gdhc45pidr | june 2013 - marketresearchtherapeutics in 2012, the base year of the forecast period,...

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


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



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



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.



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.



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



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.”


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.”


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.”




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



5.4 Germany .............................................................................................................................. 80



5.5 Italy ...................................................................................................................................... 82



5.6 Spain .................................................................................................................................... 84



5.7 UK ....................................................................................................................................... 87



5.8 Japan ................................................................................................................................... 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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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


10.4 Germany ............................................................................................................................ 201

10.4.1 Forecast ....................................................................................................................... 201

10.4.2 Key Events ................................................................................................................... 204


10.5 Italy .................................................................................................................................... 205

10.5.1 Forecast ....................................................................................................................... 205

10.5.2 Key Events ................................................................................................................... 207


10.6 Spain .................................................................................................................................. 209



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Table of Contents

10.6.1 Forecast ....................................................................................................................... 209

10.6.2 Key Events ................................................................................................................... 211


10.7 United Kingdom .................................................................................................................. 213

10.7.1 Forecast ....................................................................................................................... 213

10.7.2 Key Events ................................................................................................................... 216


10.8 Japan ................................................................................................................................. 217

10.8.1 Forecast ....................................................................................................................... 217

10.8.2 Key Events ................................................................................................................... 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 of Contents

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 of Contents

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 of Contents

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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Table of Contents

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.

gdhc45pidr | june 2013 - marketresearchtherapeutics in 2012, the base year of the forecast period,...

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