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PharmaPoint: Heart Failure - Global Drug Forecast and Market Analysis to 2026

Published By :

GlobalData

Published Date : Jul 2017

Category :

Pharmaceutical

No. of Pages : 241 Pages

PharmaPoint: Heart Failure - Global Drug Forecast and Market Analysis to 2026

Summary

GlobalData estimates sales of HF therapeutics to be approximately $3.7B across the 7MM in 2016, encompassing the US, the five major European markets (5EU: France, Germany, Italy, Spain and UK), and Japan. By 2026, GlobalData expects the HF market to grow at a strong Compound Annual Growth Rate (CAGR) of 15.7%, reaching sales of $16.1B by the end of the forecast period. Chronic HF therapeutics accounted for 95.9% of the total HF market in 2015, and despite the launch of a new acute HF therapy, this figure is expected to increase slightly to 98.7% by 2026. GlobalData expects uptake of Novartis Entresto will be the strongest driver of the chronic HF and total HF markets in the 7MM, reaching peak sales of $8.6B in 2022.

Key Questions Answered

- The level of unmet needs in the HF market is significantly high. Will the pipeline drugs fulfil these unmet needs of the market? Key Opinion Leaders (KOLs) interviewed by GlobalData provide insights and highlight opportunities for drug developers.
- The HF market is crowded with cheap, generic, me-too drugs, making it a particularly difficult market to penetrate. The current late-stage pipeline consists of several chronic HF therapies, and three novel acute HF therapies. How will the market be impacted by the launch of these drugs? Which of the marketed and pipeline drugs will have the highest peak sales at the highest CAGR, and why?
- Will Entresto become the new standard-of-care in the chronic HF market? What are the main barriers a new therapy faces when entering the HF market?

Scope

- Overview of HF, both chronic and acute, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
- Annualized HF therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2016 and forecast for ten years to 2026.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the chronic and acute HF therapeutics markets.
- Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs.
- Analysis of the current and future market competition in the global HF therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

