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Chronic Heart Failure – Global Drug Forecast and Market Analysis to 2022 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
REFERENCE CODE GDHC45PIDR | PUBLICATION DATE JUNE 2013
CHRONIC HEART FAILURE – GLOBAL DRUG FORECAST AND MARKET ANALYSIS
TO 2022
Chronic Heart Failure – Global Drug Forecast and Market Analysis to 2022 2 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
Executive Summary
CHRONIC HEART FAILURE – GLOBAL DRUG FORECAST AND MARKET ANALYSIS
TO 2022
CHF: Key Metrics in the Seven Major Pharmaceutical Markets*
2012 Epidemiology
CHF prevalent population 14.9 billion
2012 Market Sales
US $1.30bn
5EU $1.05bn
Japan $213.4m
Total $2.56bn
Pipeline Assessment
Number of drugs in Phase I–II 5
Number of first-in-class drugs in Phase IIb and III 2
Most Promising Pipeline Drug 2022 Sales
LCZ-696 (Novartis) $1.87bn
Key Events (2012–2022) Level of Impact
Launch of LCZ-696 in the US in 2015 ↑↑↑
Launch of LCZ-696 in the 5EU in 2016 ↑↑↑
Launch of generic competitors for Diovan (valsartan) and Atacand (candesartan) in 2013 in the US
↓↓
Launch of generic competitors for Inspra (eplerenone) in France, Germany, and the UK in 2015
↓
Launch of generic competitors for Procoralan (ivabradine) in the EU in 2017 ↓
2022 Market Sales
US $2.91bn
5EU $1.35bn
Japan $193.0m
Total $4.45bn Source: GlobalData *7MM = US, 5EU (France, Germany, Italy, Spain, UK), and Japan EU = European Union The values listed in this table have been rounded to the nearest decimal; totals were derived from the rounded numbers.
This table provides a summary of the key metrics
for chronic heart failure (CHF) in the seven major
pharmaceutical markets during the forecast period
from 2012–2022.
Sales for Chronic Heart Failure by Region 2012–2022
GlobalData estimates that sales of CHF
therapeutics in 2012, the base year of the forecast
period, totalled approximately $2.56 billion in the
seven major markets (7MM): US, France,
Germany, Italy, Spain, UK, and Japan. Branded
drugs alone accounted for only $1.02 billion across
the markets, while generics made up the majority
of sales. As a result of higher drug prices and a
large CHF population, the US dominated the 2012
base-year sales, with 51% of the overall market,
totalling approximately $1.30 billion in sales. The
CHF market has been slowly overtaken by generic
drugs, and more branded products are expected to
lose market exclusivity during the next few years.
By the end of the forecast period in 2022, CHF
sales will grow to $4.45 billion at a Compound
Annual Growth Rate (CAGR) of 5.7%, as shown in
the figure below
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CHRONIC HEART FAILURE – GLOBAL DRUG FORECAST AND MARKET ANALYSIS
TO 2022
Executive Summary
Sales for CHF by Region, 2012–2022
51%
8%
19%
6%
6%
2%8% 2012 Total: $2.6bn
United States
France
Germany
Italy
Spain
UK
Japan
65%6%
14%
4%
5%2%
4% 2022 Total: $4.5bn
United States
France
Germany
Italy
Spain
UK
Japan
Source: GlobalData
The major drivers of CHF market growth over the
forecast period are:
The launch of Novartis’ novel combination drug
LCZ-696 in 2015 will mark the first entrance of
a novel branded CHF drug in the past five
years, boosting the overall market size
considerably during the forecast period.
The prescription of mineralocorticoid receptor
antagonists (MRAs), such as spironolactone, is
expected to increase across the CHF markets
within this report’s 10-year forecast period.
The major barriers that will restrict the growth of
the CHF market during the forecast period are:
A significant barrier faced by the CHF market
is the lack of late-stage pipeline drugs.
Patent expirations of most of the drugs
marketed for CHF have resulted in a market
that is crowded with generics; the presence of
inexpensive generics will diminish the overall
value of the market and may hamper the
uptake of LCZ-696.
The table below represents the drivers and barriers
in the global CHF market during the forecast
period.
