Blood Glucose Testing and Diabetes Management

Publisher Name :
Date: 01-May-2014
No. of pages: 296

There has been a dramatic increase in the incidence of diabetes worldwide, which has been exacerbated by the growing obesity problem across the globe. Once thought of as primarily a childhood disease--sometimes referred to as juvenile diabetes, now mostly Type 1 diabetes--the obesity crisis linked to the adoption of a high-fat, high-carbohydrate, high-calorie American diet has resulted in skyrocketing rates of diabetes, particularly Type 2 diabetes, among adults across the world. As such, the global market for blood glucose testing products is undergoing a significant transition driven by the advent of new analytical technologies and developments in diabetes treatment. Although the blood 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. What’s more, non-invasive testing now represents a major new area for the application of IVD testing. Additionally, direct access testing--or over-the-counter testing, which allows consumers to order tests themselves without visiting a doctor--has emerged as a strong force in the blood glucose testing segment. 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, doctor’s offices and at-home care locations. The report has made a survey of selected companies marketing, manufacturing or developing various blood glucose testing and diabetes management supplies throughout the world. 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 share data are also included

Blood Glucose Testing and Diabetes Management

Table of Contents

1. Overview 12
1.1 Statement of Report 12
1.2 About This Report 12
1.3 Scope of the Report 13
1.4 Methodology 14
1.5 Executive Summary 15

2. Diabetes 20
2.1 Demographics of Diabetes 21
2.1.1 Worldwide Diabetes Incidence 21
2.1.2 Diabetes in the U.S. 25
2.2 Understanding the Metabolic Conditions Underlying and Associated with Diabetes 30
2.2.1 Pre-Diabetes Syndrome 31
2.2.2 Metabolic Syndrome 31
2.2.3 Progression of Diabetes 31
2.2.4 Diabetes and Inflammation 32
2.2.5 Risk Factors and Diabetes 32 Obesity 33 Stress-Induced Hyperglycemia 35
2.2.6 Complications and Co-Morbidities in Diabetes 36 Preventing Complications and Co-Morbidities in Diabetes 40 Cardiovascular Disease Facts 41
2.3 Economics of Diabetes 44
2.3.1 Worldwide Costs of Diabetes 45
2.3.2 Costs of Diabetes in the U.S. 45

3. Market Analysis: Size, Growth, Share and Competitors 50
3.1 Worldwide Glucose Testing Market 51
3.1.1 Global Blood Glucose Self-Testing Market 53
3.1.2 Worldwide Professional Blood Glucose Testing Market 56
3.1.3 Continuous Glucose Monitoring Markets 57
3.2 U.S. Market 58
3.2.1 U.S. Over-the-Counter (OTC) Self-Testing Glucose Market 59
3.2.2 U.S. Professional Glucose Testing Market 63
3.3 European Market 64
3.4 Asian Market 65
3.4.1 Japanese Market 67
3.4.2 Chinese Market 68
3.4.3 Indian Market 71
3.4.4 Korean Market 73
3.4.5 Southeast Asian Market 73
3.4.6 ROW Markets 75
3.5 Competitive Situation 75
3.5.1 Key Players in the Self-Testing Market 75
3.5.2 Analyses of the Self-Testing Market Conditions, Competition and Product Mix 76
3.5.3 Analyses of the Professional Blood Glucose Monitoring Market 78
3.6 Market Drivers and Restraints 81
3.6.1 Market Drivers 81
3.6.2 Market Restraints 83
3.7 Market and Product Trends 85
3.7.1 Market Trends 86
3.7.2 Technology Trends 86
3.8 Strategic Recommendations 87
3.9 Competitive Strategies 90
3.10 New Opportunities in the Professional Blood Glucose Meter Market 91
3.11 Adjacent Markets 91

4. Glucose Diagnostic and Monitoring Recommendations 92
4.1 Diagnosis of Diabetes Mellitus 92
4.2 Tight Glucose Control in Treating Diabetes 95
4.2.1 Tight Glucose Control Lowers Cardiovascular Complications 96
4.3 Recommendations for Glucose Control in Diabetic Patients 96
4.3.1 Recommended Frequency of Blood Glucose Testing 98
4.3.2 Using Blood Glucose Data to Monitor and Modify Patient Therapy 99
4.3.3 Testing in Individuals with Type 2 Diabetes 100
4.3.4 Continuous Glucose Monitoring (CGM) 101
4.3.5 A1c Testing Recommendations 102
4.3.6 Blood Glucose Testing for All Hospitalized Patients According to Guidelines by The Endocrine Society 103
4.4 Hypoglycemia and Treatment 103