The report will enable you to -
- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline. Additionally a list of acquisition targets included in the pipeline product company list.
- Develop business strategies by understanding the trends shaping and driving the HF therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the HF therapeutics market in future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- Track drug sales in the 7MM HF therapeutics market from 2016-2026.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 9
1.2 List of Figures 10
2 Heart Failure: Executive Summary 12
2.1 The HF Market Will Exhibit Strong Growth Between 2016 and 2026 12
2.2 Label Expansion to HF with Preserved Ejection Fraction Will Fuel Market Growth 14
2.3 The HF Market Has Considerable Unmet Needs, Despite the Availability of Well-Established Therapies and a Promising Pipeline 15
2.4 Opportunities Remain for All Aspects of HF, But What the Market Really Needs Is a Transformational Therapy 16
2.5 Entresto Will Dominate the HF Market 16
2.6 What Do Physicians Think? 17
3 Introduction 20
3.1 Catalyst 20
3.2 Related Reports 20
4 Disease Overview 21
4.1 Etiology and Pathophysiology 21
4.1.1 Etiology 21
4.1.2 Pathophysiology 23
4.1.3 Biomarkers/Targets of Interest 25
4.2 Classification or Staging Systems 26
4.3 Symptoms 27
4.4 Prognosis 28
4.5 Quality of Life 29
5 Epidemiology 30
5.1 Disease Background 30
5.2 Risk Factors and Comorbidities 31
5.3 Global and Historical Trends 32
5.4 Forecast Methodology 34
5.4.1 Sources 35
5.4.2 Forecast assumptions and methods 40
5.4.3 Diagnosed Incident Cases of HF by EF 43
5.4.4 Diagnosed Incident Cases of HF by Ventricular Dysfunction 45
5.4.5 Acute HF Hospitalizations 45
5.4.6 Hospital Length of Stay for Acute HF Hospitalization 47
5.4.7 Diagnosed Prevalent Cases of CHF 48
5.4.8 Diagnosed Prevalent Cases of CHF by EF 51
5.4.9 Diagnosed Prevalent Cases of CHF by NYHA Classes 52
5.5 Epidemiological Forecast for Heart Failure (2016-2026) 54
5.5.1 Diagnosed Incident Cases of HF 54
5.5.2 Age-Specific Diagnosed Incident Cases of HF 55
5.5.3 Sex-Specific Diagnosed Incident Cases of HF 55
5.5.4 Diagnosed Incident Cases of HF by EF 56
5.5.5 Diagnosed Incident Cases of HF by VD 57
5.5.6 Acute HF Hospitalizations 58
5.5.7 Hospital Length of Stay for Acute HF Hospitalization 61
5.5.8 Diagnosed Prevalent Cases of CHF 61
5.5.9 Age-Specific Diagnosed Prevalent Cases of CHF 62
5.5.10 Sex-Specific Diagnosed Prevalent Cases of CHF 63
5.5.11 Diagnosed Prevalent Cases of CHF by EF 64
5.5.12 Diagnosed Prevalent Cases of CHF by NYHA Class 65
5.6 Discussion 68
5.6.1 Epidemiological Forecast Insight 68
5.6.2 Limitations of Analysis 69
5.6.3 Strengths of Analysis 69
6 Disease Management 70
6.1 Diagnosis Overview 70
6.2 Treatment Overview 73
6.2.1 Treatment Guidelines and Leading Prescribed Drugs 73
6.2.2 Clinical Practice 75
6.3 US 79
6.4 5EU 81
6.5 Japan 84
7 Competitive Assessment 87
7.1 Overview 87
7.2 Angiotensin-Converting Enzyme Inhibitors 88
7.2.1 Overview 88
7.2.2 Efficacy 89
7.2.3 Safety 89
7.2.4 Forecast 90
7.3 Angiotensin Receptor Blockers 90
7.3.1 Overview 90
7.3.2 Efficacy 91
7.3.3 Safety 91
7.3.4 Forecast 92
7.4 Entresto (Sacubitril + Valsartan) 92
7.4.1 Overview 92
7.4.2 Efficacy 99
7.4.3 Safety 101
7.4.4 SWOT Analysis 103
7.4.5 Forecast 104
7.5 Diuretics 105
7.5.1 Overview 105
7.5.2 Efficacy 106
7.5.3 Safety 107
7.5.4 Forecast 107
7.6 Beta Blockers 108
7.6.1 Overview 108
7.6.2 Efficacy 109
7.6.3 Safety 109
7.6.4 Forecast 110
7.7 Procoralan (Ivabradine) 110
7.7.1 Overview 110
7.7.2 Efficacy 113
7.7.3 Safety 115
7.7.4 SWOT Analysis 116
7.7.5 Forecast 116
7.8 Mineralocorticoid Receptor Antagonists 117
7.8.1 Overview 117
7.8.2 Efficacy 119
7.8.3 Safety 119
7.8.4 Forecast 120
7.9 Digoxin 120
7.9.1 Overview 120
7.9.2 Efficacy 121
7.9.3 Safety 122
7.9.4 Forecast 122
7.10 Pharmacological Therapies for Acute HF 122
8 Unmet Needs and Opportunity Assessment 124
8.1 Overview 124
8.2 Lack of Therapies for HF-PEF Patients 125
8.2.1 Unmet Need 125
8.2.2 Gap Analysis 126
8.2.3 Opportunity 127
8.3 Lack of Therapies for Acute HF 128
8.3.1 Unmet Need 128
8.3.2 Gap Analysis 129
