World Glucose Self-Testing Markets

Published: July 2014
No. of Pages: 263
   

The worldwide incidence of diabetes is dramatically increasing, and it is estimated that 439 million people will have developed the disease by 2030. As such, the global market for blood glucose self-testing products is undergoing a significant transition driven by the advent of new analytical technologies and new recommendations for tight glucose control for monitoring diabetes. In addition, the proliferation of the middle class within developing nations, particularly China and India, has resulted in both a substantial rise in Type 2 diabetes and the financial means to manage the disease. The purpose of this TriMark Publications report is to provide a comprehensive analysis of the specific segment of the over-the-counter diagnostics sector known as the glucose self-testing market. The term "self-testing" is used to distinguish it from in vitro diagnostics testing for blood glucose in hospitals, commercial labs and doctor's offices, the so-called "professional" component of the glucose testing market. This study reviews the viable technology drivers and assesses the market dynamics of the glucose self-testing market worldwide. This report also looks at the industry challenges and potential threats, and it makes strategic recommendations for boosting market share. Detailed tables and charts with sales forecasts and market share data are also included.

World Glucose Self-Testing Markets

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 Objectives 13
1.5 Methodology 14
1.6 Executive Summary 15

2. Diabetes 18
2.1 Demographics of Diabetes 19
2.1.1 Worldwide Diabetes Incidence 19
2.1.2 Diabetes in the U.S. 23
2.2 Understanding the Metabolic Conditions Underlying and Associated with Diabetes 28
2.2.1 Pre-Diabetes Syndrome  29
2.2.2 Metabolic Syndrome 29
2.2.3 Progression of Diabetes  29
2.2.4 Diabetes and Inflammation 30
2.2.5 Risk Factors and Diabetes  30
2.2.5.1 Obesity 31
2.2.5.2 Stress-Induced Hyperglycemia 33
2.2.6 Complications and Co-Morbidities in Diabetes 34
2.2.6.1 Preventing Complications and Co-Morbidities in Diabetes 38
2.3 Economics of Diabetes  39
2.3.1 Worldwide Costs of Diabetes 40
2.3.2 Costs of Diabetes in the U.S. 40

3. Market Analysis: Size, Growth, Share and Competitors 45
3.1 Worldwide Glucose Testing Market 45
3.2 Global Glucose Self-Testing Market 47
3.2.1 Continuous Glucose Monitoring Markets 50
3.3 U.S. Market  51
3.4 European Market  55
3.5 Asian Market  56
3.5.1 Japanese Market  57
3.5.2 Chinese Market  58
3.5.3 Indian Market  60
3.5.4 Korean Market  61
3.5.5 Southeast Asian Market  61
3.5.6 ROW Markets 62
.6 Competitive Situation 63
3.6.1 Key Players 63
3.6.2 Analyses of the Current Market Conditions, Competition and Product Mix 63
3.7 Market Drivers and Restraints 66
3.7.1 Market Drivers  66
3.7.2 Market Restraints  68
3.8 Market and Product Trends 69
3.8.1 Market Trends 70
3.8.2 Technology Trends 71
3.9 Strategic Recommendations 72
3.10 Competitive Strategies 74
3.11 Adjacent Markets  75

4. Glucose Diagnostic and Monitoring Recommendations 76
4.1 Diagnosis of Diabetes Mellitus 76
4.2 Tight Glucose Control in Treating Diabetes  79
4.2.1 Tight Glucose Control Lowers Cardiovascular Complications  80
4.3 Recommendations for Glucose Control in Diabetic Patients 80
4.3.1 Recommended Frequency of Blood Glucose Testing  82
4.3.2 Using Blood Glucose Data to Monitor and Modify Patient Therapy 83
4.3.3 Testing in Individuals with Type 2 Diabetes  84
4.3.4 Continuous Glucose Monitoring (CGM) 85
4.3.5 A1c Testing Recommendations 86
4.4 Hypoglycemia and Treatment 86

