Summary
GlobalData estimates sales of Heart Failure (HF) therapeutics to be approximately $3.2B across the 7MM in 2015, encompassing the US, 5EU, and Japan. The HF market will grow at a strong CAGR of 13.5% over the forecast period, reaching sales of $11.5B by 2025. The 7MM chronic HF market size in 2015 was $3.1B, and is expected to increase to $10.1B by 2025 at a CAGR of 12.7%. The US was the largest market for chronic HF therapies, contributing 61.2% of total sales in the base year. GlobalData expects uptake of Novartis’ Entresto to be the strongest driver of the chronic HF and total HF markets in the 7MM, reaching peak sales of $5.9B in 2022. The acute HF market is expected to increase from just $188.1M in 2015 to $1.5B in 2025, at a CAGR of 23.0%. Japan dominated the acute HF market in the base year, 2015, accounting for 86.0% of market share. However, with the launch of several acute HF add-on therapies in the forecast period, the US will take over as the acute HF market leader, contributing 68.7% of sales to the acute HF market by 2025.
Highlights
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?
Key Findings
- The major drivers for growth across the 7MM in the HF market during the forecast period will be the launch of the first-in-class angiotensin receptor blocker/neprilysin inhibitor (ARNi), Entresto, marketed by Novartis, as well as the launches of two acute HF therapies, Cardiorentis’ ularitide and Novartis’ serelaxin.
- KOLs interviewed by GlobalData opined that Entresto has potential to replace ACE inhibitors as the first-line therapy for HF, however they expect this to occur towards the end of the forecast period.
- In other interviews, KOLs highlighted that the greatest unmet need in the HF disease space is the need to develop efficacious therapies for HF with preserved ejection fraction (HF-PEF) and acute HF.
- High cost of new drugs and the reluctance of cardiologists to prescribe these new drugs are the major barriers for growth in the HF market during the forecast period.
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 2015 and forecast for ten years to 2025.
- 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 2015-2025.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
Companies Mentioned
Novartis
Les Laboratoires Servier
Cardiorentis
Bayer (and Merck & Co.)
Cytokinetics
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1 Table of Contents
1 Table of Contents 10
1.1 List of Tables 17
1.2 List of Figures 22
2 Introduction 24
2.1 Catalyst 24
2.2 Related Reports 24
3 Disease Overview 25
3.1 Etiology and Pathophysiology 25
3.1.1 Etiology 25
3.2 Classification and Staging Systems 32
3.3 Symptoms 33
3.4 Prognosis 34
3.5 Quality of Life 35
4 Epidemiology 37
4.1 Disease Background 37
4.2 Risk Factors and Comorbidities 38
4.3 Global Trends 40
4.3.1 US 40
4.3.2 5EU 41
4.3.3 Japan 42
4.4 Forecast Methodology 42
4.4.1 Sources Used 45
4.4.2 Forecast Assumptions and Methods 48
4.4.3 Sources Not Used 63
4.5 Epidemiological Forecast for HF (2015-2025) 63
