World Glucose Self-Testing Markets

2012-01-11
Published : Jan-2012

Report Summary

Global blood glucose self-testing products market is undergoing a significant transition driven by the advent of new analytical technologies and new recommendations for tight glucose control for monitoring diabetes. The worldwide incidence of diabetes is dramatically increasing, and it is estimated that 439 million people will have developed the disease by 2030. 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.

This study analyzes the market for glucose self-testing in the following product segments:

  • Blood glucose testing devices (blood glucose test kits, blood glucose meter/monitors)
  • Diabetes testing supplies (blood glucose test strips, lancet devices, reagent strips, blood glucose sensors) and control solutions.

The purpose of this report on Global glucose self testing markets 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.
This review analyzes the size and growth of the glucose self-testing market, including factors that influence the various market segments within it and dollar volume of sales, both in the U.S. and worldwide. Also examined are:

  • Glucose detection technology platforms
  • Clinical applications of world glucose self-testing
  • The market for quantitative diagnostic glucose tests
  • Companies participating in this sector
  • New instrumentation
  • Trends in the industry
  • The internal structure of the world glucose self-testing sector

Glucose Self-Testing Markets

Published: January 2012
No.OF Pages: 235
Price: Single User License – US$ 3400

Table of Contents

1. Overview 10
1.1 Statement of Report 10
1.2 About This Report 11
1.3 Scope of the Report 12
1.4 Objectives 12
1.5 Methodology 13
1.6 Executive Summary 14

2. Diabetes 16
2.1 Demographics of Diabetes 18
2.1.1 Worldwide Diabetes Incidence 18
2.1.2 Diabetes in the U.S. 19
2.2 Economics of Diabetes 24
2.3 Understanding the Metabolic Conditions Underlying and Associated with Diabetes 29
2.3.1 Pre-Diabetes Syndrome 31
2.3.2 Metabolic Syndrome 31
2.3.3 Progression of Diabetes 31
2.3.4 Diabetes and Inflammation 31
2.3.5 Risk Factors and Diabetes 32
2.3.5.1 Obesity 33
2.3.6 Complications and Co-morbidities in Type 2 Diabetes 35
2.3.7 Hypoglycemia and Treatment 37
2.3.8 Cardiovascular Disease Facts 37

3. Market Analysis: Size, Growth, Share and Competitors 44
3.1 Worldwide Glucose Testing Market 44
3.1.1 Global Glucose Self-testing Market Share 47
3.1.2 Continuous Glucose Monitoring Markets 49
3.2 U.S. Market 50
3.2.1 Over-the-Counter (OTC) Self-testing Glucose Market 54
3.3 European Market 56
3.4 Asian Market 57
3.4.1 Japanese Market 59
3.4.2 Chinese Market 60
3.4.3 Indian Market 62
3.4.4 Korean Market 63
3.4.5 Southeast Asian Market 63
3.4.6 ROW Markets 64
3.5 Competitive Situation 64
3.5.1 Key Players 64
3.5.2 Analyses of the Current Market Conditions, Competition and Product Mix 65
3.6 Market Drivers and Restraints 68
3.6.1 Market Drivers 68
3.6.2 Market Restraints 69
3.7 Market and Product Trends 70
3.7.1 Market Trends 71
3.7.2 Technology Trends 72
3.8 Strategic Recommendations 73
3.9 Competitive Strategies 74
3.10 Adjacent Markets 75

4. Glucose Monitoring Recommendations 76
4.1 Tight Glucose Control in Treating Diabetes 76
4.2 Recommendations for Glucose Control in Diabetic Patients 76
4.2.1 Recommended Frequency of Blood Glucose Testing 77
4.2.2 Using Blood Glucose Data to Monitor and Modify Patient Therapy 78
4.2.3 Testing in Individuals with Type 2 diabetes 78
4.2.4 Continuous Glucose Monitoring (CGM) 79
4.2.5 A1c Testing Recommendations 80

