Loading... Please wait...

World Glucose Self-Testing Markets

Bookmark and Share
Price:
$3,400.00
Publication Date:
July 2014; Pages: 263
File Type:
Downloadable PDF


Description


View Sample PDF

 

The worldwide incidence of diabetes is dramatically increasing, and it is estimated that 439 million people will have developed the disease by 2030. As such, the global market for blood glucose self-testing products is undergoing a significant transition driven by the advent of new analytical technologies and new recommendations for tight glucose control for monitoring diabetes. In addition, the proliferation of the middle class within developing nations, particularly China and India, has resulted in both a substantial rise in Type 2 diabetes and the financial means to manage the disease. The purpose of this TriMark Publications report is to provide a comprehensive analysis of the specific segment of the over-the-counter diagnostics sector known as the glucose self-testing market. The term "self-testing" is used to distinguish it from in vitro diagnostics testing for blood glucose in hospitals, commercial labs and doctor's offices, the so-called "professional" component of the glucose testing market. This study reviews the viable technology drivers and assesses the market dynamics of the glucose self-testing market worldwide. This report also looks at the industry challenges and potential threats, and it makes strategic recommendations for boosting market share. Detailed tables and charts with sales forecasts and market share data are also included.

 

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    Objectives    13
1.5    Methodology    14
1.6    Executive Summary    15

2.    Diabetes    18
2.1    Demographics of Diabetes    19
2.1.1    Worldwide Diabetes Incidence    19
2.1.2    Diabetes in the U.S.    23
2.2    Understanding the Metabolic Conditions Underlying and Associated with Diabetes    28
2.2.1    Pre-Diabetes Syndrome        29
2.2.2    Metabolic Syndrome    29
2.2.3    Progression of Diabetes        29
2.2.4    Diabetes and Inflammation    30
2.2.5    Risk Factors and Diabetes        30
2.2.5.1    Obesity    31
2.2.5.2    Stress-Induced Hyperglycemia    33
2.2.6    Complications and Co-Morbidities in Diabetes    34
2.2.6.1    Preventing Complications and Co-Morbidities in Diabetes    38
2.3    Economics of Diabetes        39
2.3.1    Worldwide Costs of Diabetes    40
2.3.2    Costs of Diabetes in the U.S.    40

3.    Market Analysis: Size, Growth, Share and Competitors    45
3.1    Worldwide Glucose Testing Market    45
3.2    Global Glucose Self-Testing Market    47
3.2.1    Continuous Glucose Monitoring Markets    50
3.3    U.S. Market        51
3.4    European Market        55
3.5    Asian Market        56
3.5.1    Japanese Market        57
3.5.2    Chinese Market        58
3.5.3    Indian Market        60
3.5.4    Korean Market        61
3.5.5    Southeast Asian Market        61
3.5.6    ROW Markets    62
3.6    Competitive Situation    63
3.6.1    Key Players    63
3.6.2    Analyses of the Current Market Conditions, Competition and Product Mix    63
3.7    Market Drivers and Restraints    66
3.7.1    Market Drivers        66
3.7.2    Market Restraints        68
3.8    Market and Product Trends    69
3.8.1    Market Trends    70
3.8.2    Technology Trends    71
3.9    Strategic Recommendations    72
3.10    Competitive Strategies    74
3.11    Adjacent Markets        75

4.    Glucose Diagnostic and Monitoring Recommendations    76
4.1    Diagnosis of Diabetes Mellitus    76
4.2    Tight Glucose Control in Treating Diabetes        79
4.2.1    Tight Glucose Control Lowers Cardiovascular Complications        80
4.3    Recommendations for Glucose Control in Diabetic Patients    80
4.3.1    Recommended Frequency of Blood Glucose Testing        82
4.3.2    Using Blood Glucose Data to Monitor and Modify Patient Therapy    83
4.3.3    Testing in Individuals with Type 2 Diabetes        84
4.3.4    Continuous Glucose Monitoring (CGM)    85
4.3.5    A1c Testing Recommendations    86
4.4    Hypoglycemia and Treatment    86

