Clinical Bundle

Clinical Bundle

Published By: Trimark Publications
June 2009
R230-312
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Description

Clinical Bundle:

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

3.2 Clinical Chemistry Sector

3.2.1 Industry-Served Markets

3.2.2 Industry Players

3.2.2.1 Manufacturing Companies

3.2.3 Market Specialization

3.2.4 Revenue and Reimbursement

3.2.5 Companies

3.3 Outlook for Clinical Chemistry Testing

3.3.1 Long-Term Changes

3.3.2 Market Drivers

3.3.3 The Limits to Growth

3.3.4 Hot Sectors in the IVD Market

3.3.5 Key Technologies

3.3.6 Conclusion

4. Clinical Chemistry Instrument Market by Sector: Size, Growth, Share and Competitors

4.1 Ultra-Large Throughput Chemistry Analyzers

4.2 Large-Throughput Analyzers

4.3 Mid-Size Clinical Chemistry Analyzers

4.4 Chemistry Analyzers for the Small-Volume Market

5. Important Technology Trends

5.1 Technology Platform Innovations in Point-of-Care Testing

5.2 Sensor Systems for Diagnostic Applications

5.3 Glucose Measurements

5.4 Glucose Test Methods

5.5 Cholesterol Measurements

5.6 The New Paradigm

5.7 Consolidated Workstations

5.8 Automation in the Laboratory in Response to Labor Shortages

5.9 Laboratory Information Systems

5.10 Biosensor Technology

5.11 Data-Management Issues

5.11.1 Wireless LANs

5.11.2 Data and Workflow Management Systems

5.11.3 Beckman Central Command

5.12 Connectivity Platforms

5.12.1 Laboratory Data Linking Software and Interface to the Laboratory Information System

5.12.2 AbbottLink Analyzer Connections

5.12.3 Beckman Coulter DL2000 Data Manager v6.5

5.12.4 bioMérieux Inc. ENQ

5.12.5 Ortho-Clinical Diagnostics Inc. Software Version 1.02

6. Business Trends in the Clinical Chemistry Analyzer Sector

6.1 Key Developments

6.2 Sector Consolidation

6.3 Diagnostic Testing Growth Trends

6.4 Reagent and Hardware Business in Japan

6.5 New Products

6.6 Acquisition, License Agreements, Internal Development and Partnerships

6.7 Product Testing Depth in Clinical Chemistry Testing

6.8 Government Regulation

6.8.1 U.S. Regulation

6.8.1.1 Importing Medical Devices to the U.S.

6.8.1.2 Exporting Medical Devices from the U.S.

6.8.2 U.K. Regulation

6.8.3 E.U. Regulation

6.8.4 Japanese Regulation

6.8.5 Korean Regulation

6.9 Increased Market Penetration

6.10 Costs of Doing Business in Europe

6.11 Drivers of European Diagnostics Testing

6.12 European Reimbursement Practices

6.13 Cost Containment in Europe

6.14 Medicare Reimbursement Trends

7. Company Profiles

7.1 Abaxis

7.1.1 Point-of-Care Blood Chemistry Analyzers

7.1.2 Hematology

7.1.3 Reagent Discs

7.1.4 Orbos Process

7.1.5 VetScan Canine Heartworm Antigen Test

7.2 Abbott Diagnostics

7.2.1 Diagnostic Products

7.2.2 Business Analysis

7.2.3 TriMark Commentary

7.3 Adaltis, Inc.

7.4 Alfa Wasserman, Inc. (f/k/a Electro-Nucleonics, Inc. and Schiapparelli Biosystems, Inc.)

7.4.1 Background

7.4.2 Products

7.5 Awareness Technology

7.6 Siemens Medical Solutions Diagnostics

7.7 Beckman Coulter, Inc.

7.7.1 Overview

7.7.2 Company History

7.7.3 Products

7.7.3.1 Clinical Diagnostics Products

7.7.3.1.1 Overview

7.7.3.2 Clinical Chemistry Systems

7.7.3.3 Clinical Laboratory Automation

7.7.3.4 Hemostasis Systems

7.7.3.5 Immunodiagnostic Systems

7.7.3.6 Primary Care Diagnostics

7.7.3.7 Hematology Systems

7.7.4 TriMark Commentary

7.8 Dade Behring, Inc.

7.8.1 Products

7.8.2 Other Served Markets

7.9 Hitachi

7.9.1 Products

7.10 Horiba, Ltd.

7.11 JEOL, Ltd.

7.12 Olympus America, Inc. Clinical Instruments Division