4.5.1 Diagnosed Incident Cases 63
4.5.2 Diagnosed Prevalent Cases 77
4.6 Discussion 89
4.6.1 Epidemiological Forecast Insight 89
4.6.2 Limitations of the Analysis 89
4.6.3 Strengths of the Analysis 90
5 Disease Management 91
5.1 Diagnosis and Treatment Overview 91
5.1.1 Diagnosis 91
5.1.2 Treatment Guidelines and Leading Prescribed Drugs 94
5.1.3 Medical Devices 99
5.1.4 Clinical Practice 100
5.2 US 106
5.3 5EU 108
5.4 Japan 112
6 Competitive Assessment 115
6.1 Overview 115
6.2 Drug Profiles 116
6.2.1 Angiotensin-Converting Enzyme Inhibitors 116
6.2.2 Angiotensin Receptor Blockers 122
6.2.3 Entresto (sacubitril + valsartan) 126
6.2.4 Diuretics 141
6.2.5 Beta Blockers 146
6.2.6 Procoralan (ivabradine) 150
6.2.7 Mineralocorticoid Receptor Antagonists 158
6.2.8 Digoxin 162
6.2.9 Pharmacological Therapies for Acute HF 165
7 Unmet Needs and Opportunities 168
7.1 Overview 168
7.1.1 Acute HF - Target Opportunity Profile 170
7.1.2 HF with Preserved Ejection Fraction - Target Opportunity Profile 173
7.1.3 HF with Reduced Ejection Fraction - Target Opportunity Profile 176
7.2 Lack of Therapies for HF with Preserved Ejection Fraction Patients 181
7.2.1 Unmet Need 181
7.2.2 Gap Analysis 182
7.2.3 Opportunity 183
7.3 Lack of Therapies for Acute HF 183
7.3.1 Unmet Need 183
7.3.2 Gap analysis 184
7.3.3 Opportunity 185
7.4 Lack of Therapies for Acute HF Patients Experiencing Diuretic Resistance 186
7.4.1 Unmet Need 186
7.4.2 Gap Analysis 187
7.4.3 Opportunity 188
7.5 Lack of Therapies for Patients with Renal Impairment 188
7.5.1 Unmet Need 188
7.5.2 Gap Analysis 189
7.5.3 Opportunity 189
7.6 Treatment of Patients with Multiple Comorbidities 190
7.6.1 Unmet Need 190
7.6.2 Gap Analysis 191
7.6.3 Opportunity 191
7.7 Enhanced Diagnosis and Preventative Therapies for Patients at Risk of Developing HF 192
7.7.1 Unmet Need 192
7.7.2 Gap Analysis 193
7.7.3 Opportunity 194
7.8 Conducting Clinical Trials in Cohorts of Japanese Patients 195
7.8.1 Unmet Need 195
7.8.2 Gap Analysis 196
7.8.3 Opportunity 196
7.9 Use of Optimal Doses of HF Therapies 197
7.9.1 Unmet Need 197
7.9.2 Gap Analysis 198
7.9.3 Opportunity 199
7.10 Patient Compliance 199
7.10.1 Unmet Need 199
7.10.2 Gap Analysis 200
7.10.3 Opportunity 201
7.11 Early Detection and Treatment of Patients with Worsening Chronic HF 201
7.11.1 Unmet Need 201
7.11.2 Gap Analysis 202
7.11.3 Opportunity 203
7.12 Dynamic Management of Patients with HF 203
7.12.1 Unmet Need 203
7.12.2 Gap Analysis 205
7.12.3 Opportunity 205
7.13 Options for Advanced HF Patients Who Are Unable to Receive a Heart Transplant 206
7.13.1 Unmet Need 206
7.13.2 Gap Analysis 207
7.13.3 Opportunity 207
8 Pipeline Assessment 208
8.1 Overview 208
8.2 Promising Drugs in Late-Stage Clinical Development 210
8.2.1 Serelaxin 212
8.2.2 Ularitide 221
8.2.3 Omecamtiv Mecarbil 229
8.2.4 Vericiguat 238
8.2.5 Finerenone 245
8.2.6 Neucardin 251
8.2.7 Revatio 255
8.3 Promising Drugs in Early Stage Development 259
8.3.1 CXL-1427 259
8.3.2 Istaroxime 260
8.3.3 Perhexiline Maleate 260
8.3.4 TRV-027 261
8.4 Other Drugs in Development 261
