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Report Description

Hematology Analyzer Instrumentation and Reagent Markets
Publication Date: 24-JAN-07
Pages: 156
Study: TMRHEMA
Format/Price: PDF document / $3,400.00

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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 7
1.1 Objectives of the Report 7
1.2 Methodology 8
1.3 Scope of the Report 8
1.4 Executive Summary 9
2 IVD Clinical Hematology Analyzer Market 11
2.1 Introduction 11
2.2 Key Product Segments 17
2.2.1 Hematology and Associates Instruments 17
2.2.1.1 Hematology Analyzers 17
2.2.1.2 Hematology Instruments Offerings by Major Players 17
2.2.1.2.1 Hematology Reagents and Controls 18
2.2.1.2.2 Hematology Point of Care Instruments 19
2.2.1.3 Flow Cytometers 20
2.2.1.3.1 Flow Cytometry Technology Platforms 20
2.2.1.3.2 Clinical Applications of Flow Cytometry 20
2.2.1.3.2.1 Leukocyte Analysis 20
2.2.1.3.2.2 Immunophenotyping of Leukemias and Lymphomas 21
2.2.1.3.2.3 Neutropenia 21
2.2.1.3.2.4 Platelet Analysis 21
2.2.1.3.2.5 T Cell Subsets 22
2.2.1.3.2.6 Reticulocyte Count 22
2.2.1.3.3 Flow Cytometry Market Growth 22
2.2.1.3.3.1 Applications 23
2.2.1.3.3.2 Market Size 23
2.2.1.3.3.3 Instrumentation Preferences 24
2.2.1.3.3.4 Reagent Selection and Use 24
2.2.1.3.3.5 Instrument Manufacturers 25
2.2.1.3.3.6 Future Directions of Flow Cytometry 26
2.2.1.4 Coagulation Analyzers 26
2.2.1.4.1 Coagulation Market Size 27
2.2.1.4.2 Prothrombin Time Test 28
2.2.1.4.3 Activated Partial Thromboplastin Time (APTT) 28
2.2.1.4.4 Clinical Advantages of Coagulation Testing 29
2.2.1.4.5 Coagulation Instruments 30
2.2.1.4.5.1 Roche Diagnostics 30
2.2.1.4.5.2 Avocet Medical 31
2.2.1.4.5.3 International Technidyne Corporation 31
2.2.1.4.5.4 Cardiovascular Diagnostics 32
2.2.1.4.5.5 Diagnostica Stago's STA-R Evolution 32
2.2.1.4.5.6 Other Companies 33
2.2.1.4.5.7 Coagulation Reagents 34
2.2.1.5 Hemoglobinometers 34
2.2.1.6 Slide Stainers 34
2.2.1.7 Differential Counters 36
2.2.1.8 Hematology Stains 37
2.3 Blood Components 37
2.3.1 Complete Blood Count (CBC) 37
2.3.2 Red Blood Cells (RBCs) 38
2.3.3 White Blood Cells (WBCs) 38
2.3.4 Platelets 39
2.3.5 Hematocrit (HCT) 39
2.4 Hematology Tests 39
2.5 The Coulter Principle 40
2.6 Blood Collection 40
3. IVD Clinical Hematology Analyzer Market 41
3.1 Markets 41
3.1.1 Global Markets 41
3.1.2 Global Drivers of Clinical Hematology Analyzer Testing 45
3.1.3 Global Outlook 45
3.1.4 U.S. Market 46
3.1.5 European Market 48
3.1.5.1 German Clinical Hematology Analyzer and Reagent Diagnostic Markets 51
3.1.5.2 U.K. Clinical Hematology Market 53
3.1.5.3 French Clinical Hematology Market 55
3.1.5.4 Italian Clinical Hematology Market 55
3.1.5.5 Spanish Clinical Hematology Market 56
3.1.5.6 Belgian Clinical Hematology Market 56
3.1.5.7 Swiss Clinical Hematology Market 56
3.1.5.8 Dutch Clinical Hematology Market 57
3.1.5.9 Portuguese Clinical Hematology Market 57
3.1.5.10 Austrian Clinical Hematology Market 58
3.1.5.11 Greek Clinical Hematology Market 58
3.1.5.12 Polish Clinical Hematology Market 59
3.1.5.13 Czech Clinical Hematology Market 59
3.1.5.14 Finnish Clinical Hematology Market 60
3.1.5.15 Scandinavian Clinical Hematology Market 60
3.1.6 Asian Market 61
3.1.6.1 Indian Clinical Hematology Market 61
3.1.6.1.1 India's in vitro Diagnostic Testing Industry 61
3.1.6.1.2 Major Indian IVD Companies 62
3.1.6.2 Japanese Clinical Hematology Market 64
3.1.6.3 Chinese Clinical Hematology Market 64
3.1.7 Country Clinical Hematology Smaller Markets 68
3.1.7.1 Canada Clinical Hematology Market 68
