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 6
1.1 Objectives 6
1.2 Methodology 6
1.3 TriMark Publications Report Research and Data Acquisition Structure 8
1.4 Scope of the Report 8
1.5 Executive Summary 9
2. IVD Clinical Immunoanalyzer Market 11
2.1 Introduction 11
3. IVD Clinical Immunoanalyzer Market Analysis 13
3.1 Markets 13
3.1.1 Global Markets 13
3.1.2 Global Drivers of Clinical Immunoanalyzer Testing 14
3.1.3 Global Outlook 15
3.1.4 U.S. Market 16
3.1.5 European IVD Market 18
3.1.5.1 German Clinical Immunoanalyzer Diagnostic Markets 21
3.1.5.2 U.K. Clinical Immunoanalyzer Testing Diagnostic Market 23
3.1.5.3 French Clinical Laboratory Diagnostic Testing Market 23
3.1.5.4 Italian Clinical Immunochemistry Diagnostic Market 24
3.1.5.5 Spanish Immunoanalyzer Market 25
3.1.5.6 Finnish Immunoanalyzer Market 25
3.1.5.7 Belgian Immunoanalyzer Market 26
3.1.5.8 Swiss Immunoanalyzer Market 26
3.1.5.9 Dutch Immunoanalyzer Market 26
3.1.5.10 Portuguese Immunoanalyzer Market 27
3.1.5.11 Austrian Immunoanalyzer Market 27
3.1.5.12 Greek Immunoanalyzer Market 28
3.1.5.13 Polish Immunoanalyzer Market 28
3.1.5.14 Romanian Immunoanalyzer Market 29
3.1.6 Indian Clinical Analyzer Diagnostic Market 29
3.1.6.1 India’s in vitro Diagnostic Testing Industry 29
3.1.7 Japanese Clinical Immunoanalyzer Testing Market 34
3.1.8 Country Clinical Analyzer Smaller Markets 34
3.1.8.1 China Clinical Analyzer Market 34
3.1.8.2 Canada Clinical Analyzer Market 38
3.1.8.3 Brazil Clinical Analyzer Market 39
3.1.8.4 Turkey Clinical Immunoanalyzer Market 39
3.1.8.5 Australia Clinical Analyzer Market 40
3.1.8.6 Rest of the World Clinical Analyzer Testing Market 40
3.1.9 Overview of Asian Healthcare Market 40
3.1.9.1 Singapore 41
3.1.9.2 Malaysia 41
3.1.9.3 Thailand 41
3.1.9.4 Indonesia 41
3.1.9.5 Philippines 42
3.1.9.6 South Korea 42
3.1.9.7 India 42
3.1.9.8 Hong Kong 43
3.1.9.9 Taiwan 43
3.2 Clinical Immunoanalyzer Sector 44
3.2.1 Industry-Served Markets 45
3.2.2 Industry Players 45
3.2.2.1 Manufacturing Companies 45
3.2.3 Market Specialization 46
3.2.4 Revenue and Reimbursement 48
3.2.5 Companies 49
3.3 Outlook for Clinical Immunoanalyzer Testing 50
3.3.1 Long-Term Changes 50
3.3.2 Market Drivers 51
3.3.3 The Limits to Growth 51
3.3.4 Hot Sectors in IVD Market 52
3.3.5 Key Technologies 53
3.3.6 Analyzer Integration Chemistry/Immunoassay 53
3.3.7 Conclusion 54
4. Clinical Immunoanalyzer Instrument Market by Sector 55
4.1 Market Analysis: Size, Growth, Share and Competitors 55
4.1.1 Immunochemistry Analyzers 55
4.1.2 Large-Volume Immunochemistry Analyzers 55
4.1.2.1 Abbott Diagnostics 55
4.1.2.2 Siemens Medical Solutions Diagnostics 56
4.1.2.3 Beckman Coulter, Inc. 59
4.1.2.4 Dade Behring (Acquired by Siemens) 60
4.1.2.5 Diagnostics Products Corporation (Acquired by Siemens Healthcare Diagnostics) 61
4.1.2.6 Olympus America, Inc. 62
4.1.2.7 Ortho-Clinical Diagnostics 63
4.1.2.8 Roche Diagnostics Corp. 65
4.1.2.9 Tosoh Bioscience 67
4.1.3 Batch-Type Immunoassay Analyzers 69
4.1.3.1 Bio-Rad 69
4.1.3.2 Dade Behring (Acquired by Siemens) 69
4.1.3.3 Diamedix 69
4.1.3.4 Tosoh 72
4.1.4 Small-Volume to Mid-Volume Immunoassay Analyzers 72
4.1.4.1 Awareness Technology, Inc. 72
4.1.4.2 Siemens Healthcare Diagnostics, Inc. 72
4.1.4.3 Beckman Coulter, Inc. 73
4.1.4.4 bioMérieux SA 74
4.1.4.5 Dade Behring (Acquired by Siemens) 74
4.1.4.6 Randox Laboratories Ltd. 78
4.1.4.7 Tosoh Corporation 79
4.1.5 Other Immunoassay Analyzers 80
4.1.5.1 Inverness Medical Professional Diagnostics 80
4.1.5.2 Hycor BioMedical (A Part of Agilent Technologies) 80
4.1.5.3 Phadia AB 80
4.1.5.4 Trinity Biotech PLC. 81
4.1.5.5 Diasorin 81
4.1.5.6 Grifols U.S.A. Inc. 81
4.1.5.7 Bio-Rad Laboratories, Inc. 82
