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Hemoglobin A1c (HbA1c) testing is the most recent major technology to have entered the diabetes testing market. As the global prevalence of diabetes mellitus continues to increase rapidly, with more than 366 million diabetics worldwide, hemoglobin A1c testing is now an essential assay in the diabetes testing repertoire. Its clinical utility and improvements in its accuracy and implementation of standardized protocols have translated into continued market growth.
This TriMark Publications report describes the specific market segment that encompasses hemoglobin A1c testing for diagnosing and monitoring diabetes. The study reviews all of the generally accepted clinical analytical methods that are currently in use today for measuring HbA1c levels. Moreover, it examines clinical measurement devices and reagents as utilized in hospitals, clinics, doctor's offices and at-home care locations. The report also analyzes almost all of the companies known to be marketing, manufacturing or developing hemoglobin A1c testing. Detailed tables and charts with sales forecasts and marketshare data are also included.
TABLE OF CONTENTS 1. Overview 61.1 Statement of Reprt 61.2 About this Report 71.3 Scope of the Report 71.4 Methodology 81.5 Executive Summary 92. Diabetes 122.1 Demographics of Diabetes 132.1.1 Worldwide Diabetes Incidence 132.1.2 Diabetes in the U.S. 162.2 Understanding the Metabolic Conditions Underlying and Associated with Diabetes 192.2.1 Pre-Diabetes Syndrome 212.2.2 Metabolic Syndrome 212.2.3 Progression of Diabetes 212.2.4 Diabetes and Inflammation 212.2.5 Risk Factors and Diabetes 126.96.36.199 Obesity 188.8.131.52 Stress-Induced Hyperglycemia 252.2.6 Complications and Co-Morbidities in Diabetes 252.2.6.1 Preventing Complications and Co-Morbidities in Diabetes 2184.108.40.206 Cardiovascular Disease Facts 302.3 Economics of Diabetes 333. Market Analysis: Size, Growth, Share and Competitors 383.1 Worldwide HbA1c Testing Market 393.1.1 U.S. HbA1c Testing Market 403.2 HbA1c Self-Testing Market 413.3 Competitive Situation 433.3.1 Analyses of the Key Players, Current Market Conditions, and Product Mix 433.3.2 Competitive Strategies and Strategic Recommendations 443.3.3 Future Competing Technologies—Glycated Albumin 453.4 Market Drivers and Restraints 463.4.1 Market Drivers 463.4.2 Market Restraints 463.5 Market and Product Trends 473.5.1 Increase in POC AC1 Testing 473.5.2 Move Towards Screening for Diabetes Using HbA1c Assays 483.6 Adjacent Markets 484. Overview of HbA1c Testing 494.1 Technology Platforms Used to Measure HbA1c 504.1.1 High-Performance Liquid Chromatography (HPLC) 504.1.2 Immunoassays 504.1.3 Boronate Affinity Chromatography 504.1.4 Enzymatic Assay 514.1.5 Micro-Optical Detection Methods 514.2 Development of HbA1c Testing: A Historical Evaluation 514.2.1 The Diabetes Control and Complications Trial (DCCT) 514.3 Standardization of HbA1c Testing and Certification Criteria 524.3.1 National Glycohemoglobin Standardization Program (NGSP) 524.3.2 International Federation of Clinical Chemistry (IFCC) 534.3.3 New NGSP Certification Criteria Beginning in September 534.3.4 ADAG (A1c Derived Average Glucose) 534.3.5 2010 Consensus Statement on the Worldwide Standardization of HbA1c 534.3.6 College of American Pathologists (CAP) Proficiency Program 544.3.7 Certifications and Selecting HbA1c Assays 544.4 Advantages and Disadvantages of HbA1c Assessment 544.5 HbA1c Testing Recommendations 564.5.1 Frequency of HbA1c Testing 564.5.2 Diagnostic HbA1c Testing 574.5.3 Screening for Pre-diabetes 594.5.4 HbA1c Testing for Diabetes Management and Glycemic Goals 594.6 Accuracy and Precision in HbA1c Testing 604.6.1 Biological Variation 604.6.2 Pre-Analytical Variation 614.6.3 Analytical Variation 614.7 Potential Interfering Variables Affecting HbA1c Testing 634.8 Potential Areas of Improvement in HbA1c Testing Performance 644.9 Optimizing of Point of Care (POC) HbA1c Testing 654.10 Key Issues for HbA1c Testing 654.11 HbA1c Testing and Blood Glucose Testing: Complementary Tools 665. HbA1c Testing Devices on the Market 685.1 HbA1c Self-Testing Devices 695.1.1 A1CNow SELFCHECK 695.1.2 DTI Laboratories, Inc. 695.1.3 Flexsite Diagnostics, Inc. 705.1.4 Heritage Labs International 705.2 Professional HbA1c Testing Devices 705.2.1 Point of Care HbA1c Testing 705.2.1.1 Axis-Shield (now part of Alere) 705.2.1.2 Bio-Rad 7220.127.116.11 DiaSys Diagnostic Systems 718.104.22.168 Diazyme Laboratories 722.214.171.124 EKF Diagnostics 7126.96.36.199 Infopia 7188.8.131.52 Siemens Healthcare Diagnostics 725.2.2 HbA1c Laboratory Testing 7184.108.40.206 Abbott 7220.127.116.11 Arkray 718.104.22.168
