发布时间：2007年7月1日

摘要：

The global market for glucose testing products is undergoing a significant transition driven by the advent of new analytical technologies and developments in diabetes treatment. Although the 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, with some-such as non-invasive testing-representing major new areas of application for IVD testing. Direct access testing, or over-the-counter, which allows consumers to order tests themselves without visiting a doctor, has emerged as a strong force in the glucose-testing segment. Moreover, an increasing range of test devices is now available to consumers for use in self-testing. 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, doctors' offices and at-home care locations.
 

正文目录：

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 10
1.5 Executive Summary 11

2. Diabetes 14
2.1 Demographics of Diabetes 16
2.1.1 Worldwide Diabetes Incidence 16
2.1.2 U.S. Diabetes 17
2.2 Economics of Diabetes 20
2.3 Understanding the Metabolic Conditions Underlying and Associated with Diabetes 25
2.3.1 Pre-Diabetes Syndrome 26
2.3.2 Metabolic Syndrome 26
2.3.3 Diabetes and Inflammation 27
2.3.4 Progression of Diabetes 27
2.3.5 Complications and Co-Morbidities in Type 2 Diabetes 27
2.3.6 Hypoglycemia and Treatment 29
2.3.7 Risk Factors and Diabetes 29
2.3.8 Cardiovascular Disease Facts 31
2.4 Glucose Control in Diabetic Patients 36
2.5 Tight Glucose Control in Treating Diabetes 36
2.6 Glucose Monitoring Devices 37
2.6.1 Key Issues Identified for Glucose Monitoring 38
2.6.2 Device Description 38
2.6.3 Precision 40
2.6.4 Limitations of Existing Glucose Monitoring Products 41

