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Clinical Chemistry Analyzers
Publication Date: 15-DEC-07
Pages: 152
Study: TMRCHEM
Format/Price: PDF document / $3,400.00

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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 TriMark Publications 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, physician's 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 8
1.4 Executive Summary 9
2. IVD Clinical Chemistry Market 11
2.1 Introduction 11
3. IVD Clinical Chemistry Market 13
3.1 Markets 13
3.1.1 Global Markets 13
3.1.2 Global Drivers of Clinical Chemistry Testing 15
3.1.3 Global Outlook 15
3.1.4 U.S. Market 16
3.1.5 European Market 17
3.1.5.1 German Clinical Chemistry Diagnostic Markets 21
3.1.5.2 U.K. Clinical Chemistry Testing Diagnostic Market 23
3.1.5.2.1 U.K. Market Statistics 23
3.1.5.2.2 U.K. Competitive Analysis 24
3.1.5.2.3 U.K. Market Access 25
3.1.5.3 French Clinical Chemistry Diagnostic Market 25
3.1.5.4 Italian Clinical Chemistry Diagnostic Market 25
3.1.5.5 Spanish Clinical Chemistry Diagnostic Market 26
3.1.5.6 Indian Clinical Chemistry Diagnostic Market 26
3.1.5.6.1 India's In Vitro Diagnostic Testing Industry 26
3.1.5.7 Scandinavian Clinical Chemistry Market 28
3.1.5.8 Japanese Clinical Chemistry Testing Market 29
3.1.5.9 Country Clinical Chemistry Smaller Markets 29
3.1.5.9.1 Chinese Clinical Chemistry Market 29
3.1.5.9.2 Canada Clinical Chemistry Market 33
3.1.5.9.3 Brazil Clinical Chemistry Market 33
3.1.5.9.4 Turkey Clinical Chemistry Market 34
3.1.5.9.5 Australia Clinical Chemistry Market 34
3.1.5.9.6 Mexico IVD Market 34
3.1.5.10 Remaining World Clinical Chemistry Testing Market 35
3.1.5.11 Overview of Asian Healthcare Market 36
3.1.5.11.1 Singapore 36
3.1.5.11.2 Malaysia 36
3.1.5.11.3 Thailand 36
3.1.5.11.4 Indonesia 36
3.1.5.11.5 Philippines 37
3.1.5.11.6 South Korea 37
3.1.5.11.7 India 37
3.1.5.11.8 Hong Kong 38
3.1.5.11.9 Taiwan 38
3.1.5.12 Overview of the Latin American Diagnostics Market 38
3.2 Clinical Chemistry Sector 39
3.2.1 Industry-Served Markets 39
3.2.2 Industry Players 39
3.2.2.1 Manufacturing Companies 39
3.2.3 Market Specialization 40
3.2.4 Revenue and Reimbursement 42
3.2.5 Companies 42
3.3 Outlook for Clinical Chemistry Testing 43
3.3.1 Long-Term Changes 43
3.3.2 Market Drivers 45
3.3.3 The Limits to Growth 45
3.3.4 Hot Sectors in the IVD Market 45
3.3.5 Key Technologies 46
3.3.6 Conclusion 46
4. Clinical Chemistry Instrument Market by Sector: Size, Growth, Share and Competitors 48
4.1 Ultra-Large Throughput Chemistry Analyzers 48
4.2 Large-Throughput Analyzers 55
4.3 Mid-Size Clinical Chemistry Analyzers 66
4.4 Chemistry Analyzers for the Small-Volume Market 70
5. Important Technology Trends 77
5.1 Technology Platform Innovations in Point-of-Care Testing 77
5.2 Sensor Systems for Diagnostic Applications 77
5.3 Glucose Measurements 79
5.4 Glucose Test Methods 82
5.5 Cholesterol Measurements 82
5.6 The New Paradigm 83
5.7 Consolidated Workstations 83
5.8 Automation in the Laboratory in Response to Labor Shortages 85
5.9 Laboratory Information Systems 86
5.10 Biosensor Technology 87
5.11 Data-Management Issues 88
5.11.1 Wireless LANs 89
5.11.2 Data and Workflow Management Systems 89
5.11.3 Beckman Central Command 89
5.12 Connectivity Platforms 90
5.12.1 Laboratory Data Linking Software and Interface to the Laboratory Information System 90
5.12.2 AbbottLink Analyzer Connections 91
5.12.3 Beckman Coulter DL2000 Data Manager v6.5 91
5.12.4 bioMérieux Inc. ENQ 91
5.12.5 Ortho-Clinical Diagnostics Inc. Software Version 1.02 92
6. Business Trends in the Clinical Chemistry Analyzer Sector 93
6.1 Key Developments 93
6.2 Sector Consolidation 93
6.3 Diagnostic Testing Growth Trends 94
6.4 Reagent and Hardware Business in Japan 95
6.5 New Products 95
6.6 Acquisition, License Agreements, Internal Development and Partnerships 95
6.7 Product Testing Depth in Clinical Chemistry Testing 96
6.8 Government Regulation 96
