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 and diverse--crossing the $39 billion mark in 2008--and 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 TriMark Publications 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.
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 and LabCorp 20
2.2.3 Competitive Advantages at Quest and LabCorp 23
2.2.4 Competitive Disadvantages of Quest and LabCorp 24
2.2.5 Revenue Growth of Quest and LabCorp 25
2.2.6 Sector Consolidation 27
2.2.7 Additional Independent Clinical Laboratories 27
2.3 Hospital Market 28
2.3.1 Hospital Market Overview 28
2.3.2 Hospital Lab Testing Drivers 29
2.3.3 Evaluation Models of Laboratory Testing 29
2.3.4 GPOs and IDNs 30
2.3.5 Distributors 30
2.3.6 Clinical Lab Testing Suppliers 31
2.3.7 European Hospital Purchasing Practices 31
2.3.8 Changes in Hospital Funding 32
2.3.9 European Group Purchasing 33
2.4 POL Market 33
2.5 IVD Industry 35
2.5.1 Industry Overview 35
2.5.2 IVD Industry Leading Players Comparison and Review 35
2.5.3 Biotechnology Reagents and Supplies 56
2.5.3.1 Vendor Quality Assurance 57
2.5.3.2 Partnership Support 58
2.5.3.3 Protecting Supply of Raw Materials 59
2.5.3.4 Selecting a Second Source for Chemicals 60
2.5.3.5 Cost Analysis for Reagent Manufacture 60
2.5.3.6 Outsourcing Production of Reagents 61
2.5.4 The Fastest Growing IVD Reagent Markets 61
2.5.5 Automated Instrumentation 61
2.5.6 High Growth Applications Spur Industry Growth 62
2.6 Automated Instrument Platforms Evolution 62
2.7 Reagents and Supplies Market for Clinical Lab Instruments 62
2.8 Spending for Clinical Laboratory Testing 62
2.8.1 Reimbursement Pressure 63
2.8.2 Medicare Part B Spending Trends 63
2.8.3 Strategies for Revenue Growth 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 81
3.1.5.2 U.K. Clinical Laboratory Testing Diagnostic Market 83
3.1.5.2.1 U.K. Competitive Analysis 85
3.1.5.2.2 U.K. Market Access 86
3.1.5.3 French Clinical Laboratory Diagnostic Testing Market 86
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 99
3.1.5.18 Norwegian Clinical Laboratory Diagnostic Market 100
3.1.5.19 Irish Clinical Laboratory Diagnostic Market 100
3.1.5.20 Hungarian Clinical Laboratory Diagnostic Market 101
3.1.5.21 Bulgarian Clinical Laboratory Diagnostic Market 101
3.1.5.22 Slovakian Clinical Laboratory Diagnostic Market 102
3.1.5.23 Lithuanian Clinical Laboratory Diagnostic Market 102
3.1.5.24 Latvian Clinical Laboratory Diagnostic Market 103
3.1.5.25 Estonian Clinical Laboratory Diagnostic Market 103
3.1.5.26 Slovenian Clinical Laboratory Diagnostic Market 104
3.1.6 Asian Markets 104
3.1.6.1 Indian Clinical Laboratory Diagnostic Market 104
3.1.6.1.1 Indian IVD Testing Industry 104
3.1.6.2 Japanese Clinical Laboratory Testing Market 111
3.1.6.3 Chinese Clinical Laboratory Market 111
3.1.7 Clinical Laboratory Smaller Country Markets 119
3.1.7.1 Canadian Clinical Laboratory Market 119
3.1.7.2 Brazilian Clinical Laboratory Market 120
3.1.7.3 Australian Clinical Laboratory Market 120
3.1.8 ROW Clinical Laboratory Testing Market 121
3.1.9 Overview of Asian Healthcare Market 121
3.1.9.1 Singapore 121
3.1.9.2 Malaysia 122
3.1.9.3 Thailand 122
3.1.9.4 Indonesia 122
3.1.9.5 Philippines 123
3.1.9.6 South Korea 123
3.1.9.7 India 124
3.1.9.8 Hong Kong 124
3.1.9.9 Taiwan 124
3.1.10 Overview of the Latin American Diagnostics Market 125
3.2 Clinical Laboratory Sector 125
3.2.1 Worldwide IVD Sales 125
3.2.1.1 POLs 127
3.2.2 Industry Players 132
