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The Cardiovascular Disorders Market Outlook to 2012

Business Intelligence for the Pharmaceutical Industry
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Some key findings from this report...
• Zetia, Diovan, Crestor and Lipitor were the strongest performing major products of 2006-07. Each of these brands is forecast to maintain patent protection over the short to medium-term.
• The cardiovascular portfolios of Novartis and AstraZeneca are best positioned for high levels of future growth. Conversely, it is forecast that current market leaders Pfizer,Merck and Sanofi-Aventis will struggle to preserve their market shares over the 2008-12 period.
• The cardiac therapy area is the only segment forecast to experience a decline in net sales during the forecast period. However, generic competition to Lipitor may also result in the Dyslipidemia market suffering a fall in sales over 2011-12.
• Thrombosis will be the major growth driver of the cardiovascular area throughout the short-term, whilst heart failure has the most favourable dynamics of any indication for rapid market growth.
• Heart failure and thrombosis represent the most active areas of current drug development. Increasing competition in these traditionally less competitive therapeutic areas is forecast to become a major trend over the period up to 2012.

The Cardiovascular Market Outlook to 2012
The cardiovascular therapeutic area has historically provided the largest single source of revenue for the pharmaceutical industry. The outlook for the market remains robust, driven by high patient populations and a widespread focus on preventative treatment. However, low growth rates in established indications will prevail due to the growing availability of effective generic medicines and an overall scarcity of innovative new drug launches. Major pharma companies are now primarily focusing efforts upon compliance and protection against the generic threats posed by line extensions and combination treatments. Changes in the competitive positions of leading companies will become inevitable as new revenue sources continue to decline and established portfolios underperform. The Cardiovascular Disorders Market Outlook to 2012 is a new report published by Business Insights that provides comprehensive coverage of every class of drugs across all major cardiovascular indications. Detailed insights into recent key events and future market leaders are also provided, in addition to epidemiological analysis and forecasts for major products over the period 2007-12. With coverage of over 90% of the total market for cardiovascular products, this report profiles the underlying trends and factors driving the market and identifies the most promising areas of potential growth.

Top five reasons to order your copy today
• Assess patient potential, treatment trends and sales patterns across major cardiovascular indications with this report’s analysis of epidemiological studies, unmet medical need, and economic imperatives for stakeholders.
• Measure the market performance and strategic positioning of major pharmaceutical corporations with this report’s evaluation of the franchises and market shares of AstraZeneca, BMS, Daiichi Sankyo, GSK, Merck, Novartis, Pfizer, Sanofi-Aventis and Servier.
• Discover the market dynamics of the cardiovascular area and understand the impact of recent key events by assessing major market trends, growth drivers and the latest issues affecting R&D.
• Compare the future prospects of key players and forecast sales of leading products across major indications to 2012 with this report’s analysis of sales focus by drug class, currently marketed portfolios, R&D pipelines, and trends in promotional spend for key brands.
• Identify the strategies that offer the greatest success potential within the future cardiovascular market and understand the challenges currently facing companies within this therapeutic area.

Key issues examined in this report...
• Cardiac therapies. Heart failure treatments have become a focal point for cardiovascular drug developments. However, doubts remain over whether the marginal benefits offered by such medicines will be sufficient to generate and sustain high levels of revenue.
• Combination drugs. Although combination drugs failed to accrue strong sales growth in 2007, the growing acceptance of combination dyslipidemic therapies amongst payors and physicians will favour Merck’s Vytorin/Inegy and Novartis’ newly launched combination product Exforge (amlodipine/losartan)
• Empty pipelines. Currently marketed portfolios have taken on greater importance in light of weak late stage pipelines among players such as Merck, BMS and AstraZeneca. This lack of new revenue sources is forecast to depress future growth in the cardiovascular market.
• Market leaders. Few leading companies are expected to retain their presence in the cardiovascular market, with some major players set to experience drastic declines in revenue over the forecast period.

Your questions answered...
• Which indications will experience the greatest growth in the global cardiovascular market over the period 2007-12?
• How will generic competition influence the future of branded products and which defensive strategies provide the most effective protection?
• How have recent major product launches performed?
• What is the forecast market size and growth rate over the period 2007-2012 across the major cardiovascular indications?
• Which pipeline products offer the highest growth potential?
• What will be the competitive landscape of hypertension, thrombosis, dyslipidemia and arrhythmia in 2012?

