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.
Published: February 2012
No. of Pages:261
Price : Single User License - US$3400
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.
Table of Contents
1. Overview 11
1.1 Statement of Report 11
1.2 About this Report 11
1.3 Scope of the Report 12
1.4 Methodology 13
1.5 Executive Summary 14
2. Diabetes 17
2.1 Demographics of Diabetes 18
2.1.1 Worldwide Diabetes Incidence 18
2.1.2 Diabetes in the U.S. 21
2.2 Understanding the Metabolic Conditions Underlying and Associated with Diabetes 25
2.2.1 Pre-Diabetes Syndrome 27
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 34
2.2.6.2 Cardiovascular Disease Facts 35
2.3 Economics of Diabetes 39
3. Market Analysis: Size, Growth, Share and Competitors 45
3.1 Worldwide Glucose Testing Market 46
3.1.1 Global Blood Glucose Self-Testing Market 48
3.1.2 Worldwide Professional Blood Glucose Testing Market 51
3.1.3 Continuous Glucose Monitoring Markets 51
3.2 U.S. Market 52
3.2.1 U.S. Over-the-Counter (OTC) Self-Testing Glucose Market 53
3.2.2 U.S. Professional Glucose Testing Market 58
3.3 European Market 59
3.4 Asian Market 59
3.4.1 Japanese Market 61
3.4.2 Chinese Market 62
3.4.3 Indian Market 64
3.4.4 Korean Market 66
3.4.5 Southeast Asian Market 66
3.4.6 ROW Markets 67
3.5 Competitive Situation 67
3.5.1 Key Players 67
3.5.2 Analyses of the Current Market Conditions, Competition and Product Mix 68
3.6 Market Drivers and Restraints 71
3.6.1 Market Drivers 71
3.6.2 Market Restraints 73
3.7 Market and Product Trends 75
3.7.1 Market Trends 75
3.7.2 Technology Trends 76
3.8 Strategic Recommendations 78
3.9 Competitive Strategies 79
3.10 Adjacent Markets 81
4. Glucose Diagnostic and Monitoring Recommendations 82
4.1 Diagnosis of Diabetes Mellitus 82
4.2 Tight Glucose Control in Treating Diabetes 83
4.3 Recommendations for Glucose Control in Diabetic Patients 84
4.3.1 Recommended Frequency of Blood Glucose Testing 85
4.3.2 Using Blood Glucose Data to Monitor and Modify Patient Therapy 86
4.3.3 Testing in Individuals with Type 2 Diabetes 87
4.3.4 Continuous Glucose Monitoring (CGM) 87
4.3.5 A1c Testing Recommendations 89
4.4 Hypoglycemia and Treatment 89
5. Glucose Testing Technology Platforms and Consumable Products 92
5.1 Types of Glucose Determination Technologies 92
5.2 Enzymatic Reactions Used to Determine Glucose Concentrations 93
5.2.1 Glucose Oxidase (GOX) 93
5.2.2 Glucose Dehydrogenase (GDH) 94
5.2.2.1 GDH-NAD (Glucose Dehydrogenase-Nicotinamide Adenine Dinucleotide) 94
5.2.2.2 GDH-FAD (Glucose Dehydrogenase-Flavin Adenine Dinucleotide) 94
5.2.2.3 GDH-PQQ (Glucose Dehydrogenase-Pyrroloquinoline Quinone) 94
5.2.3 Glucose Hexokinase 95
5.3 Development of Blood Glucose Monitors: A Historical Evaluation 95
5.3.1 First Generation Blood Glucose Biosensors 95
5.3.2 Second Generation Blood Glucose Biosensors 95
5.3.3 Third Generation Blood Glucose Biosensor 96
5.4 Accuracy and Precision in Glucose Meters 96
5.4.1 FDA Recommendations 97
5.4.2 Determining Clinical Accuracy Using the Error Grid Analysis (EGA) 98
5.4.3 Quality Control Criteria 99
5.4.4 Potential Variables Affecting Glucose Concentrations 100
5.5 Key Issues for Glucose Testing Devices 100
5.5.1 Important Elements for Glucose Testing 102
5.5.2 Key Features to Aid Specific Patient Populations 103
5.6 Limitations of Existing Glucose Testing 103
5.6.1 Common User Errors in Glucose Self-Testing 104
5.6.2 Interfering Substances and Conditions 105
5.6.2.1 Environmental 105
5.6.2.2 Physiologic 105
5.6.2.3 Operational 105
5.6.2.4 Manufacturing Variations 105
5.6.2.5 Drugs 105
5.6.3 Errors Associated with GDH-PQQ Technology 106
5.6.4 Optimizing of Point-of-Care (POC) Blood Glucose Testing 109
5.7 Potential Areas of Improvement in Blood Glucose Meter Performance 109
5.8 Blood Glucose Reagent Test Strips 111
5.9 Comparison of Hand-Held Blood Glucose Meters with Clinical Laboratory Glucose Measurements 112
5.10 Continuous Glucose Monitoring Technology 112
5.10.1 Advantages of Continuous Readings 112
5.10.2 FDA Approval of CGM 113
5.10.3 CGM Functions to Consider 114
5.10.4 New Technologies for CGM 114
5.11 Summary of Technologies Being Explored for Non-Invasive Glucose Monitoring 115
5.11.1 Goals of Non-Invasive Testing 116
5.11.2 Non-Invasive Diabetes Screening Test 117
5.12 A1c Monitoring Technology 117
5.13 Related Reagents and Equipment 118
5.13.1 Lancets 118
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 Urine Strips 126
5.13.6 Ketone Testing 128
6. Glucose Testing Devices on the Market 130
6.1 Hand-Held Blood Glucose Meters and Strips for Self-testing 130
6.1.1 LifeScan 133
6.1.2 Roche Diagnostics Corporation 135
6.1.3 Bayer 136
6.1.4 Abbott (MediSense) 137
6.1.5 AgaMatrix, Inc. 139
6.1.6 ARKRAY, Inc. 140
6.1.7 Bionime Corporation 142
6.1.8 BioSense Medical Devices 143
6.1.9 Diabetic Supply of Suncoast 144
6.1.10 Prodigy Diabetes Care, LLC (an affiliate of Diagnostic Devices, Inc.) 145
6.1.11 Entra Health Systems 146
6.1.12 Fifty50 Pharmacy 146
6.1.13 Fora Care 146
6.1.14 Nipro Diagnostics, Inc. 147
6.1.15 Nova Biomedical 149
6.1.16 Oak Tree International Holdings, Inc. 149
6.1.17 Tyson Biomedical 149
6.1.18 US Diagnostics 149
6.1.19 77 Elektronika Kft. 151
6.1.20 A. Menarini Diagnostics 151
6.1.21 All Medicus 151
6.1.22 i-SENS 151
6.1.23 Apex Biotechnology Corp. 152
6.1.24 GenExel-Sein, Inc. 152
6.1.25 Glucoplus, Inc. 152
6.1.26 Polymer Technology Systems 152
6.1.27 Smiths Medical MD, Inc. 153
6.1.28 TaiDoc Technology Corp. 153
6.1.29 IN4 Technology Corporation 153
6.1.30 ACON Laboratories 153
6.1.31 Pepex Biomedical 154
6.1.32 HMD BioMedical 154
6.1.33 BTNX 154
6.2 Hand-Held Blood Glucose Meters for Professional Use 154
6.2.1 Abbott 156
6.2.2 ACON Laboratories 157
6.2.3 Alere 157
6.2.4 ARKRAY 157
6.2.5 HemoCue (a Quest Diagnostics company) 158