3.2.2.1 Manufacturing Companies 132
3.2.3 Market Specialization 134
3.2.4 Revenue and Reimbursement 136
3.2.5 Companies 136
3.3 Outlook for Clinical Laboratory Testing 137
3.3.1 Long-Term Changes 137
3.3.2 Market Drivers 139
3.3.3 The Limits to Growth 139
3.3.4 Hot Sectors in the IVD Market 139
3.3.5 Key Technologies 141
3.3.6 Conclusion 141
4. Clinical Laboratory Instrument Market by Sector 142
4.1 Chemistry Analyzers 142
4.1.1 Ultra-Large Throughput Laboratory Analyzers 142
4.1.2 Large-Throughput Analyzers 149
4.1.3 Mid-Size Clinical Laboratory Analyzers 160
4.1.4 Laboratory Analyzers for the Small Volume Market 164
4.2 Immunochemistry Analyzers 169
4.2.1 Large Immunochemistry Analyzers 169
4.2.2 Small Immunoassay Analyzers 178
4.3 Hematology Analyzers 180
4.4 POCT 194
4.4.1 U.S. POC Markets 199
4.4.2 European POCT Market 201
4.4.2.1 German POC Diagnostic Markets 204
4.4.2.2 U.K. POCT Diagnostic Market 207
4.4.2.2.1 U.K. Market Statistics 207
4.4.2.2.2 U.K. Competitive Analysis 208
4.4.2.2.3 U.K. Market Access 209
4.4.2.3 French POC Diagnostic Market 209
4.4.2.4 Italian POC Diagnostic Market 210
4.4.2.5 Spanish POC Diagnostic Market 211
4.4.2.6 Scandinavian POC Market 211
4.4.3 Japanese POCT Market 211
4.4.4 Chinese POC Market 212
4.4.5 Canadian POC Market 214
4.4.6 Brazilian POC Market 215
4.4.7 Turkish POC Market 215
4.4.8 Australian POC Market 216
4.5 ROW POCT Market 216
4.6 Cytology Testing 217
4.7 Microbiology Testing 219
4.8 Serology Testing 219
4.9 Esoteric Testing 219
4.10 Anatomic Pathology 220
4.11 Drug Testing 220
5. Important Technology Trends in IVD Instrumentation and Reagents 221
5.1 Technology Innovations in Instrument and Reagent Development 221
5.2 Sensor Systems for Diagnostic Applications 221
5.3 Glucose Measurements 223
5.4 Glucose Test Methods 226
5.5 Cholesterol Measurements 227
5.6 The New Paradigm 227
5.7 Consolidated Workstations 227
5.8 Automation in the Laboratory 229
5.9 Laboratory Information Systems 230
5.10 New User-friendly Interfaces 231
5.11 Biosensor Technology 232
5.12 Data-Management Issues 233
5.12.1 Wireless LANs 234
5.12.2 Cepheid’s POC GBS and BCR/ABL Tests 234
5.12.3 Data and Workflow Management Systems 235
5.12.4 Beckman Central Command 235
6. Business Trends in the Clinical Laboratory Analyzer and Reagents Market 236
6.1 Key Market Developments 236
6.1.1 Decreasing Revenue from Traditional IVD Markets 236
6.1.2 High Growth in POCT and Molecular Diagnostics Arena 236
6.1.3 Move Away from Traditional Kit Testing Methods 237
6.1.4 Integrated Analytical Systems 237
6.1.5 Regulatory Changes 237
6.1.6 Development of a Two-Tier Industry Structure 238
6.1.7 Labor Costs 238
6.1.8 Increasing Value of Companies with High-Margin Technology Platforms 238
6.1.9 The Joining of IVD Testing and Computer Technology 239
6.1.10 User-Friendly User Interfaces 239
6.2 Sector Consolidation 240
6.2.1 IVD Company Consolidation 240
6.2.2 Lab Company Consolidation 243
6.2.2.1 Acquisition Pricing 244
6.2.2.2 A Closer Look at Six Big Lab Deals 244
6.3 Diagnostic Testing Growth Trends 246
6.4 Reagent and Hardware Business in Japan 246
6.5 New Products 247
6.6 Acquisition, License Agreements, Internal Development and Partnerships 247
6.7 Product Testing Depth in Clinical Laboratory Testing 251
6.8 Government Regulation of IVD Devices 251
6.8.1 U.S. Regulation 251
6.8.1.1 Importing Medical Devices into the U.S. 252
6.8.1.2 Exporting Medical Devices from the U.S. 253
6.8.2 U.K. Regulation 253
