Diabetes, Metabolic Syndrome and Cardiovascular Disease

Jan 08, 2013, 09:17 ET from Reportlinker

NEW YORK, Jan. 8, 2013 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Diabetes, Metabolic Syndrome and Cardiovascular Disease

http://www.reportlinker.com/p024965/Diabetes-Metabolic-Syndrome-and-Cardiovascular-Disease.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Pathology

There has been a dramatic increase in the incidence of diabetes worldwide, which has been exacerbated by the growing obesity problem across the globe. Once thought of as primarily a childhood disease--sometimes referred to as juvenile diabetes, now mostly Type 1 diabetes--the obesity crisis linked to the adoption of a high-fat, high-carbohydrate, high-calorie American diet has resulted in skyrocketing rates of diabetes among adults across the world. To compound the global diabetes epidemic, health professionals are witnessing an alarming increase in inflammatory diseases resulting from adult onset (i.e., Type 2) diabetes. This phenomenon is referred to as "metabolic syndrome" where a confluence of inflammatory conditions occur along with the diabetes. As a result, growing evidence appears to show that metabolic syndrome makes the diabetic patient susceptible to degenerative health conditions such as cardiovascular disease, stroke and, now believed, Alzheimer's disease. As the diabetes epidemic escalates, a new sense of urgency has taken hold. Proactive strategies for prevention of the disease are being put in place by international health organizations such as the World Health Organization (WHO), as well as by the health departments of industrialized and developing countries, and even at the local level where food ingredients regulations are being passed.

This TriMark Publications report charts the changing landscape of the global diabetic population and explores the added health concerns resulting from the metabolic syndrome phenomenon and one of its major risk factors: cardiovascular disease (CVD). Furthermore, this study evaluates widely-accepted therapeutic approaches to diabetes that are currently in use, while providing an in-depth analysis of emerging technologies that will be used to treat diabetes and other inflammatory diseases in the future.

TABLE OF CONTENTS 1. Overview 8

1.1 Statement of Report 8

1.2 About this Report 8

1.3 Scope of the Report 9

1.4 Methodology 9

1.5 Executive Summary 10

2. Introduction 152.1 Demographics of Diabetes 162.1.1 Worldwide Diabetes 162.1.2 U.S. Diabetes 182.2 Economics of Diabetes 21

3. Understanding the Metabolic Conditions Underlying and Associated with Diabetes 26

3.1 Pre-Diabetes Syndrome 27

3.2 Metabolic Syndrome 27

3.3 Diabetes and Inflammation 32

3.4 Diagnosis of Diabetes Mellitus 33

3.5 Progression of Diabetes 33

3.6 Risk Factors and Diabetes 33

3.6.1 Obesity 34

3.6.2 Stress-Induced Hyperglycemia 37

3.7 Complications and Co-Morbidities in Type 2 Diabetes 37

3.7.1 Preventing Complications and Co-Morbidities in Diabetes 40

3.8 Hypoglycemia Resulting from Treatment 41

3.9 Cardiovascular Disease (CVD) 41

3.9.1 CVD Facts 41

3.9.2 Cardiac Care Therapeutics 48

3.9.2.1 Anti-Hypertensive Drugs 49

3.9.2.2 Cholesterol Management Drugs 50

3.9.2.3 Anticoagulants 53

3.9.3 CVD Diagnostics 53

4. Pharmaceutical Industry and the Anti-Diabetes Market 564.1 The Worldwide Pharmaceutical Industry 564.1.1 Pharmaceutical R&D Spending by Type, Growth Rate and Expenditure 564.1.2 Global Pharmaceutical Market 584.2 Total Diabetes Drug Market Size and Growth 624.2.1 Sales of Anti-Diabetic Drugs Continue to Rise 654.3 Diabetic Medications Overview 664.3.1 Recent Trends in Diabetic Drug Usage 674.3.2 Market Influence Factors 71

