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Clinical Chemistry Analyzers

DateAug, 2006
Pages141
Price / format€2562 / Electronic (PDF)
€5123 / Enterprisewide

€2 541 

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Abstract:
 Clinical chemistry analysis is one of the most important areas within clinical laboratory analysis. The term clinical chemistry usually refers to determining the concentration or activity of a protein, carbohydrate, lipid, electrolyte, enzyme or small molecule in easily-collected bodily fluids such as blood, serum, plasma or urine. However, it is not necessarily limited to these determinations. The analysis of virtually any biologically-active substance-any place in the body-can loosely be defined as clinical chemistry. 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 chemistry will be the subject of this study.

The purpose of this report is to describe the specific segments of the global clinical chemistry instrumentation market. Specifically, this study examines the markets for small lab and highly-automated, large lab platforms, as well as accessory equipment such as reagents, supplies and manufacturers original equipment manufacturer (OEM) additional equipment. The emphasis is on those companies and products that are actively developing and marketing chemistry analyzer products for the clinical setting, including hospitals, independent labs, physicians offices and clinics. Concentration is on the clinical chemistry instrumentation industry market segment in the U.S. and around the world. Particular attention is paid to those areas of the clinical chemistry instrumentation sector that are showing the greatest growth or the most innovation.








Table of contents:
 1. Overview 6
1.1 Objectives of the Report 6
1.2 Methodology 6
1.3 Scope of the Report 7
1.4 Executive Summary 7

2. IVD Clinical Chemistry Market 9
2.1 Introduction 9

3. IVD Clinical Chemistry Market 10
3.1 Markets 10
3.1.1 Global Markets 10
3.1.2 Global Drivers of Clinical Chemistry Testing 11
3.1.3 Global Outlook 12
3.1.4 U.S. Market 13
3.1.5 European Market 14
3.1.5.1 German Clinical Chemistry Diagnostic Markets 15
3.1.5.2 U.K. Clinical Chemistry Testing Diagnostic Market 17
3.1.5.2.1 U.K. Market Statistics 18
3.1.5.2.2 U.K. Competitive Analysis 18
3.1.5.2.3 U.K. Market Access 19
3.1.5.3 French Clinical Chemistry Diagnostic Market 19
3.1.5.4 Italian Clinical Chemistry Diagnostic Market 20
3.1.5.5 Spanish Clinical Chemistry Diagnostic Market 20
3.1.5.6 Indian Clinical Chemistry Diagnostic Market 20
3.1.5.6.1 Indias In Vitro Diagnostic Testing Industry 20
3.1.5.7 Scandinavian Clinical Chemistry Market 22
3.1.5.8 Japanese Clinical Chemistry Testing Market 23
3.1.5.9 Country Clinical Chemistry Smaller Markets 23
3.1.5.9.1 Chinese Clinical Chemistry Market 23
3.1.5.9.2 Canada Clinical Chemistry Market 27
3.1.5.9.3 Brazil Clinical Chemistry Market 27
3.1.5.9.4 Turkey Clinical Chemistry Market 27
3.1.5.9.5 Australia Clinical Chemistry Market 28
3.1.5.10 Remaining World Clinical Chemistry Testing Market 28
3.1.5.11 Overview of Asian Healthcare Market 28
3.1.5.11.1 Singapore 28
3.1.5.11.2 Malaysia 29
3.1.5.11.3 Thailand 29
3.1.5.11.4 Indonesia 29
3.1.5.11.5 Philippines 30
3.1.5.11.6 South Korea 30
3.1.5.11.7 India 31
3.1.5.11.8 Hong Kong 31
3.1.5.11.9 Taiwan 31
3.1.5.12 Overview of the Latin American Diagnostics Market 31
3.2 Clinical Chemistry Sector 32
3.2.1 Industry-Served Markets 32
3.2.2 Industry Players 34
3.2.2.1 Manufacturing Companies 34
3.2.3 Market Specialization 34
3.2.4 Revenue and Reimbursement 36
3.2.5 Companies 37
3.3 Outlook for Clinical Chemistry Testing 38
3.3.1 Long-Term Changes 38
3.3.2 Market Drivers 39
3.3.3 The Limits to Growth 40
3.3.4 Hot Sectors in the IVD Market 40
3.3.5 Key Technologies 40
3.3.6 Conclusion 41

4. Clinical Chemistry Instrument Market by Sector: Size, Growth, Share and Competitors 42
4.1 Ultra-Large Throughput Chemistry Analyzers 42
4.2 Large-Throughput Analyzers 49
4.3 Mid-Size Clinical Chemistry Analyzers 59
4.4 Chemistry Analyzers for the Small Volume Market 63

