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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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
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Report Details:
Published: July 2012
No. of Pages: 237
Price: Single User License – US$3400 Corporate User License – US$6800
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
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