U.S. Glucose Testing Markets

Introduction

Abstract

Description

U.S. glucose testing is undergoing a significant transition, driven by new analytical technologies and developments in diabetes treatment. Although the blood glucose testing segment of the in vitro diagnostics (IVD) industry is mature, several segments of the market, such as home testing devices for diabetes management and point of care (POC) instruments for use in professional settings, will exhibit strong growth. Direct access testing has emerged as a strong force in the blood glucose testing segment, and non-invasive and minimally-invasive testing now represent major new areas for the application of IVD testing. This TriMark Publications report describes the specific market segments for blood glucose testing and diabetes management in the U.S. market. It reviews all of the generally-accepted clinical analytical methods that are currently in use today for measuring serum, plasma or whole-blood glucose concentrations. Additionally, this study examines clinical measurement devices, reagents and supplies as utilized in hospitals, clinics, doctor

Table of Contents

Table of Contents

1. Overview

• 1.1 Statement of Report
• 1.2 About this Report
• 1.3 Scope of the Report
• 1.4 Methodology
• 1.5 Executive Summary

2. Diabetes

• 2.1 Demographics of Diabetes in the U.S.
• 2.2 Understanding the Metabolic Conditions Underlying and Associated with Diabetes
  • 2.2.1 Pre-Diabetes Syndrome
  • 2.2.2 Metabolic Syndrome
  • 2.2.3 Progression of Diabetes
  • 2.2.4 Diabetes and Inflammation
  • 2.2.5 Risk Factors and Diabetes
    • 2.2.5.1 Obesity
    • 2.2.5.2 Stress-induced Hyperglycemia
  • 2.2.6 Complications and Co-Morbidities in Diabetes
    • 2.2.6.1 Preventing Complications and Co-Morbidities in Diabetes
    • 2.2.6.2 Cardiovascular Disease Facts
• 2.3 Economics of Diabetes

3. Market Analysis: Size, Growth, Share and Competitors

• 3.1 U.S. Market
  • 3.1.1 U.S. Over-the-Counter (OTC) Self-testing Glucose Market
  • 3.1.2 U.S. Professional Glucose Testing Market
  • 3.1.3 Continuous Glucose Monitoring Markets
• 3.2 Competitive Situation
  • 3.2.1 Key Players
  • 3.2.2 Analyses of the Current Market Conditions, Competition and Product Mix
• 3.3 Market Drivers and Restraints
  • 3.3.1 Market Drivers
  • 3.3.2 Market Restraints
• 3.4 Market and Product Trends
  • 3.4.1 Market Trends
  • 3.4.2 Technology Trends
• 3.5 Strategic Recommendations
• 3.6 Competitive Strategies
• 3.7 Analysis of the Glucose Point of Care Market
• 3.8 Adjacent Markets

4. Glucose Diagnostic and Monitoring Recommendations

• 4.1 Diagnosis of Diabetes Mellitus
• 4.2 Tight Glucose Control in Treating Diabetes
• 4.3 Recommendations for Glucose Control in Diabetics
  • 4.3.1 Recommended Frequency of Blood Glucose Self-Testing
  • 4.3.2 Recommendations for Diabetes Care and Glucose Testing in the Hospital Setting
  • 4.3.3 Using Blood Glucose Data to Monitor and Modify Patient Therapy
  • 4.3.4 Testing in Individuals with Type 2 diabetes
  • 4.3.5 Continuous Glucose Monitoring (CGM)
  • 4.3.6 A1c Testing Recommendations
• 4.4 Hypoglycemia and Treatment

