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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 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
2.3.1 Worldwide Costs of Diabetes
2.3.2 Costs of Diabetes in the U.S.

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 in the Self-Testing Market
3.5.2 Analyses of the Self-Testing Market Conditions, Competition and Product Mix
3.5.3 Analyses of the Professional Blood Glucose Monitoring Market
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 New Opportunities in the Professional Blood Glucose Meter Market
3.11 Adjacent Markets

4. Glucose Diagnostic and Monitoring Recommendations
4.1 Diagnosis of Diabetes Mellitus
4.2 Tight Glucose Control in Treating Diabetes
4.2.1 Tight Glucose Control Lowers Cardiovascular Complications
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
4.3.6 Blood Glucose Testing for All Hospitalized Patients According to Guidelines by The Endocrine
Society
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 Clinical and Laboratory Standards Institute (CLSI) POCT12-A3
5.4.2 International Organization for Standardization (ISO) 15197:2013
5.4.3 FDA Guidelines for Blood Glucose Testing Systems
5.4.4 Determining Clinical Accuracy Using the Error Grid Analysis (EGA)
5.4.5 Quality Control Criteria
5.4.6 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/Medications
5.6.2.6 Patient Factors
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 GlucoTrack
5.11.2 Non-Invasive Glucose Monitoring Technologies in Development
5.11.3 Goals of Non-Invasive Testing
5.11.4 Non-Invasive Diabetes Screening Test
5.12 A1c Monitoring Technology
5.13 Fructosamine Test
5.14 Related Reagents and Equipment
5.14.1 Lancets
5.14.1.1 Types of Lancing Devices
5.14.1.2 Market Size
5.14.2 Control Solutions and Calibrators
5.14.3 Sharps Devices
5.14.4 Needle Destruction Devices
5.14.5 Urine Strips
5.14.6 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 CVS/pharmacy
6.1.10 Diabetic Supply of Suncoast
6.1.11 Entra Health Systems
6.1.12 Fifty50 Pharmacy
6.1.13 Fora Care
6.1.14 Genesis Health Technologies
6.1.15 GlucoCom
6.1.16 Infopia
6.1.17 Nipro Diagnostics, Inc.
6.1.18 Nova Biomedical
6.1.19 Oak Tree International Holdings, Inc.
6.1.20 Omnis Health
6.1.21 Phylosis
6.1.22 Prodigy Diabetes Care, LLC (an Affiliate of Diagnostic Devices, Inc.)
6.1.23 Sanofi
6.1.24 Target
6.1.25 Telcare
6.1.26 Tyson Biomedical
6.1.27 US Diagnostics, Inc.
6.1.28 Walgreens
6.1.29 Walmart
6.1.30 77 Elektronika Kft.
