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Clinical Chemistry Analyzers

Publication Date June 2009
Publisher TriMark Publications
Product Type Report
Pages 161
ISBN Number not applicable
Product Code TRI00006
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Summary

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.

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Content

  • 1. Overview
    • 1.1 Objectives of the Report
    • 1.2 Methodology
    • 1.3 Scope of the Report
    • 1.4 Executive Summary
  • 2. IVD Clinical Chemistry Market
    • 2.1 Introduction
  • 3. IVD Clinical Chemistry Market
    • 3.1 Markets
      • 3.1.1 Global Markets
      • 3.1.2 Global Drivers of Clinical Chemistry Testing
      • 3.1.3 Global Outlook
      • 3.1.4 U.S. Market
      • 3.1.5 European Market
        • 3.1.5.1 German Clinical Chemistry Diagnostic Markets
        • 3.1.5.2 U.K. Clinical Chemistry Testing Diagnostic Market
        • 3.1.5.2.1 U.K. Market Statistics
        • 3.1.5.2.2 U.K. Competitive Analysis
        • 3.1.5.2.3 U.K. Market Access
        • 3.1.5.3 French Clinical Chemistry Diagnostic Market
        • 3.1.5.4 Italian Clinical Chemistry Diagnostic Market
        • 3.1.5.5 Spanish Clinical Chemistry Diagnostic Market
        • 3.1.5.6 Indian Clinical Chemistry Diagnostic Market
        • 3.1.5.6.1 India?s In Vitro Diagnostic Testing Industry
        • 3.1.5.7 Scandinavian Clinical Chemistry Market
        • 3.1.5.8 Japanese Clinical Chemistry Testing Market
        • 3.1.5.9 Country Clinical Chemistry Smaller Markets
        • 3.1.5.9.1 Chinese Clinical Chemistry Market
        • 3.1.5.9.2 Canada Clinical Chemistry Market
        • 3.1.5.9.3 Brazil Clinical Chemistry Market
        • 3.1.5.9.4 Turkey Clinical Chemistry Market
        • 3.1.5.9.5 Australia Clinical Chemistry Market
        • 3.1.5.9.6 Mexico IVD Market
        • 3.1.5.10 Remaining World Clinical Chemistry Testing Market
        • 3.1.5.11 Overview of Asian Healthcare Market
        • 3.1.5.11.1 Singapore
        • 3.1.5.11.2 Malaysia
        • 3.1.5.11.3 Thailand
        • 3.1.5.11.4 Indonesia
        • 3.1.5.11.5 Philippines
        • 3.1.5.11.6 South Korea
        • 3.1.5.11.7 India
        • 3.1.5.11.8 Hong Kong
        • 3.1.5.11.9 Taiwan
        • 3.1.5.12 Overview of the Latin American Diagnostics Market
    • 3.2 Clinical Chemistry Sector
      • 3.2.1 Industry-Served Markets
      • 3.2.2 Industry Players
        • 3.2.2.1 Manufacturing Companies
      • 3.2.3 Market Specialization
      • 3.2.4 Revenue and Reimbursement
      • 3.2.5 Companies
    • 3.3 Outlook for Clinical Chemistry Testing
      • 3.3.1 Long-Term Changes
      • 3.3.2 Market Drivers
      • 3.3.3 The Limits to Growth
      • 3.3.4 Hot Sectors in the IVD Market
      • 3.3.5 Key Technologies
      • 3.3.6 Conclusion
  • 4. Clinical Chemistry Instrument Market by Sector: Size, Growth, Share and Competitors
    • 4.1 Ultra-Large Throughput Chemistry Analyzers
    • 4.2 Large-Throughput Analyzers
    • 4.3 Mid-Size Clinical Chemistry Analyzers
    • 4.4 Chemistry Analyzers for the Small-Volume Market
  • 5. Important Technology Trends
    • 5.1 Technology Platform Innovations in Point-of-Care Testing
    • 5.2 Sensor Systems for Diagnostic Applications
    • 5.3 Glucose Measurements
    • 5.4 Glucose Test Methods
    • 5.5 Cholesterol Measurements
    • 5.6 The New Paradigm
    • 5.7 Consolidated Workstations
    • 5.8 Automation in the Laboratory in Response to Labor Shortages
    • 5.9 Laboratory Information Systems
    • 5.10 Biosensor Technology
    • 5.11 Data-Management Issues
      • 5.11.1 Wireless LANs