4.1.5.8 SFRI Diagnostics 82
4.1.5.9 Qualigen Inc. 82
4.1.5.10 PerkinElmer Inc. 82
4.1.5.11 Innotrac Diagnostics Oy 83
4.1.5.12 Tecan Group Ltd. 83
5. Important Technology Trends 85
5.1 Technology Innovations in Immunoassay Testing 85
5.2 Immunoassay Detection Technology Platforms 85
5.2.1 Fluorescence Detection 85
5.2.2 Chemiluminescence Detection 85
5.3 The New Paradigm 86
5.4 Consolidated Workstations 86
5.5 Automation in the Laboratory in Response to Labor Shortages 88
5.6 Laboratory Information System (LIS) 89
5.7 Biosensor Technology 89
5.8 Data Management Issues 91
5.8.1 Wireless LANs 92
5.8.2 Data and Workflow Management Systems 93
5.8.3 Beckman Central Command 93
5.8.4 Advances in Information Management 95
5.8.5 Connectivity Platforms 98
5.8.6 DataLink Data Management System 100
5.8.8 Technical Problems of Connectivity 102
5.8.9 Web-Based Data Interface and Internet Connectivity 103
5.8.10 HIT Competition 104
5.8.11 FDA-Required Software Verification 104
5.8.12 Advantages of Connectivity 105
5.8.13 Technologies for Internet-based Remote Architecture 105
5.8.14 Abbott Multi Tiered Internet System 105
6. Business Trends in Clinical Immunoanalyzer Sector 106
6.1 Key Developments 106
6.2 Sector Consolidation 106
6.3 Diagnostic Testing Growth Trends 107
6.4 Reagents and Hardware Business in Japan 107
6.5 New Products 108
6.6 Acquisitions, License Agreements, Internal Developments and Partnerships 108
6.7 Product Testing Depth in Clinical Immunoanalyzer Testing 109
6.8 Government Regulations 109
6.8.1 U.S. Government Regulations 109
6.8.1.1 Importing Medical Devices into the U.S. 111
6.8.1.2 Exporting Medical Devices from the U.S. 111
6.8.2 U.K. Regulations 112
6.8.3 E.U. Regulations 113
6.8.4 Japanese Regulations 115
6.8.5 Korean Regulations 115
6.9 Increased Market Penetration 115
6.10 Costs of Doing Business in Europe 117
6.11 Drivers of European Diagnostics Testing 117
6.12 European Reimbursement Practices 117
6.13 Cost Containment in Europe 118
6.14 Medicare Spending Trends/Medicare Part B Spending Trends 118
7. Company Profiles 121
7.1 Abbott Diagnostics 121
7.3 Beckman Coulter, Inc. 125
7.4 bioMérieux 127
7.5 Dade Behring (Acquired by Siemens) 128
7.6 Bio-Rad Laboratories, Inc. 130
7.7 Olympus America, Inc. 130
7.8 Ortho-Clinical Diagnostics, Inc. 131
7.9 Phadia AB 132
7.10 Randox Laboratories Ltd. 133
7.11 Roche Diagnostics Corp. 133
7.12 Tosoh Corporation 135
7.13 Siemens AG 136
8. Clinical Immunoanalyzer Testing Sector: Trends and Forecasts 137
8.1 Automated Instrument Platforms Evolution 137
8.2 Reagents and Supplies Market for Clinical Lab Instruments 137
8.3 Bar Code Reading 138
8.4 Measurement and Detection for Immunoassay Analyzers 138
8.5 Robotics Systems 139
8.6 Move Away from Central Laboratory 140
8.7 Modular Automation 140
8.8 Components of Immunoassay Analyzers 140
8.9 Drivers of Clinical Immunoanalyzer Testing 144
8.10 Confluence of New Technology 144
8.11 New Trends in Clinical Laboratory Testing 145
8.11.1 Trends in Reimbursement Practices 145
8.11.2 Managed Care 148
8.11.3 Changes in Patient Management 148
8.11.4 Focused Testing 148
8.11.5 Spending for Clinical Laboratory Testing 148
8.11.6 Reimbursement Pressure 149
9. Product Launches 151
9.1 Immunoassay Analyzer Product Launches 151
9.2 Immunoassay Reagent Product Launches 152
INDEX OF TABLES
Table 2.1: Common Immunoassay Tests 11
Table 3.1: Worldwide IVD Testing Market, 2008 13
Table 3.2: Worldwide Distribution of IVD Testing, 2008 13
Table 3.3: Global Clinical Immunoassay Revenues, 2000-2012 14
Table 3.4: Worldwide Distribution of Clinical Immunoassay Testing, 2006 14
Table 3.5: U.S. Clinical Laboratory Testing Market, 2003-2012 17
