition, thereby acting as a driver for revenue growth. Despite therapeutic advances, the morbidity and mortality associated with HF continues to be considerable, particularly in elderly patients.
In fact, most hospitalizations and deaths attributable to HF occur in people aged above 65. About half of all patients diagnosed with HF die within five years and the five-year survival rate is lower than that associated with other malignancies. The poor long-term prognosis associated with HF has created a pressing need for improved therapeutic options. The marketed products landscape comprises a wide range of treatment options, including ARN-targeted therapy, ACE inhibitors, ATR blockers, If channel inhibitor, beta blockers, MRAs and diuretics.
In the current market, chronic HF-REF patients can be treated with Entresto, Procoralan, ACE inhibitors, ATR blockers and beta blockers, while patients with acute HF can be prescribed therapies such as carperitide, diuretics and isosorbide dinitrate. However, significant unmet need remains for products that can treat HF-PEF patients and evidence-based therapy for acute HF. Entresto is in the pipeline for HF-PEF patients, and omecamtiv mecarbil and vericiguat are currently in Phase III development for post-acute patients.
Scope
- The HF Asia-Pacific market will be valued at $1,435.9m in 2024, growing from $733.7m in 2017 at a CAGR of 10.1%.
- How would the approval of Entresto to treat HF-PEF patients affect the competitive landscape, with no therapy currently available to address this patient subset?
- The HF market is crowded with cheap, generic, “me-too” drugs, making it a particularly difficult market to penetrate. What are the main barriers a new therapy faces when entering the HF market?
- The pipeline for HF therapies is quite diverse with a range of molecule types and molecular targets.
- Which molecular targets appear most frequently in the pipeline?
- How have the late-stage therapies performed in clinical trials?
- The level of unmet needs in the HF market is significantly high. Will the pipeline drugs fulfill these unmet needs of the market?
- The market forecasts indicate that Japan will contribute the most to the Asia-Pacific market value due to the emergence of novel therapies.
- How will the annual cost of therapy and market size vary between the five assessed Asia-Pacific markets?
- How could changes in risk factors such as population age, CVD and lifestyle influence the market?
- Various drivers and barriers will influence the market over the forecast period.
- Licensing deals are the most common form of strategic alliance in HF, with total deal values ranging from under $0.072m to over $1000m.
- How do deal frequency and value compare between target families and molecule types?
- What were the terms and conditions of key licensing deals?
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 HF market in terms of the dominant therapies for each patient subset, along with their clinical and commercial standing. Unmet needs are highlighted to allow a competitive understanding of gaps in the market.
- Analyze the HF 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 HF market growth in the five assessed Asia-Pacific markets, with epidemiological and annual cost of therapy forecasts across India, China, Australia, South Korea and Japan, as well as the individual contributions of promising late-stage molecules to market growth.
- Identify commercial opportunities in the HF deals landscape by analyzing trends in licensing and co-development deals.
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1 Table of Contents
1 Table of Contents 5
1.1 List of Tables 7
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 15
2.5 Diagnosis 16
2.5.1 Diagnostic Algorithm for Chronic HF 16
2.5.2 Diagnostic Algorithm for Acute HF 19
2.6 Disease Classification 20