6.2.6 HMD BioMedical 158
6.2.7 Medtronic 158
6.2.8 Nova Biomedical 159
6.2.9 Polymer Technology Systems 159
6.2.10 Roche 159
6.2.11 Techno Medica Co., Ltd 160
6.2.12 LifeScan 160
6.3 Clinical Blood Chemistry Analyzers 160
6.3.1 Abaxis, Inc. 162
6.3.2 Alere 162
6.3.3 ARKRAY, Inc. 162
6.3.4 Beckman Coulter 163
6.3.5 DiaSys 163
6.3.6 Instrumentation Laboratory 164
6.3.7 International Techidyne Corporation (ITC) 164
6.3.8 Nova Biomedical 164
6.3.9 Radiometer™ 165
6.3.10 Roche 166
6.3.11 Siemens Healthcare Diagnostics 166
6.3.12 Span Diagnostics 169
6.3.13 Stanbio Laboratory 169
6.3.14 Techno Medica Co., Ltd 170
6.4 Continuous Glucose Patient Monitoring Systems 170
6.4.1 Medtronic’s Continuous Glucose Monitoring Systems (CGMS) 172
6.4.2 FreeStyle Navigator—Abbott’s Continuous Glucose Monitor System 174
6.4.3 DexCom, Inc. STS® Continuous Glucose Monitoring System 175
6.4.4 GlucoDay® S Continuous Glucose Monitor 176
6.4.5 Minimally-Invasive Continuous Glucose Monitors in Development 176
6.4.5.1 GlySens Inc. 176
6.4.5.2 Sensors for Medicine and Science 176
6.4.5.3 Ultradian 176
6.4.5.4 Luminous Medical 177
6.4.5.5 Kumetrix 177
6.4.5.6 GluMetrics 177
6.5 Non-Invasive Glucose Patient Monitoring Systems 178
6.5.1 Cygnus GlucoWatch Biographer 178
6.5.2 AiMedics 179
6.5.3 BioTex 179
6.5.4 Calisto Medical 179
6.5.5 Echo Therapeutics 180
6.5.6 EyeSense GmbH 181
6.5.7 Integrity Applications Ltd. 181
6.5.8 LighTouch Medical 181
6.5.9 OrSense Ltd 181
6.5.10 Solianis Monitoring AG 182
6.5.11 VeraLight 182
6.5.12 Xhale Inc. 183
6.5.13 Lein Applied Diagnostics 183
6.6 A1c Testing 183
6.7 New Product Launches 184
6.7.1 Didget 184
6.7.2 HealthPia GlucoPhone® 184
6.7.3 MyGlucoHealth® Diabetes 184
6.7.4 gDrive™ 185
6.7.5 Paradigm® Veo™ 185
6.7.6 Enlite™ Sensor 185
6.7.7 Abbott’s FreeStyle® InsuLinx 185
6.7.8 Roche Diagnostics launches Accu-Chek® Mobile 186
6.7.9 Bayer Introduces CONTOUR USB 186
6.7.10 Medtronic Announces Mac™ Compatibility for CareLink® Personal Therapy Management Software for Diabetes 186
6.7.11 Fora Care G31 and D30 186
6.7.12 Telcare Receives FDA Clearance for its Telcare BGM 3G Blood Glucose Meter 186
6.7.13 iglucose 187
6.7.14 OneTouch SelectSimple 187
6.8 New Blood Glucose Meters and Data Management Software in Development 187
6.8.1 LifeScan’s iPhone App 187
6.8.2 Sanofi-Aventis’s iBGStar 187
6.8.3 Jazz Wireless 187
6.9 Recent Industry Activity 187
6.9.1 Roche Diagnostics Corp. Expanding Indianapolis Manufacturing Plant 187
6.9.2 AgaMatrix and Sanofi-Aventis Enter Global Diabetes Partnership 188
6.9.3 LifeScan Inc. Terminates Exclusive Supply Agreement with Medtronic MiniMed 188
6.9.4 Kroger Selects WaveSense Diabetes Testing Products 188
6.9.5 Medtronic and Bayer Healthcare Expand International Alliance 188
6.9.6 Medtronic Opens New Diabetes Center In San Antonio 188
6.9.7 Abbott Diabetes Care Announces Recall of Certain Lots of Precision Xtra®, Precision Xceed Pro®, MediSense® Optium™, Optium™, OptiumEZ and ReliOn® Ultima Blood Glucose Test Strips in the United States and Puerto Rico 188
6.9.8 Abbott Receives FDA Clearance for New, Easier-to-Use FreeStyle Lite® Test Strips 189
6.9.9 DexCom™ Receives CE Mark Approval for the SEVEN® Continuous Glucose Monitoring System 189
6.9.10 iBGStar™ Blood Glucose Monitoring System Receives U.S. FDA 510(k) Clearance 189
6.9.11 PositiveID Corporation and IDEAL LIFE Partner to Bring iglucose to Market for Wireless Diabetes Management 189
6.9.12 Roche Diagnostics U.S. and DexCom, Inc. Announce Research and Development Agreement 190
6.10 M&A Activity 190
6.10.1 Home Diagnostics, Inc. and Nipro Diabetes Systems, Inc. Merge to Become Nipro Diagnostics, Inc. 190
6.10.2 Medtronic, Inc. Acquires New Diabetes Technology from PreciSense AS 190
6.10.3 Geonostics Acquires FlexSite's Consumer Diabetes Tests 191
6.10.4 Additional M&A 191
6.10.5 Important Deals in BGM market 191
7. Business Trends in Glucose Testing 193
7.1 Drivers of Clinical Glucose Testing 193
7.2 Competition for Services 193
7.3 Healthcare Cost Controls 193
7.4 Changes in Patient Management 194
7.5 Regionalization of Laboratory Care 194
7.6 Satellite Facilities 195
7.7 Point-of-Care Testing 195
7.8 Factors Affecting OTC Medical Product Distribution 196
7.9 Drug Stores Critical to the Diabetic Care Category 198
7.10 Drivers of OTC and Self-Testing Markets 198
7.10.1 Brand Loyalty 198
7.11 Cost Elements of Glucose Self-Testing 199
7.12 Costs of Doing Business in Europe 199
7.13 Drivers of European Diagnostics Testing 200
7.14 Cost Containment in Europe 200
7.15 Blood Glucose Self-Testing Insurance Coverage and Reimbursement 200
7.15.1 American OTC Testing and Self-Testing Reimbursement 200
7.15.2 European Reimbursement 201
7.16 Trends in U.S. Laboratory Testing Reimbursement Practices 202
7.17 Reimbursement Challenges 205
7.18 Managed Care 205
7.19 Government Regulation of Medical Devices 206
7.19.1 U.S. Regulations 206
7.19.2 E.U. Regulations 208
7.19.3 U.K. Regulations 214
7.20 Clinical Laboratory Improvement Act (CLIA) 215
7.21 FDA Labeling Requirements 217
7.22 Legal Liability for Glucose Meters 218
8. Technology Trends 219
8.1 Improving Today’s Over-The-Counter (OTC) Blood Glucose Meters 219
8.2 Biosensor Technology 220
8.3 Fructosamine Test 222
8.4 Telemedicine Devices 222
8.4.1 Remote Patient Monitoring 224
8.4.1.1 Infopia Eocene System 225
8.4.2 Health Buddy Systems Monitoring Technologies 226
8.5 Non-Traditional Methods for Sample Collection 226
8.6 Data Management 227
8.6.1 Receiver Technology 227
8.6.2 Connectivity 227
8.6.3 Advantages of Connectivity 229
8.6.4 Connectivity Platforms 229
8.6.5 DataLink Data Management System 230
8.6.6 RALS-Plus 232
8.6.7 FDA Required Software Verification 232
8.6.8 Information Management Advances 232
8.6.9 POL Laboratory Data Management 233