3. Glucose Measurements 43
3.1 Glucose Monitoring Markets 43
3.1.1 Overview of Market Segments 43
3.1.1.1 Over-the-Counter (OTC) Self-Testing Glucose Market 45
3.1.1.2 Point- of- Care Glucose Testing Market 46
3.1.1.3 Physician Office Laboratories (POL) Glucose Testing Market 47
3.1.1.4 Clinical Laboratory Glucose Testing Market 48
3.1.2 Market Analysis: Size, Growth, Share and Competitors 49
3.1.2.1 Worldwide Market 49
3.1.2.2 U.S. Market 51
3.1.2.3 European Market 55
3.1.2.4 Asian Market 56
3.1.2.4.1 Japanese Market 58
3.1.2.4.2 China Market 58
3.1.2.4.3 India Market 62
3.1.2.5 ROW Markets 65
3.2 Glucose Analytical Test Methods 65
3.2.1 Glucose Oxidase 65
3.2.2 Glucose Hexakinase 66
3.2.3 Glucose Dehydrogenase Pyrroloquinolinequinone (GDH-PQQ) 66
3.2.4 Amperometric Biosensors 67
3.2.5 Interfering Substances 68
3.2.6 Monitoring HbA1c Levels 68
3.2.7 Quality Control Criteria 68
3.3 Reagents and Equipment 69
3.3.1 Lancets 70
3.3.2 Blood Glucose Test Kit 77
3.3.3 Blood Glucose Monitor and Insulin Doser 78
3.3.4 Diabetes Tracking System 78
3.3.5 Blood Glucose Sensors 78
3.3.6 Blood Glucose Reagent Test Strips 80
3.3.7 Control Solutions and Calibrators 80
3.3.8 Sharps Devices 81
3.3.9 Needle Destruction Devices 81
3.3.10 Urine Strips 82
3.3.11 Blood Ketone Testing 83
3.3.12 Voice Operated Glucose Meters 83
3.4 Glucose Meters 86
3.4.1 LifeScan (a Johnson & Johnson Company) 86
3.4.2 Roche Accu-Chek 90
3.4.3 Bayer 92
3.4.4 Medisense (Abbott) 95
3.4.5 Acon Laboratories 97
3.4.6 HemoCue 97
3.4.7 Agamatrix, Inc. 98
3.4.8 AiMedics, Pty Ltd. 98
3.4.9 Apex Biotechnology Corp. 98
3.4.10 77 Elektronika Kft. 99
3.4.11 Arkray, Inc. 99
3.4.12 Becton Dickinson & Co. 100
3.4.13 Accurex (India) 100
3.4.14 Biosens 100
3.4.15 Axis-Shield 100
3.4.16 Home Diagnostics, Inc. 100
3.4.17 Medisys/Hypoguard 102
3.4.18 Metrika 103
3.4.19 Biopeak, Corp. 103
3.4.20 BioTex, Inc. 103
3.4.21 Calisto Medical, Inc. 103
3.4.22 Allmedicus 104
3.4.23 Diabetech, LP 104
3.4.24 Diagnostic Devices 104
3.4.26 DIRAmed LLC 105
3.4.27 Entelos 105
3.4.28 Fifty 50 Pharmacy 105
3.4.29 Fluent Biomedical Corp. 105
3.4.30 Fovi Optics, Inc. 105
3.4.31 GenExel-Sein, Inc. 106
3.4.32 GlucoLight Corp. 106
3.4.33 Glucon Medical Ltd. 106
3.4.34 GluMetrics LLC 107
3.4.35 Glucoplus, Inc. 107
3.4.36 GlySens, Inc. 107
3.4.37 HMD Bio Medical 107
3.4.38 Hypoguard 107
3.4.39 Infratec, Inc. 108
3.4.40 InLight Solutions, Inc. 109
3.4.41 Insulet Corp. 109
3.4.42 Integrity Applications 110
3.4.43 Kumetrix, Inc. 110
3.4.44 Lein Applied Diagnostics Ltd. 110
3.4.45 Cholestech 111
3.4.46 LighTouch Medical, Inc. 111
3.4.47 LG Electronics 111
3.4.48 Luminous Medical, Inc. 111
3.4.49 Menarini Diagnostics 112
3.4.50 NIR Diagnostics, Inc. 112
3.4.51 Oculir, Inc. 112
3.4.52 OrSense Ltd. 112
3.4.53 Pelikan Technologies, Inc. 113
3.4.54 Polymer Technology Systems 113
3.4.55 PreciSense A/S 114
3.4.56 QuestStar Medical, Inc. 114
3.4.57 Sensys Medical 114
3.4.58 Smiths Medical MD, Inc. 114
3.4.59 TaiDoc Technology Corp. 115
3.4.60 U.S. Diagnostics 115
3.4.61 VeraLight, Inc. 115
3.4.62 Zyvex Corp 115
3.4.63 Advanced Biosensors 116
3.4.64 Health Hero Network, Inc. 116
3.4.65 IN4 Technology Corporation 116
3.4.66 Nipro 116
3.4.67 Teco Diagnostics, Inc. 116
3.4.68 Uchain Industrial Co., Ltd. 116
3.4.69 GlucoStat System 116
3.4.70 Sanyo Junyaku 116
3.4.71 Diagnosys Medical 117
3.5 Diagnosing Diabetes Using In Vitro Laboratory Tests 120
3.5.1 New Diagnostic Guidelines 120
3.5.2 Fasting Plasma Glucose (FPG) Test 120
3.5.3 Glucose Tolerance Test 121
3.5.4 Test for Glycosylated Hemoglobin 121
3.5.5 Fructosamine 121
3.5.6 Combined Self-Testing Glucose Monitor with Insulin Delivery 122
3.6 Continuous and Non-invasive Glucose Patient Monitoring 123
3.6.1 Medtronic MiniMed Continuous Glucose Monitoring System 127
3.6.2 Cygnus GlucoWatch Biographer 128
3.6.3 Abbott FreeStyle Continuous Glucose Monitor System 130
3.6.4 DexCom, Inc. STS Continuous Glucose Monitoring System 130
3.6.5 Sontra Medical, Inc. 131
3.6.6 SpectRx 131
3.6.7 Pendragon Medical 132
3.6.8 Sensors for Medicine and Science, Inc. (SMSI) 132
3.6.9 Other Players 132
3.6.10 Strategies for Developing Non-invasive Continuous Glucose Monitoring 133
3.7 Glycosylated Hemoglobin Glucose Monitoring 133
3.8.1 Ultra-Large Throughput Chemistry Analyzers Large-Throughput Analyzers 137
3.8.2 Large-Throughput Analyzers 139
3.8.3 Mid-Size Clinical Chemistry Analyzers 142
3.8.4 Chemistry Analyzers for the Small Volume Market 145

