Blood Glucose Testing and Diabetes Management Report
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 10
1.5 Executive Summary 10
2. Diabetes 13
2.1 Demographics of Diabetes 15
2.1.1 Worldwide Diabetes Incidence 15
2.1.2 U.S. Diabetes 16
2.2 Economics of Diabetes 26
2.3 Understanding the Metabolic Conditions Underlying and Associated with Diabetes 31
2.3.1 Pre-Diabetes Syndrome 32
2.3.2 Metabolic Syndrome 32
2.3.3 Diabetes and Inflammation 33
2.3.4 Progression of Diabetes 34
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 38
2.4 Glucose Control in Diabetic Patients 47
2.5 Tight Glucose Control in Treating Diabetes 48
2.6 Glucose Monitoring Devices 49
2.6.1 Key Issues were Identified for Glucose Monitoring 49
2.6.2 Device Description 49
2.6.3 Precision 51
2.6.4 Limitations of Existing Glucose Monitoring Products 52
3. Glucose Measurements 54
3.1 Glucose Monitoring Markets 54
3.1.1 Overview of Market Segments 54
3.1.1.1 Over-the-Counter (OTC) Self-Testing Glucose Market 56
3.1.1.2 Point of Care Glucose Testing Market 57
3.1.1.3 Physician Office Laboratories (POL) Glucose Testing Market 58
3.1.1.4 Clinical Laboratory Glucose Testing Market 59
3.1.2 Market Analysis: Size, Growth, Share and Competitors 60
3.1.2.1 Worldwide Market 60
3.1.2.2 U.S. Market 62
3.1.2.3 European Market 66
3.1.2.4 Asian Market 67
3.1.2.4.1 Japanese Market 69
3.1.2.4.2 China Market 69
3.1.2.4.3 India Market 72
3.1.2.5 ROW Markets 75
3.2 Glucose Analytical Test Methods 75
3.2.1 Glucose Oxidase 75
3.2.2 Glucose Hexakinase 76
3.2.3 Glucose Dehydrogenase Pyrroloquinolinequinone (GDH-PQQ) 76
3.2.4 Amperometric Biosensors 77
3.2.5 Interfering Substances 77
3.2.6 Monitoring HbA1c Levels 78
3.2.7 Quality Control Criteria 78
3.3 Reagents and Equipment 79
3.3.1 Lancets 80
3.3.2 Blood Glucose Test Kit 86
3.3.3 Blood Glucose Monitor and Insulin Doser 87
3.3.4 Diabetes Tracking System 87
3.3.5 Blood Glucose Sensors 87
3.3.6 Blood Glucose Reagent Test Strips 89
3.3.7 Control Solutions and Calibrators 89
3.3.8 Sharps Devices 90
3.3.9 Needle Destruction Devices 90
3.3.10 Urine Strips 91
3.3.11 Blood Ketone Testing 92
3.3.12 Voice Operated Glucose Meters 92
3.4 Glucose Meters 95
3.4.1 LifeScan (a Johnson & Johnson Company) 95
3.4.2 Roche Accu-Chek 98
3.4.3 Bayer 100
3.4.4 Medisense (Abbott) 103
3.4.5 Acon Laboratories 105
3.4.6 HemoCue 105
3.4.7 Agamatrix, Inc. 106
3.4.8 Aimedics, Pty Ltd. 106
3.4.9 Apex Biotechnology Corp. 107
3.4.10 77 Elektronika Kft. 107
3.4.11 Arkray, Inc. 107
3.4.12 Becton Dickinson & Co. 108
3.4.13 Accurex (India) 108
3.4.14 Biosens 108
3.4.15 Axis-Shield 108
3.3.16 Home Diagnostics, Inc. 108
3.3.17 Medisys/Hypoguard 110
3.3.18 Metrika 111
3.4.19 Biopeak Corp. 111
3.4.20 BioTex, Inc. 111
3.4.21 Calisto Medical, Inc. 111
3.4.22 Allmedicus 112
3.4.23 Diabetech, LP 112
3.4.24 Diagnostic Devices 112
3.4.26 Diramed LLC 113
3.4.27 Entelos 113
3.4.28 Fifty50 Pharmacy 113
3.4.29 Fluent Biomedical Corp. 113
