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Blood Glucose Testing and Diabetes Management

TriMark Publications
February 1, 2012
261 Pages - SKU: TRI6822260

Abstract Table of Contents Related Reports

Blood Glucose Testing and Diabetes Management

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.

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; 2.2 Understanding the Metabolic Conditions Underlying and Associated with; Diabetes; 2.3 Economics of Diabetes
3. Market Analysis: Size, Growth, Share and Competitors: 3.1 Worldwide Glucose Testing Market; 3.2 U.S. Market; 3.3 European Market; 3.4 Asian Market; 3.5 Competitive Situation; 3.6 Market Drivers and Restraints; 3.7 Market and Product 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; 4.4 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; 5.3 Development of Blood Glucose Monitors: A Historical Evaluation; 5.4 Accuracy and Precision in Glucose Meters; 5.5 Key Issues for Glucose Testing Devices; 5.6 Limitations of Existing 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; 5.11 Summary of Technologies Being Explored for Non-Invasive Glucose Monitoring; 5.12 A1c Monitoring Technology; 5.13 Related Reagents and Equipment
6. Glucose Testing Devices on the Market: 6.1 Hand-Held Blood Glucose Meters and Strips for Self-testing; 6.2 Hand-Held Blood Glucose Meters for Professional Use; 6.3 Clinical Blood Chemistry Analyzers; 6.4 Continuous Glucose Patient Monitoring Systems; 6.5 Non-Invasive Glucose Patient Monitoring Systems; 6.6 A1c Testing; 6.7 New Product Launches; 6.8 New Blood Glucose Meters and Data Management Software in Development; 6.9 Recent Industry Activity; 6.10 M&A Activity
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; 8.5 Non-Traditional Methods for Sample Collection; 8.6 Data Management
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 GluMetrics; 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; Figure 2.2: Worldwide Prevalence of Diabetes (%) in Adults (20-79 Years), 2011; Figure 2.3: Prevalence of Diabetes by Age in the U.S., 2010; Figure 2.4: New Cases of Diabetes Diagnosed in the U.S. Adult Population, 2010; Figure 2.5: County-specific Diabetes Prevalence in the U.S., 2008; Figure 2.6: Rate of New Diabetes Cases Among Children in the U.S., 2007; Figure 2.7: Diabetes Death Rate by Race and Sex in the U.S., 1979-2006; Figure 2.8: Maintenance of Normal Blood Sugar Levels; Figure 2.9: Obesity (BMI ³ 30) Prevalence in U.S. Adults, 2010; 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; 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; Figure 2.12: Trends in Obesity Among Children and Adolescents in the U.S.,; 1963-2008; Figure 2.13: Mean Diabetes Healthcare-related Expenditures Per Adult (20-79; Years) with Diabetes (USD), 2011; Figure 2.14: How Diabetes Dollars are Spent in the U.S., 2007; Figure 3.1: Worldwide Diabetes Monitoring Market Segments, 2011; Figure 3.2: Global Unit Sales of Glucose Testing Reagent Strips, 2011; Figure 3.3: Geographic Segments of the Worldwide Glucose Self-testing Market,; 2010 and 2015; Figure 3.4: Worldwide Glucose Self-Testing Market by Region, 2015; Figure 3.5: Continuous Glucose Market Growth Rates by Region, 2009-2018; Figure 3.6: U.S. Blood Glucose Reagent Strip Market, 2005-2015; Figure 4.1: 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, 2011
INDEX OF TABLES: Table 2.1: Regional Estimates of the Number of Diabetes (20-79 Years) in; Millions, 2011 and 2030; Table 2.2: Countries with the Largest Numbers of Diabetics, 2011; Table 2.3: Countries with the Largest Estimated Numbers of Diabetics, 2030; Table 2.4: Worldwide Undiagnosed Diabetes in Adults (20-79 Years) by Region and; Income Group, 2011; Table 2.5: U.S. Population of Diabetics (Diagnosed and Undiagnosed) Aged 20; Years or Older, 2010; Table 2.6: U.S. Incidence of Diagnosed Diabetes by Age, 2009; Table 2.7: Ten Leading Diagnoses for Co-Morbid Chronic Diseases in the U.S., by; Percentage of Patient Visits, 2006; Table 2.8: Odds Ratio of Progression to Complications Associated with Type 2; Diabetes; Table 2.9: Prevalence of Complications Among Patients with Diabetes; Table 2.10: Novel Risk Factors and Possible Mechanisms of the Excess Risk of; Coronary Heart Disease in Type 2 Diabetes Mellitus; Table 2.11: Major Causes of End-stage Renal Disease; Table 2.12: Clinical Recommendations for Adults with Diabetes; Table 2.13: Laboratory Assessment of Diabetic Vascular Disease; Table 2.14: Average Years Gained Free of Diabetes-related Disease with Intensive; Management; Table 2.15: Estimated Direct and Indirect Costs of Major Cardiovascular Diseases; and Stroke in the U.S., 2008; Table 2.16: Worldwide Market for Cardiac Care Therapeutics, 2003-2010; Table 2.17: Top 20 Drugs for 2010 by U.S. Sales; Table 2.18: Cost of Diagnosed Diabetes in the U.S., 2007; Table 2.19: Cost of Diagnosed Type 1 and Type 2 Diabetes in the U.S., 2007; Table 2.20: Medical Care Costs Attributable to Diabetes in the U.S., 2010; Table 2.21: Healthcare Utilization by Diabetic Patients, 