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Clinical Immunoanalyzer Markets
Publication Date: 15-DEC-07
Pages: 156
Study: TMRCIA
Format/Price: PDF document / $3,400.00

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Clinical immunoanalyzer analysis is one of the most important functions of clinical laboratory analysis. By all accounts, automated immunoassay testing is the most rapidly developing of the traditional clinical laboratory sectors. Clinical immunoanalyzer analysis usually refers to determining the concentration or activity of protein, carbohydrate, lipid, enzyme or small molecule in easily collected body fluids, such as blood, serum, plasma or urine. However, it is not necessarily limited to these purposes. The analysis of virtually any biologically active substance in any place in the body can generally be defined as clinical immunoassay testing. In fact, traditional specialization barriers, such as microbiology, hematology, blood banking, immunology and even anatomical pathology are fading rapidly, both operationally and instrumentally. This TriMark Publications report deals with the traditional scope of clinical immunoassay, while looking at the emerging technology trends in this sector. The purpose of this study is to describe the specific segments of the global clinical immunoanalyzer instrumentation market. Within this area, the highly-active segments in terms of innovation and growth are covered. Specifically, it examines the markets for small labs and highly-automated large lab platforms, as well as the market for accessory equipment, such as reagents and supplies. Emphasis is on those companies and products that are actively developing and marketing immunoanalyzer products for clinical setting, including hospitals, independent labs, physician's offices and clinics. Readers can gain the following insights from this report:

• Complete analysis of the major sectors of the clinical immunoanalyzer instrumentation market, their size, growth rates and major drivers.

• Presentation of some of the emerging technology platforms, elucidating the potential areas that could gain traction in this market.

• Analysis of the partnerships and alliances that various key sector players have forged, including the financing linkages of these market participants, apart from insights into potential market collaborations.

• Examination of new technology platforms in the U.S., Japan and Europe that seek to dominate this mature market.

Table of Contents:

1. Overview 6
1.1 Objectives 6
1.2 Methodology 6
1.3 TriMark Publications Report Research and Data Acquisition Structure 8
1.4 Scope 8
1.5 Executive Summary 9
2. IVD Clinical Immunoanalyzer Market 11
2.1 Introduction 11
3. IVD Clinical Immunoanalyzer Market Analysis 13
3.1 Markets 13
3.1.1 Global Markets 13
3.1.2 Global Drivers of Clinical Immunoanalyzer Testing 14
3.1.3 Global Outlook 15
3.1.4 U.S. Market 16
3.1.5 European IVD Market 18
3.1.5.1 German Clinical Immunoanalyzer Diagnostic Markets 22
3.1.5.2 U.K. Clinical Immunoanalyzer Testing Diagnostic Market 24
3.1.5.3 French Clinical Laboratory Diagnostic Testing Market 25
3.1.5.4 Italian Clinical Immunochemistry Diagnostic Market 25
3.1.5.5 Spanish Immunoanalyzer Market 26
3.1.5.6 Finnish Immunoanalyzer Market 27
3.1.5.7 Belgian Immunoanalyzer Market 27
3.1.5.8 Swiss Immunoanalyzer Market 27
3.1.5.9 Dutch Immunoanalyzer Market 28
3.1.5.10 Portugese Immunoanalyzer Market 28
3.1.5.11 Austrian Immunoanalyzer Market 29
3.1.5.12 Greek Immunoanalyzer Market 29
3.1.5.13 Polish Immunoanalyzer Market 29
3.1.5.14 Romanian Immunoanalyzer Market 30
3.1.6 Indian Clinical Analyzer Diagnostic Market 30
3.1.6.1 India's in vitro Diagnostic Testing Industry 30
3.1.7 Japanese Clinical Immunoanalyzer Testing Market 36
3.1.8 Country Clinical Analyzer Smaller Markets 37
3.1.8.1 China Clinical Analyzer Market 37
3.1.8.2 Canada Clinical Analyzer Market 40
3.1.8.3 Brazil Clinical Analyzer Market 41
3.1.8.4 Turkey Clinical Immunoanalyzer Market 41
3.1.8.5 Australia Clinical Analyzer Market 41
3.1.8.6 Rest of the World Clinical Analyzer Testing Market 42
3.1.9 Overview of Asian Healthcare Market 42
3.1.9.1 Singapore 42
3.1.9.2 Malaysia 43
3.1.9.3 Thailand 43
3.1.9.4 Indonesia 43
3.1.9.5 Philippines 43
3.1.9.6 South Korea 44
3.1.9.7 India 44
3.1.9.8 Hong Kong 44
3.1.9.9 Taiwan 45
3.2 Clinical Immunoanalyzer Sector 46
3.2.1 Industry-Served Markets 47
3.2.2 Industry Players 47
3.2.2.1 Manufacturing Companies 47
3.2.3 Market Specialization 49
3.2.4 Revenue and Reimbursement 51
3.2.5 Companies 51
3.3 Outlook for Clinical Immunoanalyzer Testing 52
3.3.1 Long-Term Changes 52
3.3.2 Market Drivers 53
3.3.3 Limits to Growth 54
3.3.4 Hot Sectors in IVD Market 54
3.3.5 Key Technologies 55
3.3.6 Analyzer Integration Chemistry/Immunoassay 55
3.3.7 Conclusion 57
4. Clinical Immunoanalyzer Instrument Market by Sector 58
4.1 Market Analysis: Size, Growth, Share and Competitors 58
4.1.1 Immunochemistry Analyzers 58
4.1.2 Large-Volume Immunochemistry Analyzers 58
4.1.2.1 Abbott Diagnostics 58
4.1.2.2 Siemens Medical Solutions Diagnostics 59
4.1.2.3 Beckman Coulter 62
4.1.2.4 Dade Behring (Siemens) 63
4.1.2.5 Diagnostics Products Corporation (Siemens) 64
4.1.2.6 Olympus 65
4.1.2.7 Ortho-Clinical Diagnostics 66
4.1.2.8 Roche Diagnostics 68
4.1.2.9 Tosoh Bioscience 70
4.1.3 Batch-Type Immunoassay Analyzers 72
4.1.3.1 Bio-Rad 72
4.1.3.2 Dade Behring 72
4.1.3.3 Diamedix 72
4.1.3.4 Tosoh 75
4.1.4 Small-Volume to Mid-Volume Immunoassay Analyzers 75
4.1.4.1 Awareness Technology 75
4.1.4.2 Siemens Diagnostics 75
4.1.4.3 Beckman Coulter 76
4.1.4.4 bioMérieux 77
4.1.4.5 Dade Behring (Siemens) 77
4.1.4.6 Randox 81
4.1.4.6.1 Randox Laboratories 81
4.1.4.7 Tosoh 82
4.1.5 Other Immunoassay Analyzers 83
4.1.5.1 Inverness Medical Professional Diagnostics 83
4.1.5.2 Hycor BioMedical 83
4.1.5.3 Phadia 83
4.1.5.4 Trinity Biotech 84
4.1.5.5 Diasorin 84
4.1.5.6 Grifols 84
4.1.5.7 Bio-Rad 85
4.1.5.8 SFRI Diagnostics 85
4.1.5.9 Qualigen 85
4.1.5.10 PerkinElmer Life and Analytical Sciences 85
4.1.5.11 Innotrac Diagnostics 85
4.1.5.12 Tecan 86
5. Important Technology Trends 88
5.1 Technology Innovations in Immunoassay Testing 88
5.2 Immunoassay Detection Technology Platforms 88
5.2.1 Fluorescence Detection 88