6.8.1 U.S. Regulation 96
6.8.1.1 Importing Medical Devices to the U.S. 97
6.8.1.2 Exporting Medical Devices from the U.S. 98
6.8.2 U.K. Regulation 98
6.8.3 E.U. Regulation 100
6.8.4 Japanese Regulation 101
6.8.5 Korean Regulation 101
6.9 Increased Market Penetration 102
6.10 Costs of Doing Business in Europe 103
6.11 Drivers of European Diagnostics Testing 104
6.12 European Reimbursement Practices 104
6.13 Cost Containment in Europe 104
6.14 Medicare Reimbursement Trends 104
7. Company Profiles 107
7.1 Abaxis 107
7.1.1 Point-of-Care Blood Chemistry Analyzers 107
7.1.2 Hematology 107
7.1.3 Reagent Discs 107
7.1.4 Orbos Process 107
7.1.5 VetScan Canine Heartworm Antigen Test 108
7.2 Abbott Diagnostics 108
7.2.1 Diagnostic Products 108
7.2.2 Business Analysis 109
7.2.3 TriMark Commentary 111
7.3 Adaltis, Inc. 112
7.4 Alfa Wasserman, Inc. (f/k/a Electro-Nucleonics, Inc. and Schiapparelli Biosystems, Inc.) 113
7.4.1 Background 113
7.4.2 Products 113
7.5 Awareness Technology 113
7.6 Siemens Medical Solutions Diagnostics 114
7.7 Beckman Coulter, Inc. 114
7.7.1 Overview 114
7.7.2 Company History 115
7.7.3 Products 115
7.7.3.1 Clinical Diagnostics Products 115
7.7.3.1.1 Overview 115
7.7.3.2 Clinical Chemistry Systems 116
7.7.3.3 Clinical Laboratory Automation 116
7.7.3.4 Hemostasis Systems 117
7.7.3.5 Immunodiagnostic Systems 117
7.7.3.6 Primary Care Diagnostics 118
7.7.3.7 Hematology Systems 118
7.7.4 TriMark Commentary 119
7.8 Dade Behring, Inc. 119
7.8.1 Products 120
7.8.2 Other Served Markets 124
7.9 Hitachi 126
7.9.1 Products 127
7.10 Horiba, Ltd. 127
7.11 JEOL, Ltd. 127
7.12 Olympus America, Inc. Clinical Instruments Division 129
7.12.1 Background 129
7.12.2 Automated General Chemistry Instruments 129
7.12.3 TriMark Commentary 130
7.13 Ortho-Clinical Diagnostics, a Johnson & Johnson Company 130
7.13.1 Background 130
7.13.2 Markets 131
7.13.3 Automated General Chemistry Instruments 131
7.13.4 TriMark Commentary 132
7.14 Roche Diagnostics Corp 132
7.14.1 Background 132
7.14.2 Automated General Chemistry Instruments 133
7.14.3 Business Analysis 133
7.15 Shimadzu 134
7.15.1 Products 134
7.16 Sysmex Corporation 134
7.17 Thermo Fisher Scientific Inc. 135
7.18 Vital Scientific, NV 136
7.18.1 Background 136
7.18.2 Products 137
8. Clinical Chemistry Testing Sector Trends and Forecasts 138
8.1 Home Care Analysis 138
8.2 Non-traditional Collection for Chemistry Testing 138
8.3 New Systems for Critical-Care and Near-Patient Testing 138
8.4 Utility of Near-Patient Testing in Critical-Care Settings 138
8.5 Mergers of Diagnostic Companies 138
8.6 Information Management Advances 138
8.7 Test Ordering Patterns 138
8.8 Patient Satisfaction 138
8.9 Move Away From Central Laboratory 139
8.10 Healthcare Cost Controls 139
8.11 Competition for Services 139
8.12 Drivers of Clinical Chemistry Testing 139
8.13 Confluence of New Technology 139
8.14 New Trends in Clinical Laboratory Testing 140
8.14.1 Trends in Reimbursement Practices 140
8.14.2 Managed Care 142
8.14.3 Changes in Patient Management 143
8.14.4 Focused Testing 143
8.14.5 Satellite Facilities 143
8.14.6 Point-of-Care Testing 143
8.14.7 Regionalization of Laboratory Care 144
8.15 New Chemistry Analyzers 145
8.16 Multiplexing Technology 145
9. Clinical Chemistry Product Introductions 147
9.1 Clinical Chemistry Analyzer Product Launches 147
9.2 Clinical Chemistry Reagent Product Launches 147
10. Corporate Directory 148
INDEX OF FIGURES
Figure 3.1: European Diagnostic Reagents Markets, 2006 19
Figure 6.1: Part B Spending on Clinical Laboratory Services: 1991 to 2005 105
LIST OF TABLES
Table 3.1: The Overall In Vitro Diagnostic Testing Market Worldwide: 2006 13
Table 3.2: Worldwide Distribution of IVD Testing: 2006 13
Table 3.3: Global Clinical Chemistry Revenues: 1998 to 2012 14
Table 3.4: Worldwide Distribution of Clinical Chemistry Testing: 2006 14
Table 3.5: Ten Largest Diagnostic Companies Worldwide: 2005 14
Table 3.6: U.S. Clinical Chemistry Testing Market: 2000 to 2012 17