2008; Table 2.22: Annual Cost of Care of United Healthcare Adult Members with; Diabetes, 2009; Table 2.23: Per-Event Costs of Diabetes Complications; Table 3.1: Worldwide Glucose Testing Market ($ Billions), 2010-2016; Table 3.2: Total Global Unit Demand for Glucose Testing Reagent Strips,; 2010-2016; Table 3.3: Global Dollar Sales of Glucose Testing Reagent Strips, 2010-2016; Table 3.4: Worldwide Glucose Self-Testing Market Sales (Meters and Strips),; 2010-2016; Table 3.5: World Market Share of Glucose Self-testing Marketers, 2011; Table 3.6: Global Professional Glucose Testing Market, 2010-2016; Table 3.7: U.S. Glucose Testing Market (Meters and Strips), 2010-2016; Table 3.8: U.S. Blood Glucose Reagent Strip Market, 2005-2015; Table 3.9: Market for Glucose Self-Testing in the U.S., 2010-2016; Table 3.10: Market Share of U.S. Blood Glucose Self-Testing, 2011; Table 3.11: U.S. OTC Glucose Self-Testing Market Repeat Retail Replacement Sales; Percentages; Table 3.12: OTC Blood Glucose Instrument Reagents by Manufacturer Retail; Table 3.13: Demographic Characteristics Glucose Self-Testing Kit Buyers; Table 3.14: Top Brand Preferences for Glucose Self-Testing Kits; Table 3.15: Instances when Patients Prefer Professional’s Glucose Testing; Table 3.16: Advantages of a Glucose Self-Testing Kit; Table 3.17: Disadvantages of Using a Glucose Self-Testing Kit; Table 3.18: Popular Shopping Destinations for Buying or Seeking Information on; Glucose Self-Testing Kits; Table 3.19: Customer Priorities—Glucose Meter Self-Testing Market, 2001, 2006; and 2012; Table 3.20: Market for Professional Glucose Testing in the U.S., 2010-2016; Table 3.21: European Glucose Testing Market (Meters and Strips), 2010-2016; Table 3.22: Asian Glucose Testing Market (Meter and Strips), 2010-2016; Table 3.23: Japanese Glucose Testing Market (Meters and Strips), 2010-2016; Table 3.24: Chinese Glucose Testing Market (Meters and Strips), 2010-2016; Table 3.25: Indian Glucose Testing Market (Meters, Strips), 2010-2016; Table 3.26: Number of Clinical Labs in India, 2008; Table 3.27: Top Domestic IVD Companies in India; Table 3.28: Leading Global IVD Companies in India; Table 3.29: Southeast Asian Glucose Testing Market (Meters and Strips),; 2010-2016; Table 3.30: Southeast Asian Glucose Testing Market by Country (Meters and; Strips), 2011; Table 3.31: ROW Glucose Testing Market (Meters, Strips), 2010-2016; Table 3.32: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and; Threats of the Glucose Point-of-Care Market; Table 3.33: Key Market Drivers for Glucose Testing; Table 3.34: Market Drivers for Continuous Glucose Monitoring; Table 3.35: Point-of-Care Glucose Testing Market: Market Drivers Ranked in Order; of Impact; Table 3.36: Key Market Restraints for Glucose Testing; Table 3.37: Market Restraints for Continuous Glucose Monitoring; Table 3.38: 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: Glycemic Recommendations for Non-Pregnant Adults with Diabetes; Table 4.5: Glycemic Recommendations for Women with Gestational Diabetes; Table 4.6: Glycemic Recommendations for Pregnant Women with Pre-existing; Diabetes; Table 4.7: Glucose Monitoring Recommendations; Table 4.8: Percentage of Hypothetical Patients that Diabetes Educator’s Would; Recommend CGM, 2007-2009; Table 4.9: A1c Testing Recommendations; Table 4.10: Correlation of A1c with Mean Blood Glucose; Table 5.1: Analytic Performance Criteria for Glucose Self-Testing 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: Key Features Considered for Reagent Test Strips; Table 5.8: Differences between Laboratory Instruments for Glucose Analysis and; Hand-Held Blood Glucose Meters; Table 5.9: Relationship of A1c to Average Whole Blood and Plasma Glucose Levels; Table 5.10: Unit Sales of Homecare Lancets in the U.S., 2010-2015; Table 5.11: Unit Sales of Homecare Lancets in the E.U., 2010-2015; Table 5.12: Dollar Sales of Homecare Lancets in the U.S., 2010-2015; Table 5.13: Dollar Sales of Homecare Lancets in the E.U., 2010-2015; Table 5.14: Unit Sales of Homecare Glucose Self-Testing Lancets in the U.S.,; 2010-2015; Table 5.15: Unit Sales of Homecare Glucose Self-Testing Lancets in the E.U.,; 2010-2015; Table 5.16: Competition in the Lancet Market Segment; Table 5.17: Limitations of Urine Glucose Monitoring; Table 5.18: Advantages of Urine Glucose Monitoring; Table 5.19: Blood Ketone Reading Indications; Table 6.1: Current Blood Glucose Self-testing Meters: Sample Size, Test Time,; and Other Features; Table 6.2: Hand-Held 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: Medicare Billing Guidelines for Multi-Channel Chemistry Tests; Table 7.3: 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 World Patient Monitoring Products in the U.S. Market; Table 8.3: Customized Reports Must Support CAP and JCAHO Requirements; Table 9.1: Abaxis Blood Analysis Diagnostic Tests; Table 9.2: Reagent Discs Offered with the Piccolo Chemistry Analyzers; Table 9.3: Products Marketed by Abbott in the Diagnostic Market

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