Market Report Source

Overview

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. 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 Ac•T 128
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
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