3.4.30 Fovi Optics, Inc. 113
3.4.31 GenExel-Sein, Inc. 114
3.4.32 GlucoLight Corp. 114
3.4.33 Glucon Medical Ltd. 114
3.4.34 GluMetrics LLC 115
3.4.35 Glucoplus, Inc. 115
3.4.36 Glysens, Inc. 115
3.4.37 HMD Bio Medical 115
3.4.38 Hypoguard 115
3.4.39 Infratec, Inc. 116
3.4.40 InLight Solutions, Inc. 117
3.4.41 Insulet Corp. 117
3.4.42 Integrity Applications 118
3.4.43 Kumetrix, Inc. 118
3.4.44 Lein Applied Diagnostics Ltd. 118
3.4.45 Cholestech 119
3.4.46 LighTouch Medical, Inc. 119
3.4.47 LG Electronics 119
3.4.48 Luminous Medical, Inc. 119
3.4.49 Menarini Diagnostics 120
3.4.50 NIR Diagnostics, Inc. 120
3.4.51 Oculir, Inc. 120
3.4.52 OrSense Ltd. 120
3.4.53 Pelikan Technologies, Inc. 121
3.4.54 Polymer Technology Systems 121
3.4.55 PreciSense A/S 122
3.4.56 QuestStar Medical, Inc. 122
3.4.57 Sensys Medical 122
3.4.58 Smiths Medical MD, Inc. 122
3.4.59 TaiDoc Technology Corp. 123
3.4.60 U.S. Diagnostics 123
3.4.61 VeraLight, Inc. 123
3.4.62 Zyvex Corp. 124
3.4.63 Advanced Biosensors 124
3.4.64 Health Hero Network, Inc. 124
3.4.65 IN4 Technology Corporation 124
3.4.66 Nipro 124
3.4.67 Teco Diagnostics, Inc. 124
3.4.68 Uchain Industrial Co., Ltd. 124
3.4.69 GlucoStat System 124
3.4.70 Sanyo Junyaku 125
3.4.71 Diagnosys Medical 125
3.5 Diagnosing Diabetes Using In Vitro Laboratory Tests 125
3.5.1 New Diagnostic Guidelines 125
3.5.2 Fasting Plasma Glucose (FPG) Test 125
3.5.3 Glucose Tolerance Test 126
3.5.4 Test for Glycosylated Hemoglobin 126
3.5.5 Fructosamine 127
3.5.6 Combined Self-Testing Glucose Monitor with Insulin Delivery 127
3.6 Continuous and Non-invasive Glucose Patient Monitoring 128
3.6.1 Medtronic MiniMed Continuous Glucose Monitoring System 132
3.6.2 Cygnus GlucoWatch Biographer 133
3.6.3 Abbott FreeStyle Continuous Glucose Monitor System 135
3.6.4 DexCom, Inc. STS Continuous Glucose Monitoring System 136
3.6.5 Sontra Medical, Inc. 136
3.6.6 SpectRx 136
3.6.7 Pendragon Medical 137
3.6.8 Sensors for Medicine and Science, Inc. (SMSI) 137
3.6.9 Other Players 137
3.6.10 Strategies for Developing Non-Invasive Continuous Glucose Monitoring 138
3.7 Glycosylated Hemoglobin Glucose Monitoring 138
3.8 Clinical Laboratory Instruments 141
3.8.1 Ultra-Large Throughput Chemistry Analyzers Large-Throughput Analyzers 142
3.8.2 Large-Throughput Analyzers 144
3.8.3 Mid-Size Clinical Chemistry Analyzers 147
3.8.4 Chemistry Analyzers for the Small Volume Market 150
4. Business Trends in Glucose Testing 154
4.1 Expanding Opportunities in Blood Glucose Monitoring Market 154
4.2 Home Diabetes Test Kits an Evolving Market 154
4.3 Competitive Strategies 155
4.4 Analyses of the Current Market Conditions, Competition and Product Mix 156
4.5 The New Paradigm 157
4.6 Mergers of Diagnostic Companies 158
4.7 Healthcare Cost Controls 159
4.8 Competition for Services 159
4.9 Drivers of Clinical Glucose Testing 160
4.10 Confluence of New Technology 160
4.11 Trends in Reimbursement Practices 160
4.12 Managed Care 162
