Disease Analysis: Chronic Heart Failure


Report
98 Pages
March 2021
Region: Global
Citeline
ID: 5086943

Latest Key Takeaways

Chronic heart failure (CHF) is a progressive condition in which the heart muscle is unable to pump enough blood to meet the needs of the body. The publisher estimates that in 2018, there were approximately 80.5 million cases in Asia, Europe, Latin America and the Caribbean, Northern America, and Oceania combined.
The publisher forecasts the number of prevalent cases of CHF to increase by 9.1% between 2018 and 2027. These trends are driven by population demographics, as prevalence proportions were held constant throughout the forecast period.
The CHF market is expected to grow significantly over the next 10 years across the US, Japan, and five major European markets (France, Germany, Italy, Spain, and the UK). The CHF market has predominantly been saturated with generics, which has limited the market revenue. Angiotensin-converting enzyme inhibitors remain the current standard-of-care therapy, and are used in every line of treatment except when using Entresto. However, there are a growing number of late-stage pipeline therapies, which, combined with the rising disease prevalence, will be the major drivers of market growth.
Despite initially encountering reimbursement challenges which led to a slower than expected uptake, Entresto reached blockbuster status in 2018 and maintained solid growth in 2020, reaching global revenues of $2,497m. Continued uptake of Entresto in the CHF market due to favorable recommendations in treatment guidelines and its proven ability to reduce mortality will be a key driver of market growth. Entresto’s recent label expansion in the US to include the broad CHF population, based on the PARAGON-HF trial in HFpEF patients, will also contribute to growth.
High prices of branded therapies will translate into high revenues, despite the large number of generics on the market. The SGLT-2 inhibitors, Jardiance and Farxiga, will be major market growth drivers, as they are expected to experience strong uptake in both diabetic and non-diabetic patients. SGLT-2 inhibitors are expected to capture the greatest market share in diabetic patients due to the convenience and cost-saving benefit of using one medication for two indications.
Generic entry of dapagliflozin, ivabradine, and sacubitril/valsartan will attenuate market growth towards the end of the forecast period.
The CHF market is becoming an increasingly active space, with 10 drug candidates currently in Phase III. Therapies in mid-to-late-stage development for CHF focus on a wide variety of targets, and include both oral and injectable drug candidates.
The overall likelihood of approval of a Phase I CHF asset is 6.2%, and the average probability a drug advances from Phase III is 47.6%. CHF drugs, on average, take 10.2 years from Phase I to approval, compared to 10.1 years in the overall cardiovascular space.
Numerous high-impact upcoming events for drugs in the CHF space are expected in 2021, including Phase III trial results for a number of different drug candidates, such as data from Jardiance’s Phase III EMPEROR-Preserved trial.

OVERVIEW

Latest key takeaways

DISEASE BACKGROUND

Definition
Diagnosis
Risk factors
Symptoms
Patient segmentation

TREATMENT

Angiotensin-converting enzyme inhibitors
Angiotensin receptor blockers
Beta blockers
Aldosterone antagonists
Hyperpolarization-activated cyclic nucleotide-gated channel blockers
Angiotensin receptor-neprilysin inhibitors
Other drug classes

EPIDEMIOLOGY

Prevalence methodology

MARKETED DRUGSPIPELINE DRUGS

KEY REGULATORY EVENTS

New Entresto Label Looks Past Preserved/Reserved Framework
Merck & Co. Pushes Back On Modest Projections For Verquvo
Carmat To Launch Total Artificial Heart In Early 2021
Spironolactone TOPCAT Regional Analysis Falls Short At US FDA AdComm, But Hospitalizations Drive Vote
Tale Of Two Adcomms: US FDA Handling Of Entresto Data May Have Helped Avoid Aducanumab’s Fate
Novartis’ Entresto Gains US FDA Panel Nod For New Heart Failure Claim
Spironolactone Starts Out On ‘Unusual But Not Unprecedented’ Regulatory Path, Thanks To US FDA Reviewers
Novartis’ Entresto Labeling Expansion Bid Heads To US FDA Panel
NDAs And More: Recent Submissions For FDA Approval
Latest EU Filings
NDA Resubmission for scPharmaceuticals’ Furoscix
AZ To Adopt Indication-Based Pricing For Farxiga In Heart Failure
Novartis Seeks Entresto HFpEF Indication With Readjudicated PARAGON-HF Data