6.8.3 E.U. Regulation 255
6.8.3.1 France 256
6.8.4 Japanese Regulation 257
6.8.5 Korean Regulation 257
6.8.6 Chinese Regulation 257
6.9 Increased Market Penetration 258
6.10 Costs of Doing Business in Europe 260
6.11 Drivers of European Diagnostics Testing 260
6.12 European Reimbursement Practices 260
6.13 Cost Containment in Europe 260
6.14 Hospital Outreach Programs 260
6.15 Electronic Procurement: New Challenges 261
6.16 Competition for Supply Chain Management Solutions 263
6.17 E-Commerce in the Hospital Supply Chain 264
6.17.1 Drivers of E-Commerce Solutions 265
6.17.2 Barriers to E-Commerce Solutions 265
6.18 Top Trends in Laboratory Business Practices 268
6.19 The Value of the New Diagnostics 268
6.20 Converging Technologies—Drugs and Diagnostic Tests Combine for Improved Healthcare 269
6.21 Emerging Technologies in the Downstream Manufacture of Bio-Materials 269
6.22 GMP Readiness 269
6.23 Harnessing Human Resource Capabilities and IT Prowess: Biotechnology in the Future 269
6.24 Partnering with Patient-Based Organizations to Achieve Patient Health Goals 269
6.25 Rumors of the Platform Company’s Demise are Greatly Exaggerated 270
6.26 Who’s Going to Pay for It? 270
7. Company Profiles 273
7.1 Abaxis 273
7.2 Abbott Diagnostics 274
7.3 Adaltis, Inc. 278
7.4 Alfa Wasserman, Inc. (formerly Electro-Nucleonics, Inc. and Schiapparelli Biosystems, Inc.) 279
7.5 Awareness Technology 280
7.6 Bayer Diagnostics 280
7.7 Beckman Coulter, Inc. 281
7.8 Bio-Reference Laboratories, Inc. 286
7.9 Clarient, Inc. 286
7.10 Dade Behring, Inc. 287
7.11 Enzo Biochem, Inc. 295
7.12 Genomic Health, Inc. 295
7.13 Hitachi 296
7.14 Horiba Ltd. 296
7.15 JEOL Ltd. 297
7.16 LabCorp 297
7.17 Medtox Scientific, Inc. 298
7.18 Monogram Biosciences, Inc. 298
7.19 Myriad Genetics, Inc. 299
7.20 Nova Biomedical 299
7.21 Olympus America, Inc. Diagnostic Systems Division 299
7.22 Ortho-Clinical Diagnostics, a J&J Company 301
7.23 Psychemedics Corporation 303
7.24 Quest Diagnostics, Inc. 304
7.25 Roche Diagnostics Corp. 304
7.26 Shimadzu 307
7.27 Sysmex Corporation 307
7.28 Thermo Fisher Scientific, Inc. 308
7.29 Vital Scientific, NV 308
LIST OF FIGURES
Figure 2.1: Clinical Laboratory Testing Sector Providers 18
Figure 2.2: Part B Spending on Clinical Laboratory Services, 1991-2005 63
Figure 3.1: European IVD Market by Clinical Specialty 76
Figure 3.2: Chinese IVD Market, 1995-2004 112
Figure 3.3: Annual Worldwide IVD Market Growth, 2003-2005 126
Figure 3.4: POL Revenue, 2000-2006 128
Figure 3.5: Unweighted Average Medicare Reimbursement for Ten Most Common POL Tests, 2002 vs. 2006 128
Figure 3.6: Total Number of Non-Waived POLs, 2000-2006 129
Figure 3.7: Number of New Tests Granted CLIA-Waived Status, 2000-2006 129
Figure 3.8: High-Volume Waived Tests 130
Figure 3.9: U.S. Revenue for Six Largest IVD Vendors, 2005 132
Figure 3.10: U.S. Revenue Change for Six Largest IVD Vendors, 2005 133
Figure 6.1: Average Revenue-Multiple Paid to Acquire Labs, 2000-2006 244
Figure 6.2: Hospital Market Share for Outreach Programs 261
LIST OF TABLES
Table 2.1: Total U.S. Clinical Laboratory Revenue from Third Party and Direct Payment, 2005-2012 18
Table 2.2: U.S. Clinical Laboratory Diagnostic Test Market Segments, 2005 19
Table 2.3: Independent Commercial Laboratory Testing Market Value, 2005-2012 19
Table 2.4: Independent Commercial Laboratory Testing Test Volume, 2005-2012 19
Table 2.5: Leading U.S. Reference Laboratories Grouped by Market Capitalization, 2006 20
