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Heart Failure – Global Drug Forecast and Market Analysis to 2028

Heart failure( HF) is a clinical syndrome where the heart is unable to meet the demands of the body with a sufficient blood supply. This can be due to structural or functional cardiac abnormalities which can be caused by unexpected injury such as myocardial infarction, or an underlying pathogenesis such as hypertension (Krum and Abraham, 2009). The heart then begins to employ compensatory mechanisms that soon become maladaptive – Frank-Starling mechanism, neurohormonal activation and ventricular remodeling. All of which help to relieve stress initially but long term, cause strain on the cardiac muscle and inevitably progression of HF. Heart failure can be either acute or chronic, depending on the manifestation time frame. Heart failure is grouped into subtypes which are defined by measure of ejection fraction – the heart’s ability to eject blood.

HF is a global healthcare concern and affected patients suffer from poor quality of life and poor prognosis. Risk factors for HF include; diabetes, hypertension and obesity, all of which are on the rise in the current population. There is a large unmet need in HF for a treatment option that meets clinical end points in reduced mortality and hospitalization.

Key Questions Answered

SGLT inhibitors will enter the market and see a significant uptake in patient shares for the treatment of HF. However, there are high unmet needs within the indication. What are the main unmet needs in this market? Will the drugs under development fulfill the unmet needs of the HF market?

The current late-stage HF pipeline consists of chronic therapies such as Farxiga and Jardiance, post-acute therapies such as omecamtiv mecarbil and Zynquista, and acute therapies such as istaroxime. Will the late-stage drugs make a significant impact on the HF market? Which of these drugs will have the highest peak sales at the highest CAGR, and why?

We have seen a significant increase in the HF population, in terms of diagnosed prevalence and there is an increase in the amount of patients treated for HF-REF, HF-PEF and HF-mrEF. How will epidemiological changes impact the growth of the future market?

Scope

Overview of HF, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.

Annualized HF therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2018 and forecast for ten years to 2028.

Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the HFtherapeutics market.

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 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 main driver of the HF market expansion will be the approval and launch of the SGLT inhibitors for both HF-REF and HF-PEF.

Another prominent contributor to sales growth will be the approval of the large number of pipeline therapies across the 8MM.

The major global barrier for the HF market will be the annual cost of therapy for new pipeline drugs compared to the standard of care generics, alongside the unwillingness for prescribers to add new drugs to large therapy regimens.

The key market opportunities lie in addressing unmet needs through the development of more efficacious drugs for HF patients for acute HF , HF-PEF and HF-mrEF.

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 global HF therapeutics market.

Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global 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 global HF therapeutics market from 2018-2028.

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

Eli Lilly

Boehringer Ingelheim International GmbH

Les Laboratoires Servier

Bayer

AstraZeneca

Bristol-Myers Squibb

Novartis AG

Zensun

Lexicon

Windtree Therapeutics

Daiichi Sankyo Co Ltd

China Medical System Holdings Ltd

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 2018 and 2028

2.2 Label Expansions of Anti-Diabetic Drugs 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 Farxiga Will Dominate the Branded HF Market

2.5 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 Prognosis

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: Diagnosed Incident Cases of HF

