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U.S. Glucose Testing Markets

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Publication Date:
June 2012; Pages: 252
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U.S. glucose testing is undergoing a significant transition, driven by new analytical technologies and developments in diabetes treatment. Although the blood glucose testing segment of the in vitro diagnostics (IVD) industry is mature, several segments of the market, such as home testing devices for diabetes management and point of care (POC) instruments for use in professional settings, will exhibit strong growth. Direct access testing has emerged as a strong force in the blood glucose testing segment, and non-invasive and minimally-invasive testing now represent major new areas for the application of IVD testing. This TriMark Publications report describes the specific market segments for blood glucose testing and diabetes management in the U.S. market. It reviews all of the generally-accepted clinical analytical methods that are currently in use today for measuring serum, plasma or whole-blood glucose concentrations. Additionally, this study examines clinical measurement devices, reagents and supplies as utilized in hospitals, clinics, doctor’s offices and at-home care locations. Moreover, it analyzes almost all of the companies known to be marketing, manufacturing or developing glucose testing products for the U.S. market. Each company is discussed in extensive depth with a section on its history, product line, business and marketing analysis, and a subjective commentary of the company's market position. Detailed tables and charts with sales forecasts and market data are also included.

 

TABLE OF CONTENTS

1. Overview 11
1.1 Statement of Report 11
1.2 About this Report 11
1.3 Scope of the Report 12
1.4 Methodology 13
1.5 Executive Summary 14
2. Diabetes 16
2.1 Demographics of Diabetes in the U.S. 17
2.2 Understanding the Metabolic Conditions Underlying and Associated with Diabetes 21
2.2.1 Pre-Diabetes Syndrome 23
2.2.2 Metabolic Syndrome 23
2.2.3 Progression of Diabetes 23
2.2.4 Diabetes and Inflammation 23
2.2.5 Risk Factors and Diabetes 24
2.2.5.1 Obesity 25
2.2.5.2 Stress-induced Hyperglycemia 27
2.2.6 Complications and Co-Morbidities in Diabetes 27
2.2.6.1 Preventing Complications and Co-Morbidities in Diabetes 30
2.2.6.2 Cardiovascular Disease Facts 32
2.3 Economics of Diabetes 36
3. Market Analysis: Size, Growth, Share and Competitors 42
3.1 U.S. Market 43
3.1.1 U.S. Over-the-Counter (OTC) Self-testing Glucose Market 44
3.1.2 U.S. Professional Glucose Testing Market 50
3.1.3 Continuous Glucose Monitoring Markets 51
3.2 Competitive Situation 51
3.2.1 Key Players 51
3.2.2 Analyses of the Current Market Conditions, Competition and Product Mix 52
3.3 Market Drivers and Restraints 55
3.3.1 Market Drivers 55
3.3.2 Market Restraints 56
3.4 Market and Product Trends 58
3.4.1 Market Trends 59
3.4.2 Technology Trends 59
3.5 Strategic Recommendations 61
3.6 Competitive Strategies 62
3.7 Analysis of the Glucose Point of Care Market 64
3.8 Adjacent Markets 65
4. Glucose Diagnostic and Monitoring Recommendations 66
4.1 Diagnosis of Diabetes Mellitus 66
4.2 Tight Glucose Control in Treating Diabetes 67
4.3 Recommendations for Glucose Control in Diabetics 69
4.3.1 Recommended Frequency of Blood Glucose Self-Testing 70
