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Clinical Laboratory Testing Volume 1: Reagents and Instruments

Clinical laboratory analysis for in vitro diagnostic (IVD) testing is one of the most important sectors of medical care. By all accounts, it is very mature, large market employing over 100,000 laboratory workers, and spawning an industry for reagents and instruments comprised of thousands of companies worldwide. The term clinical laboratory analysis usually refers to determining the concentration or activity of a protein, carbohydrate, lipid, electrolyte, enzyme or small molecule in easily collected body fluids such as blood, serum, plasma or urine. However, it is not necessarily limited to these determinations.

The purpose of this report is to describe the specific segments of the global clinical laboratory instrumentation and reagent market. Within this area, the report covers those segments that are highly active in terms of innovation and growth. Specifically, this global clinical laboratory markets report examines the markets for small lab equipment all the way up to highly-automated, large lab platforms, as well as accessory equipment such as reagents, supplies and manufacturers' original equipment manufacturer (OEM) additional equipment. The emphasis in this analysis is on those companies and products that are actively developing and marketing laboratory analyzer products for the clinical setting, including hospitals, independent labs, physician's offices and miscellaneous clinics.

This study concentrates on the clinical laboratory instrumentation industry market segment and the companion reagents sector in the U.S. and around the world. The regional markets and their differences are examined, including Europe, Asia (Japan, China and India) and the rest of the world (ROW). Particular attention is paid to those areas of the clinical laboratory instrumentation and reagents sector that are showing the greatest growth or the most innovation.

Table of Contents

TABLE OF CONTENTS

1. Overview 9

• 1.1 Objectives of the Report 9
• 1.2 Methodology 10
• 1.3 Scope of the Report 11
• 1.4 Executive Summary 12

2. IVD Clinical Laboratory Market 17

• 2.1 Introduction 17
• 2.2 Independent Clinical Labs 19
  • 2.2.1 Key Players for Independent Clinical Labs 20
  • 2.2.2 Quest Diagnostics and LabCorp 20
  • 2.2.3 Competitive Advantages at Quest and LabCorp 23
  • 2.2.4 Revenue Growth of Quest and LabCorp 27
  • 2.2.5 Sector Consolidation 28
  • 2.2.6 Additional Independent Clinical Laboratories 29
• 2.3 Hospital Market 29
  • 2.3.1 Hospital Market Overview 29
  • 2.3.2 Hospital Lab Testing Drivers 30
  • 2.3.3 Evaluation Models of Laboratory Testing 30
  • 2.3.4 GPOs and IDNs 31
  • 2.3.5 Distributors 32
  • 2.3.6 Clinical Lab Testing Suppliers 32
  • 2.3.7 European Hospital Purchasing Practices 33
  • 2.3.8 Changes in Hospital Funding 34
  • 2.3.9 European Group Purchasing 34
• 2.4 POL Market 34
• 2.5 IVD Industry 39
  • 2.5.1 Industry Overview 39
  • 2.5.2 IVD Industry Leading Players Comparison and Review 39
    • 2.5.2.1 Roche Diagnostics 40
    • 2.5.2.2 Abbott Laboratories 42
    • 2.5.2.3 Siemens Healthcare Diagnostics 46
    • 2.5.2.4 Becton, Dickinson & Co. 47
    • 2.5.2.5 Beckman Coulter, Inc. 47
    • 2.5.2.6 Ortho-Clinical Diagnostics 52
    • 2.5.2.7 bioMerieux 53
    • 2.5.2.8 Sysmex 53
    • 2.5.2.9 Bio-Rad Laboratories, Inc. 54
    • 2.5.2.10 ARKAY, Inc. 54
    • 2.5.2.11 Cytyc Corporation (A Hologic Company) 54
    • 2.5.2.12 Gen-Probe, Inc. 55
  • 2.5.3 Biotechnology Reagents and Supplies 55
    • 2.5.3.1 Vendor Quality Assurance 57
    • 2.5.3.2 Partnership Support 58
    • 2.5.3.3 Protecting Supply of Raw Materials 58
    • 2.5.3.4 Selecting a Second Source for Chemicals 59
    • 2.5.3.5 Cost Analysis for Reagent Manufacture 60
    • 2.5.3.6 Outsourcing Production of Reagents 60
  • 2.5.4 The Fastest Growing IVD Reagent Markets 60
  • 2.5.5 High Growth Applications Spur Industry Growth 61
• 2.6 Automated Instrument Platforms Evolution 61
• 2.7 Reagents and Supplies Market for Clinical Lab Instruments 62
• 2.8 Spending for Clinical Laboratory Testing 62
  • 2.8.1 Reimbursement Pressure 62
  • 2.8.2 Medicare Part B Spending Trends 64
  • 2.8.3 Strategies for Revenue Growth 65
  • 2.8.4 Electronic Health Records 66

