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World Glucose Self-Testing Markets - Product Image

World Glucose Self-Testing Markets

  • Published: July 2014
  • Region: Global
  • 263 Pages
  • TriMark Publications

FEATURED COMPANIES

  • A. Menarini Diagnostics
  • Allmedicus
  • Calisto Medical
  • Fora Care
  • Lein Applied Diagnostics
  • Smiths Medical MD, Inc.
  • MORE

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 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.

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

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

3. Market Analysis: Size, Growth, Share and Competitors
3.1 Worldwide Glucose Testing Market
3.1.1 Global Glucose Self-testing Market Share
3.1.2 Continuous Glucose Monitoring Markets
3.2 U.S. Market
3.2.1 Over-the-Counter (OTC) Self-testing Glucose Market
3.3 European Market
3.4 Asian Market
3.4.1 Japanese Market
3.4.2 Chinese Market
3.4.3 Indian Market
3.4.4 Korean Market
3.4.5 Southeast Asian Market
3.4.6 ROW Markets
3.5 Competitive Situation
3.5.1 Key Players
3.5.2 Analyses of the Current Market Conditions, Competition and Product Mix
3.6 Market Drivers and Restraints
3.6.1 Market Drivers
3.6.2 Market Restraints
3.7 Market and Product Trends
3.7.1 Market Trends
3.7.2 Technology Trends
3.8 Strategic Recommendations
3.9 Competitive Strategies
3.10 Adjacent Markets

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

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

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

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

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

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

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

11. SWOT Analysis
11.1 Roche
11.2 LifeScan

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

INDEX OF FIGURES

Figure 2.1: Worldwide Rates of Diabetes Cases, 2000-2030 20
Figure 2.2: Prevalence of Diabetes by Age in the U.S., 2010 21
Figure 2.3: New Cases of Diabetes Diagnosed in the U.S. Adult Population, 2010 22
Figure 2.4: County-specific Diabetes Prevalence in the U.S., 2007 22
Figure 2.5: Rate of New Diabetes Cases among Children in the U.S., 2007 23
Figure 2.6: Diabetes Death Rate by Race and Sex in the U.S., 1979-2006 24
Figure 2.7: How Diabetes Dollars are Spent in the U.S., 2007 28
Figure 2.8: Maintenance of Normal Blood Sugar Levels 31
Figure 2.9: Prevalence of Obesity Among Men Aged 20 Years and Older by Race/Ethnicity in the U.S., 1988-1994 and 2007-2008 34
Figure 2.10: Prevalence of Obesity Among Women Aged 20 Years and Older by Race/Ethnicity in the U.S., 1988-1994 and 2007-2008 35
Figure 2.11: Trends in Obesity Among Children and Adolescents in the U.S., 1963-2008 35
Figure 2.12: Hypertension Drugs Newly Prescribed or Continued in the U.S., 1994-2007 41
Figure 3.1: Worldwide Diabetes Monitoring Market Segments, 2011 46
Figure 3.2: Global Unit Sales of Glucose Testing Reagent Strips, 2011 47
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 49
Figure 3.5: Continuous Glucose Market Growth Rates by Region, 2009-2018 50
Figure 3.6: U.S. Blood Glucose Reagent Strip Market, 2005-2015 53
Figure 5.1: EGA Zones of Clinical Accuracy 89
Figure 5.2: Single-day Continuous Blood Glucose Data 95
Figure 5.3: Personal Lancet Unit Sales Market Share by Geographic Region, 2011 112
Figure 6.1: Roche Diagnostics' Global Sales of Blood Glucose Monitors, 2003-2010 167