2.6.1 Co-morbidities and Complications 22
2.7 Prognosis 23
2.8 Treatment Options and Treatment Algorithm 24
2.8.1 Treatment Options 24
2.8.2 Treatment Algorithm 26
2.8.3 Non-pharmacological Treatments 31
3 Marketed Products 32
3.1 Overview 32
3.1.1 Entresto (sacubitril plus valsartan) - Novartis 33
3.1.2 Procoralan (ivabradine) - Les Laboratoires Servier 35
3.1.3 Angiotensin-Converting Enzyme Inhibitors 36
3.1.4 Angiotensin Receptor Blockers 37
3.1.5 Diuretics 38
3.1.6 Beta Blockers 39
3.1.7 Mineralocorticoid Receptor Antagonists 40
3.1.8 Digoxin 41
3.2 Comparative Efficacy and Safety of Marketed Products 42
4 Pipeline Analysis 44
4.1 Pipeline by Stage of Development, Molecule Type, Route of Administration and Program Type 44
4.2 Pipeline by Molecular Target 47
4.3 Promising Pipeline Candidates 49
4.3.1 Omecamtiv mecarbil (CK-1827452/AMG-423) - Cynokinetics 49
4.3.2 Vericiguat - Bayer/Merck & Co. 50
4.4 Comparative Efficacy and Safety of Pipeline Products 52
4.5 Product Competitiveness Framework 53
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 56
5.1.3 Failure Rate by Phase and Molecular Target 57
5.2 Clinical Trial Size 58
5.2.1 Patient Enrollment per Product by Molecule Type and Stage of Development 58
5.2.2 Patient Enrollment per Product by Molecular Target and Stage of Development 59
5.2.3 Patient Enrollment per Trial by Molecule Type and Stage of Development 60
5.2.4 Patient Enrollment per Trial by Molecular Target and Stage of Development 61
5.3 Clinical Trial Duration 62
5.3.1 Trial Duration by Molecule Type and Stage of Development 62
5.3.2 Trial Duration by Molecular Target and Stage of Development 63
5.4 Summary of Clinical Trial Metrics 64
6 Multi-scenario Forecast 65
6.1 Geographical Markets 65
6.2 Asia-Pacific Market 65
6.3 India 67
6.3.1 Treatment Usage Patterns 67
6.3.2 Annual Cost of Therapy 68
6.3.3 Market Size 69
6.4 China 70
6.4.1 Treatment Usage Patterns 70
6.4.2 Annual Cost of Therapy 71
6.4.3 Market Size 73
6.5 Australia 74
6.5.1 Treatment Usage Patterns 74
6.5.2 Annual Cost of Therapy 75
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 81
6.7.3 Market Size 82
7 Drivers and Barriers 84
7.1 Drivers 84
7.1.1 Rising Prevalence and Growing Awareness of the Disease to Drive Market Growth 84
7.1.2 Promising Pipeline Products that Target Unmet Needs for HF 84
7.1.3 Increasing Awareness and Diversified Healthcare Reform to Boost Market Growth 84
7.1.4 Launch of Entresto and its Label Expansion will Drive Market Growth 85
7.2 Barriers 85
7.2.1 Market Access for New Therapies as well as Crowded and Cheap Generic Market 85
7.2.2 Lack of Development of Acute HF Pipeline Products 85
7.2.3 Reluctance of Cardiologists to Adopt New Therapies 86
8 Deals and Strategic Consolidations 87
8.1 Licensing Deals 87
8.1.1 Deals by Region and Value 87
8.1.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 89
8.1.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 90
8.1.4 Key Licensing Deals 92
8.2 Co-development Deals 95
8.2.1 Deals by Region and Value 95
8.2.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 96
8.2.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 97
8.2.4 Key Co-development Deals 99
9 Appendix 101
9.1 All Pipeline Drugs by Stage of Development 101
9.1.1 Discovery 101
9.1.2 Preclinical 102
9.1.3 IND/CTA-filed 106
9.1.4 Phase I 106
9.1.5 Phase II 107
9.1.6 Phase III 109
9.1.7 Pre-registration 109
9.2 Summary of Multi-scenario Market Forecasts to 2024 110
9.2.1 Asia-Pacific 110
9.2.2 India 110
9.2.3 China 111
9.2.4 Australia 111
9.2.5 South Korea 112
9.2.6 Japan 112
9.3 Bibliography 112
9.4 Abbreviations 118
9.5 Research Methodology 119
9.5.1 Secondary Research 120
9.5.2 Marketed Product Profiles 120
9.5.3 Late-Stage Pipeline Candidates 121
9.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 121
9.5.5 Product Competitiveness Framework 121
