Blood Glucose Testing and Diabetes Management

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Publication Date: 2009-04-02

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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 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.

Table of Contents

 

  • Appendix 1: Contact Information for Companies Profiled315
  • Appendix 2: List of Competitors for Glucose Test Meters and Equipment322
  • Appendix 3: FDA Proprietary Devices for Measuring Blood Glucose331
  • Appendix 4: Overview of FDA Device Regulations340
  • Appendix 5: Retail Prices of Glucose Meters343
  • Appendix 6: Glucose Meters: Components, Design, Sources348
  • Appendix 7: Pharmaceutical Sampling Practices354


  • INDEX OF FIGURES

  • Figure 2.1: Worldwide Rates of Diabetes Cases, 2000-202518
  • Figure 2.2: Prevalence of Diabetes by Age in the U.S., 200720
  • Figure 2.3: New Cases of Diabetes Diagnosed in the U.S. Adult Population, 200721
  • Figure 2.4: Rate of New Diabetes Cases among Children in the U.S., 200722
  • Figure 2.5: Diabetes Death Rate by Race and Sex in the U.S., 1979-200625
  • Figure 2.6: Annual Death Rate of U.S. Population from Heart Disease, 1950-200826
  • Figure 2.7: How Diabetes Dollars Are Spent in the U.S., 200729
  • Figure 2.8: Percentage Breakdown of U.S. Healthcare Spending, 200830
  • Figure 2.9: Percentage of U.S. Population that is Overweight, 1976-200432
  • Figure 2.10: Hypertension Drugs Newly Prescribed or Continued in the U.S., 1994-200740
  • Figure 3.1: Glucose Self-Monitoring Market Share by Geographical Region, 200755
  • Figure 3.2: Share of the U.S. Self-Testing Diagnostic Market, 200859
  • Figure 3.3: Domestic Manufacturers\' Share of Chinese Glucose Meter Market, 200765
  • Figure 3.4: Personal Lancet Unit Sales Market Share by Geographic Region, 200883
  • Figure 3.5: Estimated U.S. Inpatient Volume, 2008154


