心不全（HF）市場、疾患管理、疫学、パイプライン評価、アンメットニーズ、医薬品の予測（～2032年）

主要7市場（米国、フランス、ドイツ、イタリア、スペイン、英国、日本）におけるHF治療薬の売上は、2022年の約319億米ドルから2032年までに530億米ドルに達し、CAGRで5.2%の高成長が予測されています。SGLT2阻害剤と3つのファーストインクラス医薬品の取り込みが、市場全体をもっとも強力に牽引すると予測されます。

急性HFも予測期間に主要7市場全体で成長が見込まれ、特に複数のパイプライン急性期薬剤と、慢性HFが悪化した場合に使用される急性期後の治療法の開発がその要因です。

予測期間におけるHF市場の主な成長促進要因は以下の通りです。

• ナトリウム-グルコース共輸送体阻害剤の適応症の拡大が見込まれること。
• 複数の経口剤と注射剤の発売。
• 世界の慢性HFの有病率の増加。

予測期間にHF市場の成長を抑制する主な障壁は以下の通りです。

• 最近開発されたHF治療薬の高い価格。
• 心臓専門医やその他の医師が新しいHF治療法の採用や処方に消極的であること。
• ジェネリックHF医薬品の利用の拡大により、価格の高いブランド治療薬の市場浸透が困難になっています。

主要7市場の慢性HFの市場規模は、2022年の296億米ドルから2032年までに490億米ドルに達し、CAGRで5.2%の成長が見込まれています。

当レポートでは、主要7市場（米国、フランス、ドイツ、イタリア、スペイン、英国、日本）における心不全（HF）について調査分析し、市場力学、地域とセグメントの分析、企業プロファイルなどを提供しています。

目次

第1章 心不全：エグゼクティブサマリー

• HF市場は2022年～2032年に力強い成長を示す
• CV医薬品のラベル拡大が市場の成長を促進
• 確立された治療法が利用できるにもかかわらず、市場にアンメットニーズが残っている
• 経口剤がHF市場を独占する
• 医師の考え

第2章 イントロダクション

第3章 疾患の概要

• 病因と病態生理学
• 分類または病期分類システム
• 予後

第4章 疫学

• 疾患の背景
• 危険因子と併存疾患
• 世界の過去の動向
• 予測手法
• 心不全の疫学予測（2022年～2032年）
• 議論
  • 疫学予測の考察
  • COVID-19の影響
  • 分析の限界
  • 分析の強み

第5章 疾病管理

• 診断と治療の概要
• 疾病管理に対するKOLの考察

第6章 競合の評価

• 概要

第7章 アンメットニーズと機会の評価

• 概要
• HF-PEF患者に対する治療法の欠如
• 急性心不全に対する治療法の欠如
• HF治療の最適な管理
• 心不全を発症するリスクのある患者に対する予防療法

第8章 研究開発戦略

• 概要
  • その他の適応症に対し承認された治療法のラベル拡大
  • 製品パイプラインを拡大する合併と買収
• 臨床試験設計
  • 心不全の臨床エンドポイント
  • 包含基準と除外基準

第9章 パイプラインの評価

• 概要
• 臨床開発中の有望な医薬品

第10章 パイプラインの評価の分析

• 概要
• 競合の評価

第11章 現在と将来の企業

• 概要
• Amgen and Cytokinetics
• Bayer
• Zensun
• AstraZeneca
• Boehringer Ingelheim
• Lexicon
• Johnson & Johnson
• Viatris
• CSL Vifor
• Eli Lilly
• Otsuka
• Novartis
• Novo Nordisk
• Mesoblast
• BioCardia
• 取引成立の動向

第12章 市場見通し

• 世界市場
• 米国
• 欧州5ヶ国
• 日本

第13章 付録

List of Tables

List of Tables

• Table 1: Heart failure: key metrics in the 7MM
• 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: Types of chronic HF
• Table 7: Comparison of two HF classification systems
• Table 8: Risk factors and comorbidities for HF
• Table 9: Treatment guidelines for HF
• Table 10: Amgen's HF portfolio assessment, 2023
• Table 11: Bayer's HF portfolio assessment, 2023
• Table 12: Zensun's HF portfolio assessment, 2023
• Table 13: AstraZeneca's HF portfolio assessment, 2023
• Table 14: Boehringer's HF portfolio assessment, 2023
• Table 15: Lexicon's HF portfolio assessment, 2023
• Table 16: Johnson & Johnson's HF portfolio assessment, 2023
• Table 17: Viatris's HF portfolio assessment, 2023
• Table 18: Vifor's HF portfolio assessment, 2023
• Table 19: Eli Lilly's HF portfolio assessment, 2023
• Table 20: Otsuka's HF Portfolio Assessment, 2023
• +S11Table 21: Novartis's HF portfolio assessment, 2023
• Table 22: Novo Nordisk's HF portfolio assessment, 2023
• Table 23: Mesoblast's HF portfolio assessment, 2023
• Table 24: BioCardia's HF portfolio assessment, 2023
• Table 25: Top 10 deals by value, 2018-2023
• Table 26: HF market - global drivers and barriers, 2022-2032
• Table 27: Key events impacting sales for HF in the US, 2022-2032
• Table 28: HF market - drivers and barriers in the US, 2022-2032
• Table 29: Key events impacting sales for HF in the 5EU, 2022-2032
• Table 30: HF market - drivers and barriers in the 5EU, 2022-2032
• Table 31: Key events impacting sales for HF in Japan, 2022-2032
• Table 32: HF market - drivers and barriers in Japan, 2022-2032
• Table 33: High-prescribing physicians (non-KOLs) surveyed, by country