9.5.6 Pipeline Analysis 121
9.5.7 Forecasting Model 122
9.5.8 Deals Data Analysis 123
9.6 Contact Us 123
9.7 Disclaimer 123
1.1 List of Tables
Table 1: Heart Failure Therapeutics Market, Symptoms 12
Table 2: Heart Failure Therapeutics Market, New York Heart Association Classification of HF 13
Table 3: Heart Failure Therapeutics Market, Etiologies of HF 14
Table 4: Heart Failure Therapeutics Market, Key Diagnostic and Prognostic Biomarkers in HF 19
Table 5: Heart Failure Therapeutics Market, Definition of HF with Preserved (HFpEF), Mid-range (HFmrEF) and Reduced Ejection Fraction (HFrEF) 21
Table 6: Heart Failure Therapeutics Market, Importance of Co-morbidities in Patients with HF 22
Table 7: Heart Failure Therapeutics Market, Drugs Used in HF with Reduced Left Ventricular Ejection Fraction 27
Table 8: Heart Failure Therapeutics Market, Global, Licensing Deals Value, 2007-2018 94
Table 9: Heart Failure Therapeutics Market, Global, Co-development Deals Value, 2007-2018 100
Table 10: Heart Failure Therapeutics Market, Global, All Pipeline Products, Discovery, 2018 101
Table 11: Heart Failure Therapeutics Market, Global, All Pipeline Products, Preclinical, 2018 102
Table 12: Heart Failure Therapeutics Market, Global, All Pipeline Products, IND/CTA-filed, 2018 106
Table 13: Heart Failure Therapeutics Market, Global, All Pipeline Products, Phase I, 2018 106
Table 14: Heart Failure Therapeutics Market, Global, All Pipeline Products, Phase II, 2018 107
Table 15: Heart Failure Therapeutics Market, Global, All Pipeline Products, Phase III, 2018 109
Table 16: Heart Failure Therapeutics Market, Global, All Pipeline Products, Phase III, 2018 109
Table 17: Heart Failure Therapeutics Market, APAC, Market Forecast, 2017-2024 110
Table 18: Heart Failure Therapeutics Market, India, Market Forecast, 2017-2024 110
Table 19: Heart Failure Therapeutics Market, China, Market Forecast, 2017-2024 111
Table 20: Heart Failure Therapeutics Market, Australia, Market Forecast, 2017-2024 111
Table 21: Heart Failure Therapeutics Market, South Korea, Market Forecast, 2017-2024 112
Table 22: Heart Failure Therapeutics Market, Japan, Market Forecast, 2017-2024 112
1.2 List of Figures
Figure 1: Heart Failure Therapeutics Market, Western Australia, Prevalence of HF Due to Risk factors (%) 11
Figure 2: Heart Failure Therapeutics Market, Types of HF 13
Figure 3: Heart Failure Therapeutics Market, Pathophysiology of HF 16
Figure 4: Heart Failure Therapeutics Market, Diagnostic Algorithm for Chronic HF 17
Figure 5: Heart Failure Therapeutics Market, Diagnosis Algorithm of Acute HF 19
Figure 6: Heart Failure Therapeutics Market, Stages of HF 20
Figure 7: Heart Failure Therapeutics Market, Approach to Management of HF with Reduced Ejection Fraction 28
Figure 8: Heart Failure Therapeutics Market, Management of Patients with Acute HF Based on Clinical Profile During an Early Phase 30
Figure 9: Heart Failure Therapeutics Market, Comparative Efficacy and Safety Heatmap for Marketed Products for Heart Failure Treatment, 2018 43
Figure 10: Heart Failure Therapeutics Market, Global, Pipeline, 2018 46
Figure 11: Heart Failure Therapeutics Market, Global, Pipeline by Molecular Target, 2018 48
Figure 12: Heart Failure Therapeutics Market, APAC, Omecamtiv Mecarbil Forecast ($m), 2022-2024 50
Figure 13: Heart Failure Therapeutics Market, APAC, Vericiguat Forecast ($m), 2021-2024 52
Figure 14: Heart Failure Therapeutics Market, Comparative Efficacy and Safety Heatmap for Pipeline Products for Heart Failure Treatment 52
Figure 15: Heart Failure Therapeutics, Global, Average Clinical Trial Failure Rate (%), 2007-2017 55
Figure 16: Heart Failure Therapeutics, Global, Clinical Trial Failure Rates by Molecule Type (%), 2007-2017 56
Figure 17: Heart Failure Therapeutics, Global, Clinical Trial Failure Rates by Molecular Target (%), 2007-2017 57
