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Clinical Bundle

TriMark Publications
May 1, 2011
SKU: TRI6282640

Abstract Table of Contents Related Reports

The Clinical Reports Bundle includes the following TriMark Publications reports at a 15% discount off the individual reports being purchased separately:

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

Below are summaries of each report.

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 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 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 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.

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; 3.2 Clinical Chemistry Sector; 3.3 Outlook for Clinical Chemistry Testing
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; 4.5 Laboratory Analyzers for the Small-Volume Market
5. Important Technology Trends: 5.1 Technology Platform Innovations in Clinical Chemistry Testing; 5.2 Sensor Systems for Diagnostic Applications; 5.3 Broad and Expanded Test Menus; 5.4 Consolidation of Analyzer Functions; 5.5 The New Paradigm; 5.6 Consolidated Workstations; 5.7 Automation in the Laboratory in Response to Labor Shortages; 5.8 Laboratory Information Systems; 5.9 Biosensor Technology; 5.10 Data-Management Issues; 5.11 Connectivity Platforms
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, China and Asia; 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; 6.9 Medicare Reimbursement Trends
7. Company Profiles: 7.1 Abaxis, Inc.; 7.2 Abbott Diagnostics; 7.3 Adaltis; 7.4 Alfa Wasserman, Inc. (f/k/a Electro-Nucleonics, Inc. and Schiapparelli Biosystems, Inc.); 7.5 Awareness Technology, Inc.; 7.6 Siemens; 7.7 Beckman Coulter, Inc.; 7.8 Dade Behring, Inc.; 7.9 Hitachi Ltd.; 7.10 Horiba Ltd.; 7.11 JEOL Ltd.; 7.12 Nova Biomedical Corporation; 7.13 Ortho-Clinical Diagnostics, Inc.; 7.14 Roche; 7.15 Shimadzu Corporation; 7.16 Sysmex Corporation; 7.17 Thermo Fisher Scientific, Inc.; 7.18 Vital Scientific B.V.; 7.19 Tosoh Corporation
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; 8.15 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: IVD Market by Clinical Specialty; Figure 3.2: Chinese IVD Market, 2006-2012; Figure 3.3: Lab Revenue by Lab Type; Figure 3.4: Lab Revenue by Test Type; Figure 4.1: U.S. Market Share for Ultra-Large Clinical Chemistry Analyzers; Figure 4.2: Non-U.S. Market Share for Ultra-Large Clinical Chemistry Analyzers; Figure 6.1: Part B Spending on Clinical Laboratory Services, 1991-2007
INDEX OF TABLES: Table 3.1: Worldwide IVD Testing Market, 2009; Table 3.2: Worldwide Geographic Distribution of IVD Testing, 2009; Table 3.3: Global Clinical Chemistry Revenues, 2000-2012; Table 3.4: Worldwide Distribution of Clinical Chemistry Testing, 2009; Table 3.5: Thirteen Largest Diagnostic Companies Worldwide, 2009; Table 3.6: U.S. Clinical Chemistry Testing Market, 2009-2015; Table 3.7: U.S. Clinical Laboratory Diagnostic Test Retail Value Market Segments, 2008; Table 3.8: European Clinical Laboratory Testing IVD Reagents and Instruments Market, 2000-2012; Table 3.9: European Clinical Laboratory Testing Diagnostics by Country Market Estimates, 2007; Table 3.10: European Clinical Chemistry Testing Market, 2000-2009; Table 3.11: German Clinical Chemistry Testing Diagnostics Products Market Sales, 2003-2012; Table 3.12: German Hospital Clinical Chemistry Market, 2000-2009; Table 3.13: U.K. Clinical Chemistry Diagnostics Products Market Sales, 2000-2009; Table 3.14: Major U.K. IVD Manufacturers; Table 3.15: U.S. IVD Manufacturers Doing Business in the U.K.; Table 3.16: Other European Companies that Manufacture IVD Products in the U.K.; Table 3.17: French Clinical Chemistry Diagnostics Products Market Sales, 2000-2009; Table 3.18: Italian Chemistry Diagnostics Products Market Sales, 2000-2009; Table 3.19: Spanish Clinical Chemistry Diagnostics Products Market Sales, 2000-2009; Table 3.20: Scandinavian Clinical Chemistry Diagnostics Products Market Sales, 2000-2009; Table 3.21: Canadian Clinical Chemistry Testing Market, 2000-2009; Table 3.22: Brazilian IVD Testing Market, 2000-2009; Table 3.23: Brazilian Clinical Chemistry Testing Market, 2000-2009; Table 3.24: Turkish Clinical Chemistry Testing Market, 2000-2009; Table 3.25: Australian Clinical Chemistry Testing Market, 2000-2009; Table 3.26: Mexican IVD Testing Market, 2000-2009; Table 3.27: Mexican Clinical Chemistry Testing Market, 2000-2009; Table 3.28: The ROW Clinical Chemistry Testing Market, 2000-2009; Table 3.29: Japanese Clinical Chemistry Testing Market, 2000-2009; Table 3.30: Drivers of Growth in the Chinese Clinical Laboratory Market; Table 3.31: Number of Chinese Medical Institutions; Table 3.32: Chinese Clinical Diagnostic Products Market, 2000-2008; Table 3.33: Chinese Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.34: Chinese IVD Market, 2008; Table 3.35: Market Share of Reagent Imports into the Chinese Clinical Lab Market by Country of Origin; Table 3.36: Market Share of Analytical Instrument Imports into the Chinese Clinical Lab Market by Country of Origin; Table 3.37: Chinese International IVD Manufacturers; Table 3.38: Chinese Domestic IVD Manufacturers; Table 3.39: Chinese IVD Distributors; Table 3.40: Indian IVD Market, 2006-2012; Table 3.41: Number of Automated Clinical Labs in India, 2004-2012; Table 3.42: Indian IVD Market, 2009; Table 3.43: Indian IVD Market for Instruments and Reagents, 2004-2012; Table 3.44: Estimated Number of Clinical Laboratories in Latin America; Table 3.45: U.S. Clinical Laboratory Testing Sector Revenue, 2005-2015; Table 3.46: U.S. Clinical Laboratory Testing Sector Segments, 2009; Table 3.47: Esoteric Tests Performed in the Clinical Laboratory; Table 3.48: Growth Rates of Test Types; Table 3.49: Drivers of Clinical Lab Testing Volume; Table 3.50: 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 Laboratory Analyzers; Table 