The Cardiovascular Market Outlook to Competitive landscape, global market analysis, key trends, and pipeline analysis

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1 The Cardiovascular Market Outlook to 2016 Competitive landscape, global market analysis, key trends, and pipeline analysis Reference Code: BI Publication Date: June

2 About Business Insights Business Insights has a team of in-house pharmaceutical and regulatory analysts drawn from consulting, R&D and competitive intelligence life sciences backgrounds. Our analysts specialize in providing detailed insight into the future of therapeutic drug markets and emerging pharmaceutical markets and have extensive analytical, forecasting and research experience in the pharmaceutical, biotech and outsourcing sectors. Our team maintains regular contact with industry executives to track market developments and base their market models on a wide range of proprietary drug sales, pipeline and epidemiological databases to provide up to date, accurate strategic insight on the future of the pharmaceutical market. Disclaimer Copyright 2011 Business Insights Ltd This report is published by Business Insights (the Publisher). This report contains information from reputable sources and although reasonable efforts have been made to publish accurate information, you assume sole responsibility for the selection, suitability and use of this report and acknowledge that the Publisher makes no warranties (either express or implied) as to, nor accepts liability for, the accuracy or fitness for a particular purpose of the information or advice contained herein. The Publisher wishes to make it clear that any views or opinions expressed in this report by individual authors or contributors are their personal views and opinions and do not necessarily reflect the views/opinions of the Publisher. 2

3 Table of Contents About Business Insights 2 Disclaimer 2 Executive Summary 13 Overview and epidemiology of cardiovascular disorders 13 Global market analysis 13 Pipeline analysis 14 Competitive landscape 15 Chapter 1 Overview and epidemiology of cardiovascular disorders 17 Summary 17 Introduction 17 Risk factors 18 Predisposing risk factors 18 Modifiable risk factors 21 Hypertension 21 Diagnosis, treatment and management 22 Epidemiology 24 Forecast epidemiology 26 Dyslipidemia 27 Diagnosis, treatment, and management 29 Epidemiology 30 Forecast epidemiology 31 Cardiovascular diseases 33 Arteriosclerosis/atherosclerosis 33 3

4 Thrombosis 33 Cardiac arrhythmias 33 Myocardial infarction (MI) 33 Acute coronary syndrome (ACS) 34 Congestive heart failure (CHF) 34 Coronary artery disease (CAD) 34 Peripheral artery disease (PAD) 34 Pulmonary hypertension 34 Angina pectoris 35 Stroke 35 Epidemiology 35 Forecast epidemiology 36 Chapter 2 Global market analysis 38 Summary 38 Introduction 39 Market analysis by geography 40 Key events in the cardiovascular market 41 European approval for Rasilamlo 41 BMS/Pfizer s apixaban likely to receive EU approval 41 Angiotensin receptor blockers (ARBs) may cause increased cancer risk 42 Crestor s patent upheld in the US 43 Plavix boxed warning for poor metabolizers 43 Market analysis by drug class 44 Antihypertensives 46 Introduction 46 Antihypertensive drug classes 46 Leading treatment brands by drug class 47 4

5 Key brands analysis 51 Diovan/Co-Diovan 51 Cozaar 51 Benicar 53 Antidyslipidemics 54 Introduction 54 Antidyslipidemic drug classes 54 Leading treatment brands by drug class 55 Key brands analysis 57 Lipitor 57 Crestor 59 Future blockbusters in the antidyslipidemic drug class 63 Antithrombotics 65 Introduction 65 Antithrombotics drug classes 66 Leading treatment brands by drug class 67 Key brands analysis 68 Plavix 68 Lovenox 71 Future blockbusters in the antithrombotic drug class 72 Other cardiovascular agents 75 Introduction 75 Leading treatment brands by drug class 76 Tracleer 77 Leading brands dynamics and sales forecasts 78 Product growth-share matrix for leading brands 78 Chapter 3 Pipeline analysis 81 Summary 81 5

