Clinical Immunoanalyzer Markets
Clinical immunoanalyzer analysis is one of the most important functions of clinical laboratory analysis. By all accounts, automated immunoassay testing is the most rapidly developing of the traditional clinical laboratory sectors. Clinical immunoanalyzer analysis usually refers to determining the concentration or activity of protein, carbohydrate, lipid, enzyme or small molecule in easily collected body fluids, such as blood, serum, plasma or urine. However, it is not necessarily limited to these purposes. The analysis of virtually any biologically active substance in any place in the body can generally be defined as clinical immunoassay testing. In fact, traditional specialization barriers, such as microbiology, hematology, blood banking, immunology and even anatomical pathology are fading rapidly, both operationally and instrumentally. This TriMark Publications report deals with the traditional scope of clinical immunoassay, while looking at the emerging technology trends in this sector. The purpose of this study is to describe the specific segments of the global clinical immunoanalyzer instrumentation market. Within this area, the highly-active segments in terms of innovation and growth are covered. Specifically, it examines the markets for small labs and highly-automated large lab platforms, as well as the market for accessory equipment, such as reagents and supplies. Emphasis is on those companies and products that are actively developing and marketing immunoanalyzer products for clinical setting, including hospitals, independent labs, physician’s offices and clinics.
# 1. Overview 5
# 1.1 Objectives 5
# 1.2 Methodology 5
# 1.3 Scope 6
# 1.4 Executive Summary 7
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# 2. IVD Clinical Immunoanalyzer Market 8
# 2.1 Introduction 8
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# 3. IVD Clinical Immunoanalyzer Market Analysis 10
# 3.1 Markets 10
# 3.1.1 Global Markets 10
# 3.1.2 Global Drivers of Clinical Immunoanalyzer Testing 12
# 3.1.3 Global Outlook 13
# 3.1.4 U.S. Market 13
# 3.1.5 European Market 15
# 3.1.6 German Clinical Immunoanalyzer Diagnostic Markets 16
# 3.1.7 U.K. Clinical Immunoanalyzer Testing Diagnostic Market 19
# 3.1.7.1 U.K. Market Statistics 19
# 3.1.7.2 U.K. Competitive Analysis 20
# 3.1.7.3 U.K. Market Access 21
# 3.1.8 French Clinical Diagnostic Market 21
# 3.1.9 Italian Clinical Analyzer Diagnostic Market 22
# 3.1.10 Spanish Clinical Analyzer Diagnostic Market 22
# 3.1.11 Indian Clinical Analyzer Diagnostic Market 23
# 3.1.11.1 India's in vitro Diagnostic Testing Industry 23
# 3.1.12 Scandinavian Clinical Immunoanalyzer Market 25
# 3.1.13 Japanese Clinical Immunoanalyzer Testing Market 26
# 3.1.14 Country Clinical Analyzer Smaller Markets 26
# 3.1.14.1 Chinese Clinical Analyzer Market 26
# 3.1.14.2 Canada Clinical Analyzer Market 30
# 3.1.14.3 Brazil Clinical Analyzer Market 30
# 3.1.14.4 Turkey Clinical Immunoanalyzer Market 30
# 3.1.14.5 Australia Clinical Analyzer Market 31
# 3.1.14.6 Rest of the World Clinical Analyzer Testing Market 31
# 3.1.15 Overview of Asian Healthcare Market 32
# 3.1.15.1 Singapore 32
# 3.1.15.2 Malaysia 32
# 3.1.15.3 Thailand 33
# 3.1.15.4 Indonesia 33
# 3.1.15.5 Philippines 33
# 3.1.15.6 South Korea 34
# 3.1.15.7 India 34
# 3.1.15.8 Hong Kong 34
# 3.1.15.9 Taiwan 35
# 3.1.16 Latin American Diagnostic Market 35
# 3.2 Clinical Immunoanalyzer Sector 36
# 3.2.1 Industry-Served Markets 37
# 3.2.2 Industry Players 38
# 3.2.2.1 Manufacturing Companies 38
# 3.2.3 Market Specialization 39
# 3.2.4 Revenue and Reimbursement 41
# 3.2.5 Companies 41
# 3.3 Outlook for Clinical Immunoanalyzer Testing 43
# 3.3.1 Long-Term Changes 43
# 3.3.2 Market Drivers 44
# 3.3.3 Limits to Growth 44
# 3.3.4 Hot Sectors in IVD Market 45
# 3.3.5 Key Technologies 46
# 3.3.6 Analyzer Integration Chemistry/Immunoassay 46
# 3.3.7 Conclusion 47
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# 4. Clinical Immunoanalyzer Instrument Market by Sector 48
