Cardiovascular Technology

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  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 11

2. Introduction 17
2.1 Demographics of Diabetes 17
2.1.1 Worldwide Diabetes 17
2.1.2 U.S. Diabetes 18
2.2 Economics of Diabetes 22

3. Understanding the Metabolic Conditions Underlying and Associated with Diabetes 28
3.1 Pre-Diabetes Syndrome 29
3.2 Metabolic Syndrome 29
3.3 Diabetes and Inflammation 32
3.4 Progression of Diabetes 32
3.5 Complications and Co-Morbidities in Type 2 Diabetes 33
3.6 Hypoglycemia and Treatment 38
3.7 Risk Factors and Diabetes 39
3.8 Cardiovascular Disease (CVD) Facts 40

4. Pharmaceutical Industry and the Anti-Diabetes Market 51
4.1 The Worldwide Pharmaceutical Industry 51
4.2 Total Diabetes Drug Market Size and Growth 58
4.2.1 Sales of Anti-Diabetic Drugs Continue to Rise 61
4.3 Epidemiology/Cost of Treatment 62
4.4 Diabetic Medications Overview 63
4.4.1 Recent Trends in Diabetic Drug Usage 63
4.4.2 Market Influence Factors 67

5. Non-Insulin Anti-Diabetes Products 69
5.1 Anti-Diabetic Drug Therapy Overview 69
5.1.1 Sulfonylureas 72
5.1.2 Meglitinides 73
5.1.3 Biguanides 73
5.1.4 Thiazolidinediones (TZDs) 74
5.1.5 a-Glucosidase Inhibitors 77
5.1.6 Incretin Mimetics/Glucagon-like Peptide (GLP-1) Analog 77
5.1.7 Amylin Analog 79
5.1.8 DPP-IV Inhibitors 79
5.1.9 Other Classes 81
5.1.10 Combination Therapy 81
5.2 Drivers and Trends 82
5.2.1 Market Share of Anti-Diabetic Drugs 82
5.2.2 Forecasts for Anti-Diabetic Drugs 82
5.2.3 Sales Forecast for the Global Diabetes Market 83
5.3 The Future 84
5.3.1 Practice Patterns 84
5.3.2 New Products in Pipeline 85
5.4 Anti-Diabetic Drug Patent Expiry 91
5.5 Regulatory Issues 91

6. Insulin 92
6.1 Insulin Markets 92
6.1.1 Major Players and Market Share 93
6.2 Insulin and Analogs 95
6.2.1 Rapid-Acting Insulin 95
6.2.2 Intermediate-Acting Insulin 97
6.2.3 Long-Acting Insulin/Ultra Long-Acting Insulin 97
6.2.4 Insulin Mixtures 99
6.3 Insulin Analogs 100
6.4 Non-Insulins in Development 100
6.5 Pipeline Insulin 101
6.6 Non-Invasive Insulin Delivery 101
6.6.1 Inhaled Insulin 101
6.6.1.1 Inhaled Insulin Overview 102
6.6.2 Oral Insulin 104
6.6.3 Transdermal Insulin 106
6.6.4 Oral Spray Insulin 108
6.7 Barriers for Non-Injected Insulin 109
6.8 Patient Potential for Non-Injected Insulin 109
6.9 Insulin Delivery Devices 109
6.9.1 Lancets and Lancing Devices 110
6.9.2 Insulin Pens 113
6.9.3 Injections Aids 117
6.9.3.1 Automatic Injectors 117
6.9.3.2 Syringe Magnifiers 118
6.9.3.3 Insulin Infusers 118
6.9.4 Insulin Jet Injectors 118
6.9.5 Insulin Pumps 119
6.9.5.1 External Insulin Pumps 119
6.9.5.2 Implantable Insulin Pumps 122
6.9.5.3 Insulin Pump Market Share 123
6.9.5.4 Drivers of Demand for Pumps 128
6.10 Market Forecasts for Insulin Administration Technologies 129

7. Emerging Anti-Diabetes Products 130
7.1 Projections for the Anti-Diabetes Drug Market 130
7.2 Artificial Pancreas 134
7.3 Insulin-Producing Cells 135
7.3.1 Cell Therapy Companies for Diabetes 135
7.4 Transplantation Procedures 137
7.4.1 Pancreatic Transplantation 138
7.4.1.1 Pancreatic Organ Transplantation 138
7.4.1.2 Allo-Islet Transplantation 138
7.4.1.3 Transplantation of Encapsulated Pancreatic Cells 139
7.4.1.4 Implantation of Genetically Engineered-Cells or Embryonic Stem Cells 139
7.4.2 Current Status 140
7.5 Gastric Bypass Surgery to Treat Type 2 Diabetes 140
7.6 Immune Modulators 141
7.7 Anti-Obesity Drug Xenical to Prevent or Delay Development of Type 2 Diabetes 141
7.8 Other Anti-Diabetic Therapy Drug Candidates 141
7.8.1 Lipid Abnormalities 142
7.8.2 High Blood Pressure 143
7.8.3 Anticoagulants 144
7.9 Drugs Used “Off-Label” 145
7.9.1 Niacin Derivatives 145
7.9.2 Benfluorex 145
7.9.3 D-Chiro-Inositol 145
7.9.4 Warfarin Sodium 145
7.10 Pipeline Diabetic Drug Candidates 146
7.11 Drug Research Overview 149
7.12 Future Anti-Diabetic Drugs in Late-Stage Development 151