4. Business Trends in Glucose Testing 149
4.1 Expanding Opportunities in Blood Glucose Monitoring Market 149
4.2 Home Diabetes Test Kits an Evolving Market 149
4.3 Competitive Strategies 150
4.4 Analyses of the Current Market Conditions, Competition and Product Mix 151
4.5 The New Paradigm 152
4.6 Mergers of Diagnostic Companies 153
4.7 Healthcare Cost Controls 154
4.8 Competition for Services 154
4.9 Drivers of Clinical Glucose Testing 155
4.10 Confluence of New Technology 155
4.11 Trends in Reimbursement Practices 155
4.12 Managed Care 157
4.13 Changes in Patient Management 158
4.14 Satellite Facilities 158
4.15 Point-of-Care Testing 158
4.16 Regionalization of Laboratory Care 159
4.17 Drivers of the Point of Care Testing Sector 160
4.18 Diagnostic Testing Growth Trends 160
4.19 PIPE Financing 161
4.20 Brand Loyalty 161
4.21 Insurance Coverage a Key Factor 161
4.22 Medicare Coverage 162
4.23 Products at Competitive Price Points 162
4.24 Drugstores Critical to the Diabetic Care Category 162
4.25 Drugstore Chains Increasingly Running Diabetes Care Programs 162
4.26 Co-branding Strategies 162

5. Important Technology Trends 164
5.1 Biosensor Technology 164
5.2 Data Management 166
5.2.1 Information Management Advances 166
5.2.2 Patient Care Information System Strategy 168
5.2.3 Connectivity Platforms 170
5.2.3.1 DataLink Data Management System 170
5.2.3.2 RALS-Plus 172
5.2.3.3 LabPortal.com 174
5.2.3.4 LifeScan Electronic Data Interfaces 174
5.2.3.5 Computer Software for Home Glucose Meters 175
5.2.3.6 Health Buddy Systems Monitoring Technologies 175
5.2.3.7 Medtronics MiniMed Paradigm Glucose Meter 175
5.2.4 POL Laboratory Data Management 175
5.2.4.1 Electronic Medical Record Systems and Physician Office Laboratory Data Linking Software 175
5.2.4.2 Physician Office Laboratory Data Linking Software and Interface to the Laboratory Information System 177
5.2.5 Technical Problems of Connectivity 177
5.2.6 Web-based Data Interface 177
5.2.7 HIT Competition 178
5.2.8 FDA Required Software Verification 178
5.3 Advantages of Connectivity 178
5.4 Home Care Analysis 179
5.5 Technology Platform Innovations in Glucose Testing 179
5.6 Move Away from Central Laboratory 179
5.7 Trends in Detection and Diagnosis 180
5.7.1 Minimally-Invasive Devices 180
5.7.2 Non-invasive Devices Future Developments and Market Strategy 182
5.7.3 Continuous Test Systems and the Future of Integrated Glucose/Insulin Delivery 183

