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U.S. Glucose Testing Markets

  • September 2015
  • -
  • TriMark Publications
  • -
  • 280 pages

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

U.S. Glucose Testing Markets










TABLE OF CONTENTS



1. Overview 14

1.1 Statement of Report 14

1.2 About This Report 14

1.3 Scope of the Report 15

1.4 Methodology 16

1.5 Executive Summary 17

2. Diabetes 19

2.1 Demographics of Diabetes in the U.S. 20

2.2 Understanding the Metabolic Conditions Underlying and Associated with
Diabetes 25

2.2.1 Pre-Diabetes Syndrome 26

2.2.2 Metabolic Syndrome 27

2.2.3 Progression of Diabetes 27

2.2.4 Diabetes and Inflammation 27

2.2.5 Risk Factors and Diabetes 28

2.2.5.1 Obesity 28

2.2.5.2 Stress-Induced Hyperglycemia 31

2.2.6 Complications and Co-Morbidities in Diabetes 31

2.2.6.1 Preventing Complications and Co-Morbidities in Diabetes 35

2.2.6.2 Cardiovascular Disease Facts 37

2.3 Economics of Diabetes 40

3. Market Analysis: Size, Growth, Share and Competitors 45

3.1 U.S. Market 46

3.1.1 U.S. Over-the-Counter (OTC) Self-Testing Glucose Market 47

3.1.2 U.S. Professional Glucose Testing Market 52

3.1.3 Continuous Glucose Monitoring Markets 53

3.2 Competitive Situation 54

3.2.1 Key Players 54

3.2.2 Analyses of the Self-Testing Market Conditions, Competition and Product
Mix 54

3.2.3 Analyses of the Professional Blood Glucose Monitoring Market 57

3.3 Market Drivers and Restraints 59

3.3.1 Market Drivers 59

3.3.2 Market Restraints 61

3.4 Market and Product Trends 63

3.4.1 Market Trends 63

3.4.2 Technology Trends 64

3.5 Strategic Recommendations 66

3.6 Competitive Strategies 68

3.7 New Opportunities in the Professional Blood Glucose Meter Market 69

3.8 Adjacent Markets 69

4. Glucose Diagnostic and Monitoring Recommendations 70

4.1 Diagnosis of Diabetes Mellitus 70

4.2 Tight Glucose Control in Treating Diabetes 73

4.2.1 Tight Glucose Control Lowers Cardiovascular Complications 74

4.3 Recommendations for Glucose Control in Diabetics 74

4.3.1 New Plasma Blood Sugar and HbA1c Target Recommendation for Children with
Type 1 Diabetes 75

4.3.2 Recommended Frequency of Blood Glucose Self-Testing 77

4.3.3 Using Blood Glucose Data to Monitor and Modify Patient Therapy 77

4.3.4 Testing in Individuals with Type 2 Diabetes 78

4.3.5 Continuous Glucose Monitoring (CGM) 79

4.3.6 A1c Testing Recommendations 80

4.3.7 Recommendations for Diabetes Care and Glucose Testing in the Hospital
Setting 81

4.4 Hypoglycemia and Treatment 84

5. Glucose Testing Technology Platforms and Consumable Products 86

5.1 Types of Glucose Determination Technologies 86

5.2 Enzymatic Reactions Used to Determine Glucose Concentrations 87

5.2.1 Glucose Oxidase (GOX) 87

5.2.2 Glucose Dehydrogenase (GDH) 88

5.2.2.1 GDH-NAD (Glucose Dehydrogenase-Nicotinamide Adenine Dinucleotide) 88

5.2.2.2 GDH-FAD (Glucose Dehydrogenase-Flavin Adenine Dinucleotide) 88

5.2.2.3 GDH-PQQ (Glucose Dehydrogenase-Pyrroloquinoline Quinone) 88

5.2.3 Glucose Hexokinase 88

5.3 Development of Blood Glucose Monitors: A Historical Evaluation 89

5.3.1 First-Generation Blood Glucose Biosensors 89

5.3.2 Second-Generation Blood Glucose Biosensors 89

5.3.3 Third-Generation Blood Glucose Biosensor 89

5.4 Accuracy and Precision in Glucose Meters 90

