Market Report Source

Overview

The global market for glucose testing products is undergoing a significant transition driven by the advent of new analytical technologies and developments in diabetes treatment. Although the 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, with some-such as non-invasive testing-representing major new areas of application for IVD testing. Direct access testing, or over-the-counter, which allows consumers to order tests themselves without visiting a doctor, has emerged as a strong force in the glucose-testing segment. Moreover, an increasing range of test devices is now available to consumers for use in self-testing.

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, doctors’ offices and at-home care locations.

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
2.1.1 Worldwide Diabetes Incidence
2.1.2 U.S. Diabetes
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 Diabetes and Inflammation
2.3.4 Progression of Diabetes
2.3.5 Complications and Co-Morbidities in Type 2 Diabetes
2.3.6 Hypoglycemia and Treatment
2.3.7 Risk Factors and Diabetes
2.3.8 Cardiovascular Disease Facts
2.4 Glucose Control in Diabetic Patients
2.5 Tight Glucose Control in Treating Diabetes
2.6 Glucose Monitoring Devices
2.6.1 Key Issues were Identified for Glucose Monitoring
2.6.2 Device Description
2.6.3 Precision
2.6.4 Limitations of Existing Glucose Monitoring Products

3. Glucose Measurements
3.1 Glucose Monitoring Markets
3.1.1 Overview of Market Segments
3.1.1.1 Over-the-Counter (OTC) Self-Testing Glucose Market
3.1.1.2 Point of Care Glucose Testing Market
3.1.1.3 Physician Office Laboratories (POL) Glucose Testing Market
3.1.1.4 Clinical Laboratory Glucose Testing Market
3.1.2 Market Analysis: Size, Growth, Share and Competitors
3.1.2.1 Worldwide Market
3.1.2.2 U.S. Market
3.1.2.3 European Market
3.1.2.4 Asian Market
3.1.2.4.1 Japanese Market
3.1.2.4.2 China Market
3.1.2.4.3 India Market
3.1.2.5 ROW Markets
3.2 Glucose Analytical Test Methods
3.2.1 Glucose Oxidase
3.2.2 Glucose Hexakinase
3.2.3 Glucose Dehydrogenase Pyrroloquinolinequinone (GDH-PQQ)
3.2.4 Amperometric Biosensors
3.2.5 Interfering Substances
3.2.6 Monitoring HbA1c Levels
3.2.7 Quality Control Criteria
3.3 Reagents and Equipment
3.3.1 Lancets
3.3.2 Blood Glucose Test Kit
3.3.3 Blood Glucose Monitor and Insulin Doser
3.3.4 Diabetes Tracking System
3.3.5 Blood Glucose Sensors
3.3.6 Blood Glucose Reagent Test Strips
3.3.7 Control Solutions and Calibrators
3.3.8 Sharps Devices
3.3.9 Needle Destruction Devices
3.3.10 Urine Strips
3.3.11 Blood Ketone Testing
3.3.12 Voice Operated Glucose Meters
3.4 Glucose Meters
3.4.1 LifeScan (a Johnson & Johnson Company)
3.4.2 Roche Accu-Chek
