Clinical Bundle

Table of Contents

Clinical Chemistry Analyzers

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 bioMerieux 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

INDEX 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

Clinical Immunoanalyzer Markets

1. Overview

• 1.1 Objectives
• 1.2 Methodology
• 1.3 TriMark Publications Report Research and Data Acquisition Structure
• 1.4 Scope of the Report
• 1.5 Executive Summary

2. IVD Clinical Immunoanalyzer Market

• 2.1 Introduction

3. IVD Clinical Immunoanalyzer Market Analysis

• 3.1 Markets
  • 3.1.1 Global Markets
  • 3.1.2 Global Drivers of Clinical Immunoanalyzer Testing
  • 3.1.3 Global Outlook
  • 3.1.4 U.S. Market
  • 3.1.5 European IVD Market
    • 3.1.5.1 German Clinical Immunoanalyzer Diagnostic Markets
    • 3.1.5.2 U.K. Clinical Immunoanalyzer Testing Diagnostic Market
    • 3.1.5.3 French Clinical Laboratory Diagnostic Testing Market
    • 3.1.5.4 Italian Clinical Immunochemistry Diagnostic Market
    • 3.1.5.5 Spanish Immunoanalyzer Market
    • 3.1.5.6 Finnish Immunoanalyzer Market
    • 3.1.5.7 Belgian Immunoanalyzer Market
    • 3.1.5.8 Swiss Immunoanalyzer Market
    • 3.1.5.9 Dutch Immunoanalyzer Market
    • 3.1.5.10 Portuguese Immunoanalyzer Market
    • 3.1.5.11 Austrian Immunoanalyzer Market
    • 3.1.5.12 Greek Immunoanalyzer Market
    • 3.1.5.13 Polish Immunoanalyzer Market
    • 3.1.5.14 Romanian Immunoanalyzer Market
  • 3.1.6 Indian Clinical Analyzer Diagnostic Market
    • 3.1.6.1 India' s in vitro Diagnostic Testing Industry
  • 3.1.7 Japanese Clinical Immunoanalyzer Testing Market
  • 3.1.8 Country Clinical Analyzer Smaller Markets
    • 3.1.8.1 China Clinical Analyzer Market
    • 3.1.8.2 Canada Clinical Analyzer Market
    • 3.1.8.3 Brazil Clinical Analyzer Market
    • 3.1.8.4 Turkey Clinical Immunoanalyzer Market
    • 3.1.8.5 Australia Clinical Analyzer Market
    • 3.1.8.6 Rest of the World Clinical Analyzer Testing Market
  • 3.1.9 Overview of Asian Healthcare Market
    • 3.1.9.1 Singapore
    • 3.1.9.2 Malaysia
    • 3.1.9.3 Thailand
    • 3.1.9.4 Indonesia
    • 3.1.9.5 Philippines
    • 3.1.9.6 South Korea
    • 3.1.9.7 India
    • 3.1.9.8 Hong Kong
    • 3.1.9.9 Taiwan
• 3.2 Clinical Immunoanalyzer 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 Immunoanalyzer 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 IVD Market
  • 3.3.5 Key Technologies
  • 3.3.6 Analyzer Integration Chemistry/Immunoassay
  • 3.3.7 Conclusion

4. Clinical Immunoanalyzer Instrument Market by Sector

• 4.1 Market Analysis: Size, Growth, Share and Competitors
  • 4.1.1 Immunochemistry Analyzers
  • 4.1.2 Large-Volume Immunochemistry Analyzers
    • 4.1.2.1 Abbott Diagnostics
    • 4.1.2.2 Siemens Medical Solutions Diagnostics
    • 4.1.2.3 Beckman Coulter, Inc.
    • 4.1.2.4 Dade Behring (Acquired by Siemens)
    • 4.1.2.5 Diagnostics Products Corporation (Acquired by Siemens Healthcare Diagnostics)
    • 4.1.2.6 Olympus America, Inc.
    • 4.1.2.7 Ortho-Clinical Diagnostics
    • 4.1.2.8 Roche Diagnostics Corp.
    • 4.1.2.9 Tosoh Bioscience
  • 4.1.3 Batch-Type Immunoassay Analyzers
    • 4.1.3.1 Bio-Rad
    • 4.1.3.2 Dade Behring (Acquired by Siemens)
    • 4.1.3.3 Diamedix
    • 4.1.3.4 Tosoh
  • 4.1.4 Small-Volume to Mid-Volume Immunoassay Analyzers
    • 4.1.4.1 Awareness Technology, Inc.
    • 4.1.4.2 Siemens Healthcare Diagnostics, Inc.
    • 4.1.4.3 Beckman Coulter, Inc.
    • 4.1.4.4 bioMerieux SA
    • 4.1.4.5 Dade Behring (Acquired by Siemens)
    • 4.1.4.6 Randox Laboratories Ltd.
    • 4.1.4.7 Tosoh Corporation
  • 4.1.5 Other Immunoassay Analyzers
    • 4.1.5.1 Inverness Medical Professional Diagnostics
    • 4.1.5.2 Hycor BioMedical (A Part of Agilent Technologies)
    • 4.1.5.3 Phadia AB
    • 4.1.5.4 Trinity Biotech PLC.
    • 4.1.5.5 Diasorin
    • 4.1.5.6 Grifols U.S.A. Inc.
    • 4.1.5.7 Bio-Rad Laboratories, Inc.
    • 4.1.5.8 SFRI Diagnostics
    • 4.1.5.9 Qualigen Inc.
    • 4.1.5.10 PerkinElmer Inc.
    • 4.1.5.11 Innotrac Diagnostics Oy
    • 4.1.5.12 Tecan Group Ltd.

