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, particularly Type 2 diabetes, among adults across the world. As such, the global market for blood glucose testing products is undergoing a significant transition driven by the advent of new analytical technologies and developments in diabetes treatment. Although the blood glucose testing segment of the in vitro diagnostics (IVD) industry is mature, certain segments of the market, such as home testing devices for diabetes management, will exhibit strong growth. What’s more, non-invasive testing now represents a major new area for the application of IVD testing. Additionally, direct access testing--or over-the-counter testing, which allows consumers to order tests themselves without visiting a doctor--has emerged as a strong force in the blood glucose testing segment. The purpose of this TriMark Publications report is to describe the specific market segments for blood glucose testing and diabetes management. This study reviews all of the generally-accepted clinical analytical methods that are currently in use today for measuring serum or plasma or whole-blood glucose concentrations. Moreover, it examines clinical measurement devices, reagents and supplies as utilized in hospitals, clinics, doctor’s offices and at-home care locations.
 

1. Overview 9
1.1 Statement of Report 9
1.2 About this Report 9
1.3 Scope of the Report 11
1.4 Methodology 11
1.5 Executive Summary 12

2. Diabetes 15
2.1 Demographics of Diabetes 17
2.1.1 Worldwide Diabetes Incidence 17
2.1.2 Diabetes in the U.S. 19
2.2 Economics of Diabetes 22
2.3 Understanding the Metabolic Conditions Underlying and Associated with Diabetes 31
2.3.1 Pre-Diabetes Syndrome 33
2.3.2 Metabolic Syndrome 33
2.3.3 Diabetes and Inflammation 33
2.3.4 Progression of Diabetes 33
2.3.5 Complications and Co-Morbidities in Type 2 Diabetes 34
2.3.6 Hypoglycemia and Treatment 36
2.3.7 Risk Factors and Diabetes 36
2.3.8 Cardiovascular Disease Facts 37
2.4 Glucose Control in Diabetic Patients 43
2.5 Tight Glucose Control in Treating Diabetes 44
2.6 Glucose Monitoring Devices 45
2.6.1 Key Issues Identified for Glucose Monitoring 45
2.6.2 Device Description 45
2.6.3 Precision 47
2.6.4 Limitations of Existing Glucose Monitoring Products 48

3. Glucose Measurements 50
3.1 Glucose Monitoring Markets 50
3.1.1 Overview of Market Segments 50
3.1.1.1 Over-the-Counter (OTC) Self-Testing Glucose Market 52
3.1.1.2 Professional Glucose Testing Market 53
3.1.2 Market Analysis: Size, Growth, Share and Competitors 54
3.1.2.1 Worldwide Market 54
3.1.2.2 U.S. Market 56
3.1.2.3 European Market 59
3.1.2.4 Asian Market 60
3.2 Glucose Analytical Test Methods 74
3.2.1 Glucose Oxidase 74
3.2.2 Glucose Hexokinase 75
3.2.3 Glucose Dehydrogenase Pyrroloquinoline quinone (GDH-PQQ) 75
3.2.4 Amperometric Biosensors 76
3.2.5 Interfering Substances 76
3.2.6 Monitoring HbA1c Levels 77
3.2.7 Quality Control Criteria 77
3.3 Reagents and Equipment 77
3.3.1 Lancets 79
3.3.2 Blood Glucose Test Kit 87
3.3.3 Blood Glucose Monitor and Insulin Doser 89
3.3.4 Diabetes Tracking System 89
3.3.5 Blood Glucose Sensors 89
3.3.6 Blood Glucose Reagent Test Strips 92
3.3.7 Control Solutions and Calibrators 93
3.3.8 Sharps Devices 94
3.3.9 Needle Destruction Devices 94
3.3.10 Urine Strips 95
3.3.11 Blood Ketone Testing 96
3.3.12 Voice Operated Glucose Meters 97
3.4 Glucose Meters 100
3.4.1 LifeScan 100
3.4.2 Roche Accu-Chek 102
3.4.3 Bayer 104
3.4.4 Abbott 106
3.4.5 Acon Laboratories 109
3.4.6 Quest Diagnostics Company 109
3.4.7 Agamatrix 110
3.4.8 AiMedics 110
3.4.9 Apex Biotechnology 111
3.4.10 77 Elektronika 111
3.4.11 Arkray 111
3.4.12 Accurex 112
3.4.13 Axis-Shield 112
3.4.14 Home Diagnostics 112
3.4.15 Hypoguard 114
3.4.16 Metrika 115
3.4.17 Biopeak 115
3.4.18 BioTex 115
3.4.19 Integrity Applications 116
3.4.20 Calisto Medical 116
3.4.21 Allmedicus 117
3.4.22 Diabetech 117
3.4.23 Diagnostic Devices 118
3.4.24 DIRAmed 118
3.4.25 Entelos 118
3.4.26 Fifty50 Pharmacy 119
3.4.27 Fluent Biomedical 119
3.4.28 GenExel-Sein 119
3.4.29 GlucoLight 119
3.4.30 GluMetrics 119
3.4.31 Glucoplus 120
3.4.32 GlySens 120
3.4.33 HMD BioMedical 120
3.4.34 InLight Solutions 120
3.4.35 Insulet 121
3.4.36 IntelliDx 121
3.4.37 Kumetrix 122
3.4.38 Lein Applied Diagnostics 122
3.4.39 Cholestech 123
3.4.40 LighTouch Medical 123
3.4.41 LG Electronics 123
3.4.42 Luminous Medical 123
3.4.43 Menarini Diagnostics 124
3.4.44 OrSense 124
3.4.45 Pelikan Technologies 125
3.4.46 Polymer Technology Systems 126
3.4.47 PreciSense 126
3.4.48 Sensys Medical 126
3.4.49 Smiths Medical MD 127
3.4.50 TaiDoc Technology 127
3.4.51 U.S. Diagnostics 127
3.4.52 VeraLight 128
3.4.53 Zyvex 128
3.4.54 Health Hero Network 128
3.4.55 IN4 Technology 128
3.4.56 Nipro 129
3.4.57 Teco Diagnostics 129
3.4.58 Uchain Industrial 129
3.4.59 GlucoStats System 129
3.4.60 Sanko Junyaku 130
3.4.61 International Technidyne 130
3.4.62 Medtronic MiniMed 130
3.4.63 Diacare 130
3.4.64 Tyson Bioresearch 130
3.4.65 Bionime 130
3.4.66 Home Diagnostics 131
3.4.67 BTNX 132
3.5 Diagnosing Diabetes Using In Vitro Laboratory Tests 133
3.5.1 New Diagnostic Guidelines 133
3.5.2 Fasting Plasma Glucose (FPG) Test 133
3.5.3 Glucose Tolerance Test 134
3.5.4 Test for Glycosylated Hemoglobin 134
3.5.5 Fructosamine 135
3.5.6 Combined Self-Testing Glucose Monitor with Insulin Delivery 136
3.6 Continuous and Non-invasive Glucose Patient Monitoring 137
3.6.1 Medtronic MiniMed Continuous Glucose Monitoring System 146
3.6.2 Cygnus GlucoWatch Biographer 147
3.6.3 Abbott FreeStyle Continuous Glucose Monitor System 147
3.6.4 DexCom, Inc. STS Continuous Glucose Monitoring System 148
3.6.5 Echo Therapeutics 148
3.6.6 Sensors for Medicine and Science 148
3.6.7 New Developments in Glucose Monitors 149
3.6.8 Strategies for Developing Non-invasive Continuous Glucose Monitoring 150
3.7 Glycosylated Hemoglobin Glucose Monitoring 151
3.8 Clinical Laboratory Instruments 153
3.8.1 Ultra-Large Throughput Chemistry Analyzers Large-Throughput Analyzers 155
3.8.2 Large-Throughput Analyzers 157
3.8.3 Mid-Size Clinical Chemistry Analyzers 160
3.8.4 Chemistry Analyzers for the Small Volume Market 163

