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 the Glucose Testing Markets 218
6.1 The Market Players 218
6.2 Device Categories 221
6.3 Range of Products 222
6.3.1 Cost of Testing 222
6.3.2 Sample Size Required 222
6.3.3 Sampling Other Areas 223
6.3.4 Time Until Patient Obtains Results 223
6.3.5 Enclosed Test Strips 223
6.3.6 Test Strip Calibration 223
6.3.7 Lancing Devices 224
6.4 Data Handling 224
6.5 New Developments 226
6.6 Marketing New Features 227
6.7 Test Strip Sales 227
6.8 Reimbursement 227
6.9 Market Demand and Composition 228
6.10 Product Mix 230
6.10.1 LifeScan 230
6.10.2 Roche Diagnostics 232
6.10.3 Bayer Diagnostics 234
6.10.4 Abbott (MediSense) 234
6.10.5 Other Players 236
6.10.5.1 Hemocue 237
6.10.5.2 Home Diagnostics, Inc. 237
6.10.5.3 ArkRay Hypoguard 238
6.10.5.4 Polymer Technology Systems, Inc. 239
6.10.5.5 QuestStar Medical, Inc. 239
6.11 Devices that Measure Glycohemoglobin 239
6.12 Market Drivers and Restraints 240
6.13 Market and Product Trends 241
6.14 Increased Market Penetration 241
6.15 Costs of Doing Business in Europe 241
6.16 Drivers of European Diagnostics Testing 242
6.17 European Reimbursement Practices 242
6.18 Cost Containment in Europe 242
6.19 Market Overview of Glucose Monitoring 242
6.19.1 U.S. Market Segment 244
6.19.2 European Market 245
6.19.3 Japanese Market 247
6.20 Competitive Strategies 248
6.21 Price Competition 249
6.22 Analyses of the Current Market Conditions, Competition and Product Mix 249
6.22.1 First-Generation Monitors 249
6.22.2 Second-Generation Monitors 250
6.22.3 Third-Generation SMBG Technologies 251
6.23 Design of Glucose Testing Devices 252
6.24 Insulin Delivery Devices 252
6.25 Key Glucose Testing Sector Developments 258
6.26 Important M&A Activity 259
6.27 Product Launches 262
7. Government Regulation of Medical Devices 264
7.1 U.S. Regulations 265
7.1.1 Importing Medical Devices into the U.S. 266
7.1.2 Exporting Medical Devices from the U.S. 267
7.2 U.K. Regulations 267
7.3 E.U. Regulations 268
7.4 French Regulations 274
7.5 Japanese Regulations 274
7.6 Korean Regulations 278
7.7 China Regulations 278
7.8 FDA Regulations and Recalls 282
7.9 Legal Liability for Glucose Meters 283
7.10 ISO 9000 Quality System 283
7.11 Recent Regulatory Approvals 284
7.12 FDA Labeling Requirements 284
8. Corporate Profiles 286
8.1 Abbott Laboratories 286
8.2 Accurex Biomedical 291
8.3 Acon Laboratories 291
8.4 AgaMatrix 291
8.5 AiMedics 291
8.6 Apex Biotechnology 292
8.7 Axis-Shield 292
8.8 Bayer 292
8.9 Biopeak Corporation 293
8.10 BioTex 293
8.11 Calisto Medical 293
8.12 Cybermedical 294
8.13 DexCom 294
8.14 Diabetech 295
8.15 DIRAmed 295
8.16 Echo Therapeutics 295
8.17 Entelos 296
8.18 Fora Care 296
8.19 Glucoplus 296
8.20 77 Elektronika 296
8.21 Flexsite Diagnostics 297
8.22 GenExel-Sein 297
8.23 GlucoLight 297
8.24 GluMetrics 298
8.25 GlySens 298
8.26 Hemocue 298
8.27 Home Diagnostics 299
8.28 HTL Strefa 300
8.29 Hypoguard 300
8.30 IN4 Technology 301
8.31 InLight Solutions 301
8.32 International Technidyne 301
8.33 Insulet 302
8.34 IntelliDx 302
8.35 Lein Applied Diagnostics 302
8.36 LifeScan 303
8.37 Luminous Medical 304
8.38 Medtronic 304
8.39 Menarini Diagnostics 305
8.40 Newton Photonics 306
8.41 Nipro Medical 306
8.42 OrSense 306
8.43 Panasonic Shikoku Electronics 306
8.44 Pelikan Technologies 307
8.45 Polymer Technology Systems 307
8.46 PreciSense 307
8.47 Roche Diagnostics 308
8.48 Sanko Junyaku 310
8.49 Sanwa Kagaku Kenkyusho 310
8.50 Sensys Medical 311
8.51 Solianis Holding 311
8.52 SurgiLance 312
8.53 Smiths Medical MD 312
8.54 SpectRx 312
8.55 Taidoc Technology 312
8.56 Teco Diagnostics 313
8.57 U.S. Diagnostics 313
8.58 VeraLight 313
8.59 Ypsomed Holding 314
8.60 Zyvex 314
Appendix 1: Contact Information for Companies Profiled 315
Appendix 2: List of Competitors for Glucose Test Meters and Equipment 322
Appendix 3: FDA Proprietary Devices for Measuring Blood Glucose 331
Appendix 4: Overview of FDA Device Regulations 340
Appendix 5: Retail Prices of Glucose Meters 343