5.    Glucose Self-Testing Technology Platforms and Consumable Products        89
5.1    Types of Glucose Self-Testing Devices    89
5.2    Enzymatic Reactions Used in Glucose Self-Testing Devices    90
5.2.1    Glucose Oxidase (GOX)        90
5.2.2    Glucose Dehydrogenase (GDH)    91
5.2.2.1    GDH-NAD (Glucose Dehydrogenase-Nicotinamide Adenine Dinucleotide)    91
5.2.2.2    GDH-FAD (Glucose Dehydrogenase-Flavin Adenine Dinucleotide)    91
5.2.2.3    GDH-PQQ (Glucose Dehydrogenase-Pyrroloquinoline Quinone)    91
5.2.3    Glucose Hexokinase    92
5.3    Development of Blood Glucose Monitors: A Historical Evaluation    92
5.3.1    First-Generation Blood Glucose Biosensors        92
5.3.2    Second-Generation Blood Glucose Biosensors    92
5.3.3    Third-Generation Blood Glucose Biosensor        93
5.4    Accuracy and Precision in Glucose Meters        93
5.4.1    International Organization for Standardization (ISO) 15197:2013    94
5.4.2    FDA Guidelines for Blood Glucose Testing Systems        95
5.4.3    Determining Clinical Accuracy Using the Error Grid Analysis (EGA)        98
5.4.4    Quality Control Criteria        99
5.4.5    Potential Variables Affecting Glucose Concentrations        99
5.4.6    Calibration Methods    99
5.4.7    Common User Errors    100
5.5    Key Issues for Glucose Self-Testing Devices        100
5.5.1    Important Elements for Glucose Self-Testing    102
5.5.2    Key Features to Aid Specific Patient Populations    103
5.6    Limitations of Existing Glucose Self-Testing Products    104
5.7    Interfering Substances and Conditions    105
5.7.1    Environmental        105
5.7.2    Physiologic    105
5.7.3    Operational    105
5.7.4    Manufacturing Variations        106
5.7.5    Drugs        106
5.7.6    Patient Factors        106
5.7.6.1    Errors Associated with GDH-PQQ Technology    106
5.8    Potential Areas of Improvement in Blood Glucose Monitor Performance    109
5.8.1    Blood Glucose Reagent Test Strips        109
5.9    Continuous Glucose Monitoring Technology        111
5.9.1    Advantages of Continuous Readings    112
5.9.2    FDA Approval of CGM        112
5.9.3    CGM Functions to Consider    113
5.9.4    New Technologies for CGM    113
5.10    Summary of Technologies being Explored for Non-Invasive Glucose Monitoring    114
5.10.1    GlucoTrack    114
5.10.2    Non-Invasive Glucose Monitoring Technologies in Development    114
5.10.3    Goals of Non-Invasive Testing    115
5.10.4    Non-Invasive Diabetes Screening Test    116
5.11    A1c Monitoring Technology    116
5.12    Fructosamine Test    118
5.13    Related Reagents and Equipment        119
5.13.1    Lancets        119
5.13.1.1    Types of Lancing Devices        119
5.13.1.2    Market Size    120
5.13.2    Control Solutions and Calibrators        125
5.13.3    Sharps Devices        125
5.13.4    Needle Destruction Devices    126
5.13.5    Ketone Testing        126
5.14    New Developments in Glucose Self-Testing Systems        127
5.14.1    Voice Operated Glucose Self-Testing Meters    127
5.14.2    Bluetooth-Enabled Glucose Self-Testing Meters    130
5.14.2.1    MyGlucoHealth Wireless Meter    130
5.14.2.2    Fora D15b, Fora G31 and Fora D30 Meters        130
5.14.2.3    OneTouch VerioSync Blood Glucose Monitoring System    130
5.14.2.4    Telcare BGM    131
5.14.3    Glucose Self-Testing Meters with Computer Connectivity    131
5.14.4    Data Management    131
5.14.4.1    Log Sheets/Spreadsheets        131
5.14.4.2    Glucose Self-Testing Software    131
5.14.4.3    Smart Phone and iPad/iPod Touch Applications    133
5.14.5    Remote Patient Monitoring    135
5.14.5.1    Infopia Eocene System    137
5.14.5.2    Health Buddy Systems Monitoring Technologies    137
5.14.5.3    GlucoCom Glucose Monitoring System    138
5.14.5.4    Alere’s DayLink Monitor        138
5.14.5.5    Alere HomeLink Receives FDA Approval for Over-the-Counter Use    138
5.14.6    Integrated Testing: Glucose Meter, Test Strips and Lancet    139
5.14.7    Long-Term Glucose Sensing Bio-Implants        139
5.14.8    Glucose Self-Testing Meters that Wirelessly Communicate with Insulin Pumps        140
5.14.8.1    Medtronic’s MiniMed Paradigm Revel    140
5.14.8.2    MiniMed 530G with Enlite    140
5.14.8.3    Nova Max Link        140
5.14.8.4    One Touch Ultra Link    140
5.14.8.5    One Touch Ping        140
5.14.8.6    Accu-Chek Combo System    141

