Diabetes, Metabolic Syndrome and Cardiovascular Disease

2012-07-31
Published : Jul-2012

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.

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Report Details: 

Published: July 2012
No. of Pages: 237 

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Table of Contents

1. Overview 9
1.1 Statement of Report 9
1.2 About This Report 9
1.3 Scope of the Report 10
1.4 Methodology 10
1.5 Executive Summary 12

2. Introduction 15
2.1 Demographics of Diabetes 16
2.1.1 Worldwide Diabetes 16
2.1.2 U.S. Diabetes 18
2.2 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 34
3.6.1 Obesity 35
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 42
3.9 Cardiovascular Disease (CVD) 42
3.9.1 CVD Facts 42
3.9.2 Cardiac Care Therapeutics 49
3.9.2.1 Anti-Hypertensive Drugs 51
3.9.2.2 Cholesterol Management Drugs 51
3.9.2.3 Anticoagulants 55
3.9.3 CVD Diagnostics 55

4. Pharmaceutical Industry and the Anti-Diabetes Market 58
4.1 The Worldwide Pharmaceutical Industry 58
4.1.1 Pharmaceutical R&D Spending by Type, Growth Rate and Expenditure 58
4.1.2 Global Pharmaceutical Market 60
4.2 Total Diabetes Drug Market Size and Growth 65
4.2.1 Sales of Anti-Diabetic Drugs Continue to Rise 68
4.3 Diabetic Medications Overview 69
4.3.1 Recent Trends in Diabetic Drug Usage 70
4.3.2 Market Influence Factors 74

5. Non-Insulin Anti-Diabetes Products 76
5.1 Anti-Diabetic Drug Therapy Overview 76
5.1.1 Sulfonylureas 80
5.1.2 Meglitinides 81
5.1.3 Biguanides 82
5.1.4 Thiazolidinediones (TZDs) 83
5.1.5 ?-Glucosidase Inhibitors 86
5.1.6 Incretin Mimetics/Glucagon-Like Peptide (GLP-1) Analogs and Agonists 87
5.1.6.1 Byetta (Exenatide) 88
5.1.6.2 Victoza (Liraglutide) 88
5.1.6.3 Bydureon (exenatide LAR) 88
5.1.7 Amylin Analog 89
5.1.8 DPP-IV Inhibitors 89
5.1.8.1 Januvia (Sitagliptin) 89
5.1.8.2 Onglyza (Saxagliptin) 90
5.1.8.3 Tradjenta (Linagliptin) 90
5.1.9 Combination Therapy 90
5.1.9.1 Youth With Recent-Onset Type 2 Diabetes Should Be Started on Combination Therapies 92
5.1.10 Comparisons of the Anti-Diabetes Drugs 92
5.2 Drivers and Trends 92
5.2.1 Market Share of Anti-Diabetic Drugs 92
5.2.2 Forecasts for Anti-Diabetic Drugs 93
5.2.3 Sales Forecast for the Global Diabetes Market 94
5.3 The Future 95
5.3.1 Practice Patterns 95
5.3.2 New Products in Pipeline 96
5.3.2.1 Novel GLP-1 Agonists and Analogs 96
5.3.2.2 Novel DPP-IV Inhibitors 98
5.3.2.3 Sodium Glucose Cotransporter 2 (SGLT-2) 98
5.3.2.4 Emerging Non-Insulin Anti-Diabetes Targets and Drugs in the Pipeline 99
5.3.2.5 Novel Approaches to Finding New Drug Targets 103
5.4 Anti-Diabetic Drug Patent Expiry 103
5.5 Regulatory Issues 103

6. Insulin 104
6.1 Insulin Markets 104
6.1.1 Major Players and Market Share 106
6.1.2 Patent Expirations 107
6.1.3 Innovation Strategies 108
6.2 Insulin Therapeutics 108
6.2.1 Recommendations for Insulin Initiation and Administration 109
6.2.2 Short-Acting Insulin 111
6.2.3 Rapid-Acting Insulin 111
6.2.4 Intermediate-Acting Insulin 113
6.2.5 Long-Acting Insulin 113
6.2.6 Long-Acting Insulins in Development 115
6.2.7 Insulin Mixtures 115
6.3 Pipeline Insulin 116
6.4 Non-Invasive Insulin Delivery 116
6.4.1 Inhaled Insulin 117
6.4.1.1 A Chronicle of Inhaled Insulins 118
6.4.2 Oral Insulin 120
6.4.3 Transdermal Insulin 124
6.5 Barriers for Non-Injected Insulin 126
6.6 Patient Potential for Non-Injected Insulin 126
6.7 Insulin Delivery Devices 126
6.7.1 Insulin Pens 127
6.7.2 Injections Aids 132
6.7.2.1 Automatic Injectors 133
6.7.2.2 Syringe Magnifiers 134
6.7.2.3 Injection Ports 134
6.7.3 Insulin Jet Injectors 134
6.7.4 Insulin Pumps 135
6.7.4.1 External Insulin Pumps 136
6.7.4.2 Insulin Patch Pumps in Development 141
6.7.4.3 Implantable Insulin Pumps 143
6.7.4.4 Insulin Pump Market Share 145
6.7.4.5 Drivers of Demand for Pumps 146
6.8 Market Forecasts for Insulin Administration Technologies 146