5. Non-Insulin Anti-Diabetes Products 73

5.1 Anti-Diabetic Drug Therapy Overview 73

5.1.1 Sulfonylureas 77

5.1.2 Meglitinides 78

5.1.3 Biguanides 79

5.1.4 Thiazolidinediones (TZDs) 80

5.1.5 a-Glucosidase Inhibitors 82

5.1.6 Incretin Mimetics/Glucagon-like Peptide (GLP-1) Analogs and Agonists 83

5.1.6.1 Byetta (Exenatide) 84

5.1.6.2 Victoza (Liraglutide) 85

5.1.6.3 Bydureon (Exenatide LAR) 85

5.1.7 Amylin Analog 85

5.1.8 DPP-IV Inhibitors 86

5.1.8.1 Januvia (Sitagliptin) 86

5.1.8.2 Onglyza (Saxagliptin) 86

5.1.8.3 Tradjenta (Linagliptin) 86

5.1.8.4 Galvus (Vildagliptin) 87

5.1.9 Combination Therapy 87

5.1.9.1 Youth with Recent-Onset Type 2 Diabetes should be Started on Combination

Therapies 88

5.1.10 Comparisons of the Anti-Diabetes Drugs 88

5.2 Drivers and Trends 89

5.2.1 Market Share of Anti-Diabetic Drugs 89

5.2.2 Forecasts for Anti-Diabetic Drugs 90

5.2.3 Sales Forecast for the Global Diabetes Market 91

5.3 The Future 92

5.3.1 Practice Patterns 92

5.3.2 New Products in Pipeline 92

5.3.2.1 Novel GLP-1 Agonists and Analogs 93

5.3.2.2 Novel DPP-IV Inhibitors 94

5.3.2.3 Sodium Glucose Cotransporter 2 (SGLT-2) 95

5.3.2.4 Emerging Non-Insulin Anti-Diabetes Targets and Drugs in the Pipeline 96

5.3.2.5 Novel Approaches to Finding New Drug Targets 99

5.4 Anti-Diabetic Drug Patent Expiry 100

5.5 Regulatory Issues 100

6. Insulin 1016.1 Insulin Markets 1016.1.1 Major Players and Market Share 1026.1.2 Patent Expirations 1046.1.3 Innovation Strategies 1046.2 Insulin Therapeutics 1056.2.1 Recommendations for Insulin Initiation and Administration 1056.2.2 Short-Acting Insulin 1086.2.3 Rapid-Acting Insulin 1086.2.4 Intermediate-Acting Insulin 1106.2.5 Long-Acting Insulin 1106.2.6 Long-Acting Insulins in Development 1116.2.7 Insulin Mixtures 1126.3 Pipeline Insulin 1126.4 Non-Invasive Insulin Delivery 1136.4.1 Inhaled Insulin 1146.4.1.1 A Chronicle of Inhaled Insulins 1156.4.2 Oral Insulin 1176.4.3 Transdermal Insulin 1206.5 Barriers for Non-Injected Insulin 1226.6 Patient Potential for Non-Injected Insulin 1226.7 Insulin Delivery Devices 1226.7.1 Insulin Pens 1236.7.2 Injections Aids 1286.7.2.1 Automatic Injectors 1296.7.2.2 Syringe Magnifiers 1296.7.2.3 Injection Ports 1306.7.3 Insulin Jet Injectors 1306.7.4 Insulin Pumps 1316.7.4.1 External Insulin Pumps 1326.7.4.2 Insulin Infusion Sets 1366.7.4.3 Insulin Patch Pumps in Development or Only Available Outside the U.S. 1376.7.4.4 Implantable Insulin Pumps 1396.7.4.5 Insulin Pump Market Share 1416.7.4.6 Drivers of Demand for Pumps 1426.8 Market Forecasts for Insulin Administration Technologies 142