5. Important Technology Trends

• 5.1 Technology Innovations in Immunoassay Testing
• 5.2 Immunoassay Detection Technology Platforms
  • 5.2.1 Fluorescence Detection
  • 5.2.2 Chemiluminescence Detection
• 5.3 The New Paradigm
• 5.4 Consolidated Workstations
• 5.5 Automation in the Laboratory in Response to Labor Shortages
• 5.6 Laboratory Information System (LIS)
• 5.7 Biosensor Technology
• 5.8 Data Management Issues
  • 5.8.1 Wireless LANs
  • 5.8.2 Data and Workflow Management Systems
  • 5.8.3 Beckman Central Command
  • 5.8.4 Advances in Information Management
  • 5.8.5 Connectivity Platforms
  • 5.8.6 DataLink Data Management System
  • 5.8.8 Technical Problems of Connectivity
  • 5.8.9 Web-Based Data Interface and Internet Connectivity
  • 5.8.10 HIT Competition
  • 5.8.11 FDA-Required Software Verification
  • 5.8.12 Advantages of Connectivity
  • 5.8.13 Technologies for Internet-based Remote Architecture
  • 5.8.14 Abbott Multi Tiered Internet System

6. Business Trends in Clinical Immunoanalyzer Sector

• 6.1 Key Developments
• 6.2 Sector Consolidation
• 6.3 Diagnostic Testing Growth Trends
• 6.4 Reagents and Hardware Business in Japan
• 6.5 New Products
• 6.6 Acquisitions, License Agreements, Internal Developments and Partnerships
• 6.7 Product Testing Depth in Clinical Immunoanalyzer Testing
• 6.8 Government Regulations
  • 6.8.1 U.S. Government Regulations
    • 6.8.1.1 Importing Medical Devices into the U.S.
    • 6.8.1.2 Exporting Medical Devices from the U.S.
  • 6.8.2 U.K. Regulations
  • 6.8.3 E.U. Regulations
  • 6.8.4 Japanese Regulations
  • 6.8.5 Korean Regulations
• 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 Spending Trends/Medicare Part B Spending Trends

7. Company Profiles

• 7.1 Abbott Diagnostics
• 7.3 Beckman Coulter, Inc.
• 7.4 bioMerieux
• 7.5 Dade Behring (Acquired by Siemens)
• 7.6 Bio-Rad Laboratories, Inc.
• 7.7 Olympus America, Inc.
• 7.8 Ortho-Clinical Diagnostics, Inc.
• 7.9 Phadia AB
• 7.10 Randox Laboratories Ltd.
• 7.11 Roche Diagnostics Corp.
• 7.12 Tosoh Corporation
• 7.13 Siemens AG

8. Clinical Immunoanalyzer Testing Sector: Trends and Forecasts

• 8.1 Automated Instrument Platforms Evolution
• 8.2 Reagents and Supplies Market for Clinical Lab Instruments
• 8.3 Bar Code Reading
• 8.4 Measurement and Detection for Immunoassay Analyzers
• 8.5 Robotics Systems
• 8.6 Move Away from Central Laboratory
• 8.7 Modular Automation
• 8.8 Components of Immunoassay Analyzers
• 8.9 Drivers of Clinical Immunoanalyzer Testing
• 8.10 Confluence of New Technology
• 8.11 New Trends in Clinical Laboratory Testing
  • 8.11.1 Trends in Reimbursement Practices
  • 8.11.2 Managed Care
  • 8.11.3 Changes in Patient Management
  • 8.11.4 Focused Testing
  • 8.11.5 Spending for Clinical Laboratory Testing
  • 8.11.6 Reimbursement Pressure

9. Product Launches

• 9.1 Immunoassay Analyzer Product Launches
• 9.2 Immunoassay Reagent Product Launches

INDEX OF TABLES

• Table 2.1: Common Immunoassay Tests
• Table 3.1: Worldwide IVD Testing Market, 2008
• Table 3.2: Worldwide Distribution of IVD Testing, 2008
• Table 3.3: Global Clinical Immunoassay Revenues, 2000-2012
• Table 3.4: Worldwide Distribution of Clinical Immunoassay Testing, 2006
• Table 3.5: U.S. Clinical Laboratory Testing Market, 2003-2012
• Table 3.6: U.S. Clinical Laboratory Diagnostic Test Market Segments, 2008
• Table 3.7: U.S. Individual Clinical Chemistry Laboratory Diagnostic Test Markets, 2007
• Table 3.8: U.S. Clinical Immunoanalyzer Testing Market, 2000-2012
• Table 3.9: European Clinical Laboratory Testing IVD Reagents and Instruments Market, 2000-2012
• Table 3.10: European Clinical Laboratory Testing IVD Reagents and Instruments Market, 2000-2012
• Table 3.11: European Clinical Laboratory Diagnostic Reagents and Instruments Markets by Analyte, 2008
• Table 3.12: European Clinical Laboratory Testing Diagnostics by Country Market Estimates, 2007
• Table 3.13: The European Immunochemistry Market, 2001-2012
• Table 3.14: European Immunochemical Reagents and Instruments Markets by Country, 2006
• Table 3.15: German Clinical Laboratory Testing Diagnostics Products Market Sales, 2003-2012
• Table 3.16: German Clinical Immunochemistry Testing Diagnostics Products Market Sales, 2006-2012
• Table 3.17: UK Clinical Immunochemistry Testing Diagnostics Products Market Sales, 2006-2012
• Table 3.18: French Clinical Immunochemistry Testing Diagnostics Products Market Sales, 2006-2012
• Table 3.19: Italian Immunochemistry Diagnostics Products Market Sales, 2006-2012
• Table 3.20: Spanish Clinical Laboratory Diagnostics Products Market Sales, 2006-2012
• Table 3.21: Finnish Clinical Immunoassay Products Market Sales, 2006-2012
• Table 3.22: Belgium Clinical Immunoassay Products Market Sales, 2006-2012
• Table 3.23: Swiss Clinical Immunoassay Products Market Sales, 2006-2012
• Table 3.24: Dutch Clinical Immunoassay Products Market Sales, 2006-2012
• Table 3.25: Portuguese Clinical Immunoassay Products Market Sales, 2006-2012
• Table 3.26: Austrian Clinical Immunoassay Products Market Sales, 2006-2012
• Table 3.27: Greek Clinical Immunoassay Products Market Sales, 2006-2012
• Table 3.28: Polish Clinical Immunoassay Products Market Sales, 2006-2012
• Table 3.29: Romanian Clinical Immunoassay Products Market Sales, 2006-2012
• Table 3.30: Indian IVD Market, 2006-2012
• Table 3.31: Number of Automated Clinical Labs in India, 2004-2012
• Table 3.32: Indian IVD Market, 2008
• Table 3.34: Japanese Clinical Immunoanalyzer Testing Market, 2000-2008
• Table 3.35: Chinese Clinical Diagnostic Products Market, 2000-2008
• Table 3.36: Canadian Clinical Analyzer Testing Market, 2000-2008
• Table 3.37: Brazilian Clinical Immunoanalyzer Testing Market, 2000-2008
• Table 3.38: Turkish Clinical Analyzer Testing Market, 2000-2008
• Table 3.39: Australian Clinical Immunoanalyzer Testing Market, 2000-2008
• Table 3.40: ROW Clinical Immunoanalyzer Testing Market, 2000-2008
• Table 3.41: Estimated Number of Clinical Laboratories in Latin America
• Table 3.42: Principal Marketers of Automated Clinical Immunoanalyzer Instruments
• Table 4.1: Samples and Sample Handling Features of Centaur CP
• Table 4.2: Large Immunochemistry Analyzers
• Table 4.3: Small- to Mid-Volume Immunoassay Analyzers
• Table 5.1: Wireless LAN Technology Companies
• Table 5.2: Applications for Wireless LAN Technology
• Table 5.3: CAP and JCAHO Requirements for Customized Reporting
• Table 6.1: Hospital Laboratory Share of Part B Medicare Spending, 1996-2006
• 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 8.1: Technology Platforms for Analyzer Detection Systems
• Table 8.2: Medicare Billing Guidelines for Multi-Channel Immunoanalyzer Tests

