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

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.

Companies mentioned

Amgen

Bayer

BMS

Cardiorentis

Cytokinetics

Les Laboratoires Servier

Merck & Co.

Novartis

Ono Pharmaceuticals

Pfizer

Amgen

Bayer

BMS

Cardiorentis

Cytokinetics

Les Laboratoires Servier

Merck & Co.

Novartis

Ono Pharmaceuticals

Pfizer

Table of Contents

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Heart Failure: Executive Summary

2.1 The ...

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Heart Failure: Executive Summary

2.1 The HF Market Will Exhibit Strong Growth Between 2016 and 2026

2.2 Label Expansion to HF with Preserved Ejection Fraction Will Fuel Market Growth

2.3 The HF Market Has Considerable Unmet Needs, Despite the Availability of Well-Established Therapies and a Promising Pipeline

2.4 Opportunities Remain for All Aspects of HF, But What the Market Really Needs Is a Transformational Therapy

2.5 Entresto Will Dominate the HF Market

2.6 What Do Physicians Think?

3 Introduction

3.1 Catalyst

3.2 Related Reports

4 Disease Overview

4.1 Etiology and Pathophysiology

4.1.1 Etiology

4.1.2 Pathophysiology

4.1.3 Biomarkers/Targets of Interest

4.2 Classification or Staging Systems

4.3 Symptoms

4.4 Prognosis

4.5 Quality of Life

5 Epidemiology

5.1 Disease Background

5.2 Risk Factors and Comorbidities

5.3 Global and Historical Trends

5.4 Forecast Methodology

5.4.1 Sources

5.4.2 Forecast assumptions and methods

5.4.3 Diagnosed Incident Cases of HF by EF

5.4.4 Diagnosed Incident Cases of HF by Ventricular Dysfunction

5.4.5 Acute HF Hospitalizations

5.4.6 Hospital Length of Stay for Acute HF Hospitalization

5.4.7 Diagnosed Prevalent Cases of CHF

5.4.8 Diagnosed Prevalent Cases of CHF by EF

5.4.9 Diagnosed Prevalent Cases of CHF by NYHA Classes

5.5 Epidemiological Forecast for Heart Failure (2016–2026)

5.5.1 Diagnosed Incident Cases of HF

5.5.2 Age-Specific Diagnosed Incident Cases of HF

5.5.3 Sex-Specific Diagnosed Incident Cases of HF

5.5.4 Diagnosed Incident Cases of HF by EF

5.5.5 Diagnosed Incident Cases of HF by VD

5.5.6 Acute HF Hospitalizations

5.5.7 Hospital Length of Stay for Acute HF Hospitalization

5.5.8 Diagnosed Prevalent Cases of CHF

5.5.9 Age-Specific Diagnosed Prevalent Cases of CHF

5.5.10 Sex-Specific Diagnosed Prevalent Cases of CHF

5.5.11 Diagnosed Prevalent Cases of CHF by EF

5.5.12 Diagnosed Prevalent Cases of CHF by NYHA Class

5.6 Discussion

5.6.1 Epidemiological Forecast Insight

5.6.2 Limitations of Analysis

5.6.3 Strengths of Analysis

6 Disease Management

6.1 Diagnosis Overview

6.2 Treatment Overview

6.2.1 Treatment Guidelines and Leading Prescribed Drugs

6.2.2 Clinical Practice

6.3 US

6.4 5EU

6.5 Japan

7 Competitive Assessment

7.1 Overview

7.2 Angiotensin-Converting Enzyme Inhibitors

7.2.1 Overview

7.2.2 Efficacy

7.2.3 Safety

7.2.4 Forecast

7.3 Angiotensin Receptor Blockers

