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Hematology Analyzer Instrumentation and Reagent Markets


Publication Date   January 2007
Publisher   TriMark Publications
Product Type   Report
Pages   156
ISBN Number   TMRHEMA07-0124
Product Code   TRI065
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Summary


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 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.

Content


  • 1. Overview
    • 1.1 Objectives of the Report
    • 1.2 Methodology
    • 1.3 Scope of the Report
    • 1.4 Executive Summary
  • 2 IVD Clinical Hematology Analyzer Market
    • 2.1 Introduction
    • 2.2 Key Product Segments
      • 2.2.1 Hematology and Associates Instruments
        • 2.2.1.1 Hematology Analyzers
        • 2.2.1.2 Hematology Instruments Offerings by Major Players
        • 2.2.1.2.1 Hematology Reagents and Controls
        • 2.2.1.2.2 Hematology Point of Care Instruments
        • 2.2.1.3 Flow Cytometers
        • 2.2.1.3.1 Flow Cytometry Technology Platforms
        • 2.2.1.3.2 Clinical Applications of Flow Cytometry
        • 2.2.1.3.2.1 Leukocyte Analysis
        • 2.2.1.3.2.2 Immunophenotyping of Leukemias and Lymphomas
        • 2.2.1.3.2.3 Neutropenia
        • 2.2.1.3.2.4 Platelet Analysis
        • 2.2.1.3.2.5 T Cell Subsets
        • 2.2.1.3.2.6 Reticulocyte Count
        • 2.2.1.3.3 Flow Cytometry Market Growth
        • 2.2.1.3.3.1 Applications
        • 2.2.1.3.3.2 Market Size
        • 2.2.1.3.3.3 Instrumentation Preferences
        • 2.2.1.3.3.4 Reagent Selection and Use
        • 2.2.1.3.3.5 Instrument Manufacturers
        • 2.2.1.3.3.6 Future Directions of Flow Cytometry
        • 2.2.1.4 Coagulation Analyzers
        • 2.2.1.4.1 Coagulation Market Size
        • 2.2.1.4.2 Prothrombin Time Test
        • 2.2.1.4.3 Activated Partial Thromboplastin Time (APTT)
        • 2.2.1.4.4 Clinical Advantages of Coagulation Testing
        • 2.2.1.4.5 Coagulation Instruments
        • 2.2.1.4.5.1 Roche Diagnostics
        • 2.2.1.4.5.2 Avocet Medical
        • 2.2.1.4.5.3 International Technidyne Corporation
        • 2.2.1.4.5.4 Cardiovascular Diagnostics
        • 2.2.1.4.5.5 Diagnostica Stago's STA-R Evolution
        • 2.2.1.4.5.6 Other Companies
        • 2.2.1.4.5.7 Coagulation Reagents
        • 2.2.1.5 Hemoglobinometers
        • 2.2.1.6 Slide Stainers
        • 2.2.1.7 Differential Counters
        • 2.2.1.8 Hematology Stains
    • 2.3 Blood Components
      • 2.3.1 Complete Blood Count (CBC)
      • 2.3.2 Red Blood Cells (RBCs)
      • 2.3.3 White Blood Cells (WBCs)
      • 2.3.4 Platelets
      • 2.3.5 Hematocrit (HCT)
    • 2.4 Hematology Tests
    • 2.5 The Coulter Principle
    • 2.6 Blood Collection
  • 3. IVD Clinical Hematology Analyzer Market
    • 3.1 Markets
      • 3.1.1 Global Markets
      • 3.1.2 Global Drivers of Clinical Hematology Analyzer Testing
      • 3.1.3 Global Outlook
      • 3.1.4 U.S. Market
      • 3.1.5 European Market
        • 3.1.5.1 German Clinical Hematology Analyzer and Reagent Diagnostic Markets
        • 3.1.5.2 U.K. Clinical Hematology Market
        • 3.1.5.3 French Clinical Hematology Market
        • 3.1.5.4 Italian Clinical Hematology Market
        • 3.1.5.5 Spanish Clinical Hematology Market
        • 3.1.5.6 Belgian Clinical Hematology Market
        • 3.1.5.7 Swiss Clinical Hematology Market
        • 3.1.5.8 Dutch Clinical Hematology Market
        • 3.1.5.9 Portuguese Clinical Hematology Market
        • 3.1.5.10 Austrian Clinical Hematology Market
        • 3.1.5.11 Greek Clinical Hematology Market
        • 3.1.5.12 Polish Clinical Hematology Market
        • 3.1.5.13 Czech Clinical Hematology Market
        • 3.1.5.14 Finnish Clinical Hematology Market
        • 3.1.5.15 Scandinavian Clinical Hematology Market
      • 3.1.6 Asian Market
        • 3.1.6.1 Indian Clinical Hematology Market