6.    Glucose Self-Testing Meters on the Market: Description of Test Meters        142
6.1    Blood Glucose Self-Testing Meters and Strips    142
6.1.1    LifeScan, Inc.    145
6.1.2    Roche Diagnostics Corporation    148
6.1.3    Bayer        149
6.1.4    Abbott (MediSense)    151
6.1.5    Agamatrix, Inc.        153
6.1.6    ARKRAY, Inc.        154
6.1.7    Bionime Corporation    156
6.1.8    BioSense Medical Devices        157
6.1.9    CVS/Pharmacy        158
6.1.10    Diabetic Supply of Suncoast    158
6.1.11    Entra Health Systems    158
6.1.12    Fifty50 Pharmacy        158
6.1.13    Fora Care    159
6.1.14    Genesis Health Technologies    160
6.1.15    GlucoCom    160
6.1.16    Infopia        160
6.1.17    Nipro Diagnostics, Inc.    161
6.1.18    Nova Biomedical        162
6.1.19    Oak Tree International Holdings, Inc.    162
6.1.20    Omnis Health    163
6.1.21    Phylosis        163
6.1.22    Prodigy Diabetes Care, LLC (an affiliate of Diagnostic Devices, Inc.)        163
6.1.23    Sanofi        164
6.1.24    Target        164
6.1.25    Telcare        164
6.1.26    Tyson Biomedical    165
6.1.27    US Diagnostics        165
6.1.28    Walgreens    166
6.1.29    Walmart        166
6.1.30    77 Elektronika Kft.    166
6.1.31    A. Menarini Diagnostics        167
6.1.32    All Medicus    167
6.1.33    i-SENS        167
6.1.34    Apex Biotechnology Corp.    168
6.1.35    Glucoplus, Inc.        168
6.1.36    Polymer Technology Systems    168
6.1.37    Smiths Medical MD, Inc.        168
6.1.38    TaiDoc Technology Corp.        168
6.1.39    IN4 Technology Corporation    168
6.1.40    ACON Laboratories    169
6.1.41    Pepex Biomedical    169
6.1.42    HMD BioMedical    170
6.1.43    BTNX, Inc.    170
6.1.44    Shasta Technologies and Decision Diagnostics Corporation        170
6.2    Continuous and Non-Invasive Glucose Patient Monitoring Systems    170
6.2.1    Medtronic’s Continuous Glucose Monitoring Systems (CGMS)    172
6.2.2    DexCom, Inc. G4 Platinum Continuous Glucose Monitoring System    174
6.2.3    FreeStyle Navigator—Abbott’s Continuous Glucose Monitor System        176
6.2.4    GlucoDay S Continuous Glucose Monitor    177
6.2.5    Minimally-Invasive Continuous Glucose Monitors in Development    177
6.2.5.1    GlySens, Inc.    177
6.2.5.2    Senseonics (formerly Sensors for Medicine and Science)    177
6.2.5.3    Ultradian    178
6.2.5.4    GluMetrics, Inc.        178
6.3    Non-Invasive Glucose Patient Monitoring Systems in Development    178
6.3.1    Cygnus GlucoWatch Biographer    179
6.3.2    AiMedics    179
6.3.3    BioTex, Inc.    180
6.3.4    Echo Therapeutics, Inc.    180
6.3.5    EyeSense GmbH        181
6.3.6    Integrity Applications Ltd.        181
6.3.7    LighTouch Medical, Inc.        182
6.3.8    OrSense Ltd.    182
6.3.9    VeraLight, Inc.        182
6.3.10    Xhale, Inc.    183
6.3.11    Lein Applied Diagnostics        183
6.4    A1c Self-Testing        183
6.4.1    A1CNow SELFCHECK        183
6.4.2    DTI Laboratories        184
6.4.3    ReliOn A1c Test        184
6.5    New Product Launches    184