4.13 Changes in Patient Management 163
4.14 Satellite Facilities 163
4.15 Point-of-Care Testing 163
4.16 Regionalization of Laboratory Care 164
4.17 Drivers of the Point of Care Testing Sector 165
4.18 Diagnostic Testing Growth Trends 165
4.19 PIPE Financing 166
4.20 Brand Loyalty 166
4.21 Insurance Coverage a Key Factor 166
4.22 Medicare Coverage 166
4.23 Products at Competitive Price Points 166
4.24 Drugstores Critical to the Diabetic Care Category 167
4.25 Drugstore Chains Increasingly Running Diabetes Care Programs 167
4.26 Co-branding Strategies 167
5. Important Technology Trends 169
5.1 Biosensor Technology 169
5.2 Data Management 171
5.2.1 Information Management Advances 171
5.2.2 Patient Care Information System Strategy 173
5.2.3 Connectivity Platforms 174
5.2.3.1 DataLink Data Management System 175
5.2.3.2 RALS-Plus 176
5.2.3.3 LabPortal.com 178
5.2.3.4 LifeScan Electronic Data Interfaces 178
5.2.3.5 Computer Software for Home Glucose Meters 179
5.2.3.6 Health Buddy Systems Monitoring Technologies 179
5.2.3.7 Medtronics Minimed Paradigm Glucose Meter 179
5.2.4 POL Laboratory Data Management 180
5.2.4.1 Electronic Medical Record Systems and Physician Office Laboratory Data Linking Software 180
5.2.4.2 Physician Office Laboratory Data Linking Software and Interface to the Laboratory Information System 181
5.2.5 Technical Problems of Connectivity 181
5.2.6 Web-based Data Interface 181
5.2.7 HIT Competition 182
5.2.8 FDA Required Software Verification 182
5.3 Advantages of Connectivity 183
5.4 Home Care Analysis 183
5.5 Technology Platform Innovations in Glucose Testing 183
5.6 Move Away from Central Laboratory 184
5.7 Trends in Detection and Diagnosis 184
5.7.1 Minimally Invasive Devices 184
5.7.2 Non-Invasive Devices Future Developments and Market Strategy 186
5.7.3 Continuous Test Systems and the Future of Integrated Glucose/Insulin Delivery 187
6. Competitive Analysis of the Glucose Testing Markets 190
6.1 The Market Players 190
6.2 Device Categories 193
6.3 Range of Products 194
6.3.1 Cost of Testing 194
6.3.2 Sample Size Required 194
6.3.3 Sampling Other Areas 195
6.3.4 Time Until Patient Obtains Results 195
6.3.5 Enclosed Test Strips 195
6.3.6 Test Strip Calibration 195
6.3.7 Built-in Lancing Device 195
6.4 Data Handling 195
6.5 New Developments 196
6.6 Marketing New Features 196
6.7 Test Strip Sales 196
6.8 Reimbursement 196
6.9 Strip Manufacturers’ Responses 196
6.10 Retailers’ Responses 197
6.11 Market Demand and Composition 197
6.12 Product Mix 199
6.12.1 LifeScan 199
6.12.2 Roche Diagnostics 202
6.12.3 Bayer Diagnostics 203
6.12.4 Becton Dickinson 204
6.12.5 Abbott (MediSense) 205
6.12.6 Other Players 206
6.12.6.1 HemoCue AB 208
6.12.6.2 Home Diagnostics, Inc. 208
6.12.6.3 Medisys Group PLC 208
6.12.6.4 Polymer Technology Systems, Inc. 209
6.12.6.5 QuestStar Medical, Inc. 209
6.13 Devices that Measure Glycohemoglobin 209
6.14 Adjacent Markets 209
6.15 Market Drivers and Restraints 210