5.4.3 Forecast Assumptions and Methods: Diagnosed Incident Cases of HF by EF

5.4.4 Forecast Assumptions and Methods: Acute Hospitalizations

5.4.5 Forecast Assumptions and Methods: Acute Hospitalizations by Worsening CHF, Advanced HF, and De Novo HF

5.4.6 Forecast Assumptions and Methods: Hospital Length of Stay

5.4.7 Forecast Assumptions and Methods: Hospital Readmissions (Within 30 Days) Post-Discharge After AHF Hospitalization

5.4.8 Forecast Assumptions and Methods: Diagnosed Prevalent Cases of CHF

5.4.9 Diagnosed Prevalent Cases of CHF by EF

5.4.10 Diagnosed Prevalent Cases of CHF by NYHA Classes

5.4.11 Forecast Assumptions and Methods: Diagnosed Prevalent Cases of CHF by ACCF/AHA Stages

5.5 Epidemiological Forecast for Heart Failure (2018–2028)

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 AHF Hospitalizations

5.5.6 Hospital Length of Stay for AHF Hospitalization

5.5.7 Hospital Readmissions (Within 30 Days) Post-Discharge After AHF Hospitalization

5.5.8 Diagnosed Prevalent Cases of CHF

5.5.9 Diagnosed Prevalent Cases of CHF by EF

5.5.10 Age-Specific Diagnosed Prevalent Cases of CHF

5.5.11 Sex-Specific Diagnosed Prevalent Cases of CHF

5.5.12 Diagnosed Prevalent Cases of CHF by NYHA Class

5.5.13 Diagnosed Prevalent Cases of CHF with PEF by NYHA Class

5.5.14 Diagnosed Prevalent Cases of CHF with REF by NYHA Class

5.5.15 Diagnosed Prevalent Cases of CHF by ACCF/AHA Classification

5.6 Discussion

5.6.1 Epidemiological Forecast Insight

5.6.2 Limitations of the Analysis

5.6.3 Strengths of the 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

6.6 China

7 Competitive Assessment

7.1 Overview

8 Unmet Needs and Opportunity Assessment

8.1 Overview

8.2 Lack of Therapies for HF-PEF Patients

8.2.1 Unmet Need

8.3 Lack of Therapies for Acute HF

8.3.1 Unmet Need

8.4 Lack of Therapies for Patients with Renal Impairment

8.4.1 Unmet Need

8.5 Preventative Therapies for Patients at Risk of Developing HF

8.5.1 Unmet Need

8.6 Compliance and Use of Optimal Doses of HF Therapies

8.6.1 Unmet Need

9 Pipeline Assessment

9.1 Overview

9.2 Promising Drugs in Clinical Development

9.3 Pipeline Obstacles

10 Current and Future Players

10.1 Overview

10.2 Trends in Corporate Strategy

10.3 Amgen and Cytokinetics

10.3.1 Overview

10.4 Bayer (and Merck & Co.)

10.4.1 Overview

10.5 Bristol-Myers Squibb

10.5.1 Overview

10.6 Les Laboratoires Servier

10.6.1 Overview

10.7 Novartis

10.7.1 Overview

10.8 Zensun

10.8.1 Overview

10.9 AstraZeneca

10.9.1 Overview

10.10 Boehringer Ingelheim (and Eli Lilly)

10.10.1 Overview

10.11 Lexicon

10.11.1 Overview

11 Market Outlook

11.1 Global Markets

11.1.1 Forecast

11.1.2 Acute HF

11.1.3 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

11.5 China

11.5.1 Forecast

11.5.2 Key Events

11.5.3 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

12.7.1 Analyst

12.7.2 Associate Therapy Area Director

12.7.3 Senior Therapy Area Director

12.7.4 Epidemiologist

12.7.5 Managing Epidemiologists

12.7.6 Global Director of Therapy Analysis and Epidemiology

12.7.7 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 8MM

Table 2: Types of Chronic HF

Table 3: Causes of HF

Table 4: Compensatory Mechanisms in HF Patients

Table 5: Symptoms of Heart Failure

Table 6: Key Diagnostic and Prognostic Biomarkers in HF

Table 7: A Comparison of Two HF Classification Systems

Table 8: Common Factors that Precipitate AHF

Table 9: HF Treatment Guidelines Most Commonly Adhered to by Physicians in the 8MM

Table 10: Chronic HF-REF Medications Most Commonly Used in the 8MM

Table 11: Country Profile – US

Table 12: Country Profile – 5EU

Table 13: Country Profile – Japan

Table 14: Country Profile – China

Table 15: Leading Treatments for HF

Table 16: Amgen’s HF Portfolio Assessment, 2019

Table 17: Bayer’s HF Portfolio Assessment, 2019

Table 18: Bristol-Myers Squibb HF Portfolio Assessment, 2019

Table 19: Servier’s HF Portfolio Assessment, 2019

Table 20: Novartis’ Disease Portfolio Assessment, 2019

Table 21: Zensun’s Disease Portfolio Assessment, 2019

Table 22: AstraZeneca’s Disease Portfolio Assessment, 2019

Table 23: Lexicon’s Disease Portfolio Assessment, 2019

Table 24: Heart Failure Market – Global Drivers and Barriers, 2018–2028

Table 25: Key Events Impacting Sales for HF in the US, 2018–2028

Table 26: HF Market – Global Drivers and Barriers in the US, 2018–2028

Table 27: Key Events Impacting Sales for Heart Failure in the 5EU, 2018–2028

Table 28: Heart Failure Market – Global Drivers and Barriers in the 5EU, 2018–2028