3.4.3 Bayer
3.4.4 Medisense (Abbott)
3.4.5 Acon Laboratories
3.4.6 HemoCue
3.4.7 Agamatrix, Inc.
3.4.8 AiMedics, Pty Ltd.
3.4.9 Apex Biotechnology Corp.
3.4.10 77 Elektronika Kft.
3.4.11 Arkray, Inc.
3.4.12 Becton Dickinson & Co.
3.4.13 Accurex (India)
3.4.14 Biosens
3.4.15 Axis-Shield
3.3.16 Home Diagnostics, Inc.
3.3.17 Medisys/Hypoguard
3.3.18 Metrika
3.4.19 Biopeak Corp.
3.4.20 BioTex, Inc.
3.4.21 Calisto Medical, Inc.
3.4.22 Allmedicus
3.4.23 Diabetech, LP
3.4.24 Diagnostic Devices
3.4.26 DIRAmed LLC
3.4.27 Entelos
3.4.28 Fifty50 Pharmacy
3.4.29 Fluent Biomedical Corp.
3.4.30 Fovi Optics, Inc.
3.4.31 GenExel-Sein, Inc.
3.4.32 GlucoLight Corp.
3.4.33 Glucon Medical Ltd.
3.4.34 GluMetrics LLC
3.4.35 Glucoplus, Inc.
3.4.36 GlySens, Inc.
3.4.37 HMD Bio Medical
3.4.38 Hypoguard
3.4.39 Infratec, Inc.
3.4.40 InLight Solutions, Inc.
3.4.41 Insulet Corp.
3.4.42 Integrity Applications
3.4.43 Kumetrix, Inc.
3.4.44 Lein Applied Diagnostics Ltd.
3.4.45 Cholestech
3.4.46 LighTouch Medical, Inc.
3.4.47 LG Electronics
3.4.48 Luminous Medical, Inc.
3.4.49 Menarini Diagnostics
3.4.50 NIR Diagnostics, Inc.
3.4.51 Oculir, Inc.
3.4.52 OrSense Ltd.
3.4.53 Pelikan Technologies, Inc.
3.4.54 Polymer Technology Systems
3.4.55 PreciSense A/S
3.4.56 QuestStar Medical, Inc.
3.4.57 Sensys Medical
3.4.58 Smiths Medical MD, Inc.
3.4.59 TaiDoc Technology Corp.
3.4.60 U.S. Diagnostics
3.4.61 VeraLight, Inc.
3.4.62 Zyvex Corp
3.4.63 Advanced Biosensors
3.4.64 Health Hero Network, Inc.
3.4.65 IN4 Technology Corporation
3.4.66 Nipro
3.4.67 Teco Diagnostics, Inc.
3.4.68 Uchain Industrial Co., Ltd.
3.4.69 GlucoStat System
3.4.70 Sanyo Junyaku
3.4.71 Diagnosys Medical
3.5 Diagnosing Diabetes Using In Vitro Laboratory Tests
3.5.1 New Diagnostic Guidelines
3.5.2 Fasting Plasma Glucose (FPG) Test
3.5.3 Glucose Tolerance Test
3.5.4 Test for Glycosylated Hemoglobin
3.5.5 Fructosamine
3.5.6 Combined Self-Testing Glucose Monitor with Insulin Delivery
3.6 Continuous and Non-invasive Glucose Patient Monitoring
3.6.1 Medtronic MiniMed Continuous Glucose Monitoring System
3.6.2 Cygnus GlucoWatch Biographer
3.6.3 Abbott FreeStyle Continuous Glucose Monitor System
3.6.4 DexCom, Inc. STS Continuous Glucose Monitoring System
3.6.5 Sontra Medical, Inc.
3.6.6 SpectRx
3.6.7 Pendragon Medical
3.6.8 Sensors for Medicine and Science, Inc. (SMSI)
3.6.9 Other Players
3.6.10 Strategies for Developing Non-invasive Continuous Glucose Monitoring
3.7 Glycosylated Hemoglobin Glucose Monitoring
3.8 Clinical Laboratory Instruments
3.8.1 Ultra-Large Throughput Chemistry Analyzers Large-Throughput Analyzers
3.8.2 Large-Throughput Analyzers
3.8.3 Mid-Size Clinical Chemistry Analyzers
3.8.4 Chemistry Analyzers for the Small Volume Market