6.5.1    OneTouch VerioSync Blood Glucose Monitoring System    184
6.5.2    Medtronic’s MiniMed 530G with Enlite Sensor Technology, the First Artificial Pancreas Device
System        185
6.5.3    Contour Next Link Meter Approved for Use with Medtronic’s New MiniMed 530G with Enlite Insulin Pump System    185
6.5.4    Abbott Receives CE Mark for FreeStyle Optium Neo Blood Glucose and Ketone Monitoring
System        185
6.5.5    LabStyle Innovations’ Dario Diabetes Management System        185
6.5.6    BlueStar by WellDoc    186
6.5.7    FDA Approves Bayer’s Contour Next EZ    186
6.5.8    Glooko Received its Second 510(k) Clearance for Glucose Monitoring Logbook App    186
6.5.9    Sanofi-Aventis’s iBGStar        187
6.5.10    iHealth Glucose Meter Device    187
6.5.11    MyGlucoHealth Diabetes        187
6.5.12    gDrive        188
6.5.13    Enlite Sensor    188
6.5.14    Abbott’s FreeStyle InsuLinx    188
6.5.15    Roche Diagnostics Launches Accu-Chek Mobile    188
6.5.16    Medtronic Announces Mac Compatibility for CareLink Personal Therapy Management Software for Diabetes        189
6.5.17    Telcare Receives FDA Clearance for its Telcare BGM 3G Blood Glucose Meter        189
6.5.18    OneTouch SelectSimple        189
6.5.19    Shasta GenStrips        189
6.6    Blood Glucose Meters, CGMs, and Data Management Software in Development        189
6.6.1    Abbott’s Flash Glucose Monitoring System        189
6.6.2    Google Announces Plan to Create Contact Lens Glucose Sensors    190
6.6.3    Socrates Health Solutions’ Companion Blood Glucose Monitor    190
6.6.4    DexCom and Johnson and Johnson’s Animas Working to Develop an Artificial Pancreas        190
6.6.5    Medtronic Enrolling Patients into Trial Testing Third-Generation, Fully-Automated Artificial
Pancreas        190
6.6.6    Boston University’s Bionic Pancreas Project        190
6.7    Recent Industry Activity        190
6.7.1    Roche Diagnostics Corp. Cutting Jobs in Diabetes Division        190
6.7.2    AgaMatrix and Sanofi-Aventis Enter Global Diabetes Partnership    190
6.7.3    LifeScan, Inc. Terminates Exclusive Supply Agreement with Medtronic MiniMed    191
6.7.4    Kroger Selects WaveSense Diabetes Testing Products        191
6.7.5    Medtronic and Bayer Healthcare Expand International Alliance    191
6.7.6    PositiveID Corporation and IDEAL LIFE Partner to Bring iglucose to Market for Wireless Diabetes Management    191
6.7.7    Roche Diagnostics U.S. and DexCom, Inc. Announce Research and Development Agreement    191
6.7.8    BD and JDRF Collaborating on a Device Using a Single Infusion Catheter for Both CGM and
Pump        192
6.7.9    Court Sides with Decision Diagnostics in Patent Infringement Case    192
6.8    M&A Activity    192
6.8.1    Home Diagnostics, Inc. and Nipro Diabetes Systems, Inc. Merge to become Nipro
Diagnostics, Inc.        192
6.8.2    Medtronic, Inc. (MDT) Acquires New Diabetes Technology from PreciSense AS    192
6.8.3    Geonostics Acquires FlexSite’s Consumer Diabetes Tests    193
6.8.4    Additional M&A        193
6.8.5    Important Deals in BGM Market    194