5. Glucose Self-testing Technology Platforms and Consumable Products 82
5.1 Types of Glucose Self-testing Devices 82
5.2 Enzymatic Reactions Used in Glucose Self-testing Devices 83
5.2.1 Glucose Oxidase (GOX) 83
5.2.2 Glucose Dehydrogenase (GDH) 84
5.2.2.1 GDH-NAD (Glucose Dehydrogenase-Nicotinamide Adenine Dinucleotide) 84
5.2.2.2 GDH-FAD (Glucose Dehydrogenase-Flavin Adenine Dinucleotide) 84
5.2.2.3 GDH-PQQ (Glucose Dehydrogenase-Pyrroloquinoline Quinone) 84
5.3 Development of Blood Glucose Monitors: A Historical Evaluation 85
5.3.1 First Generation Blood Glucose Biosensors 85
5.3.2 Second Generation Blood Glucose Biosensors 85
5.3.3 Third Generation Blood Glucose Biosensor 85
5.4 Accuracy and Precision in Glucose Meters 86
5.4.1 FDA Recommendations 87
5.4.2 Determining Clinical Accuracy Using the Error Grid Analysis (EGA) 88
5.4.3 Calibration Methods 89
5.4.4 Common User Errors 89
5.5 Key Issues for Glucose Self-testing Devices 90
5.5.1 Important Elements for Glucose Self-testing 91
5.5.2 Key Features to Aid Specific Patient Populations 93
5.6 Limitations of Existing Glucose Self-testing Products 93
5.7 Interfering Substances and Conditions 94
5.7.1 Environmental 94
5.7.2 Physiologic 94
5.7.3 Operational 95
5.7.4 Manufacturing Variations 95
5.7.5 Drugs 95
5.7.5.1 Errors Associated with GDH-PQQ Technology 95
5.8 Potential Areas of Improvement in Blood Glucose Monitor Performance 98
5.9 Continuous Glucose Monitoring Technology 99
5.9.1 Advantages of Continuous Readings 99
5.9.2 FDA Approval of CGM 100
5.9.3 CGM Functions to Consider 101
5.9.4 New Technologies for CGM 101
5.10 Summary of Technologies being Explored for Non-invasive Glucose Monitoring 102
5.10.1 Goals of Non-invasive Testing 103
5.11 A1c Monitoring Technology 104
5.12 Related Reagents and Equipment 105
5.12.1 Lancets 105
5.12.2 Control Solutions and Calibrators 113
5.12.3 Sharps Devices 113
5.12.4 Needle Destruction Devices 114
5.13 New Developments in Glucose Self-testing Systems 114
5.13.1 Voice Operated Glucose Self-testing Meters 114
5.13.2 Bluetooth-enabled Glucose Self-testing Meters 117
5.13.2.1 MyGlucoHealth Wireless Meter 117
5.13.2.2 Fora D15b, Fora G31 and Fora D30 Meters 117
5.13.2.3 Meters with Wireless Connectivity in Development 117
5.13.3 Glucose Self-testing Meters with Computer Connectivity 117
5.13.4 Data Management 118
5.13.4.1 Log Sheets/Spreadsheets 118
5.13.4.2 Glucose Self-testing Software 118
5.13.4.3 Smart Phone and iPad/iPod Touch Applications 119
5.13.4.4 Separate Devices 120
5.13.5 Telemedicine 120
5.13.6 Integrated Testing: Glucose Meter, Test Strips, and Lancet 121
5.13.7 Long-term Glucose Sensing Bio-implants 121
5.13.8 Glucose Self-testing Meters that Wirelessly Communicate with Insulin Pumps 122
5.13.8.1 Medtronics MiniMed Paradigm Revel 122
5.13.8.2 Nova Max Link 122
5.13.8.3 One Touch Ultra Link 122
5.13.8.4 One Touch Ping 122
5.13.9 Fords Onboard Sync System to Display Glucose Levels Measured by Patients CGM 122