6 Introduction 82 Key events in the cardiovascular market 82 First advanced therapy certificate for t2cure s somatic cell therapy 82 Clear evidence of safety leads to termination of apixaban s Phase III AVERROES trial 83 FDA panel to review AstraZeneca s Brilinta 83 Novartis presents successful Phase II results of LCZ Daiichi Sankyo s CS-8635 shows promising results in pivotal trial 84 Sanofi (Genzyme)/Isis mipomersen clears second Phase III trial, but raises safety concerns 85 Cardiovascular pipeline 85 Leading drugs in development 86 Profiles of key pipeline products 88 Key antihypertensive pipeline drugs 90 LCZ696 Novartis 90 Cinaciguat Bayer 92 Riociguat Bayer 93 Key antidyslipidemic pipeline drugs 95 Livalo (pitavastatin) Kowa Pharmaceuticals 95 Dalcetrapib Roche 96 Anacetrapib Merck 97 Darapladib GlaxoSmithKline 99 Key antithrombotic pipeline drugs 100 Xarelto (rivaroxaban) Bayer/J&J 100 Apixaban Bristol-Myers Squibb (BMS)/Pfizer 102 Brilinta (ticagrelor) AstraZeneca 104 Betrixaban Portola/Merck 106 Chapter 4 Competitive landscape 109 Summary 109 Introduction 109 Competitive positioning of top players in the cardiovascular market 110 6

7 Pfizer 111 Overview 111 Marketed product portfolio 112 Lipitor (atorvastatin) 112 Norvasc (amlodipine) 114 Caduet (atorvastatin/amlodipine) 114 Revatio (sildenafil) 115 Fragmin (dalteparin) 115 R&D pipeline analysis 116 Strategic and growth analysis 116 Drivers of growth 116 Resistors of growth 117 Sanofi 118 Overview 118 Marketed product portfolio 119 Lovenox (enoxaparin) 120 Plavix (clopidogrel) 121 R&D pipeline analysis 122 Strategic and growth analysis 122 Drivers of growth 122 Resistors of growth 123 AstraZeneca 124 Overview 124 Marketed product portfolio 125 Crestor (rosuvastatin) 126 Atacand (candesartan cilexetil) 127 R&D pipeline analysis 127 Strategic and growth analysis 128 Drivers of growth 128 Resistors of growth 129 Novartis 130 7

8 Overview 130 Marketed product portfolio 130 Diovan (valsartan) 131 Exforge (amlodipine/valsartan) 132 Lescol (fluvastatin) 132 Lotrel (amlodipine/benazepril) 133 R&D pipeline analysis 133 Strategic and growth analysis 134 Drivers of growth 134 Resistors of growth 135 Bristol-Myers Squibb (BMS) 136 Overview 136 Marketed product portfolio 136 Plavix (clopidogrel) 137 Avalide/Avapro (irbesartan HCT) 138 Coumadin (warfarin) 138 R&D pipeline analysis 138 Strategic and growth analysis 139 Drivers of growth 139 Resistors of growth 140 Merck 141 Overview 141 Marketed product portfolio 142 Cozaar/Hyzaar (losartan/losartan HCT) 143 Vytorin (ezetimibe/simvastatin) 143 R&D pipeline analysis 144 Strategic and growth analysis 145 Drivers of growth 145 Resistors of growth 146 Appendix 147 Scope and methodology 147 8

9 Scope 147 Methodology 148 Market size methodology 148 Epidemiology 148 Market forecast 148 Abbreviations 149 References 155 9

10 Table of figures Figure 1: Cardiovascular disease etiology 20 Figure 2: Cardiovascular risk factors and definitions 21 Figure 3: Definition and classification of hypertension 22 Figure 4: Hypertension treatment options 24 Figure 5: Types of lipoproteins 28 Figure 6: Interpretation of blood lipid levels 29 Figure 7: LDL levels and therapy patterns 30 Figure 8: Geographical segmentation of the global cardiovascular market, 2010 and Figure 9: Global market share of major cardiovascular drug classes (%), Figure 10: Sales of potential antidyslipidemic drugs versus Lipitor ($m), Figure 11: Sales of antithrombotic drugs by disease conditions in the US ($m), Figure 12: Forecast market share of antithrombotic drugs under development, Figure 13: Leading brands product growth BCG matrix 79 Figure 14: Cardiovascular pipeline by key indications and stages of development, Figure 15: Leading pipeline drugs in various cardiovascular sub-categories, Figure 16: US FDA drug approval activities, Figure 17: Pfizer cardiovascular portfolio by brand (%), Figure 18: Sanofi cardiovascular portfolio by brand (%), Figure 19: AstraZeneca cardiovascular portfolio by brand (%), Figure 20: Novartis cardiovascular portfolio by brand (%), Figure 21: BMS cardiovascular portfolio by brand (%), Figure 22: Merck cardiovascular portfolio by brand (%),