Table of Contents
The Cardiovascular Disorders Market Outlook to 2012
Executive Summary 14
Patient potential 14
Global market analysis 15
Pipeline analysis 16
Competitive landscape 17
Chapter 1 Epidemiology of Cardiovascular
disorders 20
Summary 20
Introduction 21
Cardiovascular Risk Factors 22
Hypertension 25
Overview 25
Diagnosis, treatment and management 26
Epidemiology 28
Forecast epidemiology 30
Dyslipidemia 31
Overview 31
Diagnosis, treatment and management 33
Epidemiology 35
Forecast epidemiology 36
Diabetes 37
Overview 37
Diagnosis, treatment and management 38
Epidemiology 40
Forecast epidemiology 41
Cardiovascular disease 42
Overview 42
Epidemiology 44
Acute thrombotic events 45
Acute coronary syndromes 45
Venous thromboembolism 48
Stroke 50
Cardiovascular procedures 53
Chapter 2 Global market analysis 58
Summary 58
Introduction 59
Market analysis by country 59
Licensing trends 60
Market analysis by drug class 62
Leading brands dynamics 64
Key events in the cardiovascular market 66
Use of ACE inhibitors by pregnant women linked to associated birth defects risks 66
Arrival of generic competition to key brands 67
Positive clinical trials further boost sales generation for major brands Diovan and Lipitor 67
Anti-hypertensives 68
Market analysis by drug class 68
Leading brands in the Anti-hypertensives market 70
ACE Inhibitors (ACEIs) 72
Market dynamics 74
Key brands analysis 75
Beta Blockers 80
Market dynamics 82
Diuretics 83
Market dynamics 85
Key brands analysis 85
Calcium Channel Blockers (CCBs) 86
Market dynamics 88
Key brands analysis 89
Angiotensin Receptor Blockers (ARBs) 90
Market dynamics 93
Key brands analysis 94
Sales forecasts to 2012 for Anti Hypertensives 100
Anti-dyslipidemics 102
Market analysis by drug class 102
Leading brands in the Anti-dyslipidemics market 105
Market analysis by drug class 106
Statins 106
Fibrates 113
Non-statin products 113
Other anti-dyslipidemics 115
Sales forecasts to 2012 for Anti dyslipidemics 115
Anti-Thrombotics 116
Market analysis by drug class 116
Leading brand dynamics 119
Anti-platelets 121
Market dynamics 124
Key brands analysis 125
Heparins 128
Market dynamics 130
Key brands analysis 130
Vit K antagonists 134
Fibrinolytics 136
Sales forecasts to 2012 for Anti thrombotics 137
Cardiac Therapies 138
Market analysis by drug class 138
Leading brands of Cardiac Therapies 142
Other cardiac therapies 142
Nitrites and nitrates 144
Leading-brand dynamics 144
Anti-arrhythmics 145
Sales forecasts to 2012 for Cardiac Therapies 2007-12 146
Total CVD market sales forecasts to 2012 147
Chapter 3 Pipeline analysis 150
Summary 150
Introduction 151
Key trends in cardiovascular R&D 151
Combination drugs 152
New class of drugs 153
New mechanism of action 153
New drug delivery formulations 153
The pipeline for cardiovascular disorders 154
Leading drugs in development 156
Profiles of key pipeline products 157
Phase II compounds 157
ARC 1779 157
KB 2115 158
Phase III compounds 160
Cleviprex (clevidipine) 160
Stedicor (azimilide) 162
BAY-597939 (rivaroxaban) 163
Drugs pending approval 165
Thelin (sitaxsentan) 165
Simcor (niacin and simvastatin) 167
Recently marketed drugs 169
Azor (amlodipine/olmesartan) 169
Tekturna/Rasilez (aliskiren) 171
Exforge (amlodipine/valsartan) 173
Ranexa (ranolazine) 174
Chapter 4 Competitive landscape 178
Summary 178
Company market shares 179
Pfizer 183
Overview 183
Sales focus by drug class 183
Marketed product portfolio 184
R&D pipeline analysis 185
Strategic and growth analysis 186
Drivers of growth 186
Resistors of growth 186
Merck 187
Overview 187
Sales focus by drug class 187
Marketed product portfolio 188
R&D pipeline analysis 189
Strategic and growth analysis 190
Drivers of growth 190
Resistors of growth 190
Novartis 191
Overview 191
Sales focus by drug class 191
Marketed product portfolio 192
R&D compounds 193
Strategic and growth analysis 194
Drivers of growth 194
Resistors of growth 194
Sanofi Aventis 195
Overview 195
Sales focus by drug class 195
Marketed product portfolio 196