List of Figures

List of Figures

• Figure 1: Global sales forecast by country for heart failure in 2022 and 2032
• Figure 2: Analysis of the company portfolio gap in HF during the forecast period
• Figure 3: Competitive assessment of the injectable late-stage pipeline agents that GlobalData expects to be licensed for the treatment of HF during the forecast period
• Figure 4: Competitive assessment of the oral late-stage pipeline agents that GlobalData expects to be licensed for the treatment of HF during the forecast period
• Figure 5: Changes in cardiac structure in HF
• Figure 6: 7MM, diagnosed incidence of HF (cases per 100,000 population), men and women, all ages, 2022
• Figure 7: 7MM, diagnosed prevalence of HF (%), men and women, all ages, 2022
• Figure 8: 7MM, sources used and not used to forecast the diagnosed incident cases of HF
• Figure 9: 7MM, sources used to forecast the diagnosed incident cases of HF by EF
• Figure 10: 7MM, sources used to forecast the hospitalization for acute HF
• Figure 11: 7MM, sources used to forecast the hospitalizations for acute HF by presentation
• Figure 12: 7MM, sources used to forecast the hospital LoS for acute HF
• Figure 13: 7MM, sources used to forecast the re-admissions within 30 days post-discharge after acute HF hospitalization
• Figure 14: 7MM, sources used to forecast the diagnosed prevalent cases of HF
• Figure 15: 7MM, sources used to forecast the diagnosed prevalent cases of HF by EF
• Figure 16: 7MM, sources used to forecast the diagnosed prevalent cases of HF by NYHA class
• Figure 15: 7MM, sources used to forecast the diagnosed prevalent cases of HF-PEF, HF-mrEF, and HF-REF by NYHA class
• Figure 16: 7MM, sources used to forecast the diagnosed prevalent cases of HF by EF
• Figure 17: 7MM, diagnosed incident cases of HF, N, both sexes, all ages, 2022
• Figure 18: 7MM, diagnosed incident cases of HF by age, N, both sexes, 2022
• Figure 19: 7MM, diagnosed incident cases of HF by sex, N, all ages, 2022
• Figure 20: 7MM, diagnosed incident cases of HF by EF, N, both sexes, all ages, 2022
• Figure 21: 7MM, hospitalizations for acute HF, N, both sexes, all ages, 2022
• Figure 22: 7MM, acute HF hospitalizations based on presentation, N, both sexes, all ages, 2022
• Figure 23: 7MM, hospital LoS for acute HF, days, both sexes, all ages, 2022
• Figure 24: 7MM, re-admissions within 30 days post-discharge after acute HF hospitalization, N, both sexes, all ages, 2022
• Figure 25: 7MM, diagnosed prevalent cases of HF, N, both sexes, all ages, 2022
• Figure 26: 7MM, diagnosed prevalent cases of HF by age, N, both sexes, 2022
• Figure 27: 7MM, diagnosed prevalent cases of HF by sex, N, all ages, 2022
• Figure 28: 7MM, diagnosed prevalent cases of HF by sex, N, all ages, 2022
• Figure 29: 7MM, diagnosed prevalent cases of HF by NYHA classes, N, both sexes, all ages, 2022
• Figure 30: 7MM, diagnosed prevalent cases of HF-PEF (LVEF ≥50%) by NYHA class, N, both sexes, all ages, 2022
• Figure 31: 7MM, diagnosed prevalent cases of HF-mrEF (LVEF = 40-49%) by NYHA class, N, both sexes, all ages, 2022
• Figure 32: 7MM, diagnosed prevalent cases of HF-REF (LVEF <40%) by NYHA class, N, both sexes, all ages, 2022
• Figure 33: 7MM, diagnosed prevalent cases of HF by ACCF/AHA stages, N, both sexes, all ages, 2022
• Figure 34: Diagnosis algorithm for chronic HF
• Figure 35: Unmet needs and opportunities in chronic and acute heart failure
• Figure 36: Overview of the development pipeline in heart failure
• Figure 37: Key late-stage trials for the promising pipeline agents that GlobalData expects be licensed for HF in the 7MM during the forecast period
• Figure 38: Competitive assessment of the late-stage pipeline agents that GlobalData expects to be licensed for the treatment of HF during the forecast period
• Figure 39: Competitive assessment of the oral pipeline drugs benchmarked against the standard of care (SOC)
• Figure 40: Competitive assessment of the injectable pipeline drugs benchmarked against the standard of care (SOC)
• Figure 41: Analysis of the company portfolio gap in HF during the forecast period
• Figure 42: Global (7MM) sales forecast by country for heart failure in 2022 and 2032
• Figure 43: Sales forecast by class for heart failure in the US in 2022 and 2032
• Figure 44: Sales forecast by class for heart failure in the 5EU in 2022 and 2032
• Figure 45: Sales forecast by class for heart failure in Japan in 2022 and 2032