5. Glucose Testing Technology Platforms and Consumable Products 106
5.1 Types of Glucose Determination Technologies 106
5.2 Enzymatic Reactions Used to Determine Glucose Concentrations 107
5.2.1 Glucose Oxidase (GOX) 107
5.2.2 Glucose Dehydrogenase (GDH) 108 GDH-NAD (Glucose Dehydrogenase-Nicotinamide Adenine Dinucleotide) 108 GDH-FAD (Glucose Dehydrogenase-Flavin Adenine Dinucleotide) 108 GDH-PQQ (Glucose Dehydrogenase-Pyrroloquinoline Quinone) 108
5.2.3 Glucose Hexokinase 109
5.3 Development of Blood Glucose Monitors: A Historical Evaluation 109
5.3.1 First-Generation Blood Glucose Biosensors 109
5.3.2 Second-Generation Blood Glucose Biosensors 109
5.3.3 Third-Generation Blood Glucose Biosensor 110
5.4 Accuracy and Precision in Glucose Meters 110
5.4.1 Clinical and Laboratory Standards Institute (CLSI) POCT12-A3 111
5.4.2 International Organization for Standardization (ISO) 15197:2013 112
5.4.3 FDA Guidelines for Blood Glucose Testing Systems 112
5.4.4 Determining Clinical Accuracy Using the Error Grid Analysis (EGA) 115
5.4.5 Quality Control Criteria 116
5.4.6 Potential Variables Affecting Glucose Concentrations 117
5.5 Key Issues for Glucose Testing Devices 117
5.5.1 Important Elements for Glucose Testing 118
5.5.2 Key Features to Aid Specific Patient Populations 119
5.6 Limitations of Existing Glucose Testing 120
5.6.1 Common User Errors in Glucose Self-Testing 121
5.6.2 Interfering Substances and Conditions 122 Environmental 122 Physiologic 122 Operational 122 Manufacturing Variations 122 Drugs/Medications 122 Patient Factors 122
5.6.3 Errors Associated with GDH-PQQ Technology 123
5.6.4 Optimizing of Point of Care (POC) Blood Glucose Testing 126
5.7 Potential Areas of Improvement in Blood Glucose Meter Performance 126
5.8 Blood Glucose Reagent Test Strips 128
5.9 Comparison of Hand-Held Blood Glucose Meters with Clinical Laboratory Glucose Measurements 129
5.10 Continuous Glucose Monitoring Technology 130
5.10.1 Advantages of Continuous Readings 130
5.10.2 FDA Approval of CGM 130
5.10.3 CGM Functions to Consider 131
5.10.4 New Technologies for CGM 131
5.11 Summary of Technologies Being Explored for Non-Invasive Glucose Monitoring 132
5.11.1 GlucoTrack 132
5.11.2 Non-Invasive Glucose Monitoring Technologies in Development 132
5.11.3 Goals of Non-Invasive Testing 133
5.11.4 Non-Invasive Diabetes Screening Test 134
5.12 A1c Monitoring Technology 134
5.13 Fructosamine Test 136
5.14 Related Reagents and Equipment 137
5.14.1 Lancets 137 Types of Lancing Devices 137 Market Size 138
5.14.2 Control Solutions and Calibrators 143
5.14.3 Sharps Devices 143
5.14.4 Needle Destruction Devices 144
5.14.5 Urine Strips 144
5.14.6 Ketone Testing 146

