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Hematology Analyzer Instrumentation and Reagent Markets

Clinical hematology analyzer analysis is one of the oldest and most important sectors of clinical laboratory analysis. The term clinical hematology analyzer usually refers to an automated instrument for determining the presence, number and type of cellular elements in easily collected body fluids, such as blood. However, it is not necessarily limited to these determinations.

The hematology analysis always includes determination of non-cellular parameters in blood, such as hemoglobin and hematocrit. Other closely related areas of clinical interest are coagulation and flow cytometry. In fact, traditional specialization barriers, such as microbiology, hematology, blood banking, immunology and even anatomical pathology are rapidly fading both operationally and instrumentally.

For the sake of defining the subject to a reasonable size, the more traditional scope of clinical hematology analyzer will be the focus of this examination.

The purpose of this report is to describe the specific segments of the global clinical hematology analyzer instrumentation and reagent marketplace.

The review covers those segments that are highly active in terms of innovation and growth. Specifically, this study examines the markets for small-lab, as well as highly-automated large-lab, platforms and accessory equipment, such as reagents, supplies and add-on equipment from original equipment manufacturers.

This review attempts to answer the following questions:

• Which companies are the key players?
• What are the opportunities in clinical hematology analyzer instrumentation?
• What are the development trends in hematology?
• Where are the new market growth areas in hematology instruments?
• What are the most favored technology platforms for hematology instruments?
• Where is the hematology analyzer instrument technology taking us?
• How is immunological technology blending with hematology analyzer?

Table of Contents

TABLE OF CONTENTS

• 1.Overview7
  • 1.1Objectives of the Report7
  • 1.2Methodology8
  • 1.3Scope of the Report9
  • 1.4Executive Summary10
  
  
• 2.IVD Clinical Hematology Analyzer Market11
  • 2.1Introduction11
  • 2.2Key Product Segments16
    • 2.2.1Hematology and Associates Instruments16
      • 2.2.1.1Hematology Analyzers16
      • 2.2.1.2Hematology Instruments Offerings by Major Players17
        • 2.2.1.2.1Hematology Reagents and Controls18
        • 2.2.1.2.2Hematology Point of Care Instruments19
      • 2.2.1.3Flow Cytometers20
        • 2.2.1.3.1Flow Cytometry Technology Platforms20
        • 2.2.1.3.2Clinical Applications of Flow Cytometry21
          • 2.2.1.3.2.1Leukocyte Analysis21
          • 2.2.1.3.2.2Immunophenotyping of Leukemias and Lymphomas21
          • 2.2.1.3.2.3Neutropenia21
          • 2.2.1.3.2.4Platelet Analysis21
          • 2.2.1.3.2.5T Cell Subsets22
          • 2.2.1.3.2.6Reticulocyte Count22
        • 2.2.1.3.3Flow Cytometry Market Growth22
          • 2.2.1.3.3.1Applications23
          • 2.2.1.3.3.2Market Size23
          • 2.2.1.3.3.3Instrumentation Preferences24
          • 2.2.1.3.3.4Reagent Selection and Use25
          • 2.2.1.3.3.5Instrument Manufacturers25
          • 2.2.1.3.3.6Future Directions of Flow Cytometry26
      • 2.2.1.4Coagulation Analyzers27
        • 2.2.1.4.1Coagulation Market Size27
        • 2.2.1.4.2Prothrombin Time Test28
        • 2.2.1.4.3Activated Partial Thromboplastin Time (APTT)29
        • 2.2.1.4.4Clinical Advantages of Coagulation Testing29
        • 2.2.1.4.5Coagulation Instruments30
          • 2.2.1.4.5.1Roche Diagnostics30
          • 2.2.1.4.5.2Avocet Medical (Acquired by Beckman Coulter, Inc.)31
          • 2.2.1.4.5.3International Technidyne Corporation (ITC)31
          • 2.2.1.4.5.4Diagnostica Stago\'s STA-RE Evolution32
          • 2.2.1.4.5.5Other Companies32
          • 2.2.1.4.5.6Coagulation Reagents33
      • 2.2.1.5Hemoglobinometers33
      • 2.2.1.6Slide Stainers34
      • 2.2.1.7Differential Counters36
      • 2.2.1.8Hematology Stains37
  • 2.3Blood Components37
    • 2.3.1Complete Blood Count (CBC)37
    • 2.3.2Red Blood Cells (RBCs)38
    • 2.3.3White Blood Cells (WBCs)38
    • 2.3.4Platelets38
    • 2.3.5Hematocrit (HCT)39
  • 2.4Hematology Tests39
  • 2.5The Coulter Principle40
  • 2.6Blood Collection40
  