3. IVD Clinical Laboratory Market 67

• 3.1 Markets 67
  • 3.1.1 Global Markets 67
  • 3.1.2 Global Drivers of Clinical Laboratory Testing 69
  • 3.1.3 Global Outlook 70
  • 3.1.4 U.S. Market 71
  • 3.1.5 European IVD Market 73
    • 3.1.5.1 German Clinical Laboratory Diagnostic Markets 82
    • 3.1.5.2 U.K. Clinical Laboratory Testing Diagnostic Market 84
      • 3.1.5.2.1 U.K. Competitive Analysis 85
      • 3.1.5.2.2 U.K. Market Access 87
    • 3.1.5.3 French Clinical Laboratory Diagnostic Testing Market 87
    • 3.1.5.4 Italian Clinical Laboratory Diagnostic Market 88
    • 3.1.5.5 Spanish Clinical Laboratory Diagnostic Market 89
    • 3.1.5.6 Finnish Clinical Laboratory Market 90
    • 3.1.5.7 Turkish Clinical Laboratory Market 91
    • 3.1.5.8 Belgium Clinical Laboratory Diagnostic Market 91
    • 3.1.5.9 Swiss Clinical Laboratory Diagnostic Market 92
    • 3.1.5.10 Dutch Clinical Laboratory Diagnostic Market 93
    • 3.1.5.11 Portuguese Clinical Laboratory Diagnostic Market 94
    • 3.1.5.12 Austrian Clinical Laboratory Diagnostic Market 95
    • 3.1.5.13 Greek Clinical Laboratory Diagnostic Market 96
    • 3.1.5.14 Polish Clinical Laboratory Diagnostic Market 97
    • 3.1.5.15 Romanian Clinical Laboratory Diagnostic Market 98
    • 3.1.5.16 Czech Republic Clinical Laboratory Diagnostic Market 99
    • 3.1.5.17 Swedish Clinical Laboratory Diagnostic Market 100
    • 3.1.5.18 Norwegian Clinical Laboratory Diagnostic Market 100
    • 3.1.5.19 Irish Clinical Laboratory Diagnostic Market 101
    • 3.1.5.20 Hungarian Clinical Laboratory Diagnostic Market 101
    • 3.1.5.21 Bulgarian Clinical Laboratory Diagnostic Market 102
    • 3.1.5.22 Slovakian Clinical Laboratory Diagnostic Market 102
    • 3.1.5.23 Lithuanian Clinical Laboratory Diagnostic Market 103
    • 3.1.5.24 Latvian Clinical Laboratory Diagnostic Market 103
    • 3.1.5.25 Estonian Clinical Laboratory Diagnostic Market 104
    • 3.1.5.26 Slovenian Clinical Laboratory Diagnostic Market 104
    • 3.1.5.27 Russian Clinical Laboratory Diagnostic Market 105
  • 3.1.6 Asian Markets 105
    • 3.1.6.1 Indian Clinical Laboratory Diagnostic Market 107
    • 3.1.6.1.1 Indian IVD Testing Industry 107
    • 3.1.6.2 Japanese Clinical Laboratory Testing Market 112
    • 3.1.6.3 Chinese Clinical Laboratory Market 112
  • 3.1.7 Clinical Laboratory Smaller Country Markets 122
    • 3.1.7.1 Canadian Clinical Laboratory Market 122
    • 3.1.7.2 Brazilian Clinical Laboratory Market 123
    • 3.1.7.3 Australian Clinical Laboratory Market 123
  • 3.1.8 ROW Clinical Laboratory Testing Market 124
  • 3.1.9 Overview of Asian Clinical Laboratory Market 124
    • 3.1.9.1 Singapore 126
    • 3.1.9.2 Malaysia 128
    • 3.1.9.3 Thailand 128
    • 3.1.9.4 Indonesia 128
    • 3.1.9.5 Philippines 128
    • 3.1.9.6 South Korea 129
    • 3.1.9.7 India 129
    • 3.1.9.8 Hong Kong 129
    • 3.1.9.9 Taiwan 130
  • 3.1.10 Overview of the Latin American Diagnostics Market 131
• 3.2 Clinical Laboratory Sector 132
  • 3.2.1 Industry Players 132
  • 3.2.2 Market Specialization 133
  • 3.2.3 Revenue and Reimbursement 135
  • 3.2.4 Companies 135
• 3.3 Outlook for Clinical Laboratory Testing 136
  • 3.3.1 Long-term Changes 136
  • 3.3.2 Market Drivers 138
  • 3.3.3 The Limits to Growth 139
  • 3.3.4 Hot Sectors in the IVD Market 140
  • 3.3.5 Key Technologies 141
  • 3.3.6 Conclusion 142