7. Emerging Anti-Diabetes Technologies and Products 143

7.1 Projections for the Anti-Diabetes Drug Market 143

7.2 Artificial Pancreas 146

7.3 Insulin-Producing Cells 147

7.3.1 Cell Therapy Companies for Diabetes 148

7.4 Pancreatic Transplantation 149

7.4.1 Candidates for Pancreatic Transplantation 150

7.4.1.1 Pancreatic Organ Transplantation 151

7.4.1.2 Allo-Islet Transplantation 151

7.4.1.3 Implantation of Genetically Engineered b-Cells or Embryonic Stem Cells 151

7.4.2 Current Status 152

7.5 Gastric Bypass Surgery to Treat Type 2 Diabetes 152

7.6 Immune Modulators 153

7.7 Anti-Obesity Drugs to Prevent or Delay Development of Type 2 Diabetes 153

7.8 Other Anti-Diabetic Therapy Drug Candidates 154

7.8.1 Lipid Abnormalities 154

7.8.2 High Blood Pressure 155

7.8.3 Anti-Coagulants and Anti-Platelets 156

7.9 Drugs Used "Off-Label" 157

7.9.1 Warfarin Sodium 157

8. Diagnosing Diabetes Using In Vitro Laboratory Tests 1588.1 New Diagnostic Guidelines 1588.2 Diabetes Tests 1598.2.1 Fasting Plasma Glucose (FPG) Test 1608.2.2 Glucose Tolerance Test 1608.2.3 Test for Glycosylated Hemoglobin (HbA1c or A1c) 1608.2.4 Fructosamine 1618.2.5 Screening Tests for Diabetes-Related Complications 1628.3 Glucose Monitoring 1628.3.1 Overview of Market Segment 1648.3.2 Competitive Strategies 1648.3.3 Analyses of the Current Market Conditions, Competition and Product Mix 1668.3.3.1 First-Generation Monitors 1678.3.3.2 Second-Generation Monitors 1678.3.3.3 Third-Generation SMBG Technologies 1688.3.3.4 Product Overview 1688.3.3.4.1 LifeScan 1688.3.3.4.2 Roche Diagnostics 1708.3.3.4.3 Bayer HealthCare 1728.3.3.4.4 Abbott Diabetes Care 1738.3.3.4.5 Other Players 1748.3.4 What are the Advantages of Using a Continuous Glucose-Monitoring Device? 1758.3.5 Minimally-Invasive Continuous Glucose Monitors in Development 1768.3.6 Future of Non-Invasive Glucose Technology 1768.3.7 Lancets and Lancing Devices 176