7.3.1 Overview

7.3.2 Efficacy

7.3.3 Safety

7.3.4 Forecast

7.4 Entresto (Sacubitril + Valsartan)

7.4.1 Overview

7.4.2 Efficacy

7.4.3 Safety

7.4.4 SWOT Analysis

7.4.5 Forecast

7.5 Diuretics

7.5.1 Overview

7.5.2 Efficacy

7.5.3 Safety

7.5.4 Forecast

7.6 Beta Blockers

7.6.1 Overview

7.6.2 Efficacy

7.6.3 Safety

7.6.4 Forecast

7.7 Procoralan (Ivabradine)

7.7.1 Overview

7.7.2 Efficacy

7.7.3 Safety

7.7.4 SWOT Analysis

7.7.5 Forecast

7.8 Mineralocorticoid Receptor Antagonists

7.8.1 Overview

7.8.2 Efficacy

7.8.3 Safety

7.8.4 Forecast

7.9 Digoxin

7.9.1 Overview

7.9.2 Efficacy

7.9.3 Safety

7.9.4 Forecast

7.10 Pharmacological Therapies for Acute HF

8 Unmet Needs and Opportunity Assessment

8.1 Overview

8.2 Lack of Therapies for HF-PEF Patients

8.2.1 Unmet Need

8.2.2 Gap Analysis

8.2.3 Opportunity

8.3 Lack of Therapies for Acute HF

8.3.1 Unmet Need

8.3.2 Gap Analysis

8.3.3 Opportunity

8.4 Lack of Therapies for Patients with Renal Impairment

8.4.1 Unmet Need

8.4.2 Gap Analysis

8.4.3 Opportunity

8.5 Preventative Therapies for Patients at Risk of Developing HF

8.5.1 Unmet Need

8.5.2 Gap Analysis

8.5.3 Opportunity

8.6 Use of Optimal Doses of HF Therapies

8.6.1 Unmet Need

8.6.2 Gap Analysis

8.6.3 Opportunity

8.7 Patient Compliance

8.7.1 Unmet Need

8.7.2 Gap Analysis

8.7.3 Opportunity

8.8 Early Detection and Treatment of Patients with Worsening Chronic HF

8.8.1 Unmet Need

8.8.2 Gap Analysis

8.8.3 Opportunity

8.9 Dynamic Management of Patients with HF

8.9.1 Unmet Need

8.9.2 Gap Analysis

8.9.3 Opportunity

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

8.10.1 Unmet Need

8.10.2 Gap Analysis

8.10.3 Opportunity

8.11 Better Risk Stratification of Patients Admitted to the ED with Acute HF and Enhanced Outpatient Care

8.11.1 Unmet Need

8.11.2 Gap Analysis

8.11.3 Opportunity

9 Pipeline Assessment

9.1 Overview

9.2 Drugs in Clinical Development

9.2.1 Pipeline Drugs by Patient Population

9.3 Promising Drugs in Clinical Development

9.4 Omecamtiv Mecarbil

9.4.1 Overview

9.4.2 Efficacy

9.4.3 Safety

9.4.4 Dosing and Formulation

9.4.5 Potential Clinical and Commercial Positioning

9.4.6 SWOT Analysis

9.4.7 Forecast

9.5 Vericiguat

9.5.1 Overview

9.5.2 Efficacy

9.5.3 Safety

9.5.4 Dosing and Formulation

9.5.5 Potential Clinical and Commercial Positioning

9.5.6 SWOT Analysis

9.5.7 Forecast

9.6 RT-100

9.6.1 Overview

9.6.2 Efficacy

9.6.3 Safety

9.6.4 Dosing and Formulation

9.6.5 Potential Clinical and Commercial Positioning

9.6.6 SWOT Analysis

9.6.7 Forecast

9.7 CXL-1427

9.7.1 Overview

9.7.2 Efficacy

9.7.3 Safety

9.7.4 Dosing and Formulation

9.7.5 Potential Clinical and Commercial Positioning

9.7.6 SWOT Analysis

9.7.7 Forecast

9.8 Other Drugs in Development

10 Current and Future Players

10.1 Overview

10.2 Trends in Corporate Strategy

10.3 Amgen and Cytokinetics

10.3.1 Overview

10.3.2 Portfolio Assessment

10.4 Bayer (and Merck & Co.)

10.4.1 Overview