9 Current and Future Players 263
9.1 Overview 263
9.2 Trends in Corporate Strategy 265
9.3 Company Profiles 266
9.3.1 Novartis 266
9.3.2 Les Laboratoires Servier 269
9.3.3 Cardiorentis 271
9.3.4 Bayer (and Merck & Co.) 272
9.3.5 Cytokinetics 274
10 Market Outlook 276
10.1 Global Markets 276
10.1.1 Forecast 276
10.1.2 Drivers and Barriers - Global Issues 281
10.2 US 285
10.2.1 Forecast 285
10.2.2 Key Events 289
10.2.3 Drivers and Barriers 290
10.3 France 291
10.3.1 Forecast 291
10.3.2 Key Events 295
10.3.3 Drivers and Barriers 296
10.4 Germany 297
10.4.1 Forecast 297
10.4.2 Key Events 300
10.4.3 Drivers and Barriers 301
10.5 Italy 302
10.5.1 Forecast 302
10.5.2 Key Events 305
10.5.3 Drivers and Barriers 306
10.6 Spain 307
10.6.1 Forecast 307
10.6.2 Key Events 310
10.6.3 Drivers and Barriers 311
10.7 UK 312
10.7.1 Forecast 312
10.7.2 Key Events 315
10.7.3 Drivers and Barriers 316
10.8 Japan 317
10.8.1 Forecast 317
10.8.2 Key Events 321
10.8.3 Drivers and Barriers 321
11 Appendix 324
11.1 Bibliography 324
11.2 Abbreviations 356
11.3 Methodology 364
11.4 Forecasting Methodology 364
11.4.1 Diagnosed Prevalent Chronic HF 364
11.4.2 Diagnosed Incidence of Acute HF 365
11.4.3 Percent Drug-Treated Patients 365
11.4.4 Treatment of HF with Reduced Ejection Fraction Versus HF with Preserved Ejection Fraction 365
11.4.5 Drugs Included in Each Therapeutic Class 365
11.4.6 Launch and Patent Expiry Dates 366
11.4.7 General Pricing Assumptions 367
11.4.8 Individual Drug Assumptions 368
11.4.9 Generic Erosion 373
11.4.10 Pricing of Pipeline Agents 373
11.5 Key Opinion Leaders Included in This Study 375
11.6 Payers Included in This Study 377
11.7 High-Prescribing Physician Survey 378
11.8 About the Authors 379
11.8.1 Author 379
11.8.2 Contributing Author 379
11.8.3 Therapy Area Director 379
11.8.4 Epidemiologist 380
11.8.5 Global Director of Therapy Analysis and Epidemiology 380
11.8.6 Global Head of Healthcare 381
11.9 About GlobalData 382
11.10 Disclaimer 382
1.1 List of Tables
Table 1: Leading Causes of HF 27
Table 2: A Summary of the Compensatory Mechanisms in HF 28
Table 3: The Two Main Classification Systems in HF 33
Table 4: Typical Symptoms of HF 34
Table 5: Risk Factors and Comorbidities for HF 39
Table 6: NYHA Functional Classes I-IV 44
Table 7: ACCF/AHA Stages A, B, C, and D 44
Table 8: 7MM, Sources of Epidemiological Data Used for the Forecast of HF Diagnosed Incident Cases 45
Table 9: 7MM, Sources of Epidemiological Data Used for the Forecast of Chronic HF Diagnosed Prevalent Cases 46
Table 10: 7MM, Sources of Epidemiological Data Used for the Classification of Diagnosed Prevalent Cases of Chronic HF According to the NYHA Functional Classes I-IV 47
Table 11: 7MM, Sources of Epidemiological Data Used for Forecast of HF Diagnosed Incident Cases of Acute HF Hospitalizations 48
Table 12: 7MM, Sources Not Used in Epidemiological Analysis of HF 63
Table 13: 7MM, Diagnosed Incident Cases of HF, Ages ≥45 Years, Both Sexes, N, 2015-2025 64
Table 14: 7MM, Age-Specific Diagnosed Incident Cases of HF, Both Sexes, N (Row %), 2015 66