4.3.2 Recommendations for Diabetes Care and Glucose Testing in the Hospital Setting 71
4.3.3 Using Blood Glucose Data to Monitor and Modify Patient Therapy 74
4.3.4 Testing in Individuals with Type 2 diabetes 75
4.3.5 Continuous Glucose Monitoring (CGM) 76
4.3.6 A1c Testing Recommendations 78
4.4 Hypoglycemia and Treatment 78
5. Glucose Testing Technology Platforms and Consumable Products 80
5.1 Types of Glucose Determination Technologies 80
5.2 Enzymatic Reactions Used to Determine Glucose Concentrations 81
5.2.1 Glucose Oxidase (GOX) 81
5.2.2 Glucose Dehydrogenase (GDH) 82
5.2.2.1 GDH-NAD (Glucose dehydrogenase - Nicotinamide adenine dinucleotide) 82
5.2.2.2 GDH-FAD (Glucose dehydrogenase - flavin adenine dinucleotide) 82
5.2.2.3 GDH-PQQ (Glucose dehydrogenase - Pyrroloquinoline quinone) 83
5.2.3 Glucose Hexokinase 83
5.3 Development of Blood Glucose Monitors: A Historical Evaluation 83
5.3.1 First Generation Blood Glucose Biosensors 83
5.3.2 Second Generation Blood Glucose Biosensors 83
5.3.3 Third Generation Blood Glucose Biosensor 84
5.4 Accuracy and Precision in Glucose Meters 84
5.4.1 FDA Recommendations 86
5.4.2 Determining Clinical Accuracy Using the Error Grid Analysis (EGA) 86
5.4.3 Quality Control Criteria 87
5.4.4 Potential Variables Affecting Glucose Concentrations 88
5.5 Key Issues for Glucose Testing Devices 88
5.5.1 Important Elements for Glucose Testing 90
5.5.2 Key Features to Aid Specific Patient Populations 91
5.6 Limitations of Existing Glucose Testing 92
5.6.1 Common User Errors in Glucose Self-testing 93
5.6.2 Interfering Substances and Conditions 94
5.6.2.1 Environmental 94
5.6.2.2 Physiologic 94
5.6.2.3 Operational 94
5.6.2.4 Manufacturing Variations 94
5.6.2.5 Drugs 94
5.6.3 Errors Associated with GDH-PQQ Technology 95
5.6.4 Optimizing of Point of Care (POC) Blood Glucose Testing 98
5.7 Potential Areas of Improvement in Blood Glucose Meter Performance 99
5.8 Blood Glucose Reagent Test Strips 100
5.9 Comparison of Handheld Blood Glucose Meters with Clinical Laboratory Glucose Measurements 101
5.10 Continuous Glucose Monitoring Technology 102
5.10.1 Advantages of Continuous Readings 102
5.10.2 FDA Approval of CGM 102
5.10.3 CGM Functions to Consider 103
5.10.4 New Technologies for CGM 104
5.11 Summary of Technologies Being Explored for Non-invasive Glucose Monitoring 105
5.11.1 Goals of Non-invasive Testing 106
5.11.2 Non-invasive Diabetes Screening Test 107
5.12 A1c Monitoring Technology 107
5.13 Related Reagents and Equipment 108
5.13.1 Lancets 108
5.13.1.1 Types of Lancing Devices 109
5.13.1.2 Market Size 110
5.13.2 Control Solutions and Calibrators 115
5.13.3 Sharps Devices 116
5.13.4 Needle Destruction Devices 116
5.13.5 Urine Strips 117
5.13.6 Ketone Testing 118
6. Glucose Testing Devices on the Market 120
6.1 Handheld Blood Glucose Meters and Strips for Self-testing 120
6.1.1 LifeScan 123
6.1.2 Roche Diagnostics Corporation 125
6.1.3 Bayer 126
6.1.4 Abbott (MediSense) 127
6.1.5 Agamatrix, Inc. 129
6.1.6 Arkray, Inc. 131
6.1.7 Bionime Corporation 132
6.1.8 BioSense Medical Devices 134
6.1.9 Diabetic Supply of Suncoast 134
6.1.10 Prodigy Diabetes Care, LLC (an affiliate of Diagnostic Devices, Inc.) 135
6.1.11 Entra Health Systems 136
6.1.12 Fifty50 Pharmacy 136
6.1.13 Fora Care 137
6.1.14 Nipro Diagnostics, Inc. 137
6.1.15 Nova Biomedical 139
6.1.16 Oak Tree International Holdings, Inc. 139
6.1.17 Tyson Biomedical 139
6.1.18 US Diagnostics 140
6.1.19 77 Elektronika Kft. 141
6.1.20 A. Menarini Diagnostics 141