5. Glucose Testing Technology Platforms and Consumable Products

• 5.1 Types of Glucose Determination Technologies
• 5.2 Enzymatic Reactions Used to Determine Glucose Concentrations
  • 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)
  • 5.2.3 Glucose Hexokinase
• 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) 86
  • 5.4.3 Quality Control Criteria
  • 5.4.4 Potential Variables Affecting Glucose Concentrations
• 5.5 Key Issues for Glucose Testing Devices
  • 5.5.1 Important Elements for Glucose Testing
  • 5.5.2 Key Features to Aid Specific Patient Populations
• 5.6 Limitations of Existing Glucose Testing
  • 5.6.1 Common User Errors in Glucose Self-testing
  • 5.6.2 Interfering Substances and Conditions
    • 5.6.2.1 Environmental
    • 5.6.2.2 Physiologic
    • 5.6.2.3 Operational
    • 5.6.2.4 Manufacturing Variations
    • 5.6.2.5 Drugs 94
  • 5.6.3 Errors Associated with GDH-PQQ Technology
  • 5.6.4 Optimizing of Point of Care (POC) Blood Glucose Testing
• 5.7 Potential Areas of Improvement in Blood Glucose Meter Performance
• 5.8 Blood Glucose Reagent Test Strips
• 5.9 Comparison of Handheld Blood Glucose Meters with Clinical Laboratory Glucose Measurements
• 5.10 Continuous Glucose Monitoring Technology
  • 5.10.1 Advantages of Continuous Readings
  • 5.10.2 FDA Approval of CGM
  • 5.10.3 CGM Functions to Consider
  • 5.10.4 New Technologies for CGM
• 5.11 Summary of Technologies Being Explored for Non-invasive Glucose Monitoring
  • 5.11.1 Goals of Non-invasive Testing
  • 5.11.2 Non-invasive Diabetes Screening Test
• 5.12 A1c Monitoring Technology
• 5.13 Related Reagents and Equipment
  • 5.13.1 Lancets
    • 5.13.1.1 Types of Lancing Devices
    • 5.13.1.2 Market Size
  • 5.13.2 Control Solutions and Calibrators
  • 5.13.3 Sharps Devices
  • 5.13.4 Needle Destruction Devices
  • 5.13.5 Urine Strips
  • 5.13.6 Ketone Testing