6. Glucose Testing Devices on the Market 148
6.1 Hand-Held Blood Glucose Meters and Strips for Self-Testing 148
6.1.1 LifeScan 151
6.1.2 Roche Diagnostics Corporation 154
6.1.3 Bayer 155
6.1.4 Abbott (MediSense) 157
6.1.5 AgaMatrix, Inc. 159
6.1.6 ARKRAY, Inc. 160
6.1.7 Bionime Corporation 162
6.1.8 BioSense Medical Devices 163
6.1.9 CVS/pharmacy 164
6.1.10 Diabetic Supply of Suncoast 164
6.1.11 Entra Health Systems 164
6.1.12 Fifty50 Pharmacy 165
6.1.13 Fora Care 165
6.1.14 Genesis Health Technologies 166
6.1.15 GlucoCom 166
6.1.16 Infopia 166
6.1.17 Nipro Diagnostics, Inc. 167
6.1.18 Nova Biomedical 168
6.1.19 Oak Tree International Holdings, Inc. 169
6.1.20 Omnis Health 169
6.1.21 Phylosis 169
6.1.22 Prodigy Diabetes Care, LLC (an Affiliate of Diagnostic Devices, Inc.) 169
6.1.23 Sanofi 170
6.1.24 Target 170
6.1.25 Telcare 171
6.1.26 Tyson Biomedical 171
6.1.27 US Diagnostics, Inc. 171
6.1.28 Walgreens 172
6.1.29 Walmart 172
6.1.30 77 Elektronika Kft. 172
6.1.31 A. Menarini Diagnostics 173
6.1.32 All Medicus 173
6.1.33 i-SENS 173
6.1.34 Apex Biotechnology Corp. 174
6.1.35 Glucoplus, Inc. 174
6.1.36 Polymer Technology Systems 174
6.1.37 Smiths Medical MD, Inc. 174
6.1.38 TaiDoc Technology Corp. 174
6.1.39 IN4 Technology Corporation 175
6.1.40 ACON Laboratories, Inc. 175
6.1.41 Pepex Biomedical 176
6.1.42 HMD BioMedical 176
6.1.43 BTNX 176
6.1.44 Shasta Technologies and Decision Diagnostics Corporation 176
6.2 Point of Care Blood Glucose Meters for Professional Use 177
6.2.1 Abbott 179 Precision Xceed Pro Blood Glucose and Beta-Ketone Monitoring System 179 i-STAT System 179
6.2.2 ACON Laboratories 180 On Call Platinum Blood Glucose Monitoring System 180
6.2.3 Alere 180 epoc Blood Analysis System 180 Alere Cholestech LDX System 180
6.2.4 ARKRAY, Inc. 181 Assure Platinum, Assure Pro, and Assure 4 181
6.2.5 EKF Diagnostics 181 Biosen Series of Glucose and Lactate Analyzers 181
6.2.6 HemoCue (a Quest Diagnostics Company) 181 HemoCue Glucose 201 and Glucose 201 DM Systems 181
6.2.7 HMD BioMedical 182 NS100 182
6.2.8 Medtronic 182 iPro Continuous Glucose Monitor 182
6.2.9 Nova Biomedical 182 StatStrip Hospital Glucose Monitoring System 182
6.2.10 Polymer Technology Systems 182 CardioChek PA Point of Care Device 182
6.2.11 Roche 183 Accu-Chek Inform II System 183 Accutrend Plus System 183
6.2.12 Techno Medica Co., Ltd 183 GASTAT-mini 183
6.2.13 LifeScan 184
6.3 Clinical Blood Chemistry Analyzers 184
6.3.1 Abaxis, Inc. 185
6.3.2 Alere 186
6.3.3 ARKRAY, Inc. 186
6.3.4 Beckman Coulter 187
6.3.5 DiaSys 187
6.3.6 Instrumentation Laboratory 187
6.3.7 International Technidyne Corporation (ITC) 188
6.3.8 Nova Biomedical 188
6.3.9 Radiometer 189
6.3.10 Roche 189
6.3.11 Siemens Healthcare Diagnostics 190
6.3.12 Span Diagnostics 193
6.3.13 Stanbio Laboratory 193
6.3.14 Techno Medica Co., Ltd 193
6.3.15 YSI Life Sciences 194
6.4 Continuous Glucose Patient Monitoring Systems 194
6.4.1 Medtronic’s Continuous Glucose Monitoring Systems (CGMS) 196
6.4.2 DexCom, Inc. G4 Platinum Continuous Glucose Monitoring System 198
6.4.3 FreeStyle Navigator—Abbott’s Continuous Glucose Monitor System 199
6.4.4 GlucoDay S Continuous Glucose Monitor 200
6.4.5 Minimally-Invasive Continuous Glucose Monitors in Development 200 GlySens, Inc. 200 Senseonics (Formerly Sensors for Medicine and Science) 201 Ultradian 201 GluMetrics 202
6.5 Non-Invasive Glucose Patient Monitoring Systems 202
6.5.1 Cygnus GlucoWatch Biographer 203
6.5.2 AiMedics Pty Ltd. 203
6.5.3 BioTex, Inc. 204
6.5.4 Echo Therapeutics, Inc. 204
6.5.5 EyeSense GmbH 205
6.5.6 Integrity Applications Ltd. 205
6.5.7 LighTouch Medical, Inc. 206
6.5.8 OrSense Ltd. 206
6.5.9 VeraLight, Inc. 206
6.5.10 Xhale, Inc. 207
6.5.11 Lein Applied Diagnostics 207
6.6 A1c Testing 207
6.7 New Product Launches 208
6.7.1 OneTouch Verio Sync Blood Glucose Monitoring System 208
6.7.2 Medtronic’s MiniMed 530G with Enlite Sensor Technology 208
6.7.3 Contour Next Link Meter Approved for Use with Medtronic’s New MiniMed 530G with Enlite Insulin Pump System 208
6.7.4 Roche’s ACCU-CHEK Inform II System Approved by the FDA 208
6.7.5 Abbott Receives CE Mark for FreeStyle Optium Neo Blood Glucose and Ketone Monitoring System 209
6.7.6 Abbott Receives FDA Clearance for FreeStyle Precision Pro Blood Glucose and ?-Ketone Monitoring System 209
6.7.7 LabStyle Innovations’ Dario Diabetes Management System 209
6.7.8 BlueStar by WellDoc 209
6.7.9 FDA Approves Bayer’s Contour Next EZ 210
6.7.10 Glooko Received its Second 510(k) Clearance for Glucose Monitoring Logbook App 210
6.7.11 Sanofi-Aventis’s iBGStar 210
6.7.12 iHealth Glucose Meter Device 211
6.7.13 MyGlucoHealth Diabetes 211
6.7.14 gDrive 211
6.7.15 Enlite Sensor 211
6.7.16 Abbott’s FreeStyle InsuLinx 212
6.7.17 Roche Diagnostics launches Accu-Chek Mobile 212
6.7.18 Medtronic Announces Mac Compatibility for CareLink Personal Therapy Management Software for Diabetes 212
6.7.19 Telcare Receives FDA Clearance for its Telcare BGM 3G Blood Glucose Meter 212
6.7.20 OneTouch SelectSimple 213
6.7.21 Shasta GenStrips 213
6.7.22 Medtronic Gains Approval of First Artificial Pancreas Device System, the MiniMed 530G with Enlite 213
6.8 Blood Glucose Meters, CGMs, and Data Management Software in Development 213
6.8.1 Abbott’s Flash Glucose Monitoring System 213
6.8.2 Google Announces Plan to Create Contact Lens Glucose Sensors 213
6.8.3 Socrates Health Solutions’ Companion Blood Glucose Monitor 214
6.8.4 DexCom and Johnson and Johnson’s Animas Working to Develop an Artificial Pancreas 214
6.8.5 Medtronic Enrolling Patients into Trial Testing Third-Generation, Fully-Automated Artificial Pancreas 214
6.8.6 Boston University’s Bionic Pancreas Project 214
6.9 Recent Industry Activity 214
6.9.1 Roche Diagnostics Corp. Cutting Jobs in Diabetes Division 214
6.9.2 AgaMatrix and Sanofi-Aventis Enter Global Diabetes Partnership 214
6.9.3 LifeScan, Inc. Terminates Exclusive Supply Agreement with Medtronic MiniMed 215
6.9.4 Kroger Selects WaveSense Diabetes Testing Products 215
6.9.5 Medtronic and Bayer Healthcare Expand International Alliance 215
6.9.6 PositiveID Corporation and IDEAL LIFE Partner to Bring iglucose to Market for Wireless Diabetes Management 215
6.9.7 Roche Diagnostics U.S. and DexCom, Inc. Announce Research and Development Agreement 215
6.9.8 BD and JDRF Collaborating on a Device Using a Single Infusion Catheter for Both CGM and Pump 216
6.9.9 Court Sides with Decision Diagnostics in Patent Infringment Case 216
6.10 M&A Activity 216
6.10.1 Home Diagnostics, Inc. and Nipro Diabetes Systems, Inc. Merge to Become Nipro Diagnostics, Inc. 216
6.10.2 Medtronic, Inc. Acquires New Diabetes Technology from PreciSense AS 216
6.10.3 Geonostics Acquires FlexSite’s Consumer Diabetes Tests 217
6.10.4 Radiometer Medical Acquires Hemocue 217
6.10.5 Additional M&A 217
6.10.6 Important Deals in BGM Market 218