6.1.21 Allmedicus 141
6.1.22 i-SENS 142
6.1.23 Apex Biotechnology Corp. 142
6.1.24 GenExel-Sein, Inc. 142
6.1.25 Glucoplus, Inc. 143
6.1.26 Polymer Technology Systems 143
6.1.27 Smiths Medical MD, Inc. 143
6.1.28 TaiDoc Technology Corp. 143
6.1.29 IN4 Technology Corporation 143
6.1.30 ACON Laboratories 143
6.1.31 Pepex Biomedical 144
6.1.32 HMD BioMedical 144
6.1.33 BTNX 144
6.2 Handheld Blood Glucose Meters for Professional Use 145
6.2.1 Abbott 147
6.2.2 Alere 148
6.2.3 Arkray 148
6.2.4 HemoCue (a Quest Diagnostics company) 149
6.2.5 HMD BioMedical 149
6.2.6 Medtronic 149
6.2.7 Nova Biomedical 149
6.2.8 Polymer Technology Systems 150
6.2.9 Roche 150
6.2.10 Techno Medica Co., Ltd 151
6.2.11 LifeScan 151
6.3 Clinical Blood Chemistry Analyzers 151
6.3.1 Abaxis, Inc. 154
6.3.2 Alere 154
6.3.3 Arkray 154
6.3.4 Beckman Coulter 155
6.3.5 DiaSys 155
6.3.6 Instrumentation Laboratory 156
6.3.7 International Techidyne Corporation (ITC) 156
6.3.8 Nova Biomedical 156
6.3.9 Radiometer 157
6.3.10 Roche 158
6.3.11 Siemens Healthcare Diagnostics 159
6.3.12 Span Diagnostics 161
6.3.13 Stanbio Laboratory 162
6.3.14 Techno Medica Co., Ltd 162
6.4 Continuous Glucose Patient Monitoring Systems 162
6.4.1 Medtronic’s Continuous Glucose Monitoring Systems (CGMS) 164
6.4.2 DexCom, Inc. STS Continuous Glucose Monitoring System 166
6.4.3 FreeStyle Navigator – Abbott’s Continuous Glucose Monitor System 167
6.4.4 Minimally-invasive Continuous Glucose Monitors in Development 167
6.4.4.1 GlySens Inc. 167
6.4.4.2 Sensors for Medicine and Science 168
6.4.4.3 Ultradian Diagnostics 168
6.4.4.4 Luminous Medical 168
6.4.4.5 Kumetrix 169
6.4.4.6 GluMetrics 169
6.4.4.7 GlySure Limited 170
6.5 Non-invasive Glucose Patient Monitoring Systems 170
6.5.1 Cygnus GlucoWatch Biographer 171
6.5.2 AiMedics 171
6.5.3 BioTex 171
6.5.4 Calisto Medical 171
6.5.5 Echo Therapeutics 172
6.5.6 EyeSense GmbH 173
6.5.7 Freedom Meditech 173
6.5.8 Grove Instruments 173
6.5.9 Integrity Applications Ltd. 174
6.5.10 Lein Applied Diagnostics 174
6.5.11 LighTouch Medical 174
6.5.12 OrSense Ltd 174
6.5.13 Solianis Monitoring AG 175
6.5.14 VeraLight 175
6.5.15 Xhale Inc. 176
6.6 A1c Testing 176
6.7 New Product Launches 177
6.7.1 mySentry Remote Glucose Monitor 177
6.7.2 HealthPia GlucoPhone 177
6.7.3 MyGlucoHealth Diabetes 177
6.7.4 gDrive 178
6.7.5 GluCoMo 178
6.7.6 OneTouch Delica Lancing System 178
6.7.7 ARK Care 178
6.7.8 OneTouch Verio IQ System with PatternAlert Technology 178
6.7.9 Medtronic Announces Mac Compatibility for CareLink® Personal Therapy Management
Software for Diabetes 179
6.7.10 Fora Care G31 and D30 179
6.7.11 Telcare’s BGM 3G Blood Glucose Meter 179
6.7.12 iPro2 Professional CGM 179
6.7.13 Contour USB 180
6.7.14 Roche’s Accu-Chek Aviva Plus Test Strip 180
6.7.15 Infopia’s SmartDiabetes Product Line 180
6.7.16 Infopia’s Element Plus 180
6.7.17 Wireless Connectivity for Nova Biomedical’s Hospital Glucose Meters 180
6.7.18 Glooko’s Logbook 180
6.7.19 SweetSpot Diabetes Data Management Service 181
6.7.20 Accu-Chek Nano SmartView 181
6.8 New Blood Glucose Meters and Data Management Software in Development 181
6.8.1 Paradigm Veo 181
6.8.2 Sanofi-Aventis’s iBGStar 181
6.8.3 Jazz Wireless 181
6.8.4 iglucose 181
6.8.5 Enlite Sensor 182
6.8.6 Long-term Glucose Sensing Bio-Implants 182
6.9 Recent Industry Activity 182
6.9.1 Roche Diagnostics Corp Expanding Indianapolis Manufacturing Plant 182
