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Blood Glucose Testing and Diabetes Management

Description:
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.

The report has made a survey of selected companies marketing, manufacturing or developing various blood glucose testing and diabetes management supplies throughout the world. Each company is discussed in extensive depth with a section on its history, product line, business and marketing analysis, and a subjective commentary of the company’s market position. Detailed tables and charts with sales forecasts and market share data are also included.
 
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
2.1.1 Worldwide Diabetes Incidence
2.1.2 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 Worldwide Glucose Testing Market
3.1.1 Global Blood Glucose Self-Testing Market
3.1.2 Worldwide Professional Blood Glucose Testing Market
3.1.3 Continuous Glucose Monitoring Markets
3.2 U.S. Market
3.2.1 U.S. Over-the-Counter (OTC) Self-Testing Glucose Market
3.2.2 U.S. Professional Glucose Testing 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 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 Diabetic Patients
4.3.1 Recommended Frequency of Blood Glucose Testing
4.3.2 Using Blood Glucose Data to Monitor and Modify Patient Therapy
4.3.3 Testing in Individuals with Type 2 Diabetes
4.3.4 Continuous Glucose Monitoring (CGM)
4.3.5 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)
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
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 Hand-Held 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 Hand-Held 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 All Medicus
6.1.22 i-SENS
6.1.23 Apex Biotechnology Corp.
6.1.24 GenExel-Sein, Inc.
6.1.25 Glucoplus, Inc.
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 Hand-Held Blood Glucose Meters for Professional Use
6.2.1 Abbott
6.2.2 ACON Laboratories
6.2.3 Alere
6.2.4 ARKRAY
6.2.5 HemoCue (a Quest Diagnostics company)
6.2.6 HMD BioMedical
6.2.7 Medtronic
6.2.8 Nova Biomedical
6.2.9 Polymer Technology Systems
6.2.10 Roche
6.2.11 Techno Medica Co., Ltd
6.2.12 LifeScan
6.3 Clinical Blood Chemistry Analyzers
6.3.1 Abaxis, Inc.
6.3.2 Alere
6.3.3 ARKRAY, Inc.
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 Medtronic's Continuous Glucose Monitoring Systems (CGMS)
6.4.2 FreeStyle Navigator Abbott's Continuous Glucose Monitor System
6.4.3 DexCom, Inc. STS® Continuous Glucose Monitoring System
6.4.4 GlucoDay® S Continuous Glucose Monitor
6.4.5 Minimally-Invasive Continuous Glucose Monitors in Development
6.4.5.1 GlySens Inc.
6.4.5.2 Sensors for Medicine and Science
6.4.5.3 Ultradian
6.4.5.4 Luminous Medical
6.4.5.5 Kumetrix
6.4.5.6 GluMetrics
6.5 Non-Invasive Glucose Patient Monitoring Systems
6.5.1 Cygnus GlucoWatch Biographer
6.5.2 AiMedis
6.5.3 BioTex
6.5.4 Calisto Medical
6.5.5 Echo Therapeutics
6.5.6 EyeSense GmbH
6.5.7 Integrity Applications Ltd.
6.5.8 LighTouch Medical
6.5.9 OrSense Ltd
6.5.10 Solianis Monitoring AG
6.5.11 VeraLight
6.5.12 Xhale Inc.
6.5.13 Lein Applied Diagnostics
6.6 A1c Testing
6.7 New Product Launches
6.7.1 Didget
6.7.2 HealthPia GlucoPhone®
6.7.3 MyGlucoHealth® Diabetes
6.7.4 gDrive
6.7.5 Paradigm® Veo
6.7.6 Enlite' Sensor
6.7.7 Abbott's FreeStyle® InsuLinx
6.7.8 Roche Diagnostics launches Accu-Chek® Mobile
6.7.9 Bayer Introduces CONTOUR USB
6.7.10 Medtronic Announces Mac Compatibility for CareLink® Personal Therapy Management Software for Diabetes
6.7.11 Fora Care G31 and D30
6.7.12 Telcare Receives FDA Clearance for its Telcare BGM 3G Blood Glucose Meter
6.7.13 iglucose
6.7.14 OneTouch SelectSimple
6.8 New Blood Glucose Meters and Data Management Software in Development
6.8.1 LifeScan's iPhone App
6.8.2 Sanofi-Aventis's iBGStar
6.8.3 Jazz Wireless
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 Xtra®, Precision Xceed Pro®, MediSense® Optium, Optium, OptiumEZ and ReliOn® 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 Lite® Test Strips
6.9.9 DexCom Receives CE Mark Approval for the SEVEN® Continuous Glucose Monitoring System
6.9.10 iBGStar 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
6.10 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. 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 Drug Stores 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 Costs of Doing Business in Europe
7.13 Drivers of European Diagnostics Testing
7.14 Cost Containment in Europe
7.15 Blood Glucose Self-Testing Insurance Coverage and Reimbursement
7.15.1 American OTC Testing and Self-Testing Reimbursement
7.15.2 European Reimbursement
7.16 Trends in U.S. Laboratory Testing Reimbursement Practices
7.17 Reimbursement Challenges
7.18 Managed Care
7.19 Government Regulation of Medical Devices
7.19.1 U.S. Regulations
7.19.2 E.U. Regulations
7.19.3 U.K. Regulations
7.20 Clinical Laboratory Improvement Act (CLIA)
7.21 FDA Labeling Requirements
7.22 Legal Liability for Glucose Meters
8. Technology Trends
8.1 Improving Today's Over-The-Counter (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
8.6.10 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 All Medicus
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
9.15 Bio-Rad Laboratories, Inc.
9.16 BioTex
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 Genesis Health Technologies
9.26 GenExel-Sein
9.27 GlucoPlus
9.28 GluMetris
9.29 GlySens
9.30 Hainice Medical
9.31 HemoCue (a Quest Diagnostics company)
9.32 Home Diagnostics
9.33 Infopia
9.34 IN4 Technology
9.35 International Techidyne Corporation (ITC)
9.36 Instrumentation Laboratory Company
9.37 i-Sens
9.38 Johnson & Johnson
9.39 Luminous Medical
9.40 Medtronic
9.41 Nipro Corporation
9.42 Nova Biomedical
9.43 OrSense
9.44 Polymer Technology Systems
9.45 Radiometer Medical
9.46 Roche
9.47 77 Elektronika Kft.
9.48 Siemens AG
9.49 Smiths Group
9.50 Stanbio Laboratory
9.51 TaiDoc Technology
9.52 Techno Medica Co., Ltd.
9.53 US Diagnostics
9.54 VeraLight