CHF Market: Drivers and Barriers, 2012–2022
Drivers Barriers
Approval of a novel therapy Sparsely populated CHF pipeline
Increase in prescription of MRAs CHF market is crowded with generics
Increase in the total prevalent CHF population
Source: GlobalData, based on KOL interviews conducted in January 2013
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CHRONIC HEART FAILURE – GLOBAL DRUG FORECAST AND MARKET ANALYSIS
TO 2022
Executive Summary
Drug Developers Frequently Pursue Approval in Hypertension Prior to Seeking a Label Expansion into Chronic Heart Failure
In recent years, pharmaceutical companies have
entered the CHF market only after gaining initial
approval of their drugs in hypertension (high blood
pressure). While obtaining approval in CHF has not
been an afterthought, it has been sought by
companies to expand their products’ lifecycles,
rather than serving as a leading aspect of their
market entry strategies. Novartis’ LCZ-696 will
follow in the footsteps of its predecessors by first
filing for hypertension in 2013, followed by CHF in
2014. However, the similarity ends there. Unlike
the currently marketed CHF drugs, LCZ-696
targets the underserved segment of the population
with heart failure with preserved ejection fraction
(HF-PEF); to date, no drug developer has
successfully targeted this population. Furthermore,
it is a first-in-class combination drug, whereas the
majority of CHF therapies fall into well-established
drug classes.
The CHF therapy market has been fairly stagnant
for a number of years, and is marked by the
presence of generics. However, LCZ-696’s launch
is poised to mark the beginning of a new era in
which companies will be pursuing truly novel
approaches for treating CHF. These approaches
include potentially game-changing non-
pharmacological therapeutic approaches. For
example, Celladon is developing the gene therapy
Mydicar (rAAV1-SERCA2), while Bioheart and
Cardio3 BioSciences are developing stem cell
therapies. In addition, other companies, including
Bayer and Cytokinetics, both aim to break into the
CHF market with novel drugs, in keeping with the
trend started by Novartis.
The Chronic Heart Failure Market Has Considerable Unmet Needs, Despite the Availability of Well-Established Treatments
Although the CHF market has numerous well-
established therapies, it is marked by the presence
of a number of unmet needs in current treatments.
All of the standard CHF therapies are easily
accessible to patients because most treatments
are generically available and are inexpensive.
However, these standard therapies cater to the
needs of many, but not all, CHF patients.
GlobalData’s research indicates that the overall
attainment level of unmet needs in current
treatments is within the moderate-to-high range, as
shown in the table below.
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CHRONIC HEART FAILURE – GLOBAL DRUG FORECAST AND MARKET ANALYSIS
TO 2022
Executive Summary
Overall Unmet Needs – Current Level of Attainment
Unmet Need Current Level of Attainment
Relative Importance
Therapies for HF-PEF patients 1 High
Therapies for patients with renal impairment 1 Moderate
Diagnosis of asymptomatic left ventricular dysfunction (LVD)
2 High
Treatment of patients with multiple comorbidities
1 Moderate
Increase in survival of CHF patients 3 High
Source: GlobalData, based on primary research and interviews with cardiologists in the 7MM
Of the drugs that are in late stages of development
specifically for chronic, rather than acute, heart
failure (HF), only Novartis’ LCZ-696 is likely to
address a major unmet need in the current
treatment paradigm for CHF by providing a
treatment for HF-PEF patients. LCZ-696 was
tested in HF-PEF in a Phase II trial, with
encouraging results. It is currently being evaluated
in a Phase III trial in the US, Europe and Asia to
investigate its efficacy in patients with New York
Heart Association (NYHA) Class II–III heart failure
with reduced ejection fraction (HF-REF).
GlobalData expects LCZ-696 to receive Food and
Drug Administration (FDA) approval in 2015 for
HF-REF and to launch shortly thereafter. At the
time of the publication of this report, Novartis had
not yet publically disclosed any plans to pursue
further development of LCZ-696 in the HF-PEF
population.
However, given the lack of efficacious treatments
and the corresponding high level of unmet need in
this population segment, GlobalData expects that
Novartis will conduct a Phase III trial in the HF-PEF
population. In the event that Novartis pursues the
development of LCZ-696 for HF-PEF and confirms
its efficacy in this segment of the population, it will
be the first drug to be approved for the HF-PEF
and will fulfill the unmet need of treating this
underserved population.
Market Opportunities for New Entrants
Although the CHF market has several efficacious
treatments for HF-REF patients, there is a lack of
efficacious therapies that can reduce morbidity and
mortality in this population segment. To date, no
drug has demonstrated sufficient efficacy in terms
of reducing morbidity and mortality in HF-PEF in
large-scale clinical trials. Therefore, this unmet
need presents a significant opportunity for
investment by drug developers. Novartis’ LCZ-696
is the only drug that has shown some promise in
treating the HF-PEF population. In addition to the
development of LCZ-696, a large-scale trial
sponsored by the US National Institutes of Health
(NIH) is currently underway for the treatment HF-
PEF using the well-established MRA,
spironolactone. The much-awaited results of this
trial are expected in June 2013, and will shed more
light on the possible role of MRAs in the HF-PEF
population.