R&D pipeline analysis 197
Strategic and growth analysis 198
Drivers of growth 198
Resistors of growth 198
AstraZeneca 199
Overview 199
Sales focus by drug class 199
Marketed product portfolio 200
R&D pipeline analysis 201
Strategic and growth analysis 201
Drivers of growth 201
Resistors of growth 202
Bristol-Myers Squibb 203
Overview 203
Sales focus by drug class 203
Marketed product portfolio 204
R&D pipeline analysis 205
Strategic and growth analysis 205
Drivers of growth 205
Resistors of growth 206
Daiichi Sankyo 207
Overview 207
Sales focus by drug class 207
Marketed product portfolio 208
R&D pipeline analysis 209
Strategic and growth analysis 210
Drivers of growth 210
Resistors of growth 210
Servier 211
Overview 211
Sales focus by drug class 211
Marketed product portfolio 212
R&D pipeline analysis 213
Strategic and growth analysis 213
Drivers of growth 213
Resistors of growth 213
Glaxo SmithKline 214
Overview 214
Sales focus by drug class 214
Marketed product portfolio 215
R&D pipeline analysis 216
Strategic and growth analysis 217
Drivers of growth 217
Resistors of growth 217
Chapter 5 Appendix 220
ATC codes used in analysis 220
Licensing status as per IMS Health 220
Original brand 220
Other brand 221
Licensed brand 221
Not-coded product 221
Unbranded/ generic product 221
Diagnosis profile analysis 222
Index 223
List of Figures
Figure 1.1: Relationship between Cardiovascular Risk Factors and Diseases 23
Figure 1.2: Typical treatment patterns in the treatment of hypertension 28
Figure 1.3: Typical treatment patterns in the treatment of dyslipidemia 34
Figure 1.4: Typical treatment patterns in the treatment of diabetes 39
Figure 1.5: Typical treatment patterns in the treatment of acute thrombotic events 52
Figure 2.6: Global cardiovascular market share by geography, 2007 60
Figure 2.7: Sales of types of cardiovascular brands, 2006-07 61
Figure 2.8: Competitive dynamics of the global CVD market by drug class, 2007 63
Figure 2.9: Forecast dynamics of the leading 10 cardiovascular brands, 2006-07 66
Figure 2.10: Competitive dynamics in the global anti-hypertensives market by drug class, 2006–07 69
Figure 2.11: Market movement for anti-hypertensive brands, 2006 71
Figure 2.12: Diagnosis profile of ACE inhibitor sales, 2006 73
Figure 2.13: Diagnosis profile of Beta Blockers, 2006 81
Figure 2.14: Diagnosis profile of Calcium channel blockers, 2006 87
Figure 2.15: Diagnosis profile of ARBs, 2006 92
Figure 2.16: Diagnosis profile of Anti-dyslipidemics, 2006 104
Figure 2.17: Competitive dynamics in the global anti-thrombotics market by class, 2006–07 119
Figure 2.18: Market movement for anti-thrombotic brands, 2006 121
Figure 2.19: Diagnosis profile of anti-platelets, 2006 123
Figure 2.20: Diagnosis profile of Heparins, 2006 129
Figure 2.21: Diagnosis profile of cardiac therapies, 2006 140
Figure 2.22: Competitive dynamics in the global cardiac therapies market by class, 2006–07 141
Figure 3.23: Prevailing R&D approaches for cardiovascular diseases, 2006 152
Figure 3.24: The CVD pipeline by indication and stage of development, 2006 155
Figure 3.25: Leading recently launched and late-stage cardiovascular products, 2007 156
Figure 4.26: Competitive dynamics of the leading players in the global cardiovascular market, 2007 182
Figure 4.27: Pfizer’s franchise sales by drug class, 2006 183
Figure 4.28: Merck’s franchise sales by drug class, 2006 187
Figure 4.29: Novartis’ franchise sales by drug class, 2006 191
Figure 4.30: Sanofi Aventis’ franchise sales by drug class, 2006 195
Figure 4.31: AstraZeneca’s franchise sales by drug class, 2006 199
Figure 4.32: BMS’ franchise sales by drug class, 2006 203
Figure 4.33: Daiichi’s franchise sales by drug class, 2006 207
Figure 4.34: Servier’s franchise sales by drug class, 2006 211
Figure 4.35: GSK’s franchise sales by drug class, 2006 214
List of Tables
Table 1.1: Estimated prevalence of CVD across the seven major pharmaceutical markets, 2006 24
Table 1.2: Proposed revision definition of hypertension, 2005 26