9. Market Trends, Challenges and Strategic Options 180

9.1 Overview 180

9.2 Diabetes Drug Market Trends 180

9.2.1 Overview 180

9.2.2 Emergence of Therapeutics with Improved Administration Characteristics 180

9.2.3 Increasing Prevalence of Obesity 181

9.2.4 Consumer Preference Drives Product Development in Invasive Technology

Segment 182

9.2.5 Revenue Potential of Non-Invasive Technologies 182

9.3 Diabetes Mellitus Market Challenges 182

9.3.1 Overview 182

9.3.2 Diabetic Pain Therapeutics 183

9.3.3 Market Prospects of Inhalable Insulin 183

9.4 Strategic Options 183

9.4.1 Developing Countries are Key Markets for Growth 184

9.4.2 Consumer-Driven Marketing Campaigns 185

9.4.3 Diabetes Drugs in Pipeline 185

9.5 New FDA Guidelines for Developing Anti-Diabetic Drugs 186

9.6 Recent Industry Activity 187

10. Company Profiles 18910.1 A. Menarini 18910.2 Abbott Laboratories 18910.3 Amgen 19010.4 AstraZeneca 19010.5 Bayer Pharma 19210.6 BodyMedia 19410.7 Cyber Medical Ltd. 19410.8 Debiotech 19410.9 DexCom 19510.10 Echo Therapeutics 19610.11 Eli Lilly 19810.12 Elixir Pharmaceuticals 19810.13 Eksigent Technologies 19810.14 Flamel Technologies 19910.15 GlaxoSmithKline 19910.16 Insulet 19910.17 iSense Corporation 20010.18 Isis Pharmaceuticals, Inc. 20010.19 Johnson & Johnson 20110.20 Kyorin 20210.21 M-Biotech 20310.22 Medtronic 20310.23 Merck & Company 20310.24 Mitsubishi Tanabe Pharma Corporation 20410.25 Nipro Diagnostics 20410.26 Novartis 20410.27 Novo Nordisk 20510.28 Novocell 20610.29 ONO Pharmaceutical 20610.30 Orexigen Therapeutics 20710.31 Pfizer 20710.32 Roche Diagnostics 20810.33 Sanofi-Aventis 20910.34 Sensors for Medicine and Science 21010.35 Siemens 21110.36 Smiths Medical 21110.37 SOOIL Development 21210.38 Takeda 21210.39 TheraFuse 21210.40 U.S. Diagnostics 21310.41 VeraLight 21310.42 Vivus 21310.43 Ypsomed Holding 214

Appendix 1: The History of Insulin 215

INDEX OF FIGURES Figure 2.1: Worldwide Rates of Diabetes Cases, 2012, 2020 and 2030 16

Figure 2.2: Worldwide Prevalence of Diabetes (%) in Adults (20-79 Years), 2011 18

Figure 2.3: Prevalence of Diabetes by Age in the U.S, 2010 19

Figure 2.4: New Adult Cases of Diabetes Diagnosed in the U.S., 2010 20

Figure 2.5: Mean Diabetes Healthcare-related Expenditures Per Adult (20-79 Years) with Diabetes, 2011 21

Figure 2.6: How Diabetes Dollars are Spent in the U.S., 2007 23

Figure 3.1: Maintenance of Normal Blood Sugar Levels 26

Figure 3.2: Obesity (BMI ³ 30) Prevalence in U.S. Adults, 2010 35

Figure 3.3: Percentage of Obese Adults in the U.S., 2009-2010 35

Figure 3.4: Percentage of Obese Children and Adolescents in the U.S., 2009-2010 36

Figure 3.5: Trends in Obesity Among Children and Adolescents in the U.S., 1963-2008 36

Figure 3.6: Annual Death Rate of U.S. Population from Heart Disease, 1950-2008 43

Figure 3.7: Heart Disease Death Rate by Race and Sex in the U.S., 1979-2008 44

Figure 3.8: Annual Death Rate of U.S. Population from Strokes, 1950-2008 44

Figure 3.9: U.S. Male and Female Population Death Rates from Strokes, 2008 45

Figure 3.10: Percentage of U.S. Population That Smokes, 1965-2010 46

Figure 3.11: Percentage of Obese Adults in the U.S., 1960-2008 47

Figure 3.12: Percentage of Obese Children and Adolescents in the U.S., 1971-2008 48

Figure 3.13: Number of Annual Prescriptions for Popular Cholesterol Drugs, 2006-2010 51

Figure 4.1: Top Therapeutic Classes Contributing to Growth in U.S. Drug Spending, 2010-2011 68

Figure 4.2: Top Ten Diabetes Medications in the U.S., by Number of Prescriptions 69

Figure 4.3: U.S. Non-Insulin Anti-Diabetic Drug Prescriptions, 2010 69

Figure 5.1: Comparison of the Effects of the Pioglitazone and Rosiglitazone on Lipids 81

Figure 5.2: Overview of GLP-1 and Blood Glucose 84

Figure 5.3: Global Non-Insulin Anti-Diabetes Sales by Drug Class, 2010 89

Figure 5.4: Global Non-Insulin Anti-Diabetes Prescriptions by Drug Class, 2010 90

Figure 5.5: Sales Forecast for the Global Diabetes Drug Market, 2008-2016 91

Figure 5.6: Sales Forecast for the U.S. Diabetes Drug Market, 2008-2016 92

Figure 6.1: Global Sales of Lantus, 2005-2011 104

Figure 6.2: Insulin Pump Market Share, 2011 141

INDEX OF TABLES Table 2.1: Top Ten Countries with the Largest Estimated Number of Diabetics (20 to 79 Years Age Group), 2012 and 2030 17