8. Diagnosing Diabetes Using In Vitro Laboratory Tests 154
8.1 New Diagnostic Guidelines 154
8.2 Diabetes Tests 155
8.2.1 Fasting Plasma Glucose (FPG) Test 155
8.2.2 Glucose Tolerance Test 155
8.2.3 Test for Glycosylated Hemoglobin 156
8.2.4 Fructosamine 157
8.3 Glucose Monitoring 157
8.3.1 Overview of Market Segment 160
8.3.2 Competitive Strategies 160
8.3.3 Analyses of the Current Market Conditions, Competition and Product Mix 162
8.3.3.1 First-Generation Monitors 162
8.3.3.2 Second-Generation Monitors 162
8.3.3.3 Third-Generation SMBG Technologies 164
8.3.3.4 Product Overview 165
8.3.3.4.1 LifeScan 165
8.3.3.4.2 Roche Diagnostics 168
8.3.3.4.3 Bayer Diagnostics 169
8.3.3.4.4 Abbott Diagnostics 172
8.3.3.4.5 Other Players 174
8.3.4 What Are the Advantages of Using a Continuous Glucose-Monitoring Device? 177
8.3.5 Other Monitoring Device Advancements 178
8.3.6 Future of Non-Invasive Glucose Technology 179

9. Market Trends, Challenges and Strategic Options 182
9.1 Overview 182
9.2 Diabetes Drug Market Trends 182
9.2.1 Overview 182
9.2.2 Emergence of Therapeutics with Improved Administration Characteristics 182
9.2.3 Increasing Prevalence of Obesity 183
9.3 Diabetes Mellitus Market Challenges 185
9.3.1 Overview 185
9.3.2 Diabetic Pain Therapeutics 185
9.3.3 Market Prospects of Inhalable Drugs and Their Ability to Establish Safety Levels 186
9.3.4 Changing Consumer Preference Drives Product Development in Invasive Technology Segment 186
9.3.5 Non-Invasive Technology for Revenue Potential 186
9.3.6 Developing Countries Emerging as Key Markets for Diabetes Monitoring Devices 187
9.3.7 Consumer-Driven Marketing Campaigns—Essential, though Expensive 189
9.3.8 Escalating Expenditure for R&D and Marketing Triggers Consolidation 189
9.3.9 Market Size Predictions 191
9.3.10 Major Competitors 191
9.4 Strategic Options 192
9.4.1 Overview 192
9.4.2 Combined Self-Testing Glucose Monitor with Insulin Delivery 193
9.4.3 Diabetes Drugs in Pipeline 194
9.5 FDA Therapeutic Targets 196
9.5.1 FDA Targets Cardiotoxicity 197
9.5.2 Avandia FDA Warning 197
9.6 Outlook to Anti-Diabetes Drugs 197
9.7 Outlook for Cardiovascular Drugs 201

10. Company Profiles 203
10.1 A. Menarini 203
10.2 Abbott Laboratories 203
10.3 Amgen 204
10.4 AstraZeneca 205
10.5 Bayer 206
10.6 BodyMedia 208
10.7 Cybermedical 208
10.8 Debiotech 208
10.9 DexCom 209
10.10 Echo Therapeutics 210
10.11 Elixir Pharmaceuticals 211
10.12 Eksigent 211
10.13 Flamel Technologies 211
10.14 GlaxoSmithKline 212
10.15 GlucoLight 212
10.16 Insulet 212
10.17 iSense Corporation 213
10.18 Isis Pharmaceuticals, Inc. 213
10.19 Johnson & Johnson 214
10.20 KYORIN 215
10.21 M-Biotech 215
10.22 Medtronic 215
10.23 Merck & Co. 217
10.24 Merck KGaA 218
10.25 MicroIslet 218
10.26 Mitsubishi Tanabe Pharma Corporation 219
10.27 Nipro Diabetes Systems 219
10.28 Novartis 219
10.29 Novo Nordisk 220
10.30 Novocell 221
10.31 ONO Pharmaceutical 221
10.32 Orexigen Therapeutics 222
10.33 Pfizer 223
10.34 ReNeuron 223
10.35 Roche Diagnostics 224
10.36 Sanofi-Aventis 225
10.37 Sensors for Medicine and Science 226
10.38 Siemens 227
10.39 Smiths Medical 227
10.40 Servier 228
10.41 SOOIL Development 228
10.42 Takeda 228
10.43 TheraFuse 229
10.44 Teco Diagnostics 229
10.45 Transition Therapeutics 229
10.46 U.S. Diagnostics 229
10.47 VeraLight 230
10.48 Vivus 230
10.49 Ypsomed Holding 231

Appendix 1: Contact Information for Companies Profiled 232
Appendix 2: Prescribing Patterns for Anti-Hyperglycemic Drugs 238
Appendix 3: Detailed List of Insulins Available 239
Appendix 4: The History of Insulin 240
Appendix 5: Diabetes and Obesity Drugs in Development 245
Appendix 6: Pharmaceutical Sampling Practices 253

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