5.1: Drivers of the Laboratory Information Systems Market Growth; Table 5.2: Restraints of the Laboratory Information Systems Market Growth; Table 5.3: Applications for Wireless LAN Technology; Table 5.4: Key Benefits of Laboratory Connectivity Platforms; Table 5.5: Connectivity Interface Platforms for Clinical Chemistry Analyzers; Table 6.1: Drivers of European Diagnostics Testing; Table 6.2: Drivers of European Reimbursement Practice; Table 6.3: Medicare Spending on Clinical Lab Services, 1991-2007; Table 6.4: Medicare Part B Spending Per Medicare Enrollee, 1998-2009; Table 6.5: 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 in the Diagnostics Market; Table 7.3: Clinically-Significant Tests Available from Siemens; Table 7.4: 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 Scope of the Report; 1.4 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; 6.15 Connectivity Consortium
7. Company Profiles: 7.1 Abbott Diagnostics; 7.2 Beckman Coulter, Inc.; 7.3 bioMerieux; 7.4 Dade Behring (Acquired by Siemens); 7.5 Bio-Rad Laboratories, Inc.; 7.6 Olympus America, Inc.; 7.7 Ortho-Clinical Diagnostics, Inc.; 7.8 Phadia AB; 7.9 Randox Laboratories Ltd.; 7.10 Roche; 7.11 Tosoh Corporation; 7.12 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
9. Product Launches: 9.1 Immunoassay Analyzer Product Launches; 9.2 Immunoassay Reagent Product Launches
INDEX OF FIGURES: Figure 3.1: Chinese IVD Market, 2006-2012; Figure 3.2: Lab Revenue by Lab Type; Figure 3.3: Lab Revenue by Test Type; Figure 6.1: Part B Spending on Clinical Laboratory Services, 1991- 2007
INDEX OF TABLES: Table 2.1: Common Immunoassay Tests; Table 3.1: Worldwide IVD Testing Market, 2009; Table 3.2: Worldwide Geographic Distribution of IVD Testing, 2009; Table 3.3: Global Clinical Immunoassay Revenues, 2000-2012; Table 3.4: Worldwide Distribution of Clinical Immunoassay Testing, 2009; Table 3.5: U.S. Clinical Laboratory Testing Market, 2003-2012; Table 3.6: U.S. Clinical Laboratory Diagnostic Test Market Retail Value Segments, 2008; Table 3.7: U.S. Clinical Immunoanalyzer Testing Market, 2009-2015; Table 3.8: European Clinical Laboratory Testing IVD Reagents and Instruments Market, 2000-2012; Table 3.9: European Clinical Laboratory Diagnostic Reagents and Instruments Markets by Analyte, 2008; Table 3.10: European Clinical Laboratory Testing Diagnostics by Country Market Estimates, 2007; Table 3.11: The European Immunochemistry Market, 2001-2012; Table 3.12: European Immunochemical Reagents and Instruments Markets by Country, 2006; Table 3.13: German Clinical Laboratory Testing Diagnostics Products Market Sales, 2003-2012; Table 3.14: German Clinical Immunochemistry Testing Diagnostics Products Market Sales, 2006-2012; Table 3.15: U.K. Clinical Immunochemistry Testing Diagnostics Products Market Sales, 2006-2012; Table 3.16: French Clinical Immunochemistry Testing Diagnostics Products Market Sales, 2006-2012; Table 3.17: Italian Immunochemistry Diagnostics Products Market Sales, 2006-2012; Table 3.18: Spanish Clinical Laboratory Diagnostics Products Market Sales, 2006-2012; Table 3.19: Finnish Clinical Immunoassay Products Market Sales, 2006-2012; Table 3.20: Belgian Clinical Immunoassay Products Market Sales, 2006-2012; Table 3.21: Swiss Clinical Immunoassay Products Market Sales, 2006-2012; Table 3.22: Dutch Clinical Immunoassay Products Market Sales, 2006-2012; Table 3.23: Portuguese Clinical Immunoassay Products Market Sales, 2006-2012; Table 3.24: Austrian Clinical Immunoassay Products Market Sales, 2006-2012; Table 3.25: Greek Clinical Immunoassay Products Market Sales, 2006-2012; Table 3.26: Polish Clinical Immunoassay Products Market Sales, 2006-2012; Table 3.27: Romanian Clinical Immunoassay Products Market Sales, 2006-2012; Table 3.28: Canadian Clinical Analyzer Testing Market, 2000-2009; Table 3.29: Brazilian Clinical Immunoanalyzer Testing Market, 2000-2009; Table 3.30: Turkish Clinical Analyzer Testing Market, 2000-2009; Table 3.31: Australian Clinical Immunoanalyzer Testing Market, 2000-2009; Table 3.32: ROW Clinical Immunoanalyzer Testing Market, 2000-2009; Table 3.33: Japanese Clinical Immunoanalyzer Testing Market, 2000-2009; Table 3.34: Drivers of Growth in the Chinese Clinical Laboratory Market; Table 3.35: Number of Chinese Medical Institutions; Table 3.36: Chinese Clinical Diagnostic Products Market, 2000-2008; Table 3.37: Chinese Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.38: Chinese IVD Market, 2008; Table 3.39: Market Share of Reagent Imports into the Chinese Clinical Lab Market by Country of Origin; Table 3.40: Market Share of Analytical Instrument Imports into the Chinese Clinical Lab Market by Country of Origin; Table 3.41: Chinese International IVD Manufacturers; Table 3.42: Chinese Domestic IVD Manufacturers; Table 3.43: Chinese IVD Distributors; Table 3.44: Indian IVD Market, 2006-2012; Table 3.45: Number of Automated Clinical Labs in India, 2004-2012; Table 3.46: Indian IVD Market, 2009; Table 3.47: Indian IVD Market for Instruments and Reagents, 2004-2012; Table 3.48: Estimated Number of Clinical Laboratories in Latin America; Table 3.49: U.S. Clinical Laboratory Testing Sector Revenue, 2005-2015; Table 3.50: U.S. Clinical Laboratory Testing Sector Segments, 2009; Table 3.51: Esoteric Tests Performed in the Clinical Laboratory; Table 3.52: Growth Rates of Test Types; Table 3.53: Drivers of Clinical Lab Testing Volume; Table 3.54: Principal Marketers of Automated Clinical Immunoanalyzer Instruments; Table 4.1: Samples and Sample Handling Features of Centaur CP; Table 4.2: Large- and Mid-Size Immunochemistry Analyzers; Table 4.3: Small- to Mid-Volume Immunoassay Analyzers; Table 5.1: Analytical Detection Levels for Drugs of Abuse; Table 5.2: Wireless LAN Technology Companies; Table 5.3: Applications for Wireless LAN Technology; Table 5.4: Key Benefits of Laboratory Connectivity Platforms; Table 5.5: Connectivity Interface Platforms for Clinical Chemistry Analyzers; Table 5.6: 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: Key Criteria for Assessing Data Management Capabilities of Automated Instruments for Immunochemistry Testing; Table 8.3: Medicare Billing Guidelines for Multi-Channel Immunoanalyzer Tests