LIST OF FIGURES

• Figure 6.1: Part B Spending on Clinical Lab Services, 1991 to 2007

Clinical Laboratory Testing Volume 1: Reagents and Instruments

1. Overview

• 1.1 Objectives of the Report
• 1.2 Methodology
• 1.3 Scope of the Report
• 1.4 Executive Summary

2. IVD Clinical Laboratory Market

• 2.1 Introduction
• 2.2 Independent Clinical Labs
  • 2.2.1 Key Players for Independent Clinical Labs
  • 2.2.2 Quest Diagnostics and LabCorp
  • 2.2.3 Competitive Advantages at Quest and LabCorp
  • 2.2.4 Competitive Disadvantages of Quest and LabCorp
  • 2.2.5 Revenue Growth of Quest and LabCorp
  • 2.2.6 Sector Consolidation
  • 2.2.7 Additional Independent Clinical Laboratories
• 2.3 Hospital Market
  • 2.3.1 Hospital Market Overview
  • 2.3.2 Hospital Lab Testing Drivers
  • 2.3.3 Evaluation Models of Laboratory Testing
  • 2.3.4 GPOs and IDNs
  • 2.3.5 Distributors
  • 2.3.6 Clinical Lab Testing Suppliers
  • 2.3.7 European Hospital Purchasing Practices
  • 2.3.8 Changes in Hospital Funding
  • 2.3.9 European Group Purchasing
• 2.4 POL Market
• 2.5 IVD Industry
  • 2.5.1 Industry Overview
  • 2.5.2 IVD Industry Leading Players Comparison and Review
  • 2.5.3 Biotechnology Reagents and Supplies
    • 2.5.3.1 Vendor Quality Assurance
    • 2.5.3.2 Partnership Support
    • 2.5.3.3 Protecting Supply of Raw Materials
    • 2.5.3.4 Selecting a Second Source for Chemicals
    • 2.5.3.5 Cost Analysis for Reagent Manufacture
    • 2.5.3.6 Outsourcing Production of Reagents
  • 2.5.4 The Fastest Growing IVD Reagent Markets
  • 2.5.5 Automated Instrumentation
  • 2.5.6 High Growth Applications Spur Industry Growth
• 2.6 Automated Instrument Platforms Evolution
• 2.7 Reagents and Supplies Market for Clinical Lab Instruments
• 2.8 Spending for Clinical Laboratory Testing
  • 2.8.1 Reimbursement Pressure
  • 2.8.2 Medicare Part B Spending Trends
  • 2.8.3 Strategies for Revenue Growth