5.4.1 Clinical and Laboratory Standards Institute (CLSI) POCT12-A3 91

5.4.2 International Organization for Standardization (ISO) 15197:2013 92

5.4.3 FDA Guidelines for Blood Glucose Testing Systems 92

5.4.4 Determining Clinical Accuracy Using the Error Grid Analysis (EGA) 95

5.4.5 Quality Control Criteria 96

5.4.6 Potential Variables Affecting Glucose Concentrations 97

5.5 Key Issues for Glucose Testing Devices 97

5.5.1 Important Elements for Glucose Testing 98

5.5.2 Key Features to Aid Specific Patient Populations 99

5.6 Limitations of Existing Glucose Testing 100

5.6.1 Common User Errors in Glucose Self-Testing 101

5.6.2 Interfering Substances and Conditions 102

5.6.2.1 Environmental 102

5.6.2.2 Physiologic 102

5.6.2.3 Operational 102

5.6.2.4 Manufacturing Variations 102

5.6.2.5 Drugs/Medications 102

5.6.2.6 Patient Factors 102

5.6.3 Errors Associated with GDH-PQQ Technology 103

5.6.4 Optimizing of Point of Care (POC) Blood Glucose Testing 106

5.7 Potential Areas of Improvement in Blood Glucose Meter Performance 106

5.7.1 Off-Label/Modified Use of Waived Blood Glucose Monitoring Systems 108

5.8 Blood Glucose Reagent Test Strips 108

5.9 Comparison of Hand-Held Blood Glucose Meters with Clinical Laboratory
Glucose Measurements 109

5.10 Continuous Glucose Monitoring Technology 110

5.10.1 Advantages of Continuous Readings 110

5.10.2 FDA Approval of CGM 111

5.10.3 CGM Functions to Consider 111

5.10.4 New Technologies for CGM 112

5.11 Summary of Technologies Being Explored for Non-Invasive Glucose Monitoring
113

5.11.1 GlucoTrack 113

5.11.2 Non-Invasive Glucose Monitoring Technologies in Development 113

5.11.3 Goals of Non-Invasive Testing 114

5.11.4 Non-Invasive Diabetes Screening Test 115

5.12 A1c Monitoring Technology 115

5.12.1 PTS Diagnostics' (Chek Diagnostics') A1c Home Test 116

5.13 Fructosamine Test 117

5.14 Related Reagents and Equipment 118

5.14.1 Lancets 118

5.14.1.1 Types of Lancing Devices 118

5.14.1.2 Market Size 119

5.14.2 Control Solutions and Calibrators 123

5.14.3 Sharps Devices 124

5.14.4 Needle Destruction Devices 124

5.14.5 Urine Strips 125

5.14.6 Ketone Testing 126

5.14.7 Long-Term Glucose Sensing Bio-Implants 127

6. Glucose Testing Devices on the Market 128

6.1 Hand-held Blood Glucose Meters and Strips for Self-Testing 128

6.1.1 LifeScan, Inc. 132

6.1.2 Roche Diagnostics Corporation 134

6.1.3 Bayer 136

6.1.4 Abbott 137

6.1.5 Agamatrix, Inc. 139

6.1.6 Arkray, Inc. 140

6.1.7 Bionime Corporation 141

6.1.8 BioSense Medical Devices 143

6.1.9 CVS/Pharmacy 143

6.1.10 Diabetic Supply of Suncoast 143

6.1.11 Entra Health Systems 144

6.1.12 Fifty50 Pharmacy 144

6.1.13 Fora Care 145

6.1.14 Genesis Health Technologies 145

6.1.15 GlucoCom 145

6.1.16 iHealth 146

6.1.17 Infopia 146

6.1.18 Livongo Health 147

6.1.19 Nipro Diagnostics, Inc. 147

6.1.20 Nova Biomedical 148

6.1.21 Oak Tree International Holdings, Inc. 149

6.1.22 Omnis Health 149

6.1.23 Phylosis 149

6.1.24 Prodigy Diabetes Care, LLC (an affiliate of Diagnostic Devices, Inc.) 150

6.1.25 Sanofi 151

6.1.26 Target 151

6.1.27 Telcare 151

6.1.28 Tyson Biomedical 151

6.1.29 US Diagnostics 152

6.1.30 Walgreens 153

6.1.31 Walmart 153

6.1.32 77 Elektronika Kft. 153

6.1.33 A. Menarini Diagnostics 154