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; 2.3 Hospital Market; 2.4 POL Market; 2.5 IVD Industry; 2.6 Automated Instrument Platforms Evolution; 2.7 Reagents and Supplies Market for Clinical Lab Instruments; 2.8 Spending for Clinical Laboratory Testing
3. IVD Clinical Laboratory Market: 3.1 Markets; 3.2 Clinical Laboratory Sector; 3.3 Outlook for Clinical Laboratory Testing
4. Clinical Laboratory Instrument Market by Sector: 4.1 Chemistry Analyzers; 4.2 Immunochemistry Analyzers; 4.3 Hematology Analyzers; 4.4 Point of Care Testing; 4.5 Cytology Testing; 4.6 Microbiology Testing; 4.7 Serology Testing; 4.8 Esoteric Testing; 4.9 Anatomic Pathology; 4.10 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
6. Business Trends in the Clinical Laboratory Analyzer and Reagents Market: 6.1 Key Market 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 Laboratory Testing; 6.8 Government Regulation of IVD Devices; 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; 6.18 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?; 6.27 Clinical Trials Testing.; 6.28 Life Insurer Services.; 6.29 Employer Services
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 Becton, Dickinson & Co.; 7.6 Beckman Coulter, Inc.; 7.7 Bio-Reference Laboratories, Inc.; 7.8 bioMerieux; 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 Hologic, Inc.; 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
INDEX OF FIGURES: Figure 2.1: Clinical Laboratory Testing Sector Providers; Figure 2.2: Unweighted Average Medicare Reimbursement for Ten Most Common POL Tests, 2002 vs. 2006; Figure 2.3: Total Number of Non-Waived POLs, 2000-2006; Figure 2.4: Part B Spending on Clinical Laboratory Services, 1991-2005; Figure 3.1: IVD Product Demand; Figure 3.2: European IVD Market by Clinical Specialty; Figure 3.3: Chinese IVD Market, 2006-2012; Figure 6.1: Hospital Market Share for Outreach Programs; Figure 7.1: Beckman Sales Results by Type, Segment and Region, 2009
INDEX OF TABLES: Table 2.1: Total U.S. Clinical Laboratory Revenue, 2005-2015; Table 2.2: U.S. Clinical Laboratory Diagnostic Test Market Segments Revenue, 2009; Table 2.3: Drivers of Clinical Lab Testing Volume; Table 2.4: Independent Commercial Laboratory Testing Market Sample Volume, 2005-2012; Table 2.5: Leading U.S. Reference Laboratories Grouped by Market Capitalization; Table 2.6: LabCorp Comparison of Routine and Genomic and Esoteric Testing Trends; Table 2.7: Revenue Growth at Quest Diagnostics, 2000-2009; Table 2.8: Revenue Growth at LabCorp, 2000-2009; Table 2.9: Quest's Total Volume of Requisitions and Net Revenues from Clinical Laboratory Testing; Table 2.10: Number of Hospital-based Clinical Laboratory Tests in the U.S., 2002-2012; Table 2.11: European Cardiovascular Disease Management Expenditures, 2003-2010; Table 2.12: The Most Frequent Laboratory Tests Offered at Physician Offices; Table 2.13: U.S. Doctor's Office Lab Test Dollar Volume and Growth Rates, 2009; Table 2.14: Worldwide Alternate Site Clinical Lab Instrument and Reagents Sales, 2005-2012; Table 2.15: Thirteen Largest Diagnostic Companies Worldwide; Table 2.16: Products Marketed by Abbott in the Diagnostic Market; Table 2.17: Beckman Coulter Market Share in Major Diagnostic Sectors; Table 2.18: Prodesse's ASRs; Table 2.19: CMS Reimbursement for Top 25 Clinical Laboratory Procedures; Table 3.1: Worldwide IVD Testing Market, 2009; Table 3.2: Worldwide Geographic Distribution of IVD Testing, 2009; Table 3.3: Global Clinical Laboratory Market Sales, 1998-2012; Table 3.4: U.S. Clinical Laboratory Testing Market, 2003-2012; Table 3.5: U.S. Clinical Laboratory Diagnostic Test Market Segments, 2009; Table 3.6: U.S. Clinical Diagnostic POCT and Rapid Test Market Segments, 2007; Table 3.7: U.S. Individual Clinical Chemistry Laboratory Diagnostic Test Markets, 2009; Table 3.8: European Clinical Laboratory Testing IVD Reagents and Instruments Market, 2000-2012; Table 3.9: European Clinical Laboratory Diagnostic Testing Reagents and Instruments Market by Analyte, 2006; Table 3.10: European Clinical Chemistry Testing IVD Reagents and Instruments Market, 2000-2012; Table 3.11: European Clinical Laboratory Testing Diagnostics by Country Market, 2009; Table 3.12: European Rapid POCT by Country Market, 2008; Table 3.13: European Patient Self Testing OTC Diagnostics by Country Market, 2006; Table 3.14: German Clinical Laboratory Testing Diagnostics Products Market; Sales, 2003-2012; Table 3.15: German Clinical Diagnostic Rapid Test Market Segments, 2008; Table 3.16: U.K. Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.17: U.K. Clinical Diagnostic Rapid Test Market Segments; 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 IVD Testing Diagnostics Products Market Sales, 2003-2012; Table 3.22: French Clinical Diagnostic Rapid Test Market Segments; Table 3.23: Italian Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.24: Italian Clinical Diagnostic Rapid Test Market Segments; Table 3.25: Spanish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.26: Spanish Clinical Diagnostic Rapid Test Market Segments, 2008; Table 3.27: Finnish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.28: Turkish Clinical Laboratory Testing Market, 2000-2012; Table 3.29: Belgium Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.30: Belgium Clinical Reagents and Instruments Market; Table 3.31: Swiss Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.32: Swiss Clinical Reagents and Instruments Market; Table 3.33: Dutch Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.34: Dutch Clinical Reagents