6.9.2 AgaMatrix and Sanofi-Aventis Enter Global Diabetes Partnership 183
6.9.3 LifeScan Inc. Terminates Exclusive Supply Agreement with Medtronic MiniMed 183
6.9.4 Kroger Selects WaveSense Diabetes Testing Products 183
6.9.5 Medtronic and Bayer Healthcare Expand International Alliance 183
6.9.6 Medtronic Opens New Diabetes Center In San Antonio 183
6.9.7 Abbott Diabetes Care Announces Recall of Certain Lots of Precision Xtra®, Precision
Xceed Pro®, MediSense® Optium™, Optium™, OptiumEZ and ReliOn® Ultima Blood
Glucose Test Strips in the United States and Puerto Rico 183
6.9.8 Abbott Receives FDA Clearance for New, Easier-to-Use FreeStyle Lite® Test Strips 184
6.9.9 DexCom Receives CE Mark Approval for the SEVEN(R) Continuous Glucose Monitoring
System 184
6.9.10 iBGStarTM Blood Glucose Monitoring System Receives U.S. FDA 510(k) Clearance 184
6.9.11 PositiveID Corporation and IDEAL LIFE Partner to Bring iglucose to Market for Wireless
Diabetes Management 184
6.9.12 Roche Diagnostics U.S. and DexCom, Inc. Announce Research and Development Agreement 185
6.9.13 Infopia America Partners with Walgreens Drugstores 185
6.9.14 Qualcomm Forms Qualcomm Life Subsidiary 185
6.9.15 Medtronic Partners with Ford Motor to Develop an In-car Glucose Monitor 186
6.9.16 Perrigo and AgaMatrix Enter into an Exclusive Sales and Distribution Agreement 186
6.9.17 Medtronic, Bayer Healthcare extend diabetes alliance 186
6.9.18 Zyxel Integrates its Smart Home Gateway with Entra Health Systems' Wireless Glucometer 186
6.9.19 Pepex Biomedical Signs Seven Year Deal to Manufacture Trio 186
6.9.20 DexCom and Tandem Diabetes Care Team Up for CGM Development and Commercialization 186
6.9.21 Insulet Corporation Signs Worldwide Agreement with LifeScan 187
6.10 M&A Activity 187
6.10.1 Home Diagnostics, Inc. and Nipro Diabetes Systems, Inc. Merge to Become Nipro
Diagnostics, Inc. 187
6.10.2 Medtronic, Inc. (MDT) Acquires New Diabetes Technology from PreciSense AS 187
6.10.3 Geonostics Acquires FlexSite's Consumer Diabetes Tests 188
6.10.4 Additional M&A 188
6.10.5 Important Deals in BGM market 188
7. Business Trends in Glucose Testing 190
7.1 Drivers of Clinical Glucose Testing 190
7.2 Competition for Services 190
7.3 Healthcare Cost Controls 190
7.4 Changes in Patient Management 191
7.5 Regionalization of Laboratory Care 191
7.6 Satellite Facilities 192
7.7 Point of Care Testing 192
7.8 Factors Affecting OTC Medical Product Distribution 193
7.9 Drugstores Critical to the Diabetic Care Category 195
7.10 Drivers of OTC and Self-testing Markets 195
7.10.1 Brand Loyalty 196
7.11 Cost Elements of Glucose Self-testing 196
7.12 Blood Glucose Self-testing Insurance Coverage and Reimbursement 196
7.13 Trends in U.S. Laboratory Testing Reimbursement Practices 198
7.14 Reimbursement Challenges 201
7.15 Managed Care 201
7.16 Government Regulation of Medical Devices 202
7.17 Clinical Laboratory Improvement Act (CLIA) 204
7.18 FDA Labeling Requirements 207
7.19 Legal Liability for Glucose Meters 208
8. Technology Trends 209
8.1 Improving Today’s OTC Blood Glucose Meters 209
8.2 Biosensor Technology 210
8.3 Fructosamine Test 212
8.4 Telemedicine Devices 212
8.4.1 Remote Patient Monitoring 214
8.4.1.1 Infopia Eocene System 216
8.4.2 Health Buddy Systems Monitoring Technologies 216
8.5 Non-Traditional Methods for Sample Collection 216
8.6 Data Management 217
8.6.1 Receiver Technology 217
8.6.2 Connectivity 217
8.6.3 Advantages of Connectivity 219
