Disease Analysis: Chronic Heart Failure
Author: Hannah Cohen
Publisher: Datamonitor Healthcare
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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. Datamonitor Healthcare estimates that in 2018, there were approximately 80.5 million cases in Asia, Europe, Latin America and the Caribbean, Northern America, and Oceania combined.
- Datamonitor Healthcare 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 2019. 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.
- 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 nine drug candidates currently in Phase III. Therapies in mid-to-late-stage development for CHF focus on a wide variety of targets, and include subcutaneous, oral, and injectable drug candidates.
- The overall likelihood of approval of a Phase I CHF asset is 5.5%, and the average probability that a CHF drug advances from Phase III is 42.1%. CHF drugs, on average, take 10.5 years from Phase I to approval, compared to 10.0 years in the overall cardiovascular space.
- Numerous high-impact upcoming events for drugs in the CHF space are expected in Q4 2020 and early 2021, including Phase III trial results for a number of different drug candidates, such as data from Farxiga’s Phase III DETERMINE-preserved/reduced trials.
CONTENTS
8 OVERVIEW
8 Latest key takeaways
9 DISEASE BACKGROUND
9 Definition
9 Diagnosis
10 Risk factors
10 Symptoms
11 Patient segmentation
14 TREATMENT
14 Angiotensin-converting enzyme inhibitors
14 Angiotensin receptor blockers
14 Beta blockers
14 Aldosterone antagonists
15 Hyperpolarization-activated cyclic nucleotide-gated channel blockers
15 Angiotensin receptor-neprilysin inhibitors
15 Other drug classes
17 EPIDEMIOLOGY
17 Prevalence methodology
20 MARKETED DRUGS
24 PIPELINE DRUGS
32 KEY REGULATORY EVENTS
32 NDAs And More: Recent Submissions For FDA Approval
32 Latest EU Filings
32 NDA Resubmission for scPharmaceuticals’ Furoscix
32 AZ To Adopt Indication-Based Pricing For Farxiga In Heart Failure
33 Novartis Seeks Entresto HFpEF Indication With Readjudicated PARAGON-HF Data
33 AstraZeneca’s Farxiga Approval In Heart Failure A First For SGLT-2 Inhibitors
33 Mesoblast Sees Accelerated Path To Market For Revascor In Sickest Heart Failure Patients
34 PROBABILITY OF SUCCESS
5 CLINICAL TRIAL LANDSCAPE
36 Sponsors by status
37 Sponsors by phase
38 Recent events
41 DRUG ASSESSMENT MODEL
44 MARKET DYNAMICS
45 FUTURE TRENDS
45 The high value of the CHF market will be driven by increased use of branded therapies
45 Entresto’s failure in HFpEF patients will significantly limit revenue potential
46 Entresto faces competition from SGLT-2 inhibitors
46 Generic competition will offset growth in the CHF market
47 CONSENSUS FORECASTS
49 RECENT EVENTS AND ANALYST OPINION
49 Omecamtiv Mecarbil for CHF and Cardiomyopathies (October 8, 2020)
50 Entresto for CHF and Cardiomyopathies (August 30, 2020)
51 Jardiance for CHF and Cardiomyopathies (August 29, 2020)
53 Jardiance for CHF and Cardiomyopathies (July 30, 2020)
55 Danicamtiv for CHF and Cardiomyopathies (June 22, 2020)
57 Jardiance for CHF and Cardiomyopathies (June 19, 2020)
59 Farxiga for CHF and Cardiomyopathies (June 15, 2020)
60 Vericiguat for CHF and Cardiomyopathies (June 11, 2020)
62 Mavacamten for CHF and Cardiomyopathies (May 11, 2020)
64 Mavacamten for CHF and Cardiomyopathies (March 30, 2020)
66 Vericiguat for CHF and Cardiomyopathies (March 28, 2020)
68 Elamipretide (Systemic Delivery) for CHF and Cardiomyopathies (February 18, 2020)
70 Jardiance for CHF and Cardiomyopathies (December 13, 2019)
72 Vericiguat for CHF and Cardiomyopathies (November 18, 2019)
73 Entresto for CHF and Cardiomyopathies (November 17, 2019)
74 Mavacamten for CHF and Cardiomyopathies (November 11, 2019)
78 KEY UPCOMING EVENTS
79 KEY OPINION LEADER INSIGHTS
79 Marketed drugs
79 Pipeline drugs
80 Unmet needs
81 UNMET NEEDS
81 Treatment for HFpEF patients
81 Therapies that improve cardiac contractility in patients with HFrEF