7.12.1 Background

7.12.2 Automated General Chemistry Instruments

7.12.3 TriMark Commentary

7.13 Ortho-Clinical Diagnostics, a Johnson & Johnson Company

7.13.1 Background

7.13.2 Markets

7.13.3 Automated General Chemistry Instruments

7.13.4 TriMark Commentary

7.14 Roche Diagnostics Corp

7.14.1 Background

7.14.2 Automated General Chemistry Instruments

7.14.3 Business Analysis

7.15 Shimadzu

7.15.1 Products

7.16 Sysmex Corporation

7.17 Thermo Fisher Scientific Inc.

7.18 Vital Scientific, NV

7.18.1 Background

7.18.2 Products

8. Clinical Chemistry Testing Sector Trends and Forecasts

8.1 Home Care Analysis

8.2 Non-traditional Collection for Chemistry Testing

8.3 New Systems for Critical-Care and Near-Patient Testing

8.4 Utility of Near-Patient Testing in Critical-Care Settings

8.5 Mergers of Diagnostic Companies

8.6 Information Management Advances

8.7 Test Ordering Patterns

8.8 Patient Satisfaction

8.9 Move Away From Central Laboratory

8.10 Healthcare Cost Controls

8.11 Competition for Services

8.12 Drivers of Clinical Chemistry Testing

8.13 Confluence of New Technology

8.14 New Trends in Clinical Laboratory Testing

8.14.1 Trends in Reimbursement Practices

8.14.2 Managed Care

8.14.3 Changes in Patient Management

8.14.4 Focused Testing

8.14.5 Satellite Facilities

8.14.6 Point-of-Care Testing

8.14.7 Regionalization of Laboratory Care

8.15 New Chemistry Analyzers

8.16 Multiplexing Technology

9. Clinical Chemistry Product Introductions

9.1 Clinical Chemistry Analyzer Product Launches

9.2 Clinical Chemistry Reagent Product Launches

10. Corporate Directory

INDEX OF FIGURES

Figure 3.1: European Diagnostic Reagents Markets, 2006

Figure 6.1: Part B Spending on Clinical Laboratory Services: 1991 to 2005

LIST OF TABLES

Table 3.1: The Overall In Vitro Diagnostic Testing Market Worldwide: 2006

Table 3.2: Worldwide Distribution of IVD Testing: 2006

Table 3.3: Global Clinical Chemistry Revenues: 1998 to 2012

Table 3.4: Worldwide Distribution of Clinical Chemistry Testing: 2006

Table 3.5: Ten Largest Diagnostic Companies Worldwide: 2005

Table 3.6: U.S. Clinical Chemistry Testing Market: 2000 to 2012

Table 3.7: U.S. Clinical Chemistry Diagnostic Test Market Segments: 2006

Table 3.8: U.S. Individual Clinical Chemistry Diagnostic Test Markets: 2006

Table 3.9: European Clinical Laboratory Testing IVD Reagents and Instruments Market (Dollars): 2000 to 2012

Table 3.10: European Clinical Laboratory Testing IVD Reagents and Instruments Market (Euros): 2000 to 2012

Table 3.11: European Clinical Laboratory Diagnostic Reagents and Instruments Markets by Analyte: 2006

Table 3.12: European Clinical Laboratory Testing Diagnostics by Country Market Estimates: 2006

Table 3.13: European Clinical Chemistry Testing Market: 2000 to 2008

Table 3.14: European Clinical Chemistry Reagents and Instruments Markets by Country: 2006

Table 3.15: German Clinical Chemistry Testing Diagnostics Products Market Sales: 2000 to 2007

Table 3.16: The German Patient Care Lab Test Market: 2000 to 2008

Table 3.17: The German Alternate Site Testing Market (POL): 2000 to 2008

Table 3.18: The German Hospital Clinical Chemistry Market: 2000 to 2008

Table 3.19: German Clinical Diagnostic Chemistry Test Market Segments by Analyte: 2002 and 2005

Table 3.20: U.K. Clinical Chemistry Diagnostics Products Market Sales: 2000 to 2008

Table 3.21: Major U.K. IVD Manufacturers

Table 3.22: U.S. IVD Manufacturers Doing Business in the U.K.

Table 3.23: Other European Companies That Manufacture IVD Products in the U.K.

