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Hemoglobin A1c Testing Market Size, Business Growth and Opportunities Report

Wednesday, October 5, 2016 1:28
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(Before It's News)

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 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.

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Major Points from Table of Contents

1. Overview 7

2. IVD Clinical Hematology Analyzer Market 11

3. Global Analyzer Market 41

4. Clinical Hematology Instrument Market by Type and Competitor 77

5. Important Technology Trends 92

6. Business Trends in the Clinical Hematology Analyzer Sector 103

7. Product Launches 120

8. Clinical Hematology Testing Sector Trends and Forecasts 126

9. Company Profiles 132

 

List of Tables

Table 2.1: Clinical Hematology Tests Submitted to Medicare, 2005-2012 12

Table 2.2: Clinical Hematology Tests Performed in the U.S., 2005-2012 12

Table 2.3: Allowed Charges for Top 25 Clinical Laboratory Procedures, 2009 13

Table 2.4: Competitive Landscape: Companies Participating in the Hematology IVD Sector 14

Table 2.5: Key Product Segments 16

Table 2.6: Worldwide Market for Flow Cytometry Instruments and Reagents, 2000-2010 24

Table 2.7: Worldwide Market for Rapid Coagulation Testing Dollar Volume, 2000-2008 28

Table 2.8: U.S. Market for Rapid Coagulation Testing Dollar Volume, 2000-2008 28

Table 2.9: U.S. Market for Rapid Coagulation POC Testing Dollar Volume, 2001-2012 28

Table 2.10: Slide Stainer Instruments and Manufacturers 35

Table 2.11: Hematology Stains 37

Table 3.1: The Overall In Vitro Diagnostic Testing Market Worldwide, 2008 41

Table 3.2: Worldwide Distribution of IVD Testing, 2008 41

Table 3.3: Global Clinical Hematology Analyzer and Reagent Revenues, 2005-2012 42

Table 3.4: Worldwide Distribution of Clinical Hematology Testing Analyzer and Reagent Revenues, 2006 42

Table 3.5: Ten Largest Diagnostic Companies Worldwide, 2007 43

Table 3.6 Key Players in Worldwide Hematology Analyzers and Reagent Market 43

Table 3.7: Leading Players in Worldwide Coagulation Analyzer and Reagent Market 44

Table 3.8: U.S. Clinical Hematology Analyzer Testing Market, 2000-2011 46

Table 3.9: U.S. Clinical Laboratory Diagnostic Test Market Segments, 2007 46

Table 3.10: Leading Players in the U.S. Hematology Analyzers Market 47

Table 3.11: Leading Players in the U.S. Coagulation Analyzers Market 47

Table 3.12: European Clinical Laboratory Testing IVD Reagents and Instruments Market, 2000-2012 49

Table 3.14: European Clinical Laboratory Testing Diagnostics by Country Market Estimates, 2007 49

Table 3.15: European Clinical Hematology Instrument and Reagent Testing Market, 2000-2008 50

Table 3.16: German Hematology Reagent Market Sales, 2003-2012 51

Table 3.17: UK Hematology Reagent Market Sales, 2003-2012 53

Table 3.18: French Hematology Reagent Market Sales, 2003-2012 53

Table 3.19: Italian Hematology Reagent Market Sales, 2003-2012 54

Table 3.20: Spanish Hematology Reagent Market Sales, 2003-2012 54

Table 3.21: Belgian Hematology Reagent Market Sales, 2003-2012 55

Table 3.22: Swiss Hematology Reagent Market Sales, 2003-2012 55

Table 3.23: Dutch Hematology Reagent Market Sales, 2003-2012 55

Table 3.24: Portuguese Hematology Reagent Market Sales, 2003-2012 56

Table 3.25: Austrian Hematology Reagent Market Sales, 2003-2012 56

Table 3.26: Greek Hematology Reagent Market Sales, 2003-2012 57

Table 3.27: Polish Hematology Reagent Market Sales, 2003-2012 57

Table 3.28: Czech Hematology Reagent Market Sales, 2003-2012 57

Table 3.29: Finnish Hematology Reagent Market Sales, 2003-2012 58

Table 3.30: Scandinavian Clinical Hematology Diagnostics Products Market Sales, 2002-2008 58

Table 3.31: Indian IVD Market, 2006-2012 59

Table 3.32: Indian Hematology Reagent Market Sales, 2006-2012 59

Table 3.33: Number of Automated Clinical Labs in India, 2004-2012 59

Table 3.34: Indian IVD Market, 2008 60

Table 3.36: Japanese Clinical Hematology Testing Market, 2000-2008 61

Table 3.37: Chinese Clinical Hematology Reagent Market Sales, 2000-2008 62

Table 3.38: Canadian Clinical Hematology Testing Market, 2000-2008 65

Table 3.39: Brazilian Clinical Hematology Analyzer Testing Market, 2000-2008 65

Table 3.40: Turkish Clinical Hematology Reagents Testing Market, 2000-2008 66

Table 3.41: Australian Clinical Hematology Reagents Testing Market, 2000-2008 66

Table 3.42: The ROW Clinical Hematology Reagents Testing Market, 2000-2008 66

Table 3.43: Estimated Number of Clinical Laboratories in Latin America 69

Table 3.44: Principal Marketers of Automated Clinical Hematology Analyzer Instruments 71

Table 4.1: Linearity and Precision of Abbott CELL-DYN Hematology Analyzers 79

Table 4.2: Accuracy of the Automated Differential of Abbott CELL-DYN Analyzers 80

Table 4.3: Linearity and Precision of Siemens Hematology Analyzers 81

Table 4.4: Accuracy of the Automated Differential of Siemens Hematology Analyzers 81

Table 4.5: Linearity and Precision of Beckman Coulter Hematology Instruments 83

Table 4.6: Accuracy of the Automated Differential of Beckman Coulter Hematology Analyzers 83

Table 4.7: Linearity and Precision of Horiba ABX Hematology Analyzers 85

Table 4.8: Accuracy of the Horiba ABX Hematology Analyzers 85

Table 4.9: Linearity and Precision of Sysmex Hematology Analyzers 88

Table 4.10: Accuracy of the Sysmex Hematology Analyzers 88

Table 4.11: Comparison of Linearity and Precision of Top-of-the-Line Hematology Analyzers 89

Table 4.12: Comparison of Accuracy of the Top-of-the-Line Hematology Analyzers 89

Table 4.13: Hematology Analyzers with a 5-Part WBC Differential 90

Table 4.14: Hematology Analyzers with a Three-Part WBC Differential 90

Table 5.1: Applications for Wireless LAN Technology 97

Table 8.1: Medicare Billing Guidelines for Multi-channel Hematology Analyzer Tests 129

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