Report: Blood Glucose Testing and Diabetes Management TOC

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 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 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 Professional 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
3.2 Glucose Analytical Test Methods
- 3.2.1 Glucose Oxidase
- 3.2.2 Glucose Hexokinase
- 3.2.3 Glucose Dehydrogenase Pyrroloquinoline quinone (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
- 3.4.2 Roche Accu-Chek
- 3.4.3 Bayer
- 3.4.4 Abbott
- 3.4.5 Acon Laboratories
- 3.4.6 Quest Diagnostics Company
- 3.4.7 Agamatrix
- 3.4.8 AiMedics
- 3.4.9 Apex Biotechnology
- 3.4.10 77 Elektronika
- 3.4.11 Arkray
- 3.4.12 Accurex
- 3.4.13 Axis-Shield
- 3.4.14 Home Diagnostics
- 3.4.15 Hypoguard
- 3.4.16 Metrika
- 3.4.17 Biopeak
- 3.4.18 BioTex
- 3.4.19 Integrity Applications
- 3.4.20 Calisto Medical
- 3.4.21 Allmedicus
- 3.4.22 Diabetech
- 3.4.23 Diagnostic Devices
- 3.4.24 DIRAmed
- 3.4.25 Entelos
- 3.4.26 Fifty50 Pharmacy
- 3.4.27 Fluent Biomedical
- 3.4.28 GenExel-Sein
- 3.4.29 GlucoLight
- 3.4.30 GluMetrics
- 3.4.31 Glucoplus
- 3.4.32 GlySens
- 3.4.33 HMD BioMedical
- 3.4.34 InLight Solutions
- 3.4.35 Insulet
- 3.4.36 IntelliDx
- 3.4.37 Kumetrix
- 3.4.38 Lein Applied Diagnostics
- 3.4.39 Cholestech
- 3.4.40 LighTouch Medical
- 3.4.41 LG Electronics
- 3.4.42 Luminous Medical
- 3.4.43 Menarini Diagnostics
- 3.4.44 OrSense
- 3.4.45 Pelikan Technologies
- 3.4.46 Polymer Technology Systems
- 3.4.47 PreciSense
- 3.4.48 Sensys Medical
- 3.4.49 Smiths Medical MD
- 3.4.50 TaiDoc Technology
- 3.4.51 U.S. Diagnostics
- 3.4.52 VeraLight
- 3.4.53 Zyvex
- 3.4.54 Health Hero Network
- 3.4.55 IN4 Technology
- 3.4.56 Nipro
- 3.4.57 Teco Diagnostics
- 3.4.58 Uchain Industrial
- 3.4.59 GlucoStats System
- 3.4.60 Sanko Junyaku
- 3.4.61 International Technidyne
- 3.4.62 Medtronic MiniMed
- 3.4.63 Diacare
- 3.4.64 Tyson Bioresearch
- 3.4.65 Bionime
- 3.4.66 Home Diagnostics
- 3.4.67 BTNX
- 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 Echo Therapeutics
- 3.6.6 Sensors for Medicine and Science
- 3.6.7 New Developments in Glucose Monitors
- 3.6.8 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 Medtronic' s 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
- 5.4.1 Remote Patient Monitoring
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 Lancing Devices
6.4 Data Handling
6.5 New Developments
6.6 Marketing New Features
6.7 Test Strip Sales
6.8 Reimbursement
6.9 Market Demand and Composition
6.10 Product Mix
- 6.10.1 LifeScan
- 6.10.2 Roche Diagnostics
- 6.10.3 Bayer Diagnostics
- 6.10.4 Abbott (MediSense)
- 6.10.5 Other Players
  - 6.10.5.1 Hemocue
  - 6.10.5.2 Home Diagnostics, Inc.
  - 6.10.5.3 ArkRay Hypoguard
  - 6.10.5.4 Polymer Technology Systems, Inc.
  - 6.10.5.5 QuestStar Medical, Inc.
6.11 Devices that Measure Glycohemoglobin
6.12 Market Drivers and Restraints
6.13 Market and Product Trends
6.14 Increased Market Penetration
6.15 Costs of Doing Business in Europe
6.16 Drivers of European Diagnostics Testing
6.17 European Reimbursement Practices
6.18 Cost Containment in Europe
6.19 Market Overview of Glucose Monitoring
- 6.19.1 U.S. Market Segment
- 6.19.2 European Market
- 6.19.3 Japanese Market
6.20 Competitive Strategies
6.21 Price Competition
6.22 Analyses of the Current Market Conditions, Competition and Product Mix
- 6.22.1 First-Generation Monitors
- 6.22.2 Second-Generation Monitors
- 6.22.3 Third-Generation SMBG Technologies
6.23 Design of Glucose Testing Devices
6.24 Insulin Delivery Devices
6.25 Key Glucose Testing Sector Developments
6.26 Important M&A Activity
6.27 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 China Regulations
7.8 FDA Regulations and Recalls
7.9 Legal Liability for Glucose Meters
7.10 ISO 9000 Quality System
7.11 Recent Regulatory Approvals
7.12 FDA Labeling Requirements

