Blood Glucose Testing and Diabetes Management

Published by: Trimark Publications

Published: Jul. 1, 2007 - 292 Pages

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 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

List of Appendixes

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, 20

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, 2004-20

Table 8.1: Products Marketed by Abbott in the Diagnostic Market

Table 8.2: Key Roche Diagnostic Products

Abstract

About MarketResearch.com
MarketResearch.com is an online aggregator selling over 160,000 market research reports, company profiles and country profiles from over 600 research firms. Our reports will provide you with the critical business and competitive intelligence you need for strategic planning and marketing research. Coverage includes the US, UK, Europe, Asia and global markets.