6.1.31 A. Menarini Diagnostics
6.1.32 All Medicus
6.1.33 i-SENS
6.1.34 Apex Biotechnology Corp.
6.1.35 Glucoplus, Inc.
6.1.36 Polymer Technology Systems
6.1.37 Smiths Medical MD, Inc.
6.1.38 TaiDoc Technology Corp.
6.1.39 IN4 Technology Corporation
6.1.40 ACON Laboratories, Inc.
6.1.41 Pepex Biomedical
6.1.42 HMD BioMedical
6.1.43 BTNX
6.1.44 Shasta Technologies and Decision Diagnostics Corporation
6.2 Point of Care Blood Glucose Meters for Professional Use
6.2.1 Abbott
6.2.1.1 Precision Xceed Pro Blood Glucose and Beta-Ketone Monitoring System
6.2.1.2 i-STAT System
6.2.2 ACON Laboratories
6.2.2.1 On Call Platinum Blood Glucose Monitoring System
6.2.3 Alere
6.2.3.1 epoc Blood Analysis System
6.2.3.2 Alere Cholestech LDX System
6.2.4 ARKRAY, Inc.
6.2.4.1 Assure Platinum, Assure Pro, and Assure 4
6.2.5 EKF Diagnostics
6.2.5.1 Biosen Series of Glucose and Lactate Analyzers
6.2.6 HemoCue (a Quest Diagnostics Company)
6.2.6.1 HemoCue Glucose 201 and Glucose 201 DM Systems
6.2.7 HMD BioMedical
6.2.7.1 NS100
6.2.8 Medtronic
6.2.8.1 iPro Continuous Glucose Monitor
6.2.9 Nova Biomedical
6.2.9.1 StatStrip Hospital Glucose Monitoring System
6.2.10 Polymer Technology Systems
6.2.10.1 CardioChek PA Point of Care Device
6.2.11 Roche
6.2.11.1 Accu-Chek Inform II System
6.2.11.2 Accutrend Plus System
6.2.12 Techno Medica Co., Ltd
6.2.12.1 GASTAT-mini
6.2.13 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 Technidyne 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
6.3.15 YSI Life Sciences
6.4 Continuous Glucose Patient Monitoring Systems
6.4.1 Medtronic’s Continuous Glucose Monitoring Systems (CGMS)
6.4.2 DexCom, Inc. G4 Platinum Continuous Glucose Monitoring System
6.4.3 FreeStyle Navigator—Abbott’s Continuous Glucose Monitor 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 Senseonics (Formerly Sensors for Medicine and Science)
6.4.5.3 Ultradian
6.4.5.4 GluMetrics
6.5 Non-Invasive Glucose Patient Monitoring Systems
6.5.1 Cygnus GlucoWatch Biographer
6.5.2 AiMedics Pty Ltd.
6.5.3 BioTex, Inc.
6.5.4 Echo Therapeutics, Inc.
6.5.5 EyeSense GmbH
6.5.6 Integrity Applications Ltd.
6.5.7 LighTouch Medical, Inc.
6.5.8 OrSense Ltd.
6.5.9 VeraLight, Inc.
6.5.10 Xhale, Inc.
6.5.11 Lein Applied Diagnostics
6.6 A1c Testing
6.7 New Product Launches
6.7.1 OneTouch Verio Sync Blood Glucose Monitoring System
6.7.2 Medtronic’s MiniMed 530G with Enlite Sensor Technology
6.7.3 Contour Next Link Meter Approved for Use with Medtronic’s New MiniMed 530G with Enlite Insulin Pump System
6.7.4 Roche’s ACCU-CHEK Inform II System Approved by the FDA
6.7.5 Abbott Receives CE Mark for FreeStyle Optium Neo Blood Glucose and Ketone Monitoring
System
6.7.6 Abbott Receives FDA Clearance for FreeStyle Precision Pro Blood Glucose and ß-Ketone Monitoring System
6.7.7 LabStyle Innovations’ Dario Diabetes Management System
6.7.8 BlueStar by WellDoc
6.7.9 FDA Approves Bayer’s Contour Next EZ
6.7.10 Glooko Received its Second 510(k) Clearance for Glucose Monitoring Logbook App
6.7.11 Sanofi-Aventis’s iBGStar
6.7.12 iHealth Glucose Meter Device
6.7.13 MyGlucoHealth Diabetes
6.7.14 gDrive
6.7.15 Enlite Sensor
6.7.16 Abbott’s FreeStyle InsuLinx
6.7.17 Roche Diagnostics launches Accu-Chek Mobile
6.7.18 Medtronic Announces Mac Compatibility for CareLink Personal Therapy Management Software for Diabetes
6.7.19 Telcare Receives FDA Clearance for its Telcare BGM 3G Blood Glucose Meter