INDEX OF TABLES

Table 2.1: Criteria for the Diagnosis of Diabetes 18
Table 2.2: Categories of Increased Risk for Diabetes 19
Table 2.3: Countries with the Largest Numbers of Diabetics, 2010 and 2030 20
Table 2.4: U.S. Population of Diabetics (Diagnosed and Undiagnosed) Aged 20 Years or Older, 2010 21
Table 2.5: U.S. Incidence of Diagnosed Diabetes by Age, 2009 23
Table 2.6: Cost of Diagnosed Diabetes in the U.S., 2007 25
Table 2.7: Cost of Type 1 and Type 2 Diabetes in the U.S., 2007 25
Table 2.8 Total Cost of Diabetes in the U.S., 2007 25
Table 2.9: Per-event Costs of Diabetes Complications 27
Table 2.10: Healthcare Utilization by Diabetic Patients, 2008 27
Table 2.11: Clinical Recommendations for Adults with Diabetes 28
Table 2.12: Ten Leading Diagnoses for Co-morbid Chronic Diseases in the U.S., by Percentage of Patient Visits, 2006 29
Table 2.13: Odds Ratio of Progression to Complications Associated with Type 2 Diabetes 36
Table 2.14: Prevalence of Complications Among Patients with Diabetes 36
Table 2.15: Novel Risk Factors and Possible Mechanisms of the Excess Risk of Coronary Heart Disease in Type 2 Diabetes Mellitus 37
Table 2.16: Major Causes of End-stage Renal Disease 37
Table 2.17: Average Years Gained Free of Diabetes-related Disease with Intensive Management 38
Table 2.18: Estimated Direct and Indirect Costs of Major Cardiovascular Diseases and Stroke in the U.S.,
2008 40
Table 2.19: Worldwide Market for Cardiac Care Therapeutics, 2003-2010 40
Table 2.20: Top 20 Drugs for 2010 by U.S. Sales 42
Table 3.1: Total Global Unit Demand for Glucose Testing Reagent Strips, 2010-2016 47
Table 3.2: Global Dollar Sales of Glucose Testing Reagent Strips, 2010-2016 47
Table 3.3: Worldwide Glucose Self-testing Market Sales (Meters and Strips), 2005-2015 48
Table 3.4: World Market Share of Glucose Self-testing Marketers, 2011 50
Table 3.5: Market for Glucose Self-testing in the U.S., 2005-2015 51
Table 3.6: U.S. Blood Glucose Reagent Strip Market, 2005-2015 52
Table 3.7: Market Share of U.S. Blood Glucose Self-testing, 2011 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 55
Table 3.10: Demographic Characteristics Glucose Self-testing Kit Buyers 56
Table 3.11: Top Brand Preferences for Glucose Self-testing Kits 56
Table 3.12: Instances when Patients Prefer Professional's Glucose Testing 56
Table 3.13: Advantages of a Glucose Self-testing Kit 56
Table 3.14: Disadvantages of Using a Glucose Self-testing Kit 57
Table 3.15: Popular Shopping Destinations for Buying or Seeking Information on Glucose
Self-testing Kits 57
Table 3.16: Customer Priorities?Glucose Meter Self-testing Market, 2001-2012 57
Table 3.17: European Glucose Self-testing Market (Meters and Strips), 2005-2015 58
Table 3.18: European Glucose Self-testing Market by Country, 2010 58
Table 3.19: Asian Glucose Self-testing Market (Meter and Strips), 2005-2015 60
Table 3.20: Japanese Glucose Self-testing Market (Meters and Strips), 2005-2015 61
Table 3.21: Chinese Glucose Self-testing Market (Meters and Strips), 2005-2015 62
Table 3.22: Indian Glucose Self-testing Market (Meters, Strips, Lancets), 2005-2015 63
Table 3.23: Southeast Asian Glucose Self-testing Market by Country (Meters and Strips), 2010 64
Table 3.24: Southeast Asian Glucose Self-testing Market (Meters and Strips), 2009-2015 64
Table 3.25: ROW Glucose Self-testing Market (Meters, Strips, Lancets), 2005-2015 65
Table 3.26: Key Market Drivers for Glucose Self-testing 70
Table 3.27: Market Drivers for Continuous Glucose Monitoring 70
Table 3.28: Key Market Restraints for Glucose Self-testing 71
Table 3.29: Market Restraints for Continuous Glucose Monitoring 71
Table 4.1: Glycemic Recommendations for Non-Pregnant Adults with Diabetes 78
Table 4.2: Glycemic Recommendations for Women with Gestational Diabetes 78
Table 4.3: Glycemic Recommendations for Pregnant Women with Pre-existing Diabetes 78
Table 4.4: Percentage of Hypothetical Patients that Diabetes Educator's would Recommend CGM,
2007-2009 81
Table 4.5: Glucose Monitoring Recommendations 81
Table 4.6: A1c Testing Recommendations 81
Table 4.7: Correlation of A1c with Mean Blood Glucose 82
Table 5.1: Analytic Performance Criteria for Glucose Self-testing Meters 87
Table 5.2: Common User Errors Made While Self-testing for Blood Glucose 90
Table 5.3: Key Features Considered for Glucose Self-testing Devices 93
Table 5.4: Key Features Considered for Reagent Test Strips 93
Table 5.5: Compatibility of Various Blood Glucose Meters with Icodextrin PD Solution 97
Table 5.6: Ten Factors Needed to Improve the Performance of Blood Glucose Monitors 99
Table 5.7: Relationship of A1c to Average Whole Blood and Plasma Glucose Levels 105
Table 5.8: Unit Sales of Homecare Lancets in the U.S., 2003-2015 109
Table 5.9: Unit Sales of Homecare Lancets in the E.U., 2003-2015 109
Table 5.10: Dollar Sales of Homecare Lancets in the U.S., 2003-2015 110
Table 5.11: Dollar Sales of Homecare Lancets in the E.U., 2003-2015 110
Table 5.12: Unit Sales of Homecare Glucose Self-testing Lancets in the U.S., 2003-2015 111
Table 5.13: Unit Sales of Homecare Glucose Self-testing Lancets in the E.U., 2003-2015 111
Table 5.14: Competition in the Lancet Market Segment 112
Table 6.1: Current Blood Glucose Self-testing Meters: Sample Size, Test Time, and Other Features 125
Table 6.2: Performance Comparison of Popular Self-testing Glucose Meters 128
Table 6.3: Detailed Features of Selected CGM Systems Currently Available 150
Table 6.4: Non-invasive Glucose Monitoring Systems in Development 158
Table 7.1: Financial Comparison for Moderate and Waived CLIA Labs 187
Table 8.1: Features for Future Meters 191
Table 8.2: Leading World Patient Monitoring Products in the U.S. Market 194
Table 8.4: Customized Reports Must Support CAP and JCAHO Requirements 203
Table 8.5: Applications of RALS Connectivity with POCT Devices 204
Table 9.1: POC Testing: Cost Analysis 210
Table 9.2: POC Testing: Cost Analysis with Labor Included 210