6.1.34 All Medicus 154

6.1.35 i-SENS 154

6.1.36 Apex Biotechnology Corp. 155

6.1.37 Glucoplus, Inc. 155

6.1.38 Polymer Technology Systems 155

6.1.39 Smiths Medical MD, Inc. 155

6.1.40 TaiDoc Technology Corp. 155

6.1.41 IN4 Technology Corporation 156

6.1.42 ACON Laboratories, Inc. 156

6.1.43 Pepex Biomedical 156

6.1.44 HMD BioMedical 157

6.1.45 BTNX, Inc. 157

6.1.46 Shasta Technologies and Decision Diagnostics Corporation 157

6.2 Hand-held Blood Glucose Meters for Professional Use 158

6.2.1 Abbott 160

6.2.1.1 Precision Xceed Pro Blood Glucose and Beta-Ketone Monitoring System 161

6.2.1.2 i-STAT System 161

6.2.2 ACON Laboratories 162

6.2.2.1 On Call Platinum Blood Glucose Monitoring System 162

6.2.3 Alere 162

6.2.3.1 epoc Blood Analysis System 162

6.2.3.2 Alere Cholestech LDX System 162

6.2.4 Apex Biotechnology 162

6.2.5 ARKRAY, Inc. 162

6.2.5.1 Assure Platinum and Assure Prism Multi 163

6.2.6 EKF Diagnostics 163

6.2.6.1 Biosen Series of Glucose and Lactate Analyzers 163

6.2.7 Fora Care 163

6.2.7.1 VSM100 Pro Vital Sign Monitor 163

6.2.8 HemoCue (part of Radiometer) 164

6.2.8.1 HemoCueÒ Glucose 201+, Glucose 201 RT, Glucose 201 DM, and Glucose DM RT
Systems 164

6.2.9 HMD BioMedical 164

6.2.9.1 NS100 164

6.2.10 Infopia 164

6.2.10.1 Lipid Pro 164

6.2.11 Jant Pharmacal 165

6.2.11.1 LipidPlus® Lipid Profile and Glucose Measuring System 165

6.2.12 Medtronic 165

6.2.12.1 iPro Continuous Glucose Monitor 165

6.2.13 Nova Biomedical 165

6.2.13.1 StatStrip Hospital Glucose Monitoring System 166

6.2.14 Polymer Technology Systems, Inc. 166

6.2.14.1 CardioChek PA Point of Care Device 166

6.2.15 Roche 166

6.2.15.1 Accu-Chek Inform II System 166

6.2.15.2 Accutrend Plus System 166

6.2.16 Techno Medica Co., Ltd. 167

6.2.16.1 GASTAT-mini 167

6.2.17 LifeScan 167

6.3 Clinical Blood Chemistry Analyzers 167

6.3.1 Abaxis, Inc. 169

6.3.1.1 Piccolo® Xpress Blood Chemistry Analyzers 169

6.3.2 Abbott 170

6.3.2.1 ARCHITECT 170

6.3.3 Alere 170

6.3.3.1 Cholestech LDX® System 170

6.3.4 AMS 170

6.3.4.1 SAT 600 170

6.3.4.2 SAT 450 170

6.3.4.3 LIASYS 170

6.3.4.4 ELLIPSE 170

6.3.4.5 NEPHYS 171

6.3.4.6 VEGASYS 171

6.3.5 ARKRAY, Inc. 171

6.3.5.1 SPOTCHEM™ EZ 171

6.3.5.2 SPOTCHEM D-02 (SD-4810) andamp; SPOTCHEM D-03 (SD-4820) 171

6.3.6 Beckman Coulter 171

6.3.6.1 AU chemistry systems 171

6.3.6.2 UniCel® DxC chemistry systems 171

6.3.7 DiaSys 172

6.3.7.1 InnovaStar® 172

6.3.7.2 SensoStar GL30 touch and SensoStar GLHsix 172

6.3.7.3 respons® 910 and 920 172

6.3.7.4 BioMajesty® JCA-BM6010/C 172

6.3.8 Diatron 172

6.3.8.1 Pictus 500 172

6.3.8.2 Pictus 700 172

6.3.8.3 Pictus 400 172

6.3.8.4 Pictus 200 173

6.3.8.5 Pictus B 173

6.3.9 Instrumentation Laboratory 173

6.3.9.1 IL GEM Premier 4000, 3500 and 3000 173

6.3.10 LifeHealth (formerly International Techidyne Corporation) 173

6.3.10.1 IRMA TruPoint® 173

6.3.11 Nova Biomedical 174

6.3.11.1 Nova Electrolyte/Chemistry Analyzers 174

6.3.11.2 Stat Profile® Critical Care Xpress 174

6.3.11.3 Stat Profile® pHOx® Plus 174

6.3.11.4 Stat Profile® pHOx® Ultra 174

6.3.12 Radiometer™ 174

6.3.12.1 ABL™80 FLEX 174

6.3.12.2 ABL™90 FLEX 175

6.3.12.3 ABL™800 FLEX 175

6.3.13 Randox Laboratories 175

6.3.13.1 RX Series of clinical chemistry analyzers 175

6.3.14 Roche 176