7.    Business Trends in the Industry    195
7.1    Wholesale Distribution Overview        195
7.2    Factors Affecting OTC Medical Product Distribution        197
7.3    Drugstores Critical to the Diabetic Care Category    198
7.4    Drivers of OTC and Self-Testing Markets        199
7.4.1    Brand Loyalty        199
7.5    Cost Elements of Glucose Self-Testing    199
7.6    Important Elements of OTC Testing    200
7.7    Growth of Home Care and Self-Testing    200
7.8    Blood Glucose Self-Testing Insurance Coverage and Reimbursement        200
7.8.1    American OTC Testing and Self-Testing Reimbursement    200
7.8.2    European Reimbursement        203
7.8.3    Reimbursement Challenges    203
7.8.4    New Medicare Part B    204
7.9    Government Regulation of Medical Devices        204
7.9.1    U.S. Regulations        204
7.9.2    E.U. Regulations        207
7.9.3    U.K. Regulations        212
7.10    Clinical Laboratory Improvement Act (CLIA)    213
7.11    FDA Labeling Requirements    215
7.12    Legal Liability for Glucose Meters        217
7.13    FDA’s Artificial Pancreas Guidance Document    217

8.    Technology Trends    218
8.1    Improving Today’s Over-the-Counter (OTC) Blood Glucose Meters    218
8.2    Biosensor Technology    219
8.3    Artificial Pancreas    221
8.4    Fructosamine Test    222
8.5    Telemedicine    223
8.5.1    Remote Patient Monitoring    225
8.5.1.1    Infopia Eocene System        229
8.5.1.2    Health Buddy Systems Monitoring Technologies    229
8.5.1.3    GlucoCom Glucose Monitoring System    229
8.5.1.4    Alere’s DayLink Monitor        230
8.5.1.5    Alere HomeLink Receives FDA Approval for Over-the-Counter Use    230
8.6    Non-Traditional Methods for Sample Collection    230
8.7    Data Management    231
8.7.1    Medical Device Radiocommunications Service (MedRadio)        231
8.7.2    FDA Required Software Verification    231

9.    OTC Testing: Critical Issues    232
9.1    Moderators of Growth for OTC Testing    232
9.2    Attitudes of Critical Care Nurses and Physicians    232
9.3    Personnel Impact for OTC Testing        233
9.4    Data Management Issues        233

10.    Current Issues for OTC and Diagnostic Self-Testing        234
10.1    New Markets for OTC and Diagnostic Self-Testing        234
10.2    Utility of OTC and Self-Testing    235
10.3    Generational Drivers of Home Testing    236
10.4    Move Away from Central Laboratories    237
10.5    Healthcare Cost Controls        238
10.6    Mergers of Diagnostic Companies        238
10.7    Home Healthcare Trends        238
10.8    Home Healthcare Providers versus Mass Market Retailers    238
10.9    Demographic Merchandising    239
10.10    Marketing Strategies    239
10.11    Third-Party Pharmacy Networks        240
10.12    Which Customer Segments Purchase Home Healthcare? Which Products Fit Their Needs?    240
10.13    Future of Patient Self-Testing    242