and Instruments Market; Table 3.35: Portuguese Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.36: Portuguese Clinical Reagents and Instruments Market; Table 3.37: Austrian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.38: Austrian Clinical Reagents and Instruments Market; Table 3.39: Greek Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.40: Greek Clinical Reagents and Instruments Market; Table 3.41: Polish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.42: Polish Clinical Reagents and Instruments Market; Table 3.43: Romanian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.44: Romanian Clinical Reagents and Instruments Market; Table 3.45: Czech Republic Clinical Laboratory Diagnostics Products Market Sales, 2004-2012; Table 3.46: Swedish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.47: Norwegian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.48: Irish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.49: Hungarian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.50: Bulgarian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.51: Slovakian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.52: Lithuanian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.53: Latvian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.54: Estonian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.55: Slovenian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.56: Russian Clinical Laboratory Diagnostics Products Market Sales, 2007-2012; Table 3.57: Asian Geographic Distribution of IVD Testing, 2009; Table 3.58: Summary of Key Business Points of the Asian Healthcare Market; Table 3.59: Outlook for the Asian Healthcare Market, 2010-2012; Table 3.60: Asian IVD Market Drivers; Table 3.61: Asian IVD Market Restraints; Table 3.62: Top Asian IVD Growth Opportunities; Table 3.63: Indian IVD Market for Instruments and Reagents, 2004-2012; Table 3.64: Number of Automated Clinical Labs in India, 2004-2012; Table 3.65: Indian IVD Market; Table 3.66: Japanese Clinical Laboratory Testing Instrument and Reagents Market, 2003-2012; Table 3.67: Drivers of the Japanese IVD Market; Table 3.68: Barriers to the Japanese IVD Market; Table 3.69: Drivers of Growth in the Chinese Clinical Laboratory Market; Table 3.70: Number of Chinese Medical Institutions; Table 3.71: Chinese Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.72: Chinese IVD Market, 2008; Table 3.73: Proportion of Medical Expenses Paid Privately; Table 3.74: Market Share of Reagent Imports into the Chinese Clinical Lab Market by Country of Origin; Table 3.75: Analytical Instrument Imports into the Chinese Clinical Lab Market by Country of Origin; Table 3.76: Chinese International IVD Manufacturers; Table 3.77: Chinese Domestic IVD Manufacturers; Table 3.78: Chinese IVD Distributors; Table 3.79: Canadian Clinical Laboratory Testing Market, 2000-2009; Table 3.80: Brazilian Clinical Laboratory Testing Market, 2000-2009; Table 3.81: Australian Clinical Laboratory Testing Market, 2000-2009; Table 3.82: ROW Clinical Laboratory Testing Market, 2000-2009; Table 3.83: Latin American Geographic Distribution of IVD Testing, 2009; Table 3.84: Number of Clinical Laboratories in Latin America; Table 3.85: Principal Marketers of Automated Clinical Laboratory Instruments; Table 3.86: Key Market Drivers of Automated Clinical Laboratory Instruments; Table 3.87: 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 4.27: Drugs of Abuse Testing Market for POCT Worldwide, 2006-2015; Table 4.28: U.S. Point of Care Drugs of Abuse Testing Market, 2006-2015; Table 5.1: Normal Glucose Values-Fasting State; Table 5.2: Applications for Wireless LAN Technology; Table 6:1: Products Marketed by Abbott in the Diagnostics Market; Table 7.1: Abaxis Blood Analysis Diagnostic Tests; Table 7.2: Reagent Discs Offered with the Piccolo Chemistry Analyzers; Table 7.3: Comparison of JEOL Analyzers; Table 7.4: The VITROS ECiQ Immunodiagnostic System; Table 7.5: Sysmex Marketing Summary for China
Clinical Laboratory Testing Volume 2: Business Strategies
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; 3.2 Clinical Chemistry Sector; 3.3 Outlook for Clinical Chemistry Testing
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; 4.5 Laboratory Analyzers for the Small-Volume Market
5. Important Technology Trends: 5.1 Technology Platform Innovations in Clinical Chemistry Testing; 5.2 Sensor Systems for Diagnostic Applications; 5.3 Broad and Expanded Test Menus; 5.4 Consolidation of Analyzer Functions; 5.5 The New Paradigm; 5.6 Consolidated Workstations; 5.7 Automation in the Laboratory in Response to Labor Shortages; 5.8 Laboratory Information Systems; 5.9 Biosensor Technology; 5.10 Data-Management Issues; 5.11 Connectivity Platforms
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, China and Asia; 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; 6.9 Medicare Reimbursement Trends
7. Company Profiles: 7.1 Abaxis, Inc.; 7.2 Abbott Diagnostics; 7.3 Adaltis; 7.4 Alfa Wasserman, Inc. (f/k/a Electro-Nucleonics, Inc. and Schiapparelli Biosystems, Inc.); 7.5 Awareness Technology, Inc.; 7.6 Siemens; 7.7 Beckman Coulter, Inc.; 7.8 Dade Behring, Inc.; 7.9 Hitachi Ltd.; 7.10 Horiba Ltd.; 7.11 JEOL Ltd.; 7.12 Nova Biomedical Corporation; 7.13 Ortho-Clinical Diagnostics, Inc.; 7.14 Roche; 7.15 Shimadzu Corporation; 7.16 Sysmex Corporation; 7.17 Thermo Fisher Scientific, Inc.; 7.18 Vital Scientific B.V.; 7.19 Tosoh Corporation
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; 8.15 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: IVD Market by Clinical Specialty; Figure 3.2: Chinese IVD Market, 2006-2012; Figure 3.3: Lab Revenue by Lab Type; Figure 3.4: Lab Revenue by Test Type; Figure 4.1: U.S. Market Share for Ultra-Large Clinical Chemistry Analyzers; Figure 4.2: Non-U.S. Market Share for Ultra-Large Clinical Chemistry Analyzers; Figure 6.1: Part B Spending on Clinical Laboratory Services, 1991-2007