        • 3.1.6.1.1 India's in vitro Diagnostic Testing Industry
        • 3.1.6.1.2 Major Indian IVD Companies
        • 3.1.6.2 Japanese Clinical Hematology Market
        • 3.1.6.3 Chinese Clinical Hematology Market
      • 3.1.7 Country Clinical Hematology Smaller Markets
        • 3.1.7.1 Canada Clinical Hematology Market
        • 3.1.7.2 Brazil Clinical Hematology Market
        • 3.1.7.3 Turkey Clinical Hematology Market
        • 3.1.7.4 Australia Clinical Hematology Market
      • 3.1.8 Remaining World Clinical Hematology Market
      • 3.1.9 Overview of Asian Healthcare Market
        • 3.1.9.1 Singapore
        • 3.1.9.2 Malaysia
        • 3.1.9.3 Thailand
        • 3.1.9.4 Indonesia
        • 3.1.9.5 Philippines
        • 3.1.9.6 South Korea
        • 3.1.9.7 Hong Kong
        • 3.1.9.8 Taiwan
      • 3.1.10 Overview of the Latin American Diagnostics Market
    • 3.2 Clinical Hematology Analyzer and Reagents Sector
      • 3.2.1 Industry-Served Markets
      • 3.2.2 Industry Players
        • 3.2.2.1 Manufacturing Companies
      • 3.2.3 Market Specialization
      • 3.2.4 Hematology Sector Companies
    • 3.3 Outlook for Clinical Hematology Analyzer Testing
      • 3.3.1 Long-Term Changes
      • 3.3.2 Market Drivers
      • 3.3.3 The Limits to Growth
      • 3.3.4 Hot Sectors in the IVD Market
      • 3.3.5 Key Technologies
      • 3.3.6 Conclusion
  • 4. Clinical Hematology Instrument Market by Type and Competitor
    • 4.1 Abbott Diagnostics
    • 4.2 Bayer Diagnostics
    • 4.3 Beckman Coulter
    • 4.4 Drew Scientific
    • 4.5 Horiba ABX Inc.
    • 4.6 Sysmex
    • 4.7 Boule Medical
    • 4.8 Beijing Shining Sun
    • 4.9 Hematology Analyzers for Point of Care
  • 5. Important Technology Trends
    • 5.1 Technology Platform Innovations in Hematology Testing
    • 5.2 The New Paradigm
    • 5.3 Consolidated Workstations
    • 5.4 Automation in the Laboratory
    • 5.5 Laboratory Information Systems
    • 5.6 New User-friendly Interfaces
    • 5.7 Data-Management Issues
      • 5.7.1 Wireless LANs
      • 5.7.2 Data and Workflow Management Systems
      • 5.7.3 Beckman Central Command
      • 5.7.4 Middleware
    • 5.8 Robotics - Total Laboratory Automation Robotic Sample Handling
    • 5.9 Image Analysis
    • 5.10 Flow Cytometry
    • 5.11 Laser Technology
    • 5.12 Automating Preanalytics
    • 5.13 Telepathology
  • 6. Business Trends in the Clinical Hematology Analyzer Sector
    • 6.1 Key Developments
    • 6.2 Industrial Sector Consolidation
    • 6.3 Hospital and Commercial Laboratory Consolidation
    • 6.4 Changing Ordering Patterns
    • 6.5 New Products
    • 6.6 Acquisition, License Agreements, Internal Development and Partnerships
    • 6.7 Breadth of Product Offerings
    • 6.8 Government Regulation
      • 6.8.1 U.S. Regulation
        • 6.8.1.1 Importing Medical Devices into the U.S.
        • 6.8.1.2 Exporting Medical Devices from the U.S.
      • 6.8.2 U.K. Regulation
      • 6.8.3 E.U. Regulation
      • 6.8.4 Japanese Regulation
      • 6.8.5 Korean Regulation
    • 6.9 Costs of Doing Business in Europe
    • 6.10 Drivers of European Diagnostics Testing
    • 6.11 European Reimbursement Practices
    • 6.12 Cost Containment in Europe
    • 6.13 Revenue and Reimbursement
  • 7. Product Launches
    • 7.1 Horiba ABX Unveils Pentra DF 120
    • 7.2 Sysmex America Launches Software for Sysmex XE-2100 Hematology Analyzers
    • 7.3 SurroScan Develops Laser Scan Cytometry System
    • 7.4 Abbott Receives Clearance for Hematology Instrument
    • 7.5 Clinical Data Receives FDA Clearance for Excyte
    • 7.6 Becton Introduces FACSCanto
    • 7.7 Abbott's International Launch of CELL-DYN Sapphire Hematology Instrument
    • 7.8 Beckman Coulter Launches LH 1500 Series
    • 7.9 Beckman Launches High-Performance Hematology Analyzer AcT
    • 7.10 Abbott Laboratories Released its Cell-Dyn 1800 Automated Hematology Analyzer.