3. IVD Clinical Laboratory Market

• 3.1 Markets
  • 3.1.1 Global Markets
  • 3.1.2 Global Drivers of Clinical Laboratory Testing
  • 3.1.3 Global Outlook
  • 3.1.4 U.S. Market
  • 3.1.5 European IVD Market
    • 3.1.5.1 German Clinical Laboratory Diagnostic Markets
    • 3.1.5.2 U.K. Clinical Laboratory Testing Diagnostic Market
      • 3.1.5.2.1 U.K. Competitive Analysis
      • 3.1.5.2.2 U.K. Market Access
    • 3.1.5.3 French Clinical Laboratory Diagnostic Testing Market
    • 3.1.5.4 Italian Clinical Laboratory Diagnostic Market
    • 3.1.5.5 Spanish Clinical Laboratory Diagnostic Market
    • 3.1.5.6 Finnish Clinical Laboratory Market
    • 3.1.5.7 Turkish Clinical Laboratory Market
    • 3.1.5.8 Belgium Clinical Laboratory Diagnostic Market
    • 3.1.5.9 Swiss Clinical Laboratory Diagnostic Market
    • 3.1.5.10 Dutch Clinical Laboratory Diagnostic Market
    • 3.1.5.11 Portuguese Clinical Laboratory Diagnostic Market
    • 3.1.5.12 Austrian Clinical Laboratory Diagnostic Market
    • 3.1.5.13 Greek Clinical Laboratory Diagnostic Market
    • 3.1.5.14 Polish Clinical Laboratory Diagnostic Market
    • 3.1.5.15 Romanian Clinical Laboratory Diagnostic Market
    • 3.1.5.16 Czech Republic Clinical Laboratory Diagnostic Market
    • 3.1.5.17 Swedish Clinical Laboratory Diagnostic Market
    • 3.1.5.18 Norwegian Clinical Laboratory Diagnostic Market
    • 3.1.5.19 Irish Clinical Laboratory Diagnostic Market
    • 3.1.5.20 Hungarian Clinical Laboratory Diagnostic Market
    • 3.1.5.21 Bulgarian Clinical Laboratory Diagnostic Market
    • 3.1.5.22 Slovakian Clinical Laboratory Diagnostic Market
    • 3.1.5.23 Lithuanian Clinical Laboratory Diagnostic Market
    • 3.1.5.24 Latvian Clinical Laboratory Diagnostic Market
    • 3.1.5.25 Estonian Clinical Laboratory Diagnostic Market
    • 3.1.5.26 Slovenian Clinical Laboratory Diagnostic Market
  • 3.1.6 Asian Markets
    • 3.1.6.1 Indian Clinical Laboratory Diagnostic Market
      • 3.1.6.1.1 Indian IVD Testing Industry
    • 3.1.6.2 Japanese Clinical Laboratory Testing Market
    • 3.1.6.3 Chinese Clinical Laboratory Market
  • 3.1.7 Clinical Laboratory Smaller Country Markets
    • 3.1.7.1 Canadian Clinical Laboratory Market
    • 3.1.7.2 Brazilian Clinical Laboratory Market
    • 3.1.7.3 Australian Clinical Laboratory Market
  • 3.1.8 ROW Clinical Laboratory Testing Market
  • 3.1.9 Overview of Asian Healthcare Market
    • 3.1.9.1 Singapore
    • 3.1.9.2 Malaysia
    • 3.1.9.3 Thailand
    • 3.1.9.4 Indonesia
    • 3.1.9.5 Philippines
    • 3.1.9.6 South Korea
    • 3.1.9.7 India
    • 3.1.9.8 Hong Kong
    • 3.1.9.9 Taiwan
  • 3.1.10 Overview of the Latin American Diagnostics Market
• 3.2 Clinical Laboratory Sector
  • 3.2.1 Worldwide IVD Sales
    • 3.2.1.1 POLs
  • 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 Laboratory 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 Laboratory Instrument Market by Sector

• 4.1 Chemistry Analyzers
  • 4.1.1 Ultra-Large Throughput Laboratory Analyzers
  • 4.1.2 Large-Throughput Analyzers
  • 4.1.3 Mid-Size Clinical Laboratory Analyzers
  • 4.1.4 Laboratory Analyzers for the Small Volume Market
• 4.2 Immunochemistry Analyzers
  • 4.2.1 Large Immunochemistry Analyzers
  • 4.2.2 Small Immunoassay Analyzers
• 4.3 Hematology Analyzers
• 4.4 Point of Care Testing
• 4.6 Cytology Testing
• 4.7 Microbiology Testing
• 4.8 Serology Testing
• 4.9 Esoteric Testing
• 4.10 Anatomic Pathology
• 4.11 Drug Testing

5. Important Technology Trends in IVD Instrumentation and Reagents

• 5.1 Technology Innovations in Instrument and Reagent Development
• 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
• 5.9 Laboratory Information Systems
• 5.10 New User-friendly Interfaces
• 5.11 Biosensor Technology
• 5.12 Data-Management Issues
  • 5.12.1 Wireless LANs
  • 5.12.2 Cepheid' s POC GBS and BCR/ABL Tests
  • 5.12.3 Data and Workflow Management Systems
  • 5.12.4 Beckman Central Command

6. Business Trends in the Clinical Laboratory Analyzer and Reagents Market

• 6.1 Key Market Developments
  • 6.1.1 Decreasing Revenue from Traditional IVD Markets
  • 6.1.2 High Growth in POCT and Molecular Diagnostics Arena
  • 6.1.3 Move Away from Traditional Kit Testing Methods
  • 6.1.4 Integrated Analytical Systems
  • 6.1.5 Regulatory Changes
  • 6.1.6 Development of a Two-Tier Industry Structure
  • 6.1.7 Labor Costs
  • 6.1.8 Increasing Value of Companies with High-Margin Technology Platforms
  • 6.1.9 The Joining of IVD Testing and Computer Technology
  • 6.1.10 User-Friendly User Interfaces
• 6.2 Sector Consolidation
  • 6.2.1 IVD Company Consolidation
  • 6.2.2 Lab Company Consolidation
    • 6.2.2.1 Acquisition Pricing
    • 6.2.2.2 A Closer Look at Six Big Lab Deals
• 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 Laboratory Testing
• 6.8 Government Regulation of IVD Devices
  • 6.8.1 U.S. Regulation
    • 6.8.1.1 Importing Medical Devices into 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
    • 6.8.3.1 France
  • 6.8.4 Japanese Regulation
  • 6.8.5 Korean Regulation
  • 6.8.6 Chinese 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 Hospital Outreach Programs
• 6.15 Electronic Procurement: New Challenges
• 6.16 Competition for Supply Chain Management Solutions
• 6.17 E-Commerce in the Hospital Supply Chain
  • 6.17.1 Drivers of E-Commerce Solutions
  • 6.17.2 Barriers to E-Commerce Solutions
• 6.18 Top Trends in Laboratory Business Practices
• 6.19 The Value of the New Diagnostics
• 6.20 Converging Technologies-Drugs and Diagnostic Tests Combine for Improved Healthcare
• 6.21 Emerging Technologies in the Downstream Manufacture of Bio-Materials
• 6.22 GMP Readiness
• 6.23 Harnessing Human Resource Capabilities and IT Prowess: Biotechnology in the Future
• 6.24 Partnering with Patient-Based Organizations to Achieve Patient Health Goals
• 6.25 Rumors of the Platform Company' s Demise are Greatly Exaggerated
• 6.26 Who' s Going to Pay for It?