INDEX OF TABLES: Table 3.1: Worldwide IVD Testing Market, 2009; Table 3.2: Worldwide Geographic Distribution of IVD Testing, 2009; Table 3.3: Global Clinical Chemistry Revenues, 2000-2012; Table 3.4: Worldwide Distribution of Clinical Chemistry Testing, 2009; Table 3.5: Thirteen Largest Diagnostic Companies Worldwide, 2009; Table 3.6: U.S. Clinical Chemistry Testing Market, 2009-2015; Table 3.7: U.S. Clinical Laboratory Diagnostic Test Retail Value Market Segments, 2008; Table 3.8: European Clinical Laboratory Testing IVD Reagents and Instruments Market, 2000-2012; Table 3.9: European Clinical Laboratory Testing Diagnostics by Country Market Estimates, 2007; Table 3.10: European Clinical Chemistry Testing Market, 2000-2009; Table 3.11: German Clinical Chemistry Testing Diagnostics Products Market Sales, 2003-2012; Table 3.12: German Hospital Clinical Chemistry Market, 2000-2009; Table 3.13: U.K. Clinical Chemistry Diagnostics Products Market Sales, 2000-2009; Table 3.14: Major U.K. IVD Manufacturers; Table 3.15: U.S. IVD Manufacturers Doing Business in the U.K.; Table 3.16: Other European Companies that Manufacture IVD Products in the U.K.; Table 3.17: French Clinical Chemistry Diagnostics Products Market Sales, 2000-2009; Table 3.18: Italian Chemistry Diagnostics Products Market Sales, 2000-2009; Table 3.19: Spanish Clinical Chemistry Diagnostics Products Market Sales, 2000-2009; Table 3.20: Scandinavian Clinical Chemistry Diagnostics Products Market Sales, 2000-2009; Table 3.21: Canadian Clinical Chemistry Testing Market, 2000-2009; Table 3.22: Brazilian IVD Testing Market, 2000-2009; Table 3.23: Brazilian Clinical Chemistry Testing Market, 2000-2009; Table 3.24: Turkish Clinical Chemistry Testing Market, 2000-2009; Table 3.25: Australian Clinical Chemistry Testing Market, 2000-2009; Table 3.26: Mexican IVD Testing Market, 2000-2009; Table 3.27: Mexican Clinical Chemistry Testing Market, 2000-2009; Table 3.28: The ROW Clinical Chemistry Testing Market, 2000-2009; Table 3.29: Japanese Clinical Chemistry Testing Market, 2000-2009; Table 3.30: Drivers of Growth in the Chinese Clinical Laboratory Market; Table 3.31: Number of Chinese Medical Institutions; Table 3.32: Chinese Clinical Diagnostic Products Market, 2000-2008; Table 3.33: Chinese Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.34: Chinese IVD Market, 2008; Table 3.35: Market Share of Reagent Imports into the Chinese Clinical Lab Market by Country of Origin; Table 3.36: Market Share of Analytical Instrument Imports into the Chinese Clinical Lab Market by Country of Origin; Table 3.37: Chinese International IVD Manufacturers; Table 3.38: Chinese Domestic IVD Manufacturers; Table 3.39: Chinese IVD Distributors; Table 3.40: Indian IVD Market, 2006-2012; Table 3.41: Number of Automated Clinical Labs in India, 2004-2012; Table 3.42: Indian IVD Market, 2009; Table 3.43: Indian IVD Market for Instruments and Reagents, 2004-2012; Table 3.44: Estimated Number of Clinical Laboratories in Latin America; Table 3.45: U.S. Clinical Laboratory Testing Sector Revenue, 2005-2015; Table 3.46: U.S. Clinical Laboratory Testing Sector Segments, 2009; Table 3.47: Esoteric Tests Performed in the Clinical Laboratory; Table 3.48: Growth Rates of Test Types; Table 3.49: Drivers of Clinical Lab Testing Volume; Table 3.50: 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 Laboratory Analyzers; Table 5.1: Drivers of the Laboratory Information Systems Market Growth; Table 5.2: Restraints of the Laboratory Information Systems Market Growth; Table 5.3: Applications for Wireless LAN Technology; Table 5.4: Key Benefits of Laboratory Connectivity Platforms; Table 5.5: Connectivity Interface Platforms for Clinical Chemistry Analyzers; Table 6.1: Drivers of European Diagnostics Testing; Table 6.2: Drivers of European Reimbursement Practice; Table 6.3: Medicare Spending on Clinical Lab Services, 1991-2007; Table 6.4: Medicare Part B Spending Per Medicare Enrollee, 1998-2009; Table 6.5: 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 in the Diagnostics Market; Table 7.3: Clinically-Significant Tests Available from Siemens; Table 7.4: 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 Scope of the Report; 1.4 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; 6.15 Connectivity Consortium
7. Company Profiles: 7.1 Abbott Diagnostics; 7.2 Beckman Coulter, Inc.; 7.3 bioMerieux; 7.4 Dade Behring (Acquired by Siemens); 7.5 Bio-Rad Laboratories, Inc.; 7.6 Olympus America, Inc.; 7.7 Ortho-Clinical Diagnostics, Inc.; 7.8 Phadia AB; 7.9 Randox Laboratories Ltd.; 7.10 Roche; 7.11 Tosoh Corporation; 7.12 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
9. Product Launches: 9.1 Immunoassay Analyzer Product Launches; 9.2 Immunoassay Reagent Product Launches
INDEX OF FIGURES: Figure 3.1: Chinese IVD Market, 2006-2012; Figure 3.2: Lab Revenue by Lab Type; Figure 3.3: Lab Revenue by Test Type; Figure 6.1: Part B Spending on Clinical Laboratory Services, 1991- 2007