6.7.20 OneTouch SelectSimple
6.7.21 Shasta GenStrips
6.7.22 Medtronic Gains Approval of First Artificial Pancreas Device System, the MiniMed 530G with
Enlite
6.8 Blood Glucose Meters, CGMs, and Data Management Software in Development
6.8.1 Abbott’s Flash Glucose Monitoring System
6.8.2 Google Announces Plan to Create Contact Lens Glucose Sensors
6.8.3 Socrates Health Solutions’ Companion Blood Glucose Monitor
6.8.4 DexCom and Johnson and Johnson’s Animas Working to Develop an Artificial Pancreas
6.8.5 Medtronic Enrolling Patients into Trial Testing Third-Generation, Fully-Automated Artificial
Pancreas
6.8.6 Boston University’s Bionic Pancreas Project
6.9 Recent Industry Activity
6.9.1 Roche Diagnostics Corp. Cutting Jobs in Diabetes Division
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 PositiveID Corporation and IDEAL LIFE Partner to Bring iglucose to Market for Wireless Diabetes Management
6.9.7 Roche Diagnostics U.S. and DexCom, Inc. Announce Research and Development Agreement
6.9.8 BD and JDRF Collaborating on a Device Using a Single Infusion Catheter for Both CGM and
Pump
6.9.9 Court Sides with Decision Diagnostics in Patent Infringment Case
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 Radiometer Medical Acquires Hemocue
6.10.5 Additional M&A
6.10.6 Important Deals in BGM Market

7. Business Trends in Glucose Testing
7.1 Drivers of Clinical Glucose Testing
7.2 Competition for Professional POC Glucose Testing
7.3 Healthcare Cost Controls
7.4 Changes in Patient Management
7.5 Regionalization of Laboratory Care
7.6 Satellite Facilities
7.7 Professional 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
7.17.1 New Medicare Part B
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
7.23 FDA’s Artificial Pancreas Guidance Document

8. Technology Trends
8.1 Improving Today’s Over-the-Counter (OTC) Blood Glucose Meters
8.2 Biosensor Technology
8.3 Artificial Pancreas
8.4 Telemedicine
8.4.1 Remote Patient Monitoring
8.4.1.1 Infopia Eocene System
8.4.1.2 Health Buddy Systems Monitoring Technologies
8.4.1.3 GlucoCom Glucose Monitoring System
8.4.1.4 Alere’s DayLink Monitor
8.4.1.5 Alere HomeLink Receives FDA Approval for Over-the-Counter Use
8.5 Non-Traditional Methods for Sample Collection
8.6 Data Management
8.6.1 Medical Device Radiocommunications Service (MedRadio)
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 All Medicus Co., Ltd.
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, Inc.
9.17 Calisto Medical, Inc.
9.18 Cambridge Sensors
9.19 DexCom
9.20 Diagnostic Devices/Prodigy Diabetes Care
9.21 DiaSys Diagnostic Systems
9.22 Echo Therapeutics, Inc.
9.23 Entra Health Systems
9.24 Fora Care
9.25 FIFTY50 Medical, Inc.
9.26 Genesis Health Technologies
9.27 GenExel-Sein, Inc.
9.28 GlucoPlus
9.29 GlySens, Inc.
9.30 Hainice Medical
9.31 HemoCue (a Quest Diagnostics Company)
9.32 Home Diagnostics
9.33 Infopia Co., Ltd.
9.34 IN4 Technology
9.35 International Techidyne Corporation (ITC)
9.36 Instrumentation Laboratory Company
9.37 i-Sense Corporation
9.38 Johnson & Johnson
9.39 LabStyle Innovations Corporation
9.40 Medtronic
9.41 Nipro Diagnostics
9.42 Nova Biomedical
9.43 OrSense Ltd.
9.44 Polymer Technology Systems
9.45 Prodigy Diabetes Care, LLC (Formerly Diagnostic Devices, Inc.)
9.46 Radiometer Medical
9.47 Roche Diagnostics
9.48 77 Elektronika Kft.