Table 2.6: Revenue Growth at Quest Diagnostics, 2000-2006 25
Table 2.7: Revenue Growth at LabCorp, 2000-2006 25
Table 2.8: Quest Diagnostics Revenue from Managed Care Contracts, 2004-2006 26
Table 2.9: LabCorp Revenue from Managed Care Contracts, 2004-2006 26
Table 2.10: Quest’s Total Volume of Requisitions and Net Revenues from Clinical Laboratory Testing, 2005 26
Table 2.11: Number of Hospital Based Clinical Laboratory Tests in the U.S., 2002-2008 28
Table 2.12: European Cardiovascular Disease Management Expenditures, 2003-2010 32
Table 2.13: U.S. Doctor’s Office Lab Test Dollar Volume and Growth Rates, 2006 34
Table 2.14: Worldwide Alternate Site Clinical Lab Instrument and Reagents Sales, 2005-2012 34
Table 2.15: Top IVD Manufacturers, 2005 36
Table 2.16: Products Marketed by Abbott in the Diagnostic Market 41
Table 2.17: Prodesse’s ASRs 57
Table 2.18: Hospital Laboratory Share of Part B Medicare Spending, 1996-2005 64
Table 2.19: Medicare Spending on Clinical Lab Services, 1991-2005 64
Table 2.20: Medicare Part B Spending Per Medicare Enrollee, 1998-2005 65
Table 2.21: Allowed Charges for Top 25 Clinical Laboratory Procedures, 2005 65
Table 3.1: Worldwide IVD Testing Market, 2006 67
Table 3.2: Worldwide Distribution of IVD Testing, 2006 67
Table 3.3: Global Clinical Laboratory Market Sales, 1998-2010 68
Table 3.4: Top 15 IVD Manufacturers’ Worldwide Revenue 69
Table 3.5: U.S. Clinical Laboratory Testing Market, 2003-2012 71
Table 3.6: U.S. Clinical Laboratory Diagnostic Test Market Segments, 2006 72
Table 3.7: U.S. Clinical Laboratory Diagnostic Testing Reagents and Instruments Market by Analyte, 2006 72
Table 3.8: U.S. Individual Clinical Chemistry Laboratory Diagnostic Test Markets, 2006 72
Table 3.9: European Clinical Laboratory Testing IVD Reagents and Instruments Market, 2000-2012 73
Table 3.10: European Clinical Laboratory Diagnostic Testing Reagents and Instruments Market by Analyte, 2006 73
Table 3.11: European Clinical Chemistry Testing Reagents and Instruments Market, 2006 74
Table 3.12: European Clinical Laboratory Testing Diagnostics by Country Market, 2006 74
Table 3.13: European Rapid POCT by Country Market, 2006 75
Table 3.14: European Patient Self Testing OTC Diagnostics by Country Market, 2006 75
Table 3.15: German Clinical Laboratory Testing Diagnostics Products Market Sales, 2003-2012 82
Table 3.16: German Clinical Reagents and Instruments Market, 2003 82
Table 3.17: U.K. Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 84
Table 3.18: U.K. Clinical Reagents and Instruments Market, 2006 84
Table 3.19: Major U.K. IVD Manufacturers 85
Table 3.20: U.S. IVD Manufacturers Doing Business in the U.K. 85
Table 3.21: Other European Companies that Manufacture IVD Products in the U.K. 86
Table 3.22: French Clinical IVD Testing Diagnostics Products Market Sales, 2003-2012 87
Table 3.23: French Clinical Reagents and Instruments Market, 2006 87
Table 3.24: Italian Laboratory Diagnostics Products Market Sales, 2003-2012 88
Table 3.25: Italian Clinical Reagents and Instruments Market, 2006 88
Table 3.26: Spanish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 89
Table 3.27: Spanish Clinical Reagents and Instruments Market, 2006 89
Table 3.28: Finnish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 90
Table 3.29: Finnish Clinical Reagents and Instruments Market, 2006 90
Table 3.30: Turkish Clinical Laboratory Testing Market, 2003-2012 91
Table 3.31: Belgium Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 91