5. Important Technology Trends 69
5.1 Technology Platform Innovations in Point-of-Care Testing 69
5.2 Sensor Systems for Diagnostic Applications 69
5.3 Glucose Measurements 71
5.4 Glucose Test Methods 74
5.5 Cholesterol Measurements 74
5.6 The New Paradigm 75
5.7 Consolidated Workstations 75
5.8 Automation in the Laboratory 77
5.9 Laboratory Information Systems 78
5.10 Biosensor Technology 78
5.11 Data-Management Issues 80
5.11.1 Wireless LANs 80
5.11.2 Data and Workflow Management Systems 80
5.11.3 Beckman Central Command 81

6. Business Trends in the Clinical Chemistry Analyzer Sector 82
6.1 Key Developments 82
6.2 Sector Consolidation 82
6.3 Diagnostic Testing Growth Trends 83
6.4 Reagent and Hardware Business in Japan 84
6.5 New Products 84
6.6 Acquisition, License Agreements, Internal Development and Partnerships 84
6.7 Product Testing Depth in Clinical Chemistry Testing 85
6.8 Government Regulation 85
6.8.1 U.S. Regulation 85
6.8.1.1 Importing Medical Devices Into the U.S. 86
6.8.1.2 Exporting Medical Devices From the U.S. 87
6.8.2 U.K. Regulation 87
6.8.3 E.U. Regulation 89
6.8.4 Japanese Regulation 90
6.8.5 Korean Regulation 91
6.9 Increased Market Penetration 91
6.10 Costs of Doing Business in Europe 93
6.11 Drivers of European Diagnostics Testing 93
6.12 European Reimbursement Practices 93
6.13 Cost Containment in Europe 93

7. Company Profiles 94
7.1 Abaxis 94
7.1.1 Point-of-Care Blood Chemistry Analyzers 94
7.1.2 Hematology 94
7.1.3 Reagent Discs 94
7.1.4 Orbos Process 94
7.1.5 VetScan Canine Heartworm Antigen Test 95
7.2 Abbott Diagnostics 95
7.2.1 Diagnostic Products 95
7.2.2 Business Analysis 97
7.2.3 TriMark Commentary 98
7.3 Adaltis, Inc. 99
7.4 Alfa Wasserman, Inc. (f/k/a Electro-Nucleonics, Inc. and Schiapparelli Biosystems, Inc.) 99
7.4.1 Background 99
7.4.2 Products 100
7.5 Awareness Technology 100
7.6 Bayer Diagnostics 100
7.6.1 Background 101
7.6.2 General Automated Clinical Chemistry Instruments 101
7.6.2.1 Advia® 2400, 1800, 1650 and 1200 Chemistry Systems 101
7.6.3 Business Analysis 103
7.6.4 TriMark Commentary 103
7.7 Beckman Coulter, Inc. 103
7.7.1 Overview 103
7.7.2 Company History 104
7.7.3 Products 104
7.7.3.1 Clinical Diagnostics Products 104
7.7.3.1.1 Overview 104
7.7.3.2 Clinical Chemistry Systems 105
7.7.3.3 Clinical Laboratory Automation 105
7.7.3.4 Hemostasis Systems 106
7.7.3.5 Immunodiagnostic Systems 106
7.7.3.6 Primary Care Diagnostics 107
7.7.3.7 Hematology Systems 107
7.7.4 TriMark Commentary 108
7.8 Dade Behring, Inc. 108
7.8.1 Products 109
7.8.2 Other Served Markets 112
7.8.3 Business 115
7.8.4 TriMark Commentary 116
7.9 Hitachi 116
7.9.1 Products 116
7.10 Horiba, Ltd. 117
7.11 JEOL, Ltd. 117
7.12 Olympus America, Inc., Clinical Instruments Division 118
7.12.1 Background 118
7.12.2 Automated General Chemistry Instruments 119
7.12.3 TriMark Commentary 119
7.13 Ortho-Clinical Diagnostics, a Johnson and Johnson Company 120
7.13.1 Background 120
7.13.2 Markets 120
7.13.3 Automated General Chemistry Instruments 120
7.13.4 Business Analysis 122
7.13.5 TriMark Commentary 122
7.14 Roche Diagnostics Corp 122
7.14.1 Background 123
7.14.2 Automated General Chemistry Instruments 123
7.14.3 Business Analysis 123
7.15 Shimadzu 124
7.15.1 Products 124
7.16 Sysmex Corporation 125
7.17 Thermo Electron Corp. 125
7.18 Vital Scientific, NV 126
7.18.1 Background 126
7.18.2 Products 127
7.18.3 Business 127
7.18.4 TriMark Commentary 128