  
• 3.Global Analyzer Market41
  • 3.1Global Markets41
    • 3.1.1Global Drivers of Clinical Hematology Analyzer Testing44
    • 3.1.2Global Outlook45
    • 3.1.3U.S. Market46
    • 3.1.4European Market48
      • 3.1.5.1German Clinical Hematology Analyzer and Reagent Diagnostic Markets50
      • 3.1.5.2U.K. Clinical Hematology Market52
      • 3.1.5.3French Clinical Hematology Market53
      • 3.1.5.4Italian Clinical Hematology Market54
      • 3.1.5.5Spanish Clinical Hematology Market54
      • 3.1.5.6Belgian Clinical Hematology Market54
      • 3.1.5.7Swiss Clinical Hematology Market55
      • 3.1.5.8Dutch Clinical Hematology Market55
      • 3.1.5.9Portuguese Clinical Hematology Market56
      • 3.1.5.10Austrian Clinical Hematology Market56
      • 3.1.5.11Greek Clinical Hematology Market56
      • 3.1.5.12Polish Clinical Hematology Market57
      • 3.1.5.13Czech Clinical Hematology Market57
      • 3.1.5.14Finnish Clinical Hematology Market58
      • 3.1.5.15Scandinavian Clinical Hematology Market58
    • 3.1.6 Asian Market58
      • 3.1.6.1Indian Clinical Hematology Market58
        • 3.1.6.1.1 India\'s in vitro Diagnostic Testing Industry58
        • 3.1.6.1.2Major Indian IVD Companies60
      • 3.1.6.2Japanese Clinical Hematology Market61
      • 3.1.6.3 Chinese Clinical Hematology Market61
    • 3.1.7Country Clinical Hematology Smaller Markets65
      • 3.1.7.1Canada Clinical Hematology Market65
      • 3.1.7.2Brazil Clinical Hematology Market65
      • 3.1.7.3Turkey Clinical Hematology Market66
      • 3.1.7.4Australia Clinical Hematology Market66
    • 3.1.8Remaining World Clinical Hematology Market66
    • 3.1.9Overview of Asian Healthcare Market67
      • 3.1.9.1 Singapore67
      • 3.1.9.2Malaysia67
      • 3.1.9.3Thailand67
      • 3.1.9.4Indonesia68
      • 3.1.9.5Philippines68
      • 3.1.9.6South Korea68
      • 3.1.9.7Hong Kong69
    • 3.1.10Overview of the Latin American Diagnostics Market69
  • 3.2Clinical Hematology Analyzer and Reagents Sector70
    • 3.2.1Industry-Served Markets70
    • 3.2.2Industry Players71
      • 3.2.2.1Manufacturing Companies71
    • 3.2.3Market Specialization72
    • 3.2.4Hematology Sector Companies72
  • 3.3Outlook for Clinical Hematology Analyzer Testing73
    • 3.3.1Long-Term Changes73
    • 3.3.2Market Drivers75
    • 3.3.3The Limits to Growth75
    • 3.3.4Hot Sectors in the IVD Market75
    • 3.3.5Key Technologies76
    • 3.3.6Conclusion76
    