10.4.2 Portfolio Assessment

10.5 Bristol-Myers Squibb

10.5.1 Overview

10.5.2 Portfolio Assessment

10.6 Les Laboratoires Servier

10.6.1 Overview

10.6.2 Portfolio Assessment

10.7 Novartis

10.7.1 Overview

10.7.2 Portfolio Assessment

10.8 Renova Therapeutics

10.8.1 Overview

10.8.2 Portfolio Assessment

11 Market Outlook

11.1 Global Markets

11.1.1 Forecast

11.1.2 Drivers and Barriers – Global Issues

11.2 US

11.2.1 Forecast

11.2.2 Key Events

11.2.3 Drivers and Barriers

11.3 5EU

11.3.1 Forecast

11.3.2 Key Events

11.3.3 Drivers and Barriers

11.4 Japan

11.4.1 Forecast

11.4.2 Key Events

11.4.3 Drivers and Barriers

12 Appendix

12.1 Bibliography

12.2 Abbreviations

12.3 Methodology

12.3.1 Forecasting Methodology

12.3.2 Diagnosed Prevalent Chronic HF

12.3.3 Diagnosed Incidence of Acute HF

12.3.4 Percent Drug-Treated Patients

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

12.3.6 Drugs Included in Each Therapeutic Class

12.3.7 Launch and Patent Expiry Dates

12.3.8 General Pricing Assumptions

12.3.9 Individual Drug Assumptions

12.3.10 Generic Erosion

12.3.11 Pricing of Pipeline Agents

12.4 Primary Research – KOLs Interviewed for this Report

12.5 Primary Research – Payers Included in this Study

12.6 Primary Research – Prescriber Survey

12.7 About the Authors

12.12.7.1 Analyst

12.7.2 Therapy Area Director

12.7.3 Epidemiologist

12.7.4 Managing Epidemiologists

12.7.5 Global Director of Therapy Analysis and Epidemiology

12.7.6 Global Head and EVP of Healthcare Operations and Strategy

12.8 About GlobalData

12.9 Contact Us

12.10 Disclaimer

7.1 Analyst

12.7.2 Therapy Area Director

12.7.3 Epidemiologist

12.7.4 Managing Epidemiologists

12.7.5 Global Director of Therapy Analysis and Epidemiology

12.7.6 Global Head and EVP of Healthcare Operations and Strategy

12.8 About GlobalData

12.9 Contact Us

12.10 Disclaimer

List of Tables

Table 1: Heart Failure: Key Metrics in the 7MM

Table 2: Types of Chronic HF

Table 3: The leading causes, as well as other less ...

Table 1: Heart Failure: Key Metrics in the 7MM

Table 2: Types of Chronic HF

Table 3: The leading causes, as well as other less common causes, of HF.

Table 4: The compensatory mechanisms that are activated in a patient with HF.

Table 5: Key Diagnostic and prognostic biomarkers in HF.

Table 6: Overview of Clinically Relevant Biomarkers in HF

Table 7: shows a comparison of these two HF classification systems.

Table 8: Symptoms of Heart Failure

Table 9: Risk Factors and Comorbidities for HF

Table 10: NYHA Functional Classification for CHF (Classes I–IV).

Table 11: 7MM, Diagnosed Incident Cases of HF, Both Sexes, Ages ≥45 Years, N, Selected Years 2016–2026

Table 12: 7MM, Diagnosed Prevalent Cases of CHF, Both Sexes, Ages ≥45 Years, N, Selected Years 2016–2026

Table 13: lists the common factors that precipitate acute HF.

Table 14: HF Treatment guidelines most commonly adhered to by physicians in the 7MM.