Abstract

This report covers the 7MM (US, France, Germany, Italy, Spain, UK, Japan) and provides an Excel-based forecast model for the Heart Failure (HF) market through 2032.

GlobalData estimates sales of HF therapeutics to be approximately $31.9 billion across the 7MM in 2022. By 2032, GlobalData expects the HF market to grow at a strong Compound Annual Growth Rate (CAGR) of 5.2%, reaching sales of $53 billion by the end of the forecast period. GlobalData expects uptake of SGLT2 inhibitors and three first-in-class drugs to be the strongest driver of the total HF markets in the 7MM.

Acute HF will also see growth across the 7MM over the forecast period, most notably due to the development of multiple pipeline acute agents and the post-acute therapies, used in cases of worsening chronic HF.

Major drivers of HF market growth over the forecast period are the -

• Anticipated expanded indications for sodium-glucose co-transporter inhibitors.
• Launch of several oral and injectable agents.
• Increase in the global prevalence of chronic HF.

Major barriers that will restrict the growth of the HF market during the forecast period are the -

• High price of recently developed HF therapies.
• General reluctance of cardiologists and other physicians to adopt and prescribe new HF therapies.
• Widespread use of generic HF drugs, making it difficult for high-priced branded therapies to penetrate the market.

The 7MM chronic HF market size in 2022 was $29.6 billion, and is expected to increase to $49 billion by 2032 at a CAGR of 5.2%.

Key Highlights

In 2022, GlobalData estimated that the global HF market reached $31.9 billion across the 7MM, and expects the HF market to grow at a strong Compound Annual Growth Rate of 5.2%, reaching sales of $53 billion by 2032.

Major drivers of HF market growth over the forecast period are the:

Anticipated expanded indications for sodium-glucose co-transporter inhibitors.

Launch of several oral and injectable agents.

Increase in the global prevalence of chronic HF.

Scope

• Overview of HF, including epidemiology, symptoms, diagnosis, and disease management.
• Annualized HF therapeutics market revenue, cost of therapy per patient, and treatment usage patterns forecast from 2022 to 2032.
• Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping, and implications of these factors for the HF therapeutics market.
• Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for HF treatment. The most promising candidates in late-stage development are profiled.
• 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

• 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.
• Develop business strategies by understanding the trends shaping and driving the 7MM HF therapeutics market.
• Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the 7MM HF therapeutics market in the future.
• Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
• Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
• Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Table of Contents

Table of Contents

1 Heart Failure: Executive Summary

• 1.1 The HF Market Will Exhibit Strong Growth Between 2022 and 2032
• 1.2 Label expansions of CV drugs will fuel market growth.
• 1.3 Unmet needs remain in the HF market despite the availability of well-established therapies.
• 1.4 Oral agents will dominate HF market.
• 1.5 What do physicians think?

2 Introduction

• 2.1 Catalyst
• 2.2 Related reports

3 Disease Overview

• 3.1 Etiology and pathophysiology
  • 3.1.1 Etiology
  • 3.1.2 Pathophysiology
  • 3.1.3 Biomarkers/Targets of interest
• 3.2 Classification or staging systems
• 3.3 Prognosis