7. Company Profiles

• 7.1 Abaxis
• 7.2 Abbott
• 7.3 Adaltis, Inc.
• 7.4 Alfa Wasserman, Inc. (formerly Electro-Nucleonics, Inc. and Schiapparelli Biosystems, Inc.)
• 7.5 Awareness Technology
• 7.6 Beckman Coulter, Inc.
• 7.7 Bio-Reference Laboratories, Inc.
• 7.8 Dade Behring, Inc.
• 7.9 Enzo Biochem, Inc.
• 7.10 Genomic Health, Inc.
• 7.11 Hitachi
• 7.12 Horiba Ltd.
• 7.13 JEOL Ltd.
• 7.14 LabCorp
• 7.15 MEDTOX Scientific, Inc.
• 7.16 Monogram Biosciences, Inc.
• 7.17 Myriad Genetics, Inc.
• 7.18 Nova Biomedical
• 7.19 Olympus America, Inc. Diagnostic Systems Division
• 7.20 Ortho-Clinical Diagnostics, a J&J Company
• 7.21 Psychemedics Corporation
• 7.22 Quest Diagnostics, Inc.
• 7.23 Roche Diagnostics Corp.
• 7.24 Shimadzu
• 7.25 Sysmex Corporation
• 7.26 Thermo Fisher Scientific, Inc.
• 7.27 Vital Scientific, NV

LIST OF FIGURES

• Figure 2.1: Clinical Laboratory Testing Sector Providers
• Figure 2.2: Part B Spending on Clinical Laboratory Services, 1991-2007
• Figure 3.1: IVD Product Demand
• Figure 3.2: European IVD Market by Clinical Specialty
• Figure 3.3: Chinese IVD Market, 2006-2012
• Figure 3.4: Annual Worldwide IVD Market Growth, 2003-2012
• Figure 3.5: POL Revenue, 2000-2006
• Figure 3.6: Unweighted Average Medicare Reimbursement for Ten Most Common POL Tests, 2002 vs. 2006
• Figure 3.7: Total Number of Non-Waived POLs, 2000-2006
• Figure 3.8: Number of New Tests Granted CLIA-Waived Status, 2000-2006
• Figure 3.9: High-Volume Waived Tests
• Figure 6.1: Average Revenue-Multiple Paid to Acquire Labs, 2000-2006
• Figure 6.2: Hospital Market Share for Outreach Programs

