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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 hematology instrument and reagent market is centered around a group of instruments called hematology analyzers. 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. But 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 TriMark Publications 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

• 1.Overview7
  • 1.1Objectives of the Report7
  • 1.2Methodology8
  • 1.3Scope of the Report8
  • 1.4Executive Summary9
  
  
• 2IVD Clinical Hematology Analyzer Market11
  • 2.1Introduction11
  • 2.2Key Product Segments17
    • 2.2.1Hematology and Associates Instruments17
      • 2.2.1.1Hematology Analyzers17
      • 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 Cytometry20
          • 2.2.1.3.2.1Leukocyte Analysis20
          • 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 Use24
          • 2.2.1.3.3.5Instrument Manufacturers25
          • 2.2.1.3.3.6Future Directions of Flow Cytometry26
      • 2.2.1.4Coagulation Analyzers26
        • 2.2.1.4.1Coagulation Market Size27
        • 2.2.1.4.2Prothrombin Time Test28
        • 2.2.1.4.3Activated Partial Thromboplastin Time (APTT)28
        • 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 Medical31
          • 2.2.1.4.5.3International Technidyne Corporation31
          • 2.2.1.4.5.4Cardiovascular Diagnostics32
          • 2.2.1.4.5.5Diagnostica Stago's STA-R Evolution32
          • 2.2.1.4.5.6Other Companies33
          • 2.2.1.4.5.7Coagulation Reagents34
      • 2.2.1.5Hemoglobinometers34
      • 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
    • 2.3.4Platelets39
    • 2.3.5Hematocrit (HCT)39
  • 2.4Hematology Tests39
  • 2.5The Coulter Principle40
  • 2.6Blood Collection40
  
  
• 3.IVD Clinical Hematology Analyzer Market41
  • 3.1Markets41
    • 3.1.1Global Markets41
    • 3.1.2Global Drivers of Clinical Hematology Analyzer Testing45
    • 3.1.3Global Outlook45
    • 3.1.4U.S. Market46
    • 3.1.5European Market48
      • 3.1.5.1German Clinical Hematology Analyzer and Reagent Diagnostic Markets51
      • 3.1.5.2U.K. Clinical Hematology Market53
      • 3.1.5.3French Clinical Hematology Market55
      • 3.1.5.4Italian Clinical Hematology Market55
      • 3.1.5.5Spanish Clinical Hematology Market56
      • 3.1.5.6Belgian Clinical Hematology Market56
      • 3.1.5.7Swiss Clinical Hematology Market56
      • 3.1.5.8Dutch Clinical Hematology Market57
      • 3.1.5.9Portuguese Clinical Hematology Market57
      • 3.1.5.10Austrian Clinical Hematology Market58
      • 3.1.5.11Greek Clinical Hematology Market58
      • 3.1.5.12Polish Clinical Hematology Market59
      • 3.1.5.13Czech Clinical Hematology Market59
      • 3.1.5.14Finnish Clinical Hematology Market60
      • 3.1.5.15Scandinavian Clinical Hematology Market60
    • 3.1.6 Asian Market61
      • 3.1.6.1Indian Clinical Hematology Market61
        • 3.1.6.1.1 India's in vitro Diagnostic Testing Industry61
        • 3.1.6.1.2Major Indian IVD Companies62
      • 3.1.6.2Japanese Clinical Hematology Market64
      • 3.1.6.3 Chinese Clinical Hematology Market64
    • 3.1.7Country Clinical Hematology Smaller Markets68
      • 3.1.7.1Canada Clinical Hematology Market68
      • 3.1.7.2Brazil Clinical Hematology Market68
      • 3.1.7.3Turkey Clinical Hematology Market68
      • 3.1.7.4Australia Clinical Hematology Market69
    • 3.1.8Remaining World Clinical Hematology Market69
    • 3.1.9Overview of Asian Healthcare Market70
      • 3.1.9.1 Singapore70
      • 3.1.9.2Malaysia70
      • 3.1.9.3Thailand70
      • 3.1.9.4Indonesia71
      • 3.1.9.5Philippines71
      • 3.1.9.6South Korea72
      • 3.1.9.7Hong Kong72
      • 3.1.9.8Taiwan72
    • 3.1.10Overview of the Latin American Diagnostics Market73
  • 3.2Clinical Hematology Analyzer and Reagents Sector73
    • 3.2.1Industry-Served Markets73
    • 3.2.2Industry Players75
      • 3.2.2.1Manufacturing Companies75
    • 3.2.3Market Specialization75
    • 3.2.4Hematology Sector Companies76
  • 3.3Outlook for Clinical Hematology Analyzer Testing77
    • 3.3.1Long-Term Changes77
    • 3.3.2Market Drivers78
    • 3.3.3The Limits to Growth79
    • 3.3.4Hot Sectors in the IVD Market79
    • 3.3.5Key Technologies79
    • 3.3.6Conclusion80
    