- LifeScan
- Roche Diagnostics Corporation
- Bayer
- Abbott (MediSense)
- Agamatrix, Inc.
- Arkray, Inc.
- Bionime Corporation
- BioSense Medical Devices
- Diabetic Supply of Suncoast
- Prodigy Diabetes Care, LLC (an Affiliate of Diagnostic Devices, Inc.)
- Entra Health Systems
- Fifty50 Pharmacy
- Fora Care
- Nipro Diagnostics, Inc.
- Nova Biomedical
- Oak Tree International Holdings, Inc.
- U.S. Diagnostics
- Elektronika Kft.
- A. Menarini Diagnostics
- Allmedicus
- i-SENS
- Apex Biotechnology Corp.
- GenExel-Sein, Inc.
- Glucoplus, Inc.
- Polymer Technology Systems
- Smiths Medical MD, Inc.
- TaiDoc Technology Corp.
- IN4 Technology Corporation
- ACON Laboratories
- HemoCue
- Pepex Biomedical
- GlySens, Inc.
- Ultradion
- Cygnus GlucoWatch Biographer
- AiMedics
- BioTex
- Calisto Medical
- Echo Therapeutics
- EyeSense GmbH
- Integrity Applications Ltd.
- LighTouch Medical
- OrSense Ltd.
- Solianis Monitoring AG
- VeraLight
- Xhale, Inc.
- Lein Applied Diagnostics
- A1c Self-testing
- A1CNow+ SELFCHECK
- Diabetes Technologies
- Flexsite Diagnostics, Inc.
- Heritage Labs

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