PharmaPoint: Heart Failure – Global Drug Forecast and Market Analysis to 2025

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GlobalData estimates sales of 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.

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.

Key Highlights

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?

Amgen
Bayer
BMS
Cardiorentis
Cytokinetics
Daiichi Sankyo Co. Ltd.
Heart Metabolics Ltd.
Lee’s Pharmaceutical Holdings Ltd.
Les Laboratoires Servier
Merck & Co.
Novartis
Ono Pharmaceuticals
Pfizer
Trevena Inc.

Table of Contents

1Table of Contents

1.1List of Tables

1.2List of Figures

2Introduction

2.1Catalyst

2.2Related Reports

3Disease Overview

3.1Etiology and Pathophysiology

3.1.1Etiology

3.2Classification and Staging Systems

3.3Symptoms

3.4Prognosis

3.5Quality of Life

4Epidemiology

4.1Disease Background

4.2Risk Factors and Comorbidities

4.3Global Trends

4.3.1US

4.3.25EU

4.3.3Japan

4.4Forecast Methodology

4.4.1Sources Used

4.4.2Forecast Assumptions and Methods

4.4.3Sources Not Used

4.5Epidemiological Forecast for HF (2015–2025)

4.5.1Diagnosed Incident Cases

4.5.2Diagnosed Prevalent Cases

4.6Discussion

4.6.1Epidemiological Forecast Insight

4.6.2Limitations of the Analysis

4.6.3Strengths of the Analysis

5Disease Management

5.1Diagnosis and Treatment Overview

5.1.1Diagnosis

5.1.2Treatment Guidelines and Leading Prescribed Drugs

5.1.3Medical Devices

5.1.4Clinical Practice

5.2US

5.35EU

5.4Japan

6Competitive Assessment

6.1Overview

6.2Drug Profiles

6.2.1Angiotensin-Converting Enzyme Inhibitors

6.2.2Angiotensin Receptor Blockers

6.2.3Entresto (sacubitril + valsartan)

6.2.4Diuretics

6.2.5Beta Blockers

6.2.6Procoralan (ivabradine)

6.2.7Mineralocorticoid Receptor Antagonists

6.2.8Digoxin

6.2.9Pharmacological Therapies for Acute HF

7Unmet Needs and Opportunities

7.1Overview

7.1.1Acute HF – Target Opportunity Profile

7.1.2HF with Preserved Ejection Fraction – Target Opportunity Profile

7.1.3HF with Reduced Ejection Fraction – Target Opportunity Profile

7.2Lack of Therapies for HF with Preserved Ejection Fraction Patients

7.2.1Unmet Need

7.2.2Gap Analysis

7.2.3Opportunity

7.3Lack of Therapies for Acute HF

7.3.1Unmet Need

7.3.2Gap analysis

7.3.3Opportunity

7.4Lack of Therapies for Acute HF Patients Experiencing Diuretic Resistance

7.4.1Unmet Need

7.4.2Gap Analysis

7.4.3Opportunity

7.5Lack of Therapies for Patients with Renal Impairment

7.5.1Unmet Need

7.5.2Gap Analysis

7.5.3Opportunity

7.6Treatment of Patients with Multiple Comorbidities

7.6.1Unmet Need

7.6.2Gap Analysis

7.6.3Opportunity

7.7Enhanced Diagnosis and Preventative Therapies for Patients at Risk of Developing HF

7.7.1Unmet Need

7.7.2Gap Analysis

7.7.3Opportunity

7.8Conducting Clinical Trials in Cohorts of Japanese Patients

7.8.1Unmet Need

7.8.2Gap Analysis

7.8.3Opportunity

7.9Use of Optimal Doses of HF Therapies

7.9.1Unmet Need

7.9.2Gap Analysis

7.9.3Opportunity

7.10Patient Compliance

7.10.1Unmet Need

7.10.2Gap Analysis

7.10.3Opportunity

7.11Early Detection and Treatment of Patients with Worsening Chronic HF

7.11.1Unmet Need

7.11.2Gap Analysis

7.11.3Opportunity

7.12Dynamic Management of Patients with HF

7.12.1Unmet Need

7.12.2Gap Analysis

7.12.3Opportunity

7.13Options for Advanced HF Patients Who Are Unable to Receive a Heart Transplant

7.13.1Unmet Need

7.13.2Gap Analysis

7.13.3Opportunity

8Pipeline Assessment

8.1Overview

8.2Promising Drugs in Late-Stage Clinical Development

8.2.1Serelaxin

8.2.2Ularitide

8.2.3Omecamtiv Mecarbil

8.2.4Vericiguat

8.2.5Finerenone

8.2.6Neucardin

8.2.7Revatio

8.3Promising Drugs in Early Stage Development

8.3.1CXL-1427

8.3.2Istaroxime

8.3.3Perhexiline Maleate

8.3.4TRV-027

8.4Other Drugs in Development

9Current and Future Players

9.1Overview

9.2Trends in Corporate Strategy

9.3Company Profiles

9.3.1Novartis

9.3.2Les Laboratoires Servier

9.3.3Cardiorentis

9.3.4Bayer (and Merck & Co.)