9.49 Siemens AG
9.50 Smiths Group
9.51 TaiDoc Technology
9.52 Techno Medica Co., Ltd.
9.53 Telcare
9.54 U.S. Diagnostics
9.55 VeraLight
9.56 Ypsomed Holding
9.57 YSI Life Sciences

INDEX OF FIGURES

Figure 2.1: Worldwide Diabetes Cases, 2013 and 2035
Figure 2.2: Worldwide Prevalence of Diabetes (%) in Adults (20-79 Years), 2013
Figure 2.3: Annual Number of New Cases of Diagnosed Diabetes Among U.S. Adults Aged 18-79 Years, 1980-2011
Figure 2.4: New Cases of Diabetes Diagnosed in the U.S. Adult Population by Age, 2010
Figure 2.5: Prevalence of Diabetes by Age in the U.S., 2010
Figure 2.6: Diagnosed Diabetes by Age in the U.S., 2013
Figure 2.7: Number of Deaths from Diabetes by Age in the U.S., 2010
Figure 2.8: Number of Diabetes Deaths by Race and Sex in the U.S., 2010
Figure 2.9: Maintenance of Normal Blood Sugar Levels
Figure 2.10: Prevalence of Self-Reported Obesity (BMI = 30) Among U.S. Adults, 2012
Figure 2.11: Prevalence of Obesity Among Adults in the U.S., 2009-2010
Figure 2.12: Trends in Obesity Among Children and Adolescents in the U.S., 1988-2010
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
Figure 2.14: Percentage of Adults with Diagnosed Diabetes Reporting Any Mobility Limitation, by Age, in the U.S., 1997-2011
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
Figure 2.16: Mean Diabetes Healthcare-related Expenditures Per Adult (20-79 Years) with Diabetes (U.S. Dollars), 2013
Figure 2.17: How Diabetes Dollars are Spent in the U.S., 2012
Figure 3.1: Global Unit Sales of Glucose Testing Reagent Strips, 2013
Figure 3.2: Geographic Segments of the Worldwide Glucose Self-Testing Market, 2012 and 2018
Figure 3.3: Worldwide Glucose Self-Testing Market by Region, 2018
Figure 4.1: Approach to Management of Hypoglycemia
Figure 4.2: 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, 2013
Figure 6.1: Medtronic’s Threshold Suspend Feature

INDEX OF TABLES

Table 2.1: Regional Estimates of the Number of Diabetes (20-79 Years) in Millions, 2013 and 2035
Table 2.2: Countries with the Largest Numbers of Diabetics, 2013
Table 2.3: Countries with the Largest Estimated Numbers of Diabetics, 2035
Table 2.4: Worldwide Undiagnosed Diabetes in Adults (20-79 Years) by Region and Income Group, 2013
Table 2.5: Countries with the Largest Number of Deaths Attributable to Diabetes, 2013
Table 2.6: U.S. Population of Diagnosed Diabetics Aged 20-79 Years, 2013
Table 2.7: Percentage of U.S. Adults with Diagnosed Diabetes by State, 2010
Table 2.8: Ten Leading Diagnoses for Co-Morbid Chronic Diseases in the U.S.
Table 2.9: Odds Ratio of Progression to Complications Associated with Type 2 Diabetes
Table 2.10: Prevalence of Complications Among Patients with Diabetes
Table 2.11: Novel Risk Factors and Possible Mechanisms of the Excess Risk of Coronary Heart Disease in Type 2 Diabetes Mellitus
Table 2.12: Major Causes of End-Stage Renal Disease
Table 2.13: Clinical Recommendations for Adults with Diabetes
Table 2.14: Laboratory Assessment of Diabetic Vascular Disease
Table 2.15: Average Years Gained Free of Diabetes-Related Disease with Intensive Management
Table 2.16: Estimated Direct and Indirect Costs of Major Cardiovascular Diseases and Stroke in the U.S., 2010
Table 2.17: Cost of Diagnosed Diabetes in the U.S., 2012
Table 2.18: Annual Cost of Care of United Healthcare Adult Members with Diabetes, 2009
Table 2.19: Healthcare Utilization by Diabetic Patients, 2012
Table 3.1: Worldwide Comprehensive Glucose Testing Market (Includes Reagents and Supplies in both the Self-Testing and Professional Markets in $ Billions), 2012-2018
Table 3.2: Total Global Unit Demand for Glucose Testing Reagent Strips, 2012-2018
Table 3.3: Global Dollar Sales of Glucose Testing Reagent Strips, 2012-2018
Table 3.4: Worldwide Glucose Self-Testing Market Sales (Meters, Strips, and Lancets), 2012-2018
Table 3.5: World Market Share of Glucose Self-Testing Marketers, 2013