6. Glucose Self-testing Meters on the Market: Description of Test Meters 124
6.1 Blood Glucose Self-testing Meters and Strips 124
6.1.1 LifeScan 127
6.1.2 Roche Diagnostics Corporation 129
6.1.3 Bayer 130
6.1.4 Abbott (MediSense) 131
6.1.5 Agamatrix, Inc. 133
6.1.6 Arkray, Inc. 135
6.1.7 Bionime Corporation 136
6.1.8 BioSense Medical Devices 138
6.1.9 Diabetic Supply of Suncoast 138
6.1.10 Prodigy Diabetes Care, LLC (an Affiliate of Diagnostic Devices, Inc.) 139
6.1.11 Entra Health Systems 140
6.1.12 Fifty50 Pharmacy 141
6.1.13 Fora Care 141
6.1.14 Nipro Diagnostics, Inc. 141
6.1.15 Nova Biomedical 143
6.1.16 Oak Tree International Holdings, Inc. 143
6.1.17 U.S. Diagnostics 143
6.1.18 77 Elektronika Kft. 144
6.1.19 A. Menarini Diagnostics 145
6.1.20 Allmedicus 145
6.1.21 i-SENS 145
6.1.22 Apex Biotechnology Corp. 146
6.1.23 GenExel-Sein, Inc. 146
6.1.24 Glucoplus, Inc. 146
6.1.25 Polymer Technology Systems 146
6.1.26 Smiths Medical MD, Inc. 147
6.1.27 TaiDoc Technology Corp. 147
6.1.28 IN4 Technology Corporation 147
6.1.29 ACON Laboratories 147
6.1.30 HemoCue 148
6.1.31 Pepex Biomedical 148
6.1.32 Comparisons of Popular Blood Glucose Self-monitoring Meters 148
6.2 Continuous and Non-invasive Glucose Patient Monitoring Systems 149
6.2.1 Medtronics Continuous Glucose Monitoring Systems (CGMS) 152
6.2.2 FreeStyle Navigator Abbotts Continuous Glucose Monitor System 153
6.2.3 DexCom, Inc. STS Continuous Glucose Monitoring System 154
6.2.4 GlucoDay S Continuous Glucose Monitor 155
6.2.5 Minimally-invasive Continuous Glucose Monitors in Development 155
6.2.5.1 GlySens, Inc. 155
6.2.5.2 Sensors for Medicine and Science 156
6.2.5.3 Ultradion 156
6.3 Non-invasive Glucose Patient Monitoring Systems in Development 156
6.3.1 Cygnus GlucoWatch Biographer 157
6.3.2 AiMedics 157
6.3.3 BioTex 157
6.3.4 Calisto Medical 158
6.3.5 Echo Therapeutics 158
6.3.6 EyeSense GmbH 159
6.3.7 Integrity Applications Ltd. 159
6.3.8 LighTouch Medical 160
6.3.9 OrSense Ltd. 160
6.3.10 Solianis Monitoring AG 160
6.3.11 VeraLight 161
6.3.12 Xhale, Inc. 161
6.3.13 Lein Applied Diagnostics 161
6.4 A1c Self-testing 161
6.4.1 A1CNow+ SELFCHECK 162
6.4.2 Diabetes Technologies 162
6.4.3 Flexsite Diagnostics, Inc. 162
6.4.4 Heritage Labs 163
6.5 New Product Launches 163
6.5.1 Didget 163
6.5.2 HealthPia GlucoPhone 163
6.5.3 MyGlucoHealth Diabetes 163
6.5.4 gDrive 164
6.5.5 Paradigm Veo 164
6.5.6 Enlite Sensor 164
6.5.7 Abbotts FreeStyle InsuLinx 164
6.5.8 Roche Diagnostics launches Accu-Chek Mobile 165
6.5.9 Bayer Introduces CONTOUR USB 165
6.5.10 Medtronic Announces Mac Compatibility for CareLink Personal Therapy Management Software for Diabetes 165
6.6 New Blood Glucose Meters and Data Management Software in Development 165
6.6.1 LifeScans iPhone App 165
6.6.2 Sanofi-Aventiss iBGStar 165
6.6.3 Jazz Wireless 166
6.6.4 Fora Care G31 and D30 166
6.7 Recent Industry Activity 166
6.7.1 Roche Diagnostics Corp Expanding Indianapolis Manufacturing Plant 166
6.7.2 AgaMatrix and Sanofi-Aventis Enter Global Diabetes Partnership 166
6.7.3 LifeScan, Inc. Terminates Exclusive Supply Agreement with Medtronic MiniMed 167
6.7.4 Kroger Selects WaveSense Diabetes Testing Products 167
6.7.5 Medtronic and Bayer Healthcare Expand International Alliance 167
6.7.6 Medtronic Opens New Diabetes Center in San Antonio 167
6.7.7 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 U.S. and
Puerto Rico 167
6.7.8 Abbott Receives FDA Clearance for New, Easier-to-Use FreeStyle Lite Test Strips 168
6.7.9 DexCom Receives CE Mark Approval for the SEVEN Continuous Glucose
Monitoring System 168
6.8 M&A Activity 168
6.8.1 Home Diagnostics, Inc. and Nipro Diabetes Systems, Inc. Merge to become
Nipro Diagnostics, Inc. 168
6.8.2 Medtronic, Inc. (MDT) Acquires New Diabetes Technology from PreciSense AS 169
6.8.3 Geonostics Acquires FlexSite’s Consumer Diabetes Tests 169
6.8.4 Additional M&A 169
6.8.5 Important Deals in BGM market 170
6.9 Competitive Developments for the Self-testing World Market 170