    
• 4.Clinical Hematology Instrument Market by Type and Competitor77
  • 4.1 Abbott Diagnostics77
  • 4.2 Siemens Healthcare Diagnostics80
  • 4.3Beckman Coulter, Inc.81
  • 4.4Drew Scientific Group83
  • 4.5Horiba ABX Inc.84
  • 4.6Sysmex Corporation85
  • 4.7Boule Medical AB90
  • 4.8Beijing ShiningSun Technology Co., Ltd.91
  • 4.9 Hematology Analyzers for Point of Care91
  
  
• 5.Important Technology Trends92
  • 5.1Technology Platform Innovations in Hematology Testing92
  • 5.2The New Paradigm92
  • 5.3Consolidated Workstations92
  • 5.4Automation in the Laboratory94
  • 5.5Laboratory Information Systems95
  • 5.6New User-friendly Interfaces96
  • 5.7Data-Management Issues97
    • 5.7.1Wireless LANs97
    • 5.7.2Data and Workflow Management Systems98
    • 5.7.3Beckman Central Command Central Version 2.098
    • 5.7.4Middleware98
  • 5.8 Robotics - Total Laboratory Automation Robotic Sample Handling99
  • 5.9 Image Analysis100
  • 5.10Flow Cytometry100
  • 5.11Laser Technology101
  • 5.12Automating Preanalytics101
  • 5.13 Telepathology101
  
  
• 6.Business Trends in the Clinical Hematology Analyzer Sector103
  • 6.1Key Developments103
  • 6.2Industrial Sector Consolidation103
  • 6.3Hospital and Commercial Laboratory Consolidation105
  • 6.4Changing Ordering Patterns106
  • 6.5New Products106
  • 6.6Acquisition, License Agreements, Internal Development and Partnerships108
  • 6.7Breadth of Product Offerings111
  • 6.8Government Regulation111
    • 6.8.1U.S. Regulation111
      • 6.8.1.1Importing Medical Devices into the U.S.112
      • 6.8.1.2Exporting Medical Devices from the U.S.113
    • 6.8.2U.K. Regulation113
    • 6.8.3E.U. Regulation114
    • 6.8.4Japanese Regulation117
    • 6.8.5Korean Regulation117
  • 6.9Costs of Doing Business in Europe118
  • 6.10Drivers of European Diagnostics Testing118
  • 6.11European Reimbursement Practices118
  • 6.12Cost Containment in Europe118
  • 6.13 Revenue and Reimbursement118
  
  
• 7. Product Launches120
  • 7.1Horiba ABX Unveils Pentra DX 120120
  • 7.2Sysmex to Launch Sales of the XT-4000i Hematology Analyzers120
  • 7.3 Laser Scan Cytometry System121
  • 7.4 Abbott Receives Clearance for Hematology Instrument121
  • 7.5 Vital Diagnostics announced the Addition of the Excyte Mini Automated ESR Analyzer121
  • 7.6 Becton Introduces FACSCanto II121
  • 7.7 Abbott\'s International Launch of CELL-DYN Emerald™ Hematology Instrument122
  • 7.8 Beckman Coulter Launches UniCel DxH 800122
  • 7.9Beckman Launches High-Performance Hematology Analyzer Ac•T123
  • 7.10Abbott Laboratories Released its Cell-Dyn 1800 Automated Hematology Analyzer.123
  • 7.11BD (Becton Dickinson Biosciences) Imagn System123
  • 7.12Sysmex Network Communications System123
  • 7.13Sysmex XT-V Multi-Species Hematology Analyzer123
  • 7.14The Melet Schloesing MS4-5124
  • 7.15Roche CoaguChek XS Plus System124
  • 7.16Sysmex Corp Launches KX-4500124
  • 7.17Streck nRBC-Chex124
  • 7.18 HORIBA ABX Introduces Micros CRP 200124
  • 7.19 Heska Corporation Introduces Veterinary Hematology Analyzer124
  • 7.20Specialized Master Software Programs for the Sysmex XE-2100 Hematology Analyzers125
  • 7.21HORIBA ABX e-Sat module125
  • 7.22Medonic M series Hematology Analyzer125
  • 7.23Streck\'s ESR-AutoPlus125
  • 7.24Streck Quality Control Reagents125
  