6. Glucose Testing Devices on the Market

• 6.1 Handheld Blood Glucose Meters and Strips for Self-testing
  • 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 Tyson Biomedical
  • 6.1.18 US Diagnostics
  • 6.1.19 77 Elektronika Kft.
  • 6.1.20 A. Menarini Diagnostics
  • 6.1.21 Allmedicus
  • 6.1.22 i-SENS
  • 6.1.23 Apex Biotechnology Corp.
  • 6.1.24 GenExel-Sein, Inc. 142
  • 6.1.25 Glucoplus, Inc. 143
  • 6.1.26 Polymer Technology Systems
  • 6.1.27 Smiths Medical MD, Inc.
  • 6.1.28 TaiDoc Technology Corp.
  • 6.1.29 IN4 Technology Corporation
  • 6.1.30 ACON Laboratories
  • 6.1.31 Pepex Biomedical
  • 6.1.32 HMD BioMedical
  • 6.1.33 BTNX
• 6.2 Handheld Blood Glucose Meters for Professional Use
  • 6.2.1 Abbott
  • 6.2.2 Alere
  • 6.2.3 Arkray
  • 6.2.4 HemoCue (a Quest Diagnostics company)
  • 6.2.5 HMD BioMedical
  • 6.2.6 Medtronic
  • 6.2.7 Nova Biomedical
  • 6.2.8 Polymer Technology Systems
  • 6.2.9 Roche
  • 6.2.10 Techno Medica Co., Ltd
  • 6.2.11 LifeScan
• 6.3 Clinical Blood Chemistry Analyzers
  • 6.3.1 Abaxis, Inc.
  • 6.3.2 Alere
  • 6.3.3 Arkray
  • 6.3.4 Beckman Coulter
  • 6.3.5 DiaSys
  • 6.3.6 Instrumentation Laboratory
  • 6.3.7 International Techidyne Corporation (ITC)
  • 6.3.8 Nova Biomedical
  • 6.3.9 Radiometer
  • 6.3.10 Roche
  • 6.3.11 Siemens Healthcare Diagnostics
  • 6.3.12 Span Diagnostics
  • 6.3.13 Stanbio Laboratory
  • 6.3.14 Techno Medica Co., Ltd
• 6.4 Continuous Glucose Patient Monitoring Systems
  • 6.4.1 MedtronicA's Continuous Glucose Monitoring Systems (CGMS)
  • 6.4.2 DexCom, Inc. STS Continuous Glucose Monitoring System
  • 6.4.3 FreeStyle Navigator A - AbbottA's Continuous Glucose Monitor System
  • 6.4.4 Minimally-invasive Continuous Glucose Monitors in Development
  • 6.4.4.1 GlySens Inc.
  • 6.4.4.2 Sensors for Medicine and Science
  • 6.4.4.3 Ultradian Diagnostics
  • 6.4.4.4 Luminous Medical
  • 6.4.4.5 Kumetrix
  • 6.4.4.6 GluMetrics
  • 6.4.4.7 GlySure Limited 170
• 6.5 Non-invasive Glucose Patient Monitoring Systems
  • 6.5.1 Cygnus GlucoWatch Biographer
  • 6.5.2 AiMedics
  • 6.5.3 BioTex
  • 6.5.4 Calisto Medical
  • 6.5.5 Echo Therapeutics
  • 6.5.6 EyeSense GmbH
  • 6.5.7 Freedom Meditech
  • 6.5.8 Grove Instruments
  • 6.5.9 Integrity Applications Ltd.
  • 6.5.10 Lein Applied Diagnostics 174
  • 6.5.11 LighTouch Medical
  • 6.5.12 OrSense Ltd 174
  • 6.5.13 Solianis Monitoring AG
  • 6.5.14 VeraLight
  • 6.5.15 Xhale Inc.
• 6.6 A1c Testing
• 6.7 New Product Launches
  • 6.7.1 mySentry Remote Glucose Monitor
  • 6.7.2 HealthPia GlucoPhone
  • 6.7.3 MyGlucoHealth Diabetes
  • 6.7.4 gDrive
  • 6.7.5 GluCoMo
  • 6.7.6 OneTouch Delica Lancing System
  • 6.7.7 ARK Care
  • 6.7.8 OneTouch Verio IQ System with PatternAlert Technology
  • 6.7.9 Medtronic Announces Mac Compatibility for CareLinkR Personal Therapy Management Software for Diabetes
  • 6.7.10 Fora Care G31 and D30
