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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.

This 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. Readers can gain the following insights from this report:

• Complete analysis of the major sectors of the clinical immunoanalyzer instrumentation market, their size, growth rates and major drivers.
• Presentation of some of the emerging technology platforms, elucidating the potential areas that could gain traction in this market.
• Analysis of the partnerships and alliances that various key sector players have forged, including the financing linkages of these market participants, apart from insights into potential market collaborations.
• Examination of new technology platforms in the U.S., Japan and Europe that seek to dominate this mature market.

Table of Contents

1. Overview 7

• 1.1 Objectives 7
• 1.2 Methodology 8
• 1.3 Scope of the Report 9
• 1.4 Executive Summary 10

2. IVD Clinical Immunoanalyzer Market 12

• 2.1 Introduction 12

3. IVD Clinical Immunoanalyzer Market Analysis 15

• 3.1 Markets 15
  • 3.1.1 Global Markets 15
  • 3.1.2 Global Drivers of Clinical Immunoanalyzer Testing 16
  • 3.1.3 Global Outlook 17
  • 3.1.4 U.S. Market 18
  • 3.1.5 European IVD Market 20
    • 3.1.5.1 German Clinical Immunoanalyzer Diagnostic Market 22
    • 3.1.5.2 U.K. Clinical Immunoanalyzer Testing Diagnostic Market 24
    • 3.1.5.3 French Clinical Laboratory Diagnostic Testing Market 25
    • 3.1.5.4 Italian Clinical Immunochemistry Diagnostic Market 25
    • 3.1.5.5 Spanish Immunoanalyzer Market 26
    • 3.1.5.6 Finnish Immunoanalyzer Market 26
    • 3.1.5.7 Belgian Immunoanalyzer Market 27
    • 3.1.5.8 Swiss Immunoanalyzer Market 27
    • 3.1.5.9 Dutch Immunoanalyzer Market 28
    • 3.1.5.10 Portuguese Immunoanalyzer Market 28
    • 3.1.5.11 Austrian Immunoanalyzer Market 29
    • 3.1.5.12 Greek Immunoanalyzer Market 29
    • 3.1.5.13 Polish Immunoanalyzer Market 30
    • 3.1.5.14 Romanian Immunoanalyzer Market 30
  • 3.1.6 Country Clinical Analyzer Smaller Markets 31
    • 3.1.6.1 Canadian Clinical Analyzer Market 31
    • 3.1.6.2 Brazilian Clinical Analyzer Market 31
    • 3.1.6.3 Turkish Clinical Immunoanalyzer Market 32
    • 3.1.6.4 Australian Clinical Analyzer Market 32
    • 3.1.6.5 Rest of the World Clinical Analyzer Testing Market 33
  • 3.1.7 Overview of Asian Healthcare Market 33
    • 3.1.7.1 Japanese Clinical Immunoanalyzer Testing Market 33
    • 3.1.7.2 Chinese Clinical Analyzer Market 34
    • 3.1.7.3 Indian Clinical Chemistry Diagnostic Market 44
      • 3.1.7.3.1 India's In Vitro Diagnostic Testing Industry 44
  • 3.1.8 Overview of the Latin American Diagnostics Market 48
• 3.2 Clinical Immunoanalyzer Sector 48
  • 3.2.1 Industry-served Markets 49
  • 3.2.2 Industry Players 52
    • 3.2.2.1 Manufacturing Companies 52
  • 3.2.3 Market Specialization 53
  • 3.2.4 Revenue and Reimbursement 55
  • 3.2.5 Companies 55
• 3.3 Outlook for Clinical Immunoanalyzer Testing 57
  • 3.3.1 Long-term Changes 57
  • 3.3.2 Market Drivers 58
  • 3.3.3 The Limits to Growth 58
  • 3.3.4 Hot Sectors in IVD Market 59
  • 3.3.5 Key Technologies 59
  • 3.3.6 Analyzer Integration Chemistry/Immunoassay 60
  • 3.3.7 Conclusion 61

