Blood Glucose Testing and Diabetes Management

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Publication Date: 2007-07-01

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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

 

  • Appendix 1:List of Competitors for Glucose Test Meters and Equipment267
  • Appendix 2:FDA Proprietary Devices for Measuring Blood Glucose275
  • Appendix 3:Overview of FDA Device Regulations283
  • Appendix 4:Retail Prices of Glucose Meters286


  • INDEX OF FIGURES

  • Figure 2.1: Demographic Changes in Diabetes Populations in 2010, 2025 and 205018
  • Figure 2.2: Annual Number of New Cases of Diagnosed Diabetes among Adults Aged 18 to 79 Years, U.S., 1997-200219
  • Figure 2.3: Crude and Age-Adjusted Incidence of Diagnosed Diabetes per 1,000 Population Aged 18 to 79 Years, U.S., 1997-200219
  • Figure 2.4: Incidence of Diagnosed Diabetes per 1,000 Population Aged 18 to 79 Years, by Age, U.S., 1997-200220
  • Figure 2.5: Age-Adjusted Incidence of Diagnosed Diabetes per 1,000 Population Aged 18 to 79 Years, by Sex, U.S., 1997-200220
  • Figure 2.6: Incidence of Diagnosed Diabetes per 1,000 Population Aged 18 to 79 Years, by Sex and Age, U.S., 1997-200221
  • Figure 2.7: Age-Adjusted Incidence of Diagnosed Diabetes per 1,000 Population Aged 18 to 79 Years, by Race, U.S., 1997-200221
  • Figure 2.8: Distribution of Duration of Diabetes Among Adults Aged 18 to 79 Years, U.S., 200222
  • Figure 2.9: Number of Hospital Discharges with Diabetes as First-Listed Diagnosis, U.S., 1980-200122
  • Figure 2.10: Crude and Age-Standardized Hospital Discharge Rates for Diabetes as First-Listed Diagnosis per 1,000 Persons in Diabetic Population, U.S., 1980-200123
  • Figure 2.11: Distribution of Age at Diagnosis of Diabetes Adults Aged 18 to 79 Years, U.S., 200223
  • Figure 2.12: Number of Adults with Diabetes Using Diabetes Medication by Type of Medication, U.S., 1997-200224
  • Figure 2.13: Age-Adjusted Percentage of Adults with Diabetes Using Diabetes Medication by Type of Medication, U.S., 1997-200224
  • Figure 2.14: Crude and Age-Adjusted Percentage of Adults with Diabetes Using Diabetes Medication, U.S., 1997-200225
  • Figure 2.15: Percentage of Adults with Diabetes Using Diabetes Medication, by Age, U.S., 1997-200226
  • Figure 2.16: How Diabetes Dollars Are Spent in the U.S.29
  • Figure 2.17: Standardized Prevalence of Diagnosed and Undiagnosed Diabetes and Impaired Fasting Glucose in the U.S. Adult Population33
  • Figure 2.18: Overlap Between Individuals Diagnosed as Diabetic According to Fasting Plasma Glucose Concentration (ADA Criteria) or the Two-Hour Glucose Value (WHO Criteria)37
  • Figure 2.19: Single Day Continuous Blood Glucose Data53
  • Figure 3.1: Share of the U.S. Self-Testing Diagnostic Market, 200665
  • Figure 3.2: U.S. Mass-Market Sales of Glucose Testing Kits, 2000-201265
  • Figure 7.1: World Medical Device Markets232
  • Figure 7.2: Medical Device Market Share by U.S. Owned Companies232