7. Emerging Anti-Diabetes Technologies and Products 148
7.1 Projections for the Anti-Diabetes Drug Market 148
7.2 Artificial Pancreas 151
7.3 Insulin-Producing Cells 152
7.3.1 Cell Therapy Companies for Diabetes 153
7.4 Transplantation Procedures 155
7.4.1 Pancreatic Transplantation 156
7.4.1.1 Pancreatic Organ Transplantation 156
7.4.1.2 Allo-Islet Transplantation 156
7.4.1.3 Transplantation of Encapsulated Pancreatic Cells 156
7.4.1.4 Implantation of Genetically Engineered ?-Cells or Embryonic Stem Cells 156
7.4.2 Current Status 157
7.5 Gastric Bypass Surgery to Treat Type 2 Diabetes 158
7.6 Immune Modulators 158
7.7 Anti-Obesity Drugs to Prevent or Delay Development of Type 2 Diabetes 159
7.8 Other Anti-Diabetic Therapy Drug Candidates 159
7.8.1 Lipid Abnormalities 160
7.8.2 High Blood Pressure 161
7.8.3 Anticoagulants 162
7.9 Drugs Used “Off-Label” 163
7.9.1 Warfarin Sodium 163

8. Diagnosing Diabetes Using In Vitro Laboratory Tests 164
8.1 New Diagnostic Guidelines 164
8.2 Diabetes Tests 165
8.2.1 Fasting Plasma Glucose (FPG) Test 165
8.2.2 Glucose Tolerance Test 166
8.2.3 Test for Glycosylated Hemoglobin 167
8.2.4 Fructosamine 168
8.3 Glucose Monitoring 169
8.3.1 Overview of Market Segment 171
8.3.2 Competitive Strategies 171
8.3.3 Analyses of the Current Market Conditions, Competition and Product Mix 173
8.3.3.1 First-Generation Monitors 174
8.3.3.2 Second-Generation Monitors 174
8.3.3.3 Third-Generation SMBG Technologies 174
8.3.3.4 Product Overview 174
8.3.4 What Are the Advantages of Using a Continuous Glucose-Monitoring Device? 182
8.3.5 Minimally-Invasive Continuous Glucose Monitors in Development 184
8.3.6 Future of Non-Invasive Glucose Technology 184
8.3.7 Lancets and Lancing Devices 184

9. Market Trends, Challenges and Strategic Options 188
9.1 Overview 188
9.2 Diabetes Drug Market Trends 188
9.2.1 Overview 188
9.2.2 Emergence of Therapeutics With Improved Administration Characteristics 189
9.2.3 Increasing Prevalence of Obesity 189
9.3 Diabetes Mellitus Market Challenges 191
9.3.1 Overview 191
9.3.2 Diabetic Pain Therapeutics 191
9.3.3 Market Prospects of Inhalable Drugs and Their Ability to Establish Safety Levels 192
9.3.4 Changing Consumer Preference Drives Product Development in Invasive Technology Segment 192
9.3.5 Non-Invasive Technology for Revenue Potential 193
9.3.6 Developing Countries Emerging as Key Markets for Diabetes Monitoring Devices 193
9.3.7 Consumer-Driven Marketing Campaigns—Essential, Though Expensive 195
9.3.8 Escalating Expenditure for R&D and Marketing Triggers Consolidation 195
9.4 Strategic Options 196
9.4.1 Overview 196
9.4.2 Combined Self-Testing Glucose Monitor with Insulin Delivery 196
9.4.3 Diabetes Drugs in Pipeline 197
9.5 FDA Therapeutic Targets 199
9.5.1 FDA Targets Cardiotoxicity 200
9.5.2 Avandia FDA Warning 200
9.6 Outlook to Anti-Diabetes Drugs 200
9.7 Outlook for Cardiovascular Drugs 203
9.8 Recent Industry Activity 204