4. Clinical Laboratory Instrument Market by Sector 143

• 4.1 Chemistry Analyzers 143
  • 4.1.1 Ultra-Large Throughput Laboratory Analyzers 143
  • 4.1.2 Large-Throughput Analyzers 150
  • 4.1.3 Mid-size Clinical Laboratory Analyzers 161
  • 4.1.4 Laboratory Analyzers for the Small Volume Market 165
• 4.2 Immunochemistry Analyzers 171
  • 4.2.1 Large Immunochemistry Analyzers 172
  • 4.2.2 Small Immunoassay Analyzers 180
• 4.3 Hematology Analyzers 182
• 4.4 Point of Care Testing 197
• 4.5 Cytology Testing 202
• 4.6 Microbiology Testing 204
• 4.7 Serology Testing 204
• 4.8 Esoteric Testing 204
• 4.9 Anatomic Pathology 205
  • 4.9.1 Histology 205
  • 4.9.2 IHC Staining 206
  • 4.9.3 ISH Staining 206
  • 4.9.4 Special Stains Staining 207
  • 4.9.5 Tissue Staining Market 207
  • 4.9.6 Cancer Diagnostics; Anatomic Pathology 208
• 4.10 Drug Testing 208

5. Important Technology Trends in IVD Instrumentation and Reagents 212

• 5.1 Technology Innovations in Instrument and Reagent Development 212
• 5.2 Sensor Systems for Diagnostic Applications 212
• 5.3 Glucose Measurements 217
• 5.4 Glucose Test Methods 219
• 5.5 Cholesterol Measurements 220
• 5.6 The New Paradigm 221
• 5.7 Consolidated Workstations 221
• 5.8 Automation in the Laboratory 224
• 5.9 Laboratory Information Systems 224
• 5.10 New User-friendly Interfaces 225
• 5.11 Biosensor Technology 226
• 5.12 Data-Management Issues 228
  • 5.12.1 Wireless LANs 228
  • 5.12.2 Cepheid's POC GBS and BCR/ABL Tests 228
  • 5.12.3 Data and Workflow Management Systems 229
  • 5.12.4 Beckman Central Command 229

