Heart Failure: Treatment Landscape After the 2025 JCS/JHFS Guideline Update | Market Intelligence

Description

List of Tables

Heart failure is now Japan's dominant cardiovascular condition, and its center of gravity has shifted. The preserved-ejection-fraction form, long the diagnosis without a therapy, accounts for the majority of cases in an elderly population and now has pharmacological options. In August 2025 the Japanese Circulation Society and the Japanese Heart Failure Society issued a guideline update that consolidates this shift: SGLT2 inhibitors across the ejection-fraction spectrum, finerenone in cardiorenal territory, mavacamten for obstructive hypertrophic cardiomyopathy, the transthyretin amyloidosis therapies, and, for the first time, a dedicated frailty section acknowledging that most of the patients in question are old, on multiple drugs, and poorly served by evidence built in younger cohorts.

The guideline resolves one problem and exposes several others. HFpEF therapy now has a framework, but diagnosis in elderly patients remains confounded by comorbidity and frailty itself. ATTR cardiac amyloidosis has moved from rare-disease obscurity to a contested commercial category with three distinct mechanisms, stabilizers, silencers, and next-generation entrants, competing for a population whose detection depends on imaging and biopsy pathways that few centers run well. Remote monitoring and home-based management are promoted in principle while reimbursement for the devices and programs remains thin. Each of these is a commercial question as much as a clinical one.

This report reads the guideline as a market document. It maps the treatment-landscape changes class by class: Entresto and the ARNI position; Farxiga and Jardiance with their Japanese co-promotion structures through Ono and Mitsubishi Tanabe; Kerendia's cardiorenal expansion; Camzyos and the aficamten challenger program with Bayer holding Japan rights; and the ATTR-CM contest among Pfizer's tafamidis, BridgeBio's acoramidis with AstraZeneca as Japan partner, Alnylam's vutrisiran, and Ionis's eplontersen. It then examines the delivery system: heart-failure clinic infrastructure, the frailty section's implications for prescribing, remote-monitoring reimbursement status, and NHI pricing across the category, with US, EU5, and China comparison throughout.

The report serves heart-failure and ATTR franchise owners, their Japanese partners, remote-monitoring and device companies, hospital systems planning heart-failure programs, and investors. Guideline recommendations are presented as framework, and each class chapter ends with the commercial questions the guideline leaves open.

Scope and Coverage

The report covers the Japanese heart-failure treatment landscape after the 2025 JCS/JHFS guideline update, spanning HFrEF, HFpEF, hypertrophic cardiomyopathy, and ATTR-CM, with drug-class, delivery-system, and reimbursement analysis across the US, EU5, Japan, and China. It describes guideline structure and market organization rather than comparative efficacy results.

Report Highlights

2025 JCS/JHFS guideline changes mapped class by class
HFpEF treatment framework and the diagnostic challenges in elderly patients
ATTR-CM category analysis: stabilizers, silencers, and detection pathways
Japanese co-promotion structures: Ono, Mitsubishi Tanabe, AstraZeneca, and Bayer
Frailty-section implications for prescribing in the oldest patients
Remote-monitoring reimbursement status and delivery-system gaps