    
• 4.Clinical Hematology Instrument Market by Type and Competitor81
  • 4.1 Abbott Diagnostics81
  • 4.2 Bayer Diagnostics84
  • 4.3Beckman Coulter85
  • 4.4Drew Scientific87
  • 4.5Horiba ABX Inc.88
  • 4.6Sysmex89
  • 4.7Boule Medical94
  • 4.8Beijing Shining Sun95
  • 4.9 Hematology Analyzers for Point of Care95
  
  
• 5.Important Technology Trends97
  • 5.1Technology Platform Innovations in Hematology Testing97
  • 5.2The New Paradigm97
  • 5.3Consolidated Workstations97
  • 5.4Automation in the Laboratory99
  • 5.5Laboratory Information Systems100
  • 5.6New User-friendly Interfaces101
  • 5.7Data-Management Issues102
    • 5.7.1Wireless LANs102
    • 5.7.2Data and Workflow Management Systems103
    • 5.7.3Beckman Central Command103
    • 5.7.4Middleware104
  • 5.8 Robotics - Total Laboratory Automation Robotic Sample Handling104
  • 5.9 Image Analysis105
  • 5.10Flow Cytometry106
  • 5.11Laser Technology106
  • 5.12Automating Preanalytics106
  • 5.13 Telepathology107
  
  
• 6.Business Trends in the Clinical Hematology Analyzer Sector108
  • 6.1Key Developments108
  • 6.2Industrial Sector Consolidation108
  • 6.3Hospital and Commercial Laboratory Consolidation110
  • 6.4Changing Ordering Patterns111
  • 6.5New Products111
  • 6.6Acquisition, License Agreements, Internal Development and Partnerships114
  • 6.7Breadth of Product Offerings117
  • 6.8Government Regulation117
    • 6.8.1U.S. Regulation117
      • 6.8.1.1Importing Medical Devices into the U.S.118
      • 6.8.1.2Exporting Medical Devices from the U.S.119
    • 6.8.2U.K. Regulation120
    • 6.8.3E.U. Regulation121
    • 6.8.4Japanese Regulation123
    • 6.8.5Korean Regulation123
  • 6.9Costs of Doing Business in Europe124
  • 6.10Drivers of European Diagnostics Testing124
  • 6.11European Reimbursement Practices124
  • 6.12Cost Containment in Europe124
  • 6.13Revenue and Reimbursement124
  