Table 2.2: U.S. Population of Diabetics (Diagnosed and Undiagnosed) Aged 20 Years or Older, 2010 19

Table 2.3: Cost of Diagnosed Diabetes in the U.S., 2007 21

Table 2.4: Medical Care Costs Attributable to Diabetes in the U.S., 2010 22

Table 2.5: Healthcare Utilization by Diabetic Patients 22

Table 2.6: Annual Cost of Care of UnitedHealthcare Adult Members with Diabetes, 2009 23

Table 2.7: Per-Event Costs of Diabetes Complications 24

Table 3.1: International Diabetes Federation (IDF) Diagnostic Criteria for Metabolic Syndrome 28

Table 3.2: American Heart Association and National Heart, Lung, and Blood Institute (AHA/NHLBI) Diagnostic Criteria for Metabolic Syndrome 28

Table 3.3: Additional Metabolic Criteria for Research 30

Table 3.4: Ten Leading Diagnoses for Co-Morbid Chronic Diseases in the U.S. 37

Table 3.5: Odds Ratio of Progression to Complications Associated with Type 2 Diabetes 39

Table 3.6: Prevalence of Complications Among Patients with Diabetes 39

Table 3.7: Novel Risk Factors and Possible Mechanisms of the Excess Risk of Coronary Heart Disease in Type 2 Diabetes Mellitus 39

Table 3.8: Major Causes of End-Stage Renal Disease 39

Table 3.9: Clinical Recommendations for Adults with Diabetes 40

Table 3.10: Laboratory Assessment of Diabetic Vascular Disease 40

Table 3.11: Average Years Gained Free of Diabetes-related Disease with Intensive Management 41

Table 3.12: Summary of Cardiovascular Diseases (CVDs) 41

Table 3.13: Death Rate from Cardiovascular Diseases by Country, 2008 43

Table 3.14: Percentage of Adults Smokers by Country, 2008 47

Table 3.15: Selected Potential Patent Expirations of Cardiac Care Drugs, 2012-2013 48

Table 3.16: Worldwide Market for Cardiac Care Therapeutics, 2007-2014 49

Table 4.1: Global R&D Spending in the Pharmaceutical Industry, 2008-2012 56

Table 4.2: Pharmaceutical Companies Ranked by Total R&D Expenditures, 2011 56

Table 4.3: Leading Therapy Classes for R&D, 2012 57

Table 4.4: Global Pharmaceutical Sales by Region and Country, 2010 and 2015, and CAGR 2006-2010 and 2011-2015 58

Table 4.5: World Pharmaceutical Sales Share by Region, 2010 59

Table 4.6: Top Ten Global Pharmaceutical Companies by Global Sales, 2011 59

Table 4.7: Leading Ten Therapeutic Classes by U.S. Sales, 2006-2011 60

Table 4.8: Top Ten Therapeutic Classes by U.S. Dispensed Prescriptions, 2006-2011 60

Table 4.9: Leading Therapy Classes by Global Pharmaceutical Sales, 2015, and CAGR 2011-2015 61

Table 4.10: Top Selling Drugs in the U.S., 2010 61

Table 4.11: Worldwide Anti-Diabetes Drug Market, 2008-2016 63

Table 4.12: Oral Anti-Diabetic Therapy Major World Markets, 2010 63

Table 4.13: The Leading Five Anti-Diabetics by Sales, 2011 65

Table 4.14: American College of Physicians 2012 Practical Guideline for the Use of Anti-Diabetes Drugs for Type 2 Diabetes 66

Table 4.15: Summary of Glucose-Lowering Interventions as Monotherapy 70

Table 5.1: Classes of Non-Insulin Hypoglycemic Agents 73

Table 5.2: Non-Insulin Hypoglycemic Drugs Used to Treat Type 2 Diabetes, 2012 75

Table 5.3: Relative Efficacy of Diabetes Drugs 75

Table 5.4: Average Dose and Cost Comparison of Oral Hypoglycemic Agents 76

Table 5.5: Fixed-Dose Oral Anti-Diabetes Drug Combinations 88

Table 5.6: Delivery Method of Non-Insulin Anti-Diabetes Drugs in the Pipeline, 2011 93