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

Amgen Hands Omecamtiv Back To Cytokinetics

CLINICAL TRIAL LANDSCAPE

Sponsors by status
Sponsors by phase
Recent events

DRUG ASSESSMENT MODEL

Entresto
Corlanor
Farxiga and Jardiance
Verquvo
Omecamtiv mecarbil
ARRY-797
Finerenone
MPC-150-IM

MARKET DYNAMICS

FUTURE TRENDS

The high value of the CHF market will be driven by increased use of branded therapies
New approvals for HFpEF patients will contribute to growth of the CHF market
Approval of generically available spironolactone in HFpEF could limit the growth potential of the HFpEF market
Entresto faces competition from SGLT-2 inhibitors
Generic competition will offset growth in the CHF market

CONSENSUS FORECASTS

RECENT EVENTS AND ANALYST OPINION

Zynquista for CHF and Cardiomyopathies (January 14, 2021)
Entresto for CHF and Cardiomyopathies (December 15, 2020)
MPC-150-IM for CHF and Cardiomyopathies (December 14, 2020)
Entresto for CHF and Cardiomyopathies (December 11, 2020)
Furoscix for CHF and Cardiomyopathies (December 3, 2020)
Zynquista for CHF and Cardiomyopathies (November 16, 2020)
Omecamtiv Mecarbil (Oral) for CHF and Cardiomyopathies (November 13, 2020)
Omecamtiv Mecarbil (Oral) for CHF and Cardiomyopathies (October 8, 2020)
Entresto for CHF and Cardiomyopathies (August 30, 2020)
Jardiance for CHF and Cardiomyopathies (August 29, 2020)
Jardiance for CHF and Cardiomyopathies (July 30, 2020)
Danicamtiv for CHF and Cardiomyopathies (June 22, 2020)
Jardiance for CHF and Cardiomyopathies (June 19, 2020)
Farxiga for CHF and Cardiomyopathies (June 15, 2020)
Verquvo for CHF and Cardiomyopathies (June 11, 2020)
Mavacamten for CHF and Cardiomyopathies (May 11, 2020)
Mavacamten for CHF and Cardiomyopathies (March 30, 2020)
Verquvo for CHF and Cardiomyopathies (March 28, 2020)

KEY UPCOMING EVENTS

KEY OPINION LEADER INSIGHTS

Marketed drugs
Pipeline drugs
Unmet needs

UNMET NEEDS

Additional treatments for HFpEF patients
Therapies that improve cardiac contractility in patients with HFrEF
Other unmet needs
Cardiologist rankings of unmet needs in CHF