6.16 Market and Product Trends 210
6.17 Increased Market Penetration 210
6.18 Costs of Doing Business in Europe 211
6.19 Drivers of European Diagnostics Testing 211
6.20 European Reimbursement Practices 212
6.21 Cost Containment in Europe 212
6.22 Market Overview of Glucose Monitoring 212
6.22.1 U.S. Market Segment 212
6.22.2 European Market 214
6.22.3 Japanese Market 214
6.23 Competitive Strategies 215
6.24 Price Competition 217
6.25 Analyses of the Current Market Conditions, Competition and Product Mix 217
6.25.1 First-Generation Monitors 217
6.25.2 Second-Generation Monitors 218
6.25.3 Third-Generation SMBG Technologies 219
6.26 Product Overview 219
6.26.1 LifeScan 220
6.27 Design of Glucose Testing Devices 221
6.28 Insulin Delivery Devices 223
6.29 Key Glucose Testing Sector Developments 227
6.30 Important M&A Activity 227
6.30.1 Cygnus, Inc. Divests its Glucose-Monitoring Assets to Animas Corporation 227
6.30.2 Bayer Diagnostics Business Splits into Two Units 227
6.30.3 Abbott Laboratories Acquires TheraSense, Inc. 228
6.30.4 Roche Acquires Infusion Systems Division of Disetronic 228
6.30.5 J&J Acquires Animas Corporation 228
6.30.6 Medical Devices Pelikan Technologies, Inc. 228
6.30.7 Medical Services Amerifit Nutrition, Inc. 228
6.30.8 Owens & Minor, Inc. 228
6.30.9 Medisys Sells Business to Arkray 228
6.30.10 Cholestech Signs Agreement with Provalis 229
6.30.11 Bayer Acquires Metrika 229
6.30.12 Other Deals 229
6.31 Product Launches 230
7. Government Regulation of Medical Devices 232
7.1 U.S. Regulations 232
7.1.1 Importing Medical Devices into the U.S. 234
7.1.2 Exporting Medical Devices from the U.S. 234
7.2 U.K. Regulations 235
7.3 E.U. Regulations 236
7.4 French Regulations 239
7.5 Japanese Regulations 239
7.6 Korean Regulations 240
7.7 FDA Regulations and Recalls 240
7.8 Legal Liability for Glucose Meters 241
7.9 ISO 9000 Quality System 241
7.10 Recent Regulatory Approvals 241
7.11 FDA Labeling Requirements 241
8. Corporate Profiles 243
8.1 Abbott Diagnostics 243
8.2 Abbott Laboratories 244
8.3 Acon Laboratories 247
8.4 Agamatrix 248
8.5 AiMedics Pty Ltd. 248
8.6 Animas Corp. 248
8.7 Apex Biotechnology Corporation 248
8.8 Bayer Corporation 248
8.9 Biopeak Corporation 251
8.10 BioTex 252
8.11 Dexcom, Inc. 252
8.12 Diabetech, LP 252
8.13 77 Elektronika Kft. 252
8.14 Flexsite Diagnostics 252
8.15 Genexel-Sein, Inc. 253
8.16 GlucoLight 253
8.17 Glucon 253
8.18 GluMetrics, Inc. 253
8.19 GlySens, Inc. 253
8.20 Hemocue 254
8.21 Hypoguard 254
8.22 Infratec, Inc. 255
8.23 IN4 Technology 255
8.24 InLight Solutions 255
8.25 ITC (International Technidyne Corporation) 255
8.26 LifeScan Corporation 256
8.27 MediSense 257
8.28 Metrika 257
8.29 NIR Diagnostics 257
8.30 Nipro Medical Corporation 258
8.31 OrSense Ltd. 258
8.32 Pelikan Technologies 258
8.33 Polymer Technology Systems 258
8.34 PreciSense 259
8.35 QuestStar Medical 259
8.36 Roche Diagnostics 259
8.37 Sankyo Junyaku 263
8.38 Sanwa Kagaku Kenkyusho Co., Ltd. 263