5. Glucose Self-Testing Technology Platforms and Consumable Products  89
5.1 Types of Glucose Self-Testing Devices 89
5.2 Enzymatic Reactions Used in Glucose Self-Testing Devices 90
5.2.1 Glucose Oxidase (GOX)  90
5.2.2 Glucose Dehydrogenase (GDH) 91
5.2.2.1 GDH-NAD (Glucose Dehydrogenase-Nicotinamide Adenine Dinucleotide) 91
5.2.2.2 GDH-FAD (Glucose Dehydrogenase-Flavin Adenine Dinucleotide) 91
5.2.2.3 GDH-PQQ (Glucose Dehydrogenase-Pyrroloquinoline Quinone) 91
5.2.3 Glucose Hexokinase 92
5.3 Development of Blood Glucose Monitors: A Historical Evaluation 92
5.3.1 First-Generation Blood Glucose Biosensors  92
5.3.2 Second-Generation Blood Glucose Biosensors 92
5.3.3 Third-Generation Blood Glucose Biosensor  93
5.4 Accuracy and Precision in Glucose Meters  93
5.4.1 International Organization for Standardization (ISO) 15197:2013 94
5.4.2 FDA Guidelines for Blood Glucose Testing Systems  95
5.4.3 Determining Clinical Accuracy Using the Error Grid Analysis (EGA)  98
5.4.4 Quality Control Criteria  99
5.4.5 Potential Variables Affecting Glucose Concentrations  99
5.4.6 Calibration Methods 99
5.4.7 Common User Errors 100
5.5 Key Issues for Glucose Self-Testing Devices  100
5.5.1 Important Elements for Glucose Self-Testing 102
5.5.2 Key Features to Aid Specific Patient Populations 103
5.6 Limitations of Existing Glucose Self-Testing Products 104
5.7 Interfering Substances and Conditions 105
5.7.1 Environmental  105
5.7.2 Physiologic 105
5.7.3 Operational 105
5.7.4 Manufacturing Variations  106
5.7.5 Drugs  106
5.7.6 Patient Factors  106
5.7.6.1 Errors Associated with GDH-PQQ Technology 106
5.8 Potential Areas of Improvement in Blood Glucose Monitor Performance 109
5.8.1 Blood Glucose Reagent Test Strips  109
5.9 Continuous Glucose Monitoring Technology  111
5.9.1 Advantages of Continuous Readings 112
5.9.2 FDA Approval of CGM  112
5.9.3 CGM Functions to Consider 113
5.9.4 New Technologies for CGM 113
5.10 Summary of Technologies being Explored for Non-Invasive Glucose Monitoring 114
5.10.1 GlucoTrack 114
5.10.2 Non-Invasive Glucose Monitoring Technologies in Development 114
5.10.3 Goals of Non-Invasive Testing 115
5.10.4 Non-Invasive Diabetes Screening Test 116
5.11 A1c Monitoring Technology 116
5.12 Fructosamine Test 118
5.13 Related Reagents and Equipment  119
5.13.1 Lancets  119
5.13.1.1 Types of Lancing Devices  119
5.13.1.2 Market Size 120
5.13.2 Control Solutions and Calibrators  125
5.13.3 Sharps Devices  125
5.13.4 Needle Destruction Devices 126
5.13.5 Ketone Testing  126
5.14 New Developments in Glucose Self-Testing Systems  127
5.14.1 Voice Operated Glucose Self-Testing Meters 127
5.14.2 Bluetooth-Enabled Glucose Self-Testing Meters 130
5.14.2.1 MyGlucoHealth Wireless Meter 130
5.14.2.2 Fora D15b, Fora G31 and Fora D30 Meters  130
5.14.2.3 OneTouch VerioSync Blood Glucose Monitoring System 130
5.14.2.4 Telcare BGM 131
5.14.3 Glucose Self-Testing Meters with Computer Connectivity 131
5.14.4 Data Management 131
5.14.4.1 Log Sheets/Spreadsheets  131
5.14.4.2 Glucose Self-Testing Software 131
5.14.4.3 Smart Phone and iPad/iPod Touch Applications 133
5.14.5 Remote Patient Monitoring 135
5.14.5.1 Infopia Eocene System 137
5.14.5.2 Health Buddy Systems Monitoring Technologies 137
5.14.5.3 GlucoCom Glucose Monitoring System 138
5.14.5.4 Alere’s DayLink Monitor  138
5.14.5.5 Alere HomeLink Receives FDA Approval for Over-the-Counter Use 138
5.14.6 Integrated Testing: Glucose Meter, Test Strips and Lancet 139
5.14.7 Long-Term Glucose Sensing Bio-Implants  139
5.14.8 Glucose Self-Testing Meters that Wirelessly Communicate with Insulin Pumps  140
5.14.8.1 Medtronic’s MiniMed Paradigm Revel 140
5.14.8.2 MiniMed 530G with Enlite 140
5.14.8.3 Nova Max Link  140
5.14.8.4 One Touch Ultra Link 140
5.14.8.5 One Touch Ping  140
5.14.8.6 Accu-Chek Combo System 141