  • 6.7.11 TelcareA's BGM 3G Blood Glucose Meter
  • 6.7.12 iPro2 Professional CGM
  • 6.7.13 Contour USB 180
  • 6.7.14 RocheA's Accu-Chek Aviva Plus Test Strip
  • 6.7.15 InfopiaA's SmartDiabetes Product Line
  • 6.7.16 InfopiaA's Element Plus
  • 6.7.17 Wireless Connectivity for Nova BiomedicalA's Hospital Glucose Meters
  • 6.7.18 GlookoA's Logbook
  • 6.7.19 SweetSpot Diabetes Data Management Service
  • 6.7.20 Accu-Chek Nano SmartView
• 6.8 New Blood Glucose Meters and Data Management Software in Development
  • 6.8.1 Paradigm Veo
  • 6.8.2 Sanofi-AventisA's iBGStar
  • 6.8.3 Jazz Wireless
  • 6.8.4 iglucose
  • 6.8.5 Enlite Sensor
• 6.9 Recent Industry Activity
  • 6.9.1 Roche Diagnostics Corp Expanding Indianapolis Manufacturing Plant
  • 6.9.2 AgaMatrix and Sanofi-Aventis Enter Global Diabetes Partnership
  • 6.9.3 LifeScan Inc. Terminates Exclusive Supply Agreement with Medtronic MiniMed
  • 6.9.4 Kroger Selects WaveSense Diabetes Testing Products
  • 6.9.5 Medtronic and Bayer Healthcare Expand International Alliance
  • 6.9.6 Medtronic Opens New Diabetes Center In San Antonio
  • 6.9.7 Abbott Diabetes Care Announces Recall of Certain Lots of Precision XtraR, Precision Xceed ProR, MediSenseR OptiumA"!, OptiumA"!, OptiumEZ and ReliOnR Ultima Blood
• Glucose Test Strips in the United States and Puerto Rico
  • 6.9.8 Abbott Receives FDA Clearance for New, Easier-to-Use FreeStyle LiteR Test Strips
  • 6.9.9 DexCom Receives CE Mark Approval for the SEVEN(R) Continuous Glucose Monitoring System
  • 6.9.10 iBGStarTM Blood Glucose Monitoring System Receives U.S. FDA 510(k) Clearance
  • 6.9.11 PositiveID Corporation and IDEAL LIFE Partner to Bring iglucose to Market for Wireless Diabetes Management
  • 6.9.12 Roche Diagnostics U.S. and DexCom, Inc. Announce Research and Development Agreement
  • 6.9.13 Infopia America Partners with Walgreens Drugstores 185
  • 6.9.14 Qualcomm Forms Qualcomm Life Subsidiary 185
  • 6.9.15 Medtronic Partners with Ford Motor to Develop an In-car Glucose Monitor
  • 6.9.16 Perrigo and AgaMatrix Enter into an Exclusive Sales and Distribution Agreement
  • 6.9.17 Medtronic, Bayer Healthcare extend diabetes alliance 186
  • 6.9.18 Zyxel Integrates its Smart Home Gateway with Entra Health Systems' Wireless Glucometer
  • 6.9.19 Pepex Biomedical Signs Seven Year Deal to Manufacture Trio
  • 6.9.20 DexCom and Tandem Diabetes Care Team Up for CGM Development and Commercialization
  • 6.9.21 Insulet Corporation Signs Worldwide Agreement with LifeScan 187
• 6.10 M&A Activity
  • 6.10.1 Home Diagnostics, Inc. and Nipro Diabetes Systems, Inc. Merge to Become Nipro Diagnostics, Inc.
  • 6.10.2 Medtronic, Inc. (MDT) Acquires New Diabetes Technology from PreciSense AS
  • 6.10.3 Geonostics Acquires FlexSite's Consumer Diabetes Tests
  • 6.10.4 Additional M&A
  • 6.10.5 Important Deals in BGM market