Table 3.7: U.S. Clinical Chemistry Diagnostic Test Market Segments: 2006 17
Table 3.8: U.S. Individual Clinical Chemistry Diagnostic Test Markets: 2006 17
Table 3.9: European Clinical Laboratory Testing IVD Reagents and Instruments Market (Dollars): 2000 to 2012 18
Table 3.10: European Clinical Laboratory Testing IVD Reagents and Instruments Market (Euros): 2000 to 2012 18
Table 3.11: European Clinical Laboratory Diagnostic Reagents and Instruments Markets by Analyte: 2006 18
Table 3.12: European Clinical Laboratory Testing Diagnostics by Country Market Estimates: 2006 19
Table 3.13: European Clinical Chemistry Testing Market: 2000 to 2008 20
Table 3.14: European Clinical Chemistry Reagents and Instruments Markets by Country: 2006 20
Table 3.15: German Clinical Chemistry Testing Diagnostics Products Market Sales: 2000 to 2007 21
Table 3.16: The German Patient Care Lab Test Market: 2000 to 2008 21
Table 3.17: The German Alternate Site Testing Market (POL): 2000 to 2008 22
Table 3.18: The German Hospital Clinical Chemistry Market: 2000 to 2008 22
Table 3.19: German Clinical Diagnostic Chemistry Test Market Segments by Analyte: 2002 and 2005 22
Table 3.20: U.K. Clinical Chemistry Diagnostics Products Market Sales: 2000 to 2008 23
Table 3.21: Major U.K. IVD Manufacturers 24
Table 3.22: U.S. IVD Manufacturers Doing Business in the U.K. 24
Table 3.23: Other European Companies That Manufacture IVD Products in the U.K. 25
Table 3.24: French Clinical Chemistry Diagnostics Products Market Sales: 1998 to 2008 25
Table 3.25: Italian Chemistry Diagnostics Products Market Sales: 1998 to 2008 26
Table 3.26: Spanish Clinical Chemistry Diagnostics Products Market Sales: 1998 to 2008 26
Table 3.27: Indian IVD Market: 2006 to 2012 26
Table 3.28: Number of Automated Clinical Labs in India: 2004 to 2012 27
Table 3.29: Indian IVD Market: 2006 27
Table 3.30: Market Sales of IVD Equipment and Reagents by Company in India: 2004 and 2005 28
Table 3.31: Scandinavian Clinical Chemistry Diagnostics Products Market Sales: 2000 to 2008 28
Table 3.32: Japan Clinical Chemistry Testing Market: 2000 to 2008 29
Table 3.33: Chinese Clinical Chemistry Diagnostics Products Market Sales: 2000 to 2008 29
Table 3.34: Canadian Clinical Chemistry Testing Market: 2000 to 2008 33
Table 3.35: Brazilian IVD Testing Market: 2000 to 2008 33
Table 3.36: Brazilian Clinical Chemistry Testing Market: 2000 to 2008 33
Table 3.37: Turkish Clinical Chemistry Testing Market: 2000 to 2008 34
Table 3.38: Australian Clinical Chemistry Testing Market: 2000 to 2008 34
Table 3.39: Mexican IVD Testing Market: 2000 to 2008 35
Table 3.40: Mexican Clinical Chemistry Testing Market: 2000 to 2008 35
Table 3.41: The ROW Clinical Chemistry Testing Market: 2000 to 2008 35
Table 3.42: Estimated Number of Clinical Laboratories in Latin America 38
Table 3.43: Principal Marketers of Automated Clinical Chemistry Instruments 39
Table 4.1: Ultra-Large Clinical Chemistry Analyzers 54
Table 4.2: JEOL Analyzer Comparison 62
Table 4.3: Large Clinical Chemistry Analyzers 66
Table 4.4: Mid-size Clinical Chemistry Analyzers 70
Table 4.5: Small Clinical Chemistry Analyzers 76
Table 5.1: Normal Glucose Values-Fasting State 81
Table 5.2: Applications for Wireless LAN Technology 89
Table 6.1: Hospital Laboratory Share of Part B Medicare Spending: 1996 to 2005 105
Table 6.2: Medicare Part B Spending Per Medicare Enrollee: 1998 to 2005 106
Table 6.3: Allowed Charges for Top 25 Clinical Laboratory Procedures: 2005 106
Table 7.1: Products Marketed by Abbott in the Diagnostic Market 111
Table 7.2: Products Marketed by Dade Behring in the Diagnostics Market 121
Table 7.3: Clinically-Significant Tests Available From Dade 125
Table 7.4: Comparison of JEOL Analyzers 128
Table 7.5: VITROS ECiQ Immunodiagnostic System 131
Table 7.6: Sysmex Marketing Summary for China 135
Table 8.1: Medicare Billing Guidelines for Multi-channel Chemistry Tests 141

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