血液解析裝置及試劑市場

Abstract

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.

Table of Contents

1. Overview

• 1.1Objectives of the Report
• 1.2Methodology
• 1.3Scope of the Report
• 1.4Executive Summary

2. IVD Clinical Hematology Analyzer Market

• 2.1Introduction
• 2.2Key Product Segments
  • 2.2.1Hematology and Associates Instruments
    • 2.2.1.1Hematology Analyzers
    • 2.2.1.2Hematology Instruments Offerings by Major Players
      • 2.2.1.2.1Hematology Reagents and Controls
      • 2.2.1.2.2Hematology Point of Care Instruments
    • 2.2.1.3Flow Cytometers
      • 2.2.1.3.1Flow Cytometry Technology Platforms
      • 2.2.1.3.2Clinical Applications of Flow Cytometry
        • 2.2.1.3.2.1Leukocyte Analysis
        • 2.2.1.3.2.2Immunophenotyping of Leukemias and Lymphomas
        • 2.2.1.3.2.3Neutropenia
        • 2.2.1.3.2.4Platelet Analysis
        • 2.2.1.3.2.5T Cell Subsets
        • 2.2.1.3.2.6Reticulocyte Count
      • 2.2.1.3.3Flow Cytometry Market Growth
        • 2.2.1.3.3.1Applications
        • 2.2.1.3.3.2Market Size
        • 2.2.1.3.3.3Instrumentation Preferences
        • 2.2.1.3.3.4Reagent Selection and Use
        • 2.2.1.3.3.5Instrument Manufacturers
        • 2.2.1.3.3.6Future Directions of Flow Cytometry
      • 2.2.1.4Coagulation Analyzers
        • 2.2.1.4.1Coagulation Market Size
        • 2.2.1.4.2Prothrombin Time Test
        • 2.2.1.4.3Activated Partial Thromboplastin Time (APTT)
        • 2.2.1.4.4Clinical Advantages of Coagulation Testing
        • 2.2.1.4.5Coagulation Instruments
          • 2.2.1.4.5.1Roche Diagnostics
          • 2.2.1.4.5.2Avocet Medical
          • 2.2.1.4.5.3International Technidyne Corporation
          • 2.2.1.4.5.4Cardiovascular Diagnostics
          • 2.2.1.4.5.5Diagnostica Stago' s STA-R Evolution
          • 2.2.1.4.5.6Other Companies
          • 2.2.1.4.5.7Coagulation Reagents
      • 2.2.1.5Hemoglobinometers
      • 2.2.1.6Slide Stainers
      • 2.2.1.7Differential Counters
      • 2.2.1.8Hematology Stains
• 2.3Blood Components
  • 2.3.1Complete Blood Count (CBC)
  • 2.3.2Red Blood Cells (RBCs)
  • 2.3.3White Blood Cells (WBCs)
  • 2.3.4Platelets
  • 2.3.5Hematocrit (HCT)
• 2.4Hematology Tests
• 2.5The Coulter Principle
• 2.6Blood Collection

3. IVD Clinical Hematology Analyzer Market

• 3.1Markets
  • 3.1.1Global Markets
  • 3.1.2Global Drivers of Clinical Hematology Analyzer Testing
  • 3.1.3Global Outlook
  • 3.1.4U.S. Market
  • 3.1.5European Market
    • 3.1.5.1German Clinical Hematology Analyzer and Reagent Diagnostic Markets
    • 3.1.5.2U.K. Clinical Hematology Market
    • 3.1.5.3French Clinical Hematology Market
    • 3.1.5.4Italian Clinical Hematology Market
    • 3.1.5.5Spanish Clinical Hematology Market
    • 3.1.5.6Belgian Clinical Hematology Market
    • 3.1.5.7Swiss Clinical Hematology Market
    • 3.1.5.8Dutch Clinical Hematology Market
    • 3.1.5.9Portuguese Clinical Hematology Market
    • 3.1.5.10Austrian Clinical Hematology Market
    • 3.1.5.11Greek Clinical Hematology Market
    • 3.1.5.12Polish Clinical Hematology Market
    • 3.1.5.13Czech Clinical Hematology Market
    • 3.1.5.14Finnish Clinical Hematology Market
    • 3.1.5.15Scandinavian Clinical Hematology Market
  • 3.1.6 Asian Market
    • 3.1.6.1Indian Clinical Hematology Market
      • 3.1.6.1.1 India' s in vitro Diagnostic Testing Industry
      • 3.1.6.1.2Major Indian IVD Companies
    • 3.1.6.2Japanese Clinical Hematology Market
    • 3.1.6.3 Chinese Clinical Hematology Market
  • 3.1.7Country Clinical Hematology Smaller Markets
    • 3.1.7.1Canada Clinical Hematology Market
    • 3.1.7.2Brazil Clinical Hematology Market
    • 3.1.7.3Turkey Clinical Hematology Market
    • 3.1.7.4Australia Clinical Hematology Market
  • 3.1.8Remaining World Clinical Hematology Market
  • 3.1.9Overview of Asian Healthcare Market
    • 3.1.9.1 Singapore
    • 3.1.9.2Malaysia
    • 3.1.9.3Thailand
    • 3.1.9.4Indonesia
    • 3.1.9.5Philippines
    • 3.1.9.6South Korea
    • 3.1.9.7Hong Kong
    • 3.1.9.8Taiwan
  • 3.1.10Overview of the Latin American Diagnostics Market
• 3.2Clinical Hematology Analyzer and Reagents Sector
  • 3.2.1Industry-Served Markets
  • 3.2.2Industry Players
    • 3.2.2.1Manufacturing Companies
  • 3.2.3Market Specialization
  • 3.2.4Hematology Sector Companies
• 3.3Outlook for Clinical Hematology Analyzer Testing
  • 3.3.1Long-Term Changes
  • 3.3.2Market Drivers
  • 3.3.3The Limits to Growth
  • 3.3.4Hot Sectors in the IVD Market
  • 3.3.5Key Technologies
  • 3.3.6Conclusion