Table 3.24: French Clinical Chemistry Diagnostics Products Market Sales: 1998 to 2008

Table 3.25: Italian Chemistry Diagnostics Products Market Sales: 1998 to 2008

Table 3.26: Spanish Clinical Chemistry Diagnostics Products Market Sales: 1998 to 2008

Table 3.27: Indian IVD Market: 2006 to 2012

Table 3.28: Number of Automated Clinical Labs in India: 2004 to 2012

Table 3.29: Indian IVD Market: 2006

Table 3.30: Market Sales of IVD Equipment and Reagents by Company in India: 2004 and 2005

Table 3.31: Scandinavian Clinical Chemistry Diagnostics Products Market Sales: 2000 to 2008

Table 3.32: Japan Clinical Chemistry Testing Market: 2000 to 2008

Table 3.33: Chinese Clinical Chemistry Diagnostics Products Market Sales: 2000 to 2008

Table 3.34: Canadian Clinical Chemistry Testing Market: 2000 to 2008

Table 3.35: Brazilian IVD Testing Market: 2000 to 2008

Table 3.36: Brazilian Clinical Chemistry Testing Market: 2000 to 2008

Table 3.37: Turkish Clinical Chemistry Testing Market: 2000 to 2008

Table 3.38: Australian Clinical Chemistry Testing Market: 2000 to 2008

Table 3.39: Mexican IVD Testing Market: 2000 to 2008

Table 3.40: Mexican Clinical Chemistry Testing Market: 2000 to 2008

Table 3.41: The ROW Clinical Chemistry Testing Market: 2000 to 2008

Table 3.42: Estimated Number of Clinical Laboratories in Latin America

Table 3.43: Principal Marketers of Automated Clinical Chemistry Instruments

Table 4.1: Ultra-Large Clinical Chemistry Analyzers

Table 4.2: JEOL Analyzer Comparison

Table 4.3: Large Clinical Chemistry Analyzers

Table 4.4: Mid-size Clinical Chemistry Analyzers

Table 4.5: Small Clinical Chemistry Analyzers

Table 5.1: Normal Glucose Values—Fasting State

Table 5.2: Applications for Wireless LAN Technology

Table 6.1: Hospital Laboratory Share of Part B Medicare Spending: 1996 to 2005

Table 6.2: Medicare Part B Spending Per Medicare Enrollee: 1998 to 2005

Table 6.3: Allowed Charges for Top 25 Clinical Laboratory Procedures: 2005

Table 7.1: Products Marketed by Abbott in the Diagnostic Market

Table 7.2: Products Marketed by Dade Behring in the Diagnostics Market

Table 7.3: Clinically-Significant Tests Available From Dade

Table 7.4: Comparison of JEOL Analyzers

Table 7.5: VITROS ECiQ Immunodiagnostic System

Table 7.6: Sysmex Marketing Summary for China

Table 8.1: Medicare Billing Guidelines for Multi-channel Chemistry Tests

Clinical Immunoanalyzer Markets

1. Overview: 1.1 Objectives; 1.2 Methodology; 1.3 TriMark Publications Report Research and Data Acquisition Structure; 1.4 Scope; 1.5 Executive Summary
2. IVD Clinical Immunoanalyzer Market: 2.1 Introduction
3. IVD Clinical Immunoanalyzer Market Analysis: 3.1 Markets; 3.2 Clinical Immunoanalyzer Sector; 3.3 Outlook for Clinical Immunoanalyzer Testing
4. Clinical Immunoanalyzer Instrument Market by Sector: 4.1 Market Analysis: Size, Growth, Share and Competitors
5. Important Technology Trends: 5.1 Technology Innovations in Immunoassay Testing; 5.2 Immunoassay Detection Technology Platforms; 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
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; 6.9 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; 7.2 Bayer Healthcare; 7.3 Beckman Coulter; 7.4 bioMérieux; 7.5 Dade Behring; 7.6 Bio-Rad Laboratories; 7.7 Olympus; 7.8 Ortho-Clinical Diagnostics; 7.9 Phadia; 7.10 Randox Laboratories; 7.11 Roche Diagnostics; 7.12 Tosoh; 7.13 Siemens
8. Clinical Immunoanalyzer Testing Sector: Trends and Forecasts: 8.1 Automated Intrument 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; 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