6. Glucose Self-Testing Meters on the Market: Description of Test Meters  142
6.1 Blood Glucose Self-Testing Meters and Strips 142
6.1.1 LifeScan, Inc. 145
6.1.2 Roche Diagnostics Corporation 148
6.1.3 Bayer  149
6.1.4 Abbott (MediSense) 151
6.1.5 Agamatrix, Inc.  153
6.1.6 ARKRAY, Inc.  154
6.1.7 Bionime Corporation 156
6.1.8 BioSense Medical Devices  157
6.1.9 CVS/Pharmacy  158
6.1.10 Diabetic Supply of Suncoast 158
6.1.11 Entra Health Systems 158
6.1.12 Fifty50 Pharmacy  158
6.1.13 Fora Care 159
6.1.14 Genesis Health Technologies 160
6.1.15 GlucoCom 160
6.1.16 Infopia  160
6.1.17 Nipro Diagnostics, Inc. 161
6.1.18 Nova Biomedical  162
6.1.19 Oak Tree International Holdings, Inc. 162
6.1.20 Omnis Health 163
6.1.21 Phylosis  163
6.1.22 Prodigy Diabetes Care, LLC (an affiliate of Diagnostic Devices, Inc.)  163
6.1.23 Sanofi  164
6.1.24 Target  164
6.1.25 Telcare  164
6.1.26 Tyson Biomedical 165
6.1.27 US Diagnostics  165
6.1.28 Walgreens 166
6.1.29 Walmart  166
6.1.30 77 Elektronika Kft. 166
6.1.31 A. Menarini Diagnostics  167
6.1.32 All Medicus 167
6.1.33 i-SENS  167
6.1.34 Apex Biotechnology Corp. 168
6.1.35 Glucoplus, Inc.  168
6.1.36 Polymer Technology Systems 168
6.1.37 Smiths Medical MD, Inc.  168
6.1.38 TaiDoc Technology Corp.  168
6.1.39 IN4 Technology Corporation 168
6.1.40 ACON Laboratories 169
6.1.41 Pepex Biomedical 169
6.1.42 HMD BioMedical 170
6.1.43 BTNX, Inc. 170
6.1.44 Shasta Technologies and Decision Diagnostics Corporation  170
6.2 Continuous and Non-Invasive Glucose Patient Monitoring Systems 170
6.2.1 Medtronic’s Continuous Glucose Monitoring Systems (CGMS) 172
6.2.2 DexCom, Inc. G4 Platinum Continuous Glucose Monitoring System 174
6.2.3 FreeStyle Navigator—Abbott’s Continuous Glucose Monitor System  176
6.2.4 GlucoDay S Continuous Glucose Monitor 177
6.2.5 Minimally-Invasive Continuous Glucose Monitors in Development 177
6.2.5.1 GlySens, Inc. 177
6.2.5.2 Senseonics (formerly Sensors for Medicine and Science) 177
6.2.5.3 Ultradian 178
6.2.5.4 GluMetrics, Inc.  178
6.3 Non-Invasive Glucose Patient Monitoring Systems in Development 178
6.3.1 Cygnus GlucoWatch Biographer 179
6.3.2 AiMedics 179
6.3.3 BioTex, Inc. 180
6.3.4 Echo Therapeutics, Inc. 180
6.3.5 EyeSense GmbH  181
6.3.6 Integrity Applications Ltd.  181
6.3.7 LighTouch Medical, Inc.  182
6.3.8 OrSense Ltd. 182
6.3.9 VeraLight, Inc.  182
6.3.10 Xhale, Inc. 183
6.3.11 Lein Applied Diagnostics  183
6.4 A1c Self-Testing  183
6.4.1 A1CNow SELFCHECK  183
6.4.2 DTI Laboratories  184
6.4.3 ReliOn A1c Test  184
6.5 New Product Launches 184
6.5.1 OneTouch VerioSync Blood Glucose Monitoring System 184
6.5.2 Medtronic’s MiniMed 530G with Enlite Sensor Technology, the First Artificial Pancreas Device System  185
6.5.3 Contour Next Link Meter Approved for Use with Medtronic’s New MiniMed 530G with Enlite Insulin Pump System 185
6.5.4 Abbott Receives CE Mark for FreeStyle Optium Neo Blood Glucose and Ketone Monitoring System  185
6.5.5 LabStyle Innovations’ Dario Diabetes Management System  185
6.5.6 BlueStar by WellDoc 186
6.5.7 FDA Approves Bayer’s Contour Next EZ 186
6.5.8 Glooko Received its Second 510(k) Clearance for Glucose Monitoring Logbook App 186
6.5.9 Sanofi-Aventis’s iBGStar  187
6.5.10 iHealth Glucose Meter Device 187
6.5.11 MyGlucoHealth Diabetes  187
6.5.12 gDrive  188
6.5.13 Enlite Sensor 188
6.5.14 Abbott’s FreeStyle InsuLinx 188
6.5.15 Roche Diagnostics Launches Accu-Chek Mobile 188
6.5.16 Medtronic Announces Mac Compatibility for CareLink Personal Therapy Management Software for Diabetes  189
6.5.17 Telcare Receives FDA Clearance for its Telcare BGM 3G Blood Glucose Meter  189
6.5.18 OneTouch SelectSimple  189
6.5.19 Shasta GenStrips  189
6.6 Blood Glucose Meters, CGMs, and Data Management Software in Development  189
6.6.1 Abbott’s Flash Glucose Monitoring System  189
6.6.2 Google Announces Plan to Create Contact Lens Glucose Sensors 190
6.6.3 Socrates Health Solutions’ Companion Blood Glucose Monitor 190
6.6.4 DexCom and Johnson and Johnson’s Animas Working to Develop an Artificial Pancreas  190
6.6.5 Medtronic Enrolling Patients into Trial Testing Third-Generation, Fully-Automated Artificial Pancreas  190
6.6.6 Boston University’s Bionic Pancreas Project  190
6.7 Recent Industry Activity  190
6.7.1 Roche Diagnostics Corp. Cutting Jobs in Diabetes Division  190
6.7.2 AgaMatrix and Sanofi-Aventis Enter Global Diabetes Partnership 190
6.7.3 LifeScan, Inc. Terminates Exclusive Supply Agreement with Medtronic MiniMed 191
6.7.4 Kroger Selects WaveSense Diabetes Testing Products  191
6.7.5 Medtronic and Bayer Healthcare Expand International Alliance 191
6.7.6 PositiveID Corporation and IDEAL LIFE Partner to Bring iglucose to Market for Wireless Diabetes Management 191
6.7.7 Roche Diagnostics U.S. and DexCom, Inc. Announce Research and Development Agreement 191
6.7.8 BD and JDRF Collaborating on a Device Using a Single Infusion Catheter for Both CGM and Pump  192
6.7.9 Court Sides with Decision Diagnostics in Patent Infringement Case 192
6.8 M&A Activity 192
6.8.1 Home Diagnostics, Inc. and Nipro Diabetes Systems, Inc. Merge to become Nipro Diagnostics, Inc.  192
6.8.2 Medtronic, Inc. (MDT) Acquires New Diabetes Technology from PreciSense AS 192
6.8.3 Geonostics Acquires FlexSite’s Consumer Diabetes Tests 193
6.8.4 Additional M&A  193
6.8.5 Important Deals in BGM Market 194