4. Business Trends in Glucose Testing 167
4.1 Expanding Opportunities in Blood Glucose Monitoring Market 167
4.2 Home Diabetes Test Kits an Evolving Market 167
4.3 Competitive Strategies 168
4.4 Analyses of the Current Market Conditions, Competition and Product Mix 170
4.5 The New Paradigm 171
4.6 Mergers of Diagnostic Companies 171
4.7 Healthcare Cost Controls 174
4.8 Competition for Services 174
4.9 Drivers of Clinical Glucose Testing 175
4.10 Confluence of New Technology 176
4.11 Trends in Reimbursement Practices 176
4.12 Managed Care 179
4.13 Changes in Patient Management 179
4.14 Satellite Facilities 180
4.15 Point-of-Care Testing 180
4.16 Regionalization of Laboratory Care 181
4.17 Drivers of the Point of Care Testing Sector 182
4.18 Diagnostic Testing Growth Trends 183
4.19 PIPE Financing 184
4.20 Brand Loyalty 184
4.21 Insurance Coverage a Key Factor 184
4.22 Medicare Coverage 184
4.23 Products at Competitive Price Points 184
4.24 Drugstores Critical to the Diabetic Care Category 184
4.25 Drugstore Chains Increasingly Running Diabetes Care Programs 185
4.26 Co-branding Strategies 185

5. Important Technology Trends 186
5.1 Biosensor Technology 186
5.2 Data Management 190
5.2.1 Information Management Advances 192
5.2.2 Patient Care Information System Strategy 195
5.2.3 Connectivity Platforms 196
5.2.3.1 DataLink Data Management System 197
5.2.3.2 RALS-Plus 198
5.2.3.3 LabPortal.com 200
5.2.3.4 LifeScan Electronic Data Interfaces 200
5.2.3.5 Computer Software for Home Glucose Meters 201
5.2.3.6 Health Buddy Systems Monitoring Technologies 201
5.2.3.7 Medtronic’s MiniMed Paradigm Glucose Meter 201
5.2.4 POL Laboratory Data Management 202
5.2.4.1 Electronic Medical Record Systems and Physician Office Laboratory Data Linking Software 202
5.2.4.2 Physician Office Laboratory Data Linking Software and Interface to the Laboratory Information System 204
5.2.5 Technical Problems of Connectivity 204
5.2.6 Web-based Data Interface 205
5.2.7 HIT Competition 205
5.2.8 FDA Required Software Verification 205
5.3 Advantages of Connectivity 206
5.4 Home Care Analysis 206
5.4.1 Remote Patient Monitoring 206
5.5 Technology Platform Innovations in Glucose Testing 209
5.6 Move Away from Central Laboratory 210
5.7 Trends in Detection and Diagnosis 210
5.7.1 Minimally-Invasive Devices 210
5.7.2 Non-invasive Devices Future Developments and Market Strategy 213
5.7.3 Continuous Test Systems and the Future of Integrated Glucose/Insulin Delivery 215

6. Competitive Analysis of<