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Clinical Chemistry Analyzers


Description: 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.


Contents: 1. Overview
1.1 Objectives of the Report
1.2 Methodology
1.3 Scope of the Report
1.4 Executive Summary

2. IVD Clinical Chemistry Market
2.1 Introduction

3. IVD Clinical Chemistry Market
3.1 Markets
3.1.1 Global Markets
3.1.2 Global Drivers of Clinical Chemistry Testing
3.1.3 Global Outlook
3.1.4 U.S. Market
3.1.5 European Market
3.1.5.1 German Clinical Chemistry Diagnostic Markets
3.1.5.2 U.K. Clinical Chemistry Testing Diagnostic Market
3.1.5.2.1 U.K. Market Statistics
3.1.5.2.2 U.K. Competitive Analysis
3.1.5.2.3 U.K. Market Access
3.1.5.3 French Clinical Chemistry Diagnostic Market
3.1.5.4 Italian Clinical Chemistry Diagnostic Market
3.1.5.5 Spanish Clinical Chemistry Diagnostic Market
3.1.5.6 Scandinavian Clinical Chemistry Market
3.1.5.7 Country Clinical Chemistry Smaller Markets
3.1.5.7.1 Canadian Clinical Chemistry Market
3.1.5.7.2 Brazilian Clinical Chemistry Market
3.1.5.7.3 Turkish Clinical Chemistry Market
3.1.5.7.4 Australian Clinical Chemistry Market
3.1.5.7.5 Mexican IVD Market
3.1.5.8 Remaining World Clinical Chemistry Testing Market
3.1.5.9 Overview of Asian Healthcare Market
3.1.5.10 Japanese Clinical Chemistry Testing Market
3.1.5.11 Chinese Clinical Analyzer Market
3.1.5.12 Indian Clinical Chemistry Diagnostic Market
3.1.5.12.1 India's In Vitro Diagnostic Testing Industry
3.1.5.13 Overview of the Latin American Diagnostics Market
3.2 Clinical Chemistry Sector
3.2.1 Industry-served Markets
3.2.2 Industry Players
3.2.2.1 Manufacturing Companies
3.2.3 Market Specialization
3.2.4 Revenue and Reimbursement
3.2.5 Companies
3.3 Outlook for Clinical Chemistry Testing
3.3.1 Long-term Changes
3.3.2 Market Drivers
3.3.3 The Limits to Growth
3.3.4 Hot Sectors in the IVD Market
3.3.5 Key Technologies
3.3.6 Conclusion

4. Clinical Chemistry Instrument Market by Sector: Size, Growth, Share and Competitors
4.1 Ultra-Large Throughput Chemistry Analyzers
4.2 Large-Throughput Analyzers
4.3 Mid-Size Clinical Chemistry Analyzers
4.4 Chemistry Analyzers for the Small-Volume Market
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
5.10.1 Wireless LANs
5.10.2 Data and Workflow Management Systems
5.10.3 Beckman Command Central Version 2.0
5.11 Connectivity Platforms
5.11.1 Laboratory Data Linking Software and Interface to the Laboratory Information System
5.11.2 AbbottLink Analyzer Connections
5.11.3 Beckman Coulter DL2000 Data Manager v6.5
5.11.4 bioMerieux, Inc. ENQ
5.11.5 Siemens Easy Link Data Management System

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
6.8.1 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
6.8.6 Regulatory Trends for IVD Devices
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
8.14.1 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: 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 1
Table 8.1: Medicare Billing Guidelines for Multi-channel Chemistry Tests


Companies Mentioned - Abaxis, Inc. - Abbott Diagnostics - Adaltis - Alfa Wasserman, Inc. (f/k/a Electro-Nucleonics, Inc. and Schiapparelli Biosystems, Inc.) - Awareness Technology, Inc. - Siemens - Beckman Coulter, Inc. - Dade Behring, Inc. - Hitachi Ltd. - Horiba Ltd. - JEOL Ltd. - Nova Biomedical Corporation - Ortho-Clinical Diagnostics, Inc. - Roche - Shimadzu Corporation - Sysmex Corporation - Thermo Fisher Scientific, Inc. - Vital Scientific B.V. - Tosoh Corporation


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