7. Business Trends in Glucose Testing

• 7.1 Drivers of Clinical Glucose Testing
• 7.2 Competition for Services
• 7.3 Healthcare Cost Controls
• 7.4 Changes in Patient Management
• 7.5 Regionalization of Laboratory Care
• 7.6 Satellite Facilities
• 7.7 Point of Care Testing
• 7.8 Factors Affecting OTC Medical Product Distribution
• 7.9 Drugstores Critical to the Diabetic Care Category
• 7.10 Drivers of OTC and Self-testing Markets
• 7.10.1 Brand Loyalty
• 7.11 Cost Elements of Glucose Self-testing
• 7.12 Blood Glucose Self-testing Insurance Coverage and Reimbursement
• 7.13 Trends in U.S. Laboratory Testing Reimbursement Practices
• 7.14 Reimbursement Challenges
• 7.15 Managed Care
• 7.16 Government Regulation of Medical Devices
• 7.17 Clinical Laboratory Improvement Act (CLIA)
• 7.18 FDA Labeling Requirements
• 7.19 Legal Liability for Glucose Meters

8. Technology Trends 209

• 8.1 Improving TodayA's OTC Blood Glucose Meters
• 8.2 Biosensor Technology
• 8.3 Fructosamine Test
• 8.4 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 Advantages of Connectivity
  • 8.6.4 Connectivity Platforms
  • 8.6.5 DataLink Data Management System
  • 8.6.6 RALS-Plus
  • 8.6.7 FDA Required Software Verification
  • 8.6.8 Information Management Advances
  • 8.6.9 POL Laboratory Data Management
    • 8.6.9.1 Electronic Medical Record Systems and Physician Office Laboratory Data-linking Software
    • 8.6.9.2 Physician Office Laboratory Data-linking software and Interface to the Laboratory Information System
    • 8.6.9.3 Technical Problems of Connectivity
    • 8.6.9.4 Web-based Data Interface
  • 8.6.10 HIT Competition