8.6.9.1 Electronic Medical Record Systems and Physician Office Laboratory Data Linking Software 234
8.6.9.2 Physician Office Laboratory Data Linking Software and Interface to the Laboratory Information System 236
8.6.9.3 Technical Problems of Connectivity 236
8.6.9.4 Web-Based Data Interface 236
8.6.10 HIT Competition 237
9. Company Profiles 238
9.1 Abaxis, Inc. 238
9.2 Abbott Laboratories 241
9.3 ACON Laboratories 243
9.4 AgaMatrix 243
9.5 Alere 243
9.6 All Medicus 244
9.7 Amedica Biotech 244
9.8 A. Menarini Diagnostics 245
9.9 Apex Biotechnology Corporation 245
9.10 ARKRAY 245
9.11 Bayer 245
9.12 B. Braun Melsungen 246
9.13 Beckman Coulter 246
9.14 Bionime 248
9.15 Bio-Rad Laboratories, Inc. 248
9.16 BioTex 249
9.17 Calisto Medical 249
9.18 Cambridge Sensors 249
9.19 DexCom 249
9.20 Diagnostic Devices/Prodigy Diabetes Care 250
9.21 DiaSys 250
9.22 Echo Therapeutics 250
9.23 Entra Health Systems 250
9.24 Fora Care 250
9.25 Genesis Health Technologies 251
9.26 GenExel-Sein 251
9.27 GlucoPlus 251
9.28 GluMetrics 251
9.29 GlySens 251
9.30 Hainice Medical 252
9.31 HemoCue (a Quest Diagnostics company) 252
9.32 Home Diagnostics 252
9.33 Infopia 252
9.34 IN4 Technology 252
9.35 International Techidyne Corporation (ITC) 253
9.36 Instrumentation Laboratory Company 253
9.37 i-Sens 253
9.38 Johnson & Johnson 253
9.39 Luminous Medical 254
9.40 Medtronic 254
9.41 Nipro Corporation 255
9.42 Nova Biomedical 255
9.43 OrSense 255
9.44 Polymer Technology Systems 255
9.45 Radiometer Medical 256
9.46 Roche 256
9.47 77 Elektronika Kft. 257
9.48 Siemens AG 257
9.49 Smiths Group 258
9.50 Stanbio Laboratory 258
9.51 TaiDoc Technology 259
9.52 Techno Medica Co., Ltd. 259
9.53 US Diagnostics 259
9.54 VeraLight 259
List of Tables
Table 2.1: Regional Estimates of the Number of Diabetes (20-79 Years) in Millions, 2011 and 2030 19
Table 2.2: Countries with the Largest Numbers of Diabetics, 2011 20
Table 2.3: Countries with the Largest Estimated Numbers of Diabetics, 2030 20
Table 2.4: Worldwide Undiagnosed Diabetes in Adults (20-79 Years) by Region and Income Group, 2011 21
Table 2.5: U.S. Population of Diabetics (Diagnosed and Undiagnosed) Aged 20 Years or Older, 2010 22
Table 2.6: U.S. Incidence of Diagnosed Diabetes by Age, 2009 24
Table 2.7: Ten Leading Diagnoses for Co-Morbid Chronic Diseases in the U.S., by Percentage of Patient Visits, 2006 32
Table 2.8: Odds Ratio of Progression to Complications Associated with Type 2 Diabetes 33
Table 2.9: Prevalence of Complications Among Patients with Diabetes 33
Table 2.10: Novel Risk Factors and Possible Mechanisms of the Excess Risk of Coronary Heart Disease in Type 2 Diabetes Mellitus 33
Table 2.11: Major Causes of End-stage Renal Disease 34
Table 2.12: Clinical Recommendations for Adults with Diabetes 34
Table 2.13: Laboratory Assessment of Diabetic Vascular Disease 35
Table 2.14: Average Years Gained Free of Diabetes-related Disease with Intensive Management 35
Table 2.15: Estimated Direct and Indirect Costs of Major Cardiovascular Diseases and Stroke in the U.S., 2008 37
Table 2.16: Worldwide Market for Cardiac Care Therapeutics, 2003-2010 37
Table 2.17: Top 20 Drugs for 2010 by U.S. Sales 38
Table 2.18: Cost of Diagnosed Diabetes in the U.S., 2007 40
Table 2.19: Cost of Diagnosed Type 1 and Type 2 Diabetes in the U.S., 2007 40
Table 2.20: Medical Care Costs Attributable to Diabetes in the U.S., 2010 41
Table 2.21: Healthcare Utilization by Diabetic Patients, 2008 41
Table 2.22: Annual Cost of Care of United Healthcare Adult Members with Diabetes, 2009 43
Table 2.23: Per-Event Costs of Diabetes Complications 43
Table 3.1: Worldwide Glucose Testing Market ($ Billions), 2010-2016 46
Table 3.2: Total Global Unit Demand for Glucose Testing Reagent Strips, 2010-2016 47
Table 3.3: Global Dollar Sales of Glucose Testing Reagent Strips, 2010-2016 48
Table 3.4: Worldwide Glucose Self-Testing Market Sales (Meters and Strips), 2010-2016 49
Table 3.5: World Market Share of Glucose Self-testing Marketers, 2011 50
Table 3.6: Global Professional Glucose Testing Market, 2010-2016 51
Table 3.7: U.S. Glucose Testing Market (Meters and Strips), 2010-2016 52
Table 3.8: U.S. Blood Glucose Reagent Strip Market, 2005-2015 53
Table 3.9: Market for Glucose Self-Testing in the U.S., 2010-2016 54
Table 3.10: Market Share of U.S. Blood Glucose Self-Testing, 2011 54
Table 3.11: U.S. OTC Glucose Self-Testing Market Repeat Retail Replacement Sales Percentages 55
Table 3.12: OTC Blood Glucose Instrument Reagents by Manufacturer Retail 56
Table 3.13: Demographic Characteristics Glucose Self-Testing Kit Buyers 57
Table 3.14: Top Brand Preferences for Glucose Self-Testing Kits 57
Table 3.15: Instances when Patients Prefer Professional’s Glucose Testing 57
Table 3.16: Advantages of a Glucose Self-Testing Kit 57
Table 3.17: Disadvantages of Using a Glucose Self-Testing Kit 58
Table 3.18: Popular Shopping Destinations for Buying or Seeking Information on Glucose Self-Testing Kits 58
Table 3.19: Customer Priorities—Glucose Meter Self-Testing Market, 2001, 2006 and 2012 58
Table 3.20: Market for Professional Glucose Testing in the U.S., 2010-2016 58
Table 3.21: European Glucose Testing Market (Meters and Strips), 2010-2016 59
Table 3.22: Asian Glucose Testing Market (Meter and Strips), 2010-2016 61
Table 3.23: Japanese Glucose Testing Market (Meters and Strips), 2010-2016 62
Table 3.24: Chinese Glucose Testing Market (Meters and Strips), 2010-2016 63
Table 3.25: Indian Glucose Testing Market (Meters, Strips), 2010-2016 65
Table 3.26: Number of Clinical Labs in India, 2008 65
Table 3.27: Top Domestic IVD Companies in India 65
Table 3.28: Leading Global IVD Companies in India 65
Table 3.29: Southeast Asian Glucose Testing Market (Meters and Strips), 2010-2016 66
Table 3.30: Southeast Asian Glucose Testing Market by Country (Meters and Strips), 2011 67