6. Business Trends in the Clinical Laboratory Analyzer and Reagents Market 231

• 6.1 Key Market Developments 231
  • 6.1.1 Decreasing Revenue from Traditional IVD Markets 231
  • 6.1.2 High Growth in POCT and Molecular Diagnostics Arena 231
  • 6.1.3 Move Away from Traditional Kit Testing Methods 232
  • 6.1.4 Integrated Analytical Systems 232
  • 6.1.5 Regulatory Changes 233
  • 6.1.6 Development of a Two-Tier Industry Structure 233
  • 6.1.7 Labor Costs 233
  • 6.1.8 Increasing Value of Companies with High-Margin Technology Platforms 233
  • 6.1.9 The Joining of IVD Testing and Computer Technology 234
  • 6.1.10 User-friendly User Interfaces 234
• 6.2 Sector Consolidation 235
  • 6.2.1 IVD Company Consolidation 235
  • 6.2.2 Lab Company Consolidation 240
    • 6.2.2.1 Acquisition Pricing 241
    • 6.2.2.2 A Closer Look at Six Big Lab Deals 241
• 6.3 Diagnostic Testing Growth Trends 243
• 6.4 Reagent and Hardware Business in Japan 243
• 6.5 New Products 243
• 6.6 Acquisition, License Agreements, Internal Development and Partnerships 243
• 6.7 Product Testing Depth in Clinical Laboratory Testing 245
• 6.8 Government Regulation of IVD Devices 245
  • 6.8.1 U.S. Regulation 245
    • 6.8.1.1 Importing Medical Devices into the U.S. 247
    • 6.8.1.2 Exporting Medical Devices from the U.S. 247
  • 6.8.2 U.K. Regulation 248
  • 6.8.3 E.U. Regulation 249
    • 6.8.3.1 France 251
  • 6.8.4 Japanese Regulation 252
  • 6.8.5 Korean Regulation 252
  • 6.8.6 Chinese Regulation 252
• 6.9 Increased Market Penetration 253
• 6.10 Costs of Doing Business in Europe 254
• 6.11 Drivers of European Diagnostics Testing 254
• 6.12 European Reimbursement Practices 254
• 6.13 Cost Containment in Europe 254
• 6.14 Hospital Outreach Programs 256
• 6.15 Electronic Procurement: New Challenges 257
• 6.16 Competition for Supply Chain Management Solutions 259
• 6.17 E-Commerce in the Hospital Supply Chain 260
  • 6.17.1 Drivers of E-Commerce Solutions 261
  • 6.17.2 Barriers to E-Commerce Solutions 261
• 6.18 Top Trends in Laboratory Business Practices 263
• 6.19 The Value of the New Diagnostics 266
• 6.20 Converging Technologies-Drugs and Diagnostic Tests Combine for Improved Healthcare 266
• 6.21 Emerging Technologies in the Downstream Manufacture of Bio-Materials 266
• 6.22 GMP Readiness 267
• 6.23 Harnessing Human Resource Capabilities and IT Prowess: Biotechnology in the Future 267
• 6.24 Partnering with Patient-based Organizations to Achieve Patient Health Goals 267
• 6.25 Rumors of the Platform Company's Demise are Greatly Exaggerated 267
• 6.26 Who's Going to Pay for It? 268
• 6.27 Clinical Trials Testing. 269
• 6.28 Life Insurer Services. 269
• 6.29 Employer Services 270

7. Company Profiles 271

• 7.1 Abaxis 271
• 7.2 Abbott 274
• 7.3 Adaltis, Inc. 276
• 7.4 Alfa Wasserman, Inc. (Formerly Electro-Nucleonics, Inc. and Schiapparelli Biosystems, Inc.) 276
• 7.5 Becton, Dickinson & Co. 277
• 7.6 Beckman Coulter, Inc. 278
• 7.7 Bio-Reference Laboratories, Inc. 289
• 7.8 bioMerieux 290
• 7.9 Enzo Biochem, Inc. 290
• 7.10 Genomic Health, Inc. 290
• 7.11 Hitachi 291
• 7.12 Horiba Ltd. 292
• 7.13 JEOL Ltd. 292
• 7.14 LabCorp 293
• 7.15 MEDTOX Scientific, Inc. 294
• 7.16 Monogram Biosciences, Inc. 294
• 7.17 Myriad Genetics, Inc. 295
• 7.18 Nova Biomedical 295
• 7.19 Hologic, Inc. 295
• 7.20 Ortho-Clinical Diagnostics, a J&J Company 296
• 7.21 Psychemedics Corporation 298
• 7.22 Quest Diagnostics, Inc. 299
• 7.23 Roche Diagnostics Corp. 300
• 7.24 Shimadzu 303
• 7.25 Sysmex Corporation 304
• 7.26 Thermo Fisher Scientific, Inc. 305
• 7.27 Vital Scientific, NV 306