4. Business Trends in Glucose Testing
4.1 Expanding Opportunities in Blood Glucose Monitoring Market
4.2 Home Diabetes Test Kits an Evolving Market
4.3 Competitive Strategies
4.4 Analyses of the Current Market Conditions, Competition and Product Mix
4.5 The New Paradigm
4.6 Mergers of Diagnostic Companies
4.7 Healthcare Cost Controls
4.8 Competition for Services
4.9 Drivers of Clinical Glucose Testing
4.10 Confluence of New Technology
4.11 Trends in Reimbursement Practices
4.12 Managed Care
4.13 Changes in Patient Management
4.14 Satellite Facilities
4.15 Point-of-Care Testing
4.16 Regionalization of Laboratory Care
4.17 Drivers of the Point of Care Testing Sector
4.18 Diagnostic Testing Growth Trends
4.19 PIPE Financing
4.20 Brand Loyalty
4.21 Insurance Coverage a Key Factor
4.22 Medicare Coverage
4.23 Products at Competitive Price Points
4.24 Drugstores Critical to the Diabetic Care Category
4.25 Drugstore Chains Increasingly Running Diabetes Care Programs
4.26 Co-branding Strategies

5. Important Technology Trends
5.1 Biosensor Technology
5.2 Data Management
5.2.1 Information Management Advances
5.2.2 Patient Care Information System Strategy
5.2.3 Connectivity Platforms
5.2.3.1 DataLink Data Management System
5.2.3.2 RALS-Plus
5.2.3.3 LabPortal.com
5.2.3.4 LifeScan Electronic Data Interfaces
5.2.3.5 Computer Software for Home Glucose Meters
5.2.3.6 Health Buddy Systems Monitoring Technologies
5.2.3.7 Medtronics MiniMed Paradigm Glucose Meter
5.2.4 POL Laboratory Data Management
5.2.4.1 Electronic Medical Record Systems and Physician Office Laboratory Data Linking Software
5.2.4.2 Physician Office Laboratory Data Linking Software and Interface to the Laboratory Information System
5.2.5 Technical Problems of Connectivity
5.2.6 Web-based Data Interface
5.2.7 HIT Competition
5.2.8 FDA Required Software Verification
5.3 Advantages of Connectivity
5.4 Home Care Analysis
5.5 Technology Platform Innovations in Glucose Testing
5.6 Move Away from Central Laboratory
5.7 Trends in Detection and Diagnosis
5.7.1 Minimally-Invasive Devices
5.7.2 Non-invasive Devices Future Developments and Market Strategy
5.7.3 Continuous Test Systems and the Future of Integrated Glucose/Insulin Delivery

6. Competitive Analysis of the Glucose Testing Markets
6.1 The Market Players
6.2 Device Categories
6.3 Range of Products
6.3.1 Cost of Testing
6.3.2 Sample Size Required
6.3.3 Sampling Other Areas
6.3.4 Time Until Patient Obtains Results
6.3.5 Enclosed Test Strips
6.3.6 Test Strip Calibration
6.3.7 Built-in Lancing Device
6.4 Data Handling
6.5 New Developments
6.6 Marketing New Features
6.7 Test Strip Sales
6.8 Reimbursement
6.9 Strip Manufacturers’ Responses
6.10 Retailers’ Responses
6.11 Market Demand and Composition
6.12 Product Mix
6.12.1 LifeScan
6.12.2 Roche Diagnostics
6.12.3 Bayer Diagnostics
6.12.4 Becton Dickinson
6.12.5 Abbott (MediSense)
6.12.6 Other Players
6.12.6.1 HemoCue AB
6.12.6.2 Home Diagnostics, Inc.
6.12.6.3 Medisys Group PLC
6.12.6.4 Polymer Technology Systems, Inc.
6.12.6.5 QuestStar Medical, Inc.
6.13 Devices that Measure Glycohemoglobin
6.14 Adjacent Markets
6.15 Market Drivers and Restraints
6.16 Market and Product Trends
6.17 Increased Market Penetration
6.18 Costs of Doing Business in Europe
6.19 Drivers of European Diagnostics Testing
6.20 European Reimbursement Practices
6.21 Cost Containment in Europe
6.22 Market Overview of Glucose Monitoring
6.22.1 U.S. Market Segment
6.22.2 European Market
6.22.3 Japanese Market
6.23 Competitive Strategies
6.24 Price Competition
6.25 Analyses of the Current Market Conditions, Competition and Product Mix
6.25.1 First-Generation Monitors
6.25.2 Second-Generation Monitors
6.25.3 Third-Generation SMBG Technologies
6.26 Product Overview
6.26.1 LifeScan
6.27 Design of Glucose Testing Devices
6.28 Insulin Delivery Devices
6.29 Key Glucose Testing Sector Developments
6.30 Important M&A Activity
6.30.1 Cygnus, Inc. Divests its Glucose-Monitoring Assets to Animas Corporation
6.30.2 Bayer Diagnostics Business Splits into Two Units
6.30.3 Abbott Laboratories Acquires TheraSense, Inc.
6.30.4 Roche Acquires Infusion Systems Division of Disetronic
6.30.5 J&J Acquires Animas Corporation
6.30.6 Medical Devices Pelikan Technologies, Inc.
6.30.7 Medical Services Amerifit Nutrition, Inc.
6.30.8 Owens & Minor, Inc.
6.30.9 Medisys Sells Business to Arkray
6.30.10 Cholestech Signs Agreement with Provalis
6.30.11 Bayer Acquires Metrika
6.30.12 Other Deals
6.31 Product Launches