Table 15: 7MM, Sex-Specific Diagnosed Incident Cases of HF, Ages ≥45 Years, N (Row %), 2015 68
Table 16: 7MM, Diagnosed Incident Cases of Acute HF Hospitalizations, Ages ≥45 Years, Both Sexes, N, 2015-2025 73
Table 17: 7MM, Readmissions (Within Three Months) Post-Discharge After Acute HF Hospitalization Among Diagnosed Incident Cases of Acute HF, Ages ≥45 Years, Both Sexes, N, 2015-2025 75
Table 18: 7MM, Diagnosed Prevalent Cases of Chronic HF, Ages ≥45 Years, Both Sexes, N, 2015-2025 78
Table 19: 7MM, Age-Specific Diagnosed Prevalent Cases of Chronic HF, Both Sexes, N (Row %), 2015 80
Table 20: 7MM, Sex-Specific Diagnosed Prevalent Cases of Chronic HF, Ages ≥45 Years, N (Row %), 2015 82
Table 21: Guideline Recommended Tests for the Diagnosis of HF 92
Table 22: Common Factors that Precipitate Acute HF 94
Table 23: Treatment Guidelines for HF 95
Table 24: Comparison of the ACCF/AHA and NYHA HF Classification Systems 96
Table 25: Most Prescribed Drugs for HF by Class in the Global Markets, 2015 97
Table 26: Country Profile for HF - US 107
Table 27: Country Profile for HF - 5EU 110
Table 28: Country Profile for HF - Japan 113
Table 29: Efficacy of Enalapril 118
Table 30: Efficacy of Perindopril 120
Table 31: Global Sales Forecasts ($M) for ACE inhibitors, 2015-2025 122
Table 32: Global Sales Forecasts ($M) for ARBs, 2015-2025 126
Table 33: Product Profile - Entresto 133
Table 34: Efficacy of Entresto 134
Table 35: Safety of Entresto 136
Table 36: Entresto SWOT Analysis, 2015 138
Table 37: Global Sales Forecasts ($M) for Entresto, 2015-2025 141
Table 38: Global Sales Forecasts ($M) for Diuretics in the Chronic HF Market, 2015-2025 145
Table 39: Global Sales Forecasts ($M) for Loop Diuretics in the Acute HF Market, 2015-2025 145
Table 40: Global Sales Forecasts ($M) for Beta Blockers, 2015-2025 150
Table 41: Product Profile - Ivabradine 153
Table 42: Efficacy of Ivabradine 154
Table 43: Ivabradine SWOT Analysis, 2015 156
Table 44: Global Sales Forecasts ($M) for Procoralan/Corlanor (ivabradine), 2015-2025 158
Table 45: Global Sales Forecasts ($M) for MRAs, 2015-2025 162
Table 46: Global Sales Forecasts ($M) for Digoxin, 2015-2025 165
Table 47: Unmet Needs and Opportunities in HF 169
Table 48: Target Opportunity Profile for Acute HF 171
Table 49: Target Opportunity Profile for HF-PEF 175
Table 50: Target Opportunity Profile for HF-REF 178
Table 51: Chronic HF Comorbidities in the 7MM 192
Table 52: Comparison of Therapeutic Classes in Development for HF, 2015 212
Table 53: Product Profile - Serelaxin 215
Table 54: Efficacy of Serelaxin 217
Table 55: Serelaxin SWOT Analysis, 2015 220
Table 56: Global Sales Forecasts ($M) for Serelaxin, 2015-2025 221
Table 57: Product Profile - Ularitide 224
Table 58: Safety of Ularitide 226
Table 59: Ularitide SWOT Analysis, 2015 228
Table 60: Global Sales Forecasts ($M) for Ularitide, 2015-2025 229
Table 61: Product Profile - OM 232
Table 62: Efficacy of OM 233
Table 63: OM SWOT Analysis, 2015 236
Table 64: Global Sales Forecasts ($M) for OM (Chronic HF), 2015-2025 237