Table 15: summarizes the chronic HF-REF medications and drug classes most commonly used in the US, 5EU, and Japan, based on GlobalData’s primary and secondary research.

Table 16: Country Profile – US

Table 17: Country Profile – 5EU

Table 18: Country Profile – Japan

Table 19: Summary of major clinical trials assessing the efficacy of ACE inhibitors in HF-REF patients.

Table 20: Summary of major clinical trials assessing the efficacy of ARBs in HF-REF patients.

Table 21: Product Profile – Entresto

Table 22: Efficacy of Entresto, PARADIGM-HF

Table 23: Safety of Entresto, PARADIGM-HF

Table 24: Entresto SWOT Analysis, 2016

Table 25: Summary of major clinical trials assessing the efficacy of beta blockers in HF-REF patients.

Table 26: Product Profile – Procoralan

Table 27: Efficacy of Procoralan, SHIFT study

Table 28: Procoralan SWOT Analysis, 2016

Table 29: Unmet Need and Opportunity in HF, 2016

Table 30: Product Profile – Omecamtiv Mecarbil

Table 31: Efficacy of Omecamtiv Mecarbil, COSMIC-HF

Table 32: Omecamtiv Mecarbil SWOT Analysis, 2016

Table 33: Product Profile – Vericiguat

Table 34: Efficacy of Vericiguat, SOCRATES-Reduced

Table 35: Safety of Vericiguat, SOCRATES-Reduced

Table 36: Vericiguat SWOT Analysis, 2016

Table 37: Product Profile – RT-100

Table 38: RT-100 SWOT Analysis, 2016

Table 39: Product Profile – CXL-1427

Table 40: CXL-1427 SWOT Analysis, 2016

Table 41: Drugs in Development for Heart Failure, 2016

Table 42: Key Companies in the Heart Failure Market in the 7MM, 2016

Table 43: Amgen’s HF Portfolio Assessment, 2016

Table 44: Bayer’s HF Portfolio Assessment, 2016

Table 45: Bristol-Myers Squibb HF Portfolio Assessment, 2016

Table 46: Servier’s HF Portfolio Assessment, 2016

Table 47: Novartis’ Disease Portfolio Assessment, 2016

Table 48: Renova Therapeutics’ Disease Portfolio Assessment, 2016

Table 49: Heart Failure Market – Global Drivers and Barriers, 2016–2026

Table 50: Key Events Impacting Sales for HF in the US, 2016–2026

Table 51: HF Market – Global Drivers and Barriers in the US, 2016–2026

Table 52: Key Events Impacting Sales for Heart Failure in the 5EU, 2016–2026

Table 53: Heart Failure Market – Global Drivers and Barriers in the 5EU, 2016–2026

Table 54: Key Events Impacting Sales for Heart Failure in Japan, 2016–2026

Table 55: Heart Failure Market – Global Drivers and Barriers in Japan, 2016–2026

Table 56: Key Historical and Projected Launch Dates for HF

Table 57: Key Historical and Projected Patent Expiry Dates for Heart Failure

Table 58: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of Figures

Figure 1: Global Sales for Heart Failure by Country, 2016 and 2026

Figure 2: Competitive Assessment of Late-Stage Pipeline Agents in Heart Failure, 2016–2026 ...

Figure 1: Global Sales for Heart Failure by Country, 2016 and 2026

Figure 2: Competitive Assessment of Late-Stage Pipeline Agents in Heart Failure, 2016–2026

Figure 3: Changes in Cardiac Structure in HF

Figure 4: RAAS Mechanism of Action

Figure 5: 7MM, Age-Standardized Diagnosed Incidence of HF (Cases per 100,000 Population), Men and Women, Ages ≥45 Years, 2016

Figure 6: 7MM, Age-Standardized Diagnosed Prevalence of CHF (%), Men and Women, Ages ≥45 Years, 2016

Figure 7: 7MM, Sources Used to Forecast Diagnosed Incident Cases of HF

Figure 8: 7MM, Sources Used and Not Used to Forecast Diagnosed Prevalent Cases of CHF