7. Business Trends in the Industry 174
7.1 Wholesale Distribution Overview 174
7.2 Factors Affecting OTC Medical Product Distribution 175
7.3 Drugstores Critical to the Diabetic Care Category 177
7.4 Drivers of OTC and Self-testing Markets 178
7.4.1 Brand Loyalty 178
7.5 Cost Elements of Glucose Self-testing 178
7.6 Important Elements of OTC Testing 179
7.7 Growth of Home Care and Self-testing 179
7.8 Blood Glucose Self-testing Insurance Coverage and Reimbursement 179
7.8.1 American OTC Testing and Self-testing Reimbursement 179
7.8.2 European Reimbursement 180
7.9 Government Regulation of Medical Devices 181
7.9.1 U.S. Regulations 181
7.9.2 U.K. Regulations 183
7.10 Clinical Laboratory Improvement Act (CLIA) 185
7.11 M&A Activity 187
7.12 Important Deals in BGM Market 188

8. Technology Trends 189
8.1 Improving Todays OTC Blood Glucose Meters 189
8.2 Biosensor Technology 190
8.3 Fructosamine Test 192
8.4 World Telemedicine Devices 192
8.4.1 Remote Patient Monitoring 194
8.4.1.1 Infopia Eocene System 197
8.4.2 Health Buddy Systems Monitoring Technologies 197
8.5 Non-Traditional Methods for Sample Collection 197
8.6 Data Management 198
8.6.1 Receiver Technology 198
8.6.2 Connectivity 198
8.6.3 DataLink Data Management System 201
8.6.4 RALS-Plus 202
8.6.5 LifeScan Electronic Data Interfaces 204
8.6.6 FDA Required Software Verification 205

9. OTC Testing: Critical Issues 206
9.1 Moderators of Growth for OTC Testing 206
9.2 Attitudes of Critical Care Nurses and Physicians 206
9.3 Personnel Impact for OTC Testing 207
9.4 Data Management Issues 207
9.5 POC Decentralization Issues 207
9.6 POC Testing and Clinical Outcomes 207
9.7 Focused Testing 207
9.8 Satellite Facilities 207
9.9 POC Testing Comparison and Cost Analysis 208

10. Current Issues for OTC and Diagnostic Self-testing 211
10.1 New Markets for OTC and Diagnostic Self-testing 211
10.2 Utility of OTC and Self-testing 214
10.3 Corporate Screening 214
10.4 Generational Drivers of Home Testing 216
10.5 Move Away from Central Laboratories 218
10.6 Healthcare Cost Controls 218
10.7 Mergers of Diagnostic Companies 218
10.8 Home Healthcare Trends 218
10.9 Home Healthcare Providers versus Mass Market Retailers 218
10.10 Demographic Merchandising 219
10.11 Marketing Strategies 219
10.12 Third-party Pharmacy Networks 220
10.13 Which Customer Segments Purchase Home Healthcare? Which Products Fit Their Needs? 220
10.14 Future of Patient Self-testing 222

11. SWOT Analysis 223
11.1 Roche 223
11.2 LifeScan 224

12. Company Profiles 226
12.1 Abbott Laboratories 226
12.2 ACON Laboratories 226
12.3 AgaMatrix 226
12.4 Allmedicus 226
12.5 Amedica Biotech 226
12.6 Apex Biotechnology Corporation 227
12.7 Arkray 227
12.8 Bayer 227
12.9 B. Braun Melsungen 228
12.10 Bionime 228
12.11 Cambridge Sensors 228
12.12 DexCom 228
12.13 Diagnostic Devices/Prodigy Diabetes Care 229
12.14 Echo Therapeutics 229
12.15 Entra Health Systems 229
12.16 Fora Care 229
12.17 Genesis Health Technologies 229
12.18 GlucoPlus 229
12.19 Hainice Medical 229
12.20 Home Diagnostics 229
12.21 Infopia 230
12.22 IN4 Technology 230
12.23 i-Sens 230
12.24 Johnson & Johnson 230
12.25 Medtronic 231
12.26 Menarini Group 231
12.27 Nipro Corporation 232
12.28 Nova Biomedical 232
12.29 Roche 232
12.30 77 Elektronika Kft. 233
12.31 Smiths Group 233
12.32 TaiDoc Technology 234
12.33 U.S. Diagnostics 234

List of Tables and figures


 

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