6. Competitive Analysis of the Glucose Testing Markets 186
6.1 The Market Players 186
6.2 Device Categories 189
6.3 Range of Products 190
6.3.1 Cost of Testing 190
6.3.2 Sample Size Required 190
6.3.3 Sampling Other Areas 191
6.3.4 Time Until Patient Obtains Results 191
6.3.5 Enclosed Test Strips 191
6.3.6 Test Strip Calibration 191
6.3.7 Built-in Lancing Device 191
6.4 Data Handling 191
6.5 New Developments 192
6.6 Marketing New Features 192
6.7 Test Strip Sales 192
6.8 Reimbursement 192
6.9 Strip Manufacturers' Responses 192
6.10 Retailers' Responses 193
6.11 Market Demand and Composition 193
6.12 Product Mix 195
6.12.1 LifeScan 195
6.12.2 Roche Diagnostics 198
6.12.3 Bayer Diagnostics 199
6.12.4 Becton Dickinson 200
6.12.5 Abbott (MediSense) 201
6.12.6 Other Players 202
6.12.6.1 HemoCue AB 204
6.12.6.2 Home Diagnostics, Inc. 204
6.12.6.3 Medisys Group PLC 204
6.12.6.4 Polymer Technology Systems, Inc. 205
6.12.6.5 QuestStar Medical, Inc. 205
6.13 Devices that Measure Glycohemoglobin 205
6.14 Adjacent Markets 205
6.15 Market Drivers and Restraints 206
6.16 Market and Product Trends 206
6.17 Increased Market Penetration 206
6.18 Costs of Doing Business in Europe 207
6.19 Drivers of European Diagnostics Testing 208
6.20 European Reimbursement Practices 208
6.21 Cost Containment in Europe 208
6.22 Market Overview of Glucose Monitoring 208
6.22.1 U.S. Market Segment 209
6.22.2 European Market 210
6.22.3 Japanese Market 211
6.23 Competitive Strategies 212
6.24 Price Competition 213
6.25 Analyses of the Current Market Conditions, Competition and Product Mix 213
6.25.1 First-Generation Monitors 214
6.25.2 Second-Generation Monitors 214
6.25.3 Third-Generation SMBG Technologies 215
6.26 Product Overview 216
6.26.1 LifeScan 216
6.27 Design of Glucose Testing Devices 217
6.28 Insulin Delivery Devices 219
6.29 Key Glucose Testing Sector Developments 223
6.30 Important M&A Activity 224
6.30.1 Cygnus, Inc. Divests its Glucose-Monitoring Assets to Animas Corporation 224
6.30.2 Bayer Diagnostics Business Splits into Two Units 224
6.30.3 Abbott Laboratories Acquires TheraSense, Inc. 224
6.30.4 Roche Acquires Infusion Systems Division of Disetronic 224
6.30.5 J&J Acquires Animas Corporation 224
6.30.6 Medical Devices Pelikan Technologies, Inc. 225
6.30.7 Medical Services Amerifit Nutrition, Inc. 225
6.30.8 Owens & Minor, Inc. 225
6.30.9 Medisys Sells Business to Arkray 225
6.30.10 Cholestech Signs Agreement with Provalis 225
6.30.11 Bayer Acquires Metrika 225
6.30.12 Other Deals 225
6.31 Product Launches 226

7. Government Regulation of Medical Devices 229
7.1 U.S. Regulations 229
7.1.1 Importing Medical Devices into the U.S. 231
7.1.2 Exporting Medical Devices from the U.S. 231
7.2 U.K. Regulations 232
7.3 E.U. Regulations 233
7.4 French Regulations 236
7.5 Japanese Regulations 236
7.6 Korean Regulations 237
7.7 FDA Regulations and Recalls 237
7.8 Legal Liability for Glucose Meters 238
7.9 ISO 9000 Quality System 238
7.10 Recent Regulatory Approvals 238
7.11 FDA Labeling Requirements 238

8 Corporate Profiles 241
8.1 Abbott Diagnostics 241
8.2 Abbott Laboratories 241
8.3 Acon Laboratories 246
8.4 AgaMatrix 246
8.5 AiMedics Pty Ltd. 246
8.6 Animas Corp. 247
8.7 Apex Biotechnology Corporation 247
8.8 Bayer Corporation 247
8.9 Biopeak Corporation 249
8.10 BioTex 249
8.11 Dexcom, Inc. 250
8.12 Diabetech, LP 250
8.13 77 Elektronika Kft. 250
8.14 Flexsite Diagnostics 250
8.15 GenExel-Sein, Inc. 251
8.16 GlucoLight 251
8.17 Glucon 251
8.18 GluMetrics, Inc. 251
8.19 GlySens, Inc. 251
8.20 Hemocue 252
8.21 Hypoguard 252
8.22 Infratec, Inc. 252
8.23 IN4 Technology 253
8.24 InLight Solutions 253
8.25 ITC (International Technidyne Corporation) 253
8.26 LifeScan Corporation 254
8.27 MediSense 255
8.28 Metrika 255
8.29 NIR Diagnostics 255
8.30 Nipro Medical Corporation 255
8.31 OrSense Ltd. 256
8.32 Pelikan Technologies 256
8.33 Polymer Technology Systems 256
8.34 PreciSense 256
8.35 QuestStar Medical 257
8.36 Roche Diagnostics 257
8.37 Sankyo Junyaku 260
8.38 Sanwa Kagaku Kenkyusho Co., Ltd. 260
8.39 Sensys Medical 260
8.40 SurgiLance 261
8.41 Smiths Medical MD, Inc. 261
8.42 SpectRx 261
8.43 Taidoc Technology 262
8.44 Teco Diagnostics 262
8.45 U.S. Diagnostics 262
8.46 VeraLight 262