9.3.5Cytokinetics

10Market Outlook

10.1Global Markets

10.1.1Forecast

10.1.2Drivers and Barriers – Global Issues

10.2US

10.2.1Forecast

10.2.2Key Events

10.2.3Drivers and Barriers

10.3France

10.3.1Forecast

10.3.2Key Events

10.3.3Drivers and Barriers

10.4Germany

10.4.1Forecast

10.4.2Key Events

10.4.3Drivers and Barriers

10.5Italy

10.5.1Forecast

10.5.2Key Events

10.5.3Drivers and Barriers

10.6Spain

10.6.1Forecast

10.6.2Key Events

10.6.3Drivers and Barriers

10.7UK

10.7.1Forecast

10.7.2Key Events

10.7.3Drivers and Barriers

10.8Japan

10.8.1Forecast

10.8.2Key Events

10.8.3Drivers and Barriers

11Appendix

11.1Bibliography

11.2Abbreviations

11.3Methodology

11.4Forecasting Methodology

11.4.1Diagnosed Prevalent Chronic HF

11.4.2Diagnosed Incidence of Acute HF

11.4.3Percent Drug-Treated Patients

11.4.4Treatment of HF with Reduced Ejection Fraction Versus HF with Preserved Ejection Fraction

11.4.5Drugs Included in Each Therapeutic Class

11.4.6Launch and Patent Expiry Dates

11.4.7General Pricing Assumptions

11.4.8Individual Drug Assumptions

11.4.9Generic Erosion

11.4.10Pricing of Pipeline Agents

11.5Key Opinion Leaders Included in This Study

11.6Payers Included in This Study

11.7High-Prescribing Physician Survey

11.8About the Authors

11.8.1Author

11.8.2Contributing Author

11.8.3Therapy Area Director

11.8.4Epidemiologist

11.8.5Global Director of Therapy Analysis and Epidemiology

11.8.6Global Head of Healthcare

11.9About GlobalData

11.10Contact Us

11.11Disclaimer

Table

Table 1: Leading Causes of HF

Table 2: A Summary of the Compensatory Mechanisms in HF

Table 3: The Two Main Classification Systems in HF

Table 4: Typical Symptoms of HF

Table 5: Risk Factors and Comorbidities for HF

Table 6: NYHA Functional Classes I–IV

Table 7: ACCF/AHA Stages A, B, C, and D

Table 8: 7MM, Sources of Epidemiological Data Used for the Forecast of HF Diagnosed Incident Cases

Table 9: 7MM, Sources of Epidemiological Data Used for the Forecast of Chronic HF Diagnosed Prevalent Cases

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

Table 11: 7MM, Sources of Epidemiological Data Used for Forecast of HF Diagnosed Incident Cases of Acute HF Hospitalizations

Table 12: 7MM, Sources Not Used in Epidemiological Analysis of HF

Table 13: 7MM, Diagnosed Incident Cases of HF, Ages =45 Years, Both Sexes, N, 2015–2025

Table 14: 7MM, Age-Specific Diagnosed Incident Cases of HF, Both Sexes, N (Row %), 2015

Table 15: 7MM, Sex-Specific Diagnosed Incident Cases of HF, Ages =45 Years, N (Row %), 2015

Table 16: 7MM, Diagnosed Incident Cases of Acute HF Hospitalizations, Ages =45 Years, Both Sexes, N, 2015–2025

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

Table 18: 7MM, Diagnosed Prevalent Cases of Chronic HF, Ages =45 Years, Both Sexes, N, 2015–2025

Table 19: 7MM, Age-Specific Diagnosed Prevalent Cases of Chronic HF, Both Sexes, N (Row %), 2015

Table 20: 7MM, Sex-Specific Diagnosed Prevalent Cases of Chronic HF, Ages =45 Years, N (Row %), 2015