11 Table of tables Table 1: Estimated prevalence of cardiovascular disorders across the 7MM, Table 2: Estimated prevalence of hypertension across the 7MM, Table 3: Forecast epidemiology of hypertension across the 7MM, Table 4: Estimated prevalence of dyslipidemia across the 7MM, Table 5: Forecast epidemiology of dyslipidemia across the 7MM, Table 6: Estimated prevalence of stroke across the 7MM, Table 7: Forecast epidemiology of stroke across the 7MM, Table 8: Geographical segmentation of the global cardiovascular market, Table 9: Global market size of major cardiovascular drug classes ($m), Table 10: Sales of leading antihypertensive drugs ($m), Table 11: Sales of leading antidyslipidemic drugs ($m), Table 12: Sales of leading antithrombotic drugs ($m), Table 13: Snapshot of the major antithrombotic drugs under development 74 Table 14: Sales of leading Other cardiovascular drugs ($m), Table 15: Sales of leading cardiovascular brands ($m), Table 16: Leading pipeline drugs in the cardiovascular market, 2010 (part 1) 87 Table 17: Leading pipeline drugs in the cardiovascular market, 2010 (part 2) 88 Table 18: An overview of LCZ Table 19: An overview of cinaciguat 92 Table 20: An overview of riociguat 94 Table 21: An overview of Livalo 95 Table 22: An overview of dalcetrapib 97 Table 23: An overview of anacetrapib 98 Table 24: An overview of darapladib 99 Table 25: An overview of Xarelto 101 Table 26: An overview of apixaban 103 Table 27: An overview of Brilinta 105 Table 28: An overview of betrixaban 106 Table 29: Sales of leading players in the global cardiovascular market ($m), Table 30: Pfizer sales of leading cardiovascular brands ($m), Table 31: Pfizer late-stage cardiovascular pipeline, Table 32: Sanofi sales of leading cardiovascular brands ($m), Table 33: AstraZeneca sales of leading cardiovascular brands ($m), Table 34: AstraZeneca late-stage cardiovascular pipeline,

12 Table 35: Novartis sales of leading cardiovascular brands ($m), Table 36: Novartis late-stage cardiovascular pipeline, Table 37: BMS sales of leading cardiovascular brands ($m), Table 38: BMS cardiovascular portfolio, Table 39: Merck sales of leading cardiovascular brands ($m), Table 40: Merck late-stage cardiovascular pipeline,

13 Executive Summary Overview and epidemiology of cardiovascular disorders Cardiovascular diseases encompass a range of ailments such as hypertension, dyslipidemia, stroke, atherosclerosis, thrombosis, and coronary artery disease. The risk factors for cardiovascular diseases can be classified broadly into two groups: immutable factors such as age, sex, heredity, and modifiable factors that are largely lifestyle-related such as diet, obesity, tobacco consumption, stress, and physical inactivity. Dyslipidemia was the indication with the highest reported prevalence in 2010, with an estimated 336 million cases in the seven major markets (7MM). According to World Health Organization (WHO) estimates, stroke was one of the leading causes of mortality in 2010, and its prevalence rate across the seven major markets was estimated at approximately 0.2%. Global market analysis The global cardiovascular market recorded sales of $170bn in 2010 and is set to grow to $187bn in 2016 at a CAGR of 1.6%. The US continued to be the largest market, with a share of 40% of the overall market. After a decline in sales in 2008 due to maturity of key drug categories and the increasing generic presence, the US witnessed a resurgence in Antihypertensives remained the largest drug class in 2010, with global sales of $37.6bn and a global market share of 22%. Novartis s Diovan led the antihypertensives segment with $3.6bn in sales, followed by Benicar with sales of $2.9bn. Pfizer s Norvasc, one of the blockbusters in this sub-category suffered strong sales erosion and lost significant market share to Diovan. Angiotensin receptor blockers (ARBs) remained the most prescribed therapeutic class within antihypertensives, driven by key brands such as Diovan, Cozaar, and Avapro. However, the advent of 13