8.6.4 Connectivity Platforms 220
8.6.5 DataLink Data Management System 221
8.6.6 RALS-Plus 222
8.6.7 FDA Required Software Verification 222
8.6.8 Information Management Advances 223
8.6.9 POL Laboratory Data Management 224
8.6.9.1 Electronic Medical Record Systems and Physician Office Laboratory Data-linking Software 225
8.6.9.2 Physician Office Laboratory Data-linking software and Interface to the Laboratory
Information System 226
8.6.9.3 Technical Problems of Connectivity 227
8.6.9.4 Web-based Data Interface 227
8.6.10 HIT Competition 228
9. Company Profiles 229
9.1 Abaxis, Inc. 229
9.2 Abbott Laboratories 232
9.3 ACON Laboratories 234
9.4 AgaMatrix 234
9.5 Alere 234
9.6 Allmedicus 236
9.7 Amedica Biotech 236
9.8 A. Menarini Diagnostics 236
9.9 Apex Biotechnology Corporation 236
9.10 Arkray 237
9.11 Bayer 237
9.12 B. Braun Melsungen 237
9.13 Beckman Coulter 238
9.14 Bionime 240
9.15 Bio-Rad Laboratories, Inc. 240
9.16 BioTex 241
9.17 Calisto Medical 241
9.18 Cambridge Sensors 241
9.19 DexCom 241
9.20 Diagnostic Devices/Prodigy Diabetes Care 241
9.21 DiaSys 242
9.22 Echo Therapeutics 242
9.23 Entra Health Systems 242
9.24 Fora Care 242
9.25 Freedom Meditech 242
9.26 Genesis Health Technologies 242
9.27 GenExel-Sein 242
9.28 GlucoPlus 243
9.29 GluMetrics 243
9.30 GlySens 243
9.31 GlySure Limited 244
9.32 Grove Instruments 244
9.33 Hainice Medical 244
9.34 HemoCue (a Quest Diagnostics company) 244
9.35 Home Diagnostics 244
9.36 Infopia 244
9.37 IN4 Technology 245
9.38 International Techidyne Corporation (ITC) 245
9.39 Instrumentation Laboratory Company 245
9.40 i-Sens 245
9.41 Johnson & Johnson 246
9.42 Luminous Medical 246
9.43 Medtronic 247
9.44 Nipro Corporation 247
9.45 Nova Biomedical 247
9.46 OrSense 248
9.47 Polymer Technology Systems 248
9.48 Radiometer Medical 248
9.49 Roche 249
9.50 77 Elektronika Kft. 250
9.51 Siemens AG 250
9.52 Smiths Group 251
9.53 Stanbio Laboratory 251
9.54 TaiDoc Technology 252
9.55 Techno Medica Co., Ltd. 252
9.56 U.S. Diagnostics 252
9.57 VeraLight 252

INDEX OF FIGURES

Figure 2.1: Prevalence of Diabetes by Age in the U.S., 2010 18
Figure 2.2: New Cases of Diabetes Diagnosed in the U.S. Adult Population, 2010 19
Figure 2.3: County-specific Diabetes Prevalence in the U.S., 2008 19
Figure 2.4: Diabetes Death Rate by Race and Sex in the U.S., 1979-2006 20
Figure 2.5: Rate of New Diabetes Cases among Children in the U.S., 2007 21
Figure 2.6: Maintenance of Normal Blood Sugar Levels 22
Figure 2.7: Obesity (BMI ³ 30) Prevalence in U.S. Adults, 2010 25
Figure 2.8: Prevalence of Obesity among Men Aged 20 Years and Older by Race/Ethnicity in the U.S.,
1988-1994 and 2007-2008 26
Figure 2.9: Prevalence of Obesity among Women Aged 20 Years and Older by Race/Ethnicity in the U.S.,
1988-1994 and 2007-2008 26
Figure 2.10: Trends in Obesity among Children and Adolescents in the U.S., 1963-2008 27
Figure 2.11: Mean Diabetes Healthcare-related Expenditures Per Adult (20-79 Years) with
Diabetes (USD), 2011 36
Figure 2.12: How Diabetes Dollars are Spent in the U.S., 2007 39
Figure 3.1: Forecasted Test Strip Usage by Different Diabetic Populations 45
Figure 4.1: Glycemic Status - Ranges and Health Implications 72
Figure 5.1: EGA Zones of Clinical Accuracy 87
Figure 5.2: Single-day Continuous Blood Glucose Data 93
Figure 5.3: Factors that May Adversely Affect Glucose Testing 95
Figure 5.4: Personal Lancet Unit Sales Market Share by Geographic Region, 2011 113

INDEX OF TABLES