INDEX OF TABLES: Table 2.1: Common Immunoassay Tests; Table 3.1: Worldwide IVD Testing Market, 2009; Table 3.2: Worldwide Geographic Distribution of IVD Testing, 2009; Table 3.3: Global Clinical Immunoassay Revenues, 2000-2012; Table 3.4: Worldwide Distribution of Clinical Immunoassay Testing, 2009; Table 3.5: U.S. Clinical Laboratory Testing Market, 2003-2012; Table 3.6: U.S. Clinical Laboratory Diagnostic Test Market Retail Value Segments, 2008; Table 3.7: U.S. Clinical Immunoanalyzer Testing Market, 2009-2015; Table 3.8: European Clinical Laboratory Testing IVD Reagents and Instruments Market, 2000-2012; Table 3.9: European Clinical Laboratory Diagnostic Reagents and Instruments Markets by Analyte, 2008; Table 3.10: European Clinical Laboratory Testing Diagnostics by Country Market Estimates, 2007; Table 3.11: The European Immunochemistry Market, 2001-2012; Table 3.12: European Immunochemical Reagents and Instruments Markets by Country, 2006; Table 3.13: German Clinical Laboratory Testing Diagnostics Products Market Sales, 2003-2012; Table 3.14: German Clinical Immunochemistry Testing Diagnostics Products Market Sales, 2006-2012; Table 3.15: U.K. Clinical Immunochemistry Testing Diagnostics Products Market Sales, 2006-2012; Table 3.16: French Clinical Immunochemistry Testing Diagnostics Products Market Sales, 2006-2012; Table 3.17: Italian Immunochemistry Diagnostics Products Market Sales, 2006-2012; Table 3.18: Spanish Clinical Laboratory Diagnostics Products Market Sales, 2006-2012; Table 3.19: Finnish Clinical Immunoassay Products Market Sales, 2006-2012; Table 3.20: Belgian Clinical Immunoassay Products Market Sales, 2006-2012; Table 3.21: Swiss Clinical Immunoassay Products Market Sales, 2006-2012; Table 3.22: Dutch Clinical Immunoassay Products Market Sales, 2006-2012; Table 3.23: Portuguese Clinical Immunoassay Products Market Sales, 2006-2012; Table 3.24: Austrian Clinical Immunoassay Products Market Sales, 2006-2012; Table 3.25: Greek Clinical Immunoassay Products Market Sales, 2006-2012; Table 3.26: Polish Clinical Immunoassay Products Market Sales, 2006-2012; Table 3.27: Romanian Clinical Immunoassay Products Market Sales, 2006-2012; Table 3.28: Canadian Clinical Analyzer Testing Market, 2000-2009; Table 3.29: Brazilian Clinical Immunoanalyzer Testing Market, 2000-2009; Table 3.30: Turkish Clinical Analyzer Testing Market, 2000-2009; Table 3.31: Australian Clinical Immunoanalyzer Testing Market, 2000-2009; Table 3.32: ROW Clinical Immunoanalyzer Testing Market, 2000-2009; Table 3.33: Japanese Clinical Immunoanalyzer Testing Market, 2000-2009; Table 3.34: Drivers of Growth in the Chinese Clinical Laboratory Market; Table 3.35: Number of Chinese Medical Institutions; Table 3.36: Chinese Clinical Diagnostic Products Market, 2000-2008; Table 3.37: Chinese Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.38: Chinese IVD Market, 2008; Table 3.39: Market Share of Reagent Imports into the Chinese Clinical Lab Market by Country of Origin; Table 3.40: Market Share of Analytical Instrument Imports into the Chinese Clinical Lab Market by Country of Origin; Table 3.41: Chinese International IVD Manufacturers; Table 3.42: Chinese Domestic IVD Manufacturers; Table 3.43: Chinese IVD Distributors; Table 3.44: Indian IVD Market, 2006-2012; Table 3.45: Number of Automated Clinical Labs in India, 2004-2012; Table 3.46: Indian IVD Market, 2009; Table 3.47: Indian IVD Market for Instruments and Reagents, 2004-2012; Table 3.48: Estimated Number of Clinical Laboratories in Latin America; Table 3.49: U.S. Clinical Laboratory Testing Sector Revenue, 2005-2015; Table 3.50: U.S. Clinical Laboratory Testing Sector Segments, 2009; Table 3.51: Esoteric Tests Performed in the Clinical Laboratory; Table 3.52: Growth Rates of Test Types; Table 3.53: Drivers of Clinical Lab Testing Volume; Table 3.54: Principal Marketers of Automated Clinical Immunoanalyzer Instruments; Table 4.1: Samples and Sample Handling Features of Centaur CP; Table 4.2: Large- and Mid-Size Immunochemistry Analyzers; Table 4.3: Small- to Mid-Volume Immunoassay Analyzers; Table 5.1: Analytical Detection Levels for Drugs of Abuse; Table 5.2: Wireless LAN Technology Companies; Table 5.3: Applications for Wireless LAN Technology; Table 5.4: Key Benefits of Laboratory Connectivity Platforms; Table 5.5: Connectivity Interface Platforms for Clinical Chemistry Analyzers; Table 5.6: 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: Key Criteria for Assessing Data Management Capabilities of Automated Instruments for Immunochemistry Testing; Table 8.3: Medicare Billing Guidelines for Multi-Channel Immunoanalyzer Tests
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; 2.3 Hospital Market; 2.4 POL Market; 2.5 IVD Industry; 2.6 Automated Instrument Platforms Evolution; 2.7 Reagents and Supplies Market for Clinical Lab Instruments; 2.8 Spending for Clinical Laboratory Testing
3. IVD Clinical Laboratory Market: 3.1 Markets; 3.2 Clinical Laboratory Sector; 3.3 Outlook for Clinical Laboratory Testing
4. Clinical Laboratory Instrument Market by Sector: 4.1 Chemistry Analyzers; 4.2 Immunochemistry Analyzers; 4.3 Hematology Analyzers; 4.4 Point of Care Testing; 4.5 Cytology Testing; 4.6 Microbiology Testing; 4.7 Serology Testing; 4.8 Esoteric Testing; 4.9 Anatomic Pathology; 4.10 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
6. Business Trends in the Clinical Laboratory Analyzer and Reagents Market: 6.1 Key Market 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 Laboratory Testing; 6.8 Government Regulation of IVD Devices; 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; 6.18 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?; 6.27 Clinical Trials Testing.; 6.28 Life Insurer Services.; 6.29 Employer Services
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 Becton, Dickinson & Co.; 7.6 Beckman Coulter, Inc.; 7.7 Bio-Reference Laboratories, Inc.; 7.8 bioMerieux; 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 Hologic, Inc.; 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
INDEX OF FIGURES: Figure 2.1: Clinical Laboratory Testing Sector Providers; Figure 2.2: Unweighted Average Medicare Reimbursement for Ten Most Common POL Tests, 2002 vs. 2006; Figure 2.3: Total Number of Non-Waived POLs, 2000-2006; Figure 2.4: Part B Spending on Clinical Laboratory Services, 1991-2005; Figure 3.1: IVD Product Demand; Figure 3.2: European IVD Market by Clinical Specialty; Figure 3.3: Chinese IVD Market, 2006-2012; Figure 6.1: Hospital Market Share for Outreach Programs; Figure 7.1: Beckman Sales Results by Type, Segment and Region, 2009