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CHRONIC HEART FAILURE – GLOBAL DRUG FORECAST AND MARKET ANALYSIS
TO 2022
Executive Summary
There is a significant need for CHF treatments that
are safe to use in the presence of comorbidities
such as renal impairment, anemia, arthritis, chronic
obstructive pulmonary disease (COPD) and
asthma. Due to the high prevalence of multiple
comorbidities in the elderly population, physicians
often face difficulties in treating these patients
because many of the CHF drugs are
contraindicated in them because of these
comorbidities.
There remains an opportunity to develop more
efficacious treatments that could further increase
survival times for CHF patients, particularly in
patients who continue to suffer from worsening
CHF, despite the use of the existing treatments.
Novel Combination Drug LCZ-696 Will Be a Major Market Player by 2022
Novartis’ LCZ-696, a combination of Diovan
(valsartan) and a new agent — a neprilysin
inhibitor, AHU-377 — is the only drug forecast to
be launched in the next 10 years. The market entry
of this novel combination drug in 2015 will mark the
first entrance of a novel branded CHF drug in the
past five years, boosting the overall market size
considerably during the forecast period. LCZ-696
has the potential to replace angiotensin-converting
enzyme (ACE) inhibitors in the treatment paradigm
for CHF. In addition, LCZ-696 will also steal patient
share from Diovan and other angiotensin receptor
blockers (ARBs), which are given to patients who
cannot tolerate ACE inhibitors.
GlobalData forecasts that LCZ-696 will achieve
sales of approximately $1.87 billion by 2022, the
final year of the forecast period.
What Do the Physicians Think?
Physician experts interviewed by GlobalData
acknowledged that LCZ-696 could change the
treatment paradigm for CHF if it shows significantly
superior efficacy to ACE inhibitors in its ongoing
trials. However, if LCZ-696 shows similar efficacy
to ACE inhibitors, it is unlikely to have a significant
impact on the CHF market. Although Phase II trials
of LCZ-696 did not raise any safety concerns, one
physician pointed out the risk of heightened
adverse effects due to its dual action.
“The objective of the currently-running trial [for
LCZ-696] is to see whether we can replace ACE
inhibitors, which is one of the pillars, one of those
foundations, of the pharmacological treatment of
heart failure. That trial is a head-to-head trial of
LCZ-696 versus the gold-standard ACE inhibitor
treatment [enalapri]. So, if LCZ-696 were to be
significantly superior to enalapril, then it would
potentially replace ACE inhibitors and other key
drugs [ARBs, MRAs, beta blockers]. So,
absolutely, yes, of course, it could be at a very
important position in the guideline. It could be right
at the top where you start.”
Key opinion leader, January 2013
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CHRONIC HEART FAILURE – GLOBAL DRUG FORECAST AND MARKET ANALYSIS
TO 2022
Executive Summary
“I am skeptical about the dual blockade because
dual blockade in the RAAS [renin-angiotensin-
aldosterone] system does not really have
convincing data. If you combine drugs that may
induce hypotension, it may not be beneficial; in
fact, it may be risky for the patients. So, the
ongoing trial results need to show that this
combination will provide benefit for the patient.”
Key opinion leader, January 2013
As indicated in the published treatment guidelines,
all interviewed key opinion leaders (KOLs) agree
that ACE inhibitors and beta blockers are the
current standard care of therapy in CHF, and are
likely to remain so during the next 10 years.
“According to the guidelines, everyone should be
started with an ACE inhibitor and a beta blocker.
The order is usually…to start with an ACE, reach a
reasonable dose, then start a beta blocker and up-
titrate. The order of this — which one to use first —
is debated. A couple of trials looked at it and said it
is clear now that it doesn’t matter which one we
use first. But because the trials for ACE inhibitors
were done first, and those with beta blockers later,
the convention is you start someone who comes in
untreated with an ACE inhibitor for [a] few weeks,
build up the dose to a middle region, and then start
a beta blocker and then up-titrate it.”
Key opinion leader, January 2013
Interviewed KOLs also indicated that MRAs are
used more frequently in Europe than in the US for
CHF treatment, and they anticipate that the use of
MRAs will increase in the US and Japan during the
forecast period.
“Mineralocorticoid receptor antagonists, even in
2012, are used much less in the US and Canada
than they are in Europe and Latin America. That is
because among some physicians, they have a bad
reputation in the US and Canada, in terms of
safety. Whereas in Eastern, Central, and Southern
Europe, physicians use mineralocorticoid receptor
antagonists very widely and very happily.”