4. Clinical Immunoanalyzer Instrument Market by Sector 62

• 4.1 Market Analysis: Size, Growth, Share and Competitors 62
  • 4.1.1 Immunochemistry Analyzers 62
  • 4.1.2 Large- and Mid-Volume Immunochemistry Analyzers 62
    • 4.1.2.1 Abbott Diagnostics 62
    • 4.1.2.2 Siemens Medical Solutions Diagnostics 64
    • 4.1.2.3 Beckman Coulter, Inc. 69
    • 4.1.2.4 Dade Behring (Acquired by Siemens) 71
    • 4.1.2.5 Diagnostics Products Corporation (Acquired by Siemens Healthcare Diagnostics) 71
    • 4.1.2.6 Olympus America, Inc. (now Beckman Coulter) 73
    • 4.1.2.7 Ortho-Clinical Diagnostics 74
    • 4.1.2.8 Roche Diagnostics Corp. 76
    • 4.1.2.9 Tosoh Bioscience, Inc. 78
  • 4.1.3 Batch-type Immunoassay Analyzers 80
    • 4.1.3.1 Bio-Rad 80
    • 4.1.3.2 Diamedix 80
    • 4.1.3.3 Tosoh 83
• 4.1.4 Small- to Mid-Volume Immunoassay Analyzers 83
  • 4.1.4.1 Awareness Technology, Inc. 83
  • 4.1.4.2 Siemens Healthcare Diagnostics, Inc. 83
  • 4.1.4.3 Beckman Coulter, Inc. 84
  • 4.1.4.4 bioMerieux SA 85
  • 4.1.4.5 Dade Behring (Acquired by Siemens) 85
  • 4.1.4.6 Randox Laboratories Ltd. 89
  • 4.1.4.7 Tosoh Corporation 90
• 4.1.5 Other Immunoassay Analyzers 91
  • 4.1.5.1 Inverness Medical Professional Diagnostics 91
  • 4.1.5.2 Hycor BioMedical (A Part of Agilent Technologies) 91
  • 4.1.5.3 Phadia AB 92
  • 4.1.5.4 Trinity Biotech Plc 92
  • 4.1.5.5 DiaSorin 92
  • 4.1.5.6 Grifols U.S.A., Inc. 92
  • 4.1.5.7 Bio-Rad Laboratories, Inc. 93
  • 4.1.5.8 SFRI Diagnostics 93
  • 4.1.5.9 Qualigen, Inc. 93
  • 4.1.5.10 PerkinElmer, Inc. 93
  • 4.1.5.11 Innotrac Diagnostics Oy 94
  • 4.1.5.12 Tecan Group Ltd. 94

5. Important Technology Trends 96

• 5.1 Technology Innovations in Immunoassay Testing 96
• 5.2 Immunoassay Detection Technology Platforms 96
  • 5.2.1 Fluorescence Detection 97
  • 5.2.2 Chemiluminescence Detection 97
• 5.3 The New Paradigm 97
• 5.4 Consolidated Workstations 97
• 5.5 Automation in the Laboratory in Response to Labor Shortages 99
• 5.6 Laboratory Information System (LIS) 100
• 5.7 Biosensor Technology 100
• 5.8 Data Management Issues 102
  • 5.8.1 Wireless LANs 103
  • 5.8.2 Data and Workflow Management Systems 104
  • 5.8.3 Beckman Central Command 104
  • 5.8.4 Advances in Information Management 106
  • 5.8.5 Connectivity Platforms 109
    • 5.8.5.1 Laboratory Data Linking Software and Interface to the Laboratory Information System 111
    • 5.8.5.2 Abbott Link Analyzer Connections 111
    • 5.8.5.3 Beckman Coulter DL2000 Data Manager v6.5 112
    • 5.8.5.4 bioMerieux, Inc. ENQ 112
    • 5.8.5.5 Ortho-Clinical Diagnostics, Inc. e-Connectivity Interactive System Management 113
  • 5.8.6 DataLink Data Management System 113
  • 5.8.7 LifeScan Electronic Data Interfaces 114
  • 5.8.8 Technical Problems of Connectivity 115
  • 5.8.9 Web-based Data Interface and Internet Connectivity 116
  • 5.8.10 HIT Competition 117
  • 5.8.11 FDA-required Software Verification 117
  • 5.8.12 Advantages of Connectivity 118
  • 5.8.13 Technologies for Internet-based Remote Architecture 118
  • 5.8.14 Abbott Multi-tiered Internet System 118

6. Business Trends in Clinical Immunoanalyzer Sector 119

• 6.1 Key Developments 119
• 6.2 Sector Consolidation 119
• 6.3 Diagnostic Testing Growth Trends 120
• 6.4 Reagents and Hardware Business in Japan 120
• 6.5 New Products 120
• 6.6 Acquisitions, License Agreements, Internal Developments and Partnerships 121
• 6.7 Product Testing Depth in Clinical Immunoanalyzer Testing 122
• 6.8 Government Regulations 122
  • 6.8.1 U.S. Government Regulations 122
    • 6.8.1.1 Importing Medical Devices into the U.S. 124
    • 6.8.1.2 Exporting Medical Devices from the U.S. 124
  • 6.8.2 U.K. Regulations 125
  • 6.8.3 E.U. Regulations 126
  • 6.8.4 Japanese Regulations 127
  • 6.8.5 Korean Regulations 128
• 6.9 Increased Market Penetration 128
• 6.10 Costs of Doing Business in Europe 130
• 6.11 Drivers of European Diagnostics Testing 130
• 6.12 European Reimbursement Practices 130
• 6.13 Cost Containment in Europe 130
• 6.14 Medicare Spending Trends/Medicare Part B Spending Trends 131
• 6.15 Connectivity Consortium 133