Table 65: Global Sales Forecasts ($M) for OM (Acute HF), 2015-2025 238
Table 66: Product Profile - Vericiguat 240
Table 67: Efficacy of Vericiguat 241
Table 68: Safety of Vericiguat 242
Table 69: Vericiguat SWOT Analysis, 2015 244
Table 70: Global Sales Forecasts ($M) for vericiguat, 2015-2025 245
Table 71: Product Profile - Finerenone 247
Table 72: Finerenone SWOT Analysis, 2015 250
Table 73: Product Profile - Neucardin 252
Table 74: Neucardin SWOT Analysis, 2015 255
Table 75: Product Profile - Revatio 256
Table 76: Efficacy of Revatio 257
Table 77: Revatio SWOT Analysis, 2015 259
Table 78: Drugs in Development, 2015 262
Table 79: Key Companies in the HF Market in the 7MM, 2015-2025 264
Table 80: Novartis’ HF Portfolio Assessment, 2015 268
Table 81: Serviers’ HF Portfolio Assessment, 2015 270
Table 82: Cardiorentis’ HF Portfolio Assessment, 2015 272
Table 83: Bayer’s HF Portfolio Assessment, 2015 274
Table 84: Cytokinetics’ HF Portfolio Assessment, 2015 275
Table 85: Global Sales Forecasts ($M) for Chronic HF, 2015-2025 277
Table 86: Global Sales Forecasts ($M) for Acute HF, 2015-2025 279
Table 87: HF Global Market - Drivers and Barriers, 2015-2025 281
Table 88: Sales Forecasts ($M) for HF in the US, 2015-2025 287
Table 89: Key Events Impacting Sales for HF in the US, 2015-2025 289
Table 90: US HF Market - Drivers and Barriers, 2015-2025 290
Table 91: Sales Forecasts ($M) for HF in France, 2015-2025 293
Table 92: Key Events Impacting Sales for HF in France, 2015-2025 295
Table 93: French HF market - Drivers and Barriers, 2015-2025 296
Table 94: Sales Forecasts ($M) for HF in Germany, 2015-2025 298
Table 95: Key Events Impacting Sales for HF in Germany, 2015-2025 300
Table 96: Germany HF market - Drivers and Barriers, 2015-2025 301
Table 97: Sales Forecasts ($M) for HF in Italy, 2015-2025 303
Table 98: Key Events Impacting Sales for HF in Italy, 2015-2025 305
Table 99: Italy HF market - Drivers and Barriers, 2015-2025 306
Table 100: Sales Forecasts ($M) for HF in Spain, 2015-2025 308
Table 101: Key Events Impacting Sales for HF in Spain, 2015-2025 310
Table 102: Spain HF market - Drivers and Barriers, 2015-2025 311
Table 103: Sales Forecasts ($M) for HF in the UK, 2015-2025 313
Table 104: Key Events Impacting Sales for HF in the UK, 2015-2025 315
Table 105: UK HF market - Drivers and Barriers, 2015-2025 316
Table 106: Sales Forecasts ($M) for HF in Japan, 2015-2025 318
Table 107: Key Events Impacting Sales for HF in Japan, 2015-2025 321
Table 108: Japan HF market - Drivers and Barriers, 2015-2025 321
Table 109: Key Launch Dates 366
Table 110: Key Patent Expiries 366
Table 111: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 378
1.2 List of Figures
Figure 1: RAAS Mechanism of Action 30
Figure 2: 7MM, Diagnosed Incident Cases of HF, Ages ≥45 Years, Both Sexes, N, 2015-2025 65
Figure 3: 7MM, Diagnosed Incident Cases of HF by Age Group, Both Sexes, N, 2015 67
Figure 4: 7MM, Sex-Specific Diagnosed Incident Cases of HF, Ages ≥45 Years, N, 2015 69