Key opinion leader, January 2013
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CHRONIC HEART FAILURE – GLOBAL DRUG FORECAST AND MARKET ANALYSIS
TO 2022
Table of Contents
1 Table of Contents
1 Table of Contents .......................................................................................................................... 8
1.1 List of Tables ........................................................................................................................ 15
1.2 List of Figures ....................................................................................................................... 18
2 Introduction ................................................................................................................................. 20
2.1 Catalyst ................................................................................................................................ 20
2.2 Related Reports ................................................................................................................... 20
2.3 Upcoming Related Reports ................................................................................................... 20
3 Disease Overview ....................................................................................................................... 21
3.1 Etiology and Pathophysiology ............................................................................................... 21
3.1.1 Etiology ........................................................................................................................... 21
3.1.2 Pathophysiology ............................................................................................................. 23
3.2 Prognosis ............................................................................................................................. 27
3.3 Quality of Life ....................................................................................................................... 27
3.4 Symptoms ............................................................................................................................ 28
4 Epidemiology ............................................................................................................................... 30
4.1 Risk Factors and Comorbidities ............................................................................................ 30
4.1.1 Age and sex are highly associated with the risk of chronic heart failure .......................... 32
4.1.2 History of cardiovascular disease increases the risk of developing chronic heart failure . 32
4.1.3 Unhealthy lifestyles increase the risk of chronic heart failure .......................................... 33
4.1.4 People with diabetes mellitus are twice as likely to develop chronic heart failure ............ 33
4.1.5 Nearly 20% of patients with chronic kidney disease develop chronic heart failure........... 34
4.1.6 Comorbidities .................................................................................................................. 34
4.1.7 Prognosis for chronic heart failure remains poor ............................................................. 35
4.2 Global Trends ....................................................................................................................... 36
4.2.1 United States .................................................................................................................. 36
4.2.2 France ............................................................................................................................ 37
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Table of Contents
4.2.3 Germany ......................................................................................................................... 38
4.2.4 Italy ................................................................................................................................. 38
4.2.5 Spain .............................................................................................................................. 38
4.2.6 United Kingdom .............................................................................................................. 39
4.2.7 Japan.............................................................................................................................. 39
4.2.8 China .............................................................................................................................. 40
4.3 Forecast Methodology .......................................................................................................... 40
4.3.1 Sources Used ................................................................................................................. 40
4.3.2 Forecast Assumptions and Methods ............................................................................... 45
4.3.3 Forecast Assumptions and Methods for New York Heart Association Class Distributions ....................................................................................................................................... 48
4.3.4 Sources Not Used........................................................................................................... 49
4.4 Epidemiology Forecast (2012–2022) .................................................................................... 49
4.4.1 Prevalent Cases of Chronic Heart Failure ....................................................................... 49
4.4.2 Age-Specific Prevalent Cases......................................................................................... 52
4.4.3 Sex-Specific Prevalent Cases ......................................................................................... 54
4.4.4 Age-Standardized Prevalence ........................................................................................ 59
4.4.5 New York Heart Association Class Distributions ............................................................. 61
4.5 Discussion ............................................................................................................................ 62
4.5.1 Limitations of Analysis .................................................................................................... 64
4.5.2 Strengths of Analysis ...................................................................................................... 64
5 Disease Management.................................................................................................................. 65
5.1 Treatment Overview ............................................................................................................. 66
5.1.1 Pharmacological Treatments .......................................................................................... 68
5.1.2 Mechanical Devices ........................................................................................................ 74
5.2 US ....................................................................................................................................... 75
5.2.1 Diagnosis and Referral Patterns ..................................................................................... 75
5.2.2 Clinical Practice .............................................................................................................. 76
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Table of Contents
5.3 France .................................................................................................................................. 77
5.3.1 Diagnosis and Referral Patterns ..................................................................................... 77
5.3.2 Clinical Practice .............................................................................................................. 78
5.4 Germany .............................................................................................................................. 80
5.4.1 Diagnosis and Referral Patterns ..................................................................................... 80