6.3.14.1 cobas® 4000, cobas® 6000, and cobas® 8000 modular Analyzer Series 176

6.3.14.2 cobas® c 111 Analyzer 176

6.3.14.3 cobas® b 221 System 176

6.3.14.4 Reflotron® Systems 176

6.3.15 Siemens Healthcare Diagnostics 176

6.3.15.1 Point-of-care Blood Gas Analyzers 177

6.3.15.2 Central (Core) Laboratory Clinical Chemistry Systems 177

6.3.16 Span Diagnostics 179

6.3.16.1 Autochem Xact 179

6.3.16.2 BT 1500 179

6.3.17 Stanbio Laboratory 179

6.3.17.1 Excel Semi-Automated Clinical Chemistry Analyzer 179

6.3.17.2 Sirrus® Clinical Chemistry Analyzer 179

6.3.18 Techno Medica Co., Ltd 180

6.3.19 Thermo Fisher Scientific 180

6.3.19.1 Indiko™ Clinical and Specialty Chemistry System 180

6.3.19.2 Indiko™ Plus Clinical and Specialty Chemistry System 180

6.3.19.3 Konelab™ 20XT Clinical Chemistry Analyzer 180

6.3.19.4 Konelab™ PRIME 60 Clinical Chemistry Analyzer 180

6.3.19.5 MGC 240 Benchtop Analyzer 180

6.3.20 Tokyo Boeki Medisys 180

6.3.20.1 BiOLis family of analyzers 180

6.3.21 YSI Life Sciences 180

6.3.21.1 YSI 2300 STAT Plus™ Glucose andamp; Lactate Analyzer 180

6.4 Continuous Glucose Patient Monitoring Systems 181

6.4.1 Medtronic's Continuous Glucose Monitoring Systems (CGMS) 183

6.4.1.1 MiniMed Paradigm REAL-Time Revel System 183

6.4.1.2 Guardian REAL-Time 184

6.4.1.3 MiniMed 530G with Enlite 185

6.4.1.4 iPro®2 Professional CGM 186

6.4.2 Dexcom, Inc.'s Continuous Glucose Monitoring System 186

6.4.2.1 G4 Platinum Continuous Glucose Monitoring System 186

6.4.2.2 Dexcom G4 Platinum Continuous Glucose Monitoring System with Share 187

6.4.2.3 Dexcom G5 Mobile Continuous Glucose Monitoring System 187

6.4.3 Animas Vibe System 187

6.4.4 Abbott's Continuous Glucose Monitor System 188

6.4.4.1 FreeStyle Libre 188

6.4.4.2 FreeStyle Navigator (discontinued) 188

6.4.5 GlucoDay® S Continuous Glucose Monitor 189

6.4.6 Minimally-Invasive Continuous Glucose Monitors in Development 189

6.4.6.1 GlySens Inc. 189

6.4.6.2 Senseonics (formerly Sensors for Medicine and Science) 190

6.4.6.3 Ultradian 191

6.5 Non-Invasive Glucose Patient Monitoring Systems 191

6.5.1 Cygnus GlucoWatch Biographer 192

6.5.2 AiMedics 192

6.5.3 Echo Therapeutics 192

6.5.4 EyeSense GmbH 193

6.5.5 Freedom Meditech 194

6.5.6 Google and Novartis 194

6.5.7 Integrity Applications Ltd. 194

6.5.8 Lein Applied Diagnostics 195

6.5.9 LighTouch Medical 195

6.5.10 Miraculins, Inc. 195

6.5.11 Xhale Inc. 196

6.6 A1c Testing 196

6.7 New Product Launches 197

6.7.1 OneTouch Verio Sync Blood Glucose Monitoring System 197

6.7.2 Medtronic's MiniMed 530G with Enlite Sensor Technology 197

6.7.3 Contour Next Link Meter Approved for Use with Medtronic's New MiniMed 530G
with Enlite Insulin Pump System 197

6.7.4 Abbott Receives CE Mark for FreeStyle Optium Neo Blood Glucose and Ketone
Monitoring System 198

6.7.5 Abbott Receives FDA Clearance for FreeStyle Precision Pro Blood Glucose
and ß-Ketone Monitoring System 198

6.7.6 LabStyle Innovations' Dario Diabetes Management System 198

6.7.7 BlueStar by WellDoc 198

6.7.8 FDA Approves Bayer's Contour Next EZ 199

6.7.9 Glooko Received its Second 510(k) Clearance for Glucose Monitoring Logbook
App 199

6.7.10 Sanofi-Aventis's iBGStar 199

6.7.11 iHealth Glucose Meter Device 200

6.7.12 MyGlucoHealth Diabetes 200

6.7.13 Enlite™ Sensor 200