14 Cozaar generics in 2010 is expected to erode sales significantly. Angiotensin converting enzyme (ACE) inhibitors have also been on the decline due to competition from ARBs and increased genericization. Antidyslipidemics remained the second largest therapeutic sub-category with $29.9bn in sales and a market share of 18% in The entry of Lipitor generics in 2011 is expected to negatively impact future prospects of sales in this segment. Dalcetrapib, manufactured by Roche, is a potential blockbuster in this category and could serve to offset the negative impact in the antidyslipidemic market created by the genericization of Lipitor. Antithrombotics recorded $18.7bn in sales in 2010 and a market share of 11%. This segment is forecast to deliver strong growth in the next two years owing to the commercialization of recently approved products such as Pradaxa and Xarelto and the expected launch of Pfizer/BMS s apixaban. The antiarrythmic market is likely to remain a relatively smaller opportunity owing to the limitation of drug therapy. However, promising products such as Sanofi s Multaq are expected to provide a fillip to the segment by Pipeline analysis Anticoagulants are expected to be the subject of intensive R&D activity, with the presence of promising products such as BMS/Pfizer s apixaban and Bayer/J&J s Xarelto. Since most of the factor Xa inhibitors are in oral form, they are expected to widen the market significantly. The superior effectiveness and better bleeding profile of Brilinta (ticagrelor) over Plavix make it a key antithrombotic drug that could be a major player in acute coronary syndrome (ACS). Brilinta also has a potential therapeutic advantage in atherosclerosis and can be administered to 15 30% of atherosclerosis patients who do not respond to Plavix. Moreover, its use could be initially confined to ACS with no significant patient monitoring anticipated for respiratory or cardiac function or postmarketing surveillance requirements. LCZ696, one of Novartis s key pipeline products, delivered favorable Phase IIb results. The data demonstrated that LCZ696 not only improved blood pressure significantly in patients with mild-to- 14

15 moderate hypertension but also provided complementary action with neprilysin inhibition and ARB blockade. Merck/Portola s betrixaban appears to have a differentiated half-life (19 hours), competitive bioavailability, and minimal renal excretion which theoretically could result in a superior bleeding profile and allow recruitment of patients irrespective of renal function. In its Phase IIb results announced in March 2010, betrixaban demonstrated strong bleeding benefits over warfarin, further strengthening its case. The antidyslipidemic category is set to undergo significant declines in sales owing to the patent expiry of Lipitor. Falling sales could be rescued with the approval of dalcetrapib, a potent CETP inhibitor that treats dyslipidemia through increasing the levels of HDL cholesterol. Early trial results indicate that anacetrapib is a more potent CETP inhibitor than dalcetrapib. However, the early entry of dalcetrapib could serve to establish it as a prescription drug of choice, thus giving it a significant advantage over anacetrapib. Competitive landscape The global cardiovascular market registered $170bn in sales in Pfizer retained its position as the market leader with $15.2bn in 2010 sales, led by key brands such as Lipitor, Norvasc, Caduet, and Viagra. The top 10 companies in the cardiovascular market registered $76.4bn in combined sales in 2010, accounting for a substantial 44.9% of the global cardiovascular market. Sanofi remained the second largest company, registering $10.5bn in 2010 sales and a 6.2% share of the global cardiovascular market. The company has benefited strongly from the performance of Lovenox and Plavix, which generated $3.8bn and $2.8bn respectively in 2010 sales. AstraZeneca was the third largest company in the global cardiovascular market, recording sales of $9.4bn in Sales were strongly driven by the blockbuster drugs Crestor and Atacand 15

16 Novartis was the fourth largest company, with 2010 sales of $8.6bn. Its position was strongly supported by the ARBs, ARBs in combination with diuretics, and the statins. All Novartis s leading brands, including Diovan ($3.6bn), Co-Diovan ($2.4bn), and Exforge ($904m) registered strong Y-o-Y growth in Merck and BMS were the other leading companies, registering 2010 sales of $7.5bn and $8.4bn respectively. 16