5.2.2 Chemiluminescence Detection 88
5.3 The New Paradigm 89
5.4 Consolidated Workstations 89
5.5 Automation in the Laboratory in Response to Labor Shortages 91
5.6 Laboratory Information System (LIS) 92
5.7 Biosensor Technology 92
5.8 Data Management Issues 94
5.8.1 Wireless LANs 95
5.8.2 Data and Workflow Management Systems 96
5.8.3 Beckman Central Command 96
5.8.4 Advances in Information Management 98
5.8.5 Connectivity Platforms 101
5.8.6 DataLink Data Management System 103
5.8.7 LabPortal.com 105
5.8.8 LifeScan Electronic Data Interfaces 105
5.8.9 Technical Problems of Connectivity 106
5.8.10 Web-Based Data Interface and Internet Connectivity 106
5.8.11 HIT Competition 107
5.8.12 FDA-Required Software Verification 108
5.8.13 Advantages of Connectivity 108
5.8.14 Technologies for Internet-based Remote Architecture 109
5.8.15 Abbott Multitiered Internet System 109
6. Business Trends in Clinical Immunoanalyzer Sector 110
6.1 Key Developments 110
6.2 Sector Consolidation 110
6.3 Diagnostic Testing Growth Trends 111
6.4 Reagents and Hardware Business in Japan 111
6.5 New Products 112
6.6 Acquisitions, License Agreements, Internal Developments and Partnerships 112
6.7 Product Testing Depth in Clinical Immunoanalyzer Testing 113
6.8 Government Regulations 113
6.8.1 U.S. Government Regulations 113
6.8.1.1 Importing Medical Devices into the U.S. 115
6.8.1.2 Exporting Medical Devices from the U.S. 115
6.8.2 U.K. Regulations 116
6.8.3 E.U. Regulations 117
6.8.4 Japanese Regulations 119
6.8.5 Korean Regulations 119
6.9 Increased Market Penetration 119
6.10 Costs of Doing Business in Europe 121
6.11 Drivers of European Diagnostics Testing 121
6.12 European Reimbursement Practices 121
6.13 Cost Containment in Europe 122
6.14 Medicare Spending Trends/Medicare Part B Spending Trends 122
7. Company Profiles 125
7.1 Abbott Diagnostics 125
7.2 Bayer Healthcare 127
7.3 Beckman Coulter 127
7.4 bioMérieux 129
7.5 Dade Behring 129
7.6 Bio-Rad Laboratories 131
7.7 Olympus 132
7.8 Ortho-Clinical Diagnostics 133
7.9 Phadia 134
7.10 Randox Laboratories 135
7.11 Roche Diagnostics 135
7.12 Tosoh 137
7.13 Siemens 137
8. Clinical Immunoanalyzer Testing Sector: Trends and Forecasts 139
8.1 Automated Intrument Platforms Evolution 139
8.2 Reagents and Supplies Market for Clinical Lab Instruments 139
8.3 Bar Code Reading 140
8.4 Measurement and Detection for Immunoassay Analyzers 140
8.5 Robotics 141
8.6 Move Away from Central Laboratory 142
8.7 Modular Automation 142
8.8 Components of Immunoassay Analyzers 142
8.9 Drivers of Clinical Immunoanalyzer Testing 146
8.10 Confluence of New Technology 147
8.11 New Trends in Clinical Laboratory Testing 147
8.11.1 Trends in Reimbursement Practices 147
8.11.2 Managed Care 150
8.11.3 Changes in Patient Management 150
8.11.4 Focused Testing 150
8.11.5 Spending for Clinical Laboratory Testing 150
8.11.6 Reimbursement Pressure 151
8.11.7 Multiplexing Technology 151
9. Product Launches 153
9.1 Immunoassay Analyzer Product Launches 153
9.2 Immunoassay Reagent Product Launches 154
INDEX OF TABLES
Table 2.1: Common Immunoassay Tests 11
Table 3.1: The Overall IVD Diagnostic Testing Market Worldwide, 2006 13
Table 3.2: Worldwide Distribution of IVD Testing, 2006 13
Table 3.3: Global Clinical Immunoassay Revenues, 2000 to 2012 14
Table 3.4: Worldwide Distribution of Clinical Immunoassay Testing, 2006 14
Table 3.5: U.S. Clinical Laboratory Testing Market, 2003 to 2012 17
Table 3.6: U.S. Clinical Laboratory Diagnostic Test Market Segments, 2006 17
Table 3.7: U.S. Clinical Laboratory Diagnostic Testing Reagents and Instruments Markets by Analyte, 2006 18
Table 3.8: U.S. Clinical Immunoanalyzer Testing Market, 2000 to 2012 18