INDEX OF FIGURES

Figure 2.1: Worldwide Diabetes Cases, 2011 and 2030 18
Figure 2.2: Worldwide Prevalence of Diabetes (%) in Adults (20-79 Years), 2011 19
Figure 2.3: Prevalence of Diabetes by Age in the U.S., 2010 22
Figure 2.4: New Cases of Diabetes Diagnosed in the U.S. Adult Population, 2010 22
Figure 2.5: County-specific Diabetes Prevalence in the U.S., 2008 23
Figure 2.6: Rate of New Diabetes Cases Among Children in the U.S., 2007 24
Figure 2.7: Diabetes Death Rate by Race and Sex in the U.S., 1979-2006 25
Figure 2.8: Maintenance of Normal Blood Sugar Levels 26
Figure 2.9: Obesity (BMI ³ 30) Prevalence in U.S. Adults, 2010 29
Figure 2.10: Prevalence of Obesity Among Men Aged 20 Years and Older by Race/Ethnicity in the U.S., 1988-1994 and 2007-2008 30
Figure 2.11: Prevalence of Obesity Among Women Aged 20 Years and Older by Race/Ethnicity in the U.S., 1988-1994 and 2007-2008 30
Figure 2.12: Trends in Obesity Among Children and Adolescents in the U.S., 1963-2008 31
Figure 2.13: Mean Diabetes Healthcare-related Expenditures Per Adult (20-79 Years) with Diabetes (USD), 2011 40
Figure 2.14: How Diabetes Dollars are Spent in the U.S., 2007 42
Figure 3.1: Worldwide Diabetes Monitoring Market Segments, 2011 47
Figure 3.2: Global Unit Sales of Glucose Testing Reagent Strips, 2011 48
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 50
Figure 3.5: Continuous Glucose Market Growth Rates by Region, 2009-2018 52
Figure 3.6: U.S. Blood Glucose Reagent Strip Market, 2005-2015 53
Figure 4.1: Glycemic Status Ranges and Health Implications 91
Figure 5.1: EGA Zones of Clinical Accuracy 98
Figure 5.2: Single-Day Continuous Blood Glucose Data 104
Figure 5.3: Factors that May Adversely Affect Glucose Testing 106
Figure 5.4: Personal Lancet Unit Sales Market Share by Geographic Region, 2011 122