4. Clinical Hematology Instrument Market by Type and Competitor

• 4.1 Abbott Diagnostics
• 4.2 Bayer Diagnostics
• 4.3Beckman Coulter
• 4.4Drew Scientific
• 4.5Horiba ABX Inc.
• 4.6Sysmex
• 4.7Boule Medical
• 4.8Beijing Shining Sun
• 4.9 Hematology Analyzers for Point of Care

5. Important Technology Trends

• 5.1Technology Platform Innovations in Hematology Testing
• 5.2The New Paradigm
• 5.3Consolidated Workstations
• 5.4Automation in the Laboratory
• 5.5Laboratory Information Systems0
• 5.6New User-friendly Interfaces1
• 5.7Data-Management Issues2
  • 5.7.1Wireless LANs2
  • 5.7.2Data and Workflow Management Systems3
  • 5.7.3Beckman Central Command3
  • 5.7.4Middleware4
• 5.8 Robotics - Total Laboratory Automation Robotic Sample Handling4
• 5.9 Image Analysis5
• 5.10Flow Cytometry
• 5.11Laser Technology
• 5.12Automating Preanalytics
• 5.13 Telepathology

6. Business Trends in the Clinical Hematology Analyzer Sector

• 6.1Key Developments
• 6.2Industrial Sector Consolidation
• 6.3Hospital and Commercial Laboratory Consolidation
• 6.4Changing Ordering Patterns
• 6.5New Products
• 6.6Acquisition, License Agreements, Internal Development and Partnerships
• 6.7Breadth of Product Offerings
• 6.8Government Regulation
  • 6.8.1U.S. Regulation
    • 6.8.1.1Importing Medical Devices into the U.S.
    • 6.8.1.2Exporting Medical Devices from the U.S.
  • 6.8.2U.K. Regulation
  • 6.8.3E.U. Regulation
  • 6.8.4Japanese Regulation
  • 6.8.5Korean Regulation
• 6.9Costs of Doing Business in Europe
• 6.10Drivers of European Diagnostics Testing
• 6.11European Reimbursement Practices
• 6.12Cost Containment in Europe
• 6.13Revenue and Reimbursement

7. Product Launches

• 7.1Horiba ABX Unveils Pentra DF 120
• 7.2Sysmex 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 Ac-T
• 7.10Abbott Laboratories Released its Cell-Dyn 1800 Automated Hematology Analyzer.
• 7.11Becton Dickinson Biosciences' Imagn System
• 7.12Sysmex Network Communications System
• 7.13Sysmex XS-1000i Automated Hematology Analyzer
• 7.14The Melet Schloesing MS4-5
• 7.15Roche CoaguChek XS Plus System
• 7.16Sysmex Corp Launches KX-21
• 7.17Streck nRBC-Chex
• 7.18 HORIBA ABX Introduces Micros CRP 200
• 7.19 Heska Corporation Introduces Advanced Hematology Analyzer
• 7.20Specialized Master Software Programs for the Sysmex XE-2100 Hematology Analyzers
• 7.21HORIBA ABX e-Sat module
• 7.22Medonic M series Hematology Analyzer
• 7.23Streck' s ESR-AutoPlus
• 7.24Streck Quality Control Reagents

8. Clinical Hematology Testing Sector Trends and Forecasts

• 8.1Home Care Analysis
• 8.2Non-Traditional Collection for Hematology Analyzer Testing
• 8.3New Systems for Critical-Care and Near-Patient Testing
• 8.4Utility of Near-Patient Testing in Critical-Care Settings
• 8.5Mergers of Diagnostic Companies
• 8.6Information Management Advances
• 8.7Test Ordering Patterns
• 8.8Patient Satisfaction
• 8.9Move Away From Central Laboratory
• 8.10Healthcare Cost Controls
• 8.11Competition for Services
• 8.12Drivers of Clinical Hematology analyzer Testing
• 8.13Confluence of New Technology
• 8.14New Trends in Clinical Laboratory Testing
  • 8.14.1Trends in Reimbursement Practices
  • 8.14.2Managed Care
  • 8.14.3Changes in Patient Management
  • 8.14.4Focused Testing
  • 8.14.5Satellite Facilities
• 8.15 Demographic Trends

9. Corporate Profiles

• 9.1Abbott Diagnostics
• 9.2A.Menarini Diagnostics
• 9.3Bayer Diagnostics
• 9.4Beckman Coulter
• 9.5Becton Dickenson Biosciences
• 9.6Bio-Rad Laboratories Inc.
• 9.7Boule Medical AB
• 9.8Careside Inc.
• 9.9Cholestech
• 9.10Dade Behring
• 9.11HemoCue
• 9.12Heska Corporation
• 9.13Horiba Group
• 9.14Melet Schloesing
• 9.15Micronics
• 9.16Nihon Kohden
• 9.17PPD
• 9.18Roche Diagnostics
• 9.19Shenzhen Mindray Bio-Medical Electronics Co. Ltd.
• 9.20Streck
• 9.21Sysmex

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 3.6Key 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