臨床化学分析装置

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 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

• 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 Central Command
• 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 bioMérieux Inc. ENQ
  • 5.12.5 Ortho-Clinical Diagnostics Inc. Software Version 1.02

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
  • 7.1.1 Point-of-Care Blood Chemistry Analyzers
  • 7.1.2 Hematology
  • 7.1.3 Reagent Discs
  • 7.1.4 Orbos Process
  • 7.1.5 VetScan Canine Heartworm Antigen Test
• 7.2 Abbott Diagnostics
  • 7.2.1 Diagnostic Products
  • 7.2.2 Business Analysis
  • 7.2.3 TriMark Commentary
• 7.3 Adaltis, Inc.
• 7.4 Alfa Wasserman, Inc. (f/k/a Electro-Nucleonics, Inc. and Schiapparelli Biosystems, Inc.)
  • 7.4.1 Background
  • 7.4.2 Products
• 7.5 Awareness Technology
• 7.6 Siemens Medical Solutions Diagnostics
• 7.7 Beckman Coulter, Inc.
  • 7.7.1 Overview
  • 7.7.2 Company History
  • 7.7.3 Products
    • 7.7.3.1 Clinical Diagnostics Products
      • 7.7.3.1.1 Overview
    • 7.7.3.2 Clinical Chemistry Systems
    • 7.7.3.3 Clinical Laboratory Automation
    • 7.7.3.4 Hemostasis Systems
    • 7.7.3.5 Immunodiagnostic Systems
    • 7.7.3.6 Primary Care Diagnostics
    • 7.7.3.7 Hematology Systems
  • 7.7.4 TriMark Commentary
• 7.8 Dade Behring, Inc.
  • 7.8.1 Products
  • 7.8.2 Other Served Markets
• 7.9 Hitachi
  • 7.9.1 Products
• 7.10 Horiba, Ltd.
• 7.11 JEOL, Ltd.
• 7.12 Olympus America, Inc. Clinical Instruments Division
  • 7.12.1 Background
  • 7.12.2 Automated General Chemistry Instruments
  • 7.12.3 TriMark Commentary
• 7.13 Ortho-Clinical Diagnostics, a Johnson & Johnson Company
  • 7.13.1 Background
  • 7.13.2 Markets
  • 7.13.3 Automated General Chemistry Instruments
  • 7.13.4 TriMark Commentary
• 7.14 Roche Diagnostics Corp
  • 7.14.1 Background
  • 7.14.2 Automated General Chemistry Instruments
  • 7.14.3 Business Analysis
• 7.15 Shimadzu
  • 7.15.1 Products
• 7.16 Sysmex Corporation
• 7.17 Thermo Fisher Scientific Inc.
• 7.18 Vital Scientific, NV
  • 7.18.1 Background
  • 7.18.2 Products

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

INDEX OF FIGURES

• Figure 3.1: European Diagnostic Reagents Markets, 2006
• Figure 6.1: Part B Spending on Clinical Laboratory Services: 1991 to 2005