6.7.14 Medtronic Gains Approval of First Artificial Pancreas Device System, the
MiniMed® 530G with Enlite® 201

6.7.15 Nipro Diagnostics TrueMetrix Air 201

6.7.16 Animas Vibe System 201

6.7.17 Abbott's FreeStyle Libre and FreeStyle Libre Pro 201

6.7.18 Abbott's FreeStyle Precision Neo Blood Glucose Monitoring System 202

6.7.19 Dexcom G4 Platinum Continuous Glucose Monitoring System with Share 202

6.7.20 Medtronic's MiniMed Connect 202

6.7.21 Dexcom G5 Mobile CGM System 202

6.8 Blood Glucose Meters, CGMs, and Data Management Software in Development 203

6.8.1 Abbott's Flash Glucose Monitoring System 203

6.8.2 Google Announces Plan to Create Contact Lens Glucose Sensors 203

6.8.3 Socrates Health Solutions' Companion Blood Glucose Monitor 203

6.8.4 Boston University's Bionic Pancreas Project 203

6.8.5 IGI Stat's Test to Identify Type 1 Diabetes 204

6.8.6 Medtronic's Next-generation Combination Pump and CGM 204

6.8.7 Medtronic and IBM's Watson Health to Develop Data Management Solutions 204

6.9 Recent Industry Activity 205

6.9.1 Roche Diagnostics Corp. Cutting Jobs in Diabetes Division 205

6.9.2 AgaMatrix and Sanofi-Aventis Enter Global Diabetes Partnership 205

6.9.3 LifeScan, Inc. Terminates Exclusive Supply Agreement with Medtronic
MiniMed 205

6.9.4 Medtronic and Bayer Healthcare Expand International Alliance 205

6.9.5 PositiveID Corporation Licenses iglucose Technology to Smart Glucose Meter
Corp 205

6.9.6 BD and JDRF Collaborating on a Device Using a Single Infusion Catheter for
Both CGM and Pump 206

6.9.7 Court Sides with Decision Diagnostics in Patent Infringment Case 206

6.9.8 Senseonics Partners with Rubin Medical to Commercialize New CGM 206

6.9.9 Abbott re-entering Continuous Glucose Monitoring Market in Europe with
FreeStyle Libre 206

6.9.10 Medtronic and IBM's Watson Health Partnering to Develop Personalized
Diabetes Management Solutions 206

6.10 Mandamp;A Activity 207

6.10.1 Home Diagnostics, Inc. and Nipro Diabetes Systems, Inc. Merge to Become
Nipro Diagnostics, Inc. 207

6.10.2 Medtronic, Inc. (MDT) Acquires New Diabetes Technology from PreciSense AS
207

6.10.3 Geonostics Acquires FlexSite's Consumer Diabetes Tests 208

6.10.4 Radiometer Medical Acquires Hemocue 208

6.10.5 Additional Mandamp;A 208

6.10.6 Important Deals in BGM market 209

7. Business Trends in Glucose Testing 211

7.1 Drivers of Clinical Glucose Testing 211

7.2 Competition for Professional POC Glucose Testing 211

7.3 Healthcare Cost Controls 211

7.4 Changes in Patient Management 212

7.5 Regionalization of Laboratory Care 212

7.6 Satellite Facilities 213

7.7 Professional Point of Care Testing 213

7.8 Factors Affecting OTC Medical Product Distribution 214

7.9 Drug Stores Critical to the Diabetic Care Category 216

7.10 Drivers of OTC and Self-Testing Markets 216

7.10.1 Brand Loyalty 216

7.11 Cost Elements of Glucose Self-Testing 217

7.12 Blood Glucose Self-Testing Insurance Coverage and Reimbursement 217

7.13 Reimbursement Challenges 220

7.13.1 New Medicare Part B 221

7.14 Managed Care 221

7.15 Government Regulation of Medical Devices 221

7.16 Clinical Laboratory Improvement Act (CLIA) 224

7.16.1 Off-Label/Modified Use of Waived Blood Glucose Monitoring Systems 226

7.17 FDA Labeling Requirements 226

7.18 Legal Liability for Glucose Meters 228