Figure 18: Heart Failure Therapeutics, Global, Clinical Trial Size per Product by Molecule Type (participants), 2007-2017 58
Figure 19: Heart Failure Therapeutics, Global, Clinical Trial Size per Product by Molecular Target (participants), 2007-2017 59
Figure 20: Heart Failure Therapeutics, Global, Clinical Trial Size per Trial by Molecule Type (participants), 2007-2017 60
Figure 21: Heart Failure Therapeutics, Global, Clinical Trial Size per Trial by Molecular Target (participants), 2007-2017 61
Figure 22: Heart Failure Therapeutics, Global, Clinical Trial Duration by Molecule Type (months), 2007-2017 62
Figure 23 Heart Failure Therapeutics, Global, Clinical Trial Duration by Molecular Target (months), 2007-2017 63
Figure 24: Heart Failure Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecule Type 64
Figure 25: Heart Failure Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecular Target 64
Figure 26: Heart Failure Therapeutics Market, APAC, Treatment Patterns (‘000), 2017-2024 66
Figure 27: Heart Failure Therapeutics Market, APAC, Market Size ($m), 2017-2024 66
Figure 28: Heart Failure Therapeutics Market, India, Treatment Patterns (‘000), 2017-2024 67
Figure 29: Heart Failure Therapeutics Market, India, Annual Cost of Therapy ($), 2017-2024 69
Figure 30: Heart Failure Therapeutics Market, India, Market Size ($m), 2017-2024 69
Figure 31: Heart Failure Therapeutics Market, China, Treatment Patterns (‘000), 2017-2024 71
Figure 32: Heart Failure Therapeutics Market, China, Annual Cost of Therapy ($), 2017-2024 72
Figure 33: Heart Failure Therapeutics Market, China, Market Size ($m), 2017-2024 73
Figure 34: Heart Failure Therapeutics Market, Australia, Treatment Patterns (‘000), 2017-2024 74
Figure 35: Heart Failure Therapeutics Market, Australia, Annual Cost of Therapy ($), 2017-2024 76
Figure 36: Heart Failure Therapeutics Market, Australia, Market Size ($m), 2017-2024 76
Figure 37: Heart Failure Therapeutics Market, South Korea, Treatment Patterns (‘000), 2017-2024 77
Figure 38: Heart Failure Therapeutics Market, South Korea, Annual Cost of Therapy ($), 2017-2024 79
Figure 39: Heart Failure Therapeutics Market, South Korea, Market Size ($m), 2017-2024 79
Figure 40: Heart Failure Therapeutics Market, Japan, Treatment Patterns (‘000), 2017-2024 80
Figure 41: Heart Failure Therapeutics Market, Japan, Annual Cost of Therapy ($), 2017-2024 82
Figure 42: Heart Failure Therapeutics Market, Japan, Market Size ($m), 2017-2024 82
Figure 43: Heart Failure Therapeutics Market, Global, Licensing Deals by Region and Value, 2007-2018 88
Figure 44: Herat Failure Therapeutics Market, Global, Number of Disclosed and Undisclosed Licensing Deals by Year, Aggregate Deal Value and Aggregate Upfront Payment Value, 2007-2018 89
Figure 45: Heart Failure Therapeutics Market, Global, Licensing Deals by Stage of Development, Deal Value and Upfront Payment Value, 2007-2018 90
Figure 46: Heart Failure Therapeutics Market, Global, Licensing Deals by Molecule Type and Stage of Development, 2007-2018 91
Figure 47: Heart Failure Therapeutics Market, Global, Licensing Deals by Molecular Targets and Aggregate Deal Value ($), 2007-2018 92
Figure 48: Heart Failure Therapeutics Market, Global, Co-development Deals by Region and Deal Value, 2007-2018 95
Figure 49: Heart Failure Therapeutics Market, Global, Number of Disclosed and Undisclosed Co-development Deals by Year, Aggregate Deal Value and Aggregate Upfront Payment Value, 2007-2018 96
Figure 50: Heart Failure Therapeutics Market, Global, Co-development Deals by Stage of Development, Deal Value and Upfront Payment Value, 2007-2018 97
Figure 51: Heart Failure Therapeutics Market, Global, Co-development Deals by Molecule Type and Stage of Development, 2007-2018 98
Figure 52: Heart Failure Therapeutics Market, Global, Co-development Deals by Molecular Target, 2007-2018 99