9. Company Profiles

• 9.1 Abaxis, Inc.
• 9.2 Abbott Laboratories
• 9.3 ACON Laboratories
• 9.4 AgaMatrix
• 9.5 Alere
• 9.6 Allmedicus
• 9.7 Amedica Biotech
• 9.8 A. Menarini Diagnostics
• 9.9 Apex Biotechnology Corporation
• 9.10 Arkray
• 9.11 Bayer
• 9.12 B. Braun Melsungen
• 9.13 Beckman Coulter
• 9.14 Bionime 240
• 9.15 Bio-Rad Laboratories, Inc.
• 9.16 BioTex 241
• 9.17 Calisto Medical
• 9.18 Cambridge Sensors
• 9.19 DexCom
• 9.20 Diagnostic Devices/Prodigy Diabetes Care
• 9.21 DiaSys
• 9.22 Echo Therapeutics
• 9.23 Entra Health Systems
• 9.24 Fora Care
• 9.25 Freedom Meditech
• 9.26 Genesis Health Technologies
• 9.27 GenExel-Sein
• 9.28 GlucoPlus
• 9.29 GluMetrics
• 9.30 GlySens
• 9.31 GlySure Limited
• 9.32 Grove Instruments
• 9.33 Hainice Medical
• 9.34 HemoCue (a Quest Diagnostics company)
• 9.35 Home Diagnostics
• 9.36 Infopia
• 9.37 IN4 Technology
• 9.38 International Techidyne Corporation (ITC)
• 9.39 Instrumentation Laboratory Company
• 9.40 i-Sens
• 9.41 Johnson & Johnson
• 9.42 Luminous Medical
• 9.43 Medtronic
• 9.44 Nipro Corporation
• 9.45 Nova Biomedical
• 9.46 OrSense
• 9.47 Polymer Technology Systems
• 9.48 Radiometer Medical
• 9.49 Roche
• 9.50 77 Elektronika Kft.
• 9.51 Siemens AG
• 9.52 Smiths Group
• 9.53 Stanbio Laboratory
• 9.54 TaiDoc Technology
• 9.55 Techno Medica Co., Ltd.
• 9.56 U.S. Diagnostics
• 9.57 VeraLight

INDEX OF FIGURES

• Figure 2.1: Prevalence of Diabetes by Age in the U.S., 2010
• Figure 2.2: New Cases of Diabetes Diagnosed in the U.S. Adult Population, 2010
• Figure 2.3: County-specific Diabetes Prevalence in the U.S., 2008
• Figure 2.4: Diabetes Death Rate by Race and Sex in the U.S., 1979-2006
• Figure 2.5: Rate of New Diabetes Cases among Children in the U.S., 2007
• Figure 2.6: Maintenance of Normal Blood Sugar Levels
• Figure 2.7: Obesity (BMI 3 30) Prevalence in U.S. Adults, 2010
• Figure 2.8: Prevalence of Obesity among Men Aged 20 Years and Older by Race/Ethnicity in the U.S., 1988-1994 and 2007-2008
• Figure 2.9: Prevalence of Obesity among Women Aged 20 Years and Older by Race/Ethnicity in the U.S., 1988-1994 and 2007-2008
• Figure 2.10: Trends in Obesity among Children and Adolescents in the U.S., 1963-2008
• Figure 2.11: Mean Diabetes Healthcare-related Expenditures Per Adult (20-79 Years) with Diabetes (USD), 2011
• Figure 2.12: How Diabetes Dollars are Spent in the U.S., 2007
• Figure 3.1: Forecasted Test Strip Usage by Different Diabetic Populations
• Figure 4.1: Glycemic Status - Ranges and Health Implications
• Figure 5.1: EGA Zones of Clinical Accuracy
• Figure 5.2: Single-day Continuous Blood Glucose Data
• Figure 5.3: Factors that May Adversely Affect Glucose Testing
• Figure 5.4: Personal Lancet Unit Sales Market Share by Geographic Region, 2011