7. Business Trends in the Industry 195
7.1 Wholesale Distribution Overview  195
7.2 Factors Affecting OTC Medical Product Distribution  197
7.3 Drugstores Critical to the Diabetic Care Category 198
7.4 Drivers of OTC and Self-Testing Markets  199
7.4.1 Brand Loyalty  199
7.5 Cost Elements of Glucose Self-Testing 199
7.6 Important Elements of OTC Testing 200
7.7 Growth of Home Care and Self-Testing 200
7.8 Blood Glucose Self-Testing Insurance Coverage and Reimbursement  200
7.8.1 American OTC Testing and Self-Testing Reimbursement 200
7.8.2 European Reimbursement  203
7.8.3 Reimbursement Challenges 203
7.8.4 New Medicare Part B 204
7.9 Government Regulation of Medical Devices  204
7.9.1 U.S. Regulations  204
7.9.2 E.U. Regulations  207
7.9.3 U.K. Regulations  212
7.10 Clinical Laboratory Improvement Act (CLIA) 213
7.11 FDA Labeling Requirements 215
7.12 Legal Liability for Glucose Meters  217
7.13 FDA’s Artificial Pancreas Guidance Document 217

8. Technology Trends 218
8.1 Improving Today’s Over-the-Counter (OTC) Blood Glucose Meters 218
8.2 Biosensor Technology 219
8.3 Artificial Pancreas 221
8.4 Fructosamine Test 222
8.5 Telemedicine 223
8.5.1 Remote Patient Monitoring 225
8.5.1.1 Infopia Eocene System  229
8.5.1.2 Health Buddy Systems Monitoring Technologies 229
8.5.1.3 GlucoCom Glucose Monitoring System 229
8.5.1.4 Alere’s DayLink Monitor  230
8.5.1.5 Alere HomeLink Receives FDA Approval for Over-the-Counter Use 230
8.6 Non-Traditional Methods for Sample Collection 230
8.7 Data Management 231
8.7.1 Medical Device Radiocommunications Service (MedRadio)  231
8.7.2 FDA Required Software Verification 231

9. OTC Testing: Critical Issues 232
9.1 Moderators of Growth for OTC Testing 232
9.2 Attitudes of Critical Care Nurses and Physicians 232
9.3 Personnel Impact for OTC Testing  233
9.4 Data Management Issues  233

10. Current Issues for OTC and Diagnostic Self-Testing  234
10.1 New Markets for OTC and Diagnostic Self-Testing  234
10.2 Utility of OTC and Self-Testing 235
10.3 Generational Drivers of Home Testing 236
10.4 Move Away from Central Laboratories 237
10.5 Healthcare Cost Controls  238
10.6 Mergers of Diagnostic Companies  238
10.7 Home Healthcare Trends  238
10.8 Home Healthcare Providers versus Mass Market Retailers 238
10.9 Demographic Merchandising 239
10.10 Marketing Strategies 239
10.11 Third-Party Pharmacy Networks  240
10.12 Which Customer Segments Purchase Home Healthcare? Which Products Fit Their Needs? 240
10.13 Future of Patient Self-Testing 242