8. Corporate Profiles

8.1 Abbott Laboratories
8.2 Accurex Biomedical
8.3 Acon Laboratories
8.4 AgaMatrix
8.5 AiMedics
8.6 Apex Biotechnology
8.7 Axis-Shield
8.8 Bayer
8.9 Biopeak Corporation
8.10 BioTex
8.11 Calisto Medical
8.12 Cybermedical
8.13 DexCom
8.14 Diabetech
8.15 DIRAmed
8.16 Echo Therapeutics
8.17 Entelos
8.18 Fora Care
8.19 Glucoplus
8.20 77 Elektronika
8.21 Flexsite Diagnostics
8.22 GenExel-Sein
8.23 GlucoLight
8.24 GluMetrics
8.25 GlySens
8.26 Hemocue
8.27 Home Diagnostics
8.28 HTL Strefa
8.29 Hypoguard
8.30 IN4 Technology
8.31 InLight Solutions
8.32 International Technidyne
8.33 Insulet
8.34 IntelliDx
8.35 Lein Applied Diagnostics
8.36 LifeScan
8.37 Luminous Medical
8.38 Medtronic
8.39 Menarini Diagnostics
8.40 Newton Photonics
8.41 Nipro Medical
8.42 OrSense
8.43 Panasonic Shikoku Electronics
8.44 Pelikan Technologies
8.45 Polymer Technology Systems
8.46 PreciSense
8.47 Roche Diagnostics
8.48 Sanko Junyaku
8.49 Sanwa Kagaku Kenkyusho
8.50 Sensys Medical
8.51 Solianis Holding
8.52 SurgiLance
8.53 Smiths Medical MD
8.54 SpectRx
8.55 Taidoc Technology
8.56 Teco Diagnostics
8.57 U.S. Diagnostics
8.58 VeraLight
8.59 Ypsomed Holding
8.60 Zyvex

Appendix

Appendix 1: Contact Information for Companies Profiled
Appendix 2: List of Competitors for Glucose Test Meters and Equipment
Appendix 3: FDA Proprietary Devices for Measuring Blood Glucose
Appendix 4: Overview of FDA Device Regulations
Appendix 5: Retail Prices of Glucose Meters
Appendix 6: Glucose Meters: Components, Design, Sources
Appendix 7: Pharmaceutical Sampling Practices