7. Government Regulation of Medical Devices
7.1 U.S. Regulations
7.1.1 Importing Medical Devices into the U.S.
7.1.2 Exporting Medical Devices from the U.S.
7.2 U.K. Regulations
7.3 E.U. Regulations
7.4 French Regulations
7.5 Japanese Regulations
7.6 Korean Regulations
7.7 FDA Regulations and Recalls
7.8 Legal Liability for Glucose Meters
7.9 ISO 9000 Quality System
7.10 Recent Regulatory Approvals
7.11 FDA Labeling Requirements

8. Corporate Profiles
8.1 Abbott Diagnostics
8.2 Abbott Laboratories
8.3 Acon Laboratories
8.4 AgaMatrix
8.5 AiMedics Pty Ltd.
8.6 Animas Corp.
8.7 Apex Biotechnology Corporation
8.8 Bayer Corporation
8.9 Biopeak Corporation
8.10 BioTex
8.11 Dexcom, Inc.
8.12 Diabetech, LP
8.13 77 Elektronika Kft.
8.14 Flexsite Diagnostics
8.15 GenExel-Sein, Inc.
8.16 GlucoLight
8.17 Glucon
8.18 GluMetrics, Inc.
8.19 GlySens, Inc.
8.20 Hemocue
8.21 Hypoguard
8.22 Infratec, Inc.
8.23 IN4 Technology
8.24 InLight Solutions
8.25 ITC (International Technidyne Corporation)
8.26 LifeScan Corporation
8.27 MediSense
8.28 Metrika
8.29 NIR Diagnostics
8.30 Nipro Medical Corporation
8.31 OrSense Ltd.
8.32 Pelikan Technologies
8.33 Polymer Technology Systems
8.34 PreciSense
8.35 QuestStar Medical
8.36 Roche Diagnostics
8.37 Sankyo Junyaku
8.38 Sanwa Kagaku Kenkyusho Co., Ltd.
8.39 Sensys Medical
8.40 SurgiLance
8.41 Smiths Medical MD, Inc.
8.42 SpectRx
8.43 Taidoc Technology
8.44 Teco Diagnostics
8.45 U.S. Diagnostics
8.46 VeraLight

Appendix 1: List of Competitors for Glucose Test Meters and Equipment
Appendix 2: FDA Proprietary Devices for Measuring Blood Glucose
Appendix 3: Overview of FDA Device Regulations
Appendix 4: Retail Prices of Glucose Meters

