臨床検査市場に関する報告書セット

当商品の販売は、2011年05月12日を持ちまして終了しました。

原文目次

Abstract

The Clinical Bundle includes the following reports:

• Clinical Chemistry Analyzers.
• Clinical Immunoanalyzer Markets.
• Clinical Laboratory Testing Volume 1: Reagents and Instruments.
• Clinical Laboratory Testing Volume 2: Business Strategies.

Clinical Chemistry Analyzers

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.

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.

Clinical Laboratory Testing Volume 1: Reagents and Instruments

Clinical laboratory analysis for in vitro diagnostic (IVD) testing is one of the most important sectors of medical care. By all accounts, it is very mature, large and diverse-crossing the $33 billion mark in 2006-and employing over 100,000 laboratory workers, and spawning an industry for reagents and instruments comprised of thousands of companies worldwide. The term clinical laboratory analysis usually refers to determining the concentration or activity of a protein, carbohydrate, lipid, electrolyte, enzyme or small molecule in easily collected body fluids such as blood, serum, plasma or urine. However, it is not necessarily limited to these determinations. The purpose of this TriMark Publications report is to describe the specific segments of the global clinical laboratory instrumentation and reagent market. Within this area, the report covers those segments that are highly active in terms of innovation and growth. Specifically, this global clinical laboratory markets report examines the markets for small lab equipment all the way up to highly-automated, large lab platforms, as well as accessory equipment such as reagents, supplies and manufacturers' original equipment manufacturer (OEM) additional equipment. The emphasis in this analysis is on those companies and products that are actively developing and marketing laboratory analyzer products for the clinical setting, including hospitals, independent labs, physician' s offices and miscellaneous clinics. This study concentrates on the clinical laboratory instrumentation industry market segment and the companion reagents sector in the U.S. and around the world. The regional markets and their differences are examined, including Europe, Asia (Japan, China and India) and the rest of the world (ROW). Particular attention is paid to those areas of the clinical laboratory instrumentation and reagents sector that are showing the greatest growth or the most innovation.

Clinical Laboratory Testing Volume 2: Business Strategies

Clinical laboratory testing is generally categorized as either of two general areas-clinical testing and anatomical pathology testing. Clinical and anatomical pathology procedures are frequently ordered as part of regular physician office visits and hospital admissions in connection with the diagnosis and treatment of illnesses. As such, clinical laboratory analysis is one of the most important sections of medical care. The purpose of this TriMark Publications report is to describe the specific segments of the clinical laboratory analysis business. The emphasis in this review is on those companies that are actively developing and marketing laboratory data for the clinical setting, including hospitals, independent labs, physician' s offices and miscellaneous clinics. This study concentrates on the clinical laboratory industry in the U.S. It defines the dollar volume of sales in each major market and analyzes the factors that influence the size and the growth of the individual market segments. The study surveys some of the primary companies known to be marketing clinical laboratory data into the market. Each company is discussed in depth with a section on the history of the company, the product line, business and marketing analysis, and a subjective commentary of the position of the company in its market.

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

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