11.    SWOT Analysis        243
11.1    Roche        243
11.2    LifeScan    243

12.    Company Profiles    246
12.1    A. Menarini Diagnostics    246
12.2    Abbott Laboratories    246
12.3    ACON Laboratories    250
12.4    AgaMatrix    250
12.5    Allmedicus Co., Ltd.    250
12.6    Apex Biotechnology Corporation        250
12.7    ARKRAY USA, Inc.    250
12.8    Bayer        251
12.9    B. Braun Melsungen    252
12.10    Bionime        253
12.11    Cambridge Sensors    253
12.12    DexCom    253
12.13    Diagnostic Devices/Prodigy Diabetes Care        255
12.14    Echo Therapeutics, Inc.    255
12.15    Entra Health Systems    256
12.16    Fora Care    256
12.17    FIFTY50 Medical, Inc.    256
12.18    Genesis Health Technologies    256
12.19    GlucoPlus    257
12.20    GlySens, Inc.    257
12.21    Hainice Medical        257
12.22    Home Diagnostics    257
12.23    Infopia        258
12.24    IN4 Technology        258
12.25    i-Sens        258
12.26    Johnson & Johnson    258
12.27    LabStyle Innovations Corporation        259
12.28    Medtronic    259
12.29    Nipro Corporation    259
12.30    Nova Biomedical        260
12.31    OrSense Ltd.    260
12.32    Prodigy Diabetes Care, LLC (formerly Diagnostic Devices, Inc.)    260
12.33    Roche        261
12.34    77 Elektronika Kft.    262
12.35    Smiths Group        262
12.36    TaiDoc Technology    262
12.37    Telcare        263
12.38    US Diagnostics        263
12.39    VeraLight    263


 
INDEX OF FIGURES

Figure 2.1: Worldwide Diabetes Cases, 2013 and 2035    19
Figure 2.2: Worldwide Prevalence of Diabetes (%) in Adults (20-79 Years), 2013    20
Figure 2.3: Annual Number of New Cases of Diagnosed Diabetes Among U.S. Adults Aged 18-79 Years,
1980-2011    23
Figure 2.4: New Cases of Diabetes Diagnosed in the U.S. Adult Population by Age, 2010        24
Figure 2.5: Prevalence of Diabetes by Age in the U.S., 2010        24
Figure 2.6: Diagnosed Diabetes by Age in the U.S., 2013    25
Figure 2.7: Number of Deaths from Diabetes by Age in the U.S., 2010        27
Figure 2.8: Number of Diabetes Deaths by Race and Sex in the U.S., 2010    27
Figure 2.9: Maintenance of Normal Blood Sugar Levels    28
Figure 2.10: Prevalence of Self-Reported Obesity (BMI ≥30) Among U.S. Adults, 2012        32
Figure 2.11: Prevalence of Obesity Among Adults in the U.S., 2009-2010    32
Figure 2.12: Trends in Obesity Among Children and Adolescents in the U.S., 1988-2010        33
Figure 2.13: Age-Adjusted Percentage of People with Diabetes Aged 35 Years or Older Reporting Heart Disease or Stroke, by Sex, in the U.S., 1997-2011    35
Figure 2.14: Percentage of Adults with Diagnosed Diabetes Reporting Any Mobility Limitation, by Age, in the U.S., 1997-2011    37
Figure 2.15: Number (in Millions) of Adults Aged 18 Years or Older with Diagnosed Diabetes Reporting Visual Impairment in the U.S., 1997-2011        38
Figure 2.16: Mean Diabetes Healthcare-Related Expenditures Per Adult (20-79 Years) with Diabetes (U.S. Dollars), 2013    40
Figure 2.17: How Diabetes Dollars are Spent in the U.S., 2012        42
Figure 3.1: Geographic Segments of the Worldwide Glucose Self-Testing Market, 2012 and 2018        48
Figure 3.2: Worldwide Glucose Self-Testing Market by Region, 2018        48
Figure 3.3: Worldwide Glucose Self-Testing Market Segments, 2013        49
Figure 4.1: Approach to Management of Hypoglycemia    82
Figure 4.2: Glycemic Status—Ranges and Health Implications        88
Figure 5.1: EGA Zones of Clinical Accuracy        98
Figure 5.2: Single-Day Continuous Blood Glucose Data    105
Figure 5.3: Factors that may Adversely Affect Glucose Testing    106
Figure 5.4: Personal Lancet Unit Sales Market Share by Geographic Region, 2013    122
Figure 6.1: Medtronic’s Threshold Suspend Feature        174