  
• 7. Product Launches126
  • 7.1Horiba ABX Unveils Pentra DF 120126
  • 7.2Sysmex America Launches Software for Sysmex XE-2100 Hematology Analyzers126
  • 7.3 SurroScan™ Develops Laser Scan Cytometry System127
  • 7.4 Abbott Receives Clearance for Hematology Instrument127
  • 7.5 Clinical Data Receives FDA Clearance for Excyte128
  • 7.6 Becton Introduces FACSCanto™128
  • 7.7 Abbott's International Launch of CELL-DYN Sapphire™ Hematology Instrument128
  • 7.8 Beckman Coulter Launches LH 1500 Series128
  • 7.9Beckman Launches High-Performance Hematology Analyzer Ac•T128
  • 7.10Abbott Laboratories Released its Cell-Dyn 1800 Automated Hematology Analyzer.129
  • 7.11Becton Dickinson Biosciences' Imagn System129
  • 7.12Sysmex Network Communications System129
  • 7.13Sysmex XS-1000i Automated Hematology Analyzer129
  • 7.14The Melet Schloesing MS4-5129
  • 7.15Roche CoaguChek XS Plus System130
  • 7.16Sysmex Corp Launches KX-21130
  • 7.17Streck nRBC-Chex130
  • 7.18 HORIBA ABX Introduces Micros CRP 200130
  • 7.19 Heska Corporation Introduces Advanced Hematology Analyzer130
  • 7.20Specialized Master Software Programs for the Sysmex XE-2100 Hematology Analyzers130
  • 7.21HORIBA ABX e-Sat module130
  • 7.22Medonic M series Hematology Analyzer131
  • 7.23Streck's ESR-AutoPlus131
  • 7.24Streck Quality Control Reagents131
  
  
• 8.Clinical Hematology Testing Sector Trends and Forecasts132
  • 8.1Home Care Analysis132
  • 8.2Non-Traditional Collection for Hematology Analyzer Testing132
  • 8.3New Systems for Critical-Care and Near-Patient Testing132
  • 8.4Utility of Near-Patient Testing in Critical-Care Settings132
  • 8.5Mergers of Diagnostic Companies132
  • 8.6Information Management Advances132
  • 8.7Test Ordering Patterns132
  • 8.8Patient Satisfaction132
  • 8.9Move Away From Central Laboratory133
  • 8.10Healthcare Cost Controls133
  • 8.11Competition for Services133
  • 8.12Drivers of Clinical Hematology analyzer Testing133
  • 8.13Confluence of New Technology133
  • 8.14New Trends in Clinical Laboratory Testing134
    • 8.14.1Trends in Reimbursement Practices134
    • 8.14.2Managed Care136
    • 8.14.3Changes in Patient Management137
    • 8.14.4Focused Testing137
    • 8.14.5Satellite Facilities137
  • 8.15 Demographic Trends137
  
  
• 9.Corporate Profiles138
  • 9.1Abbott Diagnostics138
  • 9.2A.Menarini Diagnostics140
  • 9.3Bayer Diagnostics140
  • 9.4Beckman Coulter142
  • 9.5Becton Dickenson Biosciences146
  • 9.6Bio-Rad Laboratories Inc.146
  • 9.7Boule Medical AB147
  • 9.8Careside Inc.147
  • 9.9Cholestech147
  • 9.10Dade Behring148
  • 9.11HemoCue149
  • 9.12Heska Corporation150
  • 9.13Horiba Group150
  • 9.14Melet Schloesing151
  • 9.15Micronics151
  • 9.16Nihon Kohden152
  • 9.17PPD152
  • 9.18Roche Diagnostics152
  • 9.19Shenzhen Mindray Bio-Medical Electronics Co. Ltd.154
  • 9.20Streck154
  • 9.21Sysmex154
  
  
  

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, 200513

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, 2000-201023

Table 2.7:Worldwide Market for Rapid Coagulation Testing Dollar Volume, 2000-200827

Table 2.8:U.S. Market for Rapid Coagulation Testing Dollar Volume, 2000-200827

Table 2.9:U.S. Market for Rapid Coagulation POC Testing Dollar Volume, 1996-200728

Table 2.10:Slide Stainer Instruments and Manufacturers35

Table 2.11:Hematology Stains37

Table 3.1:The Overall In Vitro Diagnostic Testing Market Worldwide in 200541

Table 3.2:Worldwide Distribution of IVD Testing in 200541

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, 200542

Table 3.5:Top 15 IVD Manufacturers' Worldwide Revenue ($ Millions)43

Table 3.6Key Players in Worldwide Hematology Analyzers and Reagent Market44

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

Table 3.8:U.S. Clinical Hematology Analyzer Testing Market, 2000-201147

Table 3.9:U.S. Clinical Hematology Diagnostic Test Market Segments, 200547

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

Table 3.11:Leading Players in the U.S. Coagulation Analyzers Market48

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

Table 3.13:European Clinical Laboratory Diagnostic Testing Markets by Analyte, 200350