8.3.3 Opportunity 129
8.4 Lack of Therapies for Patients with Renal Impairment 130
8.4.1 Unmet Need 130
8.4.2 Gap Analysis 130
8.4.3 Opportunity 131
8.5 Preventative Therapies for Patients at Risk of Developing HF 131
8.5.1 Unmet Need 131
8.5.2 Gap Analysis 132
8.5.3 Opportunity 133
8.6 Use of Optimal Doses of HF Therapies 133
8.6.1 Unmet Need 133
8.6.2 Gap Analysis 135
8.6.3 Opportunity 135
8.7 Patient Compliance 136
8.7.1 Unmet Need 136
8.7.2 Gap Analysis 136
8.7.3 Opportunity 137
8.8 Early Detection and Treatment of Patients with Worsening Chronic HF 138
8.8.1 Unmet Need 138
8.8.2 Gap Analysis 138
8.8.3 Opportunity 139
8.9 Dynamic Management of Patients with HF 139
8.9.1 Unmet Need 139
8.9.2 Gap Analysis 140
8.9.3 Opportunity 141
8.10 Options for Advanced HF Patients Who Are Unable to Receive a Heart Transplant 142
8.10.1 Unmet Need 142
8.10.2 Gap Analysis 142
8.10.3 Opportunity 143
8.11 Better Risk Stratification of Patients Admitted to the ED with Acute HF and Enhanced Outpatient Care 143
8.11.1 Unmet Need 143
8.11.2 Gap Analysis 143
8.11.3 Opportunity 144
9 Pipeline Assessment 145
9.1 Overview 145
9.2 Drugs in Clinical Development 147
9.2.1 Pipeline Drugs by Patient Population 147
9.3 Promising Drugs in Clinical Development 148
9.4 Omecamtiv Mecarbil 148
9.4.1 Overview 148
9.4.2 Efficacy 151
9.4.3 Safety 152
9.4.4 Dosing and Formulation 152
9.4.5 Potential Clinical and Commercial Positioning 152
9.4.6 SWOT Analysis 154
9.4.7 Forecast 154
9.5 Vericiguat 155
9.5.1 Overview 155
9.5.2 Efficacy 156
9.5.3 Safety 157
9.5.4 Dosing and Formulation 158
9.5.5 Potential Clinical and Commercial Positioning 158
9.5.6 SWOT Analysis 159
9.5.7 Forecast 159
9.6 RT-100 160
9.6.1 Overview 160
9.6.2 Efficacy 161
9.6.3 Safety 161
9.6.4 Dosing and Formulation 162
9.6.5 Potential Clinical and Commercial Positioning 162
9.6.6 SWOT Analysis 163
9.6.7 Forecast 163
9.7 CXL-1427 163
9.7.1 Overview 163
9.7.2 Efficacy 165
9.7.3 Safety 165
9.7.4 Dosing and Formulation 165
9.7.5 Potential Clinical and Commercial Positioning 165
9.7.6 SWOT Analysis 166
9.7.7 Forecast 166
9.8 Other Drugs in Development 167
10 Current and Future Players 169
10.1 Overview 169
10.2 Trends in Corporate Strategy 171
10.3 Amgen and Cytokinetics 173
10.3.1 Overview 173
10.3.2 Portfolio Assessment 174
10.4 Bayer (and Merck & Co.) 174
10.4.1 Overview 174
10.4.2 Portfolio Assessment 175
10.5 Bristol-Myers Squibb 176
10.5.1 Overview 176
10.5.2 Portfolio Assessment 176
10.6 Les Laboratoires Servier 177
10.6.1 Overview 177
10.6.2 Portfolio Assessment 178
10.7 Novartis 179
10.7.1 Overview 179
10.7.2 Portfolio Assessment 180
10.8 Renova Therapeutics 181
10.8.1 Overview 181
10.8.2 Portfolio Assessment 181
11 Market Outlook 183
11.1 Global Markets 183
11.1.1 Forecast 183
11.1.2 Drivers and Barriers - Global Issues 186
11.2 US 188
11.2.1 Forecast 188
11.2.2 Key Events 190
11.2.3 Drivers and Barriers 190
11.3 5EU 191
11.3.1 Forecast 191
11.3.2 Key Events 193
11.3.3 Drivers and Barriers 194
11.4 Japan 195
11.4.1 Forecast 195
11.4.2 Key Events 197
11.4.3 Drivers and Barriers 197
12 Appendix 199
12.1 Bibliography 199
12.2 Abbreviations 216
12.3 Methodology 222
12.3.1 Forecasting Methodology 222
12.3.2 Diagnosed Prevalent Chronic HF 222
12.3.3 Diagnosed Incidence of Acute HF 222
12.3.4 Percent Drug-Treated Patients 223
12.3.5 Treatment of HF with Reduced Ejection Fraction Versus HF with Preserved Ejection Fraction 223
12.3.6 Drugs Included in Each Therapeutic Class 223
12.3.7 Launch and Patent Expiry Dates 224
12.3.8 General Pricing Assumptions 224
12.3.9 Individual Drug Assumptions 225
12.3.10 Generic Erosion 230
12.3.11 Pricing of Pipeline Agents 230
12.4 Primary Research - KOLs Interviewed for this Report 232
12.5 Primary Research - Payers Included in this Study 234
12.6 Primary Research - Prescriber Survey 236
12.7 About the Authors 237
12.7.1 Analyst 237
12.7.2 Therapy Area Director 237
12.7.3 Epidemiologist 237
12.7.4 Managing Epidemiologists 238
12.7.5 Global Director of Therapy Analysis and Epidemiology 239
12.7.6 Global Head and EVP of Healthcare Operations and Strategy 240
12.8 About GlobalData 241
12.9 Contact Us 241
12.10 Disclaimer 241