Beckman Coulter 722.214.171.124 Bio-Rad 7126.96.36.199 Diazyme Laboratories 7188.8.131.52 EKF Diagnostics 7184.108.40.206 Ortho Clinical Diagnostics (part of Johnson & Johnson) 7220.127.116.11 Pointe Scientific, Inc. 718.104.22.168 Randox Laboratories 722.214.171.124 Roche 7126.96.36.199 Siemens Healthcare Diagnostics 7188.8.131.52 Tosoh 7184.108.40.206 Trinity Biotech 775.3 New Product Innovations and Introductions 785.3.1 Trinity Biotech Launches the Premier Hb9210 785.3.2 Siemens Healthcare Announced a New Version of the DCA Vantage Analyzer 785.3.3 EKF Diagnostics to Launch the Quo-Lab HbA1c 785.3.4 Trivitron to Enter HbA1c Market 795.3.5 Tosoh Introduces the ST AIA-PACK HbA1c Assay 795.3.6 Tosoh Introduces a Comprehensive HbA1c Product Line 795.3.7 Axis-Shield Introduces the Afinion II 805.3.8 Infopia Obtains CE Certification of HbA1c Analyzer 805.3.9 Bio-Rad Introduces the in2it Analyzer 805.4 Recent Industry Activity & Corporate Developments 805.4.1 Axis-Shield Acquired by Alere 805.4.2 EKF Diagnostics Opens New Manufacturing Facility at its Quotient Diagnostics Base 805.4.3 EKF Diagnostics Acquires Quotient Diagnostics 805.4.4 Beckman Coulter Acquires Olympus' Lab-based Diagnostics Business 815.4.5 Trinity Biotech Acquires Primus Corporation 815.4.6 Geonostics Acquires FlexSite's Diagnostics 815.4.7 Trinity Biotech Signs Distribution Agreements with Fisher and Menarini Diagnostics 815.4.8 Bayer Divests Diagnostics Division to Siemens 815.4.9 Bayer Diabetes Care Acquires Metrika, Inc. 81
5.4.10 Sysmex America and Bio-Rad Sign Long-term Distribution Agreement 826. Business Trends in HbA1c Testing 836.1 Drivers and Trends of Clinical HbA1c Testing 836.2 Healthcare Cost Controls 836.3 Affordable Care Act Excise Tax on Medical Devices 836.4 Changes in Patient Management 846.5 Regionalization of Laboratory Care 846.6 Satellite Facilities 856.7 Point of Care Testing 866.7.1 Key Issues in the POC Diagnostic Testing Sector 866.7.2 Current Market Trends and Drivers 866.7.3 Effectiveness of POCT 896.7.4 Key Customer Segments 896.8 Factors Affecting OTC Medical Product Distribution 896.9 Drivers and Restraints of OTC and Self-Testing HbA1c Markets 917. Regulatory Environment and Insurance Reimbursements 927.1 U.S. Government Regulation of Medical Devices 927.2 FDA Labeling Requirements 937.3 Clinical Laboratory Improvement Act (CLIA) 937.4 HbA1c Testing Insurance Coverage and Reimbursement 967.5 Trends in U.S. Laboratory Testing Reimbursement Practices 977.6 Managed Care 988. Company Profiles 998.1 Abbott Laboratories 998.2 A. Menarini Diagnostics 1028.3 Alere, Inc. 1028.4 ARKRAY
USA, Inc. 1038.5 Axis-Shield Plc 1038.6 Bayer Healthcare Diagnostics 1048.7
Beckman Coulter, Inc 1068.8 Bio-Rad Laboratories, Inc. 1108.9 EKF Diagnostics 1118.10 Infopia Co., Ltd. 1128.11 Ortho Clinical Diagnostics (part of Johnson & Johnson) 1128.12 Quotient Diagnostics 1128.13 Randox Laboratories 1138.14 Roche Diagnostics 1138.15 Siemens AG 1158.16 Tosoh Bioscience, Inc. 1158.17 Trinity Biotech Plc 115