Product Code: JPH-013

Table of Content

1. Executive Summary

2. Heart Failure: Overview and Clinical Background

3. Epidemiology and Patient Population: US, EU5, Japan, and China

4. Current Treatment Landscape and Standard of Care

5. Pipeline and Development Activity

6. Regulatory Pathways: FDA, EMA, PMDA, and NMPA Considerations

7. Reimbursement and Pricing Analysis with a Focus on Japan's NHI System

8. Competitive Landscape and Key Companies

9. Unmet Needs and Commercial Opportunities in Japan

10. Appendix: Methodology and Sources

Companies Mentioned

Novartis (CH) - Entresto ARNI anchor of HFrEF therapy
AstraZeneca (UK) - Farxiga (dapagliflozin) with Ono as Japan partner
Boehringer Ingelheim (DE) - Jardiance (empagliflozin) co-developed with Lilly
Eli Lilly (US) - Jardiance co-commercialization with Mitsubishi Tanabe in Japan
Bayer (DE) - Kerendia (finerenone) cardiorenal agent added in the 2025 guideline
Bristol Myers Squibb (US) - Camzyos (mavacamten) for obstructive hypertrophic cardiomyopathy
Cytokinetics (US) - aficamten next-generation myosin inhibitor with Bayer holding Japan rights
BridgeBio (US) - Attruby (acoramidis) ATTR-CM stabilizer with AstraZeneca as Japan partner
Alnylam (US) - Amvuttra (vutrisiran) ATTR-CM RNAi therapy
Pfizer (US) - Vyndaqel/Vyndamax (tafamidis) incumbent ATTR-CM stabilizer
Ono Pharmaceutical (JP) - Farxiga Japan co-promotion
Mitsubishi Tanabe (JP) - Jardiance Japan promotion
Ionis (US) - Wainua (eplontersen) ATTR franchise

Product Code: JPH-013

List of Tables

Table 1. Heart-failure classification: HFrEF, HFmrEF, and HFpEF frameworks
Table 2. 2025 JCS/JHFS guideline structure and revision process
Table 3. Guideline lineage: changes from prior editions by topic
Table 4. Milestones in Japanese heart-failure pharmacotherapy by year
Table 5. Heart-failure population structure by phenotype, age, and care setting
Table 6. HFpEF in elderly Japanese patients: diagnostic-confounder framework
Table 7. Comorbidity structure: CKD, diabetes, atrial fibrillation, and frailty
Table 8. ATTR-CM detection populations: red-flag frameworks and referral triggers
Table 9. Hospitalization and readmission pathway structure
Table 10. Foundational-therapy framework: ARNI, beta-blocker, MRA, and SGLT2 inhibitor positioning
Table 11. Entresto (Novartis): ARNI class position in Japanese practice
Table 12. Farxiga (AstraZeneca with Ono): SGLT2 inhibitor integration into heart-failure care
Table 13. Jardiance (Boehringer Ingelheim and Lilly with Mitsubishi Tanabe): parallel SGLT2 positioning
Table 14. Kerendia (Bayer): finerenone's cardiorenal role under the 2025 guideline
Table 15. Diuretic, digoxin, and legacy-therapy positions in elderly practice
Table 16. Camzyos (Bristol Myers Squibb): mavacamten for obstructive HCM
Table 17. Aficamten (Cytokinetics, Bayer Japan rights): next-generation myosin-inhibitor program
Table 18. Vyndaqel/Vyndamax (Pfizer): tafamidis incumbent position in ATTR-CM
Table 19. Attruby (BridgeBio, AstraZeneca Japan partner): acoramidis program structure
Table 20. Amvuttra (Alnylam): vutrisiran RNAi program in ATTR-CM
Table 21. Wainua (Ionis): eplontersen and the ATTR franchise extension
Table 22. ATTR-CM diagnostic pathway: scintigraphy, biopsy, and genetic-testing workflow
Table 23. Frailty section of the 2025 guideline: content and prescribing implications
Table 24. Polypharmacy management frameworks in elderly heart failure
Table 25. Remote-monitoring technologies: implantable and non-invasive categories
Table 26. Cardiac-rehabilitation and home-based management program structures
Table 27. PMDA pathway considerations for cardiorenal and amyloidosis indications
Table 28. FDA and EMA label comparison across the heart-failure classes
Table 29. China regulatory and pipeline context for the category
Table 30. NHI pricing structure across heart-failure drug classes
Table 31. Repricing exposure of long-listed heart-failure brands
Table 32. Remote-monitoring reimbursement status under NHI
Table 33. Heart-failure clinic and program fee structures
Table 34. US and EU5 payment comparison for heart-failure management
Table 35. Novartis: Entresto franchise and Japan strategy
Table 36. AstraZeneca and Ono: Farxiga co-promotion structure
Table 37. Boehringer Ingelheim, Lilly, and Mitsubishi Tanabe: Jardiance Japan structure
Table 38. Bayer: Kerendia franchise and aficamten Japan rights
Table 39. Bristol Myers Squibb and Cytokinetics: myosin-inhibitor competition
Table 40. Pfizer: tafamidis franchise defense strategy
Table 41. BridgeBio, AstraZeneca, Alnylam, and Ionis: ATTR challenger structures
Table 42. Device and remote-monitoring vendor landscape in Japan
Table 43. Unmet needs: HFpEF diagnosis, frailty-adapted prescribing, and monitoring access
Table 44. ATTR-CM detection-capacity gaps and expansion options
Table 45. Heart-failure program business cases for hospital systems
Table 46. Device-vendor opportunities in monitoring and home management
Table 47. Guideline-implementation levers for pharma and device participants
Table 48. Open commercial questions left by the 2025 guideline
Table 49. Report methodology: guideline analysis, literature, and interview base
Table 50. Glossary of phenotypes, classes, and program terms