7. Business Trends in Glucose Testing 219
7.1 Drivers of Clinical Glucose Testing 219
7.2 Competition for Professional POC Glucose Testing 219
7.3 Healthcare Cost Controls 219
7.4 Changes in Patient Management 220
7.5 Regionalization of Laboratory Care 220
7.6 Satellite Facilities 221
7.7 Professional Point of Care Testing 221
7.8 Factors Affecting OTC Medical Product Distribution 222
7.9 Drug Stores Critical to the Diabetic Care Category 224
7.10 Drivers of OTC and Self-Testing Markets 224
7.10.1 Brand Loyalty 224
7.11 Cost Elements of Glucose Self-Testing 225
7.12 Costs of Doing Business in Europe 225
7.13 Drivers of European Diagnostics Testing 226
7.14 Cost Containment in Europe 226
7.15 Blood Glucose Self-Testing Insurance Coverage and Reimbursement 226
7.15.1 American OTC Testing and Self-Testing Reimbursement 226
7.15.2 European Reimbursement 227
7.16 Trends in U.S. Laboratory Testing Reimbursement Practices 228
7.17 Reimbursement Challenges 229
7.17.1 New Medicare Part B 230
7.18 Managed Care 230
7.19 Government Regulation of Medical Devices 230
7.19.1 U.S. Regulations 230
7.19.2 E.U. Regulations 233
7.19.3 U.K. Regulations 238
7.20 Clinical Laboratory Improvement Act (CLIA) 239
7.21 FDA Labeling Requirements 241
7.22 Legal Liability for Glucose Meters 243
7.23 FDA’s Artificial Pancreas Guidance Document 243

