Clinical Immunoanalyzer Markets
TriMark Publications, October 2010, Pages: 165
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.
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
3.1.1 Global Markets
3.1.2 Global Drivers of Clinical Immunoanalyzer Testing
3.1.3 Global Outlook
3.1.4 U.S. Market
3.1.5 European IVD Market
3.1.5.1 German Clinical Immunoanalyzer Diagnostic Market
3.1.5.2 U.K. Clinical Immunoanalyzer Testing Diagnostic Market
3.1.5.3 French Clinical Laboratory Diagnostic Testing Market
3.1.5.4 Italian Clinical Immunochemistry Diagnostic Market
3.1.5.5 Spanish Immunoanalyzer Market
3.1.5.6 Finnish Immunoanalyzer Market
3.1.5.7 Belgian Immunoanalyzer Market
3.1.5.8 Swiss Immunoanalyzer Market
3.1.5.9 Dutch Immunoanalyzer Market
3.1.5.10 Portuguese Immunoanalyzer Market
3.1.5.11 Austrian Immunoanalyzer Market
3.1.5.12 Greek Immunoanalyzer Market
3.1.5.13 Polish Immunoanalyzer Market
3.1.5.14 Romanian Immunoanalyzer Market
3.1.6 Country Clinical Analyzer Smaller Markets
3.1.6.1 Canadian Clinical Analyzer Market
3.1.6.2 Brazilian Clinical Analyzer Market
3.1.6.3 Turkish Clinical Immunoanalyzer Market
3.1.6.4 Australian Clinical Analyzer Market
3.1.6.5 Rest of the World Clinical Analyzer Testing Market
3.1.7 Overview of Asian Healthcare Market
3.1.7.1 Japanese Clinical Immunoanalyzer Testing Market
3.1.7.2 Chinese Clinical Analyzer Market
3.1.7.3 Indian Clinical Chemistry Diagnostic Market
3.1.7.3.1 India's In Vitro Diagnostic Testing Industry
3.1.8 Overview of the Latin American Diagnostics Market
3.2 Clinical Immunoanalyzer Sector
3.2.1 Industry-served Markets
3.2.2 Industry Players
3.2.2.1 Manufacturing Companies
3.2.3 Market Specialization
3.2.4 Revenue and Reimbursement
3.2.5 Companies
3.3 Outlook for Clinical Immunoanalyzer Testing
3.3.1 Long-term Changes
3.3.2 Market Drivers
3.3.3 The Limits to Growth
3.3.4 Hot Sectors in IVD Market
3.3.5 Key Technologies
3.3.6 Analyzer Integration Chemistry/Immunoassay
3.3.7 Conclusion
4. Clinical Immunoanalyzer Instrument Market by Sector
4.1 Market Analysis: Size, Growth, Share and Competitors
4.1.1 Immunochemistry Analyzers
4.1.2 Large- and Mid-Volume Immunochemistry Analyzers
4.1.2.1 Abbott Diagnostics
4.1.2.2 Siemens Medical Solutions Diagnostics
4.1.2.3 Beckman Coulter, Inc.
4.1.2.4 Dade Behring (Acquired by Siemens)
4.1.2.5 Diagnostics Products Corporation (Acquired by Siemens Healthcare Diagnostics)
4.1.2.6 Olympus America, Inc. (now Beckman Coulter)
4.1.2.7 Ortho-Clinical Diagnostics
4.1.2.8 Roche Diagnostics Corp.
4.1.2.9 Tosoh Bioscience, Inc.
4.1.3 Batch-type Immunoassay Analyzers
4.1.3.1 Bio-Rad
4.1.3.2 Diamedix
4.1.3.3 Tosoh
4.1.4 Small- to Mid-Volume Immunoassay Analyzers
4.1.4.1 Awareness Technology, Inc.
4.1.4.2 Siemens Healthcare Diagnostics, Inc.
4.1.4.3 Beckman Coulter, Inc.
4.1.4.4 bioMerieux SA
4.1.4.5 Dade Behring (Acquired by Siemens)
4.1.4.6 Randox Laboratories Ltd.
4.1.4.7 Tosoh Corporation
4.1.5 Other Immunoassay Analyzers
4.1.5.1 Inverness Medical Professional Diagnostics
4.1.5.2 Hycor BioMedical (A Part of Agilent Technologies)
4.1.5.3 Phadia AB
4.1.5.4 Trinity Biotech Plc
4.1.5.5 DiaSorin
4.1.5.6 Grifols U.S.A., Inc.
4.1.5.7 Bio-Rad Laboratories, Inc.
4.1.5.8 SFRI Diagnostics
4.1.5.9 Qualigen, Inc.
4.1.5.10 PerkinElmer, Inc.
4.1.5.11 Innotrac Diagnostics Oy