Table 3.6: Global Revenues for Total Professional Blood Glucose Monitoring (Central Laboratory Testing and Hospital POC and POL), 2012-2018
Table 3.7: Global Revenues for Professional Point of Care Blood Glucose Monitoring Systems (within Hospitals and Physician’s Offices), 2012-2018
Table 3.8: Global Revenues for Continuous Glucose Monitoring Systems, 2012-2018
Table 3.9: Comprehensive Glucose Testing Market in the U.S. (Includes Reagents and Supplies in the Self-Testing and Professional Markets), 2012-2018
Table 3.10: U.S. Blood Glucose Reagent Strip Market (Includes both Self-Testing and Professional Markets),
2012-2018
Table 3.11: Market for Glucose Self-Testing in the U.S. (Includes Meters, Strips and Lancets), 2012-2018
Table 3.12: Market Share of U.S. Blood Glucose Self-Testing, 2013
Table 3.13: U.S. OTC Glucose Self-Testing Market Repeat Retail Replacement Sales Percentages
Table 3.14: OTC Blood Glucose Instrument Reagents by Manufacturer Retail
Table 3.15: Demographic Characteristics Glucose Self-Testing Kit Buyers
Table 3.16: Top Brand Preferences for Glucose Self-Testing Kits
Table 3.17: Instances when Patients Prefer Professional’s Glucose Testing
Table 3.18: Advantages of a Glucose Self-Testing Kit
Table 3.19: Disadvantages of Using a Glucose Self-Testing Kit
Table 3.20: Popular Shopping Destinations for Buying or Seeking Information on Glucose Self-Testing Kits
Table 3.21: Customer Priorities—Glucose Meter Self-Testing Market, 2001, 2006 and 2012
Table 3.22: Market for Total Professional Glucose Testing (Central Laboratory and Hospital POC and POL) in the U.S., 2012-2018
Table 3.23: U.S. Revenues for Professional POC Blood Glucose Monitoring (Hospital and POL),
2012-2018
Table 3.24: European Comprehensive Glucose Testing Market (Includes Reagents and Supplies in the Self-Testing and Professional Markets), 2012-2018
Table 3.25: European Market for Glucose Self-Testing (Includes Meters, Strips and Lancets), 2012-2018
Table 3.26: Asian Comprehensive Glucose Testing Market (Includes Reagents and Supplies in the Self-Testing and Professional Markets), 2012-2018
Table 3.27: Asian Market for Glucose Self-Testing (Includes Meters, Strips and Lancets), 2012-2018
Table 3.28: Japanese Comprehensive Glucose Testing Market (Includes Reagents and Supplies in the Self-Testing and Professional Markets), 2012-2018
Table 3.29: Japanese Market for Glucose Self-Testing (Includes Meters, Strips and Lancets), 2012-2018
Table 3.30: Chinese Comprehensive Glucose Testing Market (Includes Reagents and Supplies in the Self-Testing and Professional Markets), 2012-2018
Table 3.31: Chinese Market for Glucose Self-Testing (Includes Meters, Strips and Lancets), 2012-2018
Table 3.32: Indian Comprehensive Glucose Testing Market (Includes Reagents and Supplies in the Self-Testing and Professional Markets), 2012-2018
Table 3.33: Indian Market for Glucose Self-Testing (Includes Meters, Strips and Lancets), 2012-2018
Table 3.34: Number of Clinical Labs in India, 2008
Table 3.35: Top Domestic IVD Companies in India
Table 3.36: Leading Global IVD Companies in India
Table 3.37: Southeast Asian Comprehensive Glucose Testing Market (Includes Reagents and Supplies in the Self-Testing and Professional Markets), 2012-2018
Table 3.38: Southeast Asian Market for Glucose Self-Testing (Includes Meters, Strips and Lancets), 2012-2018
Table 3.39: Southeast Asian Comprehensive Glucose Testing Market by Country, 2013
Table 3.40: Southeast Asian Market for Glucose Self-Testing by Country (Includes Meters, Strips and Lancets), 2013
Table 3.41: ROW Comprehensive Glucose Testing Market (Includes Reagents and Supplies in the Self-Testing and Professional Markets), 2012-2018
Table 3.42: ROW Market for Glucose Self-Testing (Includes Meters, Strips and Lancets), 2012-2018
Table 3.43: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats of the Glucose Point of Care Market
Table 3.44: Key Market Drivers for Glucose Testing
Table 3.45: Market Drivers for Continuous Glucose Monitoring