5.4.2 Clinical Practice .............................................................................................................. 80
5.5 Italy ...................................................................................................................................... 82
5.5.1 Diagnosis and Referral Patterns ..................................................................................... 82
5.5.2 Clinical Practice .............................................................................................................. 82
5.6 Spain .................................................................................................................................... 84
5.6.1 Diagnosis and Referral Patterns ..................................................................................... 84
5.6.2 Clinical Practice .............................................................................................................. 85
5.7 UK ....................................................................................................................................... 87
5.7.1 Diagnosis and Referral Patterns ..................................................................................... 87
5.7.2 Clinical Practice .............................................................................................................. 88
5.8 Japan ................................................................................................................................... 90
5.8.1 Diagnosis and Referral Patterns ..................................................................................... 90
5.8.2 Clinical Practice .............................................................................................................. 90
6 Competitive Assessment ............................................................................................................. 92
6.1 Overview .............................................................................................................................. 92
6.2 Strategic Competitor Assessment ......................................................................................... 92
6.3 Drug Profiles......................................................................................................................... 95
6.3.1 Angiotensin-Converting Enzyme (ACE) Inhibitors ........................................................... 95
6.3.2 Diuretics ......................................................................................................................... 98
6.3.3 Angiotensin Receptor Blockers ..................................................................................... 100
6.3.4 Beta Blockers ............................................................................................................... 113
6.3.5 Procoralan (ivabradine)................................................................................................. 125
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Table of Contents
6.3.6 Mineralocorticoid Receptor Antagonists ........................................................................ 129
6.3.7 Digoxin ......................................................................................................................... 132
7 Opportunity and Unmet Need .................................................................................................... 135
7.1 Overview ............................................................................................................................ 135
7.2 Lack of Therapies for HF-PEF Patients .............................................................................. 136
7.3 Lack of Therapies for Patients with Renal Impairment ........................................................ 137
7.4 Diagnosis of Asymptomatic Left Ventricular Dysfunction .................................................... 137
7.5 Treatment of Patients with Multiple Comorbidities .............................................................. 138
7.6 Increase in Survival of CHF Patients .................................................................................. 138
7.7 Unmet Needs Gap Analysis ................................................................................................ 139
7.8 Opportunity: Treatment of Patients with HF-PEF ................................................................ 140
7.9 Opportunity: Therapies for Patients with Renal Impairment and Multiple Comorbidities ...... 140
7.10 Opportunity: New Drugs that Show Increase in Survival of CHF Patients ........................... 140
8 Pipeline Assessment ................................................................................................................. 141
8.1 Overview ............................................................................................................................ 141
8.1.1 Clinical Trials by Country .............................................................................................. 142
8.2 Clinical Trials by Phase and Trial Status ............................................................................. 143
8.3 Promising Drugs in Clinical Development ........................................................................... 144
8.3.1 LCZ-696 ....................................................................................................................... 145
8.3.2 Tekturna (aliskiren) ....................................................................................................... 151
8.3.3 Neucardin (rhNRG-1) .................................................................................................... 155
8.4 Innovative Early-Stage Approaches .................................................................................... 159
8.4.1 BAY 94-8862 ................................................................................................................ 159
8.4.2 Omecamtiv mecarbil ..................................................................................................... 162
8.5 Promising Non-Pharmacological Approaches ..................................................................... 165
8.5.1 MyoCell ........................................................................................................................ 166
8.5.2 C-Cure (C3BS-CQR-1) ................................................................................................. 171
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Table of Contents
8.5.3 Mydicar (rAAV1-SERCA2a) .......................................................................................... 174
9 Current and Future Players ....................................................................................................... 179
9.1 Overview ............................................................................................................................ 179
9.2 Trends in Corporate Strategy ............................................................................................. 180
9.3 Company Profiles ............................................................................................................... 181
9.3.1 Novartis ........................................................................................................................ 181
10 Market Outlook .......................................................................................................................... 185
10.1 Global Markets ................................................................................................................... 185
10.1.1 Forecast ....................................................................................................................... 185
10.1.2 Drivers and Barriers – Global Issues............................................................................. 188
10.2 United States ...................................................................................................................... 191