BIBLIOGRAPHY

Prescription information

APPENDIX

LIST OF FIGURES

Figure 1: Summary of treatment guidelines in CHF
Figure 2: Trends in prevalent cases of CHF, 2018–27
Figure 3: Overview of pipeline drugs for CHF in the US
Figure 4: Pipeline drugs for CHF, by company
Figure 5: Pipeline drugs for CHF, by drug type
Figure 6: Pipeline drugs for CHF, by classification
Figure 7: Probability of success in the CHF pipeline
Figure 8: Clinical trials in CHF
Figure 9: Top 10 drugs for clinical trials in CHF
Figure 10: Top 10 companies for clinical trials in CHF
Figure 11: Trial locations in CHF
Figure 12: CHF trials status
Figure 13: CHF trials sponsors, by phase
Figure 14: The publisher’s drug assessment summary for CHF
Figure 15: Market dynamics in CHF
Figure 16: Future trends in CHF
Figure 17: Zynquista for CHF and Cardiomyopathies (November 16, 2020): Phase III - SOLOIST-WHF (Heart Failure Study)
Figure 18: Zynquista for CHF and Cardiomyopathies (November 16, 2020): Phase III - SCORED
Figure 19: Omecamtiv Mecarbil (Oral) for CHF and Cardiomyopathies (November 13, 2020): Phase III - GALACTIC-HF
Figure 20: Entresto for CHF and Cardiomyopathies (August 30, 2020): Phase III - PARALLAX
Figure 21: Jardiance for CHF and Cardiomyopathies (August 29, 2020): Phase III - EMPEROR-Reduced
Figure 22: Jardiance for CHF and Cardiomyopathies (July 30, 2020): Phase III - EMPEROR-Reduced
Figure 23: Danicamtiv for CHF and Cardiomyopathies (June 22, 2020): Phase Ib/IIa - Symptomatic DCM
Figure 24: Jardiance for CHF and Cardiomyopathies (June 19, 2020): Phase III - EMPERIAL-Preserved, Phase III - EMPERIALReduced
Figure 25: Farxiga for CHF and Cardiomyopathies (June 15, 2020): Phase III - DAPA-HF
Figure 26: Verquvo for CHF and Cardiomyopathies (June 11, 2020): Phase II - VITALITY-HFpEF
Figure 27: Mavacamten for CHF and Cardiomyopathies (May 11, 2020): Phase III - EXPLORER-HCM
Figure 28: Mavacamten for CHF and Cardiomyopathies (March 30, 2020): Phase II - MAVERICK-HCM
Figure 29: Verquvo for CHF and Cardiomyopathies (March 28, 2020): Phase III - VICTORIA
Figure 30: Key upcoming events in CHF
Figure 31: Average scores of unmet needs in CHF in the US (n=40)
Figure 32: Average scores of unmet needs in CHF in Europe (n=41)

LIST OF TABLES

Table 1: Definition of HFrEF and HFpEF
Table 2: New York Heart Association functional classification based on severity of symptoms and physical activity
Table 3: Prevalent cases of CHF, 2018–27
Table 4: Marketed drugs for CHF
Table 5: Pipeline drugs for CHF in the US
Table 6: Historical global sales, by drug ($m), 2015–19
Table 7: Forecasted global sales, by drug ($m), 2021–25
Table 8: Zynquista for CHF and Cardiomyopathies (January 14, 2021)
Table 9: Entresto for CHF and Cardiomyopathies (December 15, 2020)
Table 10: MPC-150-IM for CHF and Cardiomyopathies (December 14, 2020)
Table 11: Entresto for CHF and Cardiomyopathies (December 11, 2020)
Table 12: Furoscix for CHF and Cardiomyopathies (December 3, 2020)
Table 13: Zynquista for CHF and Cardiomyopathies (November 16, 2020)
Table 14: Omecamtiv Mecarbil (Oral) for CHF and Cardiomyopathies (November 13, 2020)
Table 15: Omecamtiv Mecarbil (Oral) for CHF and Cardiomyopathies (October 8, 2020)
Table 16: Entresto for CHF and Cardiomyopathies (August 30, 2020)
Table 17: Jardiance for CHF and Cardiomyopathies (August 29, 2020)
Table 18: Jardiance for CHF and Cardiomyopathies (July 30, 2020)
Table 19: Danicamtiv for CHF and Cardiomyopathies (June 22, 2020)
Table 20: Jardiance for CHF and Cardiomyopathies (June 19, 2020)
Table 21: Farxiga for CHF and Cardiomyopathies (June 15, 2020)
Table 22: Verquvo for CHF and Cardiomyopathies (June 11, 2020)
Table 23: Mavacamten for CHF and Cardiomyopathies (May 11, 2020)
Table 24: Mavacamten for CHF and Cardiomyopathies (March 30, 2020)
Table 25: Verquvo for CHF and Cardiomyopathies (March 28, 2020)

Table of Contents

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