Table 3.32: Belgium Clinical Reagents and Instruments Market, 2006 92
Table 3.33: Swiss Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 92
Table 3.34: Swiss Clinical Reagents and Instruments Market, 2006 93
Table 3.35: Dutch Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 93
Table 3.36: Dutch Clinical Reagents and Instruments Market, 2006 93
Table 3.37: Portuguese Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 94
Table 3.38: Portuguese Clinical Reagents and Instruments Market, 2006 94
Table 3.39: Austrian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 95
Table 3.40: Austrian Clinical Reagents and Instruments Market, 2006 95
Table 3.41: Greek Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 96
Table 3.42: Greek Clinical Reagents and Instruments Market, 2006 96
Table 3.43: Polish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 97
Table 3.44: Polish Clinical Reagents and Instruments Market, 2006 97
Table 3.45: Romanian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 98
Table 3.46: Romanian Clinical Reagents and Instruments Market, 2006 98
Table 3.47: Czech Republic Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 99
Table 3.48: Swedish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 99
Table 3.49: Norwegian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 100
Table 3.50: Irish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 100
Table 3.51: Hungarian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 101
Table 3.52: Bulgarian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 101
Table 3.53: Slovakian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 102
Table 3.54: Lithuanian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 102
Table 3.55: Latvian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 103
Table 3.56: Estonian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 103
Table 3.57: Slovenian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 104
Table 3.58: Indian IVD Market for Instruments and Reagents, 2004-2012 104
Table 3.59: Number of Automated Clinical Labs in India, 2004-2012 105
Table 3.60: Indian IVD Market, 2006 105
Table 3.61: Market Sales of IVD Equipment and Reagents by Company in India, 2004 and 2005 108
Table 3.62: Japanese Clinical Laboratory Testing Instrument and Reagents Market, 2003-2012 111
Table 3.63: Chinese Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 112
Table 3.64: Chinese IVD Market 112
Table 3.65: Proportion of Medical Expenses Paid Privately 114
Table 3.66: Chinese International IVD Manufacturers 115
Table 3.67: Chinese Domestic IVD Manufacturers 116
Table 3.68: Chinese IVD Distributors 118
Table 3.69: Canadian Clinical Laboratory Testing Market, 2000-2008 119
Table 3.70: Brazilian Clinical Laboratory Testing Market, 2000-2008 120
Table 3.71: Australian Clinical Laboratory Testing Market, 2000-2008 120
Table 3.72: ROW Clinical Laboratory Testing Market, 2000-2008 121
Table 3.73: Number of Clinical Laboratories in Latin America 125
Table 3.74: Twenty Most Common Laboratory Tests Offered at Family Physician Offices 131
Table 3.75: Important New Waived Tests 132
Table 3.76: Principal Marketers of Automated Clinical Laboratory Instruments 133
Table 4.1: Ultra-Large Clinical Laboratory Analyzers 149
Table 4.2: JEOL Analyzer Comparison 157
Table 4.3: Large Clinical Laboratory Analyzers 160
Table 4.4: Mid-size Clinical Laboratory Analyzers 163
Table 4.5: Small Clinical Laboratory Analyzers 168
