Blood Glucose Testing and Diabetes Management
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.
1. Overview 8
1.1 Statement of Report 8
1.2 About this Report 8
1.3 Scope of the Report 9
1.4 Methodology 10
1.5 Executive Summary 11
2. Diabetes 14
2.1 Demographics of Diabetes 16
2.2 Economics of Diabetes 20
2.3 Understanding the Metabolic Conditions Underlying and Associated with Diabetes 25
2.4 Glucose Control in Diabetic Patients 36
2.5 Tight Glucose Control in Treating Diabetes 36
2.6 Glucose Monitoring Devices 37
3. Glucose Measurements 42
3.1 Glucose Monitoring Markets 42
3.2 Glucose Analytical Test Methods 63
3.3 Reagents and Equipment 67
3.4 Glucose Meters 83
3.5 Diagnosing Diabetes Using In Vitro Laboratory Tests 118
3.6 Continuous and Non-invasive Glucose Patient Monitoring 121
3.7 Glycosylated Hemoglobin Glucose Monitoring 131
3.8 Clinical Laboratory Instruments 134
4. Business Trends in Glucose Testing 147
4.1 Expanding Opportunities in Blood Glucose Monitoring Market 147
4.2 Home Diabetes Test Kits an Evolving Market 147
4.3 Competitive Strategies 148
4.4 Analyses of the Current Market Conditions, Competition and Product Mix 149
4.5 The New Paradigm 150
4.6 Mergers of Diagnostic Companies 151
4.7 Healthcare Cost Controls 152
4.8 Competition for Services 152
4.9 Drivers of Clinical Glucose Testing 153
4.10 Confluence of New Technology 153
4.11 Trends in Reimbursement Practices 153
4.12 Managed Care 155
4.13 Changes in Patient Management 156
4.14 Satellite Facilities 156
4.15 Point-of-Care Testing 156
4.16 Regionalization of Laboratory Care 157
4.17 Drivers of the Point of Care Testing Sector 158
4.18 Diagnostic Testing Growth Trends 158
4.19 PIPE Financing 159
4.20 Brand Loyalty 159
4.21 Insurance Coverage a Key Factor 159
4.22 Medicare Coverage 160
4.23 Products at Competitive Price Points 160
4.24 Drugstores Critical to the Diabetic Care Category 160
4.25 Drugstore Chains Increasingly Running Diabetes Care Programs 160
4.26 Co-branding Strategies 160
5. Important Technology Trends 162
5.1 Biosensor Technology 162
5.2 Data Management 164
5.3 Advantages of Connectivity 175
5.4 Home Care Analysis 176
5.5 Technology Platform Innovations in Glucose Testing 176
5.6 Move Away from Central Laboratory 176
5.7 Trends in Detection and Diagnosis 177
6. Competitive Analysis of the Glucose Testing Markets 183
6.1 The Market Players 183
6.2 Device Categories 186
6.3 Range of Products 187
6.4 Data Handling 188
6.5 New Developments 189
6.6 Marketing New Features 189
6.7 Test Strip Sales 189
6.8 Reimbursement 189
6.9 Strip Manufacturers’ Responses 189
6.10 Retailers’ Responses 190
6.11 Market Demand and Composition 190
6.12 Product Mix 192
6.13 Devices that Measure Glycohemoglobin 202
6.14 Adjacent Markets 202
6.15 Market Drivers and Restraints 203
6.16 Market and Product Trends 203
6.17 Increased Market Penetration 203
6.18 Costs of Doing Business in Europe 204
6.19 Drivers of European Diagnostics Testing 204
6.20 European Reimbursement Practices 205
6.21 Cost Containment in Europe 205
6.22 Market Overview of Glucose Monitoring 205
6.23 Competitive Strategies 208
6.24 Price Competition 210
6.25 Analyses of the Current Market Conditions, Competition and Product Mix 210
6.26 Product Overview 212
6.27 Design of Glucose Testing Devices 214
6.28 Insulin Delivery Devices 216
6.29 Key Glucose Testing Sector Developments 220
6.30 Important M&A Activity 220
6.31 Product Launches 223
7. Government Regulation of Medical Devices 225
7.1 U.S. Regulations 225
7.2 U.K. Regulations 228
7.3 E.U. Regulations 229
7.4 French Regulations 232
7.5 Japanese Regulations 232
7.6 Korean Regulations 233
7.7 FDA Regulations and Recalls 233
7.8 Legal Liability for Glucose Meters 234
7.9 ISO 9000 Quality System 234
7.10 Recent Regulatory Approvals 234
7.11 FDA Labeling Requirements 234
8. Corporate Profiles 236
8.1 Abbott Diagnostics 236
8.2 Abbott Laboratories 237
8.3 Acon Laboratories 240
8.4 AgaMatrix 241
8.5 AiMedics Pty Ltd. 241
8.6 Animas Corp. 241
8.7 Apex Biotechnology Corporation 241
8.8 Bayer Corporation 241
8.9 Biopeak Corporation 244
8.10 BioTex 245
8.11 Dexcom, Inc. 245
8.12 Diabetech, LP 245
8.13 77 Elektronika Kft. 245
8.14 Flexsite Diagnostics 245
8.15 GenExel-Sein, Inc. 246
8.16 GlucoLight 246
8.17 Glucon 246
8.18 GluMetrics, Inc. 246
8.19 GlySens, Inc. 246
8.20 Hemocue 247
8.21 Hypoguard 247
8.22 Infratec, Inc. 248
8.23 IN4 Technology 248
8.24 InLight Solutions 248
8.25 ITC (International Technidyne Corporation) 248
8.26 LifeScan Corporation 249
8.27 MediSense 250
8.28 Metrika 250
8.29 NIR Diagnostics 250
8.30 Nipro Medical Corporation 251
8.31 OrSense Ltd. 251
8.32 Pelikan Technologies 251
8.33 Polymer Technology Systems 251
8.34 PreciSense 252
8.35 QuestStar Medical 252
8.36 Roche Diagnostics 252
8.37 Sankyo Junyaku 256
8.38 Sanwa Kagaku Kenkyusho Co., Ltd. 257
8.39 Sensys Medical 257
8.40 SurgiLance 257
8.41 Smiths Medical MD, Inc. 257
8.42 SpectRx 258
8.43 Taidoc Technology 258
8.44 Teco Diagnostics 258
8.45 U.S. Diagnostics 259
8.46 VeraLight 259