Table 1.3: Estimated prevalence of hypertension in across seven major markets, 2006 29
Table 1.4: Forecast epidemiology of hypertension across the seven major markets, 2006-12 30
Table 1.5: Clinical guidelines for adult patients at borderline and high risk of cardiovascular disease by serum levels of lipids 33
Table 1.6: Estimated prevalence of dyslipidemia across seven major markets, 2006 35
Table 1.7: Forecast epidemiology of dyslipidemia across the seven major markets, 2006-12 36
Table 1.8: Various pharmacological therapies for the treatment and management of diabetes 39
Table 1.9: Estimated prevalence of diabetes in the seven major markets, 2006 40
Table 1.10: Forecast epidemiology of diabetes across the seven major markets, 2006-12 41
Table 1.11: Estimated prevalence of major cardiovascular diseases in the seven major markets, 2006 44
Table 1.12: Estimated incidence of ACS in the seven major markets, 2006 47
Table 1.13: Estimated incidence of VTE in the seven major markets, 2006 49
Table 1.14: Prevalence of stroke in the seven major markets, 2006 51
Table 1.15: Estimated incidence of cardiovascular procedures in the seven major markets, 2006 54
Table 2.16: Breakdown of the global CVD market by drug class, 2003-07 62
Table 2.17: Leading brands in the global cardiovascular market, 2006–07 64
Table 2.18: Breakdown of the global anti-hypertensive market by drug class, 2003-07 68
Table 2.19: Leading anti-hypertensive brands, 2006–07 70
Table 2.20: Leading ACE inhibitor brands, 2006–07 74
Table 2.21: Leading Beta blocker brands, 2006–07 82
Table 2.22: Leading diuretics brands, 2006–07 85
Table 2.23: Leading CCBs brands in the global CVD market, 2006–07 88
Table 2.24: Leading ARBs brands in the global CVD market, 2006–07 93
Table 2.25: Anti-hypertensives sales forecast for ARBs, Beta-blockers & CCBs, 2007-12 100
Table 2.26: Anti-hypertensives sales forecast for ACE inhibitors, Diuretics & Pipeline products, 2007-12 101
Table 2.27: Breakdown of the global anti-dyslipidemic market by drug class, 2003-07 103
Table 2.28: Leading anti-dyslipidemia products in the global CVD market, 2006–07 105
Table 2.29: Anti-dyslipidemics sales forecasts, 2007-12 116
Table 2.30: Breakdown of the global anti-thrombotics market by drug class, 2003-07 117
Table 2.31: Leading anti-thrombotics products in the global CVD market, 2006–07 120
Table 2.32: Leading anti-platelet brands in the global CVD market, 2006–07 124
Table 2.33: Leading heparin brands in the global CVD market, 2006–07 130
Table 2.34: Anti-thrombotics sales forecasts, 2007-12 137
Table 2.35: Breakdown of the global anti-thrombotics market by drug class, 2003-07 139
Table 2.36: Leading cardiac therapy products in the global CVD market, 2006–07 142
Table 2.37: Cardiac therapies’ sales forecasts, 2007-12 146
Table 2.38: Cardiovacular market sales forecasts by drug class, 2006-12 ($m) 147
Table 4.39: Leading players in the global cardiovascular disorders market, 2006-07 179
Table 4.40: Pfizer’s CVD product portfolio, 2005-06 184
Table 4.41: Pfizer’s cardiovascular product pipeline, 2006 185
Table 4.42: Merck’s CVD product portfolio, 2005-06 188
Table 4.43: Merck’s cardiovascular R&D product pipeline, 2006 189
Table 4.44: Novartis’ CVD product portfolio, 2005-06 192
Table 4.45: Novartis’ cardiovascular R&D product pipeline, 2006 193
Table 4.46: Sanofi Aventis’ CVD product portfolio, 2005-06 196
Table 4.47: Sanofi Aventis’ cardiovascular R&D product pipeline, 2006 197
Table 4.48: AstraZeneca’s CVD product portfolio, 2005-06 200
Table 4.49: AstraZeneca’s cardiovascular R&D product pipeline, 2006 201
Table 4.50: BMS’s CVD product portfolio, 2005-06 204
Table 4.51: BMS’ cardiovascular R&D product pipeline, 2006 205
Table 4.52: Daiichi’s CVD product portfolio, 2005-06 208
Table 4.53: Daichii’s cardiovascular R&D product pipeline, 2006 209
Table 4.54: Servier’s CVD product portfolio, 2005-06 212
Table 4.55: GSK’s CVD product portfolio, 2005-06 215
Table 4.56: GSK’s cardiovascular R&D product pipeline, 2006 216