INDEX OF TABLES

• Table 2.1: U.S. Population of Diabetics (Diagnosed and Undiagnosed) Aged 20 Years or Older, 2010
• Table 2.2: U.S. Incidence of Diagnosed Diabetes by Age, 2009
• Table 2.3: Ten Leading Diagnoses for Co-morbid Chronic Diseases in the U.S., by Percentage of Patient Visits, 2006
• Table 2.4: Odds Ratio of Progression to Complications Associated with Type 2 Diabetes
• Table 2.5: Prevalence of Complications among Patients with Diabetes
• Table 2.6: Novel Risk Factors and Possible Mechanisms of the Excess Risk of Coronary Heart Disease in Type 2 Diabetes Mellitus
• Table 2.7: Major Causes of End-stage Renal Disease
• Table 2.8: Clinical Recommendations for Adults with Diabetes
• Table 2.9: Laboratory Assessment of Diabetic Vascular Disease
• Table 2.10: Average Years Gained Free of Diabetes-related Disease with Intensive Management
• Table 2.11: Estimated Direct and Indirect Costs of Major Cardiovascular Diseases and Stroke in the U.S., 2008
• Table 2.12: Worldwide Market for Cardiac Care Therapeutics, 2003-2010
• Table 2.13: Top 20 Drugs for 2010 by U.S. Sales
• Table 2.14: Cost of Diagnosed Diabetes in the U.S., 2007
• Table 2.15: Cost of Diagnosed Type 1 and Type 2 Diabetes in the U.S., 2007
• Table 2.16: Medical Care Costs Attributable to Diabetes in the U.S., 2010
• Table 2.17: Healthcare Utilization by Diabetic Patients, 2008
• Table 2.18: Annual Cost of Care of United Healthcare Adult Members with Diabetes, 2009
• Table 2.19: Per-event Costs of Diabetes Complications
• Table 3.1: Comprehensive U.S. Glucose Testing Market (includes reagents and supplies in the Self-testing and Professional Markets), 2010-2016
• Table 3.2: U.S. Blood Glucose Reagent Strip Market (includes both Self-testing and Professional Markets), 2010-2016
• Table 3.3: Market for Glucose Self-testing in the U.S. (includes Meters, Strips, and Lancets), 2010-2016
• Table 3.4: Market Share of U.S. Blood Glucose Self-testing, 2011
• Table 3.5: U.S. OTC Glucose Self-testing Market Repeat Retail Replacement Sales Percentages
• Table 3.6: OTC Blood Glucose Instrument Reagents by Manufacturer Retail
• Table 3.7: Demographic Characteristics of Glucose Self-testing Kit Buyers
• Table 3.8: Top Brand Preferences for Glucose Self-testing Kits
• Table 3.9: Instances when Patients Prefer ProfessionalA's Glucose Testing
• Table 3.10: Advantages of a Glucose Self-testing Kit
• Table 3.11: Disadvantages of Using a Glucose Self-testing Kit
• Table 3.12: Popular Shopping Destinations for Buying or Seeking Information on Glucose Self-testing Kits
• Table 3.13: Customer PrioritiesA - Glucose Meter Self-testing Market, 2001-2012
• Table 3.14: Total Market for Professional Glucose Testing (Central Laboratory and Hospital POC & POL) in the U.S., 2010-2016 50
• Table 3.15: U.S. Revenues for POC Blood Glucose Monitoring (Hospital & POL), 2010-2016
• Table 3.16: U.S. Continuous Glucose Monitoring Market, 2010-2016
• Table 3.17: Key Market Drivers for Glucose Testing
• Table 3.18: Market Drivers for Continuous Glucose Monitoring
• Table 3.19: Point of Care Glucose Testing Market: Market Drivers Ranked in Order of Impact
• Table 3.20: Key Market Restraints for Glucose Testing
• Table 3.21: Market Restraints for Continuous Glucose Monitoring
• Table 3.22: Point of Care Glucose Testing Market: Market Restraints Ranked in Order of Impact
• Table 3.23: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats of the Glucose Point of Care Market
• Table 4.1: Criteria for the Diagnosis of Diabetes
• Table 4.2: Categories of Increased Risk for Diabetes (Pre-diabetes)
• Table 4.3: Normal Glucose ValuesA - Fasting State
• Table 4.4: Key Concepts in Setting Glycemic Goals
• Table 4.5: Glycemic Recommendations for Non-Pregnant Adults with Diabetes
• Table 4.6: Glycemic Recommendations for Women with Gestational Diabetes
• Table 4.7: Glycemic Recommendations for Pregnant Women with Pre-existing Diabetes
• Table 4.8: Glucose Monitoring Recommendations
• Table 4.9: Glucose Monitoring Recommendations for Hospital Settings
• Table 4.10: Glycemic Goals for Hospital Patients
• Table 4.11: Percentage of Hypothetical Patients that Diabetes EducatorA's would Recommend CGM, 2007-2009
• Table 4.12: Ideal Diabetic Patient Attributes for Successful CGM Use
• Table 4.13: A1c Testing Recommendations
• Table 4.14: Correlation of A1c with Mean Blood Glucose
• Table 5.1: Analytic Performance Criteria for Glucose Self-testing Meters
• Table 5.2: Potential Variables Affecting Glucose Concentrations
• Table 5.3: Key Features Considered for Glucose Testing Devices
• Table 5.4: Common User Errors Made While Self-testing for Blood Glucose
• Table 5.5: Compatibility of Various Blood Glucose Meters with Icodextrin PD Solution
• Table 5.6: Ten Factors Needed to Improve the Performance of Blood Glucose Meters
• Table 5.7: Key Features Considered for Reagent Test Strips
• Table 5.8: Differences between Laboratory Instruments for Glucose Analysis and Handheld Blood Glucose Meters
• Table 5.9: Relationship of A1c to Average Whole Blood and Plasma Glucose Levels
• Table 5.10: Unit Sales of Homecare Lancets in the U.S., 2010-2015
• Table 5.11: Unit Sales of Homecare Lancets in the E.U., 2010-2015
• Table 5.12: Dollar Sales of Homecare Lancets in the U.S., 2010-2015
• Table 5.13: Dollar Sales of Homecare Lancets in the E.U., 2010-2015
• Table 5.14: Unit Sales of Homecare Glucose Self-testing Lancets in the U.S., 2010-2015
• Table 5.15: Unit Sales of Homecare Glucose Self-testing Lancets in the E.U., 2010-2015
• Table 5.16: Competition in the Lancet Market Segment
• Table 5.17: Limitations of Urine Glucose Monitoring
• Table 5.18: Advantages of Urine Glucose Monitoring
• Table 5.19: Blood Ketone Reading Indications
• Table 6.1: Current Blood Glucose Self-testing Meters: Sample Size, Test Time, and Other Features
• Table 6.2: Handheld Blood Glucose or Blood Gas Meters Marketed for Professional Use
• Table 6.3: Clinical Blood Chemistry Analyzers with Glucose Assays
• Table 6.4: Detailed Features of Selected CGM Systems Currently Available
• Table 6.5: Non-invasive Glucose Monitoring Systems in Development
• Table 7.1: POC Procedural Advantages for Hospital Testing
• Table 7.2: Medicare Billing Guidelines for Multi-channel Chemistry Tests
• Table 7.3: Financial Comparison for Moderate and Waived CLIA Labs
• Table 8.1: Data Entry and Data Management Features to Include in Future Meters
• Table 8.2: Leading World Patient Monitoring Products in the U.S. Market
• Table 8.3: Customized Reports Must Support CAP and JCAHO Requirements
• Table 9.1: Abaxis Blood Analysis Diagnostic Tests
• Table 9.2: Reagent Discs Offered with the Piccolo Chemistry Analyzers
• Table 9.3: Products Marketed by Abbott in the Diagnostic Market

U.S. Glucose Testing Markets published by Trimark Publications in June 1, 2012. This report consists of 252 Pages and the price starts from US $ 3400.