INDEX OF TABLES: Table 2.1: Total U.S. Clinical Laboratory Revenue, 2005-2015; Table 2.2: U.S. Clinical Laboratory Diagnostic Test Market Segments Revenue, 2009; Table 2.3: Drivers of Clinical Lab Testing Volume; Table 2.4: Independent Commercial Laboratory Testing Market Sample Volume, 2005-2012; Table 2.5: Leading U.S. Reference Laboratories Grouped by Market Capitalization; Table 2.6: LabCorp Comparison of Routine and Genomic and Esoteric Testing Trends; Table 2.7: Revenue Growth at Quest Diagnostics, 2000-2009; Table 2.8: Revenue Growth at LabCorp, 2000-2009; Table 2.9: Quest's Total Volume of Requisitions and Net Revenues from Clinical Laboratory Testing; Table 2.10: Number of Hospital-based Clinical Laboratory Tests in the U.S., 2002-2012; Table 2.11: European Cardiovascular Disease Management Expenditures, 2003-2010; Table 2.12: The Most Frequent Laboratory Tests Offered at Physician Offices; Table 2.13: U.S. Doctor's Office Lab Test Dollar Volume and Growth Rates, 2009; Table 2.14: Worldwide Alternate Site Clinical Lab Instrument and Reagents Sales, 2005-2012; Table 2.15: Thirteen Largest Diagnostic Companies Worldwide; Table 2.16: Products Marketed by Abbott in the Diagnostic Market; Table 2.17: Beckman Coulter Market Share in Major Diagnostic Sectors; Table 2.18: Prodesse's ASRs; Table 2.19: CMS Reimbursement for Top 25 Clinical Laboratory Procedures; Table 3.1: Worldwide IVD Testing Market, 2009; Table 3.2: Worldwide Geographic Distribution of IVD Testing, 2009; Table 3.3: Global Clinical Laboratory Market Sales, 1998-2012; Table 3.4: U.S. Clinical Laboratory Testing Market, 2003-2012; Table 3.5: U.S. Clinical Laboratory Diagnostic Test Market Segments, 2009; Table 3.6: U.S. Clinical Diagnostic POCT and Rapid Test Market Segments, 2007; Table 3.7: U.S. Individual Clinical Chemistry Laboratory Diagnostic Test Markets, 2009; Table 3.8: European Clinical Laboratory Testing IVD Reagents and Instruments Market, 2000-2012; Table 3.9: European Clinical Laboratory Diagnostic Testing Reagents and Instruments Market by Analyte, 2006; Table 3.10: European Clinical Chemistry Testing IVD Reagents and Instruments Market, 2000-2012; Table 3.11: European Clinical Laboratory Testing Diagnostics by Country Market, 2009; Table 3.12: European Rapid POCT by Country Market, 2008; Table 3.13: European Patient Self Testing OTC Diagnostics by Country Market, 2006; Table 3.14: German Clinical Laboratory Testing Diagnostics Products Market Sales, 2003-2012; Table 3.15: German Clinical Diagnostic Rapid Test Market Segments, 2008; Table 3.16: U.K. Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.17: U.K. Clinical Diagnostic Rapid Test Market Segments; 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 IVD Testing Diagnostics Products Market Sales, 2003-2012; Table 3.22: French Clinical Diagnostic Rapid Test Market Segments; Table 3.23: Italian Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.24: Italian Clinical Diagnostic Rapid Test Market Segments; Table 3.25: Spanish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.26: Spanish Clinical Diagnostic Rapid Test Market Segments, 2008; Table 3.27: Finnish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.28: Turkish Clinical Laboratory Testing Market, 2000-2012; Table 3.29: Belgium Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.30: Belgium Clinical Reagents and Instruments Market; Table 3.31: Swiss Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.32: Swiss Clinical Reagents and Instruments Market; Table 3.33: Dutch Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.34: Dutch Clinical Reagents and Instruments Market; Table 3.35: Portuguese Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.36: Portuguese Clinical Reagents and Instruments Market; Table 3.37: Austrian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.38: Austrian Clinical Reagents and Instruments Market; Table 3.39: Greek Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.40: Greek Clinical Reagents and Instruments Market; Table 3.41: Polish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.42: Polish Clinical Reagents and Instruments Market; Table 3.43: Romanian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.44: Romanian Clinical Reagents and Instruments Market; Table 3.45: Czech Republic Clinical Laboratory Diagnostics Products Market Sales, 2004-2012; Table 3.46: Swedish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.47: Norwegian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.48: Irish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.49: Hungarian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.50: Bulgarian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.51: Slovakian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.52: Lithuanian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.53: Latvian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.54: Estonian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.55: Slovenian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.56: Russian Clinical Laboratory Diagnostics Products Market Sales, 2007-2012; Table 3.57: Asian Geographic Distribution of IVD Testing, 2009; Table 3.58: Summary of Key Business Points of the Asian Healthcare Market; Table 3.59: Outlook for the Asian Healthcare Market, 2010-2012; Table 3.60: Asian IVD Market Drivers; Table 3.61: Asian IVD Market Restraints; Table 3.62: Top Asian IVD Growth Opportunities; Table 3.63: Indian IVD Market for Instruments and Reagents, 2004-2012; Table 3.64: Number of Automated Clinical Labs in India, 2004-2012; Table 3.65: Indian IVD Market; Table 3.66: Japanese Clinical Laboratory Testing Instrument and Reagents Market, 2003-2012; Table 3.67: Drivers of the Japanese IVD Market; Table 3.68: Barriers to the Japanese IVD Market; Table 3.69: Drivers of Growth in the Chinese Clinical Laboratory Market; Table 3.70: Number of Chinese Medical Institutions; Table 3.71: Chinese Clinical Laboratory Diagnostics Products Market Sales, 2003-2012; Table 3.72: Chinese IVD Market, 2008; Table 3.73: Proportion