INDEX OF FIGURES

• Figure 2.1: Clinical Laboratory Testing Sector Providers 18
• Figure 2.2: Unweighted Average Medicare Reimbursement for Ten Most Common POL Tests, 2002 vs. 2006 35
• Figure 2.3: Total Number of Non-Waived POLs, 2000-2006 36
• Figure 2.4: Part B Spending on Clinical Laboratory Services, 1991-2005 64
• Figure 3.1: IVD Product Demand 71
• Figure 3.2: European IVD Market by Clinical Specialty 77
• Figure 3.3: Chinese IVD Market, 2006-2012 115
• Figure 6.1: Hospital Market Share for Outreach Programs 256
• Figure 7.1: Beckman Sales Results by Type, Segment and Region, 2009 288

INDEX OF TABLES

• Table 2.1: Total U.S. Clinical Laboratory Revenue, 2005-2015 18
• Table 2.2: U.S. Clinical Laboratory Diagnostic Test Market Segments Revenue, 2009 19
• Table 2.3: Drivers of Clinical Lab Testing Volume 19
• Table 2.4: Independent Commercial Laboratory Testing Market Sample Volume, 2005-2012 19
• Table 2.5: Leading U.S. Reference Laboratories Grouped by Market Capitalization 20
• Table 2.6: LabCorp Comparison of Routine and Genomic and Esoteric Testing Trends 25
• Table 2.7: Revenue Growth at Quest Diagnostics, 2000-2009 27
• Table 2.8: Revenue Growth at LabCorp, 2000-2009 27
• Table 2.9: Quest's Total Volume of Requisitions and Net Revenues from Clinical Laboratory Testing 28
• Table 2.10: Number of Hospital-based Clinical Laboratory Tests in the U.S., 2002-2012 30
• Table 2.11: European Cardiovascular Disease Management Expenditures, 2003-2010 33
• Table 2.12: The Most Frequent Laboratory Tests Offered at Physician Offices 37
• Table 2.13: U.S. Doctor's Office Lab Test Dollar Volume and Growth Rates, 2009 38
• Table 2.14: Worldwide Alternate Site Clinical Lab Instrument and Reagents Sales, 2005-2012 38
• Table 2.15: Thirteen Largest Diagnostic Companies Worldwide 40
• Table 2.16: Products Marketed by Abbott in the Diagnostic Market 45
• Table 2.17: Beckman Coulter Market Share in Major Diagnostic Sectors 52
• Table 2.18: Prodesse's ASRs 57
• Table 2.19: CMS Reimbursement for Top 25 Clinical Laboratory Procedures 65
• Table 3.1: Worldwide IVD Testing Market, 2009 67
• Table 3.2: Worldwide Geographic Distribution of IVD Testing, 2009 67
• Table 3.3: Global Clinical Laboratory Market Sales, 1998-2012 68
• Table 3.4: U.S. Clinical Laboratory Testing Market, 2003-2012 72
• Table 3.5: U.S. Clinical Laboratory Diagnostic Test Market Segments, 2009 72
• Table 3.6: U.S. Clinical Diagnostic POCT and Rapid Test Market Segments, 2007 72
• Table 3.7: U.S. Individual Clinical Chemistry Laboratory Diagnostic Test Markets, 2009 73
• Table 3.8: European Clinical Laboratory Testing IVD Reagents and Instruments Market, 2000-2012 74
• Table 3.9: European Clinical Laboratory Diagnostic Testing Reagents and Instruments Market by Analyte, 2006 74
• Table 3.10: European Clinical Chemistry Testing IVD Reagents and Instruments Market, 2000-2012 74
• Table 3.11: European Clinical Laboratory Testing Diagnostics by Country Market, 2009 75
• Table 3.12: European Rapid POCT by Country Market, 2008 76
• Table 3.13: European Patient Self Testing OTC Diagnostics by Country Market, 2006 76
• Table 3.14: German Clinical Laboratory Testing Diagnostics Products Market Sales, 2003-2012 83
• Table 3.15: German Clinical Diagnostic Rapid Test Market Segments, 2008 83
• Table 3.16: U.K. Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 84
• Table 3.17: U.K. Clinical Diagnostic Rapid Test Market Segments 85
• Table 3.18: Major U.K. IVD Manufacturers 86
• Table 3.19: U.S. IVD Manufacturers Doing Business in the U.K. 86
• Table 3.20: Other European Companies that Manufacture IVD Products in the U.K. 86