Table 3.31: ROW Glucose Testing Market (Meters, Strips), 2010-2016 67
Table 3.32: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats of the Glucose Point-of-Care Market 70
Table 3.33: Key Market Drivers for Glucose Testing 72
Table 3.34: Market Drivers for Continuous Glucose Monitoring 72
Table 3.35: Point-of-Care Glucose Testing Market: Market Drivers Ranked in Order of Impact 72
Table 3.36: Key Market Restraints for Glucose Testing 74
Table 3.37: Market Restraints for Continuous Glucose Monitoring 74
Table 3.38: Point-of-Care Glucose Testing Market: Market Restraints Ranked in Order of Impact 74
Table 4.1: Criteria for the Diagnosis of Diabetes 82
Table 4.2: Categories of Increased Risk for Diabetes (Pre-Diabetes) 83
Table 4.3: Normal Glucose Values—Fasting State 83
Table 4.4: Glycemic Recommendations for Non-Pregnant Adults with Diabetes 85
Table 4.5: Glycemic Recommendations for Women with Gestational Diabetes 85
Table 4.6: Glycemic Recommendations for Pregnant Women with Pre-existing Diabetes 85
Table 4.7: Glucose Monitoring Recommendations 86
Table 4.8: Percentage of Hypothetical Patients that Diabetes Educator’s Would Recommend CGM, 2007-2009 88
Table 4.9: A1c Testing Recommendations 89
Table 4.10: Correlation of A1c with Mean Blood Glucose 89
Table 5.1: Analytic Performance Criteria for Glucose Self-Testing Meters 96
Table 5.2: Potential Variables Affecting Glucose Concentrations 100
Table 5.3: Key Features Considered for Glucose Testing Devices 102
Table 5.4: Common User Errors Made While Self-Testing for Blood Glucose 105
Table 5.5: Compatibility of Various Blood Glucose Meters with Icodextrin Peritoneal Dialysis (PD) Solution 107
Table 5.6: Ten Factors Needed to Improve the Performance of Blood Glucose Meters 109
Table 5.7: Key Features Considered for Reagent Test Strips 111
Table 5.8: Differences between Laboratory Instruments for Glucose Analysis and Hand-Held Blood Glucose Meters 112
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., 2010-2015 120
Table 5.11: Unit Sales of Homecare Lancets in the E.U., 2010-2015 121
Table 5.12: Dollar Sales of Homecare Lancets in the U.S., 2010-2015 121
Table 5.13: Dollar Sales of Homecare Lancets in the E.U., 2010-2015 121
Table 5.14: Unit Sales of Homecare Glucose Self-Testing Lancets in the U.S., 2010-2015 121
Table 5.15: Unit Sales of Homecare Glucose Self-Testing Lancets in the E.U., 2010-2015 122
Table 5.16: Competition in the Lancet Market Segment 123
Table 5.17: Limitations of Urine Glucose Monitoring 127
Table 5.18: Advantages of Urine Glucose Monitoring 128
Table 5.19: Blood Ketone Reading Indications 128
Table 6.1: Current Blood Glucose Self-testing Meters: Sample Size, Test Time, and Other Features 130
Table 6.2: Hand-Held Blood Glucose or Blood Gas Meters Marketed for Professional Use 155
Table 6.3: Clinical Blood Chemistry Analyzers with Glucose Assays 161
Table 6.4: Detailed Features of Selected CGM Systems Currently Available 170
Table 6.5: Non-Invasive Glucose Monitoring Systems in Development 178
Table 7.1: POC Procedural Advantages for Hospital Testing 193
Table 7.2: Medicare Billing Guidelines for Multi-Channel Chemistry Tests 203
Table 7.3: Financial Comparison for Moderate and Waived CLIA Labs 216
Table 8.1: Data Entry and Data Management Features to Include in Future Meters 220
Table 8.2: Leading World Patient Monitoring Products in the U.S. Market 223
Table 8.3: Customized Reports Must Support CAP and JCAHO Requirements 231
Table 9.1: Abaxis Blood Analysis Diagnostic Tests 239
Table 9.2: Reagent Discs Offered with the Piccolo Chemistry Analyzers 240
Table 9.3: Products Marketed by Abbott in the Diagnostic Market 242
List of Figures
Figure 2.1: Worldwide Diabetes Cases, 2011 and 2030 18
Figure 2.2: Worldwide Prevalence of Diabetes (%) in Adults (20-79 Years), 2011 19
Figure 2.3: Prevalence of Diabetes by Age in the U.S., 2010 22
Figure 2.4: New Cases of Diabetes Diagnosed in the U.S. Adult Population, 2010 22
Figure 2.5: County-specific Diabetes Prevalence in the U.S., 2008 23
Figure 2.6: Rate of New Diabetes Cases Among Children in the U.S., 2007 24
Figure 2.7: Diabetes Death Rate by Race and Sex in the U.S., 1979-2006 25
Figure 2.8: Maintenance of Normal Blood Sugar Levels 26
Figure 2.9: Obesity (BMI ³ 30) Prevalence in U.S. Adults, 2010 29
Figure 2.10: Prevalence of Obesity Among Men Aged 20 Years and Older by Race/Ethnicity in the U.S., 1988-1994 and 2007-2008 30
Figure 2.11: Prevalence of Obesity Among Women Aged 20 Years and Older by Race/Ethnicity in the U.S., 1988-1994 and 2007-2008 30
Figure 2.12: Trends in Obesity Among Children and Adolescents in the U.S., 1963-2008 31
Figure 2.13: Mean Diabetes Healthcare-related Expenditures Per Adult (20-79 Years) with Diabetes (USD), 2011 40
Figure 2.14: How Diabetes Dollars are Spent in the U.S., 2007 42
Figure 3.1: Worldwide Diabetes Monitoring Market Segments, 2011 47
Figure 3.2: Global Unit Sales of Glucose Testing Reagent Strips, 2011 48
Figure 3.3: Geographic Segments of the Worldwide Glucose Self-testing Market, 2010 and 2015 49
Figure 3.4: Worldwide Glucose Self-Testing Market by Region, 2015 50
Figure 3.5: Continuous Glucose Market Growth Rates by Region, 2009-2018 52
Figure 3.6: U.S. Blood Glucose Reagent Strip Market, 2005-2015 53
Figure 4.1: Glycemic Status—Ranges and Health Implications 91
Figure 5.1: EGA Zones of Clinical Accuracy 98
Figure 5.2: Single-Day Continuous Blood Glucose Data 104
Figure 5.3: Factors that May Adversely Affect Glucose Testing 106
Figure 5.4: Personal Lancet Unit Sales Market Share by Geographic Region, 2011 122
Blood Glucose & Diabetes Testing Market
Published: February 2012
No. of Pages:261
Price : Single User License - US$3400
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.