LIST OF TABLES

• Table 3.1: The Overall In Vitro Diagnostic Testing Market Worldwide: 2006
• Table 3.2: Worldwide Distribution of IVD Testing: 2006
• Table 3.3: Global Clinical Chemistry Revenues: 1998 to 2012
• Table 3.4: Worldwide Distribution of Clinical Chemistry Testing: 2006
• Table 3.5: Ten Largest Diagnostic Companies Worldwide: 2005
• Table 3.6: U.S. Clinical Chemistry Testing Market: 2000 to 2012
• Table 3.7: U.S. Clinical Chemistry Diagnostic Test Market Segments: 2006
• Table 3.8: U.S. Individual Clinical Chemistry Diagnostic Test Markets: 2006
• Table 3.9: European Clinical Laboratory Testing IVD Reagents and Instruments Market (Dollars): 2000 to 2012
• Table 3.10: European Clinical Laboratory Testing IVD Reagents and Instruments Market (Euros): 2000 to 2012
• Table 3.11: European Clinical Laboratory Diagnostic Reagents and Instruments Markets by Analyte: 2006
• Table 3.12: European Clinical Laboratory Testing Diagnostics by Country Market Estimates: 2006
• Table 3.13: European Clinical Chemistry Testing Market: 2000 to 2008
• Table 3.14: European Clinical Chemistry Reagents and Instruments Markets by Country: 2006
• Table 3.15: German Clinical Chemistry Testing Diagnostics Products Market Sales: 2000 to 2007
• Table 3.16: The German Patient Care Lab Test Market: 2000 to 2008
• Table 3.17: The German Alternate Site Testing Market (POL): 2000 to 2008
• Table 3.18: The German Hospital Clinical Chemistry Market: 2000 to 2008
• Table 3.19: German Clinical Diagnostic Chemistry Test Market Segments by Analyte: 2002 and 2005
• Table 3.20: U.K. Clinical Chemistry Diagnostics Products Market Sales: 2000 to 2008
• Table 3.21: Major U.K. IVD Manufacturers
• Table 3.22: U.S. IVD Manufacturers Doing Business in the U.K.
• Table 3.23: Other European Companies That Manufacture IVD Products in the U.K.
• Table 3.24: French Clinical Chemistry Diagnostics Products Market Sales: 1998 to 2008
• Table 3.25: Italian Chemistry Diagnostics Products Market Sales: 1998 to 2008
• Table 3.26: Spanish Clinical Chemistry Diagnostics Products Market Sales: 1998 to 2008
• Table 3.27: Indian IVD Market: 2006 to 2012
• Table 3.28: Number of Automated Clinical Labs in India: 2004 to 2012
• Table 3.29: Indian IVD Market: 2006
• Table 3.30: Market Sales of IVD Equipment and Reagents by Company in India: 2004 and 2005
• Table 3.31: Scandinavian Clinical Chemistry Diagnostics Products Market Sales: 2000 to 2008
• Table 3.32: Japan Clinical Chemistry Testing Market: 2000 to 2008
• Table 3.33: Chinese Clinical Chemistry Diagnostics Products Market Sales: 2000 to 2008
• Table 3.34: Canadian Clinical Chemistry Testing Market: 2000 to 2008
• Table 3.35: Brazilian IVD Testing Market: 2000 to 2008
• Table 3.36: Brazilian Clinical Chemistry Testing Market: 2000 to 2008
• Table 3.37: Turkish Clinical Chemistry Testing Market: 2000 to 2008
• Table 3.38: Australian Clinical Chemistry Testing Market: 2000 to 2008
• Table 3.39: Mexican IVD Testing Market: 2000 to 2008
• Table 3.40: Mexican Clinical Chemistry Testing Market: 2000 to 2008
• Table 3.41: The ROW Clinical Chemistry Testing Market: 2000 to 2008
• Table 3.42: Estimated Number of Clinical Laboratories in Latin America
• Table 3.43: 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 4.5: Small Clinical Chemistry Analyzers
• Table 5.1: Normal Glucose Values-Fasting State
• Table 5.2: Applications for Wireless LAN Technology
• Table 6.1: Hospital Laboratory Share of Part B Medicare Spending: 1996 to 2005
• Table 6.2: Medicare Part B Spending Per Medicare Enrollee: 1998 to 2005
• Table 6.3: Allowed Charges for Top 25 Clinical Laboratory Procedures: 2005
• Table 7.1: Products Marketed by Abbott in the Diagnostic Market
• Table 7.2: Products Marketed by Dade Behring in the Diagnostics Market
• Table 7.3: Clinically-Significant Tests Available From Dade
• Table 7.4: Comparison of JEOL Analyzers
• Table 7.5: VITROS ECiQ Immunodiagnostic System
• Table 7.6: Sysmex Marketing Summary for China
• Table 8.1: Medicare Billing Guidelines for Multi-channel Chemistry Tests

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