10.2.1 Forecast ....................................................................................................................... 191
10.2.2 Key Events ................................................................................................................... 195
10.2.3 Drivers and Barriers ...................................................................................................... 195
10.3 France ................................................................................................................................ 197
10.3.1 Forecast ....................................................................................................................... 197
10.3.2 Key Events ................................................................................................................... 200
10.3.3 Drivers and Barriers ...................................................................................................... 200
10.4 Germany ............................................................................................................................ 201
10.4.1 Forecast ....................................................................................................................... 201
10.4.2 Key Events ................................................................................................................... 204
10.4.3 Drivers and Barriers ...................................................................................................... 204
10.5 Italy .................................................................................................................................... 205
10.5.1 Forecast ....................................................................................................................... 205
10.5.2 Key Events ................................................................................................................... 207
10.5.3 Drivers and Barriers ...................................................................................................... 208
10.6 Spain .................................................................................................................................. 209
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Table of Contents
10.6.1 Forecast ....................................................................................................................... 209
10.6.2 Key Events ................................................................................................................... 211
10.6.3 Drivers and Barriers ...................................................................................................... 212
10.7 United Kingdom .................................................................................................................. 213
10.7.1 Forecast ....................................................................................................................... 213
10.7.2 Key Events ................................................................................................................... 216
10.7.3 Drivers and Barriers ...................................................................................................... 216
10.8 Japan ................................................................................................................................. 217
10.8.1 Forecast ....................................................................................................................... 217
10.8.2 Key Events ................................................................................................................... 220
10.8.3 Drivers and Barriers ...................................................................................................... 220
11 Appendix ................................................................................................................................... 223
11.1 Bibliography........................................................................................................................ 223
11.2 Abbreviations...................................................................................................................... 240
11.3 Methodology ....................................................................................................................... 244
11.4 Forecasting Methodology ................................................................................................... 244
11.4.1 NYHA Class Segmentation of Total Prevalent CHF Population .................................... 244
11.4.2 Diagnosed CHF Population .......................................................................................... 245
11.4.3 Drug-Treated CHF Population ...................................................................................... 246
11.4.4 Patient Population Breakdown: HF-REF versus HF-PEF .............................................. 246
11.4.5 Treatment of HF-REF versus HF-PEF .......................................................................... 246
11.4.6 Drugs Included in Each Therapeutic Class ................................................................... 247
11.4.7 Launch and Patent Expiry Dates ................................................................................... 247
11.4.8 General Pricing Assumptions ........................................................................................ 248
11.4.9 Drugs Assumptions ....................................................................................................... 249
11.4.10 Generic Erosion ...................................................................................................... 254
11.4.11 Pricing of Pipeline Agents ....................................................................................... 254
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Table of Contents
11.5 Physicians and Specialists Included in this Study ............................................................... 255
11.6 Survey of Prescribing Physicians ........................................................................................ 256
11.7 About the Authors ............................................................................................................... 257
11.7.1 Author ........................................................................................................................... 257
11.7.2 Epidemiologist .............................................................................................................. 257
11.7.3 Global Head of Healthcare ............................................................................................ 258
11.8 About GlobalData ............................................................................................................... 259
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Table of Contents
1.1 List of Tables
Table 1: Leading Causes of CHF ................................................................................................................... 22
Table 2: Other Causes of CHF ....................................................................................................................... 22
Table 3: Compensatory Mechanisms in CHF ................................................................................................. 23
Table 4: Typical Symptoms of CHF ................................................................................................................ 28
Table 5: NYHA Classification of HF Based on Symptoms and Physical Ability of Patients .............................. 29
Table 6: Risk Factors and Comorbidities for CHF ........................................................................................... 31
Table 7: Sources of Epidemiological Data Used for the Forecast.................................................................... 41
Table 8: NYHA Class Distributions ................................................................................................................. 48