Appendix 1: List of Competitors for Glucose Test Meters and Equipment 264
Appendix 2: FDA Proprietary Devices for Measuring Blood Glucose 273
Appendix 3: Overview of FDA Device Regulations 282
Appendix 4: Retail Prices of Glucose Meters 285

图表目录：
INDEX OF FIGURES

Figure 2.1: Demographic Changes in Diabetes Populations in 2010, 2025 and 2050 19
Figure 2.2: How Diabetes Dollars Are Spent in the U.S. 23
Figure 2.3: Overlap between Individuals Diagnosed as Diabetic According to Fasting Plasma Glucose Concentration (ADA Criteria) or the Two-Hour Glucose Value (WHO Criteria) 30
Figure 2.4: Single Day Continuous Blood Glucose Data 42
Figure 3.1: Share of the U.S. Self-Testing Diagnostic Market, 2006 54
Figure 3.2: U.S. Mass-Market Sales of Glucose Testing Kits, 2000-2012 54
Figure 7.1: World Medical Device Markets 229
Figure 7.2: Medical Device Market Share by U.S. Owned Companies 229

INDEX OF TABLES

Table 2.1: Normal Glucose Values-Fasting State 15
Table 2.2: Population with Diabetes in the World and in Selected Nations, 2000 and 2030 17
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, 2002-2007 19
Table 2.5: Healthcare Utilization by Diabetic Patients 19
Table 2.6: Age-Adjusted Percentage of Adults with Diabetes Using Diabetes Medication by Type of Medication U.S., 2002-2007 20
Table 2.7: Crude and Age-Adjusted Percentage of Adults with Diabetes Using Diabetes Medication, U.S., 2002-2007 20
Table 2.8: Percentages of Adults with Diabetes Using Diabetes Medication by Age, U.S., 2002-2007 20
Table 2.9: Annual Estimated Cost of U.S. Diabetes Care 21
Table 2.10: Leading Ten Diagnoses by Total U.S. Patient Visits, 2007 22
Table 2.11: U.S. Incidence of Diabetes by Age, 2007 22
Table 2.12: Prevalence, Cost and Medicines for Major Diseases in the U.S., 2007 22
Table 2.13: Top Ten Causes of Death in the U.S., 2007 23
Table 2.14: Per-Event Costs of Diabetes Complications 24
Table 2.15: Percentage of Persons with Type 1 Diabetes Experiencing Various Complications 28
Table 2.16: Incidence and Relative Risk: Patients with Diabetes versus Those without Diabetes 28
Table 2.17: Novel Risk Factors and Possible Mechanisms of the Excess Risk of Coronary Heart Disease in Type 2 Diabetes Mellitus 28
Table 2.19: Worldwide Market for Cardiac Care Therapeutics, 1999-2010 33
Table 2.20: Major Causes of End-Stage Renal Disease 36
Table 2.21: Key Features Considered for Glucose Meter Devices 39
Table 3.1: Laboratory Assessment of Diabetic Vascular Disease 44
Table 3.2: Key Market Drivers for Glucose Testing 44
Table 3.3: Key Customer Segments of Glucose Testing 44
Table 3.4: Demographic Characteristics Home Testing Kit Buyers 45
Table 3.5: Top Brand Preferences for Home Glucose Testing Kits 45
Table 3.6: Instances When Patients Prefer Professional's Glucose Testing 45
Table 3.7: Advantages of a Home Testing Kit 46
Table 3.8: Disadvantages of Using a Home Testing Kit 46
Table 3.9: Popular Shopping Destinations for Buying or Seeking Information on Home Testing Kits 46
Table 3.10: Total Dedicated U.S. Professional Glucose Testing Market, 2000-2012 47
Table 3.11: Point of Care Glucose Testing U.S. (Hospitals), 2000-2012 47
Table 3.12: U.S. POL Glucose Testing, 2000-2012 48
Table 3.13: U.S. Central Lab Glucose Testing (Hospitals and Reference Labs), 2000-2012 49
Table 3.14: Worldwide Central Lab Glucose Testing (Hospitals and Reference Labs), 2000-2012 49
Table 3.15: Worldwide Glucose Self-Testing Market Sales (Meters, Strips, Lancets), 2000-2012 50
Table 3.16: Worldwide Glucose Market for Self-Testing Sales (Meters, Strips, Lancets), 2000-2012 51
