Hematology Analyzer Instrumentation and Reagent Markets

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?
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1. Overview 7
1.1 Objectives of the Report 7
1.2 Methodology 8
1.3 Scope of the Report 9
1.4 Executive Summary 10

2. IVD Clinical Hematology Analyzer Market 11
2.1 Introduction 11
2.2 Key Product Segments 16
2.2.1 Hematology and Associates Instruments 16
2.2.1.1 Hematology Analyzers 16
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 21
2.2.1.3.2.1 Leukocyte Analysis 21
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 25
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 27
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) 29
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 (Acquired by Beckman Coulter, Inc.) 31
2.2.1.4.5.3 International Technidyne Corporation (ITC) 31
2.2.1.4.5.4 Diagnostica Stago's STA-RE Evolution 32
2.2.1.4.5.5 Other Companies 32
2.2.1.4.5.6 Coagulation Reagents 33
2.2.1.5 Hemoglobinometers 33
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 38
2.3.5 Hematocrit (HCT) 39
2.4 Hematology Tests 39
2.5 The Coulter Principle 40
2.6 Blood Collection 40

3. Global Analyzer Market 41
3.1 Global Markets 41
3.1.1 Global Drivers of Clinical Hematology Analyzer Testing 44
3.1.2 Global Outlook 45
3.1.3 U.S. Market 46
3.1.4 European Market 48
3.1.5.1 German Clinical Hematology Analyzer and Reagent Diagnostic Markets 50
3.1.5.2 U.K. Clinical Hematology Market 52
3.1.5.3 French Clinical Hematology Market 53
3.1.5.4 Italian Clinical Hematology Market 54
3.1.5.5 Spanish Clinical Hematology Market 54
3.1.5.6 Belgian Clinical Hematology Market 54
3.1.5.7 Swiss Clinical Hematology Market 55
3.1.5.8 Dutch Clinical Hematology Market 55
3.1.5.9 Portuguese Clinical Hematology Market 56
3.1.5.10 Austrian Clinical Hematology Market 56
3.1.5.11 Greek Clinical Hematology Market 56
3.1.5.12 Polish Clinical Hematology Market 57
3.1.5.13 Czech Clinical Hematology Market 57
3.1.5.14 Finnish Clinical Hematology Market 58
3.1.5.15 Scandinavian Clinical Hematology Market 58
3.1.6 Asian Market 58
3.1.6.1 Indian Clinical Hematology Market 58
3.1.6.1.1 India's in vitro Diagnostic Testing Industry 58
3.1.6.1.2 Major Indian IVD Companies 60
3.1.6.2 Japanese Clinical Hematology Market 61
3.1.6.3 Chinese Clinical Hematology Market 61
3.1.7 Country Clinical Hematology Smaller Markets 65
3.1.7.1 Canada Clinical Hematology Market 65
3.1.7.2 Brazil Clinical Hematology Market 65
3.1.7.3 Turkey Clinical Hematology Market 66
3.1.7.4 Australia Clinical Hematology Market 66
3.1.8 Remaining World Clinical Hematology Market 66
3.1.9 Overview of Asian Healthcare Market 67
3.1.9.1 Singapore 67
3.1.9.2 Malaysia 67
3.1.9.3 Thailand 67
3.1.9.4 Indonesia 68
3.1.9.5 Philippines 68
3.1.9.6 South Korea 68
3.1.9.7 Hong Kong 69
3.1.10 Overview of the Latin American Diagnostics Market 69
3.2 Clinical Hematology Analyzer and Reagents Sector 70
3.2.1 Industry-Served Markets 70
3.2.2 Industry Players 71
3.2.2.1 Manufacturing Companies 71
3.2.3 Market Specialization 72
3.2.4 Hematology Sector Companies 72
3.3 Outlook for Clinical Hematology Analyzer Testing 73
3.3.1 Long-Term Changes 73
3.3.2 Market Drivers 75
3.3.3 The Limits to Growth 75
3.3.4 Hot Sectors in the IVD Market 75
3.3.5 Key Technologies 76
3.3.6 Conclusion 76

4. Clinical Hematology Instrument Market by Type and Competitor 77
4.1 Abbott Diagnostics 77
4.2 Siemens Healthcare Diagnostics 80
4.3 Beckman Coulter, Inc. 81
4.4 Drew Scientific Group 83
4.5 Horiba ABX Inc. 84
4.6 Sysmex Corporation 85
4.7 Boule Medical AB 90
4.8 Beijing ShiningSun Technology Co., Ltd. 91
4.9 Hematology Analyzers for Point of Care 91

5. Important Technology Trends 92
5.1 Technology Platform Innovations in Hematology Testing 92
5.2 The New Paradigm 92
5.3 Consolidated Workstations 92
5.4 Automation in the Laboratory 94
5.5 Laboratory Information Systems 95
5.6 New User-friendly Interfaces 96
5.7 Data-Management Issues 97
5.7.1 Wireless LANs 97
5.7.2 Data and Workflow Management Systems 98
5.7.3 Beckman Central Command Central Version 2.0 98
5.7.4 Middleware 98
5.8 Robotics - Total Laboratory Automation Robotic Sample Handling 99
5.9 Image Analysis 100
5.10 Flow Cytometry 100
5.11 Laser Technology 101
5.12 Automating Preanalytics 101
5.13 Telepathology 101