List of Figures

Figure 1. Heart-failure classification map by ejection-fraction phenotype
Figure 2. 2025 guideline revision structure diagram
Figure 3. Guideline-change timeline across editions
Figure 4. Japanese heart-failure pharmacotherapy timeline
Figure 5. Population structure framework by phenotype and setting
Figure 6. HFpEF diagnostic-confounder schematic
Figure 7. Comorbidity web in elderly heart failure
Figure 8. ATTR-CM red-flag and referral framework
Figure 9. Hospitalization and readmission pathway flow
Figure 10. Foundational-therapy positioning diagram
Figure 11. Entresto class-position map
Figure 12. Farxiga integration pathway with Ono co-promotion
Figure 13. Jardiance positioning with Mitsubishi Tanabe structure
Figure 14. Finerenone cardiorenal role schematic
Figure 15. Legacy-therapy position map in elderly practice
Figure 16. Mavacamten HCM positioning diagram
Figure 17. Aficamten program and Japan-rights structure
Figure 18. Tafamidis incumbent position map
Figure 19. Acoramidis program structure with AstraZeneca partnership
Figure 20. Vutrisiran RNAi program schematic
Figure 21. Eplontersen franchise-extension diagram
Figure 22. ATTR-CM diagnostic workflow
Figure 23. Frailty-section content map and prescribing implications
Figure 24. Polypharmacy management framework
Figure 25. Remote-monitoring technology taxonomy
Figure 26. Cardiac-rehabilitation and home-management program map
Figure 27. PMDA pathway considerations for new indications
Figure 28. FDA and EMA label comparison diagram
Figure 29. China regulatory context map
Figure 30. NHI pricing structure across classes
Figure 31. Repricing exposure map for long-listed brands
Figure 32. Remote-monitoring reimbursement decision points
Figure 33. Heart-failure program fee structure diagram
Figure 34. US and EU5 payment comparison map
Figure 35. Novartis franchise structure diagram
Figure 36. Farxiga co-promotion structure map
Figure 37. Jardiance Japan promotion structure
Figure 38. Bayer franchise and aficamten rights diagram
Figure 39. Myosin-inhibitor competition map
Figure 40. Pfizer franchise defense structure
Figure 41. ATTR challenger structure map
Figure 42. Device and monitoring vendor landscape
Figure 43. Unmet-need map: diagnosis, frailty prescribing, monitoring
Figure 44. ATTR-CM detection-capacity gap diagram
Figure 45. Hospital heart-failure program business-case framework
Figure 46. Device-vendor opportunity map
Figure 47. Guideline-implementation lever map
Figure 48. Open commercial question map from the 2025 guideline
Figure 49. Methodology flow: guideline analysis, literature, interviews
Figure 50. Data cut-off and update cadence schematic

Heart Failure: Treatment Landscape After the 2025 JCS/JHFS Guideline Update | Market Intelligence | US, EU5, Japan & China

Description

Table of Contents

List of Tables

Table of Content

1. Executive Summary

2. Heart Failure: Overview and Clinical Background

3. Epidemiology and Patient Population: US, EU5, Japan, and China

4. Current Treatment Landscape and Standard of Care

5. Pipeline and Development Activity

6. Regulatory Pathways: FDA, EMA, PMDA, and NMPA Considerations

7. Reimbursement and Pricing Analysis with a Focus on Japan's NHI System

8. Competitive Landscape and Key Companies

9. Unmet Needs and Commercial Opportunities in Japan

10. Appendix: Methodology and Sources

Companies Mentioned

List of Tables

List of Figures