Table of Contents
1. Overview 11
1.1 Statement of Report 11
1.2 About this Report 11
1.3 Scope of the Report 12
1.4 Methodology 13
1.5 Executive Summary 14
2. Diabetes 17
2.1 Demographics of Diabetes 18
2.1.1 Worldwide Diabetes Incidence 18
2.1.2 Diabetes in the U.S. 21
2.2 Understanding the Metabolic Conditions Underlying and Associated with Diabetes 25
2.2.1 Pre-Diabetes Syndrome 27
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 34
2.2.6.2 Cardiovascular Disease Facts 35
2.3 Economics of Diabetes 39
3. Market Analysis: Size, Growth, Share and Competitors 45
3.1 Worldwide Glucose Testing Market 46
3.1.1 Global Blood Glucose Self-Testing Market 48
3.1.2 Worldwide Professional Blood Glucose Testing Market 51
3.1.3 Continuous Glucose Monitoring Markets 51
3.2 U.S. Market 52
3.2.1 U.S. Over-the-Counter (OTC) Self-Testing Glucose Market 53
3.2.2 U.S. Professional Glucose Testing Market 58
3.3 European Market 59
3.4 Asian Market 59
3.4.1 Japanese Market 61
3.4.2 Chinese Market 62
3.4.3 Indian Market 64
3.4.4 Korean Market 66
3.4.5 Southeast Asian Market 66
3.4.6 ROW Markets 67
3.5 Competitive Situation 67
3.5.1 Key Players 67
3.5.2 Analyses of the Current Market Conditions, Competition and Product Mix 68
3.6 Market Drivers and Restraints 71
3.6.1 Market Drivers 71
3.6.2 Market Restraints 73
3.7 Market and Product Trends 75
3.7.1 Market Trends 75
3.7.2 Technology Trends 76
3.8 Strategic Recommendations 78
3.9 Competitive Strategies 79
3.10 Adjacent Markets 81
4. Glucose Diagnostic and Monitoring Recommendations 82
4.1 Diagnosis of Diabetes Mellitus 82
4.2 Tight Glucose Control in Treating Diabetes 83
4.3 Recommendations for Glucose Control in Diabetic Patients 84
4.3.1 Recommended Frequency of Blood Glucose Testing 85
4.3.2 Using Blood Glucose Data to Monitor and Modify Patient Therapy 86
4.3.3 Testing in Individuals with Type 2 Diabetes 87
4.3.4 Continuous Glucose Monitoring (CGM) 87
4.3.5 A1c Testing Recommendations 89
4.4 Hypoglycemia and Treatment 89
5. Glucose Testing Technology Platforms and Consumable Products 92
5.1 Types of Glucose Determination Technologies 92
5.2 Enzymatic Reactions Used to Determine Glucose Concentrations 93
5.2.1 Glucose Oxidase (GOX) 93
5.2.2 Glucose Dehydrogenase (GDH) 94
5.2.2.1 GDH-NAD (Glucose Dehydrogenase-Nicotinamide Adenine Dinucleotide) 94
5.2.2.2 GDH-FAD (Glucose Dehydrogenase-Flavin Adenine Dinucleotide) 94
5.2.2.3 GDH-PQQ (Glucose Dehydrogenase-Pyrroloquinoline Quinone) 94
5.2.3 Glucose Hexokinase 95
5.3 Development of Blood Glucose Monitors: A Historical Evaluation 95
5.3.1 First Generation Blood Glucose Biosensors 95
5.3.2 Second Generation Blood Glucose Biosensors 95
5.3.3 Third Generation Blood Glucose Biosensor 96
5.4 Accuracy and Precision in Glucose Meters 96
5.4.1 FDA Recommendations 97
5.4.2 Determining Clinical Accuracy Using the Error Grid Analysis (EGA) 98
5.4.3 Quality Control Criteria 99
5.4.4 Potential Variables Affecting Glucose Concentrations 100
5.5 Key Issues for Glucose Testing Devices 100
5.5.1 Important Elements for Glucose Testing 102
5.5.2 Key Features to Aid Specific Patient Populations 103
5.6 Limitations of Existing Glucose Testing 103
5.6.1 Common User Errors in Glucose Self-Testing 104
5.6.2 Interfering Substances and Conditions 105
5.6.2.1 Environmental 105
5.6.2.2 Physiologic 105
5.6.2.3 Operational 105
5.6.2.4 Manufacturing Variations 105
5.6.2.5 Drugs 105
5.6.3 Errors Associated with GDH-PQQ Technology 106
5.6.4 Optimizing of Point-of-Care (POC) Blood Glucose Testing 109
5.7 Potential Areas of Improvement in Blood Glucose Meter Performance 109
5.8 Blood Glucose Reagent Test Strips 111
5.9 Comparison of Hand-Held Blood Glucose Meters with Clinical Laboratory Glucose Measurements 112
5.10 Continuous Glucose Monitoring Technology 112
5.10.1 Advantages of Continuous Readings 112
5.10.2 FDA Approval of CGM 113
5.10.3 CGM Functions to Consider 114
5.10.4 New Technologies for CGM 114
5.11 Summary of Technologies Being Explored for Non-Invasive Glucose Monitoring 115
5.11.1 Goals of Non-Invasive Testing 116
5.11.2 Non-Invasive Diabetes Screening Test 117
5.12 A1c Monitoring Technology 117
5.13 Related Reagents and Equipment 118
5.13.1 Lancets 118
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 Urine Strips 126
5.13.6 Ketone Testing 128
6. Glucose Testing Devices on the Market 130
6.1 Hand-Held Blood Glucose Meters and Strips for Self-testing 130
6.1.1 LifeScan 133
6.1.2 Roche Diagnostics Corporation 135
6.1.3 Bayer 136
6.1.4 Abbott (MediSense) 137
6.1.5 AgaMatrix, Inc. 139
6.1.6 ARKRAY, Inc. 140
6.1.7 Bionime Corporation 142
6.1.8 BioSense Medical Devices 143
6.1.9 Diabetic Supply of Suncoast 144
6.1.10 Prodigy Diabetes Care, LLC (an affiliate of Diagnostic Devices, Inc.) 145
6.1.11 Entra Health Systems 146
6.1.12 Fifty50 Pharmacy 146
6.1.13 Fora Care 146
6.1.14 Nipro Diagnostics, Inc. 147
6.1.15 Nova Biomedical 149
6.1.16 Oak Tree International Holdings, Inc. 149
6.1.17 Tyson Biomedical 149
6.1.18 US Diagnostics 149
6.1.19 77 Elektronika Kft. 151
6.1.20 A. Menarini Diagnostics 151
6.1.21 All Medicus 151
6.1.22 i-SENS 151
6.1.23 Apex Biotechnology Corp. 152
6.1.24 GenExel-Sein, Inc. 152
6.1.25 Glucoplus, Inc. 152
6.1.26 Polymer Technology Systems 152
6.1.27 Smiths Medical MD, Inc. 153
6.1.28 TaiDoc Technology Corp. 153
6.1.29 IN4 Technology Corporation 153
6.1.30 ACON Laboratories 153
6.1.31 Pepex Biomedical 154
6.1.32 HMD BioMedical 154
6.1.33 BTNX 154
6.2 Hand-Held Blood Glucose Meters for Professional Use 154
6.2.1 Abbott 156
6.2.2 ACON Laboratories 157
6.2.3 Alere 157
6.2.4 ARKRAY 157
6.2.5 HemoCue (a Quest Diagnostics company) 158
6.2.6 HMD BioMedical 158
6.2.7 Medtronic 158
6.2.8 Nova Biomedical 159
6.2.9 Polymer Technology Systems 159