3.1.7.2 Brazil Clinical Hematology Market 68
3.1.7.3 Turkey Clinical Hematology Market 68
3.1.7.4 Australia Clinical Hematology Market 69
3.1.8 Remaining World Clinical Hematology Market 69
3.1.9 Overview of Asian Healthcare Market 70
3.1.9.1 Singapore 70
3.1.9.2 Malaysia 70
3.1.9.3 Thailand 70
3.1.9.4 Indonesia 71
3.1.9.5 Philippines 71
3.1.9.6 South Korea 72
3.1.9.7 Hong Kong 72
3.1.9.8 Taiwan 72
3.1.10 Overview of the Latin American Diagnostics Market 73
3.2 Clinical Hematology Analyzer and Reagents Sector 73
3.2.1 Industry-Served Markets 73
3.2.2 Industry Players 75
3.2.2.1 Manufacturing Companies 75
3.2.3 Market Specialization 75
3.2.4 Hematology Sector Companies 76
3.3 Outlook for Clinical Hematology Analyzer Testing 77
3.3.1 Long-Term Changes 77
3.3.2 Market Drivers 78
3.3.3 The Limits to Growth 79
3.3.4 Hot Sectors in the IVD Market 79
3.3.5 Key Technologies 79
3.3.6 Conclusion 80
4. Clinical Hematology Instrument Market by Type and Competitor 81
4.1 Abbott Diagnostics 81
4.2 Bayer Diagnostics 84
4.3 Beckman Coulter 85
4.4 Drew Scientific 87
4.5 Horiba ABX Inc. 88
4.6 Sysmex 89
4.7 Boule Medical 94
4.8 Beijing Shining Sun 95
4.9 Hematology Analyzers for Point of Care 95
5. Important Technology Trends 97
5.1 Technology Platform Innovations in Hematology Testing 97
5.2 The New Paradigm 97
5.3 Consolidated Workstations 97
5.4 Automation in the Laboratory 99
5.5 Laboratory Information Systems 100
5.6 New User-friendly Interfaces 101
5.7 Data-Management Issues 102
5.7.1 Wireless LANs 102
5.7.2 Data and Workflow Management Systems 103
5.7.3 Beckman Central Command 103
5.7.4 Middleware 104
5.8 Robotics - Total Laboratory Automation Robotic Sample Handling 104
5.9 Image Analysis 105
5.10 Flow Cytometry 106
5.11 Laser Technology 106
5.12 Automating Preanalytics 106
5.13 Telepathology 107
6. Business Trends in the Clinical Hematology Analyzer Sector 108
6.1 Key Developments 108
6.2 Industrial Sector Consolidation 108
6.3 Hospital and Commercial Laboratory Consolidation 110
6.4 Changing Ordering Patterns 111
6.5 New Products 111
6.6 Acquisition, License Agreements, Internal Development and Partnerships 114
6.7 Breadth of Product Offerings 117
6.8 Government Regulation 117
6.8.1 U.S. Regulation 117
6.8.1.1 Importing Medical Devices into the U.S. 118
6.8.1.2 Exporting Medical Devices from the U.S. 119
6.8.2 U.K. Regulation 120
6.8.3 E.U. Regulation 121
6.8.4 Japanese Regulation 123
6.8.5 Korean Regulation 123
6.9 Costs of Doing Business in Europe 124
6.10 Drivers of European Diagnostics Testing 124
6.11 European Reimbursement Practices 124
6.12 Cost Containment in Europe 124
6.13 Revenue and Reimbursement 124
7. Product Launches 126
7.1 Horiba ABX Unveils Pentra DF 120 126
7.2 Sysmex America Launches Software for Sysmex XE-2100 Hematology Analyzers 126
7.3 SurroScan™ Develops Laser Scan Cytometry System 127
7.4 Abbott Receives Clearance for Hematology Instrument 127
7.5 Clinical Data Receives FDA Clearance for Excyte 128
7.6 Becton Introduces FACSCanto™ 128
7.7 Abbott's International Launch of CELL-DYN Sapphire™ Hematology Instrument 128
7.8 Beckman Coulter Launches LH 1500 Series 128
7.9 Beckman Launches High-Performance Hematology Analyzer Ac•T 128
7.10 Abbott Laboratories Released its Cell-Dyn 1800 Automated Hematology Analyzer. 129
7.11 Becton Dickinson Biosciences' Imagn System 129
7.12 Sysmex Network Communications System 129
7.13 Sysmex XS-1000i Automated Hematology Analyzer 129
7.14 The Melet Schloesing MS4-5 129
7.15 Roche CoaguChek XS Plus System 130