LIST OF TABLES

• Table 2.1: Total U.S. Clinical Laboratory Revenue from Third Party and Direct Payment, 2005-2012
• Table 2.2: U.S. Clinical Laboratory Diagnostic Test Market Segments, 2007
• Table 2.3: Independent Commercial Laboratory Testing Market Value, 2005-2012
• Table 2.4: Independent Commercial Laboratory Testing Test Volume, 2005-2012
• Table 2.5: Leading U.S. Reference Laboratories Grouped by Market Capitalization, 2008
• Table 2.6: Revenue Growth at Quest Diagnostics, 2000-2008
• Table 2.7: Revenue Growth at LabCorp, 2000-2008
• Table 2.8: Quest' s Total Volume of Requisitions and Net Revenues from Clinical Laboratory Testing, 2007
• Table 2.9: Number of Hospital Based Clinical Laboratory Tests in the U.S., 2002-2008
• Table 2.10: European Cardiovascular Disease Management Expenditures, 2003-2010
• Table 2.11: U.S. Doctor' s Office Lab Test Dollar Volume and Growth Rates, 2006
• Table 2.12: Worldwide Alternate Site Clinical Lab Instrument and Reagents Sales, 2005-2012
• Table 2.13: Thirteen Largest Diagnostic Companies Worldwide, 2007
• Table 2.14: Products Marketed by Abbott in the Diagnostic Market
• Table 2.15: Prodesse' s ASRs
• Table 2.16: Allowed Charges for Top 25 Clinical Laboratory Procedures, 2009
• Table 3.1: Worldwide IVD Testing Market, 2008
• Table 3.2: Worldwide Distribution of IVD Testing, 2008
• Table 3.3: Global Clinical Laboratory Market Sales, 1998-2012
• Table 3.4: Thirteen Largest Diagnostic Companies Worldwide, 2007
• Table 3.5: U.S. Clinical Laboratory Testing Market, 2003-2012
• Table 3.6: U.S. Clinical Laboratory Diagnostic Test Market Segments, 2007
• Table 3.7: U.S. Clinical Diagnostic POCT and Rapid Test Market Segments, 2007
• Table 3.8: U.S. Individual Clinical Chemistry Laboratory Diagnostic Test Markets, 2007
• Table 3.9: European Clinical Laboratory Testing IVD Reagents and Instruments Market, 2000-2012
• Table 3.10: European Clinical Laboratory Diagnostic Testing Reagents and Instruments Market by Analyte, 2006
• Table 3.11: European Clinical Chemistry Testing IVD Reagents and Instruments Market, 2000-2012
• Table 3.12: European Clinical Laboratory Testing Diagnostics by Country Market, 2008
• Table 3.13: European Rapid POCT by Country Market, 2008
• Table 3.14: European Patient Self Testing OTC Diagnostics by Country Market, 2006
• Table 3.15: German Clinical Laboratory Testing Diagnostics Products Market Sales, 2003-2012
• Table 3.16: German Clinical Diagnostic Rapid Test Market Segments, 2008
• Table 3.17: U.K. Clinical Laboratory Diagnostics Products Market Sales, 2003-2012
• Table 3.18: U.K. Clinical Diagnostic Rapid Test Market Segments, 2008
• Table 3.19: Major U.K. IVD Manufacturers
• Table 3.20: U.S. IVD Manufacturers Doing Business in the U.K.
• Table 3.21: Other European Companies that Manufacture IVD Products in the U.K.
• Table 3.22: French Clinical IVD Testing Diagnostics Products Market Sales, 2003-2012
• Table 3.23: French Clinical Diagnostic Rapid Test Market Segments, 2008
• Table 3.24: Italian Laboratory Diagnostics Products Market Sales, 2003-2012
• Table 3.25: Italian Clinical Diagnostic Rapid Test Market Segments, 2008
• Table 3.26: Spanish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012
• Table 3.27: Spanish Clinical Diagnostic Rapid Test Market Segments, 2008
• Table 3.28: Finnish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012
• Table 3.29: Turkish Clinical Laboratory Testing Market, 2000-2012
• Table 3.30: Belgium Clinical Laboratory Diagnostics Products Market Sales, 2003-2012
• Table 3.31: Belgium Clinical Reagents and Instruments Market, 2006
• Table 3.32: Swiss Clinical Laboratory Diagnostics Products Market Sales, 2003-2012
• Table 3.33: Swiss Clinical Reagents and Instruments Market, 2006
• Table 3.34: Dutch Clinical Laboratory Diagnostics Products Market Sales, 2003-2012
• Table 3.35: Dutch Clinical Reagents and Instruments Market, 2006
• Table 3.36: Portuguese Clinical Laboratory Diagnostics Products Market Sales, 2003-2012
• Table 3.37: Portuguese Clinical Reagents and Instruments Market, 2006
• Table 3.38: Austrian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012
• Table 3.39: Austrian Clinical Reagents and Instruments Market, 2006
• Table 3.40: Greek Clinical Laboratory Diagnostics Products Market Sales, 2003-2012
• Table 3.41: Greek Clinical Reagents and Instruments Market, 2006
• Table 3.42: Polish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012
• Table 3.43: Polish Clinical Reagents and Instruments Market, 2006
• Table 3.44: Romanian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012
• Table 3.45: Romanian Clinical Reagents and Instruments Market, 2006
• Table 3.46: Czech Republic Clinical Laboratory Diagnostics Products Market Sales, 2003-2012
• Table 3.47: Swedish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012
• Table 3.48: Norwegian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012
• Table 3.49: Irish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012
• Table 3.50: Hungarian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012
• Table 3.51: Bulgarian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012
• Table 3.52: Slovakian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012
• Table 3.53: Lithuanian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012
• Table 3.54: Latvian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012
• Table 3.55: Estonian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012
• Table 3.56: Slovenian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012
• Table 3.57: Indian IVD Market for Instruments and Reagents, 2004-2012
• Table 3.58: Number of Automated Clinical Labs in India, 2004-2012
• Table 3.59: Indian IVD Market, 2008
• Table 3.60: Japanese Clinical Laboratory Testing Instrument and Reagents Market, 2003-2012
• Table 3.61: Chinese Clinical Laboratory Diagnostics Products Market Sales, 2003-2012
• Table 3.62: Chinese IVD Market, 2008
• Table 3.63: Proportion of Medical Expenses Paid Privately
• Table 3.64: Chinese International IVD Manufacturers
• Table 3.65: Chinese Domestic IVD Manufacturers
• Table 3.66: Chinese IVD Distributors
• Table 3.67: Canadian Clinical Laboratory Testing Market, 2000-2008
• Table 3.68: Brazilian Clinical Laboratory Testing Market, 2000-2008
• Table 3.69: Australian Clinical Laboratory Testing Market, 2000-2008
• Table 3.70: ROW Clinical Laboratory Testing Market, 2000-2008
• Table 3.71: Number of Clinical Laboratories in Latin America
• Table 3.72: Twenty Most Common Laboratory Tests Offered at Family Physician Offices
• Table 3.73: Important New Waived Tests
• Table 3.74: Principal Marketers of Automated Clinical Laboratory Instruments
• Table 3.75: Key Market Drivers of Automated Clinical Laboratory Instruments
• Table 3.76: Key Market Limits of Automated Clinical Laboratory Instruments
• Table 4.1: Ultra-Large Clinical Laboratory Analyzers
• Table 4.2: JEOL Analyzer Comparison
• Table 4.3: Large Clinical Laboratory Analyzers
• Table 4.4: Mid-size Clinical Laboratory Analyzers
• Table 4.5: Small Clinical Laboratory Analyzers
• Table 4.6: Large Immunochemistry Analyzers
• Table 4.7: Small Immunoassay Analyzers
• Table 4.8: Linearity and Precision of Abbott CELL-DYN Hematology Analyzers
• Table 4.9: Accuracy of the Automated Differential of Abbott CELL-DYN Analyzers
• Table 4.10: Linearity and Precision of Siemens Hematology Analyzers
• Table 4.11: Accuracy of the Automated Differential of Siemens Hematology Analyzers
• Table 4.12: Linearity and Precision of Beckman Coulter Hematology Instruments
• Table 4.13: Accuracy of the Automated Differential of Beckman Coulter Hematology Analyzers
• Table 4.14: Linearity and Precision of Horiba ABX Hematology Analyzers
• Table 4.15: Accuracy of the Horiba ABX Hematology Analyzers
• Table 4.16: Linearity and Precision of Sysmex Hematology Analyzers
• Table 4.17: Accuracy of the Sysmex Hematology Analyzers
• Table 4.18: Comparison of Linearity and Precision of Top-of-the-Line Hematology Analyzers
• Table 4.19: Comparison of Accuracy of the Top-of-the-Line Hematology Analyzers
• Table 4.20: Hematology Analyzers with a Five-Part WBC Differential
• Table 4.21: Hematology Analyzers with a Three-Part WBC Differential
• Table 4.22: Point of Care Testing
• Table 4.23: Number of ER Visits in U.S. Hospitals, 1997-2007
• Table 4.24: Number of POCT in U.S., 2000-2012
• Table 4.25: PAP Tests in Top European Markets
• Table 4.26: PAP Tests in Top Asian Markets
• Table 5.1: Normal Glucose Values-Fasting State
• Table 5.2: Applications for Wireless LAN Technology
• Table 7.1: Products Marketed by Abbott in the Diagnostics Market
• Table 7.2: Comparison of JEOL Analyzers
• Table 7.3: The VITROS ECiQ Immunodiagnostic System
• Table 7.4: Sysmex Marketing Summary for China

