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World Glucose Self-Testing Markets

August 4, 2014

LONDON, Aug. 4, 2014 /PRNewswire/ — Reportbuyer.com has added a new market research report:

World Glucose Self-Testing Markets

http://www.reportbuyer.com/pharma_healthcare/diseases/diabetes/world_glucose_self_testing_markets.html

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.

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

3.6 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

INDEX 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

INDEX 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 Glu

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World Glucose Self-Testing Markets

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