8. Clinical Chemistry Testing Sector Trends and Forecasts 129
8.1 Home Care Analysis 129
8.2 Non-traditional Collection for Chemistry Testing 129
8.3 New Systems for Critical-Care and Near-Patient Testing 129
8.4 Utility of Near-Patient Testing in Critical-Care Settings 129
8.5 Mergers of Diagnostic Companies 129
8.6 Information Management Advances 129
8.7 Test Ordering Patterns 129
8.8 Patient Satisfaction 129
8.9 Move Away From Central Laboratory 130
8.10 Healthcare Cost Controls 130
8.11 Competition for Services 130
8.12 Drivers of Clinical Chemistry Testing 130
8.13 Confluence of New Technology 130
8.14 New Trends in Clinical Laboratory Testing 131
8.14.1 Trends in Reimbursement Practices 131
8.14.2 Managed Care 133
8.14.3 Changes in Patient Management 134
8.14.4 Focused Testing 134
8.14.5 Satellite Facilities 134
8.14.6 Point-of-Care Testing 134
8.14.7 Regionalization of Laboratory Care 135
8.15 New Chemistry Analyzers 136
9. Corporate Directory 137


LIST OF TABLES

Table 3.1: The Overall In Vitro Diagnostic Testing Market Worldwide in 2005 10
Table 3.2: Worldwide Distribution of IVD Testing in 2005 10
Table 3.3: Global Clinical Chemistry Revenues 10
Table 3.4: Worldwide Distribution of Clinical Chemistry Testing 2005 11
Table 3.5: Ten Largest Diagnostic Companies Worldwide 2005 11
Table 3.6: U.S. Clinical Chemistry Testing Market 14
Table 3.7: U.S. Clinical Chemistry Diagnostic Test Market Segments 2005 14
Table 3.8: U.S. Individual Clinical Chemistry Diagnostic Test Markets 2005 14
Table 3.9: European Clinical Chemistry Testing Market 15
Table 3.10: European Clinical Chemistry Testing Diagnostics by Country Market 2005 15
Table 3.11: German Clinical Chemistry Testing Diagnostics Products Market Sales 16
Table 3.12: The German Patient Care Lab Test Market 16
Table 3.13: The German Alternate Site Testing Market (POL) 16
Table 3.14: The German Hospital Clinical Chemistry Market 16
Table 3.15: German Clinical Diagnostic Chemistry Test Market Segments by Analyte 17
Table 3.16: U.K. Clinical Chemistry Diagnostics Products Market Sales 18
Table 3.17: Major U.K. IVD Manufacturers 18
Table 3.18: U.S. IVD Manufacturers Doing Business in the U.K. 19
Table 3.19: Other European Companies That Manufacture IVD Products in the U.K. 19
Table 3.20: French Clinical Chemistry Diagnostics Products Market Sales 20
Table 3.21: Italian Chemistry Diagnostics Products Market Sales 20
Table 3.22: Spanish Clinical Chemistry Diagnostics Products Market Sales 20
Table 3.23: Indian IVD Market 21
Table 3.24: Number of Automated Clinical Labs in India 21
Table 3.25: Indian IVD Market 2006 21
Table 3.26: Market Sales of IVD Equipment and Reagents by Company in India 22
Table 3.27: Scandinavian Clinical Chemistry Diagnostics Products Market Sales 23
Table 3.28: Japan Clinical Chemistry Testing Market 23
Table 3.29: Chinese Clinical Chemistry Diagnostics Products Market Sales 24
Table 3.30: Canadian Clinical Chemistry Testing Market 27
Table 3.31: Brazilian Clinical Chemistry Testing Market 27
Table 3.32: Turkish Clinical Chemistry Testing Market 28
Table 3.33: Australian Clinical Chemistry Testing Market 28
Table 3.34: The ROW Clinical Chemistry Testing Market 28
Table 3.35: Estimated Number of Clinical Laboratories in Latin America 32
Table 3.36: Principal Marketers of Automated Clinical Chemistry Instruments 34
Table 4.1: Ultra-Large Clinical Chemistry Analyzers 48
Table 4.2: JEOL Analyzer Comparison 56
Table 4.3: Large Clinical Chemistry Analyzers 59
Table 4.4: Mid-size Clinical Chemistry Analyzers 63
Table 4.5: Small Clinical Chemistry Analyzers 68
Table 5.1: Normal Glucose Values - Fasting State 73
Table 5.2: Applications for Wireless LAN Technology 80
Table 7.1: Abbott Diagnostics Division Sales by Segment 96
Table 7.2: Products Marketed by Abbott in the Diagnostic Market 98
Table 7.3: Clinically Significant Tests Available From Dade 114
Table 7.4: Comparison of JEOL Analyzers 117
Table 7.5: Sysmex Marketing Summary for China 125
Table 8.1: Medicare Billing Guidelines for Multi-channel Chemistry Tests 132




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