Table 2.1: U.S. Population of Diabetics (Diagnosed and Undiagnosed) Aged 20 Years or Older, 2010 17
Table 2.2: U.S. Incidence of Diagnosed Diabetes by Age, 2009 18
Table 2.3: Ten Leading Diagnoses for Co-morbid Chronic Diseases in the U.S., by Percentage of Patient
Visits, 2006 28
Table 2.4: Odds Ratio of Progression to Complications Associated with Type 2 Diabetes 29
Table 2.5: Prevalence of Complications among Patients with Diabetes 29
Table 2.6: Novel Risk Factors and Possible Mechanisms of the Excess Risk of Coronary Heart Disease in
Type 2 Diabetes Mellitus 30
Table 2.7: Major Causes of End-stage Renal Disease 30
Table 2.8: Clinical Recommendations for Adults with Diabetes 31
Table 2.9: Laboratory Assessment of Diabetic Vascular Disease 31
Table 2.10: Average Years Gained Free of Diabetes-related Disease with Intensive Management 31
Table 2.11: Estimated Direct and Indirect Costs of Major Cardiovascular Diseases and Stroke in the U.S., 2008 33
Table 2.12: Worldwide Market for Cardiac Care Therapeutics, 2003-2010 33
Table 2.13: Top 20 Drugs for 2010 by U.S. Sales 34
Table 2.14: Cost of Diagnosed Diabetes in the U.S., 2007 36
Table 2.15: Cost of Diagnosed Type 1 and Type 2 Diabetes in the U.S., 2007 37
Table 2.16: Medical Care Costs Attributable to Diabetes in the U.S., 2010 37
Table 2.17: Healthcare Utilization by Diabetic Patients, 2008 38
Table 2.18: Annual Cost of Care of United Healthcare Adult Members with Diabetes, 2009 39
Table 2.19: Per-event Costs of Diabetes Complications 40
Table 3.1: Comprehensive U.S. Glucose Testing Market (includes reagents and supplies in the Self-testing
and Professional Markets), 2010-2016 43
Table 3.2: U.S. Blood Glucose Reagent Strip Market (includes both Self-testing and Professional Markets),
2010-2016 44
Table 3.3: Market for Glucose Self-testing in the U.S. (includes Meters, Strips, and Lancets), 2010-2016 45
Table 3.4: Market Share of U.S. Blood Glucose Self-testing, 2011 46
Table 3.5: U.S. OTC Glucose Self-testing Market Repeat Retail Replacement Sales Percentages 46
Table 3.6: OTC Blood Glucose Instrument Reagents by Manufacturer Retail 48
Table 3.7: Demographic Characteristics of Glucose Self-testing Kit Buyers 48
Table 3.8: Top Brand Preferences for Glucose Self-testing Kits 48
Table 3.9: Instances when Patients Prefer Professional’s Glucose Testing 49
Table 3.10: Advantages of a Glucose Self-testing Kit 49
Table 3.11: Disadvantages of Using a Glucose Self-testing Kit 49
Table 3.12: Popular Shopping Destinations for Buying or Seeking Information on Glucose Self-testing Kits 49
Table 3.13: Customer Priorities—Glucose Meter Self-testing Market, 2001-2012 49
Table 3.14: Total Market for Professional Glucose Testing (Central Laboratory and Hospital POC & POL)
in the U.S., 2010-2016 50
Table 3.15: U.S. Revenues for POC Blood Glucose Monitoring (Hospital & POL), 2010-2016 50
Table 3.16: U.S. Continuous Glucose Monitoring Market, 2010-2016 51
Table 3.17: Key Market Drivers for Glucose Testing 55
Table 3.18: Market Drivers for Continuous Glucose Monitoring 56
Table 3.19: Point of Care Glucose Testing Market: Market Drivers Ranked in Order of Impact 56
Table 3.20: Key Market Restraints for Glucose Testing 57
Table 3.21: Market Restraints for Continuous Glucose Monitoring 57
Table 3.22: Point of Care Glucose Testing Market: Market Restraints Ranked in Order of Impact 58
Table 3.23: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats of the