7.19 FDA's Artificial Pancreas Guidance Document 228

8. Technology Trends 229

8.1 Improving Today's OTC Blood Glucose Meters 229

8.2 Biosensor Technology 230

8.3 Fructosamine Test 232

8.4 Artificial Pancreas 232

8.5 Telemedicine Devices 233

8.5.1 Remote Patient Monitoring 236

8.5.1.1 Infopia Eocene System 238

8.5.1.2 Health Buddy Systems Monitoring Technologies 239

8.5.1.3 GlucoCom Glucose Monitoring System 239

8.5.1.4 Alere's DayLink Monitor 239

8.5.1.5 Alere HomeLink Receives FDA Approval for Over-the-Counter Use 239

8.5.1.6 iGlucose System 240

8.6 Non-Traditional Methods for Sample Collection 240

8.7 Data Management 241

8.7.1 Medical Device Radiocommunications Service (MedRadio) 241

8.7.2 Connectivity 241

8.7.3 Advantages of Connectivity 243

8.7.4 Connectivity Platforms 243

8.6.5 DataLink Data Management System 244

8.7.6 RALS-Plus 245

8.7.7 FDA Required Software Verification 245

8.7.8 Information Management Advances 246

8.7.9 POL Laboratory Data Management 247

8.7.9.1 Electronic Medical Record Systems and Physician Office Laboratory Data
Linking Software 248

8.7.9.2 Physician Office Laboratory Data Linking Software and Interface to the
Laboratory Information System 249

8.7.9.3 Technical Problems of Connectivity 250

8.7.9.4 Web-Based Data Interface 250

8.7.10 HIT Competition 250

9. Company Profiles 252

9.1 Abaxis, Inc. 252

9.2 Abbott Laboratories 252

9.3 ACON Laboratories 256

9.4 AgaMatrix 256

9.5 Alere, Inc. 256

9.6 All Medicus, Co., Ltd. 257

9.7 AMS Alliance 257

9.8 A. Menarini Diagnostics 257

9.9 Apex Biotechnology Corporation 258

9.10 ARKRAY USA, Inc. 258

9.11 Bayer AG 258

9.12 B. Braun Melsungen 260

9.13 Beckman Coulter 260

9.14 Bionime 265

9.15 Bio-Rad Laboratories, Inc. 265

9.16 Cambridge Sensors 266

9.17 Cardiocom 266

9.18 DexCom 266

9.19 Diagnostic Devices/Prodigy Diabetes Care 267

9.20 DiaSys 267

9.21 Diatron 267

9.22 Echo Therapeutics, Inc. 267

9.23 Entra Health Systems 269

9.24 Fora Care 269

9.25 FIFTY50 Medical, Inc. 269

9.26 Freedom Meditech 269

9.27 Genesis Health Technologies 269

9.28 GenExel-Sein, Inc. 269

9.29 GlucoPlus 269

9.30 GlySens, Inc. 270

9.31 GlySure Limited 270

9.32 Grove Instruments 270

9.33 Hainice Medical 270

9.34 HemoCue (a Quest Diagnostics company) 270

9.35 Home Diagnostics 271

9.36 Infopia Co., Ltd. 271

9.37 IN4 Technology 271

9.38 International Techidyne Corporation (ITC) 271

9.39 Instrumentation Laboratory Company 272

9.40 i-Sens 272

9.41 Jant Pharmacal 272

9.42 Johnson andamp; Johnson 272

9.43 LabStyle Innovations Corporation 274

9.44 LifeHealth, LLC 274

9.45 Medtronic 274

9.46 Miraculins 275

9.47 Nipro Diagnostics 275

9.48 Nova Biomedical 275

9.49 Polymer Technology Systems 276

9.50 Prodigy Diabetes Care, LLC (formerly Diagnostic Devices, Inc.) 276

9.51 Radiometer Medical 277

9.52 Roche Diagnostics 277

9.53 Senseonics 278

9.54 77 Elektronika Kft. 278

9.55 Siemens AG 278

9.56 Smiths Group 279

9.57 Stanbio Laboratory 279

9.58 TaiDoc Technology 280

9.59 Techno Medica Co., Ltd. 280

9.60 Telcare 280

9.61 Tokyo Boeki Medisys 280

9.62 US Diagnostics 281

9.63 Ypsomed Holding 281

9.64 YSI Life Sciences 281





INDEX OF FIGURES



Figure 2.1: New Cases of Diabetes Diagnosed in the U.S. Adult Population by Age
21