11. SWOT Analysis  243
11.1 Roche  243
11.2 LifeScan 243

12. Company Profiles 246
12.1 A. Menarini Diagnostics 246
12.2 Abbott Laboratories 246
12.3 ACON Laboratories 250
12.4 AgaMatrix 250
12.5 Allmedicus Co., Ltd. 250
12.6 Apex Biotechnology Corporation  250
12.7 ARKRAY USA, Inc. 250
12.8 Bayer  251
12.9 B. Braun Melsungen 252
12.10 Bionime  253
12.11 Cambridge Sensors 253
12.12 DexCom 253
12.13 Diagnostic Devices/Prodigy Diabetes Care  255
12.14 Echo Therapeutics, Inc. 255
12.15 Entra Health Systems 256
12.16 Fora Care 256
12.17 FIFTY50 Medical, Inc. 256
12.18 Genesis Health Technologies 256
12.19 GlucoPlus 257
12.20 GlySens, Inc. 257
12.21 Hainice Medical  257
12.22 Home Diagnostics 257
12.23 Infopia  258
12.24 IN4 Technology  258
12.25 i-Sens  258
12.26 Johnson & Johnson 258
12.27 LabStyle Innovations Corporation  259
12.28 Medtronic 259
12.29 Nipro Corporation 259
12.30 Nova Biomedical  260
12.31 OrSense Ltd. 260
12.32 Prodigy Diabetes Care, LLC (formerly Diagnostic Devices, Inc.) 260
12.33 Roche  261
12.34 77 Elektronika Kft. 262
12.35 Smiths Group  262
12.36 TaiDoc Technology 262
12.37 Telcare  263
12.38 US Diagnostics  263
12.39 VeraLight 263