      • 5.11.2 Data and Workflow Management Systems
      • 5.11.3 Beckman Command Central Version 2.0
    • 5.12 Connectivity Platforms
      • 5.12.1 Laboratory Data Linking Software and Interface to the Laboratory Information System
      • 5.12.2 AbbottLink Analyzer Connections
      • 5.12.3 Beckman Coulter DL2000 Data Manager v6.5
      • 5.12.4 bioM?rieux Inc. ENQ
  • 6. Business Trends in the Clinical Chemistry Analyzer Sector
    • 6.1 Key Developments
    • 6.2 Sector Consolidation
    • 6.3 Diagnostic Testing Growth Trends
    • 6.4 Reagent and Hardware Business in Japan
    • 6.5 New Products
    • 6.6 Acquisition, License Agreements, Internal Development and Partnerships
    • 6.7 Product Testing Depth in Clinical Chemistry Testing
    • 6.8 Government Regulation
      • 6.8.1 U.S. Regulation
        • 6.8.1.1 Importing Medical Devices to the U.S
        • 6.8.1.2 Exporting Medical Devices from the U.S
      • 6.8.2 U.K. Regulation
      • 6.8.3 E.U. Regulation
      • 6.8.4 Japanese Regulation
      • 6.8.5 Korean Regulation
    • 6.9 Increased Market Penetration
    • 6.10 Costs of Doing Business in Europe
    • 6.11 Drivers of European Diagnostics Testing
    • 6.12 European Reimbursement Practices
    • 6.13 Cost Containment in Europe
    • 6.14 Medicare Reimbursement Trends
  • 7. Company Profiles
    • 7.1 Abaxis, Inc
    • 7.2 Abbott Diagnostics
    • 7.3 Adaltis Inc
    • 7.4 Alfa Wasserman, Inc. (f/k/a Electro-Nucleonics, Inc. and Schiapparelli Biosystems, Inc.)
    • 7.5 Awareness Technology, Inc
    • 7.6 Siemens Medical Solutions USA, Inc
    • 7.7 Beckman Coulter, Inc
    • 7.8 Dade Behring, Inc. (Acquired by Siemens Medical Solutions)
    • 7.9 Hitachi, Ltd
    • 7.10 Horiba, Ltd
    • 7.11 JEOL Ltd
    • 7.12 Nova Biomedical Corporation
    • 7.13 Olympus America, Inc
    • 7.14 Ortho-Clinical Diagnostics, Inc
    • 7.15 Roche Diagnostics Corp
    • 7.16 Shimadzu Corporation
    • 7.17 Sysmex Corporation
    • 7.18 Thermo Fisher Scientific Inc
    • 7.19 Vital Scientific B.V
  • 8. Clinical Chemistry Testing Sector Trends and Forecasts
    • 8.1 Home Care Analysis
    • 8.2 Non-traditional Collection for Chemistry Testing
    • 8.3 New Systems for Critical-Care and Near-Patient Testing
    • 8.4 Utility of Near-Patient Testing in Critical-Care Settings
    • 8.5 Mergers of Diagnostic Companies
    • 8.6 Information Management Advances
    • 8.7 Test Ordering Patterns
    • 8.8 Patient Satisfaction
    • 8.9 Move Away From Central Laboratory
    • 8.10 Healthcare Cost Controls
    • 8.11 Competition for Services
    • 8.12 Drivers of Clinical Chemistry Testing
    • 8.13 Confluence of New Technology
    • 8.14 New Trends in Clinical Laboratory Testing
      • 8.14.1 Trends in Reimbursement Practices
      • 8.14.2 Managed Care
      • 8.14.3 Changes in Patient Management
      • 8.14.4 Focused Testing
      • 8.14.5 Satellite Facilities
      • 8.14.6 Point-of-Care Testing
      • 8.14.7 Regionalization of Laboratory Care
    • 8.15 New Chemistry Analyzers
    • 8.16 Multiplexing Technology
  • 9. Clinical Chemistry Product Introductions
    • 9.1 Clinical Chemistry Analyzer Product Launches
    • 9.2 Clinical Chemistry Reagent Product Launches
  • 10. Corporate Directory
  • List of Figures
    • Figure 3.1:
    • Figure 6.1:
  • List of Tables
    • Table 3.1: The Overall In Vitro Diagnostic Testing Market Worldwide, 2008
    • Table 3.2: Worldwide Distribution of IVD Testing, 2008
    • Table 3.3: Global Clinical Chemistry Revenues, 1998-2012
    • Table 3.4: Worldwide Distribution of Clinical Chemistry Testing, 2006
    • Table 3.5: Thirteen Largest Diagnostic Companies Worldwide, 2007