Figure 9: 7MM, Sources Used to Forecast Diagnosed Incident Cases of HF by EF

Figure 10: 7MM, Sources Used to Forecast Diagnosed Prevalent Cases of CHF by EF

Figure 11: 7MM, Sources Used to Forecast Diagnosed Incident Cases of HF by Ventricular Dysfunction

Figure 12: 7MM, Sources Used to Forecast Hospitalizations for Acute HF

Figure 13: 7MM, Sources Used to Forecast Hospitalizations for Acute HF by Worsening CHF, Advanced HF, and de novo HF

Figure 14: 7MM, Sources Used to Forecast Hospital Length of Stay for Acute HF Hospitalization

Figure 15: 7MM, Sources Used to Forecast Diagnosed Prevalent Cases of CHF by NYHA Class

Figure 16: 7MM, Age-Specific Diagnosed Incident Cases of HF, Both Sexes, Ages ≥45 Years, N, 2016

Figure 17: 7MM, Sex-Specific Diagnosed Incident Cases of HF, Ages ≥45 Years, N, 2016

Figure 18: 7MM, Diagnosed Incident Cases of HF by EF, Both Sexes, Ages ≥45 Years, N, 2016

Figure 19: 7MM, Diagnosed Incident Cases of HF by VD, Both Sexes, Ages ≥45 Years, N, 2016

Figure 20: 7MM, Acute HF Hospitalizations, Both Sexes, Ages ≥45 Years, N, 2016 to 2026

Figure 21: 7MM, Acute HF Hospitalizations by Patients Admitted and Discharged, Both Sexes, Ages ≥45 Years, 2016

Figure 22: 7MM, Acute HF Hospitalizations by Worsening Chronic HF, Advanced HF, and De Novo HF, Both Sexes, Ages ≥45 Years, 2016

Figure 23: 7MM, Hospital Length of Stay for Acute HF Hospitalization, Both Sexes, Ages ≥45 Years, N, 2016

Figure 24: 7MM, Age-Specific Diagnosed Prevalent Cases of CHF, Both Sexes, Ages ≥45 Years, N, 2016

Figure 25: 7MM, Sex-Specific Diagnosed Prevalent Cases of CHF, Both Sexes, Ages ≥45 Years, N, 2016

Figure 26: 7MM, Diagnosed Prevalent Cases of CHF by EF, Both Sexes, Ages ≥45 Years, N, 2016

Figure 27: 7MM, Diagnosed Prevalent Cases of CHF by NYHA Class, Both Sexes, Ages ≥45 Years, N, 2016

Figure 28: 7MM, Diagnosed Prevalent Cases of CHF with REF by NYHA Class, Both Sexes, Ages ≥45 Years, N, 2016

Figure 29: 7MM, Diagnosed Prevalent Cases of CHF with PEF by NYHA Class, Both Sexes, Ages ≥45 Years, N, 2016

Figure 30: Diagnostic Algorithm for Chronic HF

Figure 31: Diagnostic Algorithm for Acute HF

Figure 32: HF based on the ACCF/AHA staging system

Figure 33: Classification of acute HF patients

Figure 34: Management of acute HF patients

Figure 35: Heart Failure – Drugs in Development, 2016

Figure 36: Competitive Assessment of Late-Stage Pipeline Agents in Heart Failure, 2016–2026

Figure 37: Company Portfolio Gap Analysis in Heart Failure, 2016–2026

Figure 38: Global Sales for Chronic HF by Country, 2016 and 2026

Figure 39: Global Sales for acute HF by Country, 2016 and 2026

Figure 40: Sales for Chronic HF by Drug Class in the US, 2016 and 2026

Figure 41: Sales for Chronic HF by Drug Class in the 5EU, 2016 and 2026

Figure 42: Sales for HF by Drug Class in Japan, 2016 and 2026

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