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Clinical Immunoanalyzer Markets

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. Overview5
  • 1.1Objectives5
  • 1.2Methodology5
  • 1.3Scope6
  • 1.4Executive Summary7
  
  
• 2.IVD Clinical Immunoanalyzer Market8
  • 2.1Introduction8
  
  
• 3.IVD Clinical Immunoanalyzer Market Analysis10
  • 3.1Markets10
    • 3.1.1Global Markets10
    • 3.1.2Global Drivers of Clinical Immunoanalyzer Testing12
    • 3.1.3Global Outlook13
    • 3.1.4U.S. Market13
    • 3.1.5European Market15
    • 3.1.6German Clinical Immunoanalyzer Diagnostic Markets16
    • 3.1.7U.K. Clinical Immunoanalyzer Testing Diagnostic Market19
      • 3.1.7.1U.K. Market Statistics19
      • 3.1.7.2U.K. Competitive Analysis20
      • 3.1.7.3U.K. Market Access21
    • 3.1.8French Clinical Diagnostic Market21
    • 3.1.9Italian Clinical Analyzer Diagnostic Market22
    • 3.1.10Spanish Clinical Analyzer Diagnostic Market22
    • 3.1.11Indian Clinical Analyzer Diagnostic Market23
      • 3.1.11.1India's in vitro Diagnostic Testing Industry23
    • 3.1.12Scandinavian Clinical Immunoanalyzer Market25
    • 3.1.13Japanese Clinical Immunoanalyzer Testing Market26
    • 3.1.14Country Clinical Analyzer Smaller Markets26
      • 3.1.14.1Chinese Clinical Analyzer Market26
      • 3.1.14.2Canada Clinical Analyzer Market30
      • 3.1.14.3Brazil Clinical Analyzer Market30
      • 3.1.14.4Turkey Clinical Immunoanalyzer Market30
      • 3.1.14.5Australia Clinical Analyzer Market31
      • 3.1.14.6Rest of the World Clinical Analyzer Testing Market31
    • 3.1.15Overview of Asian Healthcare Market32
      • 3.1.15.1Singapore32
      • 3.1.15.2Malaysia32
      • 3.1.15.3Thailand33
      • 3.1.15.4Indonesia33
      • 3.1.15.5Philippines33
      • 3.1.15.6South Korea34
      • 3.1.15.7India34
      • 3.1.15.8Hong Kong34
      • 3.1.15.9Taiwan35
    • 3.1.16Latin American Diagnostic Market35
  • 3.2Clinical Immunoanalyzer Sector36
    • 3.2.1Industry-Served Markets37
    • 3.2.2Industry Players38
      • 3.2.2.1Manufacturing Companies38
    • 3.2.3Market Specialization39
    • 3.2.4Revenue and Reimbursement41
    • 3.2.5Companies41
  • 3.3Outlook for Clinical Immunoanalyzer Testing43
    • 3.3.1Long-Term Changes43
    • 3.3.2Market Drivers44
    • 3.3.3Limits to Growth44
    • 3.3.4Hot Sectors in IVD Market45
    • 3.3.5Key Technologies46
    • 3.3.6Analyzer Integration Chemistry/Immunoassay46
    • 3.3.7Conclusion47
    
    
• 4.Clinical Immunoanalyzer Instrument Market by Sector48
  • 4.1Market Analysis: Size, Growth, Share and Competitors48
    • 4.1.1Immunochemistry Analyzers48
    • 4.1.2Large-Volume Immunochemistry Analyzers48
      • 4.1.2.1Abbott Diagnostics48
      • 4.1.2.2Bayer Diagnostics49
      • 4.1.2.3Beckman Coulter52
      • 4.1.2.4Dade Behring53
      • 4.1.2.5Diagnostics Products Corporation54
      • 4.1.2.6Olympus55
      • 4.1.2.7Ortho-Clinical Diagnostics55
      • 4.1.2.8Roche Diagnostics58
      • 4.1.2.9Tosoh Bioscience59
    • 4.1.3Batch-Type Immunoassay Analyzers61
    • 4.1.4Small-Volume to Mid-Volume Immunoassay Analyzers64
      • 4.1.4.1Awareness Technology64
      • 4.1.4.2Bayer Diagnostics64
      • 4.1.4.3Beckman Coulter64
      • 4.1.4.4bioMérieux65
      • 4.1.4.5Dade Behring66
      • 4.1.4.6Nichols Institute70
      • 4.1.4.7Tosoh70
    • 4.1.5Other Immunoassay Analyzers71
    