INDEX OF TABLES

Table 2.1: Regional Estimates of the Number of Diabetes (20-79 Years) in Millions, 2011 and 2030 19
Table 2.2: Countries with the Largest Numbers of Diabetics, 2011 20
Table 2.3: Countries with the Largest Estimated Numbers of Diabetics, 2030 20
Table 2.4: Worldwide Undiagnosed Diabetes in Adults (20-79 Years) by Region and Income Group, 2011 21
Table 2.5: U.S. Population of Diabetics (Diagnosed and Undiagnosed) Aged 20 Years or Older, 2010 22
Table 2.6: U.S. Incidence of Diagnosed Diabetes by Age, 2009 24
Table 2.7: Ten Leading Diagnoses for Co-Morbid Chronic Diseases in the U.S., by Percentage of Patient Visits, 2006 32
Table 2.8: Odds Ratio of Progression to Complications Associated with Type 2 Diabetes 33
Table 2.9: Prevalence of Complications Among Patients with Diabetes 33
Table 2.10: Novel Risk Factors and Possible Mechanisms of the Excess Risk of Coronary Heart Disease in Type 2 Diabetes Mellitus 33
Table 2.11: Major Causes of End-stage Renal Disease 34
Table 2.12: Clinical Recommendations for Adults with Diabetes 34
Table 2.13: Laboratory Assessment of Diabetic Vascular Disease 35
Table 2.14: Average Years Gained Free of Diabetes-related Disease with Intensive Management 35
Table 2.15: Estimated Direct and Indirect Costs of Major Cardiovascular Diseases and Stroke in the U.S., 2008 37
Table 2.16: Worldwide Market for Cardiac Care Therapeutics, 2003-2010 37
Table 2.17: Top 20 Drugs for 2010 by U.S. Sales 38
Table 2.18: Cost of Diagnosed Diabetes in the U.S., 2007 40
Table 2.19: Cost of Diagnosed Type 1 and Type 2 Diabetes in the U.S., 2007 40
Table 2.20: Medical Care Costs Attributable to Diabetes in the U.S., 2010 41
Table 2.21: Healthcare Utilization by Diabetic Patients, 2008 41
Table 2.22: Annual Cost of Care of United Healthcare Adult Members with Diabetes, 2009 43
Table 2.23: Per-Event Costs of Diabetes Complications 43
Table 3.1: Worldwide Glucose Testing Market ($ Billions), 2010-2016 46
Table 3.2: Total Global Unit Demand for Glucose Testing Reagent Strips, 2010-2016 47
Table 3.3: Global Dollar Sales of Glucose Testing Reagent Strips, 2010-2016 48
Table 3.4: Worldwide Glucose Self-Testing Market Sales (Meters and Strips), 2010-2016 49
Table 3.5: World Market Share of Glucose Self-testing Marketers, 2011 50
Table 3.6: Global Professional Glucose Testing Market, 2010-2016 51
Table 3.7: U.S. Glucose Testing Market (Meters and Strips), 2010-2016 52
Table 3.8: U.S. Blood Glucose Reagent Strip Market, 2005-2015 53
Table 3.9: Market for Glucose Self-Testing in the U.S., 2010-2016 54
Table 3.10: Market Share of U.S. Blood Glucose Self-Testing, 2011 54
Table 3.11: U.S. OTC Glucose Self-Testing Market Repeat Retail Replacement Sales Percentages 55
Table 3.12: OTC Blood Glucose Instrument Reagents by Manufacturer Retail 56
Table 3.13: Demographic Characteristics Glucose Self-Testing Kit Buyers 57
Table 3.14: Top Brand Preferences for Glucose Self-Testing Kits 57
Table 3.15: Instances when Patients Prefer Professional's Glucose Testing 57
Table 3.16: Advantages of a Glucose Self-Testing Kit 57
Table 3.17: Disadvantages of Using a Glucose Self-Testing Kit 58
Table 3.18: Popular Shopping Destinations for Buying or Seeking Information on Glucose Self-Testing Kits 58
Table 3.19: Customer Priorities' Glucose Meter Self-Testing Market, 2001, 2006 and 2012 58
Table 3.20: Market for Professional Glucose Testing in the U.S., 2010-2016 58
Table 3.21: European Glucose Testing Market (Meters and Strips), 2010-2016 59
Table 3.22: Asian Glucose Testing Market (Meter and Strips), 2010-2016 61
Table 3.23: Japanese Glucose Testing Market (Meters and Strips), 2010-2016 62
Table 3.24: Chinese Glucose Testing Market (Meters and Strips), 2010-2016 63
Table 3.25: Indian Glucose Testing Market (Meters, Strips), 2010-2016 65
Table 3.26: Number of Clinical Labs in India, 2008 65
Table 3.27: Top Domestic IVD Companies in India 65