17 Chapter 1 Overview and epidemiology of cardiovascular disorders Summary Cardiovascular diseases encompass a range of ailments such as hypertension, dyslipidemia, stroke, atherosclerosis, thrombosis, and coronary artery disease. The risk factors for cardiovascular diseases can be classified broadly into two groups: immutable factors such as age, sex, heredity, and modifiable factors that are largely lifestyle-related such as diet, obesity, tobacco consumption, stress, and physical inactivity. Dyslipidemia was the indication with the highest reported prevalence in 2010, with an estimated 336 million cases in the seven major markets (7MM). According to World Health Organization (WHO) estimates, stroke was one of the leading causes of mortality in 2010, and its prevalence rate across the seven major markets was estimated at approximately 0.2%. Introduction This chapter provides a background to the cardiovascular therapeutic category by identifying the key indications, providing detailed overviews of each of the indications, and listing their current and forecast prevalence through In accordance with the scope of this report, the primary focus of this chapter is restricted to hypertension, dyslipidemia, and stroke. The chapter also provides a brief overview of the predisposing factors that lead to cardiovascular diseases. Among the various cardiovascular diseases, dyslipidemia had the highest prevalence in 2010, with 336 million reported cases. The following table provides the consolidated estimates of the prevalence of cardiovascular diseases discussed in this chapter. 17

18 Table 1: Estimated prevalence of cardiovascular disorders across the 7MM, 2010 Country Hypertension (000s) Dyslipidemia (000s) Stroke (000s) France 16,372 31, Germany 29,612 54, Italy 22,376 20, Spain 18,715 9, UK 23,649 29, EU5 110, , US 76, , Japan 47,085 26, Total 234, ,002 1,518 Source: American Heart Association, National Health Statistics, CDC, WHO BUSINESS INSIGHTS Risk factors Predisposing risk factors Predisposing factors are those conditions and lifestyle habits that put people at a greater risk of developing cardiovascular diseases. They can be broadly classified into two categories: immutable factors such as age, sex, heredity, and modifiable factors that are largely lifestyle-related such as diet, tobacco consumption, physical inactivity, obesity, and stress. While having a certain predisposing factor or set of factors increases the likelihood of an individual developing a cardiovascular disease, it does not always lead to the condition. Conversely, the absence of a predisposing factor does not nullify the possibility of the individual developing a particular disease. In essence, the factors have a cumulative effect, that is, the presence of a large number of identifiable factors increases the probability of an individual developing cardiovascular disease. Owing to the statistical relationship between these factors and cardiovascular disease, a treatment for the predisposing factor may not entirely eliminate the possibility of the disease. Similarly, if the factor is very prominent in an individual, treating it even with a very effective treatment may not reduce the disease risk. 18

19 However, studies have shown that the treatment of predisposing risk factors such as smoking, high blood pressure, and high cholesterol, can reduce the likelihood of a heart attack. Given the rather complicated nature of this association between predisposing/risk factors and cardiovascular disease, demonstrating it is considered to be a major scientific challenge. For instance, a disease such as atherosclerosis can be caused by various factors and is found to some degree in all individuals. Thus, it is difficult to design and implement studies that show the effectiveness of a particular treatment. 19

20 Figure 1: Cardiovascular disease etiology Predisposing factors Non-manageable Age Sex Heredity Race Manageable Diet Smoking Physical inactivity Stress Substance abuse Risk factors Glucose intolerance Diabetes Dyslipidemia High blood pressure Cardiovascular diseases Arteriosclerosis Thrombosis Myocardial infarction Acute coronary syndrome Congestive heart failure Coronary artery disease Peripheral artery disease Pulmonary hypertension Stroke Clinical manifestations Angina pectoris Aneurysm Edema Source: Yale Heart Book BUSINESS INSIGHTS 20