    
• 5.Important Technology Trends74
  • 5.1Technology Innovations in Immunoassay Testing74
  • 5.2Sensor Systems for Diagnostic Applications74
  • 5.3The New Paradigm76
  • 5.4Consolidated Workstations77
  • 5.5Automation in the Laboratory78
  • 5.6Laboratory Information System (LIS)79
  • 5.7Biosensor Technology79
  • 5.8Data Management Issues81
    • 5.8.1Wireless LANs81
    • 5.8.2Data and Workflow Management Systems83
    • 5.8.3Beckman Central Command83
    • 5.8.4Advances in Information Management85
    • 5.8.5Connectivity Platforms88
    • 5.8.6DataLink Data Management System88
    • 5.8.7LabPortal.com90
    • 5.8.8LifeScan Electronic Data Interfaces90
    • 5.8.9Technical Problems of Connectivity91
    • 5.8.10Web-Based Data Interface92
    • 5.8.11HIT Competition92
    • 5.8.12FDA-Required Software Verification92
    • 5.8.13Advantages of Connectivity93
    
    
• 6.Business Trends in Clinical Immunoanalyzer Sector94
  • 6.1Key Developments94
  • 6.2Sector Consolidation94
  • 6.3Diagnostic Testing Growth Trends95
  • 6.4Reagents and Hardware Business in Japan96
  • 6.5New Products96
  • 6.6Acquisitions, License Agreements, Internal Developments and Partnerships96
  • 6.7Product Testing Depth in Clinical Immunoanalyzer Testing97
  • 6.8Market Share97
    • 6.8.1U.S. Government Regulations97
      • 6.8.1.1Importing Medical Devices into the U.S.98
      • 6.8.1.2Exporting Medical Devices from the U.S.99
    • 6.8.2U.K. Regulations99
    • 6.8.3E.U. Regulations101
    • 6.8.4Japanese Regulations102
    • 6.8.5Korean Regulations103
  • 6.9Increased Market Penetration103
  • 6.10Costs of Doing Business in Europe105
  • 6.11Drivers of European Diagnostics Testing105
  • 6.12European Reimbursement Practices105
  • 6.13Cost Containment in Europe105
  
  
• 7.Company Profiles106
  • 7.1Abbott Diagnostics106
  • 7.2Bayer Healthcare107
  • 7.3Beckman Coulter109
  • 7.4bioMérieux113
  • 7.5Dade Behring113
  • 7.6Nichols Institute115
  • 7.7Olympus116
  • 7.8Ortho-Clinical Diagnostics116
  • 7.9Phadia117
  • 7.10Randox Laboratories117
  • 7.11Roche Diagnostics118
  • 7.12Tosoh119
  
  
• 8.Clinical Immunoanalyzer Testing Sector: Trends and Forecasts120
  • 8.1Utility of Near-Patient Testing in Critical-Care Settings120
  • 8.2Mergers of Diagnostic Companies120
  • 8.3Information Management Advances120
  • 8.4Test Ordering Patterns120
  • 8.5Patient Satisfaction120
  • 8.6Move away from Central Laboratory120
  • 8.7Healthcare Cost Controls120
  • 8.8Competition for Services120
  • 8.9Drivers of Clinical Immunoanalyzer Testing121
  • 8.10Confluence of New Technology121
  • 8.11New Trends in Clinical Laboratory Testing121
    • 8.11.1Trends in Reimbursement Practices121
    • 8.11.2Managed Care124
    • 8.11.3Changes in Patient Management124
    • 8.11.4Focused Testing124
    • 8.11.5Satellite Facilities124
    • 8.11.6Point-of-Care Testing125
    • 8.11.7Regionalization of Laboratory Care125
    