INDEX OF FIGURES

Figure 2.1: Worldwide Rates of Diabetes Cases, 2000-2025
Figure 2.2: Prevalence of Diabetes by Age in the U.S., 2007
Figure 2.3: New Cases of Diabetes Diagnosed in the U.S. Adult Population, 2007
Figure 2.4: Rate of New Diabetes Cases among Children in the U.S., 2007
Figure 2.5: Diabetes Death Rate by Race and Sex in the U.S., 1979-2006
Figure 2.6: Annual Death Rate of U.S. Population from Heart Disease, 1950-2008
Figure 2.7: How Diabetes Dollars Are Spent in the U.S., 2007
Figure 2.8: Percentage Breakdown of U.S. Healthcare Spending, 2008
Figure 2.9: Percentage of U.S. Population that is Overweight, 1976-2004
Figure 2.10: Hypertension Drugs Newly Prescribed or Continued in the U.S., 1994-2007
Figure 3.1: Glucose Self-Monitoring Market Share by Geographical Region, 2007
Figure 3.2: Share of the U.S. Self-Testing Diagnostic Market, 2008
Figure 3.3: Domestic Manufacturers' Share of Chinese Glucose Meter Market, 2007
Figure 3.4: Personal Lancet Unit Sales Market Share by Geographic Region, 2008
Figure 3.5: Estimated U.S. Inpatient Volume, 2008