• Table 3.21: French Clinical IVD Testing Diagnostics Products Market Sales, 2003-2012 87
• Table 3.22: French Clinical Diagnostic Rapid Test Market Segments 87
• Table 3.23: Italian Laboratory Diagnostics Products Market Sales, 2003-2012 88
• Table 3.24: Italian Clinical Diagnostic Rapid Test Market Segments 89
• Table 3.25: Spanish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 89
• Table 3.26: Spanish Clinical Diagnostic Rapid Test Market Segments, 2008 90
• Table 3.27: Finnish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 90
• Table 3.28: Turkish Clinical Laboratory Testing Market, 2000-2012 91
• Table 3.29: Belgium Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 91
• Table 3.30: Belgium Clinical Reagents and Instruments Market 92
• Table 3.31: Swiss Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 92
• Table 3.32: Swiss Clinical Reagents and Instruments Market 93
• Table 3.33: Dutch Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 93
• Table 3.34: Dutch Clinical Reagents and Instruments Market 94
• Table 3.35: Portuguese Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 94
• Table 3.36: Portuguese Clinical Reagents and Instruments Market 95
• Table 3.37: Austrian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 95
• Table 3.38: Austrian Clinical Reagents and Instruments Market 96
• Table 3.39: Greek Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 96
• Table 3.40: Greek Clinical Reagents and Instruments Market 97
• Table 3.41: Polish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 97
• Table 3.42: Polish Clinical Reagents and Instruments Market 98
• Table 3.43: Romanian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 98
• Table 3.44: Romanian Clinical Reagents and Instruments Market 99
• Table 3.45: Czech Republic Clinical Laboratory Diagnostics Products Market Sales, 2004-2012 99
• Table 3.46: Swedish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 100
• Table 3.47: Norwegian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 100
• Table 3.48: Irish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 101
• Table 3.49: Hungarian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 101
• Table 3.50: Bulgarian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 102
• Table 3.51: Slovakian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 102
• Table 3.52: Lithuanian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 103
• Table 3.53: Latvian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 103
• Table 3.54: Estonian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 104
• Table 3.55: Slovenian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 104
• Table 3.56: Russian Clinical Laboratory Diagnostics Products Market Sales, 2007-2012 105
• Table 3.57: Asian Geographic Distribution of IVD Testing, 2009 105
• Table 3.58: Summary of Key Business Points of the Asian Healthcare Market 106
• Table 3.59: Outlook for the Asian Healthcare Market, 2010-2012 106
• Table 3.60: Asian IVD Market Drivers 106
• Table 3.61: Asian IVD Market Restraints 106
• Table 3.62: Top Asian IVD Growth Opportunities 106
• Table 3.63: Indian IVD Market for Instruments and Reagents, 2004-2012 107
• Table 3.64: Number of Automated Clinical Labs in India, 2004-2012 107
• Table 3.65: Indian IVD Market 108
• Table 3.66: Japanese Clinical Laboratory Testing Instrument and Reagents Market, 2003-2012 112
• Table 3.67: Drivers of the Japanese IVD Market 112
• Table 3.68: Barriers to the Japanese IVD Market 112
• Table 3.69: Drivers of Growth in the Chinese Clinical Laboratory Market 113
• Table 3.70: Number of Chinese Medical Institutions 113