Table 9: All Markets, Prevalent Cases (N) of CHF, Ages ≥45 Years, Men and Women, 2012–2022 ............... 50
Table 10:All Markets, Prevalent Cases of CHF, by Age, Men and Women, N (Row %), 2012 ......................... 53
Table 11:All Markets, Prevalent Cases of CHF, by Sex, Ages ≥ 45 Years, N (Row %), 2012 .......................... 55
Table 12:All Markets, Prevalent Cases of CHF by NYHA Class, Ages ≥45 Years, Men and Women, N (Row %), 2012 ................................................................................................................................ 61
Table 13:ACC/AHA Classification of HF Based on Disease Progression ........................................................ 65
Table 14:NYHA Classification of HF Based on Symptoms and Physical Activity of Patients ............................ 65
Table 15:Commonly Used Treatment Guidelines for CHF .............................................................................. 67
Table 16:Most Prescribed Drugs for CHF by NYHA Class in the Major Markets, 2012 .................................. 69
Table 17:Select Products Used for CHF Treatment, 2012 .............................................................................. 94
Table 18:Global Sales Forecasts ($m) for ACE inhibitors, 2012–2022 ............................................................ 97
Table 19:Global Sales Forecasts ($m) for Diuretics, 2012–2022 .................................................................. 100
Table 20:Global Sales Forecasts ($m) for ARBs, 2012–2022 ....................................................................... 103
Table 21:Product Profile – Diovan ................................................................................................................ 105
Table 22:Diovan SWOT Analysis, 2012 ....................................................................................................... 107
Table 23:Global Sales Forecasts ($m) for Diovan, 2012–2022 ..................................................................... 108
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Table 24:Product Profile – Atacand .............................................................................................................. 110
Table 25:Atacand SWOT Analysis, 2012 ..................................................................................................... 111
Table 26:Global Sales Forecasts ($m) for Atacand, 2012–2022 ................................................................... 112
Table 27:Global Sales Forecasts ($m) for Beta Blockers, 2012–2022 .......................................................... 116
Table 28:Product Profile – Carvedilol ........................................................................................................... 117
Table 29:Carvedilol SWOT Analysis, 2012 ................................................................................................... 119
Table 30:Global Sales Forecasts ($m) for Carvedilol, 2012–2022 ................................................................ 120
Table 31:Product Profile – Nebivilol ............................................................................................................. 122
Table 32:Nebivilol SWOT Analysis, 2012 ..................................................................................................... 123
Table 33:Global Sales Forecasts ($m) for Nebilet, 2012–2022 ..................................................................... 124
Table 34:Product Profile – Procoralan .......................................................................................................... 126
Table 35:Procoralan SWOT Analysis, 2012 ................................................................................................. 127
Table 36:Global Sales Forecasts ($m) for Procoralan, 2012–2022 ............................................................... 128
Table 37:Global Sales Forecasts ($m) for MRAs, 2012–2022 ...................................................................... 131
Table 38:Global Sales Forecasts ($m) for Digoxin, 2012–2022 .................................................................... 134
Table 39:Overall Unmet Needs – Current Level of Attainment ...................................................................... 135
Table 40:Clinical Unmet Needs – Gap Analysis, 2013 .................................................................................. 139
Table 41:CHF – Clinical Trials by Phase and Status, 2012 ........................................................................... 143
Table 42:CHF – Promising Late-Stage Pipeline, 2012 .................................................................................. 144
Table 43:Comparison of Therapeutic Classes in Development for CHF, 2012 .............................................. 144
Table 44:Product Profile – LCZ-696 ............................................................................................................. 146
Table 45:LCZ-696 SWOT Analysis, 2012 ..................................................................................................... 149
Table 46:Global Sales Forecasts ($) for LCZ-696, 2012–2022 ..................................................................... 150
Table 47:Product Profile – Tekturna ............................................................................................................. 153
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Table 48:Tekturna SWOT Analysis, 2012 .................................................................................................... 155
Table 49:Product Profile – Neucardin .......................................................................................................... 156
Table 50:CHF – Innovative Early-Stage Approaches, 2012 .......................................................................... 159
Table 51:Product Profile – BAY 94-8862 ...................................................................................................... 161
Table 52:Product Profile – Omecamtiv mecarbil ........................................................................................... 164
Table 53:CHF – Promising Non-Pharmacological Approaches, 2012 ........................................................... 165
Table 54:Product Profile – MyoCell .............................................................................................................. 168
Table 55:Product Profile – C-Cure ............................................................................................................... 172
Table 56:Product Profile – Mydicar .............................................................................................................. 175
Table 57:Key Companies in the CHF Market, 2012 ...................................................................................... 180
Table 58:Novartis’ CHF Portfolio Assessment, 2012 .................................................................................... 183
Table 59:Novartis SWOT Analysis, 2012 ..................................................................................................... 184
Table 60:Global Sales Forecasts ($m) for CHF, 2012-2022 ......................................................................... 186
Table 61:Global CHF Market – Drivers and Barriers, 2012–2022 ................................................................. 188
Table 62:Sales Forecasts ($m) for CHF in the United States, 2012–2022 .................................................... 193
Table 63:Key Events Impacting Sales for CHF in the United States, 2012–2022 .......................................... 195
Table 64:CHF Market in the United States – Drivers and Barriers, 2012–2022 ............................................. 195
Table 65:Sales Forecasts ($m) for CHF in the France, 2012–2022 .............................................................. 198
Table 66:Key Events Impacting Sales for CHF in France, 2012–2022 .......................................................... 200
Table 67:CHF Market – Drivers and Barriers in France, 2012–2022 ............................................................. 200