Appendix 6: Glucose Meters: Components, Design, Sources 348
Appendix 7: Pharmaceutical Sampling Practices 354
INDEX OF FIGURES
Figure 2.1: Worldwide Rates of Diabetes Cases, 2000-2025 18
Figure 2.2: Prevalence of Diabetes by Age in the U.S., 2007 20
Figure 2.3: New Cases of Diabetes Diagnosed in the U.S. Adult Population, 2007 21
Figure 2.4: Rate of New Diabetes Cases among Children in the U.S., 2007 22
Figure 2.5: Diabetes Death Rate by Race and Sex in the U.S., 1979-2006 25
Figure 2.6: Annual Death Rate of U.S. Population from Heart Disease, 1950-2008 26
Figure 2.7: How Diabetes Dollars Are Spent in the U.S., 2007 29
Figure 2.8: Percentage Breakdown of U.S. Healthcare Spending, 2008 30
Figure 2.9: Percentage of U.S. Population that is Overweight, 1976-2004 32
Figure 2.10: Hypertension Drugs Newly Prescribed or Continued in the U.S., 1994-2007 40
Figure 3.1: Glucose Self-Monitoring Market Share by Geographical Region, 2007 55
Figure 3.2: Share of the U.S. Self-Testing Diagnostic Market, 2008 59
Figure 3.3: Domestic Manufacturers’ Share of Chinese Glucose Meter Market, 2007 65
Figure 3.4: Personal Lancet Unit Sales Market Share by Geographic Region, 2008 83
Figure 3.5: Estimated U.S. Inpatient Volume, 2008 154
INDEX OF TABLES
Table 2.1: Normal Glucose Values—Fasting State 16
Table 2.2: Countries with the Largest Numbers of Diabetics, 2007 and 2025 18
Table 2.3: U.S. Population of Diabetics (Diagnosed and Undiagnosed) by Ethnic Group, 2007 20
Table 2.4: Healthcare Utilization by Diabetic Patients, 2006 20
Table 2.5: Cost of Diabetes in the U.S., 2007 23
Table 2.6: Ten Leading Diagnoses for Co-morbid Chronic Diseases in the U.S., by Percentage of Patient Visits, 2006 24
Table 2.7: U.S. Incidence of Diagnosed Diabetes by Age, 2006 24
Table 2.8: Prevalence and Financial Burden of Major Diseases in the U.S., 2007 24
Table 2.9: Top Twelve Causes of Death in the U.S., 2006 25
Table 2.10: Death Rate from Cardiovascular Diseases by Country, 2008 26
Table 2.11: Life Expectancy Rate by Country, 2008 27
Table 2.12: Per-Event Costs of Diabetes Complications 28
Table 2.13: Odds Ratio of Progression to Complications Associated With Type 2 Diabetes 34
Table 2.14: Prevalence of Complications among Patients with Diabetes 34
Table 2.15: Novel Risk Factors and Possible Mechanisms of the Excess Risk of Coronary Heart Disease in Type 2 Diabetes Mellitus 35
Table 2.16: Average Years Gained Free of Diabetes-Related Disease with Intensive Management 35
Table 2.17: Estimated Direct and Indirect Costs of Major Cardiovascular Diseases and Stroke in the U.S., 2008 38
Table 2.18: Worldwide Market for Cardiac Care Therapeutics, 2003-2010 39
Table 2.19: Top 20 Drugs for 2007 by U.S. Sales 41
Table 2.20: Major Causes of End-Stage Renal Disease 43
Table 2.21: Key Features Considered for Glucose Meter Devices 46
Table 3.1: Laboratory Assessment of Diabetic Vascular Disease 51
Table 3.2: Key Market Drivers for Glucose Testing 51
Table 3.3: Key Aspects of Professional Glucose Testing 51
Table 3.4: Demographic Characteristics Home Testing Kit Buyers 52
Table 3.5: Top Brand Preferences for Home Glucose Testing Kits 52
Table 3.6: Instances When Patients Prefer Professional Glucose Testing 52
Table 3.7: Advantages of a Home Testing Kit 53
Table 3.8: Disadvantages of Using a Home Testing Kit 53
Table 3.9: Popular Shopping Destinations for Buying or Seeking Information on Home Testing Kits 53
Table 3.10: Total Global Professional Glucose Testing Market, 2007-2012 53
Table 3.11: Worldwide Glucose Self-Testing Market Sales (Meters, Strips, Lancets), 2004-2012 55
Table 3.12: Percentage of GDP Healthcare Spending by Country, 2008 56
Table 3.13: Worldwide Glucose Market for Self-Testing Sales (Meters and Strips), 2004-2012 56
Table 3.14: U.S. Blood Glucose Reagent Strip Market, 2004-2013 57
Table 3.15: U.S. Sales for OTC Blood Glucose Meters and Strips, 2007 58
Table 3.16: Top Four Players in the U.S. Blood Glucose Strips Market (Ranked by % Sales), 2008 59