Glucose Point of Care Market 64
Table 4.1: Criteria for the Diagnosis of Diabetes 66
Table 4.2: Categories of Increased Risk for Diabetes (Pre-diabetes) 67
Table 4.3: Normal Glucose Values—Fasting State 67
Table 4.4: Key Concepts in Setting Glycemic Goals 69
Table 4.5: Glycemic Recommendations for Non-Pregnant Adults with Diabetes 69
Table 4.6: Glycemic Recommendations for Women with Gestational Diabetes 69
Table 4.7: Glycemic Recommendations for Pregnant Women with Pre-existing Diabetes 70
Table 4.8: Glucose Monitoring Recommendations 71
Table 4.9: Glucose Monitoring Recommendations for Hospital Settings 73
Table 4.10: Glycemic Goals for Hospital Patients 74
Table 4.11: Percentage of Hypothetical Patients that Diabetes Educator’s would Recommend CGM, 2007-2009 77
Table 4.12: Ideal Diabetic Patient Attributes for Successful CGM Use 77
Table 4.13: A1c Testing Recommendations 78
Table 4.14: Correlation of A1c with Mean Blood Glucose 78
Table 5.1: Analytic Performance Criteria for Glucose Self-testing Meters 85
Table 5.2: Potential Variables Affecting Glucose Concentrations 88
Table 5.3: Key Features Considered for Glucose Testing Devices 91
Table 5.4: Common User Errors Made While Self-testing for Blood Glucose 93
Table 5.5: Compatibility of Various Blood Glucose Meters with Icodextrin PD Solution 96
Table 5.6: Ten Factors Needed to Improve the Performance of Blood Glucose Meters 99
Table 5.7: Key Features Considered for Reagent Test Strips 101
Table 5.8: Differences between Laboratory Instruments for Glucose Analysis and Handheld Blood
Glucose Meters 101
Table 5.9: Relationship of A1c to Average Whole Blood and Plasma Glucose Levels 107
Table 5.10: Unit Sales of Homecare Lancets in the U.S., 2010-2015 111
Table 5.11: Unit Sales of Homecare Lancets in the E.U., 2010-2015 111
Table 5.12: Dollar Sales of Homecare Lancets in the U.S., 2010-2015 111
Table 5.13: Dollar Sales of Homecare Lancets in the E.U., 2010-2015 112
Table 5.14: Unit Sales of Homecare Glucose Self-testing Lancets in the U.S., 2010-2015 112
Table 5.15: Unit Sales of Homecare Glucose Self-testing Lancets in the E.U., 2010-2015 112
Table 5.16: Competition in the Lancet Market Segment 113
Table 5.17: Limitations of Urine Glucose Monitoring 118
Table 5.18: Advantages of Urine Glucose Monitoring 118
Table 5.19: Blood Ketone Reading Indications 118
Table 6.1: Current Blood Glucose Self-testing Meters: Sample Size, Test Time, and Other Features 120
Table 6.2: Handheld Blood Glucose or Blood Gas Meters Marketed for Professional Use 146
Table 6.3: Clinical Blood Chemistry Analyzers with Glucose Assays 153
Table 6.4: Detailed Features of Selected CGM Systems Currently Available 162
Table 6.5: Non-invasive Glucose Monitoring Systems in Development 170
Table 7.1: POC Procedural Advantages for Hospital Testing 190
Table 7.2: Medicare Billing Guidelines for Multi-channel Chemistry Tests 199
Table 7.3: Financial Comparison for Moderate and Waived CLIA Labs 206
Table 8.1: Data Entry and Data Management Features to Include in Future Meters 210
Table 8.2: Leading World Patient Monitoring Products in the U.S. Market 213
Table 8.3: Customized Reports Must Support CAP and JCAHO Requirements 222
Table 9.1: Abaxis Blood Analysis Diagnostic Tests 230
Table 9.2: Reagent Discs Offered with the Piccolo Chemistry Analyzers 231
Table 9.3: Products Marketed by Abbott in the Diagnostic Market 233

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