• Table 3.71: Chinese Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 114
• Table 3.72: Chinese IVD Market, 2008 115
• Table 3.73: Proportion of Medical Expenses Paid Privately 117
• Table 3.74: Market Share of Reagent Imports into the Chinese Clinical Lab Market by Country of Origin 118
• Table 3.75: Analytical Instrument Imports into the Chinese Clinical Lab Market by Country of Origin 118
• Table 3.76: Chinese International IVD Manufacturers 118
• Table 3.77: Chinese Domestic IVD Manufacturers 119
• Table 3.78: Chinese IVD Distributors 121
• Table 3.79: Canadian Clinical Laboratory Testing Market, 2000-2009 122
• Table 3.80: Brazilian Clinical Laboratory Testing Market, 2000-2009 123
• Table 3.81: Australian Clinical Laboratory Testing Market, 2000-2009 123
• Table 3.82: ROW Clinical Laboratory Testing Market, 2000-2009 124
• Table 3.83: Latin American Geographic Distribution of IVD Testing, 2009 131
• Table 3.84: Number of Clinical Laboratories in Latin America 131
• Table 3.85: Principal Marketers of Automated Clinical Laboratory Instruments 132
• Table 3.86: Key Market Drivers of Automated Clinical Laboratory Instruments 138
• Table 3.87: Key Market Limits of Automated Clinical Laboratory Instruments 139
• Table 4.1: Ultra-Large Clinical Laboratory Analyzers 150
• Table 4.2: JEOL Analyzer Comparison 157
• Table 4.3: Large Clinical Laboratory Analyzers 160
• Table 4.4: Mid-size Clinical Laboratory Analyzers 164
• Table 4.5: Small Clinical Laboratory Analyzers 170
• Table 4.6: Large Immunochemistry Analyzers 179
• Table 4.7: Small Immunoassay Analyzers 182
• Table 4.8: Linearity and Precision of Abbott CELL-DYN Hematology Analyzers 185
• Table 4.9: Accuracy of the Automated Differential of Abbott CELL-DYN Analyzers 185
• Table 4.10: Linearity and Precision of Siemens Hematology Analyzers 186
• Table 4.11: Accuracy of the Automated Differential of Siemens Hematology Analyzers 187
• Table 4.12: Linearity and Precision of Beckman Coulter Hematology Instruments 189
• Table 4.13: Accuracy of the Automated Differential of Beckman Coulter Hematology Analyzers 189
• Table 4.14: Linearity and Precision of Horiba ABX Hematology Analyzers 191
• Table 4.15: Accuracy of the Horiba ABX Hematology Analyzers 191
• Table 4.16: Linearity and Precision of Sysmex Hematology Analyzers 194
• Table 4.17: Accuracy of the Sysmex Hematology Analyzers 194
• Table 4.18: Comparison of Linearity and Precision of Top-of-the-Line Hematology Analyzers 195
• Table 4.19: Comparison of Accuracy of the Top-of-the-Line Hematology Analyzers 195
• Table 4.20: Hematology Analyzers with a Five-Part WBC Differential 196
• Table 4.21: Hematology Analyzers with a Three-Part WBC Differential 197
• Table 4.22: Point of Care Testing 198
• Table 4.23: Number of ER Visits in U.S. Hospitals, 1997-2007 201
• Table 4.24: Number of POCT in U.S., 2000-2012 201
• Table 4.25: PAP Tests in Top European Markets 203
• Table 4.26: PAP Tests in Top Asian Markets 203
• Table 4.27: Drugs of Abuse Testing Market for POCT Worldwide, 2006-2015 210
• Table 4.28: U.S. Point of Care Drugs of Abuse Testing Market, 2006-2015 211
• Table 5.1: Normal Glucose Values-Fasting State 219
• Table 5.2: Applications for Wireless LAN Technology 228
• Table 6:1: Products Marketed by Abbott in the Diagnostics Market 238
• Table 7.1: Abaxis Blood Analysis Diagnostic Tests 272
• Table 7.2: Reagent Discs Offered with the Piccolo Chemistry Analyzers 273
• Table 7.3: Comparison of JEOL Analyzers 293
• Table 7.4: The VITROS ECiQ Immunodiagnostic System 297
• Table 7.5: Sysmex Marketing Summary for China 304

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