Table 3.6: U.S. Clinical Laboratory Diagnostic Test Market Segments, 2008 17
Table 3.7: U.S. Individual Clinical Chemistry Laboratory Diagnostic Test Markets, 2007 17
Table 3.8: U.S. Clinical Immunoanalyzer Testing Market, 2000-2012 18
Table 3.9: European Clinical Laboratory Testing IVD Reagents and Instruments Market, 2000-2012 18
Table 3.10: European Clinical Laboratory Testing IVD Reagents and Instruments Market, 2000-2012 19
Table 3.11: European Clinical Laboratory Diagnostic Reagents and Instruments Markets by Analyte, 2008 19
Table 3.12: European Clinical Laboratory Testing Diagnostics by Country Market Estimates, 2007 20
Table 3.13: The European Immunochemistry Market, 2001-2012 20
Table 3.14: European Immunochemical Reagents and Instruments Markets by Country, 2006 21
Table 3.15: German Clinical Laboratory Testing Diagnostics Products Market Sales, 2003-2012 22
Table 3.16: German Clinical Immunochemistry Testing Diagnostics Products Market Sales, 2006-2012 22
Table 3.17: UK Clinical Immunochemistry Testing Diagnostics Products Market Sales, 2006-2012 23
Table 3.18: French Clinical Immunochemistry Testing Diagnostics Products Market Sales, 2006-2012 24
Table 3.19: Italian Immunochemistry Diagnostics Products Market Sales, 2006-2012 24
Table 3.20: Spanish Clinical Laboratory Diagnostics Products Market Sales, 2006-2012 25
Table 3.21: Finnish Clinical Immunoassay Products Market Sales, 2006-2012 25
Table 3.22: Belgium Clinical Immunoassay Products Market Sales, 2006-2012 26
Table 3.23: Swiss Clinical Immunoassay Products Market Sales, 2006-2012 26
Table 3.24: Dutch Clinical Immunoassay Products Market Sales, 2006-2012 27
Table 3.25: Portuguese Clinical Immunoassay Products Market Sales, 2006-2012 27
Table 3.26: Austrian Clinical Immunoassay Products Market Sales, 2006-2012 27
Table 3.27: Greek Clinical Immunoassay Products Market Sales, 2006-2012 28
Table 3.28: Polish Clinical Immunoassay Products Market Sales, 2006-2012 28
Table 3.29: Romanian Clinical Immunoassay Products Market Sales, 2006-2012 29
Table 3.30: Indian IVD Market, 2006-2012 29
Table 3.31: Number of Automated Clinical Labs in India, 2004-2012 30
Table 3.32: Indian IVD Market, 2008 30
Table 3.34: Japanese Clinical Immunoanalyzer Testing Market, 2000-2008 34
Table 3.35: Chinese Clinical Diagnostic Products Market, 2000-2008 35
Table 3.36: Canadian Clinical Analyzer Testing Market, 2000-2008 38
Table 3.37: Brazilian Clinical Immunoanalyzer Testing Market, 2000-2008 39
Table 3.38: Turkish Clinical Analyzer Testing Market, 2000-2008 39
Table 3.39: Australian Clinical Immunoanalyzer Testing Market, 2000-2008 40
Table 3.40: ROW Clinical Immunoanalyzer Testing Market, 2000-2008 40
Table 3.41: Estimated Number of Clinical Laboratories in Latin America 43
Table 3.42: Principal Marketers of Automated Clinical Immunoanalyzer Instruments 45
Table 4.1: Samples and Sample Handling Features of Centaur CP 58
Table 4.2: Large Immunochemistry Analyzers 68
Table 4.3: Small- to Mid-Volume Immunoassay Analyzers 83
Table 5.1: Wireless LAN Technology Companies 92
Table 5.2: Applications for Wireless LAN Technology 93
Table 5.3: CAP and JCAHO Requirements for Customized Reporting 101
Table 6.1: Hospital Laboratory Share of Part B Medicare Spending, 1996-2006 119
Table 6.2: Medicare Part B Spending Per Medicare Enrollee, 1998-2009 119
Table 6.3: Allowed Charges for Top 25 Clinical Laboratory Procedures, 2009 120
Table 8.1: Technology Platforms for Analyzer Detection Systems 138
Table 8.2: Medicare Billing Guidelines for Multi-Channel Immunoanalyzer Tests 146
LIST OF FIGURES
Figure 6.1: Part B Spending on Clinical Lab Services, 1991 to 2007 118
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