    
    

INDEX OF TABLES

Table 2.1: Common Immunoassay Tests8

Table 3.1: Overall in vitro Diagnostic Testing Market Worldwide in 200510

Table 3.2: Worldwide Distribution of IVD Testing in 200510

Table 3.3: Global Clinical Immunoassay Revenues: 2000 to 201211

Table 3.4: Worldwide Distribution of Clinical Immunoassay Testing in 200511

Table 3.5: Ten Largest Diagnostic Companies Worldwide in 200511

Table 3.6: U.S. Clinical Immunoanalyzer Testing Market: 2000 to 200814

Table 3.7: U.S. Clinical Analyzer Testing Market: 2000 to 201114

Table 3.8: U.S. Clinical Diagnostic Test Market Segments in 200515

Table 3.9: U.S. Individual Clinical Immunoanalyzer Diagnostic Test Markets in 200515

Table 3.10: European Clinical Testing Market: 2000 to 200816

Table 3.11: European Clinical Testing Diagnostics Market (by Country) in 200516

Table 3.12: German Clinical Testing Diagnostic Products Market: 2000 to 200717

Table 3.13: German Patient-Care Lab Test Market: 2000 to 200817

Table 3.14: German Alternate Site Testing (POL) Market: 2000 to 200818

Table 3.15: German Hospital Clinical Analyzer Market: 2000 to 200818

Table 3.16: German Clinical Diagnostic Immunoanalyzer Test Market Segments (by Analyte)18

Table 3.17: U.K. Clinical Diagnostic Products Market Sales: 2000 to 200819

Table 3.18: Major U.K. IVD Manufacturers20

Table 3.19: U.S. IVD Manufacturers Doing Business in U.K.20

Table 3.20: Other European Companies Manufacturing IVD Products in U.K.21

Table 3.21: French Analyzer Diagnostic Products Market: 1998 to 200721

Table 3.22: Italian Diagnostic Products Market: 1998 to 200822

Table 3.23: Spanish Clinical Diagnostic Products Market: 1998 to 200822

Table 3.24: Indian IVD Market: 2006 to 201223

Table 3.25: Number of Automated Clinical Labs in India: 2004 to 201223

Table 3.26: Indian IVD Market (by Sector) in 200624

Table 3.27: IVD Equipment and Reagents Market (by Company) in India25

Table 3.28: Scandinavian Clinical Analyzer Diagnostic Products Market: 2000 to 200825

Table 3.29: Japanese Clinical Immunoanalyzer Testing Market: 2000 to 200826

Table 3.30: Chinese Clinical Diagnostic Products Market: 2000 to 200826

Table 3.31: Canadian Clinical Analyzer Testing Market: 2000 to 200830

Table 3.32: Brazilian Clinical Immunoanalyzer Testing Market: 2000 to 200830

Table 3.33: Turkish Clinical Analyzer Testing Market: 2000 to 200831

Table 3.34: Australian Clinical Immunoanalyzer Testing Market: 2000 to 200831

Table 3.35: ROW Clinical Immunoanalyzer Testing Market: 2000 to 200832

Table 3.36: Estimated Number of Clinical Laboratories in Latin America35

Table 3.37: Principal Marketers of Automated Clinical Immunoanalyzer Instruments38

Table 4.1: Samples and Sample Handling Features of Centaur CP51

Table 4.2: Large Immunochemistry Analyzers60

Table 4.3: Small-to-Mid Volume Immunoassay Analyzers72

Table 5.1: Wireless LAN Technology Companies82

Table 5.2: Applications for Wireless LAN Technology82

Table 5.3: CAP and JCAHO Requirements for Customized Reporting89

Table 8.1: Medicare Billing Guidelines for Multi-Channel Immunoanalyzer Tests122

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