Table 3.28: Leading Global IVD Companies in India 65
Table 3.29: Southeast Asian Glucose Testing Market (Meters and Strips), 2010-2016 66
Table 3.30: Southeast Asian Glucose Testing Market by Country (Meters and Strips), 2011 67
Table 3.31: ROW Glucose Testing Market (Meters, Strips), 2010-2016 67
Table 3.32: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats of the Glucose Point-of-Care Market 70
Table 3.33: Key Market Drivers for Glucose Testing 72
Table 3.34: Market Drivers for Continuous Glucose Monitoring 72
Table 3.35: Point-of-Care Glucose Testing Market: Market Drivers Ranked in Order of Impact 72
Table 3.36: Key Market Restraints for Glucose Testing 74
Table 3.37: Market Restraints for Continuous Glucose Monitoring 74
Table 3.38: Point-of-Care Glucose Testing Market: Market Restraints Ranked in Order of Impact 74
Table 4.1: Criteria for the Diagnosis of Diabetes 82
Table 4.2: Categories of Increased Risk for Diabetes (Pre-Diabetes) 83
Table 4.3: Normal Glucose Values' Fasting State 83
Table 4.4: Glycemic Recommendations for Non-Pregnant Adults with Diabetes 85
Table 4.5: Glycemic Recommendations for Women with Gestational Diabetes 85
Table 4.6: Glycemic Recommendations for Pregnant Women with Pre-existing Diabetes 85
Table 4.7: Glucose Monitoring Recommendations 86
Table 4.8: Percentage of Hypothetical Patients that Diabetes Educator's Would Recommend CGM, 2007-2009 88
Table 4.9: A1c Testing Recommendations 89
Table 4.10: Correlation of A1c with Mean Blood Glucose 89
Table 5.1: Analytic Performance Criteria for Glucose Self-Testing Meters 96
Table 5.2: Potential Variables Affecting Glucose Concentrations 100
Table 5.3: Key Features Considered for Glucose Testing Devices 102
Table 5.4: Common User Errors Made While Self-Testing for Blood Glucose 105
Table 5.5: Compatibility of Various Blood Glucose Meters with Icodextrin Peritoneal Dialysis (PD) Solution 107
Table 5.6: Ten Factors Needed to Improve the Performance of Blood Glucose Meters 109
Table 5.7: Key Features Considered for Reagent Test Strips 111
Table 5.8: Differences between Laboratory Instruments for Glucose Analysis and Hand-Held Blood Glucose Meters 112
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., 2010-2015 120
Table 5.11: Unit Sales of Homecare Lancets in the E.U., 2010-2015 121
Table 5.12: Dollar Sales of Homecare Lancets in the U.S., 2010-2015 121
Table 5.13: Dollar Sales of Homecare Lancets in the E.U., 2010-2015 121
Table 5.14: Unit Sales of Homecare Glucose Self-Testing Lancets in the U.S., 2010-2015 121
Table 5.15: Unit Sales of Homecare Glucose Self-Testing Lancets in the E.U., 2010-2015 122
Table 5.16: Competition in the Lancet Market Segment 123
Table 5.17: Limitations of Urine Glucose Monitoring 127
Table 5.18: Advantages of Urine Glucose Monitoring 128
Table 5.19: Blood Ketone Reading Indications 128
Table 6.1: Current Blood Glucose Self-testing Meters: Sample Size, Test Time, and Other Features 130
Table 6.2: Hand-Held Blood Glucose or Blood Gas Meters Marketed for Professional Use 155
Table 6.3: Clinical Blood Chemistry Analyzers with Glucose Assays 161
Table 6.4: Detailed Features of Selected CGM Systems Currently Available 170
Table 6.5: Non-Invasive Glucose Monitoring Systems in Development 178
Table 7.1: POC Procedural Advantages for Hospital Testing 193
Table 7.2: Medicare Billing Guidelines for Multi-Channel Chemistry Tests 203
Table 7.3: Financial Comparison for Moderate and Waived CLIA Labs 216
Table 8.1: Data Entry and Data Management Features to Include in Future Meters 220
Table 8.2: Leading World Patient Monitoring Products in the U.S. Market 223
Table 8.3: Customized Reports Must Support CAP and JCAHO Requirements 231
Table 9.1: Abaxis Blood Analysis Diagnostic Tests 239
Table 9.2: Reagent Discs Offered with the Piccolo Chemistry Analyzers 240
Table 9.3: Products Marketed by Abbott in the Diagnostic Market 242
 