of Medical Expenses Paid Privately; Table 3.74: Market Share of Reagent Imports into the Chinese Clinical Lab Market by Country of Origin; Table 3.75: Analytical Instrument Imports into the Chinese Clinical Lab Market by Country of Origin; Table 3.76: Chinese International IVD Manufacturers; Table 3.77: Chinese Domestic IVD Manufacturers; Table 3.78: Chinese IVD Distributors; Table 3.79: Canadian Clinical Laboratory Testing Market, 2000-2009; Table 3.80: Brazilian Clinical Laboratory Testing Market, 2000-2009; Table 3.81: Australian Clinical Laboratory Testing Market, 2000-2009; Table 3.82: ROW Clinical Laboratory Testing Market, 2000-2009; Table 3.83: Latin American Geographic Distribution of IVD Testing, 2009; Table 3.84: Number of Clinical Laboratories in Latin America; Table 3.85: Principal Marketers of Automated Clinical Laboratory Instruments; Table 3.86: Key Market Drivers of Automated Clinical Laboratory Instruments; Table 3.87: 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 4.27: Drugs of Abuse Testing Market for POCT Worldwide, 2006-2015; Table 4.28: U.S. Point of Care Drugs of Abuse Testing Market, 2006-2015; Table 5.1: Normal Glucose Values-Fasting State; Table 5.2: Applications for Wireless LAN Technology; Table 6:1: Products Marketed by Abbott in the Diagnostics Market; Table 7.1: Abaxis Blood Analysis Diagnostic Tests; Table 7.2: Reagent Discs Offered with the Piccolo Chemistry Analyzers; Table 7.3: Comparison of JEOL Analyzers; Table 7.4: The VITROS ECiQ Immunodiagnostic System; Table 7.5: 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 Medical Expenditures; 2.4 Medicare Clinical Lab Services Spending Trends
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 Testing 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 (Thermo Fisher Scientific); 7.7 Aurora Diagnostics; 7.8 Bio-Reference Laboratories, Inc.; 7.9 BioTech Labs (Laboratory Partners); 7.10 CBLPath, Inc.; 7.11 Centrex Clinical Laboratories, Inc.; 7.12 Clarient, Inc.; 7.13 Clinical Laboratories of Hawaii, LLP (Sonic Healthcare); 7.14 Clinical Reference Laboratory; 7.15 Clongen Laboratories, LLC; 7.16 CompuNet Clinical Laboratories, LLC; 7.17 Diagnostic Systems Laboratories (Beckman Coulter, Inc.); 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 Integrated Regional Laboratories (IRL); 7.26 LabCorp; 7.27 LifeLabs; 7.28 MEDTOX Scientific, Inc.; 7.29 Meriter Health Services; 7.30 Mid America Clinical Laboratories (MACL); 7.31 Monogram Biosciences, Inc.; 7.32 Myriad Genetics, Inc.; 7.33 National Jewish Medical and Research Center; 7.34 Parkway Clinical Laboratories; 7.35 Pathology Associates Medical Laboratories (PAML); 7.36 Psychemedics Corporation; 7.37 Quest Diagnostics, Inc.; 7.38 RDL Reference Laboratory; 7.39 Satellite Laboratory Services; 7.40 Spectrum Laboratory Network; 7.41 Sonic Healthcare; 7.42 ViraCor-IBT Laboratories
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
9. Key Clinical Lab Business Strategies: 9.1 Strategy 1: Acquisitions; 9.2 Strategy 2: Parallel Businesses Development; 9.3 Strategy 3: Larger Labs; 9.4 Strategy 4: Develop Specialty Areas of Testing; 9.5 Strategy 5: Marketing; 9.6 Strategy 6: Capitalize on a Unique Position within the Clinical Testing Market; 9.7 Strategy 7: Lead in Providing Medical Information; 9.8 Strategy 8: Scientific Differentiation; 9.9 Strategy 9: Drive Quality; 9.10 Strategy 10: Deliver a Superior Patient Experience
Appendix 1: Reference Laboratory Directory
Appendix 2: Current List of Laboratories which Meet Minimum Standards to Engage in Urine Drug Testing for Federal Agencies: Appendix 3: FDA/CLIA-Currently Waived Analytes
INDEX OF FIGURES: Figure 2.3: Part B Spending on Clinical Laboratory Services, 1991-2007; Figure 3.1: Lab Revenue by Lab Type; Figure 3.2: Lab Revenue by Test Type; Figure 3.3: Number of New Tests Granted CLIA-waived Status, 2000-2008; Figure 3.4: High-Volume Waived Tests; Figure 5.1: Percentage of Physicians in Practices with IT for Specific Clinical Activities; Figure 8.1: Reimbursement Distribution for Clinical Lab Service Payers
INDEX OF TABLES: Table 2.1: Drivers for Overall Medicare Spending; Table 2.2: Medicare Part B Expenditures, 1970-2008; Table 2.3: Projections of Medicare Part B Expenditures, 2009-2080; Table 2.4: Medicare Spending for Clinical Lab Services, 2000-2009; Table 3.1: U.S. Clinical Laboratory Testing Sector Revenue, 2005-2015; Table 3.2: U.S. Clinical Laboratory Testing Sector Segments, 2009; Table 3.3: Esoteric Tests Performed in the Clinical Laboratory; Table 3.4: Growth Rates of Test Types; Table 3.5: Drivers of Clinical Lab Testing Volume; Table 3.6: Independent Commercial Laboratory Testing Test Volume, 2005-2015; Table 3.7: Physician Office Laboratories Tests; Table 3.8: Revenue at Leading Publicly-traded Lab Companies, 2009; Table 3.9: Payer Group Percentage of Total Volume of Requisitions and Net Revenues; Table 3.10: Barriers to Successful Clinical Lab Operations; Table 5.1: Applications for Wireless LAN Technology; Table 6.1: Major Managed Care Players for Clinical Laboratory Services; Table 6.2: Drivers for Managed Care Spending for Clinical Laboratory Services; Table 6.3: Revenue for Quest Diagnostics, 2000-2009; Table 6.4: Revenue for LabCorp, 2000-2009; Table 6.5: Clinical Lab Quality Assurance Programs; Table 8.1: Key Elements of Clinical Lab Service; Table 8.2: Key Competitive Activities for Clinical Lab Service; Table 8.3: Challenges to the Clinical Lab Testing Industry; Table 8.4: Medicare Billing Guidelines for Multi-channel Clinical Laboratory Tests; Table 8.5: Factors for Estimating Collectibility for Clinical Lab Services; Table 8.6: Classes of Lab Service Payers; Table 8.7: U.S. POCT Market, 2000-2012; Table 8.8: U.S. POCT by Performance Location, 2008; Table 8.9: Billing Difficulties Required of Clinical Labs to Bill Third Party Payers

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