Table 3.14:European Clinical Laboratory Testing Diagnostics by Country Market Estimates, 200450

Table 3.15:European Clinical Hematology Instrument and Reagent Testing Market, 2000-200851

Table 3.16:German Hematology Reagent Market Sales, 2003-201252

Table 3.17:UK Hematology Reagent Market Sales, 2003-201254

Table 3.18:French Hematology Reagent Market Sales, 2003-201255

Table 3.19:Italian Hematology Reagent Market Sales, 2003-201255

Table 3.20:Spanish Hematology Reagent Market Sales, 2003-201256

Table 3.21:Belgian Hematology Reagent Market Sales, 2003-201256

Table 3.22:Swiss Hematology Reagent Market Sales, 2003-201257

Table 3.23:Dutch Hematology Reagent Market Sales, 2003-201257

Table 3.24:Portuguese Hematology Reagent Market Sales, 2003-201257

Table 3.25:Austrian Hematology Reagent Market Sales, 2003-201258

Table 3.26:Greek Hematology Reagent Market Sales, 2003-201258

Table 3.27:Polish Hematology Reagent Market Sales, 2003-201259

Table 3.28:Czech Hematology Reagent Market Sales, 2003-201259

Table 3.29:Finnish Hematology Reagent Market Sales, 2003-201260

Table 3.30:Scandinavian Clinical Hematology Diagnostics Products Market Sales, 2002-200860

Table 3.31:Indian IVD Market, 2006-201261

Table 3.32:Indian Hematology Reagent Market Sales, 2006-201261

Table 3.33:Number of Automated Clinical Labs in India, 2004-201262

Table 3.34:Indian IVD Market, 200662

Table 3.35:Market Sales of IVD Equipment and Reagents by Company in India63

Table 3.36:Japanese Clinical Hematology Testing Market, 2000-200864

Table 3.37:Chinese Clinical Hematology Reagent Market Sales, 2000-200865

Table 3.38:Canadian Clinical Hematology Testing Market, 2000-200868

Table 3.39:Brazilian Clinical Hematology Analyzer Testing Market, 2000-200868

Table 3.40:Turkish Clinical Hematology Reagents Testing Market, 2000-200869

Table 3.41:Australian Clinical Hematology Reagents Testing Market, 2000-200869

Table 3.42:The ROW Clinical Hematology Reagents Testing Market, 2000-200869

Table 3.43:Estimated Number of Clinical Laboratories in Latin America73

Table 3.44:Principal Marketers of Automated Clinical Hematology Analyzer Instruments75

Table 4.1:Linearity and Precision of Abbott CELL-DYN Hematology Analyzers83

Table 4.2:Accuracy of the Automated Differential of Abbott CELL-DYN Analyzers84

Table 4.3:Linearity and Precision of Bayer Hematology Analyzers85

Table 4.4:Accuracy of the Automated Differential of Bayer Hematology Analyzers85

Table 4.5:Linearity and Precision of Beckman Coulter Hematology Instruments87

Table 4.6:Accuracy of the Automated Differential of Beckman Coulter Hematology Analyzers87

Table 4.7:Linearity and Precision of Horiba ABX Hematology Analyzers89

Table 4.8:Accuracy of the Horiba ABX Hematology Analyzers89

Table 4.9:Linearity and Precision of Sysmex Hematology Analyzers92

Table 4.10:Accuracy of the Sysmex Hematology Analyzers92

Table 4.11:Comparison of Linearity and Precision of Top-of-the-Line Hematology Analyzers93

Table 4.12:Comparison of Accuracy of the Top-of-the-Line Hematology Analyzers93

Table 4.13:Hematology Analyzers with a 5-Part WBC Differential94

Table 4.14:Hematology Analyzers with a Three-Part WBC Differential94

Table 5.1:Applications for Wireless LAN Technology102

Table 8.1:Medicare Billing Guidelines for Multi-channel Hematology Analyzer Tests135

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