List of Tables

Table 2.1: Regional Estimates of the Number of Diabetes (20-79 Years) in Millions, 2013 and 2035 20
Table 2.2: Countries with the Largest Numbers of Diabetics, 2013 21
Table 2.3: Countries with the Largest Estimated Numbers of Diabetics, 2035 21
Table 2.4: Worldwide Undiagnosed Diabetes in Adults (20-79 Years) by Region and Income Group, 2013 22
Table 2.5: Countries with the Largest Number of Deaths Attributable to Diabetes, 2013  22
Table 2.6: U.S. Population of Diagnosed Diabetics Aged 20-79 Years, 2013 24
Table 2.7: Percentage of U.S. Adults with Diagnosed Diabetes by State, 2010 25
Table 2.8: Ten Leading Diagnoses for Co-Morbid Chronic Diseases in the U.S.  34
Table 2.9: Odds Ratio of Progression to Complications Associated with Type 2 Diabetes  36
Table 2.10: Prevalence of Complications Among Patients with Diabetes 36
Table 2.11: Novel Risk Factors and Possible Mechanisms of the Excess Risk of Coronary Heart Disease in Type 2 Diabetes Mellitus  37
Table 2.12: Major Causes of End-Stage Renal Disease 37
Table 2.13: Clinical Recommendations for Adults with Diabetes 39
Table 2.14: Laboratory Assessment of Diabetic Vascular Disease 39
Table 2.15: Average Years Gained Free of Diabetes-Related Disease with Intensive Management  39
Table 2.16: Cost of Diagnosed Diabetes in the U.S., 2012 41
Table 2.17: Annual Cost of Care of United Healthcare Adult Members with Diabetes, 2009 43
Table 2.18: Healthcare Utilization by Diabetic Patients, 2012  43
Table 3.1: Total Global Unit Demand for Glucose Testing Reagent Strips, 2012-2018 46
Table 3.2: Global Dollar Sales of Glucose Testing Reagent Strips, 2012-2018  47
Table 3.3: Worldwide Glucose Self-Testing Market Sales (Meters, Strips and Lancets), 2012-2018  47
Table 3.4: World Market Share of Glucose Self-Testing Marketers, 2013 49
Table 3.5: Global Revenues for Continuous Glucose Monitoring Systems, 2012-2018 50
Table 3.6: Market for Glucose Self-Testing in the U.S. (Includes Meters, Strips and Lancets), 2012-2018 51
Table 3.7: Market Share of U.S. Blood Glucose Self-Testing, 2013 52
Table 3.8: U.S. OTC Glucose Self-Testing Market Repeat Retail Replacement Sales Percentages  53
Table 3.9: OTC Blood Glucose Instrument Reagents by Manufacturer Retail 53
Table 3.10: Demographic Characteristics Glucose Self-Testing Kit Buyers 54
Table 3.11: Top Brand Preferences for Glucose Self-Testing Kits 54
Table 3.12: Instances when Patients Prefer Professional’s Glucose Testing 54
Table 3.13: Advantages of a Glucose Self-Testing Kit  55
Table 3.14: Disadvantages of Using a Glucose Self-Testing Kit 55
Table 3.15: Popular Shopping Destinations for Buying or Seeking Information on Glucose Self-Testing Kits 55
Table 3.16: Customer Priorities—Glucose Meter Self-Testing Market, 2001, 2006 and 2013 55
Table 3.17: European Market for Glucose Self-Testing (Includes Meters, Strips and Lancets), 2012-2018 56
Table 3.18: Asian Market for Glucose Self-Testing (Includes Meters, Strips and Lancets), 2012-2018 57
Table 3.19: Japanese Market for Glucose Self-Testing (Includes Meters, Strips and Lancets), 2012-2018 58
Table 3.20: Chinese Market for Glucose Self-Testing (Includes Meters, Strips and Lancets), 2012-2018 59