    • Table 3.6: U.S. Clinical Chemistry Testing Market, 2000-2012
    • Table 3.7: U.S. Clinical Laboratory Diagnostic Test Market Segments, 2008
    • Table 3.8: U.S. Individual Clinical Chemistry Diagnostic Test Markets, 2007
    • Table 3.9: European Clinical Laboratory Testing IVD Reagents and Instruments Market, 2000-2012
    • Table 3.10: European Clinical Laboratory Testing Diagnostics by Country Market Estimates, 2007
    • Table 3.11: European Clinical Chemistry Testing Market, 2000-2008
    • Table 3.12: European Rapid Point of Care Testing by Country Market Estimates, 2008
    • Table 3.13: German Clinical Chemistry Testing Diagnostics Products Market Sales, 2003-2012
    • Table 3.14: The German Patient Care Lab Test Market, 2000-2008
    • Table 3.15: The German Alternate Site Testing Market (POL), 2000-2008
    • Table 3.16: The German Hospital Clinical Chemistry Market, 2000-2008
    • Table 3.17: U.K. Clinical Chemistry Diagnostics Products Market Sales, 2000-2008
    • Table 3.18: Major U.K. IVD Manufacturers
    • Table 3.19: U.S. IVD Manufacturers Doing Business in the U.K
    • Table 3.20: Other European Companies That Manufacture IVD Products in the U.K
    • Table 3.21: French Clinical Chemistry Diagnostics Products Market Sales, 1998-2008
    • Table 3.22: Italian Chemistry Diagnostics Products Market Sales, 1998-2008
    • Table 3.23: Spanish Clinical Chemistry Diagnostics Products Market Sales, 1998-2008
    • Table 3.24: Indian IVD Market, 2006-2012
    • Table 3.25: Number of Automated Clinical Labs in India, 2004-2012
    • Table 3.26: Indian IVD Market, 2008
    • Table 3.27: Indian IVD Market for Instruments and Reagents, 2004-2012
    • Table 3.28: Scandinavian Clinical Chemistry Diagnostics Products Market Sales, 2000-2008
    • Table 3.29: Japan Clinical Chemistry Testing Market, 2000-2008
    • Table 3.30: Chinese Clinical Chemistry Diagnostics Products Market Sales, 2000-2008
    • Table 3.31: Canadian Clinical Chemistry Testing Market, 2000-2008
    • Table 3.32: Brazilian IVD Testing Market, 2000-2008
    • Table 3.33: Brazilian Clinical Chemistry Testing Market, 2000-2008
    • Table 3.34: Turkish Clinical Chemistry Testing Market, 2000-2008
    • Table 3.35: Australian Clinical Chemistry Testing Market, 2000-2008
    • Table 3.36: Mexican IVD Testing Market, 2000-2008
    • Table 3.37: Mexican Clinical Chemistry Testing Market, 2000-2008
    • Table 3.38: The ROW Clinical Chemistry Testing Market, 2000-2008
    • Table 3.39: Estimated Number of Clinical Laboratories in Latin America
    • Table 3.40: Principal Marketers of Automated Clinical Chemistry Instruments
    • Table 4.1: Ultra-Large Clinical Chemistry Analyzers
    • Table 4.2: JEOL Analyzer Comparison
    • Table 4.3: Large Clinical Chemistry Analyzers
    • Table 4.4: Mid-size Clinical Chemistry Analyzers
    • Table 5.1: Normal Glucose Values-Fasting State
    • Table 5.2: Applications for Wireless LAN Technology
    • Table 6.1: Medicare Spending on Clinical Lab Services, 1991-2007
    • Table 6.2: Medicare Part B Spending Per Medicare Enrollee, 1998-2009
    • Table 6.3: Allowed Charges for Top 25 Clinical Laboratory Procedures, 2009
    • Table 7.1: Products Marketed by Abbott in the Diagnostic Market
    • Table 7.2: Products Marketed by Siemens (formerly Dade Behring) in the Diagnostics Market
    • Table 7.3: Clinically-Significant Tests Available From Siemens
    • Table 7.4: Comparison of JEOL Analyzers
    • Table 7.5: VITROS ECiQ Immunodiagnostic System
    • Table 8.1: Medicare Billing Guidelines for Multi-channel Chemistry Tests
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