21 Modifiable risk factors Modifiable risk factors primarily include high blood pressure, high cholesterol, tobacco consumption, and type 2 diabetes. Research has indicated that the treatment of the major risk factors can greatly reduce the possibility of a heart attack. Moreover, some of these factors are lifestyle-related, and a combination of diet and exercise can work as a protective factor and reduce the likelihood of cardiovascular disease. Figure 2: Cardiovascular risk factors and definitions Risk Factor Definition Impaired glucose tolerance 2 hour glucose levels of mg/dL (7.8 to 11.0mmol) on the 75g oral glucose tolerance test Type 2 diabetes Fasting plasma glucose of 126mg/dL or 7mmol/L Low HDL 40mg/dL Hypertriglyceridemia 200mg/dL High LDL 160mg/dL Hypertension 140/90mmHg Source: Yale Heart Book BUSINESS INSIGHTS Hypertension High blood pressure or hypertension is the most important risk factor for cardiovascular disease. Physiologically, it is defined as a condition wherein the pressure of the blood flowing through blood vessels remains high for a prolonged period irrespective of the body s need. An increased blood pressure leads the heart to work harder, which makes the heart and arteries more susceptible to injury. Hypertension further increases the risk of incidents such as heart attack, heart failure, and atherosclerosis. 21

22 There are several factors that lead to hypertension, such as a sedentary lifestyle, alcohol consumption, high sodium diet, high fat diet, high alcohol intake, obesity, and age. Furthermore, people with indications such as diabetes mellitus or kidney disease, and even those with social or occupational stress, are in the high-risk group. Figure 3: Definition and classification of hypertension Category Blood pressure elevations Risk of CVD Systolic blood pressure Diastolic blood pressure Normal blood pressure Normal or rare None Less than 130mmHg Less than 85mm Hg Stage I hypertension Occasional or intermittent Low mm Hg 90 99mm Hg Stage II hypertension Sustained Progressive 160mm Hg 100mm Hg Stage III hypertension Marked and sustained Advanced mm Hg mm Hg Source: Writing Group of The American Society of Hypertension, 2005 BUSINESS INSIGHTS Diagnosis, treatment and management In over 90% of cases there may be no identifiable cause of hypertension, in which case the condition is known as essential hypertension. Some researchers believe that this may be due to hormonal factors, which control the salt-handling ability of the kidney, while others believe that it is genetically determined and environmentally controlled. In the remaining 10% of cases, hypertension may be secondary in nature as a consequence of another medical problem, such as kidney disorders, adrenal tumors, or some drugs. 22

23 Diagnosis of hypertension involves inspection of the eyes, examination of the heart, arterial blood flow check, examination of the kidneys, and checking for an enlarged thyroid. There are also some costly and less frequently used diagnostic methods for hypertension, such as an echocardiogram (ECHO), 24-hour blood pressure monitoring, and stress test. Treatment of essential hypertension targets symptomatic relief, which implies achieving a target blood pressure. Treatment of secondary hypertension involves symptomatic relief but also treatment of the primary cause of elevated blood pressure. All treatment strategies include strict dietary regulations. 23

24 Figure 4: Hypertension treatment options Note: ACEI = ACE inhibitors; ARB = angiotensin II receptor blockers; BB = beta-blockers; CCB = calcium channel blockers; TD = thiazide diuretics. Source: Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation and Treatment of High Blood Pressure BUSINESS INSIGHTS Epidemiology As detailed in Table 2 the prevalence of hypertension was very high across all the 7MM (France, Germany, Italy, Spain, UK, US, and Japan), with an estimated 234 million reported cases in The US accounted for approximately 33% of the total cases, followed by Japan at 20%. 24

25 In terms of prevalence rate, Spain led the way at 42.1%, followed by Japan at 36.9%. The average prevalence rate across the 5EU was around 35.6%, significantly higher than that in the US at 24.3%. Table 2: Estimated prevalence of hypertension across the 7MM, 2010 Country Prevalence (000s) Prevalence (%) Share (%) France 16, Germany 29, Italy 22, Spain 18, UK 23, EU5 110, US 76, Japan 47, Total 234, Source: American Heart Association, National Health Statistics, CDC, WHO BUSINESS INSIGHTS 25