Table 4.6: Large Immunochemistry Analyzers 177
Table 4.7: Small Immunoassay Analyzers 180
Table 4.8: Linearity and Precision of Abbott CELL-DYN Hematology Analyzers 182
Table 4.9: Accuracy of the Automated Differential of Abbott CELL-DYN Analyzers 183
Table 4.10: Linearity and Precision of Bayer Hematology Analyzers 184
Table 4.11: Accuracy of the Automated Differential of Bayer Hematology Analyzers 184
Table 4.12: Linearity and Precision of Beckman Coulter Hematology Instruments 186
Table 4.13: Accuracy of the Automated Differential of Beckman Coulter Hematology Analyzers 186
Table 4.14: Linearity and Precision of Horiba ABX Hematology Analyzers 188
Table 4.15: Accuracy of the Horiba ABX Hematology Analyzers 189
Table 4.16: Linearity and Precision of Sysmex Hematology Analyzers 191
Table 4.17: Accuracy of the Sysmex Hematology Analyzers 192
Table 4.18: Comparison of Linearity and Precision of Top-of-the-Line Hematology Analyzers 192
Table 4.19: Comparison of Accuracy of the Top-of-the-Line Hematology Analyzers 193
Table 4.20: Hematology Analyzers with a Five-Part WBC Differential 193
Table 4.21: Hematology Analyzers with a Three-Part WBC Differential 194
Table 4.22: POCT 195
Table 4.23: Number of ER Visits in U.S. Hospitals, 1996-2005 197
Table 4.24: Number of POCT in U.S., 2000-2011 198
Table 4.25: Global POC Revenues, 1998-2008 199
Table 4.26: Worldwide Distribution of POCT, 2005 199
Table 4.27: U.S. POCT Market, 2000-2011 200
Table 4.28: U.S. Clinical Diagnostic Test Market Segments, Revenue from Clinical Laboratory Testing, 2005 200
Table 4.29: U.S. POCT by Distribution Location, 2005 200
Table 4.30: U.S. Clinical Diagnostic POCT and Rapid Test Market Segments, 2005 201
Table 4.31: Drivers of European Diagnostics Testing 202
Table 4.32: Regional Comparison of Healthcare and IVD for Eastern Europe 203
Table 4.33: European IVD Reagent Testing Market, 2000-2012 203
Table 4.34: European Testing Diagnostics Market, 2004 203
Table 4.35: Top Dozen Country IVD Testing Markets and POC Share, 2004 204
Table 4.36: German POCT Diagnostics Products Market Sales, 2002-2007 204
Table 4.37: German Patient Care Central Lab Test Market, 2000-2008 205
Table 4.38: German Alternate Site Testing Market (POL), 2000-2008 205
Table 4.39: German Hospital POC Market, 2000-2008 205
Table 4.40: German Clinical Diagnostic Test Market Segments; Sales from Clinical Laboratory Testing, 2004 206
Table 4.41: German Clinical Diagnostic Rapid Test Market Segments 206
Table 4.42: U.K. POC Diagnostics Products Market Sales, 1998-2007 207
Table 4.43: Major U.K. IVD Manufacturers 208
Table 4.44: U.S. IVD Manufacturers Doing Business in the U.K. 208
Table 4.45: Other European Companies that Manufacture IVD Products in the U.K. 209
Table 4.46: French POC Diagnostics Products Market Sales, 1998-2007 210
Table 4.47: Italian POC Diagnostics Products Market Sales, 1998-2007 210
Table 4.48: Spanish POC Diagnostics Products Market Sales, 1998-2007 211
Table 4.49: Scandinavian POC Diagnostics Products Market Sales, 2000-2008 211
Table 4.50: Japanese POCT Market, 2000-2008 212
Table 4.51: Chinese POC Diagnostics Products Market Sales, 2000-2008 212
Table 4.52: Canadian POCT Market, 2000-2008 214
Table 4.53: Brazilian POCT Market, 2000-2008 215
Table 4.54: Turkish POCT Market, 2000-2008 215
Table 4.55: Australian POCT Market, 2000-2008 216
Table 4.56: ROW POCT Market, 2000-2007 216
Table 4.57: PAP Tests in Top European Markets 218