Figure 2.2: Prevalence of Diabetes by Age in the U.S. 21

Figure 2.3: Diagnosed Diabetes by Age in the U.S. 22

Figure 2.4: Percentage of U.S. Adults Diagnosed Diabetes by State 24

Figure 2.5: Number of Deaths from Diabetes by Age in the U.S. 24

Figure 2.6: Number of Diabetes Deaths by Race and Sex in the U.S. 25

Figure 2.7: Maintenance of Normal Blood Sugar Levels 26

Figure 2.8: Prevalence of Self-Reported Obesity (BMI ³30) Among U.S. Adults 29

Figure 2.9: Prevalence of Obesity (BMI =30) Among Adults in the U.S. 30

Figure 2.10: Trends in Obesity Among Children and Adolescents in the U.S. 30

Figure 2.11: Age-Adjusted Percentage of People with Diabetes Aged 35 Years or
Older Reporting Heart Disease or Stroke, by Sex, in the U.S. 32

Figure 2.12: Percentage of Adults with Diagnosed Diabetes Reporting Any Mobility
Limitation, by Age, in the U.S. 35

Figure 2.13: Number (in Millions) of Adults Aged 18 Years or Older with
Diagnosed Diabetes Reporting Visual Impairment, in the U.S. 35

Figure 2.14: How Diabetes Dollars are Spent in the U.S. 42

Figure 3.1: Forecasted Test Strip Usage by Different Diabetic Populations 48

Figure 4.1: Approach to Management of Hypoglycemia 76

Figure 4.2: Glycemic Status—Ranges and Health Implications 81

Figure 5.1: EGA Zones of Clinical Accuracy 96

Figure 5.2: Single-Day Continuous Blood Glucose Data 101

Figure 5.3: Factors that may Adversely Affect Glucose Testing 103

Figure 5.4: Personal Lancet Unit Sales Market Share by Geographic Region 121

Figure 6.1: Medtronic's Threshold Suspend Feature 185



INDEX OF TABLES



Table 2.1: New Cases of Diagnosed Diabetes Among U.S. Adults Aged 20 Years or
Older 21

Table 2.2: U.S. Population of Diagnosed Diabetics Aged 20-79 Years 22

Table 2.3: Percentage of U.S. Adults with Diagnosed Diabetes by State 22

Table 2.4: Ten Leading Diagnoses for Co-Morbid Chronic Diseases in the U.S. 32

Table 2.5: Odds Ratio of Progression to Complications Associated with Type 2
Diabetes 33

Table 2.6: Prevalence of Complications Among Patients with Diabetes 34

Table 2.7: Major Causes of End-Stage Renal Disease 34

Table 2.8: Novel Risk Factors and Possible Mechanisms of the Excess Risk of
Coronary Heart Disease in Type 2 Diabetes Mellitus 34

Table 2.9: Clinical Recommendations for Adults with Diabetes 36

Table 2.10: Laboratory Assessment of Diabetic Vascular Disease 36

Table 2.11: Average Years Gained Free of Diabetes-Related Disease with Intensive
Management 37

Table 2.12: Estimated Direct and Indirect Costs of Major Cardiovascular Diseases
and Stroke in the U.S. 38

Table 2.13: Cost of Diagnosed Diabetes in the U.S. 41

Table 2.14: Annual Cost of Care of United Healthcare Adult Members with Diabetes
41

Table 2.15: Healthcare Utilization by Diabetic Patients 42

Table 3.1: Comprehensive Glucose Testing Market in the U.S. (includes reagents
and supplies in the Self-testing and Professional Markets) 47

Table 3.2: U.S. Blood Glucose Reagent Strip Market (includes both Self-testing
and Professional Markets) 47

Table 3.3: Market for Glucose Self-Testing in the U.S. (includes Meters, Strips,
and Lancets) 48

Table 3.4: Market Share of U.S. Blood Glucose Self-Testing 49

Table 3.5: U.S. OTC Glucose Self-Testing Market Repeat Retail Replacement Sales
Percentages 49

Table 3.6: OTC Blood Glucose Instrument Reagents by Manufacturer Retail 50

Table 3.7: Demographic Characteristics Glucose Self-Testing Kit Buyers 51

Table 3.8: Top Brand Preferences for Glucose Self-Testing Kits 51

Table 3.9: Instances when Patients Prefer Professional's Glucose Testing 51

Table 3.10: Advantages of a Glucose Self-Testing Kit 51

Table 3.11: Disadvantages of Using a Glucose Self-Testing Kit 52

Table 3.12: Popular Shopping Destinations for Buying or Seeking Information on
Glucose Self-Testing Kits 52

Table 3.13: Customer Priorities—Glucose Meter Self-Testing Market 52

Table 3.14: Market for Total Professional Glucose Testing (Central Laboratory
and Hospital POC andamp; POL) 52