4.1.5.12 Tecan Group Ltd.
5. Important Technology Trends
5.1 Technology Innovations in Immunoassay Testing
5.2 Immunoassay Detection Technology Platforms
5.2.1 Fluorescence Detection
5.2.2 Chemiluminescence Detection
5.3 The New Paradigm
5.4 Consolidated Workstations
5.5 Automation in the Laboratory in Response to Labor Shortages
5.6 Laboratory Information System (LIS)
5.7 Biosensor Technology
5.8 Data Management Issues
5.8.1 Wireless LANs
5.8.2 Data and Workflow Management Systems
5.8.3 Beckman Central Command
5.8.4 Advances in Information Management
5.8.5 Connectivity Platforms
5.8.5.1 Laboratory Data Linking Software and Interface to the Laboratory Information System
5.8.5.2 Abbott Link Analyzer Connections
5.8.5.3 Beckman Coulter DL2000 Data Manager v6.5
5.8.5.4 bioMerieux, Inc. ENQ
5.8.5.5 Ortho-Clinical Diagnostics, Inc. e-Connectivity Interactive System Management
5.8.6 DataLink Data Management System
5.8.7 LifeScan Electronic Data Interfaces
5.8.8 Technical Problems of Connectivity
5.8.9 Web-based Data Interface and Internet Connectivity
5.8.10 HIT Competition
5.8.11 FDA-required Software Verification
5.8.12 Advantages of Connectivity
5.8.13 Technologies for Internet-based Remote Architecture
5.8.14 Abbott Multi-tiered Internet System
6. Business Trends in Clinical Immunoanalyzer Sector
6.1 Key Developments
6.2 Sector Consolidation
6.3 Diagnostic Testing Growth Trends
6.4 Reagents and Hardware Business in Japan
6.5 New Products
6.6 Acquisitions, License Agreements, Internal Developments and Partnerships
6.7 Product Testing Depth in Clinical Immunoanalyzer Testing
6.8 Government Regulations
6.8.1 U.S. Government Regulations
6.8.1.1 Importing Medical Devices into the U.S.
6.8.1.2 Exporting Medical Devices from the U.S.
6.8.2 U.K. Regulations
6.8.3 E.U. Regulations
6.8.4 Japanese Regulations
6.8.5 Korean Regulations
6.9 Increased Market Penetration
6.10 Costs of Doing Business in Europe
6.11 Drivers of European Diagnostics Testing
6.12 European Reimbursement Practices
6.13 Cost Containment in Europe
6.14 Medicare Spending Trends/Medicare Part B Spending Trends
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. 1
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
8.8.1 The User Interface
8.8.2 Display and Data Entry
8.8.3 Loading and Unloading
8.8.4 Sample Input and Handling
8.8.5 Fluidics
8.8.6 Processing
8.8.6.1 Agitation and Mixing
8.8.6.2 Temperature Control and Incubation
8.8.6.3 Separation
8.8.7 Control and Communications
8.8.7.1 Instrument Control
8.8.7.2 Scheduling
8.8.7.3 Communications and Data Management
8.9 Drivers of Clinical Immunoanalyzer Testing
8.10 Confluence of New Technology
8.11 New Trends in Clinical Laboratory Testing
8.11.1 Trends in Reimbursement Practices
8.11.2 Managed Care
8.11.3 Changes in Patient Management
8.11.4 Focused Testing
8.11.5 Spending for Clinical Laboratory Testing
8.11.6 Reimbursement Pressure
8.11.7 Multiplexing Technology
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
- Abbott Diagnostics
- Beckman Coulter, Inc.
- bioMerieux
- Dade Behring (Acquired by Siemens)
- Bio-Rad Laboratories, Inc. 1
- Olympus America, Inc.
- Ortho-Clinical Diagnostics, Inc.
- Phadia AB
- Randox Laboratories Ltd.
- Roche
- Tosoh Corporation
- Siemens AG
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