4 Epidemiology

• 4.1 Disease background
• 4.2 Risk factors and comorbidities
• 4.3 Global and historical trends
• 4.4 Forecast methodology.
  • 4.4.1 Sources
  • 4.4.2 Forecast assumptions and methods.
  • 4.4.3 Forecast assumptions and methods: diagnosed incident cases of HF - 7MM.
  • 4.4.4 Forecast assumptions and methods: diagnosed incident cases of HF by EF
  • 4.4.5 Forecast assumptions and methods: hospitalizations for acute HF.
  • 4.4.6 Forecast assumptions and methods: acute HF hospitalizations based on presentation.
  • 4.4.7 Forecast assumptions and methods: hospital LoS days for acute HF hospitalizations.
  • 4.4.8 Forecast assumptions and methods: re-admissions within 30 days post-discharge after acute HF hospitalization.
  • 4.4.9 Forecast assumptions and methods: diagnosed prevalent cases of HF - 7MM.
  • 4.4.10 Forecast assumptions and methods: diagnosed prevalent cases of HF by EF
  • 4.4.11 Forecast assumptions and methods: diagnosed prevalent cases of HF by NYAH classes.
  • 4.4.12 Forecast assumptions and methods: diagnosed prevalent cases of HF-PEF (LVEF≥50%) NYHA Class
  • 4.4.13 Forecast assumptions and methods: diagnosed prevalent cases of HF-mrEF (LVEF= 40-49%) NYHA class
  • 4.4.14 Forecast assumptions and methods: diagnosed prevalent cases of HF-REF (LVEF <40%) by NYHA class.
  • 4.4.15 Forecast assumptions and methods: diagnosed prevalent cases of HF by ACCF/AHA stages.
• 4.5 Epidemiological forecast for heart failure (2022-32)
  • 4.5.1 Diagnosed incident cases of HF.
  • 4.5.2 Age-specific diagnosed incident cases of HF
  • 4.5.3 Sex-specific diagnosed incident cases of HF
  • 4.5.4 Diagnosed incident cases of HF by EF
  • 4.5.5 Hospitalizations for acute HF
  • 4.5.6 Acute HF hospitalizations based on presentation.
  • 4.5.7 Hospital LoS for acute HF
  • 4.5.8 Re-admissions within 30 days post-discharge after acute HF
  • 4.5.9 Diagnosed prevalent cases of HF.
  • 4.5.10 Age-specific diagnosed prevalent cases of HF
  • 4.5.11 Sex-specific diagnosed prevalent cases of HF
  • 4.5.12 Diagnosed prevalent cases of HF by EF
  • 4.5.13 Diagnosed prevalent cases of HF by NYHA classes.
  • 4.5.14 Diagnosed prevalent cases of HF-PEF (LVEF ≥50%) by NYHA class.
  • 4.5.15 Diagnosed prevalent cases of HF-mrEF (LVEF = 40-49%) by NYHA class
  • 4.5.16 Diagnosed prevalent cases of HF-REF (LVEF <40%) by NYHA class
  • 4.5.17 Diagnosed prevalent cases of HF by ACCF/AHA stages.
• 4.6 Discussion
  • 4.6.1 Epidemiological forecast insight
  • 4.6.2 COVID-19 impact.
  • 4.6.3 Limitations of the analysis
  • 4.6.4 Strengths of the analysis

5 Disease Management

• 5.1 Diagnosis and treatment overview
• 5.2 KOL insights on disease management

6 Competitive Assessment

• 6.1 Overview

7 Unmet Needs and Opportunity Assessment

• 7.1 Overview
• 7.2 Lack of therapies for HF-PEF patients
• 7.3 Lack of therapies for acute HF
• 7.4 Optimal management of HF treatments
• 7.5 Preventative therapies for patients at risk of developing HF.

8 R&D Strategies

• 8.1 Overview
  • 8.1.1 Label expansion for therapies approved for other indications.
  • 8.1.2 Mergers and acquisitions to expand product pipeline.
• 8.2 Clinical Trials Design
  • 8.2.1 Clinical endpoints for HF
  • 8.2.2 Inclusion and exclusion criteria

9 Pipeline Assessment

• 9.1 Overview
• 9.2 Promising drugs in clinical development

10 Pipeline Valuation Analysis

• 10.1 Overview
• 10.2 Competitive assessment

11 Current and Future Players

• 11.1 Overview
• 11.2 Amgen and Cytokinetics
• 11.3 Bayer
• 11.4 Zensun
• 11.5 AstraZeneca
• 11.6 Boehringer Ingelheim
• 11.7 Lexicon
• 11.8 Johnson & Johnson
• 11.9 Viatris
• 11.10 CSL Vifor
• 11.11 Eli Lilly
• 11.12 Otsuka
• 11.13 Novartis
• 11.14 Novo Nordisk
• 11.15 Mesoblast
• 11.16 BioCardia
• 11.17 Deal-making trends

12 Market Outlook

• 12.1 Global markets
• 12.2 US
• 12.3 5EU
• 12.4 Japan

13 Appendix

• 13.1 Bibliography
• 13.2 Abbreviations
• 13.3 Methodology
  • 13.3.1 Forecasting methodology
• 13.4 Primary research - KOLs interviewed for this report.
  • 13.4.1 KOLs
• 13.5 Primary research - prescriber survey
• 13.6 About the authors
  • 13.6.1 Analyst
  • 13.6.2 Therapy Area Director
  • 13.6.3 Epidemiologist
  • 13.6.4 Vice President of Disease Intelligence and Epidemiology
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