8.39 Sensys Medical 264
8.40 SurgiLance 264
8.41 Smiths Medical MD, Inc. 264
8.42 SpectRx 264
8.43 Taidoc Technology 265
8.44 Teco Diagnostics 265
8.45 U.S. Diagnostics 266
8.46 VeraLight 266
Appendix 1: List of Competitors for Glucose Test Meters and Equipment 267
Appendix 2: FDA Proprietary Devices for Measuring Blood Glucose 275
Appendix 3: Overview of FDA Device Regulations 283
Appendix 4: Retail Prices of Glucose Meters 286
INDEX OF FIGURES
Figure 2.1: Demographic Changes in Diabetes Populations in 2010, 2025 and 2050 18
Figure 2.2: Annual Number of New Cases of Diagnosed Diabetes among Adults Aged 18 to 79 Years, U.S., 1997-2002 19
Figure 2.3: Crude and Age-Adjusted Incidence of Diagnosed Diabetes per 1,000 Population Aged 18 to 79 Years, U.S., 1997-2002 19
Figure 2.4: Incidence of Diagnosed Diabetes per 1,000 Population Aged 18 to 79 Years, by Age, U.S., 1997-2002 20
Figure 2.5: Age-Adjusted Incidence of Diagnosed Diabetes per 1,000 Population Aged 18 to 79 Years, by Sex, U.S., 1997-2002 20
Figure 2.6: Incidence of Diagnosed Diabetes per 1,000 Population Aged 18 to 79 Years, by Sex and Age, U.S., 1997-2002 21
Figure 2.7: Age-Adjusted Incidence of Diagnosed Diabetes per 1,000 Population Aged 18 to 79 Years, by Race, U.S., 1997-2002 21
Figure 2.8: Distribution of Duration of Diabetes Among Adults Aged 18 to 79 Years, U.S., 2002 22
Figure 2.9: Number of Hospital Discharges with Diabetes as First-Listed Diagnosis, U.S., 1980-2001 22
Figure 2.10: Crude and Age-Standardized Hospital Discharge Rates for Diabetes as First-Listed Diagnosis per 1,000 Persons in Diabetic Population, U.S., 1980-2001 23
Figure 2.11: Distribution of Age at Diagnosis of Diabetes Adults Aged 18 to 79 Years, U.S., 2002 23
Figure 2.12: Number of Adults with Diabetes Using Diabetes Medication by Type of Medication, U.S., 1997-2002 24
Figure 2.13: Age-Adjusted Percentage of Adults with Diabetes Using Diabetes Medication by Type of Medication, U.S., 1997-2002 24
Figure 2.14: Crude and Age-Adjusted Percentage of Adults with Diabetes Using Diabetes Medication, U.S., 1997-2002 25
Figure 2.15: Percentage of Adults with Diabetes Using Diabetes Medication, by Age, U.S., 1997-2002 26
Figure 2.16: How Diabetes Dollars Are Spent in the U.S. 29
Figure 2.17: Standardized Prevalence of Diagnosed and Undiagnosed Diabetes and Impaired Fasting Glucose in the U.S. Adult Population 33
Figure 2.18: Overlap Between Individuals Diagnosed as Diabetic According to Fasting Plasma Glucose Concentration (ADA Criteria) or the Two-Hour Glucose Value (WHO Criteria) 37
Figure 2.19: Single Day Continuous Blood Glucose Data 53
Figure 3.1: Share of the U.S. Self-Testing Diagnostic Market, 2006 65
Figure 3.2: U.S. Mass-Market Sales of Glucose Testing Kits, 2000-2012 65
Figure 7.1: World Medical Device Markets 232
Figure 7.2: Medical Device Market Share by U.S. Owned Companies 232
INDEX OF TABLES
Table 2.1: Normal Glucose Values—Fasting State 14