1.1 List of Tables
Table 1: Heart Failure: Key Metrics in the 7MM 12
Table 2: Types of Chronic HF 22
Table 3: The leading causes, as well as other less common causes, of HF. 23
Table 4: The compensatory mechanisms that are activated in a patient with HF. 24
Table 5: Key Diagnostic and prognostic biomarkers in HF. 25
Table 6: Overview of Clinically Relevant Biomarkers in HF 26
Table 7: shows a comparison of these two HF classification systems. 27
Table 8: Symptoms of Heart Failure 28
Table 9: Risk Factors and Comorbidities for HF 32
Table 10: NYHA Functional Classification for CHF (Classes I-IV). 35
Table 11: 7MM, Diagnosed Incident Cases of HF, Both Sexes, Ages 45 Years, N, Selected Years 2016-2026 54
Table 12: 7MM, Diagnosed Prevalent Cases of CHF, Both Sexes, Ages 45 Years, N, Selected Years 2016-2026 62
Table 13: lists the common factors that precipitate acute HF. 73
Table 14: HF Treatment guidelines most commonly adhered to by physicians in the 7MM. 73
Table 15: summarizes the chronic HF-REF medications and drug classes most commonly used in the US, 5EU, and Japan, based on GlobalDatas primary and secondary research. 74
Table 16: Country Profile - US 80
Table 17: Country Profile - 5EU 82
Table 18: Country Profile - Japan 85
Table 19: Summary of major clinical trials assessing the efficacy of ACE inhibitors in HF-REF patients. 89
Table 20: Summary of major clinical trials assessing the efficacy of ARBs in HF-REF patients. 91
Table 21: Product Profile - Entresto 99
Table 22: Efficacy of Entresto, PARADIGM-HF 100
Table 23: Safety of Entresto, PARADIGM-HF 102
Table 24: Entresto SWOT Analysis, 2016 103
Table 25: Summary of major clinical trials assessing the efficacy of beta blockers in HF-REF patients. 109
Table 26: Product Profile - Procoralan 113
Table 27: Efficacy of Procoralan, SHIFT study 114
Table 28: Procoralan SWOT Analysis, 2016 116
Table 29: Unmet Need and Opportunity in HF, 2016 125
Table 30: Product Profile - Omecamtiv Mecarbil 151
Table 31: Efficacy of Omecamtiv Mecarbil, COSMIC-HF 151
Table 32: Omecamtiv Mecarbil SWOT Analysis, 2016 154
Table 33: Product Profile - Vericiguat 156
Table 34: Efficacy of Vericiguat, SOCRATES-Reduced 157
Table 35: Safety of Vericiguat, SOCRATES-Reduced 157
Table 36: Vericiguat SWOT Analysis, 2016 159
Table 37: Product Profile - RT-100 161
Table 38: RT-100 SWOT Analysis, 2016 163
Table 39: Product Profile - CXL-1427 165
Table 40: CXL-1427 SWOT Analysis, 2016 166
Table 41: Drugs in Development for Heart Failure, 2016 167
Table 42: Key Companies in the Heart Failure Market in the 7MM, 2016 170
Table 43: Amgens HF Portfolio Assessment, 2016 174
Table 44: Bayers HF Portfolio Assessment, 2016 176
Table 45: Bristol-Myers Squibb HF Portfolio Assessment, 2016 177
Table 46: Serviers HF Portfolio Assessment, 2016 179
Table 47: Novartis Disease Portfolio Assessment, 2016 181
Table 48: Renova Therapeutics Disease Portfolio Assessment, 2016 182
Table 49: Heart Failure Market - Global Drivers and Barriers, 2016-2026 186
Table 50: Key Events Impacting Sales for HF in the US, 2016-2026 190
Table 51: HF Market - Global Drivers and Barriers in the US, 2016-2026 190
Table 52: Key Events Impacting Sales for Heart Failure in the 5EU, 2016-2026 193
Table 53: Heart Failure Market - Global Drivers and Barriers in the 5EU, 2016-2026 194
Table 54: Key Events Impacting Sales for Heart Failure in Japan, 2016-2026 197
Table 55: Heart Failure Market - Global Drivers and Barriers in Japan, 2016-2026 197
Table 56: Key Historical and Projected Launch Dates for HF 224
Table 57: Key Historical and Projected Patent Expiry Dates for Heart Failure 224
Table 58: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 236