  
• 8.Clinical Hematology Testing Sector Trends and Forecasts126
  • 8.1Home Care Analysis126
  • 8.2Non-Traditional Collection for Hematology Analyzer Testing126
  • 8.3New Systems for Critical-Care and Near-Patient Testing126
  • 8.4Utility of Near-Patient Testing in Critical-Care Settings126
  • 8.5Mergers of Diagnostic Companies126
  • 8.6Information Management Advances126
  • 8.7Test Ordering Patterns126
  • 8.8Patient Satisfaction126
  • 8.9Move Away From Central Laboratory127
  • 8.10Healthcare Cost Controls127
  • 8.11Competition for Services127
  • 8.12Drivers of Clinical Hematology analyzer Testing127
  • 8.13Confluence of New Technology127
  • 8.14New Trends in Clinical Laboratory Testing128
    • 8.14.1Trends in Reimbursement Practices128
    • 8.14.2Managed Care130
    • 8.14.3Changes in Patient Management131
    • 8.14.4Focused Testing131
    • 8.14.5Satellite Facilities131
  • 8.15 Demographic Trends131
  
  
• 9.Company Profiles132
  • 9.1Abbott Diagnostics132
  • 9.2A.Menarini Diagnostics133
  • 9.3Bayer HealthCare, AG134
  • 9.4Beckman Coulter, Inc.135
  • 9.5Becton Dickenson Biosciences139
  • 9.6Boule Diagnostics International AB140
  • 9.7Cholestech Corporation140
  • 9.8Dade Behring (Acquired by Siemens)141
  • 9.9HemoCue, Inc.141
  • 9.10Heska Corporation141
  • 9.11Horiba Group142
  • 9.12MELET SCHLOESING Laboratories142
  • 9.13Micronics, Inc.143
  • 9.14Nihon Kohden Corporation143
  • 9.15PPD (Pharmaceutical Product Development, Inc.)144
  • 9.16Roche Diagnostics (F. Hoffmann-La Roche, Ltd.)144
  • 9.17Shenzhen Mindray Bio-Medical Electronics Co. Ltd.145
  • 9.18Streck, Inc.145
  • 9.19Sysmex Corporation146
  
  
  

LIST OF TABLES

Table 2.1:Clinical Hematology Tests Submitted to Medicare, 2005-201212

Table 2.2:Clinical Hematology Tests Performed in the U.S., 2005-201212

Table 2.3:Allowed Charges for Top 25 Clinical Laboratory Procedures, 200913

Table 2.4:Competitive Landscape: Companies Participating in the Hematology IVD Sector14

Table 2.5:Key Product Segments16

Table 2.6:Worldwide Market for Flow Cytometry Instruments and Reagents, 2000-201024

Table 2.7:Worldwide Market for Rapid Coagulation Testing Dollar Volume, 2000-200828

Table 2.8:U.S. Market for Rapid Coagulation Testing Dollar Volume, 2000-200828

Table 2.9:U.S. Market for Rapid Coagulation POC Testing Dollar Volume, 2001-201228

Table 2.10:Slide Stainer Instruments and Manufacturers35

Table 2.11:Hematology Stains37

Table 3.1:The Overall In Vitro Diagnostic Testing Market Worldwide, 200841

Table 3.2:Worldwide Distribution of IVD Testing, 200841

Table 3.3:Global Clinical Hematology Analyzer and Reagent Revenues, 2005-201242

Table 3.4:Worldwide Distribution of Clinical Hematology Testing Analyzer and Reagent Revenues, 200642

Table 3.5:Ten Largest Diagnostic Companies Worldwide, 200743

Table 3.6Key Players in Worldwide Hematology Analyzers and Reagent Market43

Table 3.7:Leading Players in Worldwide Coagulation Analyzer and Reagent Market44

Table 3.8:U.S. Clinical Hematology Analyzer Testing Market, 2000-201146

Table 3.9:U.S. Clinical Laboratory Diagnostic Test Market Segments, 200746

Table 3.10:Leading Players in the U.S. Hematology Analyzers Market47

Table 3.11:Leading Players in the U.S. Coagulation Analyzers Market47

Table 3.12:European Clinical Laboratory Testing IVD Reagents and Instruments Market, 2000-201249