6. Business Trends in the Clinical Hematology Analyzer Sector 103
6.1 Key Developments 103
6.2 Industrial Sector Consolidation 103
6.3 Hospital and Commercial Laboratory Consolidation 105
6.4 Changing Ordering Patterns 106
6.5 New Products 106
6.6 Acquisition, License Agreements, Internal Development and Partnerships 108
6.7 Breadth of Product Offerings 111
6.8 Government Regulation 111
6.8.1 U.S. Regulation 111
6.8.1.1 Importing Medical Devices into the U.S. 112
6.8.1.2 Exporting Medical Devices from the U.S. 113
6.8.2 U.K. Regulation 113
6.8.3 E.U. Regulation 114
6.8.4 Japanese Regulation 117
6.8.5 Korean Regulation 117
6.9 Costs of Doing Business in Europe 118
6.10 Drivers of European Diagnostics Testing 118
6.11 European Reimbursement Practices 118
6.12 Cost Containment in Europe 118
6.13 Revenue and Reimbursement 118

7. Product Launches 120
7.1 Horiba ABX Unveils Pentra DX 120 120
7.2 Sysmex to Launch Sales of the XT-4000i Hematology Analyzers 120
7.3 Laser Scan Cytometry System 121
7.4 Abbott Receives Clearance for Hematology Instrument 121
7.5 Vital Diagnostics announced the Addition of the Excyte Mini Automated ESR Analyzer 121
7.6 Becton Introduces FACSCanto II 121
7.7 Abbott's International Launch of CELL-DYN Emerald™ Hematology Instrument 122
7.8 Beckman Coulter Launches UniCel DxH 800 122
7.9 Beckman Launches High-Performance Hematology Analyzer Ac•T 123
7.10 Abbott Laboratories Released its Cell-Dyn 1800 Automated Hematology Analyzer. 123
7.11 BD (Becton Dickinson Biosciences) Imagn System 123
7.12 Sysmex Network Communications System 123
7.13 Sysmex XT-V Multi-Species Hematology Analyzer 123
7.14 The Melet Schloesing MS4-5 124
7.15 Roche CoaguChek XS Plus System 124
7.16 Sysmex Corp Launches KX-4500 124
7.17 Streck nRBC-Chex 124
7.18 HORIBA ABX Introduces Micros CRP 200 124
7.19 Heska Corporation Introduces Veterinary Hematology Analyzer 124
7.20 Specialized Master Software Programs for the Sysmex XE-2100 Hematology Analyzers 125
7.21 HORIBA ABX e-Sat module 125
7.22 Medonic M series Hematology Analyzer 125
7.23 Streck's ESR-AutoPlus 125
7.24 Streck Quality Control Reagents 125

8. Clinical Hematology Testing Sector Trends and Forecasts 126
8.1 Home Care Analysis 126
8.2 Non-Traditional Collection for Hematology Analyzer Testing 126
8.3 New Systems for Critical-Care and Near-Patient Testing 126
8.4 Utility of Near-Patient Testing in Critical-Care Settings 126
8.5 Mergers of Diagnostic Companies 126
8.6 Information Management Advances 126
8.7 Test Ordering Patterns 126
8.8 Patient Satisfaction 126
8.9 Move Away From Central Laboratory 127
8.10 Healthcare Cost Controls 127
8.11 Competition for Services 127
8.12 Drivers of Clinical Hematology analyzer Testing 127
8.13 Confluence of New Technology 127
8.14 New Trends in Clinical Laboratory Testing 128
8.14.1 Trends in Reimbursement Practices 128
8.14.2 Managed Care 130
8.14.3 Changes in Patient Management 131
8.14.4 Focused Testing 131
8.14.5 Satellite Facilities 131
8.15 Demographic Trends 131