Table 3.21: Southeast Asian Market for Glucose Self-Testing (Includes Meters, Strips and Lancets), 2012-2018 62
Table 3.22: Southeast Asian Market for Glucose Self-Testing by Country (Includes Meters, Strips and Lancets), 2013 62
Table 3.23: ROW Market for Glucose Self-Testing (Includes Meters, Strips and Lancets), 2012-2018 62
Table 3.24: Key Market Drivers for Glucose Self-Testing 67
Table 3.25: Market Drivers for Continuous Glucose Monitoring 67
Table 3.26: Key Market Restraints for Glucose Self-Testing  68
Table 3.27: Market Restraints for Continuous Glucose Monitoring 69
Table 4.1: Criteria for the Diagnosis of Diabetes 76
Table 4.2: Categories of Increased Risk for Diabetes (Pre-Diabetes) 76
Table 4.3: Normal Glucose Values—Fasting State 77
Table 4.4: Criteria for Testing for Diabetes in Asymptomatic Adults 77
Table 4.5: Criteria for Type 2 Diabetes in Asymptomatic Children 78
Table 4.6: Screening for and Diagnosis of Gestational Diabetes Mellitus (GDM)  79
Table 4.7: Glycemic Recommendations for Non-Pregnant Adults with Diabetes  81
Table 4.8: Glycemic Recommendations for Women with Gestational Diabetes  81
Table 4.9: Glycemic Recommendations for Pregnant Women with Pre-Existing Diabetes  81
Table 4.10: Plasma Blood Glucose and A1c Goals for Type 1 Diabetes by Age-Group 81
Table 4.11: Glucose Monitoring Recommendations  83
Table 4.12: Key Issues for SMBG in Insulin-Independent Type 2 Diabetics 84
Table 4.13: A1c Testing Recommendations  86
Table 4.14: Correlation of A1c with Mean Blood Glucose 86
Table 5.1: Analytic Performance Criteria for Glucose Meters  94
Table 5.2: Potential Variables Affecting Glucose Concentrations 99
Table 5.3: Common User Errors Made while Self-Testing for Blood Glucose 100
Table 5.4: Key Features Considered for Glucose Self-Testing Devices  103
Table 5.5: Key Features Considered for Reagent Test Strips 103
Table 5.6: Compatibility of Various Blood Glucose Meters with Icodextrin PD Solution  107
Table 5.7: Ten Factors Needed to Improve the Performance of Blood Glucose Monitors  109
Table 5.8: Key Features Considered for Reagent Test Strips  110
Table 5.9: Relationship of A1c to Average Whole Blood and Plasma Glucose Levels 117
Table 5.10: Unit Sales of Homecare Lancets in the U.S., 2012-2017 121
Table 5.11: Unit Sales of Homecare Lancets in the E.U., 2012-2017 121
Table 5.12: Dollar Sales of Homecare Lancets in the U.S., 2012-2017  121
Table 5.13: Dollar Sales of Homecare Lancets in the E.U., 2012-2017  121
Table 5.14: Unit Sales of Homecare Glucose Self-Testing Lancets in the U.S., 2012-2017  122
Table 5.15: Unit Sales of Homecare Glucose Self-Testing Lancets in the E.U., 2012-2017  122
Table 5.16: Competition in the Lancet Market Segment 123
Table 5.17: Blood Ketone Reading Indications 127
Table 5.18: Leading Companies for Patient Monitoring Products 137
Table 6.1: Current Blood Glucose Self-Testing Meters: Sample Size, Test Time, and Other Features 142
Table 6.2: Detailed Features of Selected CGM Systems Currently Available 171
Table 6.3: Non-Invasive Glucose Monitoring Systems in Development  179
Table 7.1: Financial Comparison for Moderate and Waived CLIA Labs  214
Table 8.1: Data Entry and Data Management Features to Include in Future Meters 219
Table 8.2: Leading Companies for Patient Monitoring Products 228