7. Company Profiles 134

• 7.1 Abbott Diagnostics 134
• 7.2 Beckman Coulter, Inc. 138
• 7.3 bioMerieux 140
• 7.4 Dade Behring (Acquired by Siemens) 140
• 7.5 Bio-Rad Laboratories, Inc. 140
• 7.6 Olympus America, Inc. 141
• 7.7 Ortho-Clinical Diagnostics, Inc. 141
• 7.8 Phadia AB 142
• 7.9 Randox Laboratories Ltd. 142
• 7.10 Roche 143
• 7.11 Tosoh Corporation 144
• 7.12 Siemens AG 145

8. Clinical Immunoanalyzer Testing Sector: Trends and Forecasts 147

• 8.1 Automated Instrument Platforms Evolution 147
• 8.2 Reagents and Supplies Market for Clinical Lab Instruments 147
• 8.3 Bar Code Reading 148
• 8.4 Measurement and Detection for Immunoassay Analyzers 148
• 8.5 Robotics Systems 149
• 8.6 Move Away from Central Laboratory 150
• 8.7 Modular Automation 150
• 8.8 Components of Immunoassay Analyzers 150
  • 8.8.1 The User Interface 151
  • 8.8.2 Display and Data Entry 151
  • 8.8.3 Loading and Unloading 151
  • 8.8.4 Sample Input and Handling 151
  • 8.8.5 Fluidics 152
  • 8.8.6 Processing 153
    • 8.8.6.1 Agitation and Mixing 153
    • 8.8.6.2 Temperature Control and Incubation 153
    • 8.8.6.3 Separation 153
  • 8.8.7 Control and Communications 153
    • 8.8.7.1 Instrument Control 154
    • 8.8.7.2 Scheduling 154
    • 8.8.7.3 Communications and Data Management 154
• 8.9 Drivers of Clinical Immunoanalyzer Testing 155
• 8.10 Confluence of New Technology 155
• 8.11 New Trends in Clinical Laboratory Testing 155
  • 8.11.1 Trends in Reimbursement Practices 155
  • 8.11.2 Managed Care 158
  • 8.11.3 Changes in Patient Management 158
  • 8.11.4 Focused Testing 159
  • 8.11.5 Spending for Clinical Laboratory Testing 159
  • 8.11.6 Reimbursement Pressure 159
  • 8.11.7 Multiplexing Technology 159

9. Product Launches 161

• 9.1 Immunoassay Analyzer Product Launches 161
• 9.2 Immunoassay Reagent Product Launches 162

INDEX OF FIGURES

Figure 3.1: Chinese IVD Market, 2006-2012 37
Figure 3.2: Lab Revenue by Lab Type 50
Figure 3.3: Lab Revenue by Test Type 51
Figure 6.1: Part B Spending on Clinical Laboratory Services, 1991- 2007 131