10. Company Profiles 206
10.1 A. Menarini 206
10.2 Abbott Laboratories 206
10.3 Amgen 207
10.4 AstraZeneca 208
10.5 Bayer 209
10.6 BodyMedia 211
10.7 Cybermedical 211
10.8 Debiotech 211
10.9 DexCom 212
10.10 Echo Therapeutics 213
10.11 Eli Lilly 214
10.12 Elixir Pharmaceuticals 214
10.13 Eksigent 214
10.14 Flamel Technologies 215
10.15 GlaxoSmithKline 215
10.16 Insulet 215
10.17 iSense Corporation 216
10.18 Isis Pharmaceuticals, Inc. 216
10.19 Johnson & Johnson 217
10.20 KYORIN 218
10.21 M-Biotech 218
10.22 Medtronic 218
10.23 Merck & Co. 220
10.24 Merck KGaA 221
10.25 MicroIslet 221
10.26 Mitsubishi Tanabe Pharma Corporation 222
10.27 Nipro Diabetes Systems 222
10.28 Novartis 222
10.29 Novo Nordisk 223
10.30 Novocell 224
10.31 ONO Pharmaceutical 224
10.32 Orexigen Therapeutics 225
10.33 Pfizer 225
10.34 Roche Diagnostics 226
10.35 Sanofi-Aventis 227
10.36 Sensors for Medicine and Science 229
10.37 Siemens 229
10.38 Smiths Medical 230
10.39 SOOIL Development 230
10.40 Takeda 230
10.41 TheraFuse 231
10.42 U.S. Diagnostics 231
10.43 VeraLight 231
10.44 Vivus 231
10.45 Ypsomed Holding 232