Clinical Laboratory Testing Volume 2: Business Strategies

1. Overview

• 1.1 Objectives of the Report
• 1.2 Methodology
• 1.3 Scope of the Report
• 1.4 Executive Summary

2. IVD Clinical Laboratory Market

• 2.1 Introduction
• 2.2 Key Players for Independent Clinical Labs
• 2.3 Reimbursement Pressure
• 2.4 Medicare Part B Spending Trends
• 2.5 Cost of Billing and Average Receipts for Commercial Labs
• 2.6 Hospital Outreach Programs
• 2.7 Criteria for Selection of Lab Services

3. The Clinical Laboratory Testing Market

• 3.1 U.S. Market
  • 3.1.1 Hospital-based Clinical Laboratories
  • 3.1.2 Commercial Clinical Laboratory Testing
  • 3.1.3 Physician Office Laboratories (POLs)
• 3.2 Clinical Lab Testing Key Players
  • 3.2.1 Commercial Clinical Labs
  • 3.2.2 Hospital Lab Collaborative Ventures
  • 3.2.3 Specialty Labs
• 3.3 Revenue and Reimbursement
• 3.4 Outlook for Clinical Laboratory Testing
  • 3.4.1 Long-Term Changes
  • 3.4.2 Market Drivers
  • 3.4.3 The Limits to Growth
  • 3.4.4 Key Technologies
  • 3.4.5 Conclusion

4. Hot Sectors in the Clinical Lab Testing Market

• 4.1 Workplace Drugs-of-Abuse Testing
• 4.2 Clinical Toxicology
• 4.3 Clinical Testing for the Pharmaceutical Industry
• 4.4 Heavy Metal, Trace Element, and Solvent Analyses
• 4.5 Diabetes (Glucose) Testing
• 4.6 Molecular Diagnostic Testing
• 4.7 Cardiac Markers
• 4.8 Blood Bank Screening
• 4.9 Genetic Testing
• 4.10 Predictive Medicine Testing
• 4.11 Personalized Medicine
• 4.12 Cancer Testing
• 4.13 Cell Based Cancer Testing
• 4.14 Monitoring Technologies
• 4.15 Anatomic Pathology

5. Important Technology Trends

• 5.1 Technology Platform Innovations in Point-of-Care Testing
• 5.2 The New Paradigm
• 5.3 Consolidated Workstations
• 5.4 Automation in the Laboratory
• 5.5 Laboratory Information Systems
• 5.6 New User-friendly Interface
• 5.7 Data-Management Issues
  • 5.7.1 Wireless LANs
  • 5.7.2 Data and Workflow Management Systems
  • 5.7.3 Beckman Central Command
  • 5.7.4 Clinical IT More Widely Available in Physician Practices
  • 5.7.5 Physician Electronic Health Records (EHRs)
  • 5.7.6 Specimen Tracking and Processing

6. Business Trends in the Clinical Laboratory Analyzer Sector

• 6.1 Key Developments
• 6.2 Sector Consolidation
• 6.3 Acquisition Pricing
• 6.4 A Closer Look at Recent Lab Deals
• 6.5 Acquisition, License Agreements, Internal Development and Partnerships
• 6.6 Merger, Acquisition, Financing and Partnering Activities in the Clinical Lab Industry
• 6.7 Comparison of Quest and LabCorp
  • 6.7.1 Acquisitions
  • 6.7.2 Quest' s Growth, 2000-2006
  • 6.7.3 Laboratory Corporation of America
  • 6.7.4 LabCorp' s Growth, 2000-2006
  • 6.7.5 Competitive Advantages at Quest and LabCorp
  • 6.7.6 National Managed Care Contracts
  • 6.7.7 Billing and Collection Management
  • 6.7.8 Lower Reagent and Supply Costs
  • 6.7.9 Esoteric Testing Capabilities
  • 6.7.10 Ability to Invest in Web-Based Connectivity Solutions
  • 6.7.11 Competitive Disadvantages of Quest and LabCorp
  • 6.7.12 Difficulties with Turnaround Times and Stat Services
  • 6.7.13 Physician-Laboratory Communication
  • 6.7.14 Specimen Pickup Scheduling Inflexibility
• 6.8 Regulation of Clinical Laboratory Operations
  • 6.8.1 CLIA and State Regulations
  • 6.8.2 Drug Testing
  • 6.8.3 Controlled Substances
  • 6.8.4 Medical Waste, Hazardous Waste and Radioactive Materials
  • 6.8.5 FDA
  • 6.8.6 Occupational Safety
  • 6.8.7 Specimen Transportation
  • 6.8.8 Corporate Practice of Medicine
• 6.9 Hospital Outreach Programs
• 6.10 Supply Chain and GPO Contracting
• 6.11 Specialty Labs
• 6.12 Expansion of Hospital-Based Labs and Hospital Outreach Programs
• 6.13 Managed Care

