Hematology Analyzer Instrumentation and Reagent Markets

Hematology Analyzer Instrumentation and Reagent Markets

Published Date : 1 July 2009

Pages : 147

Add to Cart - 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 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 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