7.16 Sysmex Corp Launches KX-21 130
7.17 Streck nRBC-Chex 130
7.18 HORIBA ABX Introduces Micros CRP 200 130
7.19 Heska Corporation Introduces Advanced Hematology Analyzer 130
7.20 Specialized Master Software Programs for the Sysmex XE-2100 Hematology Analyzers 130
7.21 HORIBA ABX e-Sat module 130
7.22 Medonic M series Hematology Analyzer 131
7.23 Streck's ESR-AutoPlus 131
7.24 Streck Quality Control Reagents 131
8. Clinical Hematology Testing Sector Trends and Forecasts 132
8.1 Home Care Analysis 132
8.2 Non-Traditional Collection for Hematology Analyzer Testing 132
8.3 New Systems for Critical-Care and Near-Patient Testing 132
8.4 Utility of Near-Patient Testing in Critical-Care Settings 132
8.5 Mergers of Diagnostic Companies 132
8.6 Information Management Advances 132
8.7 Test Ordering Patterns 132
8.8 Patient Satisfaction 132
8.9 Move Away From Central Laboratory 133
8.10 Healthcare Cost Controls 133
8.11 Competition for Services 133
8.12 Drivers of Clinical Hematology analyzer Testing 133
8.13 Confluence of New Technology 133
8.14 New Trends in Clinical Laboratory Testing 134
8.14.1 Trends in Reimbursement Practices 134
8.14.2 Managed Care 136
8.14.3 Changes in Patient Management 137
8.14.4 Focused Testing 137
8.14.5 Satellite Facilities 137
8.15 Demographic Trends 137
9. Corporate Profiles 138
9.1 Abbott Diagnostics 138
9.2 A.Menarini Diagnostics 140
9.3 Bayer Diagnostics 140
9.4 Beckman Coulter 142
9.5 Becton Dickenson Biosciences 146
9.6 Bio-Rad Laboratories Inc. 146
9.7 Boule Medical AB 147
9.8 Careside Inc. 147
9.9 Cholestech 147
9.10 Dade Behring 148
9.11 HemoCue 149
9.12 Heska Corporation 150
9.13 Horiba Group 150
9.14 Melet Schloesing 151
9.15 Micronics 151
9.16 Nihon Kohden 152
9.17 PPD 152
9.18 Roche Diagnostics 152
9.19 Shenzhen Mindray Bio-Medical Electronics Co. Ltd. 154
9.20 Streck 154
9.21 Sysmex 154
LIST OF TABLES
Table 2.1: Clinical Hematology Tests Submitted to Medicare, 2005-2012 12
Table 2.2: Clinical Hematology Tests Performed in the U.S., 2005-2012 12
Table 2.3: Allowed Charges for Top 25 Clinical Laboratory Procedures, 2005 13
Table 2.4: Competitive Landscape: Companies Participating in the Hematology IVD Sector 14
Table 2.5: Key Product Segments 16
Table 2.6: Worldwide Market for Flow Cytometry Instruments and Reagents, 2000-2010 23
Table 2.7: Worldwide Market for Rapid Coagulation Testing Dollar Volume, 2000-2008 27
Table 2.8: U.S. Market for Rapid Coagulation Testing Dollar Volume, 2000-2008 27
Table 2.9: U.S. Market for Rapid Coagulation POC Testing Dollar Volume, 1996-2007 28
Table 2.10: Slide Stainer Instruments and Manufacturers 35
Table 2.11: Hematology Stains 37
Table 3.1: The Overall In Vitro Diagnostic Testing Market Worldwide in 2005 41
Table 3.2: Worldwide Distribution of IVD Testing in 2005 41
Table 3.3: Global Clinical Hematology Analyzer and Reagent Revenues, 2005-2012 42
Table 3.4: Worldwide Distribution of Clinical Hematology Testing Analyzer and Reagent Revenues, 2005 42
Table 3.5: Top 15 IVD Manufacturers' Worldwide Revenue ($ Millions) 43
Table 3.6 Key Players in Worldwide Hematology Analyzers and Reagent Market 44
Table 3.7: Leading Players in Worldwide Coagulation Analyzer and Reagent Market 44
Table 3.8: U.S. Clinical Hematology Analyzer Testing Market, 2000-2011 47
Table 3.9: U.S. Clinical Hematology Diagnostic Test Market Segments, 2005 47
Table 3.10: Leading Players in the U.S. Hematology Analyzers Market 47
Table 3.11: Leading Players in the U.S. Coagulation Analyzers Market 48
Table 3.12: European Clinical Laboratory Testing IVD Reagents and Instruments Market, 2000-2012 49