Table 21: Guideline Recommended Tests for the Diagnosis of HF

Table 22: Common Factors that Precipitate Acute HF

Table 23: Treatment Guidelines for HF

Table 24: Comparison of the ACCF/AHA and NYHA HF Classification Systems

Table 25: Most Prescribed Drugs for HF by Class in the Global Markets, 2015

Table 26: Country Profile for HF – US

Table 27: Country Profile for HF – 5EU

Table 28: Country Profile for HF – Japan

Table 29: Efficacy of Enalapril

Table 30: Efficacy of Perindopril

Table 31: Global Sales Forecasts ($M) for ACE inhibitors, 2015-2025

Table 32: Global Sales Forecasts ($M) for ARBs, 2015-2025

Table 33: Product Profile – Entresto

Table 34: Efficacy of Entresto

Table 35: Safety of Entresto

Table 36: Entresto SWOT Analysis, 2015

Table 37: Global Sales Forecasts ($M) for Entresto, 2015-2025

Table 38: Global Sales Forecasts ($M) for Diuretics in the Chronic HF Market, 2015–2025

Table 39: Global Sales Forecasts ($M) for Loop Diuretics in the Acute HF Market, 2015–2025

Table 40: Global Sales Forecasts ($M) for Beta Blockers, 2015–2025

Table 41: Product Profile – Ivabradine

Table 42: Efficacy of Ivabradine

Table 43: Ivabradine SWOT Analysis, 2015

Table 44: Global Sales Forecasts ($M) for Procoralan/Corlanor (ivabradine), 2015–2025