INDEX OF TABLES

Table 2.1: Regional Estimates of the Number of Diabetes (20-79 Years) in Millions, 2013 and 2035    20
Table 2.2: Countries with the Largest Numbers of Diabetics, 2013    21
Table 2.3: Countries with the Largest Estimated Numbers of Diabetics, 2035    21
Table 2.4: Worldwide Undiagnosed Diabetes in Adults (20-79 Years) by Region and Income Group, 2013    22
Table 2.5: Countries with the Largest Number of Deaths Attributable to Diabetes, 2013        22
Table 2.6: U.S. Population of Diagnosed Diabetics Aged 20-79 Years, 2013    24
Table 2.7: Percentage of U.S. Adults with Diagnosed Diabetes by State, 2010    25
Table 2.8: Ten Leading Diagnoses for Co-Morbid Chronic Diseases in the U.S.        34
Table 2.9: Odds Ratio of Progression to Complications Associated with Type 2 Diabetes        36
Table 2.10: Prevalence of Complications Among Patients with Diabetes    36
Table 2.11: Novel Risk Factors and Possible Mechanisms of the Excess Risk of Coronary Heart Disease in Type 2 Diabetes Mellitus        37
Table 2.12: Major Causes of End-Stage Renal Disease    37
Table 2.13: Clinical Recommendations for Adults with Diabetes    39
Table 2.14: Laboratory Assessment of Diabetic Vascular Disease    39
Table 2.15: Average Years Gained Free of Diabetes-Related Disease with Intensive Management        39
Table 2.16: Cost of Diagnosed Diabetes in the U.S., 2012    41
Table 2.17: Annual Cost of Care of United Healthcare Adult Members with Diabetes, 2009    43
Table 2.18: Healthcare Utilization by Diabetic Patients, 2012        43
Table 3.1: Total Global Unit Demand for Glucose Testing Reagent Strips, 2012-2018    46
Table 3.2: Global Dollar Sales of Glucose Testing Reagent Strips, 2012-2018        47
Table 3.3: Worldwide Glucose Self-Testing Market Sales (Meters, Strips and Lancets), 2012-2018        47
Table 3.4: World Market Share of Glucose Self-Testing Marketers, 2013    49
Table 3.5: Global Revenues for Continuous Glucose Monitoring Systems, 2012-2018    50
Table 3.6: Market for Glucose Self-Testing in the U.S. (Includes Meters, Strips and Lancets), 2012-2018    51
Table 3.7: Market Share of U.S. Blood Glucose Self-Testing, 2013    52
Table 3.8: U.S. OTC Glucose Self-Testing Market Repeat Retail Replacement Sales Percentages        53
Table 3.9: OTC Blood Glucose Instrument Reagents by Manufacturer Retail    53
Table 3.10: Demographic Characteristics Glucose Self-Testing Kit Buyers    54
Table 3.11: Top Brand Preferences for Glucose Self-Testing Kits    54
Table 3.12: Instances when Patients Prefer Professional’s Glucose Testing    54
Table 3.13: Advantages of a Glucose Self-Testing Kit        55
Table 3.14: Disadvantages of Using a Glucose Self-Testing Kit    55
Table 3.15: Popular Shopping Destinations for Buying or Seeking Information on Glucose Self-Testing
Kits    55
Table 3.16: Customer Priorities—Glucose Meter Self-Testing Market, 2001, 2006 and 2013    55
Table 3.17: European Market for Glucose Self-Testing (Includes Meters, Strips and Lancets), 2012-2018    56
Table 3.18: Asian Market for Glucose Self-Testing (Includes Meters, Strips and Lancets), 2012-2018    57
Table 3.19: Japanese Market for Glucose Self-Testing (Includes Meters, Strips and Lancets), 2012-2018    58
Table 3.20: Chinese Market for Glucose Self-Testing (Includes Meters, Strips and Lancets), 2012-2018    59
Table 3.21: Southeast Asian Market for Glucose Self-Testing (Includes Meters, Strips and Lancets),