List of Figures

Figure 2.1: Worldwide Diabetes Cases, 2013 and 2035 19
Figure 2.2: Worldwide Prevalence of Diabetes (%) in Adults (20-79 Years), 2013 20
Figure 2.3: Annual Number of New Cases of Diagnosed Diabetes Among U.S. Adults Aged 18-79 Years, 1980-2011 23
Figure 2.4: New Cases of Diabetes Diagnosed in the U.S. Adult Population by Age, 2010  24
Figure 2.5: Prevalence of Diabetes by Age in the U.S., 2010  24
Figure 2.6: Diagnosed Diabetes by Age in the U.S., 2013 25
Figure 2.7: Number of Deaths from Diabetes by Age in the U.S., 2010  27
Figure 2.8: Number of Diabetes Deaths by Race and Sex in the U.S., 2010 27
Figure 2.9: Maintenance of Normal Blood Sugar Levels 28
Figure 2.10: Prevalence of Self-Reported Obesity (BMI ≥30) Among U.S. Adults, 2012  32
Figure 2.11: Prevalence of Obesity Among Adults in the U.S., 2009-2010 32
Figure 2.12: Trends in Obesity Among Children and Adolescents in the U.S., 1988-2010  33
Figure 2.13: Age-Adjusted Percentage of People with Diabetes Aged 35 Years or Older Reporting Heart Disease or Stroke, by Sex, in the U.S., 1997-2011 35
Figure 2.14: Percentage of Adults with Diagnosed Diabetes Reporting Any Mobility Limitation, by Age, in the U.S., 1997-2011 37
Figure 2.15: Number (in Millions) of Adults Aged 18 Years or Older with Diagnosed Diabetes Reporting Visual Impairment in the U.S., 1997-2011  38
Figure 2.16: Mean Diabetes Healthcare-Related Expenditures Per Adult (20-79 Years) with Diabetes (U.S. Dollars), 2013 40
Figure 2.17: How Diabetes Dollars are Spent in the U.S., 2012  42
Figure 3.1: Geographic Segments of the Worldwide Glucose Self-Testing Market, 2012 and 2018  48
Figure 3.2: Worldwide Glucose Self-Testing Market by Region, 2018  48
Figure 3.3: Worldwide Glucose Self-Testing Market Segments, 2013  49
Figure 4.1: Approach to Management of Hypoglycemia 82
Figure 4.2: Glycemic Status—Ranges and Health Implications  88
Figure 5.1: EGA Zones of Clinical Accuracy  98
Figure 5.2: Single-Day Continuous Blood Glucose Data 105
Figure 5.3: Factors that may Adversely Affect Glucose Testing 106
Figure 5.4: Personal Lancet Unit Sales Market Share by Geographic Region, 2013 122
Figure 6.1: Medtronic’s Threshold Suspend Feature  174

Published By: TriMark Publications, LLC
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