1.2 List of Figures
Figure 1: Global Sales for Heart Failure by Country, 2016 and 2026 14
Figure 2: Competitive Assessment of Late-Stage Pipeline Agents in Heart Failure, 2016-2026 17
Figure 3: Changes in Cardiac Structure in HF 22
Figure 4: RAAS Mechanism of Action 24
Figure 5: 7MM, Age-Standardized Diagnosed Incidence of HF (Cases per 100,000 Population), Men and Women, Ages 45 Years, 2016 33
Figure 6: 7MM, Age-Standardized Diagnosed Prevalence of CHF (%), Men and Women, Ages 45 Years, 2016 34
Figure 7: 7MM, Sources Used to Forecast Diagnosed Incident Cases of HF 35
Figure 8: 7MM, Sources Used and Not Used to Forecast Diagnosed Prevalent Cases of CHF 36
Figure 9: 7MM, Sources Used to Forecast Diagnosed Incident Cases of HF by EF 37
Figure 10: 7MM, Sources Used to Forecast Diagnosed Prevalent Cases of CHF by EF 37
Figure 11: 7MM, Sources Used to Forecast Diagnosed Incident Cases of HF by Ventricular Dysfunction 38
Figure 12: 7MM, Sources Used to Forecast Hospitalizations for Acute HF 38
Figure 13: 7MM, Sources Used to Forecast Hospitalizations for Acute HF by Worsening CHF, Advanced HF, and de novo HF 39
Figure 14: 7MM, Sources Used to Forecast Hospital Length of Stay for Acute HF Hospitalization 39
Figure 15: 7MM, Sources Used to Forecast Diagnosed Prevalent Cases of CHF by NYHA Class 40
Figure 16: 7MM, Age-Specific Diagnosed Incident Cases of HF, Both Sexes, Ages 45 Years, N, 2016 55
Figure 17: 7MM, Sex-Specific Diagnosed Incident Cases of HF, Ages 45 Years, N, 2016 56
Figure 18: 7MM, Diagnosed Incident Cases of HF by EF, Both Sexes, Ages 45 Years, N, 2016 57
Figure 19: 7MM, Diagnosed Incident Cases of HF by VD, Both Sexes, Ages 45 Years, N, 2016 58
Figure 20: 7MM, Acute HF Hospitalizations, Both Sexes, Ages 45 Years, N, 2016 to 2026 59
Figure 21: 7MM, Acute HF Hospitalizations by Patients Admitted and Discharged, Both Sexes, Ages 45 Years, 2016 59
Figure 22: 7MM, Acute HF Hospitalizations by Worsening Chronic HF, Advanced HF, and De Novo HF, Both Sexes, Ages 45 Years, 2016 60
Figure 23: 7MM, Hospital Length of Stay for Acute HF Hospitalization, Both Sexes, Ages 45 Years, N, 2016 61
Figure 24: 7MM, Age-Specific Diagnosed Prevalent Cases of CHF, Both Sexes, Ages 45 Years, N, 2016 63
Figure 25: 7MM, Sex-Specific Diagnosed Prevalent Cases of CHF, Both Sexes, Ages 45 Years, N, 2016 64
Figure 26: 7MM, Diagnosed Prevalent Cases of CHF by EF, Both Sexes, Ages 45 Years, N, 2016 65
Figure 27: 7MM, Diagnosed Prevalent Cases of CHF by NYHA Class, Both Sexes, Ages 45 Years, N, 2016 66
Figure 28: 7MM, Diagnosed Prevalent Cases of CHF with REF by NYHA Class, Both Sexes, Ages 45 Years, N, 2016 67
Figure 29: 7MM, Diagnosed Prevalent Cases of CHF with PEF by NYHA Class, Both Sexes, Ages 45 Years, N, 2016 68
Figure 30: Diagnostic Algorithm for Chronic HF 71
Figure 31: Diagnostic Algorithm for Acute HF 72
Figure 32: HF based on the ACCF/AHA staging system 75
Figure 33: Classification of acute HF patients 77
Figure 34: Management of acute HF patients 78
Figure 35: Heart Failure - Drugs in Development, 2016 147
Figure 36: Competitive Assessment of Late-Stage Pipeline Agents in Heart Failure, 2016-2026 148
Figure 37: Company Portfolio Gap Analysis in Heart Failure, 2016-2026 171
Figure 38: Global Sales for Chronic HF by Country, 2016 and 2026 184
Figure 39: Global Sales for acute HF by Country, 2016 and 2026 185
Figure 40: Sales for Chronic HF by Drug Class in the US, 2016 and 2026 189
Figure 41: Sales for Chronic HF by Drug Class in the 5EU, 2016 and 2026 192
Figure 42: Sales for HF by Drug Class in Japan, 2016 and 2026 196

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