INDEX OF TABLES

Table 2.1: Normal Glucose Values-Fasting State
Table 2.2: Countries with the Largest Numbers of Diabetics, 2007 and 2025
Table 2.3: U.S. Population of Diabetics (Diagnosed and Undiagnosed) by Ethnic Group, 2007
Table 2.4: Healthcare Utilization by Diabetic Patients, 2006
Table 2.5: Cost of Diabetes in the U.S., 2007
Table 2.6: Ten Leading Diagnoses for Co-morbid Chronic Diseases in the U.S., by Percentage of Patient Visits, 2006
Table 2.7: U.S. Incidence of Diagnosed Diabetes by Age, 2006
Table 2.8: Prevalence and Financial Burden of Major Diseases in the U.S., 2007
Table 2.9: Top Twelve Causes of Death in the U.S., 2006
Table 2.10: Death Rate from Cardiovascular Diseases by Country, 2008
Table 2.11: Life Expectancy Rate by Country, 2008
Table 2.12: Per-Event Costs of Diabetes Complications
Table 2.13: Odds Ratio of Progression to Complications Associated With Type 2 Diabetes
Table 2.14: Prevalence of Complications among Patients with Diabetes
Table 2.15: Novel Risk Factors and Possible Mechanisms of the Excess Risk of Coronary Heart Disease in Type 2 Diabetes Mellitus
Table 2.16: Average Years Gained Free of Diabetes-Related Disease with Intensive Management
Table 2.17: Estimated Direct and Indirect Costs of Major Cardiovascular Diseases and Stroke in the U.S., 2008
Table 2.18: Worldwide Market for Cardiac Care Therapeutics, 2003-2010
Table 2.19: Top 20 Drugs for 2007 by U.S. Sales
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 Aspects of Professional 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 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 Global Professional Glucose Testing Market, 2007-2012
Table 3.11: Worldwide Glucose Self-Testing Market Sales (Meters, Strips, Lancets), 2004-2012
Table 3.12: Percentage of GDP Healthcare Spending by Country, 2008
Table 3.13: Worldwide Glucose Market for Self-Testing Sales (Meters and Strips), 2004-2012
Table 3.14: U.S. Blood Glucose Reagent Strip Market, 2004-2013
Table 3.15: U.S. Sales for OTC Blood Glucose Meters and Strips, 2007
Table 3.16: Top Four Players in the U.S. Blood Glucose Strips Market (Ranked by % Sales), 2008
Table 3.17: European Glucose Self-Testing Market (Meters, Strips, Lancets), 2003-2012
Table 3.18: Asian Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-2012
Table 3.19: Japanese Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-2012
Table 3.20: Chinese Glucose Self-Testing (Meters, Strips, Lancets) Market and Professional POC Devices, 2000-2012
Table 3.21: China Blood Glucose Reagent Strip Market, 2000-2012
Table 3.22: Indian IVD Market, 2006-2012
Table 3.23: Number of Clinical Labs in India, 2008
Table 3.24: Indian IVD Market Sectors and Market Share, 2006
Table 3.25: Indian Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-2012
Table 3.26: Indian Blood Glucose Reagent Strip Market, 2000-2012
Table 3.27: Top Domestic IVD Companies in India
Table 3.28: Leading Global IVD Companies in India, 2008
Table 3.29: BRIC countries, Percentage of GDP Spent on Healthcare, 2008
Table 3.30: ROW Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-2012
Table 3.31: Global Unit Sales of Home care Lancets, 2006-2012
Table 3.32: Dollar Sales of Lancets in the U.S., 2000-2012
Table 3.33: Dollar Sales of Lancets in the E.U., 2000-2012
Table 3.34: Unit Sales of Homecare Glucose Self-testing Lancets in the U.S., 2000-2012
Table 3.35: Unit Sales of Homecare Glucose Self-testing Lancets in the E.U., 2000-2012
Table 3.36: Competition in the Lancet Market Segment
Table 3.37: Currently Available Lancing Devices and Lancets
Table 3.38: Customer Priorities- Glucose Meter Self-Testing Market, 2001-2012
Table 3.39: Current Blood Glucose Meters: Pricing, Sample Size, Features
Table 3.40: Technology of Glucose Testing Instruments
Table 3.41: Key Features of Reagent Test Strips
Table 3.42: Limitations of Urine Glucose Monitoring
Table 3.43: Advantages of Urine Glucose Monitoring
Table 3.44: Blood Ketone Reading Indications
Table 3.45: Accu-Chek Blood Glucose Monitoring Systems
Table 3.46: GlucoTrack Comparison and Results
Table 3.47: Home Diagnostics' Current Product Portfolio
Table 3.48: Detailed Features of Selected CGM Systems Currently Available
Table 3.49: Relationship of A1C to Average Whole Blood and Plasma Glucose Levels
Table 3.50: Distributors of Glucose Meters
Table 3.51: Ultra-Large Clinical Chemistry Analyzers
Table 3.52: JEOL Analyzer Comparison
Table 3.53: Large Clinical Chemistry Analyzers
Table 3.54: Mid-size Clinical Chemistry Analyzers
Table 3.55: Small Clinical Chemistry Analyzers
Table 4.1: Medicare Billing Guidelines for Multichannel Chemistry Tests
Table 5.1: Customized Reports Must Support CAP and JCAHO Requirements
Table 5.2: Applications of RALS Connectivity with POCT Devices
Table 6.1: Comparisons of Blood Glucose Monitoring Systems
Table 6.2: Major Lancing Devices on the Market
Table 6.3: Glucose Meters Offering Data Management
Table 6.4: Comparison of A1C Home Test Kits.
Table 6.5: Unit Costs of Glucose-Monitoring Supplies in the U.K.
Table 6.6: Annual Costs of SMBG in the U.K.
Table 6.7: Syringes for Administering Insulin
Table 6.8: Insulin Pens
Table 6.9: Injection Aids
Table 6.10: Jet Injectors
Table 6.11: External Insulin Pumps
Table 6.12: Status of Inhaled Insulin Products, 2009
Table 6.13: Insulin Delivery Device Market, 2004-2014
Table 7.1: Leading Global Medical Device Companies, 2007
Table 7.2: Imports of U.S. Medical Devices to Japan, 2005-2007
Table 8.1: Products Marketed by Abbott in the Diagnostic Market
Table 8.2: Key Roche Diagnostic Products
Table A1.1: Company Headquarters Contact Information
Table A2.1: Glucose Meters and Equipment' List of Manufacturers and Suppliers
Table A3.1: Detailed Information on Available Glucose Meters
Table A5.1: Glucose Meters' Pricing
Table A6.1: Contract Manufacturers for Glucose Meter Components
Table A6.2: ASIC manufacturers

Blood Glucose Testing and Diabetes Management

Table of Contents

1. Overview

2. Diabetes

3. Glucose Measurements

4. Business Trends in Glucose Testing

5. Important Technology Trends

6. Competitive Analysis of the Glucose Testing Markets

7. Government Regulation of Medical Devices

8. Corporate Profiles

Appendix

INDEX OF FIGURES

INDEX OF TABLES