Table 3.13: European Clinical Laboratory Diagnostic Testing Markets by Analyte, 2003 50
Table 3.14: European Clinical Laboratory Testing Diagnostics by Country Market Estimates, 2004 50
Table 3.15: European Clinical Hematology Instrument and Reagent Testing Market, 2000-2008 51
Table 3.16: German Hematology Reagent Market Sales, 2003-2012 52
Table 3.17: UK Hematology Reagent Market Sales, 2003-2012 54
Table 3.18: French Hematology Reagent Market Sales, 2003-2012 55
Table 3.19: Italian Hematology Reagent Market Sales, 2003-2012 55
Table 3.20: Spanish Hematology Reagent Market Sales, 2003-2012 56
Table 3.21: Belgian Hematology Reagent Market Sales, 2003-2012 56
Table 3.22: Swiss Hematology Reagent Market Sales, 2003-2012 57
Table 3.23: Dutch Hematology Reagent Market Sales, 2003-2012 57
Table 3.24: Portuguese Hematology Reagent Market Sales, 2003-2012 57
Table 3.25: Austrian Hematology Reagent Market Sales, 2003-2012 58
Table 3.26: Greek Hematology Reagent Market Sales, 2003-2012 58
Table 3.27: Polish Hematology Reagent Market Sales, 2003-2012 59
Table 3.28: Czech Hematology Reagent Market Sales, 2003-2012 59
Table 3.29: Finnish Hematology Reagent Market Sales, 2003-2012 60
Table 3.30: Scandinavian Clinical Hematology Diagnostics Products Market Sales, 2002-2008 60
Table 3.31: Indian IVD Market, 2006-2012 61
Table 3.32: Indian Hematology Reagent Market Sales, 2006-2012 61
Table 3.33: Number of Automated Clinical Labs in India, 2004-2012 62
Table 3.34: Indian IVD Market, 2006 62
Table 3.35: Market Sales of IVD Equipment and Reagents by Company in India 63
Table 3.36: Japanese Clinical Hematology Testing Market, 2000-2008 64
Table 3.37: Chinese Clinical Hematology Reagent Market Sales, 2000-2008 65
Table 3.38: Canadian Clinical Hematology Testing Market, 2000-2008 68
Table 3.39: Brazilian Clinical Hematology Analyzer Testing Market, 2000-2008 68
Table 3.40: Turkish Clinical Hematology Reagents Testing Market, 2000-2008 69
Table 3.41: Australian Clinical Hematology Reagents Testing Market, 2000-2008 69
Table 3.42: The ROW Clinical Hematology Reagents Testing Market, 2000-2008 69
Table 3.43: Estimated Number of Clinical Laboratories in Latin America 73
Table 3.44: Principal Marketers of Automated Clinical Hematology Analyzer Instruments 75
Table 4.1: Linearity and Precision of Abbott CELL-DYN Hematology Analyzers 83
Table 4.2: Accuracy of the Automated Differential of Abbott CELL-DYN Analyzers 84
Table 4.3: Linearity and Precision of Bayer Hematology Analyzers 85
Table 4.4: Accuracy of the Automated Differential of Bayer Hematology Analyzers 85
Table 4.5: Linearity and Precision of Beckman Coulter Hematology Instruments 87
Table 4.6: Accuracy of the Automated Differential of Beckman Coulter Hematology Analyzers 87
Table 4.7: Linearity and Precision of Horiba ABX Hematology Analyzers 89
Table 4.8: Accuracy of the Horiba ABX Hematology Analyzers 89
Table 4.9: Linearity and Precision of Sysmex Hematology Analyzers 92
Table 4.10: Accuracy of the Sysmex Hematology Analyzers 92
Table 4.11: Comparison of Linearity and Precision of Top-of-the-Line Hematology Analyzers 93
Table 4.12: Comparison of Accuracy of the Top-of-the-Line Hematology Analyzers 93
Table 4.13: Hematology Analyzers with a 5-Part WBC Differential 94
Table 4.14: Hematology Analyzers with a Three-Part WBC Differential 94
Table 5.1: Applications for Wireless LAN Technology 102
Table 8.1: Medicare Billing Guidelines for Multi-channel Hematology Analyzer Tests 135

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