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: The Overall IVD Diagnostic Testing Market Worldwide, 2006; Table 3.2: Worldwide Distribution of IVD Testing, 2006; Table 3.3: Global Clinical Immunoassay Revenues, 2000 to 2012; Table 3.4: Worldwide Distribution of Clinical Immunoassay Testing, 2006; Table 3.5: U.S. Clinical Laboratory Testing Market, 2003 to 2012; Table 3.6: U.S. Clinical Laboratory Diagnostic Test Market Segments, 2006; Table 3.7: U.S. Clinical Laboratory Diagnostic Testing Reagents and Instruments Markets by Analyte, 2006; Table 3.8: U.S. Clinical Immunoanalyzer Testing Market, 2000 to 2012; Table 3.9: European Clinical Laboratory Testing IVD Reagents and Instruments Market (Dollars), 2000 to 2012; Table 3.10: European Clinical Laboratory Testing IVD Reagents and Instruments Market (Euros), 2000 to 2012; Table 3.11: European Clinical Laboratory Diagnostic Reagents and Instruments Markets by Analyte, 2006; Table 3.12: European Clinical Laboratory Testing Diagnostics by Country Market Estimates, 2006; Table 3.13: The European Immunochemistry Market, 2001 to 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 to 2012; Table 3.16: German Clinical Immunochemistry Testing Diagnostics Products Market Sales, 2006 to 2012; Table 3.17: UK Clinical Immunochemistry Testing Diagnostics Products Market Sales, 2006 to 2012; Table 3.18: French Clinical Immunochemistry Testing Diagnostics Products Market Sales, 2006 to 2012; Table 3.19: Italian Immunochemistry Diagnostics Products Market Sales, 2006 to 2012; Table 3.20: Spanish Clinical Laboratory Diagnostics Products Market Sales, 2006 to 2012; Table 3.21: Finnish Clinical Immunoassay Products Market Sales, 2006 to 2012; Table 3.22: Belgium Clinical Immunoassay Products Market Sales, 2006 to 2012; Table 3.23: Swiss Clinical Immunoassay Products Market Sales, 2006 to 2012; Table 3.24: Dutch Clinical Immunoassay Products Market Sales, 2006 to 2012; Table 3.25: Portugese Clinical Immunoassay Products Market Sales, 2006 to 2012; Table 3.26: Austrian Clinical Immunoassay Products Market Sales, 2006 to 2012; Table 3.27: Greek Clinical Immunoassay Products Market Sales, 2006 to 2012; Table 3.28: Polish Clinical Immunoassay Products Market Sales, 2006 to 2012; Table 3.29: Romanian Clinical Immunoassay Products Market Sales, 2006 to 2012; Table 3.30: Indian IVD Market, 2006 to 2012; Table 3.31: Number of Automated Clinical Labs in India, 2004 to 2012; Table 3.32: Indian IVD Market (by Sector), 2006; Table 3.33: IVD Equipment and Reagents Market (by Company) in India, 2004 and 2005; Table 3.34: Japanese Clinical Immunoanalyzer Testing Market, 2000 to 2008; Table 3.35: Chinese Clinical Diagnostic Products Market, 2000 to 2008; Table 3.36: Canadian Clinical Analyzer Testing Market, 2000 to 2008; Table 3.37: Brazilian Clinical Immunoanalyzer Testing Market, 2000 to 2008; Table 3.38: Turkish Clinical Analyzer Testing Market, 2000 to 2008; Table 3.39: Australian Clinical Immunoanalyzer Testing Market, 2000 to 2008; Table 3.40: ROW Clinical Immunoanalyzer Testing Market, 2000 to 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 to 2005; Table 6.2: Medicare Part B Spending Per Medicare Enrollee, 1998 to 2005; Table 6.3: Allowed Charges for Top 25 Clinical Laboratory Procedures, 2005; Table 8.1: Technology Platforms for Analyzer Detection Systems; Table 8.2: Medicare Billing Guidelines for Multi-Channel Immunoanalyzer Tests
LIST OF FIGURES: Figure 3.1: U.S. Revenue for Six Largest IVD Vendors, 2005; Figure 3.2: U.S. Revenue Change for Six Largest IVD Vendors, 2005; Figure 6.1: Part B Spending on Clinical Lab Services, 1991 to 2005

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 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

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; 3.2 Clinical Lab Testing Key Players; 3.3 Revenue and Reimbursement; 3.4 Outlook for Clinical Laboratory Testing
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
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; 6.8 Regulation of Clinical Laboratory Operations; 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
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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