Companies Mentioned
- Abaxis, Inc.
- Abbott Laboratories
- ACON Laboratories
- AgaMatrix
- Alere
- All Medicus
- Amedica Biotech
- A. Menarini Diagnostics
- Apex Biotechnology Corporation
- ARKRAY
- Bayer
- B. Braun Melsungen
- Beckman Coulter
- Bionime
- Bio-Rad Laboratories, Inc.
- BioTex
- Calisto Medical
- Cambridge Sensors
- DexCom
- Diagnostic Devices/Prodigy Diabetes Care
- DiaSys
- Echo Therapeutics
- Entra Health Systems
- Fora Care
- Genesis Health Technologies
- GenExel-Sein
- GlucoPlus
- GluMetris
- GlySens
- Hainice Medical
- HemoCue (a Quest Diagnostics company)
- Home Diagnostics
- Infopia
- IN4 Technology
- International Techidyne Corporation (ITC)
- Instrumentation Laboratory Company
- i-Sens
- Johnson & Johnson
- Luminous Medical
- Medtronic
- Nipro Corporation
- Nova Biomedical
- OrSense
- Polymer Technology Systems
- Radiometer Medical
- Roche
- 77 Elektronika Kft.
Siemens AG
- Smiths Group
- Stanbio Laboratory
- TaiDoc Technology
- Techno Medica Co., Ltd.
- US Diagnostics
- VeraLight
 
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Blood Glucose Testing and Diabetes Management

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