Table 68:Sales Forecasts ($m) for CHF in Germany, 2012–2022 ................................................................. 202
Table 69:Key Events Impacting Sales for CHF in Germany, 2012–2022 ...................................................... 204
Table 70:CHF Market in Germany – Drivers and Barriers, 2012–2022 ......................................................... 204
Table 71:Sales Forecasts ($m) for CHF in Italy, 2012–2022 ......................................................................... 206
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Table 72:Key Events Impacting Sales for CHF in Italy, 2012–2022 .............................................................. 207
Table 73:CHF Market in Italy – Drivers and Barriers, 2012–2022 ................................................................. 208
Table 74:Sales Forecasts ($m) for CHF in Spain, 2012–2022 ...................................................................... 210
Table 75:Key Events Impacting Sales for CHF in Spain, 2012–2022 ............................................................ 211
Table 76:CHF Market in Spain – Drivers and Barriers, 2012–2022 ............................................................... 212
Table 77:Sales Forecasts ($m) for CHF in the United Kingdom, 2012–2022................................................. 214
Table 78:Key Events Impacting Sales for CHF in the United Kingdom, 2012–2022 ...................................... 216
Table 79:CHF Market – Drivers and Barriers in the United Kingdom, 2012–2022 ......................................... 216
Table 80:Sales Forecasts ($m) for CHF in Japan, 2012–2022...................................................................... 218
Table 81:Key Events Impacting Sales for CHF in Japan, 2012–2022 ........................................................... 220
Table 82:CHF Market in Japan – Drivers and Barriers, 2012–2022 ............................................................. 220
Table 83:Key Launch or Approval Dates ...................................................................................................... 247
Table 84:Key Patent Expiries ....................................................................................................................... 247
Table 85:Physicians Surveyed, By Country .................................................................................................. 256
1.2 List of Figures
Figure 1: Worsening HF Leading to Chronic Disease ................................................................................... 25
Figure 2: All Markets, Prevalent Cases (N) of CHF, Ages ≥45 Years, Men and Women, 2012–2022 ............ 51
Figure 3: All Markets, Prevalent Cases of CHF, by Age, Men and Women, N, 2012 ..................................... 54
Figure 4: All Markets, Prevalent Cases of CHF, by Sex, Ages ≥45 Years, %, 2012 ....................................... 56
Figure 5: All Markets, Prevalent Cases of CHF, by Age and Sex, N, 2012 .................................................... 57
Figure 6: China, Prevalent Cases of CHF by Age and Sex, N, 2012 ............................................................. 58
Figure 7: All Markets, Age-Standardized Prevalence of CHF, Ages ≥45 Years, Men and Women, %, 2012 .. 60
Figure 8: Drug-Treatment Rates of Patients Diagnosed with CHF in the 7MM, by NYHA Class .................... 68
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Figure 9: Treatment of CHF Patients by Drug Class, US, 2012 .................................................................... 77
Figure 10: Treatment of CHF Patients by Drug Class, France, 2012............................................................... 79
Figure 11: Treatment of CHF Patients by Drug Class, Germany, 2012 ........................................................... 81
Figure 12: Treatment of CHF Patients by Drug Class, Italy, 2012 ................................................................... 83
Figure 13: Treatment of CHF Patients by Drug Class, Spain, 2012 ................................................................ 86
Figure 14: Treatment of CHF Patients by Drug Class, UK, 2012 .................................................................... 89
Figure 15: Treatment of CHD Patients by Drug Class, Japan, 2012 ............................................................... 91
Figure 16: CHF Therapeutics – Clinical Trials by Country, 2012 ................................................................... 142
Figure 17: Global Sales for CHF ($bn) by Region, 2012–2022 ..................................................................... 187
Figure 18: Sales for CHF ($bn) in the United States, 2012–2022.................................................................. 194
Figure 19: Sales for CHF ($m) in France, 2012–2022 .................................................................................. 199
Figure 20: Sales for CHF in Germany ($m), 2012–2022 ............................................................................... 203
Figure 21: Sales for CHF ($m) in Italy, 2012–2022 ....................................................................................... 207
Figure 22: Sales for CHF ($m) in Spain, 2012–2022 .................................................................................... 211
Figure 23: Sales for CHF ($m) in the United Kingdom, 2012–2022............................................................... 215
Figure 24: Sales for CHF ($m) in Japan, 2012–2022 .................................................................................... 219
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Introduction
2 Introduction
2.1 Catalyst
The chronic heart failure (CHF) market is a mature market that has been slowly overtaken by
generic drugs, and more branded products are expected to lose market exclusivity during the next
few years. GlobalData predicts that the major global barriers that will play a crucial role in
narrowing the global growth of the CHF market over the forecast period include the sparsely
populated CHF pipeline and an increasing number of generic competitors in a market that is
already heavily laden with generic drugs. However, the market entry of entry of Novartis’ LCZ-696,
the first novel, branded CHF drug to enter the market in five years, will noticeably enhance the
overall market size during the forecast period. LCZ-696 is currently being evaluated in a trial for
patients with heart failure with reduced ejection fraction (HF-REF), but if clinical trial data continue
to demonstrate the drug’s efficacy in patients with heart failure with preserved ejection fraction (HF-
PEF), and it gains approval for use in this population, it will be the first drug to show efficacy in this
largely underserved patient population. In addition, increased use of MRAs over the forecast period
in all seven major markets (7MM) will contribute to the increase in the global CHF market size.
2.2 Related Reports
GlobalData (2013), Osteoporosis – Global Drug Forecast and Market Analysis to 2022,
January, 2013, GDHC43PIDR.
2.3 Upcoming Related Reports
GlobalData (2013) Type 2 Diabetes – Global Drug Forecast and Market Analysis to 2022,
June, 2013, GDHC54PIDR.
GlobalData (2013) Obesity – Global Drug Forecast and Market Analysis to 2022, June, 2013,
GDHC50PIDR
GlobalData (2013). Dyslipidemia – Global Drug Forecast and Market Analysis to 2022, June,
2013, GDHC46PIDR.
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Appendix
11.8 About GlobalData
GlobalData is a leading global provider of business intelligence in the Healthcare industry.
GlobalData provides its clients with up-to-date information and analysis on the latest developments
in drug research, disease analysis, and clinical research and development. Our integrated business
intelligence solutions include a range of interactive online databases, analytical tools, reports, and
forecasts. Our analysis is supported by a 24/7 client support and analyst team.
GlobalData has offices in New York, Boston, London, India, and Singapore.