    • 7.11 Becton Dickinson Biosciences' Imagn System
    • 7.12 Sysmex Network Communications System
    • 7.13 Sysmex XS-1000i Automated Hematology Analyzer
    • 7.14 The Melet Schloesing MS4-5
    • 7.15 Roche CoaguChek XS Plus System
    • 7.16 Sysmex Corp Launches KX-21
    • 7.17 Streck nRBC-Chex
    • 7.18 HORIBA ABX Introduces Micros CRP 200
    • 7.19 Heska Corporation Introduces Advanced Hematology Analyzer
    • 7.20 Specialized Master Software Programs for the Sysmex XE-2100 Hematology Analyzers
    • 7.21 HORIBA ABX e-Sat module
    • 7.22 Medonic M series Hematology Analyzer
    • 7.23 Streck's ESR-AutoPlus
    • 7.24 Streck Quality Control Reagents
  • 8. Clinical Hematology Testing Sector Trends and Forecasts
    • 8.1 Home Care Analysis
    • 8.2 Non-Traditional Collection for Hematology Analyzer Testing
    • 8.3 New Systems for Critical-Care and Near-Patient Testing
    • 8.4 Utility of Near-Patient Testing in Critical-Care Settings
    • 8.5 Mergers of Diagnostic Companies
    • 8.6 Information Management Advances
    • 8.7 Test Ordering Patterns
    • 8.8 Patient Satisfaction
    • 8.9 Move Away From Central Laboratory
    • 8.10 Healthcare Cost Controls
    • 8.11 Competition for Services
    • 8.12 Drivers of Clinical Hematology analyzer Testing
    • 8.13 Confluence of New Technology
    • 8.14 New Trends in Clinical Laboratory Testing
      • 8.14.1 Trends in Reimbursement Practices
      • 8.14.2 Managed Care
      • 8.14.3 Changes in Patient Management
      • 8.14.4 Focused Testing
      • 8.14.5 Satellite Facilities
    • 8.15 Demographic Trends
  • 9. Corporate Profiles
    • 9.1 Abbott Diagnostics
    • 9.2 A.Menarini Diagnostics
    • 9.3 Bayer Diagnostics
    • 9.4 Beckman Coulter
    • 9.5 Becton Dickenson Biosciences
    • 9.6 Bio-Rad Laboratories Inc.
    • 9.7 Boule Medical AB
    • 9.8 Careside Inc.
    • 9.9 Cholestech
    • 9.10 Dade Behring
    • 9.11 HemoCue
    • 9.12 Heska Corporation
    • 9.13 Horiba Group
    • 9.14 Melet Schloesing
    • 9.15 Micronics
    • 9.16 Nihon Kohden
    • 9.17 PPD
    • 9.18 Roche Diagnostics
    • 9.19 Shenzhen Mindray Bio-Medical Electronics Co. Ltd.
    • 9.20 Streck
    • 9.21 Sysmex
  • List Of Tables
    • Table 2.1: Clinical Hematology Tests Submitted to Medicare, 2005-2012
    • Table 2.2: Clinical Hematology Tests Performed in the U.S., 2005-2012
    • Table 2.3: Allowed Charges for Top 25 Clinical Laboratory Procedures, 2005
    • Table 2.4: Competitive Landscape: Companies Participating in the Hematology IVD Sector
    • Table 2.5: Key Product Segments
    • Table 2.6: Worldwide Market for Flow Cytometry Instruments and Reagents, 2000-2010
    • Table 2.7: Worldwide Market for Rapid Coagulation Testing Dollar Volume, 2000-2008
    • Table 2.8: U.S. Market for Rapid Coagulation Testing Dollar Volume, 2000-2008
    • Table 2.9: U.S. Market for Rapid Coagulation POC Testing Dollar Volume, 1996-2007
    • Table 2.10: Slide Stainer Instruments and Manufacturers
    • Table 2.11: Hematology Stains
    • Table 3.1: The Overall In Vitro Diagnostic Testing Market Worldwide in 2005
    • Table 3.2: Worldwide Distribution of IVD Testing in 2005
    • Table 3.3: Global Clinical Hematology Analyzer and Reagent Revenues, 2005-2012
    • Table 3.4: Worldwide Distribution of Clinical Hematology Testing Analyzer and Reagent Revenues, 2005
    • Table 3.5: Top 15 IVD Manufacturers' Worldwide Revenue ($ Millions)
    • Table 3.6 Key Players in Worldwide Hematology Analyzers and Reagent Market
    • Table 3.7: Leading Players in Worldwide Coagulation Analyzer and Reagent Market
    • Table 3.8: U.S. Clinical Hematology Analyzer Testing Market, 2000-2011
    • Table 3.9: U.S. Clinical Hematology Diagnostic Test Market Segments, 2005
    • Table 3.10: Leading Players in the U.S. Hematology Analyzers Market