Table 3.17: European Glucose Self-Testing Market (Meters, Strips, Lancets), 2003-2012 60
Table 3.18: Asian Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-2012 61
Table 3.19: Japanese Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-2012 62
Table 3.20: Chinese Glucose Self-Testing (Meters, Strips, Lancets) Market and Professional POC Devices, 2000-2012 64
Table 3.21: China Blood Glucose Reagent Strip Market, 2000-2012 64
Table 3.22: Indian IVD Market, 2006-2012 67
Table 3.23: Number of Clinical Labs in India, 2008 68
Table 3.24: Indian IVD Market Sectors and Market Share, 2006 69
Table 3.25: Indian Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-2012 69
Table 3.26: Indian Blood Glucose Reagent Strip Market, 2000-2012 70
Table 3.27: Top Domestic IVD Companies in India 71
Table 3.28: Leading Global IVD Companies in India, 2008 71
Table 3.29: BRIC countries, Percentage of GDP Spent on Healthcare, 2008 72
Table 3.30: ROW Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-2012 74
Table 3.31: Global Unit Sales of Home care Lancets, 2006-2012 81
Table 3.32: Dollar Sales of Lancets in the U.S., 2000-2012 81
Table 3.33: Dollar Sales of Lancets in the E.U., 2000-2012 81
Table 3.34: Unit Sales of Homecare Glucose Self-testing Lancets in the U.S., 2000-2012 82
Table 3.35: Unit Sales of Homecare Glucose Self-testing Lancets in the E.U., 2000-2012 82
Table 3.36: Competition in the Lancet Market Segment 83
Table 3.37: Currently Available Lancing Devices and Lancets 85
Table 3.38: Customer Priorities—Glucose Meter Self-Testing Market, 2001-2012 88
Table 3.39: Current Blood Glucose Meters: Pricing, Sample Size, Features 88
Table 3.40: Technology of Glucose Testing Instruments 90
Table 3.41: Key Features of Reagent Test Strips 93
Table 3.42: Limitations of Urine Glucose Monitoring 96
Table 3.43: Advantages of Urine Glucose Monitoring 96
Table 3.44: Blood Ketone Reading Indications 97
Table 3.45: Accu-Chek Blood Glucose Monitoring Systems 103
Table 3.46: GlucoTrack Comparison and Results 116
Table 3.47: Home Diagnostics’ Current Product Portfolio 132
Table 3.48: Detailed Features of Selected CGM Systems Currently Available 140
Table 3.49: Relationship of A1C to Average Whole Blood and Plasma Glucose Levels 152
Table 3.50: Distributors of Glucose Meters 153
Table 3.51: Ultra-Large Clinical Chemistry Analyzers 157
Table 3.52: JEOL Analyzer Comparison 158
Table 3.53: Large Clinical Chemistry Analyzers 160
Table 3.54: Mid-size Clinical Chemistry Analyzers 163
Table 3.55: Small Clinical Chemistry Analyzers 166
Table 4.1: Medicare Billing Guidelines for Multichannel Chemistry Tests 177
Table 5.1: Customized Reports Must Support CAP and JCAHO Requirements 198
Table 5.2: Applications of RALS Connectivity with POCT Devices 198
Table 6.1: Comparisons of Blood Glucose Monitoring Systems 220
Table 6.2: Major Lancing Devices on the Market 224
Table 6.3: Glucose Meters Offering Data Management 225
Table 6.4: Comparison of A1C Home Test Kits. 240
Table 6.5: Unit Costs of Glucose-Monitoring Supplies in the U.K. 247
Table 6.6: Annual Costs of SMBG in the U.K. 247
Table 6.7: Syringes for Administering Insulin 253
Table 6.8: Insulin Pens 253
Table 6.9: Injection Aids 254
Table 6.10: Jet Injectors 254
Table 6.11: External Insulin Pumps 255
Table 6.12: Status of Inhaled Insulin Products, 2009 257
Table 6.13: Insulin Delivery Device Market, 2004-2014 258
Table 7.1: Leading Global Medical Device Companies, 2007 264
Table 7.2: Imports of U.S. Medical Devices to Japan, 2005-2007 275
Table 8.1: Products Marketed by Abbott in the Diagnostic Market 289
Table 8.2: Key Roche Diagnostic Products 310
Table A1.1: Company Headquarters Contact Information 315
Table A2.1: Glucose Meters and Equipment– List of Manufacturers and Suppliers 322
Table A3.1: Detailed Information on Available Glucose Meters 331
Table A5.1: Glucose Meters’ Pricing 343
Table A6.1: Contract Manufacturers for Glucose Meter Components 351
Table A6.2: ASIC manufacturers 353 |