2012-2018    62
Table 3.22: Southeast Asian Market for Glucose Self-Testing by Country (Includes Meters, Strips and Lancets), 2013    62
Table 3.23: ROW Market for Glucose Self-Testing (Includes Meters, Strips and Lancets), 2012-2018    62
Table 3.24: Key Market Drivers for Glucose Self-Testing    67
Table 3.25: Market Drivers for Continuous Glucose Monitoring    67
Table 3.26: Key Market Restraints for Glucose Self-Testing        68
Table 3.27: Market Restraints for Continuous Glucose Monitoring    69
Table 4.1: Criteria for the Diagnosis of Diabetes    76
Table 4.2: Categories of Increased Risk for Diabetes (Pre-Diabetes)    76
Table 4.3: Normal Glucose Values—Fasting State    77
Table 4.4: Criteria for Testing for Diabetes in Asymptomatic Adults    77
Table 4.5: Criteria for Type 2 Diabetes in Asymptomatic Children    78
Table 4.6: Screening for and Diagnosis of Gestational Diabetes Mellitus (GDM)        79
Table 4.7: Glycemic Recommendations for Non-Pregnant Adults with Diabetes        81
Table 4.8: Glycemic Recommendations for Women with Gestational Diabetes        81
Table 4.9: Glycemic Recommendations for Pregnant Women with Pre-Existing Diabetes        81
Table 4.10: Plasma Blood Glucose and A1c Goals for Type 1 Diabetes by Age-Group    81
Table 4.11: Glucose Monitoring Recommendations        83
Table 4.12: Key Issues for SMBG in Insulin-Independent Type 2 Diabetics    84
Table 4.13: A1c Testing Recommendations        86
Table 4.14: Correlation of A1c with Mean Blood Glucose    86
Table 5.1: Analytic Performance Criteria for Glucose Meters        94
Table 5.2: Potential Variables Affecting Glucose Concentrations    99
Table 5.3: Common User Errors Made while Self-Testing for Blood Glucose    100
Table 5.4: Key Features Considered for Glucose Self-Testing Devices        103
Table 5.5: Key Features Considered for Reagent Test Strips    103
Table 5.6: Compatibility of Various Blood Glucose Meters with Icodextrin PD Solution        107
Table 5.7: Ten Factors Needed to Improve the Performance of Blood Glucose Monitors        109
Table 5.8: Key Features Considered for Reagent Test Strips        110
Table 5.9: Relationship of A1c to Average Whole Blood and Plasma Glucose Levels    117
Table 5.10: Unit Sales of Homecare Lancets in the U.S., 2012-2017    121
Table 5.11: Unit Sales of Homecare Lancets in the E.U., 2012-2017    121
Table 5.12: Dollar Sales of Homecare Lancets in the U.S., 2012-2017        121
Table 5.13: Dollar Sales of Homecare Lancets in the E.U., 2012-2017        121
Table 5.14: Unit Sales of Homecare Glucose Self-Testing Lancets in the U.S., 2012-2017        122
Table 5.15: Unit Sales of Homecare Glucose Self-Testing Lancets in the E.U., 2012-2017        122
Table 5.16: Competition in the Lancet Market Segment    123
Table 5.17: Blood Ketone Reading Indications    127
Table 5.18: Leading Companies for Patient Monitoring Products    137
Table 6.1: Current Blood Glucose Self-Testing Meters: Sample Size, Test Time, and Other Features    142
Table 6.2: Detailed Features of Selected CGM Systems Currently Available    171
Table 6.3: Non-Invasive Glucose Monitoring Systems in Development        179
Table 7.1: Financial Comparison for Moderate and Waived CLIA Labs        214
Table 8.1: Data Entry and Data Management Features to Include in Future Meters    219
Table 8.2: Leading Companies for Patient Monitoring Products    228

Find Similar Products by Category