8. Technology Trends 244
8.1 Improving Today’s Over-the-Counter (OTC) Blood Glucose Meters 244
8.2 Biosensor Technology 245
8.3 Artificial Pancreas 247
8.4 Telemedicine 248
8.4.1 Remote Patient Monitoring 251 Infopia Eocene System 253 Health Buddy Systems Monitoring Technologies 254 GlucoCom Glucose Monitoring System 254 Alere’s DayLink Monitor 254 Alere HomeLink Receives FDA Approval for Over-the-Counter Use 255
8.5 Non-Traditional Methods for Sample Collection 255
8.6 Data Management 255
8.6.1 Medical Device Radiocommunications Service (MedRadio) 255
8.6.2 Connectivity 256
8.6.3 Advantages of Connectivity 257
8.6.4 Connectivity Platforms 258
8.6.5 DataLink Data Management System 259
8.6.6 RALS-Plus 260
8.6.7 FDA Required Software Verification 260
8.6.8 Information Management Advances 260
8.6.9 POL Laboratory Data Management 262 Electronic Medical Record Systems and Physician Office Laboratory Data Linking Software 263 Physician Office Laboratory Data Linking Software and Interface to the Laboratory Information System 264 Technical Problems of Connectivity 265 Web-Based Data Interface 265
8.6.10 HIT Competition 265

9. Company Profiles 267
9.1 Abaxis, Inc. 267
9.2 Abbott Laboratories 268
9.3 ACON Laboratories 272
9.4 AgaMatrix 272
9.5 Alere 272
9.6 All Medicus Co., Ltd. 273
9.7 Amedica Biotech 273
9.8 A. Menarini Diagnostics 273
9.9 Apex Biotechnology Corporation 274
9.10 ARKRAY 274
9.11 Bayer 274
9.12 B. Braun Melsungen 276
9.13 Beckman Coulter 276
9.14 Bionime 281
9.15 Bio-Rad Laboratories, Inc. 281
9.16 BioTex, Inc. 281
9.17 Calisto Medical, Inc. 281
9.18 Cambridge Sensors 282
9.19 DexCom 282
9.20 Diagnostic Devices/Prodigy Diabetes Care 284
9.21 DiaSys Diagnostic Systems 284
9.22 Echo Therapeutics, Inc. 284
9.23 Entra Health Systems 285
9.24 Fora Care 285
9.25 FIFTY50 Medical, Inc. 285
9.26 Genesis Health Technologies 286
9.27 GenExel-Sein, Inc. 286
9.28 GlucoPlus 286
9.29 GlySens, Inc. 286
9.30 Hainice Medical 286
9.31 HemoCue (a Quest Diagnostics Company) 287
9.32 Home Diagnostics 287
9.33 Infopia Co., Ltd. 287
9.34 IN4 Technology 287
9.35 International Techidyne Corporation (ITC) 287
9.36 Instrumentation Laboratory Company 288
9.37 i-Sense Corporation 288
9.38 Johnson & Johnson 288
9.39 LabStyle Innovations Corporation 290
9.40 Medtronic 290
9.41 Nipro Diagnostics 291
9.42 Nova Biomedical 291
9.43 OrSense Ltd. 292
9.44 Polymer Technology Systems 292
9.45 Prodigy Diabetes Care, LLC (Formerly Diagnostic Devices, Inc.) 292
9.46 Radiometer Medical 293
9.47 Roche Diagnostics 293
9.48 77 Elektronika Kft. 294
9.49 Siemens AG 294
9.50 Smiths Group 295
9.51 TaiDoc Technology 295
9.52 Techno Medica Co., Ltd. 296
9.53 Telcare 296
9.54 U.S. Diagnostics 296
9.55 VeraLight 296
9.56 Ypsomed Holding 297
9.57 YSI Life Sciences 297