81 Other unmet needs
81 Cardiologist rankings of unmet needs in CHF
84 BIBLIOGRAPHY
85 Prescription information
87 APPENDIX
LIST OF FIGURES
16 Figure 1: Summary of treatment guidelines in CHF
19 Figure 2: Trends in prevalent cases of CHF, 2018–27
24 Figure 3: Overview of pipeline drugs for CHF in the US
24 Figure 4: Pipeline drugs for CHF, by company
25 Figure 5: Pipeline drugs for CHF, by drug type
25 Figure 6: Pipeline drugs for CHF, by classification
34 Figure 7: Probability of success in the CHF pipeline
35 Figure 8: Clinical trials in CHF
35 Figure 9: Top 10 drugs for clinical trials in CHF
36 Figure 10: Top 10 companies for clinical trials in CHF
36 Figure 11: Trial locations in CHF
37 Figure 12: CHF trials status
38 Figure 13: CHF trials sponsors, by phase
41 Figure 14: Datamonitor Healthcare’s drug assessment summary for CHF
44 Figure 15: Market dynamics in CHF
45 Figure 16: Future trends in CHF
51 Figure 17: Entresto for CHF (August 30, 2020): Phase III – PARALLAX
53 Figure 18: Jardiance for CHF (August 29, 2020): Phase III – EMPEROR-Reduced
55 Figure 19: Jardiance for CHF (July 30, 2020): Phase III – EMPEROR-Reduced
57 Figure 20: Danicamtiv for CHF and Cardiomyopathies (June 22, 2020): Phase Ib/IIa – Symptomatic DCM
59 Figure 21: Jardiance for CHF (June 19, 2020): Phase III – EMPERIAL-Preserved, Phase III – EMPERIAL-Reduced
60 Figure 22: Farxiga for CHF (June 15, 2020): Phase III – DAPA-HF
62 Figure 23: Vericiguat for CHF (June 11, 2020): Phase II – VITALITY-HFpEF
64 Figure 24: Mavacamten for CHF and Cardiomyopathies (May 11, 2020): Phase III – EXPLORER-HCM
66 Figure 25: Mavacamten for CHF and Cardiomyopathies (March 30, 2020): Phase II – MAVERICK-HCM
68 Figure 26: Vericiguat for CHF (March 28, 2020): Phase III – VICTORIA
70 Figure 27: Elamipretide (systemic delivery) for CHF (February 18, 2020): Natural History Study
72 Figure 28: Jardiance for CHF (December 13, 2019): Phase III – EMPERIAL-Preserved, Phase III – EMPERIAL-Reduced
73 Figure 29: Vericiguat for CHF (November 18, 2019): Phase III – VICTORIA
77 Figure 30: Mavacamten for CHF and Cardiomyopathies (November 11, 2019): Phase II – MAVERICK-HCM
78 Figure 31: Key upcoming events in CHF
82 Figure 32: Average scores of unmet needs in CHF in the US (n=40)
83 Figure 33: Average scores of unmet needs in CHF in Europe (n=41)
LIST OF TABLES
12 Table 1: Definition of HFrEF and HFpEF
13 Table 2: New York Heart Association functional classification based on severity of symptoms and physical activity
18 Table 3: Prevalent cases of CHF, 2018–27
21 Table 4: Marketed drugs for CHF
26 Table 5: Pipeline drugs for CHF in the US
47 Table 6: Historical global sales, by drug ($m), 2015–19
48 Table 7: Forecasted global sales, by drug ($m), 2020–24
49 Table 8: Omecamtiv Mecarbil for CHF and Cardiomyopathies (October 8, 2020)
50 Table 9: Entresto for CHF and Cardiomyopathies (August 30, 2020)
52 Table 10: Jardiance for CHF and Cardiomyopathies (August 29, 2020)
54 Table 11: Jardiance for CHF and Cardiomyopathies (July 30, 2020)
55 Table 12: Danicamtiv for CHF and Cardiomyopathies (June 22, 2020)
58 Table 13: Jardiance for CHF and Cardiomyopathies (June 19, 2020)
59 Table 14: Farxiga for CHF and Cardiomyopathies (June 15, 2020)
61 Table 15: Vericiguat for CHF and Cardiomyopathies (June 11, 2020)
63 Table 16: Mavacamten for CHF and Cardiomyopathies (May 11, 2020)
65 Table 17: Mavacamten for CHF and Cardiomyopathies (March 30, 2020)
67 Table 18: Vericiguat for CHF and Cardiomyopathies (March 28, 2020)
69 Table 19: Elamipretide (Systemic Delivery) for CHF and Cardiomyopathies (February 18, 2020)
71 Table 20: Jardiance for CHF and Cardiomyopathies (December 13, 2019)
72 Table 21: Vericiguat for CHF and Cardiomyopathies (November 18, 2019)
74 Table 22: Entresto for CHF and Cardiomyopathies (November 17, 2019)
75 Table 23: Mavacamten for CHF and Cardiomyopathies (November 11, 2019)
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