INDEX OF FIGURES

Figure 2.1: Demographic Changes in Diabetes Populations in 2010, 2025 and 2050
Figure 2.2: How Diabetes Dollars Are Spent in the U.S.
Figure 2.3: Overlap Between Individuals Diagnosed as Diabetic According to Fasting Plasma Glucose Concentration (ADA Criteria) or the Two-Hour Glucose Value (WHO Criteria)
Figure 2.4: Single Day Continuous Blood Glucose Data
Figure 3.1: Share of the U.S. Self-Testing Diagnostic Market, 2006
Figure 3.2: U.S. Mass-Market Sales of Glucose Testing Kits, 2000-2012
Figure 7.1: World Medical Device Markets
Figure 7.2: Medical Device Market Share by U.S. Owned Companies

INDEX OF TABLES

Table 2.1: Normal Glucose Values-Fasting State
Table 2.2: Population with Diabetes in the World and in Selected Nations, 2000 and 2030
Table 2.3: U.S. Population of Diabetics by Ethnic Group
Table 2.4: Percentage of U.S. Adults with Diabetes Using Diabetes Medication by Age Group, 2002-2007
Table 2.5: Healthcare Utilization by Diabetic Patients
Table 2.6: Age-Adjusted Percentage of Adults with Diabetes Using Diabetes Medication by Type of Medication U.S., 2002-2007
Table 2.7: Crude and Age-Adjusted Percentage of Adults with Diabetes Using Diabetes Medication, U.S., 2002-2007
Table 2.8: Percentages of Adults with Diabetes Using Diabetes Medication by Age, U.S., 1997-2002
Table 2.9: Annual Estimated Cost of U.S. Diabetes Care
Table 2.10: Leading Ten Diagnoses by Total U.S. Patient Visits, 2007
Table 2.11: U.S. Incidence of Diabetes by Age, 2007
Table 2.12: Prevalence, Cost and Medicines for Major Diseases in the U.S., 2007
Table 2.13: Top Ten Causes of Death in the U.S., 2007
Table 2.14: Per-Event Costs of Diabetes Complications
Table 2.15: Percentage of Persons with Type 1 Diabetes Experiencing Various Complications
Table 2.17: Novel Risk Factors and Possible Mechanisms of the Excess Risk of Coronary Heart Disease in Type 2 Diabetes Mellitus
Table 2.18: Average Years Gained Free of Diabetes-Related Disease with Intensive Management
Table 2.19: Worldwide Market for Cardiac Care Therapeutics, 1999-2010
Table 2.20: Major Causes of End-Stage Renal Disease
Table 2.21: Key Features Considered for Glucose Meter Devices
Table 3.1: Laboratory Assessment of Diabetic Vascular Disease
Table 3.2: Key Market Drivers for Glucose Testing
Table 3.3: Key Customer Segments of Glucose Testing
Table 3.4: Demographic Characteristics Home Testing Kit Buyers
Table 3.5: Top Brand Preferences for Home Glucose Testing Kits
Table 3.6: Instances When Patients Prefer Professional’s Glucose Testing
Table 3.7: Advantages of a Home Testing Kit
Table 3.8: Disadvantages of Using a Home Testing Kit
Table 3.9: Popular Shopping Destinations for Buying or Seeking Information on Home Testing Kits
Table 3.10: Total Dedicated U.S. Professional Glucose Testing Market, 2000-2012
Table 3.11: Point of Care Glucose Testing U.S. (Hospitals), 2000-2012
Table 3.12: U.S. POL Glucose Testing, 2000-2012
Table 3.13: U.S. Central Lab Glucose Testing (Hospitals and Reference Labs), 2000-2012
Table 3.14: Worldwide Central Lab Glucose Testing (Hospitals and Reference Labs), 2000-2012
Table 3.15: Worldwide Glucose Self-Testing Market Sales (Meters, Strips, Lancets), 2000-2012
Table 3.16: Worldwide Glucose Market for Self-Testing Sales (Meters, Strips, Lancets), 2000-2012