    • Table 3.11: Leading Players in the U.S. Coagulation Analyzers Market
    • Table 3.12: European Clinical Laboratory Testing IVD Reagents and Instruments Market, 2000-2012
    • Table 3.13: European Clinical Laboratory Diagnostic Testing Markets by Analyte, 2003
    • Table 3.14: European Clinical Laboratory Testing Diagnostics by Country Market Estimates, 2004
    • Table 3.15: European Clinical Hematology Instrument and Reagent Testing Market, 2000-2008
    • Table 3.16: German Hematology Reagent Market Sales, 2003-2012
    • Table 3.17: UK Hematology Reagent Market Sales, 2003-2012
    • Table 3.18: French Hematology Reagent Market Sales, 2003-2012
    • Table 3.19: Italian Hematology Reagent Market Sales, 2003-2012
    • Table 3.20: Spanish Hematology Reagent Market Sales, 2003-2012
    • Table 3.21: Belgian Hematology Reagent Market Sales, 2003-2012
    • Table 3.22: Swiss Hematology Reagent Market Sales, 2003-2012
    • Table 3.23: Dutch Hematology Reagent Market Sales, 2003-2012
    • Table 3.24: Portuguese Hematology Reagent Market Sales, 2003-2012
    • Table 3.25: Austrian Hematology Reagent Market Sales, 2003-2012
    • Table 3.26: Greek Hematology Reagent Market Sales, 2003-2012
    • Table 3.27: Polish Hematology Reagent Market Sales, 2003-2012
    • Table 3.28: Czech Hematology Reagent Market Sales, 2003-2012
    • Table 3.29: Finnish Hematology Reagent Market Sales, 2003-2012
    • Table 3.30: Scandinavian Clinical Hematology Diagnostics Products Market Sales, 2002-2008
    • Table 3.31: Indian IVD Market, 2006-2012
    • Table 3.32: Indian Hematology Reagent Market Sales, 2006-2012
    • Table 3.33: Number of Automated Clinical Labs in India, 2004-2012
    • Table 3.34: Indian IVD Market, 2006
    • Table 3.35: Market Sales of IVD Equipment and Reagents by Company in India
    • Table 3.36: Japanese Clinical Hematology Testing Market, 2000-2008
    • Table 3.37: Chinese Clinical Hematology Reagent Market Sales, 2000-2008
    • Table 3.38: Canadian Clinical Hematology Testing Market, 2000-2008
    • Table 3.39: Brazilian Clinical Hematology Analyzer Testing Market, 2000-2008
    • Table 3.40: Turkish Clinical Hematology Reagents Testing Market, 2000-2008
    • Table 3.41: Australian Clinical Hematology Reagents Testing Market, 2000-2008
    • Table 3.42: The ROW Clinical Hematology Reagents Testing Market, 2000-2008
    • Table 3.43: Estimated Number of Clinical Laboratories in Latin America
    • Table 3.44: Principal Marketers of Automated Clinical Hematology Analyzer Instruments
    • Table 4.1: Linearity and Precision of Abbott CELL-DYN Hematology Analyzers
    • Table 4.2: Accuracy of the Automated Differential of Abbott CELL-DYN Analyzers
    • Table 4.3: Linearity and Precision of Bayer Hematology Analyzers
    • Table 4.4: Accuracy of the Automated Differential of Bayer Hematology Analyzers
    • Table 4.5: Linearity and Precision of Beckman Coulter Hematology Instruments
    • Table 4.6: Accuracy of the Automated Differential of Beckman Coulter Hematology Analyzers
    • Table 4.7: Linearity and Precision of Horiba ABX Hematology Analyzers
    • Table 4.8: Accuracy of the Horiba ABX Hematology Analyzers
    • Table 4.9: Linearity and Precision of Sysmex Hematology Analyzers
    • Table 4.10: Accuracy of the Sysmex Hematology Analyzers
    • Table 4.11: Comparison of Linearity and Precision of Top-of-the-Line Hematology Analyzers
    • Table 4.12: Comparison of Accuracy of the Top-of-the-Line Hematology Analyzers
    • Table 4.13: Hematology Analyzers with a 5-Part WBC Differential
    • Table 4.14: Hematology Analyzers with a Three-Part WBC Differential
    • Table 5.1: Applications for Wireless LAN Technology
    • Table 8.1: Medicare Billing Guidelines for Multi-channel Hematology Analyzer Tests