Table 3.14:European Clinical Laboratory Testing Diagnostics by Country Market Estimates, 200749

Table 3.15:European Clinical Hematology Instrument and Reagent Testing Market, 2000-200850

Table 3.16:German Hematology Reagent Market Sales, 2003-201251

Table 3.17:UK Hematology Reagent Market Sales, 2003-201253

Table 3.18:French Hematology Reagent Market Sales, 2003-201253

Table 3.19:Italian Hematology Reagent Market Sales, 2003-201254

Table 3.20:Spanish Hematology Reagent Market Sales, 2003-201254

Table 3.21:Belgian Hematology Reagent Market Sales, 2003-201255

Table 3.22:Swiss Hematology Reagent Market Sales, 2003-201255

Table 3.23:Dutch Hematology Reagent Market Sales, 2003-201255

Table 3.24:Portuguese Hematology Reagent Market Sales, 2003-201256

Table 3.25:Austrian Hematology Reagent Market Sales, 2003-201256

Table 3.26:Greek Hematology Reagent Market Sales, 2003-201257

Table 3.27:Polish Hematology Reagent Market Sales, 2003-201257

Table 3.28:Czech Hematology Reagent Market Sales, 2003-201257

Table 3.29:Finnish Hematology Reagent Market Sales, 2003-201258

Table 3.30:Scandinavian Clinical Hematology Diagnostics Products Market Sales, 2002-200858

Table 3.31:Indian IVD Market, 2006-201259

Table 3.32:Indian Hematology Reagent Market Sales, 2006-201259

Table 3.33:Number of Automated Clinical Labs in India, 2004-201259

Table 3.34:Indian IVD Market, 200860

Table 3.36:Japanese Clinical Hematology Testing Market, 2000-200861

Table 3.37:Chinese Clinical Hematology Reagent Market Sales, 2000-200862

Table 3.38:Canadian Clinical Hematology Testing Market, 2000-200865

Table 3.39:Brazilian Clinical Hematology Analyzer Testing Market, 2000-200865

Table 3.40:Turkish Clinical Hematology Reagents Testing Market, 2000-200866

Table 3.41:Australian Clinical Hematology Reagents Testing Market, 2000-200866

Table 3.42:The ROW Clinical Hematology Reagents Testing Market, 2000-200866

Table 3.43:Estimated Number of Clinical Laboratories in Latin America69

Table 3.44:Principal Marketers of Automated Clinical Hematology Analyzer Instruments71

Table 4.1:Linearity and Precision of Abbott CELL-DYN Hematology Analyzers79

Table 4.2:Accuracy of the Automated Differential of Abbott CELL-DYN Analyzers80

Table 4.3:Linearity and Precision of Siemens Hematology Analyzers81

Table 4.4:Accuracy of the Automated Differential of Siemens Hematology Analyzers81

Table 4.5:Linearity and Precision of Beckman Coulter Hematology Instruments83

Table 4.6:Accuracy of the Automated Differential of Beckman Coulter Hematology Analyzers83

Table 4.7:Linearity and Precision of Horiba ABX Hematology Analyzers85

Table 4.8:Accuracy of the Horiba ABX Hematology Analyzers85

Table 4.9:Linearity and Precision of Sysmex Hematology Analyzers88

Table 4.10:Accuracy of the Sysmex Hematology Analyzers88

Table 4.11:Comparison of Linearity and Precision of Top-of-the-Line Hematology Analyzers89

Table 4.12:Comparison of Accuracy of the Top-of-the-Line Hematology Analyzers89

Table 4.13:Hematology Analyzers with a 5-Part WBC Differential90

Table 4.14:Hematology Analyzers with a Three-Part WBC Differential90

Table 5.1:Applications for Wireless LAN Technology97

Table 8.1:Medicare Billing Guidelines for Multi-channel Hematology Analyzer Tests129

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