Table 3.15: U.S. Revenues for Professional POC Blood Glucose Monitoring
(Hospital andamp; POL) 53

Table 3.16: U.S. Continuous Glucose Monitoring Market 53

Table 3.17: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and
Threats of the Glucose Point of Care Market 59

Table 3.18: Key Market Drivers for Glucose Testing 60

Table 3.19: Point of Care Glucose Testing Market: Market Drivers Ranked in Order
of Impact 60

Table 3.20: Market Drivers for Continuous Glucose Monitoring 61

Table 3.21: Key Market Restraints for Glucose Testing 62

Table 3.22: Market Restraints for Continuous Glucose Monitoring 62

Table 3.23: Point of Care Glucose Testing Market: Market Restraints Ranked in
Order of Impact 62

Table 4.1: Criteria for the Diagnosis of Diabetes 70

Table 4.2: Categories of Increased Risk for Diabetes (Pre-Diabetes) 70

Table 4.3: Normal Glucose Values—Fasting State 71

Table 4.4: Criteria for Testing for Diabetes in Asymptomatic Adults 71

Table 4.5: Criteria for Type 2 Diabetes in Asymptomatic Children 72

Table 4.6: Screening for and Diagnosis of Gestational Diabetes Mellitus (GDM) 73

Table 4.7: Glycemic Recommendations for Non-Pregnant Adults with Diabetes 75

Table 4.8: Glycemic Recommendations for Women with Gestational Diabetes 75

Table 4.9: Glycemic Recommendations for Pregnant Women with Pre-Existing
Diabetes 75

Table 4.10: Plasma Blood Glucose and A1c Goals for Type 1 Diabetes by Age-group
76

Table 4.11: Glucose Monitoring Recommendations 77

Table 4.12: Key Issues for SMBG in Insulin-Independent Type 2 Diabetics 79

Table 4.13: A1c Testing Recommendations 80

Table 4.14: Correlation of A1c with Mean Blood Glucose 80

Table 4.15: Glucose Monitoring Recommendations for Hospital Settings 82

Table 4.16: Glycemic Goals for Hospital Patients 83

Table 5.1: Analytic Performance Criteria for Glucose Meters 91

Table 5.2: Potential Variables Affecting Glucose Concentrations 97

Table 5.3: Key Features Considered for Glucose Testing Devices 99

Table 5.4: Common User Errors Made While Self-Testing for Blood Glucose 101

Table 5.5: Compatibility of Various Blood Glucose Meters with Icodextrin PD
Solution 104

Table 5.6: Ten Factors Needed to Improve the Performance of Blood Glucose Meters
106

Table 5.7: Features Required for Safe and Effective Meters for Hospital Settings
107

Table 5.8: Key Features Considered for Reagent Test Strips 109

Table 5.9: Differences between Laboratory Instruments for Glucose Analysis and
Hand-Held Blood Glucose Meters 110

Table 5.10: Relationship of A1c to Average Whole Blood and Plasma Glucose Levels
115

Table 5.11: Unit Sales of Homecare Lancets in the U.S. 119

Table 5.12: Unit Sales of Homecare Lancets in the E.U. 119

Table 5.13: Dollar Sales of Homecare Lancets in the U.S. 120

Table 5.14: Dollar Sales of Homecare Lancets in the E.U. 120

Table 5.15: Unit Sales of Homecare Glucose Self-Testing Lancets in the U.S. 120

Table 5.16: Unit Sales of Homecare Glucose Self-Testing Lancets in the E.U. 120

Table 5.17: Competition in the Lancet Market Segment 121

Table 5.18: Limitations of Urine Glucose Monitoring 125

Table 5.19: Advantages of Urine Glucose Monitoring 126

Table 5.20: Blood Ketone Reading Indications 126

Table 6.1: Current Blood Glucose Self-Testing Meters: Sample Size, Test Time,
and Other Features 128

Table 6.2: Point of Care Blood Glucose or Blood Gas Meters Marketed for
Professional Use 159

Table 6.3: Clinical Blood Chemistry Analyzers with Glucose Assays 168

Table 6.4: Detailed Features of Selected CGM Systems Currently Available 182

Table 6.5: Non-Invasive Glucose Monitoring Systems in Development 191

Table 7.1: POC Procedural Advantages for Hospital Testing 211

Table 7.2: Financial Comparison for Moderate and Waived CLIA Labs 225

Table 8.1: Data Entry and Data Management Features to Include in Future Meters
229

Table 8.2: Leading Companies for Patient Monitoring Products 238

Table 8.3: Customized Reports Must Support CAP and JCAHO Requirements 245








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