Appendix 1: The History of Insulin 233

List of Tables

Table 2.1: Top Ten Countries With the Largest Estimated Number of Diabetics (20 to 79 Years Age Group) 2011 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, 2008 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. 38
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 40
Table 3.8: Major Causes of End-Stage Renal Disease 40
Table 3.9: Clinical Recommendations for Adults with Diabetes 41
Table 3.10: Laboratory Assessment of Diabetic Vascular Disease 41
Table 3.11: Average Years Gained Free of Diabetes-Related Disease with Intensive Management 41
Table 3.12: Medical Care Costs Attributable to Diabetes in the U.S., 2010 42
Table 3.13: Summary of Cardiovascular Diseases (CVDs) 42
Table 3.14: Death Rate From Cardiovascular Diseases by Country, 2008 44
Table 3.15: Percentage of Adults Smokers by Country, 2008 48
Table 3.16: Selected Potential Patent Expirations of Cardiac Care Drugs, 2012-2013 50
Table 3.17: Worldwide Market for Cardiac Care Therapeutics, 2007-2014 50
Table 4.1: Global R&D Spending in the Pharmaceutical Industry, 2008-2012 58
Table 4.2: Pharmaceutical Companies Ranked by Total R&D Expenditures, 2011 58
Table 4.3: Leading Therapy Classes for R&D, 2010 59
Table 4.4: Global Pharmaceutical Sales by Region and Country, 2010 and 2015 60
Table 4.5: World Pharmaceutical Sales Share by Region, 2010 61
Table 4.6: Top Ten Global Pharmaceutical Companies by Global Sales, 2011 61
Table 4.7: Leading Ten Therapeutic Classes by U.S. Sales, 2006-2011 62
Table 4.8: Top Ten Therapeutic Classes by U.S. Dispensed Prescriptions, 2006-2011 63
Table 4.9: Leading Therapy Classes by Global Pharmaceutical Sales, 2015 63
Table 4.10: Top Selling Drugs in the U.S., 2010 64
Table 4.11: Worldwide Anti-Diabetes Drug Market, 2008-2016 66
Table 4.12: Oral Anti-Diabetic Therapy Major World Markets, 2010 66
Table 4.13: The Leading Five Anti-Diabetics by Sales, 2011 68
Table 4.14: American College of Physicians 2012 Practical Guideline for the Use of Anti-Diabetes Drugs for
Type 2 Diabetes 69
Table 4.15: Summary of Glucose-Lowering Interventions as Monotherapy 73
Table 5.1: Classes of Non-Insulin Hypoglycemic Agents 76
Table 5.2: Non-Insulin Hypoglycemic Drugs Used to Treat Type 2 Diabetes, 2012 78
Table 5.3: Relative Efficacy of Diabetes Drugs 78
Table 5.4: Average Dose and Cost Comparison of Oral Hypoglycemic Agents 79
Table 5.5: Fixed-Dose Oral Anti-Diabetes Drug Combinations 91
Table 5.6: Delivery Method of Non-Insulin Anti-Diabetes Drugs in the Pipeline, 2011 96
Table 5.7: GLP-1 Agonist Pipeline: Selected Drugs in Development That Target GLP-1 97
Table 5.8: DPP-IV Inhibitor Pipeline 98
Table 5.9: Summary of Emerging Non-Insulin Anti-Diabetes Drug Categories 100
Table 6.1: Market Shares of Animal, Human and Modern Insulin, 1995-2010 (% of Total Insulin Market) 104
Table 6.2: Worldwide Insulin Sales, 2008-2016 105
Table 6.3: Worldwide Insulin Sales and Market Share by World Region, 2011 105
Table 6.4: Estimated U.S. Retail Insulin Sales, 2011-2015 105
Table 6.5: Worldwide Insulin Sales and Market Share by Company, 2011 106
Table 6.6: U.S. Insulin Sales and Market Share by Company, 2011 106
Table 6.7: Therapeutic Insulins on the Market 108
Table 6.8: Pharmacokinetics of Therapeutic Insulins on the Market 109
Table 6.9: Pharmacokinetics of Short-Acting Insulins 111
Table 6.10: Pharmacokinetics of Rapid-Acting Insulins 111
Table 6.11: Pharmacokinetics of Intermediate-Acting Insuslins 113
Table 6.12: Pharmacokinetics of Long-Acting Insulins 113
Table 6.13: Pharmacokinetics of Insulin Mixtures 115
Table 6.14: Status of Inhaled Insulin Products, 2011 120
Table 6.15: Key Drivers of the Type 2 Diabetes Insulin Market, 2012 126
Table 6.16: A Comparison of Existing Insulin Delivery Devices 127
Table 6.17: Insulin Pens 129
Table 6.18: Estimated Worldwide Demand for Insulin Injector Pens by Volume, 2012-2016 130
Table 6.19: Injection Aids 133
Table 6.20: Jet Injectors 135
Table 6.21: Control Averages by Treatment 135
Table 6.22: Reduced Risk for Various Diseases When Blood Glucose is Near Normal 136
Table 6.23: Leading Insulin Pump Manufacturers 136
Table 6.24: Comparison of Current External Insulin Pumps on the Market 137
Table 6.25: Insulin Infusion Sets 141
Table 6.26: Worldwide Insulin Pump Market, 2009 – 2016 145
Table 7.1: Advantages and Disadvantages of Newer Type 2 Diabetes Therapies 151
Table 7.2: Cells of the Pancreas 153
Table 7.3: Lipoprotein Risk Levels and Treatment Goals in Adult Patients with Diabetes 160
Table 7.4: Agents for Lowering Lipid Levels in Patients with Dyslipidemia 161
Table 7.5: Suggested Pharmacological Treatment Agents for Hypertension in Patients with Diabetes 162
Table 8.1: Criteria for the Diagnosis of Diabetes 166
Table 8.2: Categories of Increased Risk for Diabetes (Pre-Diabetes) 166
Table 8.3: Laboratory Assessment of Diabetic Vascular Disease 169
Table 8.4: Worldwide Glucose Self-Testing Market Sales (Meters and Strips), 2010-2016 170
Table 8.5: Market for Glucose Self-Testing in the U.S. (includes Meters, Strips and Lancets), 2010-2016 170
Table 8.6: Market Share of U.S. Blood Glucose Self-Testing, 2011 171
Table 8.7: Lancet Characteristics 187
Table 9.1: BRIC countries, Percentage of GDP Spent on Healthcare, 2008 194
Table 9.2: Summanry of Emerging Non-Insulin Anti-Diabetes Drug Categories 198
Table 9.3: Selected New Diabetes Drugs in Pipeline, 2011 198
Table 9.4: Comparison of New Molecular Entity Outcomes for FDA and EMEA (Jan 2006 to October 2008) 200
Table 9.5: Recent Milestones for Selected Diabetes Drugs 202
Table 9.6: Overview of Blockbuster Drugs Coming Off-Patent, 2008 to 2012 203
Table A1.1: Select Archived Press Release Excerpts 236

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