Table 45: Global Sales Forecasts ($M) for MRAs, 2015–2025

Table 46: Global Sales Forecasts ($M) for Digoxin, 2015-2025

Table 47: Unmet Needs and Opportunities in HF

Table 48: Target Opportunity Profile for Acute HF

Table 49: Target Opportunity Profile for HF-PEF

Table 50: Target Opportunity Profile for HF-REF

Table 51: Chronic HF Comorbidities in the 7MM

Table 52: Comparison of Therapeutic Classes in Development for HF, 2015

Table 53: Product Profile – Serelaxin

Table 54:Efficacy of Serelaxin

Table 55: Serelaxin SWOT Analysis, 2015

Table 56: Global Sales Forecasts ($M) for Serelaxin, 2015–2025

Table 57: Product Profile – Ularitide

Table 58: Safety of Ularitide

Table 59: Ularitide SWOT Analysis, 2015

Table 60: Global Sales Forecasts ($M) for Ularitide, 2015–2025

Table 61: Product Profile – OM

Table 62: Efficacy of OM

Table 63: OM SWOT Analysis, 2015

Table 64: Global Sales Forecasts ($M) for OM (Chronic HF), 2015–2025

Table 65: Product Profile – Vericiguat

Table 66: Efficacy of Vericiguat

Table 67: Safety of Vericiguat

Table 68: Vericiguat SWOT Analysis, 2015

Table 69: Global Sales Forecasts ($M) for OM (Acute HF), 2015–2025

Table 70: Product Profile – Finerenone

Table 71: Finerenone SWOT Analysis, 2015

Table 72: Global Sales Forecasts ($M) for Finerenone, 2015-2025

Table 73: Product Profile – Neucardin

Table 74: Neucardin SWOT Analysis, 2015

Table 75: Product Profile – Revatio

Table 76: Efficacy of Revatio

Table 77: Revatio SWOT Analysis, 2015

Table 78: Drugs in Development, 2015

Table 79: Key Companies in the HF Market in the 7MM, 2015–2025

Table 80: Novartis’ HF Portfolio Assessment, 2015

Table 81: Serviers’ HF Portfolio Assessment, 2015

Table 82: Cardiorentis’ HF Portfolio Assessment, 2015

Table 83: Bayer’s HF Portfolio Assessment, 2015

Table 84: Cytokinetics’ HF Portfolio Assessment, 2015

Table 85: Global Sales Forecasts ($M) for Chronic HF, 2015–2025

Table 86: Global Sales Forecasts ($M) for Acute HF, 2015–2025

Table 87: HF Global Market – Drivers and Barriers, 2015–2025

Table 88: Sales Forecasts ($M) for HF in the US, 2015–2025

Table 89: Key Events Impacting Sales for HF in the US, 2015–2025

Table 90: US HF Market – Drivers and Barriers, 2015–2025

Table 91: Sales Forecasts ($M) for HF in France, 2015–2025

Table 92: Key Events Impacting Sales for HF in France, 2015–2025

Table 93: French HF market – Drivers and Barriers, 2015–2025

Table 94: Sales Forecasts ($M) for HF in Germany, 2015–2025

Table 95: Key Events Impacting Sales for HF in Germany, 2015–2025

Table 96: Germany HF market – Drivers and Barriers, 2015–2025

Table 97: Sales Forecasts ($M) for HF in Italy, 2015–2025

Table 98: Key Events Impacting Sales for HF in Italy, 2015–2025

Table 99: Italy HF market – Drivers and Barriers, 2015–2025

Table 100: Sales Forecasts ($M) for HF in Spain, 2015–2025

Table 101: Key Events Impacting Sales for HF in Spain, 2015–2025

Table 102: Spain HF market – Drivers and Barriers, 2015–2025

Table 103: Sales Forecasts ($M) for HF in the UK, 2015–2025

Table 104: Key Events Impacting Sales for HF in the UK, 2015–2025

Table 105: UK HF market – Drivers and Barriers, 2015–2025

Table 106: Sales Forecasts ($M) for HF in Japan, 2015–2025

Table 107: Key Events Impacting Sales for HF in Japan, 2015–2025

Table 108: Japan HF market – Drivers and Barriers, 2015–2025

Table 109: Key Launch Dates

Table 110: Key Patent Expiries

Table 111: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

Figures

Figure 1: RAAS Mechanism of Action

Figure 2: 7MM, Diagnosed Incident Cases of HF, Ages =45 Years, Both Sexes, N, 2015–2025

Figure 3: 7MM, Diagnosed Incident Cases of HF by Age Group, Both Sexes, N, 2015

Figure 4: 7MM, Sex-Specific Diagnosed Incident Cases of HF, Ages =45 Years, N, 2015

Figure 5: 7MM, Age-Standardized Diagnosed Incidence of HF (Cases per 100,000 Population), Ages =45 Years, by Sex, 2015

Figure 6: 7MM, Diagnosed Incident Cases of HF Segmented by EF, Ages =45 Years, Both Sexes, N, 2015

Figure 7: 7MM, Diagnosed Incident Cases of HF Segmented by Ventricular Dysfunction, Ages =45 Years, Both Sexes, N, 2015

Figure 8: 7MM, Diagnosed Incident Cases of Acute HF Hospitalizations, Ages =45 Years, Both Sexes, N, 2015–2025

Figure 9: 7MM, Diagnosed Incident Cases of Acute HF Hospitalizations, Ages =45 Years, Both Sexes, N, 2015

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

Figure 11: 7MM, Hospital Length Of Stay For Acute HF Hospitalization, Ages =45 Years, Both Sexes, Days, 2015

Figure 12: 7MM, Diagnosed Prevalent Cases of Chronic HF, Ages =45 Years, Both Sexes, N, 2015–2025

Figure 13: 7MM, Age-Specific Diagnosed Prevalent Cases of Chronic HF, Both Sexes, N, 2015

Figure 14: 7MM, Sex-Specific Diagnosed Prevalent Cases of Chronic HF, Ages =45 Years, N, 2015

Figure 15: 7MM, Age-Standardized Diagnosed Prevalence of Chronic HF (%), Ages =45 Years, by Sex, 2015

Figure 16: 7MM, Diagnosed Prevalent Cases of Chronic HF Segmented by EF, Ages =45 Years, Both Sexes, N, 2015

Figure 17: 7MM, Diagnosed Prevalent Cases of Chronic HF Segmented by NYHA Classes, Ages =45 Years, Both Sexes, N, 2015

Figure 18: 7MM, Diagnosed Prevalent Cases of Chronic HF Segmented by ACCF/AHA Stages, Ages =45 Years, Both Sexes, N, 2015

Figure 19: 7MM, Prevalent Cases of Comorbidities Among Diagnosed Prevalent Cases of Chronic HF, Both Sexes, Ages =45 Years, N, 2015

Figure 20: HF treatment based on ACCF/AHA Stage

Figure 21: HF – Phase II–III Pipeline, 2015

Figure 22: Competitive Assessment of Late-Stage Pipeline Agents in HF, 2015-2025

Figure 23: Company Portfolio Gap Analysis in HF, 2015–2025

Figure 24: Global Sales for Chronic HF by Region, 2015–2025

Figure 25: Global Sales for Acute HF by Region, 2015–2025

Figure 26: Sales for Chronic HF in the US by Drug Class, 2015–2025

Figure 27: Sales for Acute HF in the US by Drug Class, 2025*

Figure 28: Sales for Chronic HF in France by Drug Class, 2015–2025

Figure 29: Sales for Acute HF in France by Drug Class, 2025*

Figure 30: Sales for Chronic HF in Germany by Drug Class, 2015–2025

Figure 31: Sales for Acute HF in Germany by Drug Class, 2025*

Figure 32: Sales for Chronic HF in Italy by Drug Class, 2015–2025

Figure 33: Sales for Acute HF in Italy by Drug Class, 2025*

Figure 34: Sales for Chronic HF in Spain by Drug Class, 2015–2025

Figure 35: Sales for Acute HF in Spain by Drug Class, 2025*

Figure 36: Sales for Chronic HF in the UK by Drug Class, 2015–2025

Figure 37: Sales for Acute HF in the UK by Drug Class, 2025*

Figure 38: Sales for Chronic HF in Japan by Drug Class, 2015–2025

Figure 39: Sales for Acute HF in Japan by Drug Class, 2015–2025

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