  • INDEX OF TABLES

  • Table 2.1: Normal Glucose Values-Fasting State16
  • Table 2.2: Countries with the Largest Numbers of Diabetics, 2007 and 202518
  • Table 2.3: U.S. Population of Diabetics (Diagnosed and Undiagnosed) by Ethnic Group, 200720
  • Table 2.4: Healthcare Utilization by Diabetic Patients, 200620
  • Table 2.5: Cost of Diabetes in the U.S., 200723
  • Table 2.6: Ten Leading Diagnoses for Co-morbid Chronic Diseases in the U.S., by Percentage of Patient Visits, 200624
  • Table 2.7: U.S. Incidence of Diagnosed Diabetes by Age, 200624
  • Table 2.8: Prevalence and Financial Burden of Major Diseases in the U.S., 200724
  • Table 2.9: Top Twelve Causes of Death in the U.S., 200625
  • Table 2.10: Death Rate from Cardiovascular Diseases by Country, 200826
  • Table 2.11: Life Expectancy Rate by Country, 200827
  • Table 2.12: Per-Event Costs of Diabetes Complications28
  • Table 2.13: Odds Ratio of Progression to Complications Associated With Type 2 Diabetes34
  • Table 2.14: Prevalence of Complications among Patients with Diabetes34
  • Table 2.15: Novel Risk Factors and Possible Mechanisms of the Excess Risk of Coronary Heart Disease in Type 2 Diabetes Mellitus35
  • Table 2.16: Average Years Gained Free of Diabetes-Related Disease with Intensive Management35
  • Table 2.17: Estimated Direct and Indirect Costs of Major Cardiovascular Diseases and Stroke in the U.S., 200838
  • Table 2.18: Worldwide Market for Cardiac Care Therapeutics, 2003-201039
  • Table 2.19: Top 20 Drugs for 2007 by U.S. Sales41
  • Table 2.20: Major Causes of End-Stage Renal Disease43
  • Table 2.21: Key Features Considered for Glucose Meter Devices46
  • Table 3.1: Laboratory Assessment of Diabetic Vascular Disease51
  • Table 3.2: Key Market Drivers for Glucose Testing51
  • Table 3.3: Key Aspects of Professional Glucose Testing51
  • Table 3.4: Demographic Characteristics Home Testing Kit Buyers52
  • Table 3.5: Top Brand Preferences for Home Glucose Testing Kits52
  • Table 3.6: Instances When Patients Prefer Professional Glucose Testing52
  • Table 3.7: Advantages of a Home Testing Kit53
  • Table 3.8: Disadvantages of Using a Home Testing Kit53
  • Table 3.9: Popular Shopping Destinations for Buying or Seeking Information on Home Testing Kits53
  • Table 3.10: Total Global Professional Glucose Testing Market, 2007-201253
  • Table 3.11: Worldwide Glucose Self-Testing Market Sales (Meters, Strips, Lancets), 2004-201255
  • Table 3.12: Percentage of GDP Healthcare Spending by Country, 200856
  • Table 3.13: Worldwide Glucose Market for Self-Testing Sales (Meters and Strips), 2004-201256
  • Table 3.14: U.S. Blood Glucose Reagent Strip Market, 2004-201357
  • Table 3.15: U.S. Sales for OTC Blood Glucose Meters and Strips, 200758
  • Table 3.16: Top Four Players in the U.S. Blood Glucose Strips Market (Ranked by % Sales), 200859
  • Table 3.17: European Glucose Self-Testing Market (Meters, Strips, Lancets), 2003-201260
  • Table 3.18: Asian Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-201261
  • Table 3.19: Japanese Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-201262
  • Table 3.20: Chinese Glucose Self-Testing (Meters, Strips, Lancets) Market and Professional POC Devices, 2000-201264
  • Table 3.21: China Blood Glucose Reagent Strip Market, 2000-201264
  • Table 3.22: Indian IVD Market, 2006-201267
  • Table 3.23: Number of Clinical Labs in India, 200868
  • Table 3.24: Indian IVD Market Sectors and Market Share, 200669
  • Table 3.25: Indian Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-201269
  • Table 3.26: Indian Blood Glucose Reagent Strip Market, 2000-201270
  • Table 3.27: Top Domestic IVD Companies in India71
  • Table 3.28: Leading Global IVD Companies in India, 200871
  • Table 3.29: BRIC countries, Percentage of GDP Spent on Healthcare, 200872
  • Table 3.30: ROW Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-201274
  • Table 3.31: Global Unit Sales of Home care Lancets, 2006-201281
  • Table 3.32: Dollar Sales of Lancets in the U.S., 2000-201281
  • Table 3.33: Dollar Sales of Lancets in the E.U., 2000-201281
  • Table 3.34: Unit Sales of Homecare Glucose Self-testing Lancets in the U.S., 2000-201282
  • Table 3.35: Unit Sales of Homecare Glucose Self-testing Lancets in the E.U., 2000-201282
  • Table 3.36: Competition in the Lancet Market Segment83
  • Table 3.37: Currently Available Lancing Devices and Lancets85
  • Table 3.38: Customer Priorities-Glucose Meter Self-Testing Market, 2001-201288
  • Table 3.39: Current Blood Glucose Meters: Pricing, Sample Size, Features88
  • Table 3.40: Technology of Glucose Testing Instruments90
  • Table 3.41: Key Features of Reagent Test Strips93
  • Table 3.42: Limitations of Urine Glucose Monitoring96
  • Table 3.43: Advantages of Urine Glucose Monitoring96
  • Table 3.44: Blood Ketone Reading Indications97
  • Table 3.45: Accu-Chek Blood Glucose Monitoring Systems103
  • Table 3.46: GlucoTrack Comparison and Results116
  • Table 3.47: Home Diagnostics\' Current Product Portfolio132
  • Table 3.48: Detailed Features of Selected CGM Systems Currently Available140
  • Table 3.49: Relationship of A1C to Average Whole Blood and Plasma Glucose Levels152
  • Table 3.50: Distributors of Glucose Meters153
  • Table 3.51: Ultra-Large Clinical Chemistry Analyzers157
  • Table 3.52: JEOL Analyzer Comparison158
  • Table 3.53: Large Clinical Chemistry Analyzers160
  • Table 3.54: Mid-size Clinical Chemistry Analyzers163
  • Table 3.55: Small Clinical Chemistry Analyzers166
  • Table 4.1: Medicare Billing Guidelines for Multichannel Chemistry Tests177
  • Table 5.1: Customized Reports Must Support CAP and JCAHO Requirements198
  • Table 5.2: Applications of RALS Connectivity with POCT Devices198
  • Table 6.1: Comparisons of Blood Glucose Monitoring Systems220
  • Table 6.2: Major Lancing Devices on the Market224
  • Table 6.3: Glucose Meters Offering Data Management225
  • Table 6.4: Comparison of A1C Home Test Kits.240
  • Table 6.5: Unit Costs of Glucose-Monitoring Supplies in the U.K.247
  • Table 6.6: Annual Costs of SMBG in the U.K.247
  • Table 6.7: Syringes for Administering Insulin253
  • Table 6.8: Insulin Pens253
  • Table 6.9: Injection Aids254
  • Table 6.10: Jet Injectors254
  • Table 6.11: External Insulin Pumps255
  • Table 6.12: Status of Inhaled Insulin Products, 2009257
  • Table 6.13: Insulin Delivery Device Market, 2004-2014258
  • Table 7.1: Leading Global Medical Device Companies, 2007264
  • Table 7.2: Imports of U.S. Medical Devices to Japan, 2005-2007275
  • Table 8.1: Products Marketed by Abbott in the Diagnostic Market289
  • Table 8.2: Key Roche Diagnostic Products310
  • Table A1.1: Company Headquarters Contact Information315
  • Table A2.1: Glucose Meters and Equipment- List of Manufacturers and Suppliers322
  • Table A3.1: Detailed Information on Available Glucose Meters331
  • Table A5.1: Glucose Meters\' Pricing343
  • Table A6.1: Contract Manufacturers for Glucose Meter Components351
  • Table A6.2: ASIC manufacturers353

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