7. Company Profiles

• 7.1 ACM Medical Laboratory
• 7.2 American Esoteric Laboratories (Sonic Healthcare)
• 7.3 American Pathology Partners
• 7.4 AmeriPath (Quest)
• 7.5 ARUP Laboratories
• 7.6 Athena Diagnostics
• 7.7 Aurora Diagnostics
• 7.8 Bio-Reference Laboratories, Inc.
• 7.9 BioTech Labs
• 7.10 CBLPath
• 7.11 Centrex Clinical Laboratories
• 7.12 Clarient, Inc.
• 7.13 Clinical Laboratories of Hawaii (Sonic Healthcare)
• 7.14 Clinical Reference Laboratory
• 7.15 Clongen Laboratories
• 7.16 CompuNet Clinical Laboratories
• 7.17 Diagnostic Systems Laboratories
• 7.18 Enzo Biochem, Inc.
• 7.19 Esoterix
• 7.20 Focus Diagnostics
• 7.21 Fresenius Medical Care AG & Co. KGaA
• 7.22 Geneva Laboratories
• 7.23 Genomic Health, Inc.
• 7.24 Genzyme
• 7.25 IBT Laboratories
• 7.26 Integrated Regional Laboratories (IRL)
• 7.27 LabCorp
• 7.28 MDS Diagnostic Services
• 7.29 MEDTOX Scientific, Inc.
• 7.30 Meriter Health Services
• 7.31 Mid America Clinical Laboratories (MACL)
• 7.32 Monogram Biosciences, Inc.
• 7.33 Myriad Genetics, Inc.
• 7.34 National Jewish Medical and Research Center
• 7.35 Parkway Clinical Laboratories
• 7.36 Pathology Associates Medical Laboratories (PAML)
• 7.37 Psychemedics Corporation
• 7.38 Quest Diagnostics Incorporated
• 7.39 RDL Reference Laboratory
• 7.40 Satellite Laboratory Services
• 7.41 Spectrum Laboratory Network
• 7.42 Sonic Healthcare

8. Clinical Laboratory Testing Sector Trends and Forecasts

• 8.1 Home Care Analysis
• 8.2 Non-Traditional Collection for Laboratory Testing
• 8.3 New Systems for Critical-Care and Near-Patient Testing
• 8.4 Shift to Preventative Medicine
• 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 and Barriers of Clinical Laboratory 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 Point of Care Testing
  • 8.14.4 Satellite Facilities

LIST OF FIGURES

• Figure 2.1: Total Medicare Expenditures, 1995-2008
• Figure 2.2: Effect of Medicare Laboratory Fee Schedule Changes on a $10 Test, 1984-2006
• Figure 2.3: Part B Spending on Clinical Laboratory Services, 1991-2007
• Figure 2.4: Cost Per Billable Test
• Figure 2.5: Annual Billable Tests Processed Per FTE
• Figure 2.6: Outreach Business Operated at a Freestanding Lab Facility
• Figure 2.7: Volume of Dedicated Sales and Marketing Staff for Outreach Business
• Figure 2.8: Separately Managed Outreach Billing and Collection
• Figure 3.1: Lab Revenue by Lab Type
• Figure 3.2: Lab Revenue by Test Type
• Figure 3.3: Physician Office Laboratory Revenue, 2000-2006
• Figure 3.4: Unweighted Average Medicare Reimbursement for the 10 Most Common POL Tests
• Figure 3.5: Total Number of Non-Waived POLs, 2000-2006
• Figure 3.6: Number of New Tests Granted CLIA-Waived Status, 2000-2008
• Figure 3.7: High-Volume Waived Tests
• Figure 4.1: U.S. Molecular Diagnostics Market Average Reimbursement Rate, 2009
• Figure 4.2: Laboratory Service Revenue from Pap Testing, 1998-2005
• Figure 4.3: Percentage of Pap Tests Performed Using Mono-Layer Methods, 1998-2006
• Figure 4.4: Market Share for Pap Test Vendors, 2006
• Figure 5.1: Percentage of Physicians in Practices with IT for Specific Clinical Activities
• Figure 6.1: Average Revenue Multiple Paid to Acquire Labs, 2000-2006
• Figure 6.2: Value of Laboratory Mergers, Acquisitions, and IPO' s 2004-2008
• Figure 6.3: Hospital Market Share for Outreach Programs

LIST OF TABLES

• Table 2.1: Medicare Spending on Clinical Lab Services, 1991-2007
• Table 2.2: Allowed Charges for Top 25 Clinical Laboratory Procedures, 2009
• Table 2.3: Washington G-2 Hospital Lab Outreach Survey
• Table 3.1: U.S. Clinical Laboratory Testing Market Revenue, 2005-2012
• Table 3.2: U.S. Clinical Laboratory Diagnostic Test Market Segments, 2008
• Table 3.3: Growth Rates of Test Types
• Table 3.4: Independent Commercial Laboratory Testing Test Volume, 2005-2012
• Table 3.5: Twenty Most Common Laboratory Tests Offered at Family Physician Offices
• Table 3.6: Important New Waived Tests
• Table 3.7: Revenue and at Leading Publicly-Traded Lab Companies, 2008
• Table 3.8: Payer Group wise Percentage of Total Volume of Requisitions and Net Revenues
• Table 4.1: Pap Testing at the Largest U.S. Laboratory Companies, 2006
• Table 5.1: Applications for Wireless LAN Technology
• Table 6.1: Laboratory/Pathology Acquisitions
• Table 6.2: Revenue Growth at Quest Diagnostics, 2000-2008
• Table 6.3: Revenue Growth at LabCorp, 2000-2008
• Table 6.4: LabCorp Revenue from Managed Care Contracts, 2004-2006
• Table 6.5: Quest Diagnostics Revenue from Managed Care Contracts, 2004-2006
• Table 7.1: Recent Acquisitions by Sonic Healthcare
• Table 8.1: Medicare Billing Guidelines for Multi-channel Laboratory Tests
• Table 8.2: U.S. POCT Market, 2000-2012
• Table 8.3: U.S. POCT by Performance Location, 2008
• Table 8.4: Targeted Lab Tests and Brief Educational Reminder Messages