  • INDEX OF TABLES

  • Table 2.1: Normal Glucose Values-Fasting State14
  • Table 2.2: Population with Diabetes in the World and in Selected Nations, 2000 and 203016
  • Table 2.3: U.S. Population of Diabetics by Ethnic Group18
  • Table 2.4: Percentage of U.S. Adults with Diabetes Using Diabetes Medication by Age Group, 1997-200218
  • Table 2.5: Healthcare Utilization by Diabetic Patients18
  • Table 2.6: Age-Adjusted Percentage of Adults with Diabetes Using Diabetes Medication by Type of Medication U.S., 1997-200225
  • Table 2.7: Crude and Age-Adjusted Percentage of Adults with Diabetes Using Diabetes Medication, U.S., 1997-200225
  • Table 2.8: Percentages of Adults with Diabetes Using Diabetes Medication by Age, U.S., 1997-200226
  • Table 2.9: Annual Estimated Cost of U.S. Diabetes Care27
  • Table 2.10: Impact of Diabetes on Americans28
  • Table 2.11: Leading Ten Diagnoses by Total U.S. Patient Visits, 200128
  • Table 2.12: U.S. Incidence of Diabetes by Age, 200528
  • Table 2.13: Prevalence, Cost and Medicines for Major Diseases in the U.S., 200528
  • Table 2.14: Top Ten Causes of Death in the U.S., 200329
  • Table 2.15: Per-Event Costs of Diabetes Complications30
  • Table 2.16: Percentage of Persons with Type 1 Diabetes Experiencing Various Complications34
  • Table 2.17: Novel Risk Factors and Possible Mechanisms of the Excess Risk of Coronary Heart Disease in Type 2 Diabetes Mellitus35
  • Table 2.18: Average Years Gained Free of Diabetes-Related Disease with Intensive Management36
  • Table 2.19: Worldwide Market for Cardiac Care Therapeutics, 1999-201040
  • Table 2.20: Top 200 Drugs by U.S. Sales, 200341
  • Table 2.21: Major Causes of End-Stage Renal Disease47
  • Table 2.22: Key Features Considered for Glucose Meter Devices51
  • Table 3.1: Laboratory Assessment of Diabetic Vascular Disease55
  • Table 3.2: Key Market Drivers for Glucose Testing55
  • Table 3.3: Key Customer Segments of Glucose Testing55
  • Table 3.4: Demographic Characteristics Home Testing Kit Buyers56
  • Table 3.5: Top Brand Preferences for Home Glucose Testing Kits56
  • Table 3.6: Instances When Patients Prefer Professional's Glucose Testing56
  • Table 3.7: Advantages of a Home Testing Kit57
  • Table 3.8: Disadvantages of Using a Home Testing Kit57
  • Table 3.9: Popular Shopping Destinations for Buying or Seeking Information on Home Testing Kits57
  • Table 3.10: Total Dedicated U.S. Professional Glucose Testing Market, 2000-201257
  • Table 3.11: Point of Care Glucose Testing U.S. (Hospitals), 2000-201258
  • Table 3.12: U.S. POL Glucose Testing, 2000-201259
  • Table 3.13: U.S. Central Lab Glucose Testing (Hospitals and Reference Labs), 2000-201260
  • Table 3.14: Worldwide Central Lab Glucose Testing (Hospitals and Reference Labs), 2000-201260
  • Table 3.15: Worldwide Glucose Self-Testing Market Sales (Meters, Strips, Lancets), 2000-201261
  • Table 3.16: Worldwide Glucose Market for Self-Testing Sales (Meters, Strips, Lancets), 2000-201262
  • Table 3.17: Glucose Market for Self-Testing and POC Devices in the U.S., 2000-201263
  • Table 3.18: U.S. Blood Glucose Reagent Strip Market, 2000-201263
  • Table 3.19: OTC Glucose Meter U.S. Market Share for Blood Glucose Measurements64
  • Table 3.20: U.S. Diabetes Glucose Monitoring Market Repeat Retail Replacement Sales Percentages65
  • Table 3.21: Top Four Players in the U.S. Blood Glucose Strips Market (Ranked by % Sales), 200666
  • Table 3.22: Leading Blood Glucose Meters and Strips Brands in the U.S. (% Breakdown by Dollar Sales), 200666
  • Table 3.23: European Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-201267
  • Table 3.24: European Glucose Self-Testing Market by Country Market67
  • Table 3.25: Asian Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-201268
  • Table 3.26: Japanese Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-201269
  • Table 3.27: Chinese Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-201270
  • Table 3.28: China Blood Glucose Reagent Strip Market, 2000-201270
  • Table 3.29: Indian IVD Market, 2006-201272
  • Table 3.30: Number of Automated Clinical Labs in India, 2004-201272
  • Table 3.31: Indian IVD Market, 200673
  • Table 3.32: Indian Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-201273
  • Table 3.33: Indian Blood Glucose Reagent Strip Market, 2000-201274
  • Table 3.34: ROW Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-201275
  • Table 3.35: Unit Sales of Homecare Lancets in the U.S., 2000-201282
  • Table 3.36: Unit Sales of Lancets in the E.U., 2000-201282
  • Table 3.37: Dollar Sales of Lancets in the U.S., 2000-201283
  • Table 3.38: Dollar Sales of Lancets in the E.U., 2000-201283
  • Table 3.39: Unit Sales of Homecare Glucose Self-testing Lancets in the U.S., 2000-201284
  • Table 3.40: Unit Sales of Homecare Glucose Self-testing Lancets in the E.U., 2000-201284
  • Table 3.41: Competition in the Lancet Market Segment85
  • Table 3.42: Technology of Glucose Testing Instruments88
  • Table 3.43: Key Features of Reagent Test Strips89
  • Table 3.44: Limitations of Urine Glucose Monitoring91
  • Table 3.45: Advantages of Urine Glucose Monitoring91
  • Table 3.46: Blood Ketone Reading Indications92
  • Table 3.47: Customer Priorities-Glucose Meter Self-Testing Market92
  • Table 3.48: Accu-Chek Blood Glucose Monitoring Systems99
  • Table 3.49: GlucoTrack Comparison and Results118
  • Table 3.50: Relationship of A1C to Average Whole Blood and Plasma Glucose Levels140
  • Table 3.51: Distributors of Glucose Meters140
  • Table 3.52: Ultra-Large Clinical Chemistry Analyzers144
  • Table 3.53: JEOL Analyzer Comparison145
  • Table 3.54: Large Clinical Chemistry Analyzers147
  • Table 3.55: Mid-size Clinical Chemistry Analyzers150
  • Table 3.56: Small Clinical Chemistry Analyzers152
  • Table 4.1: U.S. Diabetes Glucose Monitoring Market Segments157
  • Table 4.2: Medicare Billing Guidelines for Multichannel Chemistry Tests161
  • Table 5.1: Customized Reports must Support CAP and JCAHO Requirements175
  • Table 5.2: RALS-Plus Point of Care Market Share176
  • Table 5.3: Applications of RALS Connectivity with POCT Devices177
  • Table 6.1: Comparisons of Blood Glucose Monitoring Systems192
  • Table 6.2: U.S. Diabetes Glucose Monitoring Market, 2002214
  • Table 6.3: Syringes for Administering Insulin223
  • Table 6.4: Insulin Pens224
  • Table 6.5: Injection Aids224
  • Table 6.6: Jet Injectors225
  • Table 6.7: External Insulin Pumps225
  • Table 6.8: Insulin Delivery Device Market, 2004-2014226
  • Table 8.1: Products Marketed by Abbott in the Diagnostic Market246
  • Table 8.2: Key Roche Diagnostic Products261

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