List of Tables

Table 2.1: Regional Estimates of the Number of Diabetes (20-79 Years) in Millions, 2013 and 2035 22
Table 2.2: Countries with the Largest Numbers of Diabetics, 2013 23
Table 2.3: Countries with the Largest Estimated Numbers of Diabetics, 2035 23
Table 2.4: Worldwide Undiagnosed Diabetes in Adults (20-79 Years) by Region and Income Group, 2013 24
Table 2.5: Countries with the Largest Number of Deaths Attributable to Diabetes, 2013 24
Table 2.6: U.S. Population of Diagnosed Diabetics Aged 20-79 Years, 2013 26
Table 2.7: Percentage of U.S. Adults with Diagnosed Diabetes by State, 2010 27
Table 2.8: Ten Leading Diagnoses for Co-Morbid Chronic Diseases in the U.S. 36
Table 2.9: Odds Ratio of Progression to Complications Associated with Type 2 Diabetes 38
Table 2.10: Prevalence of Complications Among Patients with Diabetes 38
Table 2.11: Novel Risk Factors and Possible Mechanisms of the Excess Risk of Coronary Heart Disease in Type 2 Diabetes Mellitus 38
Table 2.12: Major Causes of End-Stage Renal Disease 39
Table 2.13: Clinical Recommendations for Adults with Diabetes 41
Table 2.14: Laboratory Assessment of Diabetic Vascular Disease 41
Table 2.15: Average Years Gained Free of Diabetes-Related Disease with Intensive Management 41
Table 2.16: Estimated Direct and Indirect Costs of Major Cardiovascular Diseases and Stroke in the U.S., 2010 43
Table 2.17: Cost of Diagnosed Diabetes in the U.S., 2012 46
Table 2.18: Annual Cost of Care of United Healthcare Adult Members with Diabetes, 2009 48
Table 2.19: Healthcare Utilization by Diabetic Patients, 2012 48
Table 3.1: Worldwide Comprehensive Glucose Testing Market (Includes Reagents and Supplies in both the Self-Testing and Professional Markets in $ Billions), 2012-2018 52
Table 3.2: Total Global Unit Demand for Glucose Testing Reagent Strips, 2012-2018 52
Table 3.3: Global Dollar Sales of Glucose Testing Reagent Strips, 2012-2018 53
Table 3.4: Worldwide Glucose Self-Testing Market Sales (Meters, Strips, and Lancets), 2012-2018 54
Table 3.5: World Market Share of Glucose Self-Testing Marketers, 2013 56
Table 3.6: Global Revenues for Total Professional Blood Glucose Monitoring (Central Laboratory Testing and Hospital POC and POL), 2012-2018 57
Table 3.7: Global Revenues for Professional Point of Care Blood Glucose Monitoring Systems (within Hospitals and Physician’s Offices), 2012-2018 57
Table 3.8: Global Revenues for Continuous Glucose Monitoring Systems, 2012-2018 58
Table 3.9: Comprehensive Glucose Testing Market in the U.S. (Includes Reagents and Supplies in the Self-Testing and Professional Markets), 2012-2018 58
Table 3.10: U.S. Blood Glucose Reagent Strip Market (Includes both Self-Testing and Professional Markets), 2012-2018 59
Table 3.11: Market for Glucose Self-Testing in the U.S. (Includes Meters, Strips and Lancets), 2012-2018 59
Table 3.12: Market Share of U.S. Blood Glucose Self-Testing, 2013 60
Table 3.13: U.S. OTC Glucose Self-Testing Market Repeat Retail Replacement Sales Percentages 61
Table 3.14: OTC Blood Glucose Instrument Reagents by Manufacturer Retail 61
Table 3.15: Demographic Characteristics Glucose Self-Testing Kit Buyers 62
Table 3.16: Top Brand Preferences for Glucose Self-Testing Kits 62
Table 3.17: Instances when Patients Prefer Professional’s Glucose Testing 62
Table 3.18: Advantages of a Glucose Self-Testing Kit 63
Table 3.19: Disadvantages of Using a Glucose Self-Testing Kit 63
Table 3.20: Popular Shopping Destinations for Buying or Seeking Information on Glucose Self-Testing Kits 63
Table 3.21: Customer Priorities—Glucose Meter Self-Testing Market, 2001, 2006 and 2012 63
Table 3.22: Market for Total Professional Glucose Testing (Central Laboratory and Hospital POC and POL) in the U.S., 2012-2018 64
Table 3.23: U.S. Revenues for Professional POC Blood Glucose Monitoring (Hospital and POL), 2012-2018 64
Table 3.24: European Comprehensive Glucose Testing Market (Includes Reagents and Supplies in the Self-Testing and Professional Markets), 2012-2018 65
Table 3.25: European Market for Glucose Self-Testing (Includes Meters, Strips and Lancets), 2012-2018 65
Table 3.26: Asian Comprehensive Glucose Testing Market (Includes Reagents and Supplies in the Self-Testing and Professional Markets), 2012-2018 66
Table 3.27: Asian Market for Glucose Self-Testing (Includes Meters, Strips and Lancets), 2012-2018 67
Table 3.28: Japanese Comprehensive Glucose Testing Market (Includes Reagents and Supplies in the Self-Testing and Professional Markets), 2012-2018 68
Table 3.29: Japanese Market for Glucose Self-Testing (Includes Meters, Strips and Lancets), 2012-2018 68
Table 3.30: Chinese Comprehensive Glucose Testing Market (Includes Reagents and Supplies in the Self-Testing and Professional Markets), 2012-2018 69
Table 3.31: Chinese Market for Glucose Self-Testing (Includes Meters, Strips and Lancets), 2012-2018 70