Table 3.9: European Clinical Laboratory Testing IVD Reagents and Instruments Market (Dollars), 2000 to 2012 19
Table 3.10: European Clinical Laboratory Testing IVD Reagents and Instruments Market (Euros), 2000 to 2012 19
Table 3.11: European Clinical Laboratory Diagnostic Reagents and Instruments Markets by Analyte, 2006 20
Table 3.12: European Clinical Laboratory Testing Diagnostics by Country Market Estimates, 2006 20
Table 3.13: The European Immunochemistry Market, 2001 to 2012 21
Table 3.14: European Immunochemical Reagents and Instruments Markets by Country, 2006 22
Table 3.15: German Clinical Laboratory Testing Diagnostics Products Market Sales, 2003 to 2012 23
Table 3.16: German Clinical Immunochemistry Testing Diagnostics Products Market Sales, 2006 to 2012 23
Table 3.17: UK Clinical Immunochemistry Testing Diagnostics Products Market Sales, 2006 to 2012 24
Table 3.18: French Clinical Immunochemistry Testing Diagnostics Products Market Sales, 2006 to 2012 25
Table 3.19: Italian Immunochemistry Diagnostics Products Market Sales, 2006 to 2012 26
Table 3.20: Spanish Clinical Laboratory Diagnostics Products Market Sales, 2006 to 2012 26
Table 3.21: Finnish Clinical Immunoassay Products Market Sales, 2006 to 2012 27
Table 3.22: Belgium Clinical Immunoassay Products Market Sales, 2006 to 2012 27
Table 3.23: Swiss Clinical Immunoassay Products Market Sales, 2006 to 2012 28
Table 3.24: Dutch Clinical Immunoassay Products Market Sales, 2006 to 2012 28
Table 3.25: Portugese Clinical Immunoassay Products Market Sales, 2006 to 2012 28
Table 3.26: Austrian Clinical Immunoassay Products Market Sales, 2006 to 2012 29
Table 3.27: Greek Clinical Immunoassay Products Market Sales, 2006 to 2012 29
Table 3.28: Polish Clinical Immunoassay Products Market Sales, 2006 to 2012 30
Table 3.29: Romanian Clinical Immunoassay Products Market Sales, 2006 to 2012 30
Table 3.30: Indian IVD Market, 2006 to 2012 31
Table 3.31: Number of Automated Clinical Labs in India, 2004 to 2012 31
Table 3.32: Indian IVD Market (by Sector), 2006 31
Table 3.33: IVD Equipment and Reagents Market (by Company) in India, 2004 and 2005 32
Table 3.34: Japanese Clinical Immunoanalyzer Testing Market, 2000 to 2008 36
Table 3.35: Chinese Clinical Diagnostic Products Market, 2000 to 2008 37
Table 3.36: Canadian Clinical Analyzer Testing Market, 2000 to 2008 40
Table 3.37: Brazilian Clinical Immunoanalyzer Testing Market, 2000 to 2008 41
Table 3.38: Turkish Clinical Analyzer Testing Market, 2000 to 2008 41
Table 3.39: Australian Clinical Immunoanalyzer Testing Market, 2000 to 2008 42
Table 3.40: ROW Clinical Immunoanalyzer Testing Market, 2000 to 2008 42
Table 3.41: Estimated Number of Clinical Laboratories in Latin America 45
Table 3.42: Principal Marketers of Automated Clinical Immunoanalyzer Instruments 47
Table 4.1: Samples and Sample Handling Features of Centaur CP 61
Table 4.2: Large Immunochemistry Analyzers 71
Table 4.3: Small- to Mid-Volume Immunoassay Analyzers 87
Table 5.1: Wireless LAN Technology Companies 95
Table 5.2: Applications for Wireless LAN Technology 96
Table 5.3: CAP and JCAHO Requirements for Customized Reporting 104
Table 6.1: Hospital Laboratory Share of Part B Medicare Spending, 1996 to 2005 123
Table 6.2: Medicare Part B Spending Per Medicare Enrollee, 1998 to 2005 123
Table 6.3: Allowed Charges for Top 25 Clinical Laboratory Procedures, 2005 124
Table 8.1: Technology Platforms for Analyzer Detection Systems 140
Table 8.2: Medicare Billing Guidelines for Multi-Channel Immunoanalyzer Tests 148
LIST OF FIGURES
Figure 3.1: U.S. Revenue for Six Largest IVD Vendors, 2005 48
Figure 3.2: U.S. Revenue Change for Six Largest IVD Vendors, 2005 48
Figure 6.1: Part B Spending on Clinical Lab Services, 1991 to 2005 122

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