6.2.10 Roche 159
6.2.11 Techno Medica Co., Ltd 160
6.2.12 LifeScan 160
6.3 Clinical Blood Chemistry Analyzers 160
6.3.1 Abaxis, Inc. 162
6.3.2 Alere 162
6.3.3 ARKRAY, Inc. 162
6.3.4 Beckman Coulter 163
6.3.5 DiaSys 163
6.3.6 Instrumentation Laboratory 164
6.3.7 International Techidyne Corporation (ITC) 164
6.3.8 Nova Biomedical 164
6.3.9 Radiometer™ 165
6.3.10 Roche 166
6.3.11 Siemens Healthcare Diagnostics 166
6.3.12 Span Diagnostics 169
6.3.13 Stanbio Laboratory 169
6.3.14 Techno Medica Co., Ltd 170
6.4 Continuous Glucose Patient Monitoring Systems 170
6.4.1 Medtronic’s Continuous Glucose Monitoring Systems (CGMS) 172
6.4.2 FreeStyle Navigator—Abbott’s Continuous Glucose Monitor System 174
6.4.3 DexCom, Inc. STS® Continuous Glucose Monitoring System 175
6.4.4 GlucoDay® S Continuous Glucose Monitor 176
6.4.5 Minimally-Invasive Continuous Glucose Monitors in Development 176
6.4.5.1 GlySens Inc. 176
6.4.5.2 Sensors for Medicine and Science 176
6.4.5.3 Ultradian 176
6.4.5.4 Luminous Medical 177
6.4.5.5 Kumetrix 177
6.4.5.6 GluMetrics 177
6.5 Non-Invasive Glucose Patient Monitoring Systems 178
6.5.1 Cygnus GlucoWatch Biographer 178
6.5.2 AiMedics 179
6.5.3 BioTex 179
6.5.4 Calisto Medical 179
6.5.5 Echo Therapeutics 180
6.5.6 EyeSense GmbH 181
6.5.7 Integrity Applications Ltd. 181
6.5.8 LighTouch Medical 181
6.5.9 OrSense Ltd 181
6.5.10 Solianis Monitoring AG 182
6.5.11 VeraLight 182
6.5.12 Xhale Inc. 183
6.5.13 Lein Applied Diagnostics 183
6.6 A1c Testing 183
6.7 New Product Launches 184
6.7.1 Didget 184
6.7.2 HealthPia GlucoPhone® 184
6.7.3 MyGlucoHealth® Diabetes 184
6.7.4 gDrive™ 185
6.7.5 Paradigm® Veo™ 185
6.7.6 Enlite™ Sensor 185
6.7.7 Abbott’s FreeStyle® InsuLinx 185
6.7.8 Roche Diagnostics launches Accu-Chek® Mobile 186
6.7.9 Bayer Introduces CONTOUR USB 186
6.7.10 Medtronic Announces Mac™ Compatibility for CareLink® Personal Therapy Management Software for Diabetes 186
6.7.11 Fora Care G31 and D30 186
6.7.12 Telcare Receives FDA Clearance for its Telcare BGM 3G Blood Glucose Meter 186
6.7.13 iglucose 187
6.7.14 OneTouch SelectSimple 187
6.8 New Blood Glucose Meters and Data Management Software in Development 187
6.8.1 LifeScan’s iPhone App 187
6.8.2 Sanofi-Aventis’s iBGStar 187
6.8.3 Jazz Wireless 187
6.9 Recent Industry Activity 187
6.9.1 Roche Diagnostics Corp. Expanding Indianapolis Manufacturing Plant 187
6.9.2 AgaMatrix and Sanofi-Aventis Enter Global Diabetes Partnership 188
6.9.3 LifeScan Inc. Terminates Exclusive Supply Agreement with Medtronic MiniMed 188
6.9.4 Kroger Selects WaveSense Diabetes Testing Products 188
6.9.5 Medtronic and Bayer Healthcare Expand International Alliance 188
6.9.6 Medtronic Opens New Diabetes Center In San Antonio 188
6.9.7 Abbott Diabetes Care Announces Recall of Certain Lots of Precision Xtra®, Precision Xceed Pro®, MediSense® Optium™, Optium™, OptiumEZ and ReliOn® Ultima Blood Glucose Test Strips in the United States and Puerto Rico 188
6.9.8 Abbott Receives FDA Clearance for New, Easier-to-Use FreeStyle Lite® Test Strips 189
6.9.9 DexCom™ Receives CE Mark Approval for the SEVEN® Continuous Glucose Monitoring System 189
6.9.10 iBGStar™ Blood Glucose Monitoring System Receives U.S. FDA 510(k) Clearance 189
6.9.11 PositiveID Corporation and IDEAL LIFE Partner to Bring iglucose to Market for Wireless Diabetes Management 189
6.9.12 Roche Diagnostics U.S. and DexCom, Inc. Announce Research and Development Agreement 190
6.10 M&A Activity 190
6.10.1 Home Diagnostics, Inc. and Nipro Diabetes Systems, Inc. Merge to Become Nipro Diagnostics, Inc. 190
6.10.2 Medtronic, Inc. Acquires New Diabetes Technology from PreciSense AS 190
6.10.3 Geonostics Acquires FlexSite's Consumer Diabetes Tests 191
6.10.4 Additional M&A 191
6.10.5 Important Deals in BGM market 191
7. Business Trends in Glucose Testing 193
7.1 Drivers of Clinical Glucose Testing 193
7.2 Competition for Services 193
7.3 Healthcare Cost Controls 193
7.4 Changes in Patient Management 194
7.5 Regionalization of Laboratory Care 194
7.6 Satellite Facilities 195
7.7 Point-of-Care Testing 195
7.8 Factors Affecting OTC Medical Product Distribution 196
7.9 Drug Stores Critical to the Diabetic Care Category 198
7.10 Drivers of OTC and Self-Testing Markets 198
7.10.1 Brand Loyalty 198
7.11 Cost Elements of Glucose Self-Testing 199
7.12 Costs of Doing Business in Europe 199
7.13 Drivers of European Diagnostics Testing 200
7.14 Cost Containment in Europe 200
7.15 Blood Glucose Self-Testing Insurance Coverage and Reimbursement 200
7.15.1 American OTC Testing and Self-Testing Reimbursement 200
7.15.2 European Reimbursement 201
7.16 Trends in U.S. Laboratory Testing Reimbursement Practices 202
7.17 Reimbursement Challenges 205
7.18 Managed Care 205
7.19 Government Regulation of Medical Devices 206
7.19.1 U.S. Regulations 206
7.19.2 E.U. Regulations 208
7.19.3 U.K. Regulations 214
7.20 Clinical Laboratory Improvement Act (CLIA) 215
7.21 FDA Labeling Requirements 217
7.22 Legal Liability for Glucose Meters 218
8. Technology Trends 219
8.1 Improving Today’s Over-The-Counter (OTC) Blood Glucose Meters 219
8.2 Biosensor Technology 220
8.3 Fructosamine Test 222
8.4 Telemedicine Devices 222
8.4.1 Remote Patient Monitoring 224
8.4.1.1 Infopia Eocene System 225
8.4.2 Health Buddy Systems Monitoring Technologies 226
8.5 Non-Traditional Methods for Sample Collection 226
8.6 Data Management 227
8.6.1 Receiver Technology 227
8.6.2 Connectivity 227
8.6.3 Advantages of Connectivity 229
8.6.4 Connectivity Platforms 229
8.6.5 DataLink Data Management System 230
8.6.6 RALS-Plus 232
8.6.7 FDA Required Software Verification 232
8.6.8 Information Management Advances 232
8.6.9 POL Laboratory Data Management 233