Table 3.32: Indian Comprehensive Glucose Testing Market (Includes Reagents and Supplies in the Self-Testing and Professional Markets), 2012-2018 72
Table 3.33: Indian Market for Glucose Self-Testing (Includes Meters, Strips and Lancets), 2012-2018 72
Table 3.34: Number of Clinical Labs in India, 2008 72
Table 3.35: Top Domestic IVD Companies in India 72
Table 3.36: Leading Global IVD Companies in India 73
Table 3.37: Southeast Asian Comprehensive Glucose Testing Market (Includes Reagents and Supplies in the Self-Testing and Professional Markets), 2012-2018 74
Table 3.38: Southeast Asian Market for Glucose Self-Testing (Includes Meters, Strips and Lancets), 2012-2018 74
Table 3.39: Southeast Asian Comprehensive Glucose Testing Market by Country, 2013 74
Table 3.40: Southeast Asian Market for Glucose Self-Testing by Country (Includes Meters, Strips and Lancets), 2013 74
Table 3.41: ROW Comprehensive Glucose Testing Market (Includes Reagents and Supplies in the Self-Testing and Professional Markets), 2012-2018 75
Table 3.42: ROW Market for Glucose Self-Testing (Includes Meters, Strips and Lancets), 2012-2018 75
Table 3.43: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats of the Glucose Point of Care Market 80
Table 3.44: Key Market Drivers for Glucose Testing 82
Table 3.45: Market Drivers for Continuous Glucose Monitoring 82
Table 3.46: Point of Care Glucose Testing Market: Market Drivers Ranked in Order of Impact 82
Table 3.47: Key Market Restraints for Glucose Testing 83
Table 3.48: Market Restraints for Continuous Glucose Monitoring 84
Table 3.49: Point of Care Glucose Testing Market: Market Restraints Ranked in Order of Impact 84
Table 4.1: Criteria for the Diagnosis of Diabetes 92
Table 4.2: Categories of Increased Risk for Diabetes (Pre-Diabetes) 92
Table 4.3: Normal Glucose Values—Fasting State 93
Table 4.4: Criteria for Testing for Diabetes in Asymptomatic Adults 93
Table 4.5: Criteria for Type 2 Diabetes in Asymptomatic Children 94
Table 4.6: Screening for and Diagnosis of Gestational Diabetes Mellitus (GDM) 95
Table 4.7: Glycemic Recommendations for Non-Pregnant Adults with Diabetes 97
Table 4.8: Glycemic Recommendations for Women with Gestational Diabetes 97
Table 4.9: Glycemic Recommendations for Pregnant Women with Pre-Existing Diabetes 97
Table 4.10: Plasma Blood Glucose and A1c Goals for Type 1 Diabetes by Age-Group 97
Table 4.11: Glucose Monitoring Recommendations 99
Table 4.12: Key Issues for SMBG in Insulin-Independent Type 2 Diabetics 100
Table 4.13: A1c Testing Recommendations 102
Table 4.14: Correlation of A1c with Mean Blood Glucose 102
Table 5.1: Analytic Performance Criteria for Glucose Meters 111
Table 5.2: Potential Variables Affecting Glucose Concentrations 117
Table 5.3: Key Features Considered for Glucose Testing Devices 119
Table 5.4: Common User Errors Made While Self-Testing for Blood Glucose 121
Table 5.5: Compatibility of Various Blood Glucose Meters with Icodextrin Peritoneal Dialysis (PD) Solution 124
Table 5.6: Ten Factors Needed to Improve the Performance of Blood Glucose Meters 126
Table 5.7: Features Required For Safe and Effective Meters for Hospital Settings 127
Table 5.8: Key Features Considered for Reagent Test Strips 129
Table 5.9: Differences Between Laboratory Instruments for Glucose Analysis and Hand-Held Blood Glucose Meters 129
Table 5.10: Relationship of A1c to Average Whole Blood and Plasma Glucose Levels 135
Table 5.11: Unit Sales of Homecare Lancets in the U.S., 2012-2017 139
Table 5.12: Unit Sales of Homecare Lancets in the E.U., 2012-2017 139
Table 5.13: Dollar Sales of Homecare Lancets in the U.S., 2012-2017 139
Table 5.14: Dollar Sales of Homecare Lancets in the E.U., 2012-2017 139
Table 5.15: Unit Sales of Homecare Glucose Self-Testing Lancets in the U.S., 2012-2017 140
Table 5.16: Unit Sales of Homecare Glucose Self-Testing Lancets in the E.U., 2012-2017 140
Table 5.17: Competition in the Lancet Market Segment 141
Table 5.18: Limitations of Urine Glucose Monitoring 145
Table 5.19: Advantages of Urine Glucose Monitoring 146
Table 5.20: Blood Ketone Reading Indications 146
Table 6.1: Current Blood Glucose Self-Testing Meters: Sample Size, Test Time, and Other Features 148
Table 6.2: Point of Care Blood Glucose or Blood Gas Meters Marketed for Professional Use 178
Table 6.3: Clinical Blood Chemistry Analyzers with Glucose Assays 185
Table 6.4: Detailed Features of Selected CGM Systems Currently Available 195
Table 6.5: Non-Invasive Glucose Monitoring Systems in Development 203
Table 7.1: POC Procedural Advantages for Hospital Testing 219
Table 7.2: Financial Comparison for Moderate and Waived CLIA Labs 240
Table 8.1: Data Entry and Data Management Features to Include in Future Meters 245
Table 8.2: Leading Companies for Patient Monitoring Products 253
Table 8.3: Customized Reports Must Support CAP and JCAHO Requirements 260