Table 3.17: Glucose Market for Self-Testing and POC Devices in the U.S., 2000-2012
Table 3.18: U.S. Blood Glucose Reagent Strip Market, 2000-2012
Table 3.19: OTC Glucose Meter U.S. Market Share for Blood Glucose Measurements
Table 3.20: U.S. Diabetes Glucose Monitoring Market Repeat Retail Replacement Sales Percentages
Table 3.21: Top Four Players in the U.S. Blood Glucose Strips Market (Ranked by % Sales), 2006
Table 3.22: Leading Blood Glucose Meters and Strips Brands in the U.S. (% Breakdown by Dollar Sales), 2006
Table 3.23: European Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-2012
Table 3.24: European Glucose Self-Testing Market by Country Market
Table 3.25: Asian Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-2012
Table 3.26: Japanese Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-2012
Table 3.27: Chinese Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-2012
Table 3.28: China Blood Glucose Reagent Strip Market, 2000-2012
Table 3.29: Indian IVD Market, 2006-2012
Table 3.30: Number of Automated Clinical Labs in India, 2004-2012
Table 3.31: Indian IVD Market, 2006
Table 3.32: Indian Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-2012
Table 3.33: Indian Blood Glucose Reagent Strip Market, 2000-2012
Table 3.34: ROW Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-2012
Table 3.35: Unit Sales of Homecare Lancets in the U.S., 2000-2012
Table 3.36: Unit Sales of Lancets in the E.U., 2000-2012
Table 3.37: Dollar Sales of Lancets in the U.S., 2000-2012
Table 3.38: Dollar Sales of Lancets in the E.U., 2000-2012
Table 3.39: Unit Sales of Homecare Glucose Self-testing Lancets in the U.S., 2000-2012
Table 3.40: Unit Sales of Homecare Glucose Self-testing Lancets in the E.U., 2000-2012
Table 3.41: Competition in the Lancet Market Segment
Table 3.42: Technology of Glucose Testing Instruments
Table 3.43: Key Features of Reagent Test Strips
Table 3.44: Limitations of Urine Glucose Monitoring
Table 3.45: Advantages of Urine Glucose Monitoring
Table 3.46: Blood Ketone Reading Indications
Table 3.47: Customer Priorities-Glucose Meter Self-Testing Market
Table 3.48: Accu-Chek Blood Glucose Monitoring Systems
Table 3.49: GlucoTrack Comparison and Results
Table 3.50: Home Diagnostics’ Current Product Portfolio
Table 3.51: Relationship of A1c to Average Whole Blood and Plasma Glucose Levels
Table 3.52: Distributors of Glucose Meters
Table 3.53: Ultra-Large Clinical Chemistry Analyzers
Table 3.54: JEOL Analyzer Comparison
Table 3.55: Large Clinical Chemistry Analyzers
Table 3.56: Mid-size Clinical Chemistry Analyzers
Table 3.57: Small Clinical Chemistry Analyzers
Table 4.1: U.S. Diabetes Glucose Monitoring Market Segments
Table 4.2: Medicare Billing Guidelines for Multichannel Chemistry Tests
Table 5.1: Customized Reports must Support CAP and JCAHO Requirements
Table 5.2: RALS-Plus Point of Care Market Share
Table 5.3: Applications of RALS Connectivity with POCT Devices
Table 6.1: Comparisons of Blood Glucose Monitoring Systems
Table 6.2: U.S. Diabetes Glucose Monitoring Market, 2006
Table 6.3: Syringes for Administering Insulin
Table 6.4: Insulin Pens
Table 6.5: Injection Aids
Table 6.6: Jet Injectors
Table 6.7: External Insulin Pumps
Table 6.8: Insulin Delivery Device Market, 2004-2014
Table 8.1: Products Marketed by Abbott in the Diagnostic Market
Table 8.2: Key Roche Diagnostic Products