26 Forecast epidemiology Table 3: Forecast epidemiology of hypertension across the 7MM, Country (f) 2012(f) 2013(f) 2014(f) 2015(f) 2016(f) France Prevalence (000s) 16,372 16,495 16,619 16,744 16,869 17,051 17,149 Prevalence (%) Germany Prevalence (000s) 29,612 29,701 29,791 29,881 29,971 29,994 30,112 Prevalence (%) Italy Prevalence (000s) 22,376 22,388 22,401 22,413 22,426 22,474 22,471 Prevalence (%) Spain Prevalence (000s) 18,715 18,818 18,922 19,026 19,131 19,392 19,428 Prevalence (%) UK Prevalence (000s) 23,649 23,795 23,942 24,089 24,237 24,450 24,567 Prevalence (%) EU Prevalence (000s) 110, , , , , , ,727 Prevalence (%) US Prevalence (000s) 76,198 77,335 78,488 79,659 80,847 82,584 83,475 Prevalence (%) Japan Prevalence (000s) 47,085 47,396 47,709 48,024 48,341 48,667 48,973 Prevalence (%) Total Prevalence (000s) 234, , , , , , ,175 Prevalence (%) Source: American Heart Association, National Health Statistics, CDC, WHO, Business Insights BUSINESS INSIGHTS 26

27 The prevalence of hypertension is forecast to grow from 234 million in 2010 to 246 million in 2016 across the seven major markets. In 2016, the US is still expected to be the largest market for hypertension, with an anticipated 83 million sufferers, followed by Japan at 49 million. In terms of prevalence rate, Spain is expected to lead the way in 2016 at 43% followed by Japan at 39.1%. The average prevalence rate across the 5EU in 2016 is expected to be around 36%, a slight increase over Furthermore, an increase in the mean age of the population is expected to put a significant number of individuals at hypertensive risk. According to the International Society of Hypertension, there is a clear recognition of hypertension as a major public health issue across all the 7MM. Although the awareness level differs from country to country, lifestyle changes in general are expected to play a significant role in reducing the risk factors among larger population groups. Dyslipidemia Dyslipidemia refers to an alteration in the level of blood lipids. It is of two types, hyperlipidemia and hypolipidemia, with the commonest being hyperlipidemia. 27

28 Figure 5: Types of lipoproteins Type Description Hyperlipidemia Chylomicrons Carries triglycerides from food in intestines to liver, skeletal muscle, and adipose tissue. Very low density lipoprotein (VLDL) Carries newly synthesized triglycerides from liver to adipose tissue. Intermediate density lipoprotein (IDL) Intermediate between VLDL and LDL (very low blood levels). Low density lipoproteins (LDL) Carries cholesterol from liver to other body parts ( bad cholesterol ) High density lipoproteins (HDL) Collects cholesterol from body parts and carries to the liver ( good cholesterol ). Source: Business Insights BUSINESS INSIGHTS Lipids include cholesterol, cholesterol esters, phospholipids, and triglycerides, which are transported in the blood stream as large molecules called lipoproteins. There are five major lipoprotein families, as illustrated in the above figure. The international committee for the evaluation of hypertriglyceridemia as a vascular risk factor has classified hypertriglyceridemias (hyperlipidemias) into three groups: Isolated moderate hypertriglyceridemia triglycerides mg/dL, total cholesterol <200mg/dL. Mixed hypertriglyceridemia triglycerides mg/dL, LDL cholesterol >130mg/dL. Severe hypertriglyceridemia triglycerides >400mg/dL. 28

29 Diagnosis, treatment, and management Diagnosis of dyslipidemia involves the measurement of blood levels of various lipoproteins. The National Cholesterol Education Program Adult Treatment Panel III Guidelines provide a comprehensive approach to the treatment of dyslipidemia. It primarily focuses on controlling elevated LDL-cholesterol (LDL-C) levels. Figure 6 illustrates the interpretation of blood lipid levels. Figure 6: Interpretation of blood lipid levels Lipid Blood levels (mg/dl) Comment Total cholesterol < 200 Desirable Borderline high > 240 High LDL cholesterol < 100 Optimal Near optimal/ above optimal Boderline high High 190 Very high HDL cholesterol < 40 Low 60 High Source: National Cholesterol Education Program Adult Treatment Panel III Guidelines BUSINESS INSIGHTS The priority of dyslipidemia treatment is reduction of LDL-C to less than 100mg/dL and the ratio of total cholesterol to HDL-cholesterol (HDL-C) to less than four. The American Heart Association (AHA) recommends a set of guidelines for the treatment of dyslipidemia, which is also designed for lowering LDL levels. The following figure illustrates LDL levels and therapy patterns. 29

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