Table 2.2: Population with Diabetes in the World and in Selected Nations, 2000 and 2030 16
Table 2.3: U.S. Population of Diabetics by Ethnic Group 18
Table 2.4: Percentage of U.S. Adults with Diabetes Using Diabetes Medication by Age Group, 1997-2002 18
Table 2.5: Healthcare Utilization by Diabetic Patients 18
Table 2.6: Age-Adjusted Percentage of Adults with Diabetes Using Diabetes Medication by Type of Medication U.S., 1997-2002 25
Table 2.7: Crude and Age-Adjusted Percentage of Adults with Diabetes Using Diabetes Medication, U.S., 1997-2002 25
Table 2.8: Percentages of Adults with Diabetes Using Diabetes Medication by Age, U.S., 1997-2002 26
Table 2.9: Annual Estimated Cost of U.S. Diabetes Care 27
Table 2.10: Impact of Diabetes on Americans 28
Table 2.11: Leading Ten Diagnoses by Total U.S. Patient Visits, 2001 28
Table 2.12: U.S. Incidence of Diabetes by Age, 2005 28
Table 2.13: Prevalence, Cost and Medicines for Major Diseases in the U.S., 2005 28
Table 2.14: Top Ten Causes of Death in the U.S., 2003 29
Table 2.15: Per-Event Costs of Diabetes Complications 30
Table 2.16: Percentage of Persons with Type 1 Diabetes Experiencing Various Complications 34
Table 2.17: Novel Risk Factors and Possible Mechanisms of the Excess Risk of Coronary Heart Disease in Type 2 Diabetes Mellitus 35
Table 2.18: Average Years Gained Free of Diabetes-Related Disease with Intensive Management 36
Table 2.19: Worldwide Market for Cardiac Care Therapeutics, 1999-2010 40
Table 2.20: Top 200 Drugs by U.S. Sales, 2003 41
Table 2.21: Major Causes of End-Stage Renal Disease 47
Table 2.22: Key Features Considered for Glucose Meter Devices 51
Table 3.1: Laboratory Assessment of Diabetic Vascular Disease 55
Table 3.2: Key Market Drivers for Glucose Testing 55
Table 3.3: Key Customer Segments of Glucose Testing 55
Table 3.4: Demographic Characteristics Home Testing Kit Buyers 56
Table 3.5: Top Brand Preferences for Home Glucose Testing Kits 56
Table 3.6: Instances When Patients Prefer Professional’s Glucose Testing 56
Table 3.7: Advantages of a Home Testing Kit 57
Table 3.8: Disadvantages of Using a Home Testing Kit 57
Table 3.9: Popular Shopping Destinations for Buying or Seeking Information on Home Testing Kits 57
Table 3.10: Total Dedicated U.S. Professional Glucose Testing Market, 2000-2012 57
Table 3.11: Point of Care Glucose Testing U.S. (Hospitals), 2000-2012 58
Table 3.12: U.S. POL Glucose Testing, 2000-2012 59
Table 3.13: U.S. Central Lab Glucose Testing (Hospitals and Reference Labs), 2000-2012 60
Table 3.14: Worldwide Central Lab Glucose Testing (Hospitals and Reference Labs), 2000-2012 60
Table 3.15: Worldwide Glucose Self-Testing Market Sales (Meters, Strips, Lancets), 2000-2012 61
Table 3.16: Worldwide Glucose Market for Self-Testing Sales (Meters, Strips, Lancets), 2000-2012 62
Table 3.17: Glucose Market for Self-Testing and POC Devices in the U.S., 2000-2012 63
Table 3.18: U.S. Blood Glucose Reagent Strip Marke