Figure 5: 7MM, Age-Standardized Diagnosed Incidence of HF (Cases per 100,000 Population), Ages ≥45 Years, by Sex, 2015 70
Figure 6: 7MM, Diagnosed Incident Cases of HF Segmented by EF, Ages ≥45 Years, Both Sexes, N, 2015 71
Figure 7: 7MM, Diagnosed Incident Cases of HF Segmented by Ventricular Dysfunction, Ages ≥45 Years, Both Sexes, N, 2015 72
Figure 8: 7MM, Diagnosed Incident Cases of Acute HF Hospitalizations, Ages ≥45 Years, Both Sexes, N, 2015-2025 73
Figure 9: 7MM, Diagnosed Incident Cases of Acute HF Hospitalizations, Ages ≥45 Years, Both Sexes, N, 2015 74
Figure 10: 7MM, Readmissions (Within Three Months) Post-Discharge After Acute HF Hospitalization Among Diagnosed Incident Cases of Acute HF, Ages ≥45 Years, Both Sexes, N, 2015-2025 76
Figure 11: 7MM, Hospital Length Of Stay For Acute HF Hospitalization, Ages ≥45 Years, Both Sexes, Days, 2015 77
Figure 12: 7MM, Diagnosed Prevalent Cases of Chronic HF, Ages ≥45 Years, Both Sexes, N, 2015-2025 79
Figure 13: 7MM, Age-Specific Diagnosed Prevalent Cases of Chronic HF, Both Sexes, N, 2015 81
Figure 14: 7MM, Sex-Specific Diagnosed Prevalent Cases of Chronic HF, Ages ≥45 Years, N, 2015 83
Figure 15: 7MM, Age-Standardized Diagnosed Prevalence of Chronic HF (%), Ages ≥45 Years, by Sex, 2015 84
Figure 16: 7MM, Diagnosed Prevalent Cases of Chronic HF Segmented by EF, Ages ≥45 Years, Both Sexes, N, 2015 85
Figure 17: 7MM, Diagnosed Prevalent Cases of Chronic HF Segmented by NYHA Classes, Ages ≥45 Years, Both Sexes, N, 2015 86
Figure 18: 7MM, Diagnosed Prevalent Cases of Chronic HF Segmented by ACCF/AHA Stages, Ages ≥45 Years, Both Sexes, N, 2015 87
Figure 19: 7MM, Prevalent Cases of Comorbidities Among Diagnosed Prevalent Cases of Chronic HF, Both Sexes, Ages ≥45 Years, N, 2015 88
Figure 20: HF treatment based on ACCF/AHA Stage 101
Figure 21: HF - Phase II-III Pipeline, 2015 210
Figure 22: Competitive Assessment of Late-Stage Pipeline Agents in HF, 2015-2025 211
Figure 23: Company Portfolio Gap Analysis in HF, 2015-2025 265
Figure 24: Global Sales for Chronic HF by Region, 2015-2025 278
Figure 25: Global Sales for Acute HF by Region, 2015-2025 280
Figure 26: Sales for Chronic HF in the US by Drug Class, 2015-2025 288
Figure 27: Sales for Acute HF in the US by Drug Class, 2025* 289
Figure 28: Sales for Chronic HF in France by Drug Class, 2015-2025 294
Figure 29: Sales for Acute HF in France by Drug Class, 2025* 295
Figure 30: Sales for Chronic HF in Germany by Drug Class, 2015-2025 299
Figure 31: Sales for Acute HF in Germany by Drug Class, 2025* 300
Figure 32: Sales for Chronic HF in Italy by Drug Class, 2015-2025 304
Figure 33: Sales for Acute HF in Italy by Drug Class, 2025* 305
Figure 34: Sales for Chronic HF in Spain by Drug Class, 2015-2025 309
Figure 35: Sales for Acute HF in Spain by Drug Class, 2025* 310
Figure 36: Sales for Chronic HF in the UK by Drug Class, 2015-2025 314
Figure 37: Sales for Acute HF in the UK by Drug Class, 2025* 315
Figure 38: Sales for Chronic HF in Japan by Drug Class, 2015-2025 319
Figure 39: Sales for Acute HF in Japan by Drug Class, 2015-2025 320