INDEX OF TABLES

Table 2.1: Common Immunoassay Tests 12
Table 3.1: Worldwide IVD Testing Market, 2009 15
Table 3.2: Worldwide Geographic Distribution of IVD Testing, 2009 15
Table 3.3: Global Clinical Immunoassay Revenues, 2000-2012 16
Table 3.4: Worldwide Distribution of Clinical Immunoassay Testing, 2009 16
Table 3.5: U.S. Clinical Laboratory Testing Market, 2003-2012 19
Table 3.6: U.S. Clinical Laboratory Diagnostic Test Market Retail Value Segments, 2008 19
Table 3.7: U.S. Clinical Immunoanalyzer Testing Market, 2009-2015 19
Table 3.8: European Clinical Laboratory Testing IVD Reagents and Instruments Market, 2000-2012 20
Table 3.9: European Clinical Laboratory Diagnostic Reagents and Instruments Markets by Analyte, 2008 20
Table 3.10: European Clinical Laboratory Testing Diagnostics by Country Market Estimates, 2007 21
Table 3.11: The European Immunochemistry Market, 2001-2012 21
Table 3.12: European Immunochemical Reagents and Instruments Markets by Country, 2006 22
Table 3.13: German Clinical Laboratory Testing Diagnostics Products Market Sales, 2003-2012 23
Table 3.14: German Clinical Immunochemistry Testing Diagnostics Products Market Sales, 2006-2012 23
Table 3.15: U.K. Clinical Immunochemistry Testing Diagnostics Products Market Sales, 2006-2012 24
Table 3.16: French Clinical Immunochemistry Testing Diagnostics Products Market Sales, 2006-2012 25
Table 3.17: Italian Immunochemistry Diagnostics Products Market Sales, 2006-2012 25
Table 3.18: Spanish Clinical Laboratory Diagnostics Products Market Sales, 2006-2012 26
Table 3.19: Finnish Clinical Immunoassay Products Market Sales, 2006-2012 26
Table 3.20: Belgian Clinical Immunoassay Products Market Sales, 2006-2012 27
Table 3.21: Swiss Clinical Immunoassay Products Market Sales, 2006-2012 27
Table 3.22: Dutch Clinical Immunoassay Products Market Sales, 2006-2012 28
Table 3.23: Portuguese Clinical Immunoassay Products Market Sales, 2006-2012 28
Table 3.24: Austrian Clinical Immunoassay Products Market Sales, 2006-2012 29
Table 3.25: Greek Clinical Immunoassay Products Market Sales, 2006-2012 29
Table 3.26: Polish Clinical Immunoassay Products Market Sales, 2006-2012 30
Table 3.27: Romanian Clinical Immunoassay Products Market Sales, 2006-2012 30
Table 3.28: Canadian Clinical Analyzer Testing Market, 2000-2009 31
Table 3.29: Brazilian Clinical Immunoanalyzer Testing Market, 2000-2009 31
Table 3.30: Turkish Clinical Analyzer Testing Market, 2000-2009 32
Table 3.31: Australian Clinical Immunoanalyzer Testing Market, 2000-2009 32
Table 3.32: ROW Clinical Immunoanalyzer Testing Market, 2000-2009 33
Table 3.33: Japanese Clinical Immunoanalyzer Testing Market, 2000-2009 33
Table 3.34: Drivers of Growth in the Chinese Clinical Laboratory Market 34
Table 3.35: Number of Chinese Medical Institutions 35
Table 3.36: Chinese Clinical Diagnostic Products Market, 2000-2008 35
Table 3.37: Chinese Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 36
Table 3.38: Chinese IVD Market, 2008 36
Table 3.39: Market Share of Reagent Imports into the Chinese Clinical Lab Market by Country of Origin 40
Table 3.40: Market Share of Analytical Instrument Imports into the Chinese Clinical Lab Market by Country of Origin 40
Table 3.41: Chinese International IVD Manufacturers 40
Table 3.42: Chinese Domestic IVD Manufacturers 41
Table 3.43: Chinese IVD Distributors 43
Table 3.44: Indian IVD Market, 2006-2012 44
Table 3.45: Number of Automated Clinical Labs in India, 2004-2012 45
Table 3.46: Indian IVD Market, 2009 45
Table 3.47: Indian IVD Market for Instruments and Reagents, 2004-2012 47
Table 3.48: Estimated Number of Clinical Laboratories in Latin America 48
Table 3.49: U.S. Clinical Laboratory Testing Sector Revenue, 2005-2015 50
Table 3.50: U.S. Clinical Laboratory Testing Sector Segments, 2009 50
Table 3.51: Esoteric Tests Performed in the Clinical Laboratory 51
Table 3.52: Growth Rates of Test Types 52
Table 3.53: Drivers of Clinical Lab Testing Volume 52
Table 3.54: Principal Marketers of Automated Clinical Immunoanalyzer Instruments 52
Table 4.1: Samples and Sample Handling Features of Centaur CP 65
Table 4.2: Large- and Mid-Size Immunochemistry Analyzers 79
Table 4.3: Small- to Mid-Volume Immunoassay Analyzers 95
Table 5.1: Analytical Detection Levels for Drugs of Abuse 96
Table 5.2: Wireless LAN Technology Companies 103
Table 5.3: Applications for Wireless LAN Technology 104
Table 5.4: Key Benefits of Laboratory Connectivity Platforms 110
Table 5.5: Connectivity Interface Platforms for Clinical Chemistry Analyzers 110
Table 5.6: CAP and JCAHO Requirements for Customized Reporting 114
Table 6.1: Hospital Laboratory Share of Part B Medicare Spending, 1996-2006 132
Table 6.2: Medicare Part B Spending Per Medicare Enrollee, 1998-2009 132
Table 6.3: Allowed Charges for Top 25 Clinical Laboratory Procedures, 2009 133
Table 8.1: Technology Platforms for Analyzer Detection Systems 148
Table 8.2: Key Criteria for Assessing Data Management Capabilities of Automated Instruments for Immunochemistry Testing 155
Table 8.3: Medicare Billing Guidelines for Multi-Channel Immunoanalyzer Tests 156

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