8.6.9.1 Electronic Medical Record Systems and Physician Office Laboratory Data Linking Software 234
8.6.9.2 Physician Office Laboratory Data Linking Software and Interface to the Laboratory Information System 236
8.6.9.3 Technical Problems of Connectivity 236
8.6.9.4 Web-Based Data Interface 236
8.6.10 HIT Competition 237
9. Company Profiles 238
9.1 Abaxis, Inc. 238
9.2 Abbott Laboratories 241
9.3 ACON Laboratories 243
9.4 AgaMatrix 243
9.5 Alere 243
9.6 All Medicus 244
9.7 Amedica Biotech 244
9.8 A. Menarini Diagnostics 245
9.9 Apex Biotechnology Corporation 245
9.10 ARKRAY 245
9.11 Bayer 245
9.12 B. Braun Melsungen 246
9.13 Beckman Coulter 246
9.14 Bionime 248
9.15 Bio-Rad Laboratories, Inc. 248
9.16 BioTex 249
9.17 Calisto Medical 249
9.18 Cambridge Sensors 249
9.19 DexCom 249
9.20 Diagnostic Devices/Prodigy Diabetes Care 250
9.21 DiaSys 250
9.22 Echo Therapeutics 250
9.23 Entra Health Systems 250
9.24 Fora Care 250
9.25 Genesis Health Technologies 251
9.26 GenExel-Sein 251
9.27 GlucoPlus 251
9.28 GluMetrics 251
9.29 GlySens 251
9.30 Hainice Medical 252
9.31 HemoCue (a Quest Diagnostics company) 252
9.32 Home Diagnostics 252
9.33 Infopia 252
9.34 IN4 Technology 252
9.35 International Techidyne Corporation (ITC) 253
9.36 Instrumentation Laboratory Company 253
9.37 i-Sens 253
9.38 Johnson & Johnson 253
9.39 Luminous Medical 254
9.40 Medtronic 254
9.41 Nipro Corporation 255
9.42 Nova Biomedical 255
9.43 OrSense 255
9.44 Polymer Technology Systems 255
9.45 Radiometer Medical 256
9.46 Roche 256
9.47 77 Elektronika Kft. 257
9.48 Siemens AG 257
9.49 Smiths Group 258
9.50 Stanbio Laboratory 258
9.51 TaiDoc Technology 259
9.52 Techno Medica Co., Ltd. 259
9.53 US Diagnostics 259
9.54 VeraLight 259
List of Tables
Table 2.1: Regional Estimates of the Number of Diabetes (20-79 Years) in Millions, 2011 and 2030 19
Table 2.2: Countries with the Largest Numbers of Diabetics, 2011 20
Table 2.3: Countries with the Largest Estimated Numbers of Diabetics, 2030 20
Table 2.4: Worldwide Undiagnosed Diabetes in Adults (20-79 Years) by Region and Income Group, 2011 21
Table 2.5: U.S. Population of Diabetics (Diagnosed and Undiagnosed) Aged 20 Years or Older, 2010 22
Table 2.6: U.S. Incidence of Diagnosed Diabetes by Age, 2009 24
Table 2.7: Ten Leading Diagnoses for Co-Morbid Chronic Diseases in the U.S., by Percentage of Patient Visits, 2006 32
Table 2.8: Odds Ratio of Progression to Complications Associated with Type 2 Diabetes 33
Table 2.9: Prevalence of Complications Among Patients with Diabetes 33
Table 2.10: Novel Risk Factors and Possible Mechanisms of the Excess Risk of Coronary Heart Disease in Type 2 Diabetes Mellitus 33
Table 2.11: Major Causes of End-stage Renal Disease 34
Table 2.12: Clinical Recommendations for Adults with Diabetes 34
Table 2.13: Laboratory Assessment of Diabetic Vascular Disease 35
Table 2.14: Average Years Gained Free of Diabetes-related Disease with Intensive Management 35
Table 2.15: Estimated Direct and Indirect Costs of Major Cardiovascular Diseases and Stroke in the U.S., 2008 37
Table 2.16: Worldwide Market for Cardiac Care Therapeutics, 2003-2010 37
Table 2.17: Top 20 Drugs for 2010 by U.S. Sales 38
Table 2.18: Cost of Diagnosed Diabetes in the U.S., 2007 40
Table 2.19: Cost of Diagnosed Type 1 and Type 2 Diabetes in the U.S., 2007 40
Table 2.20: Medical Care Costs Attributable to Diabetes in the U.S., 2010 41
Table 2.21: Healthcare Utilization by Diabetic Patients, 2008 41
Table 2.22: Annual Cost of Care of United Healthcare Adult Members with Diabetes, 2009 43
Table 2.23: Per-Event Costs of Diabetes Complications 43
Table 3.1: Worldwide Glucose Testing Market ($ Billions), 2010-2016 46
Table 3.2: Total Global Unit Demand for Glucose Testing Reagent Strips, 2010-2016 47
Table 3.3: Global Dollar Sales of Glucose Testing Reagent Strips, 2010-2016 48
Table 3.4: Worldwide Glucose Self-Testing Market Sales (Meters and Strips), 2010-2016 49
Table 3.5: World Market Share of Glucose Self-testing Marketers, 2011 50
Table 3.6: Global Professional Glucose Testing Market, 2010-2016 51
Table 3.7: U.S. Glucose Testing Market (Meters and Strips), 2010-2016 52
Table 3.8: U.S. Blood Glucose Reagent Strip Market, 2005-2015 53
Table 3.9: Market for Glucose Self-Testing in the U.S., 2010-2016 54
Table 3.10: Market Share of U.S. Blood Glucose Self-Testing, 2011 54
Table 3.11: U.S. OTC Glucose Self-Testing Market Repeat Retail Replacement Sales Percentages 55
Table 3.12: OTC Blood Glucose Instrument Reagents by Manufacturer Retail 56
Table 3.13: Demographic Characteristics Glucose Self-Testing Kit Buyers 57
Table 3.14: Top Brand Preferences for Glucose Self-Testing Kits 57
Table 3.15: Instances when Patients Prefer Professional’s Glucose Testing 57
Table 3.16: Advantages of a Glucose Self-Testing Kit 57
Table 3.17: Disadvantages of Using a Glucose Self-Testing Kit 58
Table 3.18: Popular Shopping Destinations for Buying or Seeking Information on Glucose Self-Testing Kits 58
Table 3.19: Customer Priorities—Glucose Meter Self-Testing Market, 2001, 2006 and 2012 58
Table 3.20: Market for Professional Glucose Testing in the U.S., 2010-2016 58
Table 3.21: European Glucose Testing Market (Meters and Strips), 2010-2016 59
Table 3.22: Asian Glucose Testing Market (Meter and Strips), 2010-2016 61
Table 3.23: Japanese Glucose Testing Market (Meters and Strips), 2010-2016 62
Table 3.24: Chinese Glucose Testing Market (Meters and Strips), 2010-2016 63
Table 3.25: Indian Glucose Testing Market (Meters, Strips), 2010-2016 65
Table 3.26: Number of Clinical Labs in India, 2008 65
Table 3.27: Top Domestic IVD Companies in India 65
Table 3.28: Leading Global IVD Companies in India 65
Table 3.29: Southeast Asian Glucose Testing Market (Meters and Strips), 2010-2016 66