INDEX OF FIGURESFigure 2.1: Worldwide Diabetes Cases, 2011 and 2030 13Figure 2.2: Worldwide Prevalence of Diabetes (%) in Adults (20-79 Years), 2011 14Figure 2.3: Prevalence of Diabetes by Age in the U.S., 2010 17Figure 2.4: New Cases of Diabetes Diagnosed in the U.S. Adult Population, 2010 17Figure 2.5: County-specific Diabetes Prevalence in the U.S., 2008 18Figure 2.6: Maintenance of Normal Blood Sugar Levels 20Figure 2.7: Obesity (BMI =30) Prevalence in U.S. Adults, 2010 23Figure 2.8: Percentage of Obese Adults in the U.S., 2009-2010 24Figure 2.9: Percentage of Obese Children and Adolescents in the U.S., 2009-2010 24Figure 2.10: Trends in Obesity Among Children and Adolescents in the U.S., 1963-2008 25Figure 2.11: Relative Risk of Diabetes Complications by Mean HbA1c 27Figure 2.12: Mean Diabetes Healthcare-related Expenditures Per Adult (20-79 Years) with Diabetes (USD), 2011 34Figure 3.1: Worldwide HbA1c Testing Market, 2008-2017 40Figure 3.2: U.S. HbA1c Testing Market, 2008-2017 41Figure 3.3: Global HbA1c Self-Testing Market, 2008-2017 42Figure 4.1: Non-Enzymatic Glycation of Hemoglobin 49Figure 4.2: Boronate Affinity Binding of Glycated Protein 51Figure 4.3: Comparison of HbA1C and Blood Glucose Measurements over a Four-Day Period 55Figure 4.4: Range of Variation in HbA1c Assay 62Figure 4.5: Range of Variation in the FPG Assay 62Figure 7.1: CLIA Laboratories by Certificate Types 94
INDEX OF TABLESTable 2.1: Regional Estimates of the Number of Diabetes (20-79 Years), 2011 and 2030 14Table 2.2: Countries with the Largest Numbers of Diabetics, 2011 15Table 2.3: Countries with the Largest Estimated Numbers of Diabetics, 2030 15Table 2.4: Worldwide Undiagnosed Diabetes in Adults (20-79 Years) by Region and Income Group, 2011 16Table 2.5: U.S. Population of Diabetics (Diagnosed and Undiagnosed) Aged 20 Years or Older, 2010 17Table 2.6: U.S. Incidence of Diagnosed Diabetes by Age, 2009 19Table 2.7: Ten Leading Diagnoses for Co-Morbid Chronic Diseases in the U.S. 26Table 2.8: Odds Ratio of Progression to Complications Associated with Type 2 Diabetes 27Table 2.9: Prevalence of Complications Among Patients with Diabetes 27Table 2.10: Novel Risk Factors and Possible Mechanisms of the Excess Risk of Coronary Heart Disease in Type 2 Diabetes Mellitus 28Table 2.11: Major Causes of End-Stage Renal Disease 28Table 2.12: Clinical Recommendations for Adults with Diabetes 29Table 2.13: Laboratory Assessment of Diabetic Vascular Disease 29Table 2.14: Average Years Gained Free of Diabetes-related Disease with Intensive Management 29Table 2.15: Estimated Direct and Indirect Costs of Major Cardiovascular Diseases and Stroke in the U.S., 2008 31Table 2.16: Worldwide Market for Cardiac Care Therapeutics, 2003-2010 31Table 2.17: Top 20 Drugs for 2010 by U.S. Sales 32Table 2.18: Cost of Diagnosed Diabetes in the U.S., 2007 34Table 2.19: Medical Care Costs Attributable to Diabetes in the U.S., 2010 35Table 2.20: Healthcare Utilization by Diabetic Patients, 2008 35Table 2.21: Per-Event Costs of Diabetes Complications 36Table 2.22: Annual Cost of Care of United Healthcare Adult Members with Diabetes, 2009 36Table 3.1: Worldwide HbA1c Testing Market, 2008-2017 39Table 3.2: U.S. HbA1c Testing Market, 2008-2017 41Table 3.3: Global HbA1c Self-Testing Market, 2008-2017 42Table 3.4: Key Players in the HbA1c Clinical Laboratory Market 43Table 3.5: Key Players in the HbA1c POC Market 44Table 3.6: Key Players in the HbA1c Self-Testing Market 44Table 3.7: Key Market Drivers for HbA1c Testing 46Table 4.1: Summary of the 2010 Consensus Statement on the Worldwide Standardization of HbA1c 53Table 4.2: Advantages of HbA1c versus Blood Glucose Testing 55Table 4.3: Disadvantages of HbA1c versus Blood Glucose Testing 56Table 4.4: HbA1c Testing Recommendations 56Table 4.5: Criteria for the Diagnosis of Diabetes 57Table 4.6: Categories of Increased Risk for Diabetes (Pre-Diabetes) 57Table 4.7: Glycemic Recommendations for Non-Pregnant Adults with Diabetes 59Table 4.8: Glycemic Recommendations for Women with Gestational Diabetes 60Table 4.9: Glycemic Recommendations for Pregnant Women with Pre-existing Diabetes 60Table 4.10: Conditions Known to Interfere with HbA1c Assays 63Table 4.11: Interference from Hb Variants in Select HbA1c Testing Systems 64Table 4.12: History of NGSP Manufacturer Certification Criteria 65Table 4.13: Correlation of HbA1c with Mean Blood Glucose 67Table 5.1: HbA1c Testing Devices and Assays on the Market 68Table 7.1: Financial Comparison for Moderate and Waived CLIA Labs 95
To order this report: Pathology Industry: Hemoglobin A1c Testing Markets
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