Table 29: Key Events Impacting Sales for Heart Failure in Japan, 2018–2028

Table 30: Heart Failure Market – Global Drivers and Barriers in Japan, 2018–2028

Table 31: Key Events Impacting Sales for Heart Failure in China, 2018–2028

Table 32: Heart Failure Market – Global Drivers and Barriers in China, 2018–2028

Table 33: Key Historical and Projected Launch Dates for HF

Table 34: Key Historical and Projected Patent Expiry Dates for Heart Failure

Table 35: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of Figures

Figure 1: Global Sales for Heart Failure by Country, 2018 and 2028

Figure 2: Analysis of the Company Portfolio Gap in Heart Failure During the Forecast Period

Figure 3: Competitive Assessment of Late-Stage Pipeline Agents in Heart Failure, 2018–2028

Figure 4: Changes in Cardiac Structure in HF

Figure 5: 8MM, Sources Used to Forecast Hospital Length of Stay for AHF Hospitalization

Figure 6: 8MM, Sources Used and Not Used to Forecast Diagnosed Prevalent Cases of CHF

Figure 7: 8MM, Sources Used to Forecast Diagnosed Prevalent Cases of CHF by NYHA Class

Figure 8: 8MM, Age-Specific Diagnosed Incident Cases of HF, Both Sexes, N, 2018

Figure 9: 8MM, Sex-Specific Diagnosed Incident Cases of HF, All Ages, N, 2018

Figure 10: 8MM, Diagnosed Incident Cases of HF by EF, Both Sexes, All Ages, N, 2018

Figure 11: 8MM, Diagnosed Prevalent Cases of CHF by EF, Both Sexes, All Ages, N, 2018

Figure 12: 8MM, Diagnosed Prevalent Cases of CHF by NYHA Class, Both Sexes, All Ages, N, 2018

Figure 13: 8MM, Diagnosed Prevalent Cases of CHF by ACCF/AHA Classification, Both Sexes, All Ages, N, 2018

Figure 14: Diagnostic Algorithm for Chronic HF

Figure 15: Diagnostic Algorithm for Acute HF

Figure 16: HF based on the ACCF/AHA staging system

Figure 17: Classification of Acute HF Patients

Figure 18: Management of Acute HF Patients

Figure 19: Unmet Needs and Opportunities in Heart Failure

Figure 20: Overview of the Development Pipeline in Heart Failure

Figure 21: Competitive Assessment of Late-Stage Pipeline Agents in Chronic and Post-Acute Heart Failure, 2018–2028

Figure 22: Competitive Assessment of Late-Stage Pipeline Agents in Acute Heart Failure, 2018–2028

Figure 23: Key Phase II/III Trials for the Promising Pipeline Agents that GlobalData Expects to Be Licensed for HF in the 8MM During the Forecast Period

Figure 24: Company Portfolio Gap Analysis in Chronic HF, 2018–2028

Figure 25: Company Portfolio Gap Analysis in Acute Heart Failure, 2018–2028

Figure 26: Global Sales for Chronic HF by Country, 2018 and 2028

Figure 27: Global Sales for Acute HF by Country, 2018 and 2028

Figure 28: Sales for Chronic HF by Drug Class in the US, 2018 and 2028

Figure 29: Sales for Chronic HF by Drug Class in the 5EU, 2018 and 2028

Figure 30: Sales for Chronic HF by Drug Class in Japan, 2018 and 2028

Figure 31: Sales for Chronic HF by Drug Class in China, 2018 and 2028

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