Table 3.30: Southeast Asian Glucose Testing Market by Country (Meters and Strips), 2011 67
Table 3.31: ROW Glucose Testing Market (Meters, Strips), 2010-2016 67
Table 3.32: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats of the Glucose Point-of-Care Market 70
Table 3.33: Key Market Drivers for Glucose Testing 72
Table 3.34: Market Drivers for Continuous Glucose Monitoring 72
Table 3.35: Point-of-Care Glucose Testing Market: Market Drivers Ranked in Order of Impact 72
Table 3.36: Key Market Restraints for Glucose Testing 74
Table 3.37: Market Restraints for Continuous Glucose Monitoring 74
Table 3.38: Point-of-Care Glucose Testing Market: Market Restraints Ranked in Order of Impact 74
Table 4.1: Criteria for the Diagnosis of Diabetes 82
Table 4.2: Categories of Increased Risk for Diabetes (Pre-Diabetes) 83
Table 4.3: Normal Glucose Values—Fasting State 83
Table 4.4: Glycemic Recommendations for Non-Pregnant Adults with Diabetes 85
Table 4.5: Glycemic Recommendations for Women with Gestational Diabetes 85
Table 4.6: Glycemic Recommendations for Pregnant Women with Pre-existing Diabetes 85
Table 4.7: Glucose Monitoring Recommendations 86
Table 4.8: Percentage of Hypothetical Patients that Diabetes Educator’s Would Recommend CGM, 2007-2009 88
Table 4.9: A1c Testing Recommendations 89
Table 4.10: Correlation of A1c with Mean Blood Glucose 89
Table 5.1: Analytic Performance Criteria for Glucose Self-Testing Meters 96
Table 5.2: Potential Variables Affecting Glucose Concentrations 100
Table 5.3: Key Features Considered for Glucose Testing Devices 102
Table 5.4: Common User Errors Made While Self-Testing for Blood Glucose 105
Table 5.5: Compatibility of Various Blood Glucose Meters with Icodextrin Peritoneal Dialysis (PD) Solution 107
Table 5.6: Ten Factors Needed to Improve the Performance of Blood Glucose Meters 109
Table 5.7: Key Features Considered for Reagent Test Strips 111
Table 5.8: Differences between Laboratory Instruments for Glucose Analysis and Hand-Held Blood Glucose Meters 112
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., 2010-2015 120
Table 5.11: Unit Sales of Homecare Lancets in the E.U., 2010-2015 121
Table 5.12: Dollar Sales of Homecare Lancets in the U.S., 2010-2015 121
Table 5.13: Dollar Sales of Homecare Lancets in the E.U., 2010-2015 121
Table 5.14: Unit Sales of Homecare Glucose Self-Testing Lancets in the U.S., 2010-2015 121
Table 5.15: Unit Sales of Homecare Glucose Self-Testing Lancets in the E.U., 2010-2015 122
Table 5.16: Competition in the Lancet Market Segment 123
Table 5.17: Limitations of Urine Glucose Monitoring 127
Table 5.18: Advantages of Urine Glucose Monitoring 128
Table 5.19: Blood Ketone Reading Indications 128
Table 6.1: Current Blood Glucose Self-testing Meters: Sample Size, Test Time, and Other Features 130
Table 6.2: Hand-Held Blood Glucose or Blood Gas Meters Marketed for Professional Use 155
Table 6.3: Clinical Blood Chemistry Analyzers with Glucose Assays 161
Table 6.4: Detailed Features of Selected CGM Systems Currently Available 170
Table 6.5: Non-Invasive Glucose Monitoring Systems in Development 178
Table 7.1: POC Procedural Advantages for Hospital Testing 193
Table 7.2: Medicare Billing Guidelines for Multi-Channel Chemistry Tests 203
Table 7.3: Financial Comparison for Moderate and Waived CLIA Labs 216
Table 8.1: Data Entry and Data Management Features to Include in Future Meters 220
Table 8.2: Leading World Patient Monitoring Products in the U.S. Market 223
Table 8.3: Customized Reports Must Support CAP and JCAHO Requirements 231
Table 9.1: Abaxis Blood Analysis Diagnostic Tests 239
Table 9.2: Reagent Discs Offered with the Piccolo Chemistry Analyzers 240
Table 9.3: Products Marketed by Abbott in the Diagnostic Market 242
List of Figures
Figure 2.1: Worldwide Diabetes Cases, 2011 and 2030 18
Figure 2.2: Worldwide Prevalence of Diabetes (%) in Adults (20-79 Years), 2011 19
Figure 2.3: Prevalence of Diabetes by Age in the U.S., 2010 22
Figure 2.4: New Cases of Diabetes Diagnosed in the U.S. Adult Population, 2010 22
Figure 2.5: County-specific Diabetes Prevalence in the U.S., 2008 23
Figure 2.6: Rate of New Diabetes Cases Among Children in the U.S., 2007 24
Figure 2.7: Diabetes Death Rate by Race and Sex in the U.S., 1979-2006 25
Figure 2.8: Maintenance of Normal Blood Sugar Levels 26
Figure 2.9: Obesity (BMI ³ 30) Prevalence in U.S. Adults, 2010 29
Figure 2.10: Prevalence of Obesity Among Men Aged 20 Years and Older by Race/Ethnicity in the U.S., 1988-1994 and 2007-2008 30
Figure 2.11: Prevalence of Obesity Among Women Aged 20 Years and Older by Race/Ethnicity in the U.S., 1988-1994 and 2007-2008 30
Figure 2.12: Trends in Obesity Among Children and Adolescents in the U.S., 1963-2008 31
Figure 2.13: Mean Diabetes Healthcare-related Expenditures Per Adult (20-79 Years) with Diabetes (USD), 2011 40
Figure 2.14: How Diabetes Dollars are Spent in the U.S., 2007 42
Figure 3.1: Worldwide Diabetes Monitoring Market Segments, 2011 47
Figure 3.2: Global Unit Sales of Glucose Testing Reagent Strips, 2011 48
Figure 3.3: Geographic Segments of the Worldwide Glucose Self-testing Market, 2010 and 2015 49
Figure 3.4: Worldwide Glucose Self-Testing Market by Region, 2015 50
Figure 3.5: Continuous Glucose Market Growth Rates by Region, 2009-2018 52
Figure 3.6: U.S. Blood Glucose Reagent Strip Market, 2005-2015 53
Figure 4.1: Glycemic Status—Ranges and Health Implications 91
Figure 5.1: EGA Zones of Clinical Accuracy 98
Figure 5.2: Single-Day Continuous Blood Glucose Data 104
Figure 5.3: Factors that May Adversely Affect Glucose Testing 106
Figure 5.4: Personal Lancet Unit Sales Market Share by Geographic Region, 2011 122