Table 3.17: Glucose Market for Self-Testing and POC Devices in the U.S., 2000-2012 52
Table 3.18: U.S. Blood Glucose Reagent Strip Market, 2000-2012 52
Table 3.19: OTC Glucose Meter U.S. Market Share for Blood Glucose Measurements 53
Table 3.20: U.S. Diabetes Glucose Monitoring Market Repeat Retail Replacement Sales Percentages 54
Table 3.21: Top Four Players in the U.S. Blood Glucose Strips Market (Ranked by % Sales), 2006 55
Table 3.22: Leading Blood Glucose Meters and Strips Brands in the U.S. (% Breakdown by Dollar Sales), 2006 55
Table 3.23: European Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-2012 56
Table 3.24: European Glucose Self-Testing Market by Country Market 56
Table 3.25: Asian Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-2012 57
Table 3.26: Japanese Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-2012 58
Table 3.27: Chinese Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-2012 59
Table 3.28: China Blood Glucose Reagent Strip Market, 2000-2012 59
Table 3.29: Indian IVD Market, 2006-2012 62
Table 3.30: Number of Automated Clinical Labs in India, 2004-2012 62
Table 3.31: Indian IVD Market, 2006 63
Table 3.32: Indian Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-2012 63
Table 3.33: Indian Blood Glucose Reagent Strip Market, 2000-2012 64
Table 3.34: ROW Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-2012 65
Table 3.35: Unit Sales of Homecare Lancets in the U.S., 2000-2012 72
Table 3.36: Unit Sales of Lancets in the E.U., 2000-2012 73
Table 3.37: Dollar Sales of Lancets in the U.S., 2000-2012 73
Table 3.38: Dollar Sales of Lancets in the E.U., 2000-2012 74
Table 3.39: Unit Sales of Homecare Glucose Self-testing Lancets in the U.S., 2000-2012 74
Table 3.40: Unit Sales of Homecare Glucose Self-testing Lancets in the E.U., 2000-2012 75
Table 3.41: Competition in the Lancet Market Segment 75
Table 3.42: Technology of Glucose Testing Instruments 79
Table 3.43: Key Features of Reagent Test Strips 80
Table 3.44: Limitations of Urine Glucose Monitoring 82
Table 3.45: Advantages of Urine Glucose Monitoring 83
Table 3.46: Blood Ketone Reading Indications 83
Table 3.47: Customer Priorities-Glucose Meter Self-Testing Market 83
Table 3.48: Accu-Chek Blood Glucose Monitoring Systems 90
Table 3.49: GlucoTrack Comparison and Results 110
Table 3.50: Home Diagnostics' Current Product Portfolio 118
Table 3.51: Relationship of A1c to Average Whole Blood and Plasma Glucose Levels 135
Table 3.52: Distributors of Glucose Meters 136
Table 3.53: Ultra-Large Clinical Chemistry Analyzers 139
Table 3.54: JEOL Analyzer Comparison 140
Table 3.55: Large Clinical Chemistry Analyzers 142
Table 3.56: Mid-size Clinical Chemistry Analyzers 145
Table 3.57: Small Clinical Chemistry Analyzers 148
Table 4.1: U.S. Diabetes Glucose Monitoring Market Segments 152
Table 4.2: Medicare Billing Guidelines for Multichannel Chemistry Tests 156
Table 5.1: Customized Reports must Support CAP and JCAHO Requirements 171
Table 5.2: RALS-Plus Point of Care Market Share 172
Table 5.3: Applications of RALS Connectivity with POCT Devices 173
Table 6.1: Comparisons of Blood Glucose Monitoring Systems 188
Table 6.2: U.S. Diabetes Glucose Monitoring Market, 2006 210
Table 6.3: Syringes for Administering Insulin 220
Table 6.4: Insulin Pens 220
Table 6.5: Injection Aids 221
Table 6.6: Jet Injectors 221
Table 6.7: External Insulin Pumps 222
Table 6.8: Insulin Delivery Device Market, 2004-2014 223
Table 7.1: Products Marketed by Abbott in the Diagnostic Market 244
Table 7.2: Key Roche Diagnostic Products 260