Table 3.46: Point of Care Glucose Testing Market: Market Drivers Ranked in Order of Impact
Table 3.47: Key Market Restraints for Glucose Testing
Table 3.48: Market Restraints for Continuous Glucose Monitoring
Table 3.49: Point of Care Glucose Testing Market: Market Restraints Ranked in Order of Impact
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 Values—Fasting State
Table 4.4: Criteria for Testing for Diabetes in Asymptomatic Adults
Table 4.5: Criteria for Type 2 Diabetes in Asymptomatic Children
Table 4.6: Screening for and Diagnosis of Gestational Diabetes Mellitus (GDM)
Table 4.7: Glycemic Recommendations for Non-Pregnant Adults with Diabetes
Table 4.8: Glycemic Recommendations for Women with Gestational Diabetes
Table 4.9: Glycemic Recommendations for Pregnant Women with Pre-Existing Diabetes
Table 4.10: Plasma Blood Glucose and A1c Goals for Type 1 Diabetes by Age-Group
Table 4.11: Glucose Monitoring Recommendations
Table 4.12: Key Issues for SMBG in Insulin-Independent Type 2 Diabetics
Table 4.13: A1c Testing Recommendations
Table 4.14: Correlation of A1c with Mean Blood Glucose
Table 5.1: Analytic Performance Criteria for Glucose 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 Peritoneal Dialysis (PD) Solution
Table 5.6: Ten Factors Needed to Improve the Performance of Blood Glucose Meters
Table 5.7: Features Required For Safe and Effective Meters for Hospital Settings
Table 5.8: Key Features Considered for Reagent Test Strips
Table 5.9: Differences Between Laboratory Instruments for Glucose Analysis and Hand-Held Blood Glucose Meters
Table 5.10: Relationship of A1c to Average Whole Blood and Plasma Glucose Levels
Table 5.11: Unit Sales of Homecare Lancets in the U.S., 2012-2017
Table 5.12: Unit Sales of Homecare Lancets in the E.U., 2012-2017
Table 5.13: Dollar Sales of Homecare Lancets in the U.S., 2012-2017
Table 5.14: Dollar Sales of Homecare Lancets in the E.U., 2012-2017
Table 5.15: Unit Sales of Homecare Glucose Self-Testing Lancets in the U.S., 2012-2017
Table 5.16: Unit Sales of Homecare Glucose Self-Testing Lancets in the E.U., 2012-2017
Table 5.17: Competition in the Lancet Market Segment
Table 5.18: Limitations of Urine Glucose Monitoring
Table 5.19: Advantages of Urine Glucose Monitoring
Table 5.20: Blood Ketone Reading Indications
Table 6.1: Current Blood Glucose Self-Testing Meters: Sample Size, Test Time, and Other Features
Table 6.2: Point of Care 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: 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 Companies for Patient Monitoring Products
Table 8.3: Customized Reports Must Support CAP and JCAHO Requirements
 
Companies Mentioned
- 77 Elektronika Kft.
- A. Menarini Diagnostics
- ACON Laboratories
- ARKRAY
- Abaxis, Inc.
- Abbott Laboratories
- AgaMatrix
- Alere
- All Medicus Co., Ltd.
- Amedica Biotech
- Apex Biotechnology Corporation
- B. Braun Melsungen
- Bayer
- Beckman Coulter
- Bio-Rad Laboratories, Inc.
- BioTex, Inc.
- Bionime
- Calisto Medical, Inc.
- Cambridge Sensors
- DexCom
- DiaSys Diagnostic Systems
- Diagnostic Devices/Prodigy Diabetes Care
- Echo Therapeutics, Inc.
- Entra Health Systems
- FIFTY50 Medical, Inc.
- Fora Care
- GenExel-Sein, Inc.
- Genesis Health Technologies
- GlucoPlus
- GlySens, Inc.
- Hainice Medical
- HemoCue (a Quest Diagnostics Company)
- Home Diagnostics
- i-Sense Corporation
- IN4 Technology
- Infopia Co., Ltd.
- Instrumentation Laboratory Company
- International Techidyne Corporation (ITC)
- Johnson & Johnson
- LabStyle Innovations Corporation
- Medtronic
- Nipro Diagnostics
- Nova Biomedical
- OrSense Ltd.
- Polymer Technology Systems
- Prodigy Diabetes Care, LLC (Formerly Diagnostic Devices, Inc.)
- Radiometer Medical
- Roche Diagnostics
- Siemens AG
- Smiths Group
- TaiDoc Technology
- Techno Medica Co., Ltd.
- Telcare
- U.S. Diagnostics
- VeraLight
- YSI Life Sciences
- Ypsomed Holding
 
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