List of Figures

Figure 2.1: Worldwide Diabetes Cases, 2013 and 2035 21
Figure 2.2: Worldwide Prevalence of Diabetes (%) in Adults (20-79 Years), 2013 22
Figure 2.3: Annual Number of New Cases of Diagnosed Diabetes Among U.S. Adults Aged 18-79 Years, 1980-2011 25
Figure 2.4: New Cases of Diabetes Diagnosed in the U.S. Adult Population by Age, 2010 26
Figure 2.5: Prevalence of Diabetes by Age in the U.S., 2010 26
Figure 2.6: Diagnosed Diabetes by Age in the U.S., 2013 27
Figure 2.7: Number of Deaths from Diabetes by Age in the U.S., 2010 29
Figure 2.8: Number of Diabetes Deaths by Race and Sex in the U.S., 2010 29
Figure 2.9: Maintenance of Normal Blood Sugar Levels 30
Figure 2.10: Prevalence of Self-Reported Obesity (BMI ? 30) Among U.S. Adults, 2012 34
Figure 2.11: Prevalence of Obesity Among Adults in the U.S., 2009-2010 34
Figure 2.12: Trends in Obesity Among Children and Adolescents in the U.S., 1988-2010 35
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 37
Figure 2.14: Percentage of Adults with Diagnosed Diabetes Reporting Any Mobility Limitation, by Age, in the U.S., 1997-2011 39
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 40
Figure 2.16: Mean Diabetes Healthcare-related Expenditures Per Adult (20-79 Years) with Diabetes (U.S. Dollars), 2013 45
Figure 2.17: How Diabetes Dollars are Spent in the U.S., 2012 47
Figure 3.1: Global Unit Sales of Glucose Testing Reagent Strips, 2013 53
Figure 3.2: Geographic Segments of the Worldwide Glucose Self-Testing Market, 2012 and 2018 54
Figure 3.3: Worldwide Glucose Self-Testing Market by Region, 2018 55
Figure 4.1: Approach to Management of Hypoglycemia 98
Figure 4.2: Glycemic Status—Ranges and Health Implications 105
Figure 5.1: EGA Zones of Clinical Accuracy 116
Figure 5.2: Single-Day Continuous Blood Glucose Data 121
Figure 5.3: Factors that May Adversely Affect Glucose Testing 123
Figure 5.4: Personal Lancet Unit Sales Market Share by Geographic Region, 2013 140
Figure 6.1: Medtronic’s Threshold Suspend Feature 197

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