Table 5.7: GLP-1 Agonist Pipeline: Selected Drugs in Development that Target GLP-1 94

Table 5.8: DPP-IV Inhibitor Pipeline 95

Table 5.9: Summary of Emerging Non-Insulin Anti-Diabetes Drug Categories 97

Table 6.1: Value Market Shares of Animal, Human and Modern Insulin, 1995-2010 101

Table 6.2: Worldwide Insulin Sales, 2008-2016 102

Table 6.3: Worldwide Insulin Sales and Market Share by World Region, 2011 102

Table 6.4: Estimated U.S. Retail Insulin Sales, 2011-2016 102

Table 6.5: Worldwide Insulin Sales and Market Share by Company, 2011 103

Table 6.6: U.S. Insulin Sales and Market Share by Company, 2011 103

Table 6.7: Insulins on the U.S. Market 105

Table 6.8: Pharmacokinetics of Therapeutic Insulins on the U.S. Market 106

Table 6.9: Pharmacokinetics of Short-Acting Insulins 108

Table 6.10: Pharmacokinetics of Rapid-Acting Insulins 108

Table 6.11: Pharmacokinetics of Intermediate-Acting Insulins 110

Table 6.12: Pharmacokinetics of Long-Acting Insulins 110

Table 6.13: Pharmacokinetics of Insulin Mixtures 112

Table 6.14: Status of Inhaled Insulin Products, 2011 117

Table 6.15: Key Drivers of the Type 2 Diabetes Insulin Market, 2012 122

Table 6.16: A Comparison of Existing Insulin Delivery Devices 123

Table 6.17: Insulin Pens 125

Table 6.18: Estimated Worldwide Demand for Insulin Injector Pens by Volume, 2012-2016 127

Table 6.19: Injection Aids 128

Table 6.20: Jet Injectors 130

Table 6.21: Control Averages by Treatment 131

Table 6.22: Reduced Risk for Various Diseases When Blood Glucose is Near Normal 131

Table 6.23: Leading Insulin Pump Manufacturers 132

Table 6.24: Comparison of Current External Insulin Pumps on the Market 132

Table 6.25: Insulin Infusion Sets 137

Table 6.26: Worldwide Insulin Pump Market, 2009-2016 141

Table 7.1: Advantages and Disadvantages of Newer Type 2 Diabetes Therapies 146

Table 7.2: Cells of the Pancreas 148

Table 7.3: Lipoprotein Risk Levels and Treatment Goals in Adult Patients with Diabetes 154

Table 7.4: Agents for Lowering Lipid Levels in Patients with Dyslipidemia 155

Table 7.5: Suggested Pharmacological Treatment Agents for Hypertension in Patients with Diabetes 156

Table 8.1: Criteria for the Diagnosis of Diabetes 159

Table 8.2: Categories of Increased Risk for Diabetes (Pre-Diabetes) 159

Table 8.3: Laboratory Assessment of Diabetic Vascular Disease 163

Table 8.4: Worldwide Glucose Self-Testing Market Sales (Meters and Strips), 2010-2016 163

Table 8.5: Market for Glucose Self-Testing in the U.S. (includes Meters, Strips, and Lancets), 2010-2016 164

Table 8.6: Market Share of U.S. Blood Glucose Self-Testing, 2011 164

Table 8.7: Lancet Characteristics 179

Table 9.1: BRIC countries, Percentage of GDP Spent on Healthcare, 2008 185

Table 9.2: Summary of Emerging Non-Insulin Anti-Diabetes Drug Categories 186

Table 9.3: Selected Diabetes Drugs in Clinical Trials, 2011 186

Table A1.1: Select Archived Press Release Excerpts 218

To order this report:Pathology Industry: Diabetes, Metabolic Syndrome and Cardiovascular Disease

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