9. Company Profiles 132
9.1 Abbott Diagnostics 132
9.2 A.Menarini Diagnostics 133
9.3 Bayer HealthCare, AG 134
9.4 Beckman Coulter, Inc. 135
9.5 Becton Dickenson Biosciences 139
9.6 Boule Diagnostics International AB 140
9.7 Cholestech Corporation 140
9.8 Dade Behring (Acquired by Siemens) 141
9.9 HemoCue, Inc. 141
9.10 Heska Corporation 141
9.11 Horiba Group 142
9.12 MELET SCHLOESING Laboratories 142
9.13 Micronics, Inc. 143
9.14 Nihon Kohden Corporation 143
9.15 PPD (Pharmaceutical Product Development, Inc.) 144
9.16 Roche Diagnostics (F. Hoffmann-La Roche, Ltd.) 144
9.17 Shenzhen Mindray Bio-Medical Electronics Co. Ltd. 145
9.18 Streck, Inc. 145
9.19 Sysmex Corporation 146
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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, 2009 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 24
Table 2.7: Worldwide Market for Rapid Coagulation Testing Dollar Volume, 2000-2008 28
Table 2.8: U.S. Market for Rapid Coagulation Testing Dollar Volume, 2000-2008 28
Table 2.9: U.S. Market for Rapid Coagulation POC Testing Dollar Volume, 2001-2012 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, 2008 41
Table 3.2: Worldwide Distribution of IVD Testing, 2008 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, 2006 42
Table 3.5: Ten Largest Diagnostic Companies Worldwide, 2007 43
Table 3.6 Key Players in Worldwide Hematology Analyzers and Reagent Market 43
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 46
Table 3.9: U.S. Clinical Laboratory Diagnostic Test Market Segments, 2007 46
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 47
Table 3.12: European Clinical Laboratory Testing IVD Reagents and Instruments Market, 2000-2012 49
Table 3.14: European Clinical Laboratory Testing Diagnostics by Country Market Estimates, 2007 49
Table 3.15: European Clinical Hematology Instrument and Reagent Testing Market, 2000-2008 50
Table 3.16: German Hematology Reagent Market Sales, 2003-2012 51
Table 3.17: UK Hematology Reagent Market Sales, 2003-2012 53
Table 3.18: French Hematology Reagent Market Sales, 2003-2012 53
Table 3.19: Italian Hematology Reagent Market Sales, 2003-2012 54
Table 3.20: Spanish Hematology Reagent Market Sales, 2003-2012 54
Table 3.21: Belgian Hematology Reagent Market Sales, 2003-2012 55
Table 3.22: Swiss Hematology Reagent Market Sales, 2003-2012 55
Table 3.23: Dutch Hematology Reagent Market Sales, 2003-2012 55
Table 3.24: Portuguese Hematology Reagent Market Sales, 2003-2012 56
Table 3.25: Austrian Hematology Reagent Market Sales, 2003-2012 56
Table 3.26: Greek Hematology Reagent Market Sales, 2003-2012 57
Table 3.27: Polish Hematology Reagent Market Sales, 2003-2012 57
Table 3.28: Czech Hematology Reagent Market Sales, 2003-2012 57
Table 3.29: Finnish Hematology Reagent Market Sales, 2003-2012 58
Table 3.30: Scandinavian Clinical Hematology Diagnostics Products Market Sales, 2002-2008 58
Table 3.31: Indian IVD Market, 2006-2012 59
Table 3.32: Indian Hematology Reagent Market Sales, 2006-2012 59
Table 3.33: Number of Automated Clinical Labs in India, 2004-2012 59
Table 3.34: Indian IVD Market, 2008 60
Table 3.36: Japanese Clinical Hematology Testing Market, 2000-2008 61
Table 3.37: Chinese Clinical Hematology Reagent Market Sales, 2000-2008 62
Table 3.38: Canadian Clinical Hematology Testing Market, 2000-2008 65
Table 3.39: Brazilian Clinical Hematology Analyzer Testing Market, 2000-2008 65
Table 3.40: Turkish Clinical Hematology Reagents Testing Market, 2000-2008 66
Table 3.41: Australian Clinical Hematology Reagents Testing Market, 2000-2008 66
Table 3.42: The ROW Clinical Hematology Reagents Testing Market, 2000-2008 66
Table 3.43: Estimated Number of Clinical Laboratories in Latin America 69
Table 3.44: Principal Marketers of Automated Clinical Hematology Analyzer Instruments 71
Table 4.1: Linearity and Precision of Abbott CELL-DYN Hematology Analyzers 79
Table 4.2: Accuracy of the Automated Differential of Abbott CELL-DYN Analyzers 80
Table 4.3: Linearity and Precision of Siemens Hematology Analyzers 81
Table 4.4: Accuracy of the Automated Differential of Siemens Hematology Analyzers 81
Table 4.5: Linearity and Precision of Beckman Coulter Hematology Instruments 83
Table 4.6: Accuracy of the Automated Differential of Beckman Coulter Hematology Analyzers 83
Table 4.7: Linearity and Precision of Horiba ABX Hematology Analyzers 85
Table 4.8: Accuracy of the Horiba ABX Hematology Analyzers 85
Table 4.9: Linearity and Precision of Sysmex Hematology Analyzers 88
Table 4.10: Accuracy of the Sysmex Hematology Analyzers 88
Table 4.11: Comparison of Linearity and Precision of Top-of-the-Line Hematology Analyzers 89
Table 4.12: Comparison of Accuracy of the Top-of-the-Line Hematology Analyzers 89
Table 4.13: Hematology Analyzers with a 5-Part WBC Differential 90
Table 4.14: Hematology Analyzers with a Three-Part WBC Differential 90
Table 5.1: Applications for Wireless LAN Technology 97
Table 8.1: Medicare Billing Guidelines for Multi-channel Hematology Analyzer Tests 129
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