# 4.1 Market Analysis: Size, Growth, Share and Competitors 48
# 4.1.1 Immunochemistry Analyzers 48
# 4.1.2 Large-Volume Immunochemistry Analyzers 48
# 4.1.2.1 Abbott Diagnostics 48
# 4.1.2.2 Bayer Diagnostics 49
# 4.1.2.3 Beckman Coulter 52
# 4.1.2.4 Dade Behring 53
# 4.1.2.5 Diagnostics Products Corporation 54
# 4.1.2.6 Olympus 55
# 4.1.2.7 Ortho-Clinical Diagnostics 55
# 4.1.2.8 Roche Diagnostics 58
# 4.1.2.9 Tosoh Bioscience 59
# 4.1.3 Batch-Type Immunoassay Analyzers 61
# 4.1.4 Small-Volume to Mid-Volume Immunoassay Analyzers 64
# 4.1.4.1 Awareness Technology 64
# 4.1.4.2 Bayer Diagnostics 64
# 4.1.4.3 Beckman Coulter 64
# 4.1.4.4 bioMérieux 65
# 4.1.4.5 Dade Behring 66
# 4.1.4.6 Nichols Institute 70
# 4.1.4.7 Tosoh 70
# 4.1.5 Other Immunoassay Analyzers 71
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# 5. Important Technology Trends 74
# 5.1 Technology Innovations in Immunoassay Testing 74
# 5.2 Sensor Systems for Diagnostic Applications 74
# 5.3 The New Paradigm 76
# 5.4 Consolidated Workstations 77
# 5.5 Automation in the Laboratory 78
# 5.6 Laboratory Information System (LIS) 79
# 5.7 Biosensor Technology 79
# 5.8 Data Management Issues 81
# 5.8.1 Wireless LANs 81
# 5.8.2 Data and Workflow Management Systems 83
# 5.8.3 Beckman Central Command 83
# 5.8.4 Advances in Information Management 85
# 5.8.5 Connectivity Platforms 88
# 5.8.6 DataLink Data Management System 88
# 5.8.7 LabPortal.com 90
# 5.8.8 LifeScan Electronic Data Interfaces 90
# 5.8.9 Technical Problems of Connectivity 91
# 5.8.10 Web-Based Data Interface 92
# 5.8.11 HIT Competition 92
# 5.8.12 FDA-Required Software Verification 92
# 5.8.13 Advantages of Connectivity 93
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# 6. Business Trends in Clinical Immunoanalyzer Sector 94
# 6.1 Key Developments 94
# 6.2 Sector Consolidation 94
# 6.3 Diagnostic Testing Growth Trends 95
# 6.4 Reagents and Hardware Business in Japan 96
# 6.5 New Products 96
# 6.6 Acquisitions, License Agreements, Internal Developments and Partnerships 96
# 6.7 Product Testing Depth in Clinical Immunoanalyzer Testing 97
# 6.8 Market Share 97
# 6.8.1 U.S. Government Regulations 97
# 6.8.1.1 Importing Medical Devices into the U.S. 98
# 6.8.1.2 Exporting Medical Devices from the U.S. 99
# 6.8.2 U.K. Regulations 99
# 6.8.3 E.U. Regulations 101
# 6.8.4 Japanese Regulations 102
# 6.8.5 Korean Regulations 103
# 6.9 Increased Market Penetration 103
# 6.10 Costs of Doing Business in Europe 105
# 6.11 Drivers of European Diagnostics Testing 105
# 6.12 European Reimbursement Practices 105
# 6.13 Cost Containment in Europe 105
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# 7. Company Profiles 106
# 7.1 Abbott Diagnostics 106
# 7.2 Bayer Healthcare 107
# 7.3 Beckman Coulter 109
# 7.4 bioMérieux 113
# 7.5 Dade Behring 113
# 7.6 Nichols Institute 115
# 7.7 Olympus 116
# 7.8 Ortho-Clinical Diagnostics 116
# 7.9 Phadia 117
# 7.10 Randox Laboratories 117
# 7.11 Roche Diagnostics 118
# 7.12 Tosoh 119
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# 8. Clinical Immunoanalyzer Testing Sector: Trends and Forecasts 120
# 8.1 Utility of Near-Patient Testing in Critical-Care Settings 120
# 8.2 Mergers of Diagnostic Companies 120
# 8.3 Information Management Advances 120
# 8.4 Test Ordering Patterns 120
# 8.5 Patient Satisfaction 120
# 8.6 Move away from Central Laboratory 120
# 8.7 Healthcare Cost Controls 120
# 8.8 Competition for Services 120
# 8.9 Drivers of Clinical Immunoanalyzer Testing 121
# 8.10 Confluence of New Technology 121
# 8.11 New Trends in Clinical Laboratory Testing 121
# 8.11.1 Trends in Reimbursement Practices 121
# 8.11.2 Managed Care 124
# 8.11.3 Changes in Patient Management 124
# 8.11.4 Focused Testing 124
# 8.11.5 Satellite Facilities 124
# 8.11.6 Point-of-Care Testing 125
# 8.11.7 Regionalization of Laboratory Care 125
