Hematology Analyzer Instrumentation and Reagent Markets

Table of Contents

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 (Acquired by Beckman Coulter, Inc.)
          • 2.2.1.4.5.3 International Technidyne Corporation (ITC)
          • 2.2.1.4.5.4 Diagnostica Stago' s STA-RE Evolution
          • 2.2.1.4.5.5 Other Companies
          • 2.2.1.4.5.6 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. Global Analyzer Market

• 3.1 Global Markets
  • 3.1.1 Global Drivers of Clinical Hematology Analyzer Testing
  • 3.1.2 Global Outlook
  • 3.1.3 U.S. Market
  • 3.1.4 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
  • 3.1.10 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 Siemens Healthcare Diagnostics
• 4.3 Beckman Coulter, Inc.
• 4.4 Drew Scientific Group
• 4.5 Horiba ABX Inc.
• 4.6 Sysmex Corporation
• 4.7 Boule Medical AB
• 4.8 Beijing ShiningSun Technology Co., Ltd.
• 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 Central Version 2.0
  • 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 DX 120
• 7.2 Sysmex to Launch Sales of the XT-4000i Hematology Analyzers
• 7.3 Laser Scan Cytometry System
• 7.4 Abbott Receives Clearance for Hematology Instrument
• 7.5 Vital Diagnostics announced the Addition of the Excyte Mini Automated ESR Analyzer
• 7.6 Becton Introduces FACSCanto II
• 7.7 Abbott' s International Launch of CELL-DYN Emerald™ Hematology Instrument
• 7.8 Beckman Coulter Launches UniCel DxH 800
• 7.9 Beckman Launches High-Performance Hematology Analyzer AcT
• 7.10 Abbott Laboratories Released its Cell-Dyn 1800 Automated Hematology Analyzer
• 7.11 BD (Becton Dickinson Biosciences) Imagn System
• 7.12 Sysmex Network Communications System
• 7.13 Sysmex XT-V Multi-Species Hematology Analyzer
• 7.14 The Melet Schloesing MS4-5
• 7.15 Roche CoaguChek XS Plus System
• 7.16 Sysmex Corp Launches KX-4500
• 7.17 Streck nRBC-Chex
• 7.18 HORIBA ABX Introduces Micros CRP 200
• 7.19 Heska Corporation Introduces Veterinary 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. Company Profiles

• 9.1 Abbott Diagnostics
• 9.2 A.Menarini Diagnostics
• 9.3 Bayer HealthCare, AG
• 9.4 Beckman Coulter, Inc.
• 9.5 Becton Dickenson Biosciences
• 9.6 Boule Diagnostics International AB
• 9.7 Cholestech Corporation
• 9.8 Dade Behring (Acquired by Siemens)
• 9.9 HemoCue, Inc.
• 9.10 Heska Corporation
• 9.11 Horiba Group
• 9.12 MELET SCHLOESING Laboratories
• 9.13 Micronics, Inc.
• 9.14 Nihon Kohden Corporation
• 9.15 PPD (Pharmaceutical Product Development, Inc.)
• 9.16 Roche Diagnostics (F. Hoffmann-La Roche, Ltd.)
• 9.17 Shenzhen Mindray Bio-Medical Electronics Co. Ltd.
• 9.18 Streck, Inc.
• 9.19 Sysmex Corporation

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, 2009
• 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, 2001-2012
• Table 2.10: Slide Stainer Instruments and Manufacturers
• Table 2.11: Hematology Stains
• Table 3.1: The Overall In Vitro Diagnostic Testing Market Worldwide, 2008
• Table 3.2: Worldwide Distribution of IVD Testing, 2008
• 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, 2006
• Table 3.5: Ten Largest Diagnostic Companies Worldwide, 2007
• 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 Laboratory Diagnostic Test Market Segments, 2007
• 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 3.14: European Clinical Laboratory Testing Diagnostics by Country Market Estimates, 2007
• 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, 2008
• 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 Siemens Hematology Analyzers
• Table 4.4: Accuracy of the Automated Differential of Siemens 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