Table 4.58: PAP Tests in Top Asian Markets 218
Table 5.1: Normal Glucose Values—Fasting State 225
Table 5.2: Applications for Wireless LAN Technology 234
Table 7.1: Products Marketed by Abbott in the Diagnostics Market 277
Table 7.2: Products Marketed by Dade Behring in the Diagnostics Market 288
Table 7.3: Clinically Significant Tests Available From Dade 292
Table 7.4: Comparison of JEOL Analyzers 297
Table 7.5: The VITROS ECiQ Immunodiagnostic System 302
Table 7.6: Sysmex Marketing Summary for China 308
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 and LabCorp 20
2.2.3 Competitive Advantages at Quest and LabCorp 23
2.2.4 Competitive Disadvantages of Quest and LabCorp 24
2.2.5 Revenue Growth of Quest and LabCorp 25
2.2.6 Sector Consolidation 27
2.2.7 Additional Independent Clinical Laboratories 27
2.3 Hospital Market 28
2.3.1 Hospital Market Overview 28
2.3.2 Hospital Lab Testing Drivers 29
2.3.3 Evaluation Models of Laboratory Testing 29
2.3.4 GPOs and IDNs 30
2.3.5 Distributors 30
2.3.6 Clinical Lab Testing Suppliers 31
2.3.7 European Hospital Purchasing Practices 31
2.3.8 Changes in Hospital Funding 32
2.3.9 European Group Purchasing 33
2.4 POL Market 33
2.5 IVD Industry 35
2.5.1 Industry Overview 35
2.5.2 IVD Industry Leading Players Comparison and Review 35
2.5.3 Biotechnology Reagents and Supplies 56
2.5.3.1 Vendor Quality Assurance 57
2.5.3.2 Partnership Support 58
2.5.3.3 Protecting Supply of Raw Materials 59
2.5.3.4 Selecting a Second Source for Chemicals 60
2.5.3.5 Cost Analysis for Reagent Manufacture 60
2.5.3.6 Outsourcing Production of Reagents 61
2.5.4 The Fastest Growing IVD Reagent Markets 61
2.5.5 Automated Instrumentation 61
2.5.6 High Growth Applications Spur Industry Growth 62
2.6 Automated Instrument Platforms Evolution 62
2.7 Reagents and Supplies Market for Clinical Lab Instruments 62
2.8 Spending for Clinical Laboratory Testing 62
2.8.1 Reimbursement Pressure 63
2.8.2 Medicare Part B Spending Trends 63
2.8.3 Strategies for Revenue Growth 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 81
3.1.5.2 U.K. Clinical Laboratory Testing Diagnostic Market 83
3.1.5.2.1 U.K. Competitive Analysis 85
3.1.5.2.2 U.K. Market Access 86
3.1.5.3 French Clinical Laboratory Diagnostic Testing Market 86
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 99
3.1.5.18 Norwegian Clinical Laboratory Diagnostic Market 100
3.1.5.19 Irish Clinical Laboratory Diagnostic Market 100
3.1.5.20 Hungarian Clinical Laboratory Diagnostic Market 101
3.1.5.21 Bulgarian Clinical Laboratory Diagnostic Market 101
3.1.5.22 Slovakian Clinical Laboratory Diagnostic Market 102
3.1.5.23 Lithuanian Clinical Laboratory Diagnostic Market 102
3.1.5.24 Latvian Clinical Laboratory Diagnostic Market 103
3.1.5.25 Estonian Clinical Laboratory Diagnostic Market 103
3.1.5.26 Slovenian Clinical Laboratory Diagnostic Market 104
3.1.6 Asian Markets 104
3.1.6.1 Indian Clinical Laboratory Diagnostic Market 104
3.1.6.1.1 Indian IVD Testing Industry 104
3.1.6.2 Japanese Clinical Laboratory Testing Market 111
3.1.6.3 Chinese Clinical Laboratory Market 111
3.1.7 Clinical Laboratory Smaller Country Markets 119
3.1.7.1 Canadian Clinical Laboratory Market 119
3.1.7.2 Brazilian Clinical Laboratory Market 120
3.1.7.3 Australian Clinical Laboratory Market 120
3.1.8 ROW Clinical Laboratory Testing Market 121
3.1.9 Overview of Asian Healthcare Market 121
3.1.9.1 Singapore 121
3.1.9.2 Malaysia 122
3.1.9.3 Thailand 122
3.1.9.4 Indonesia 122
3.1.9.5 Philippines 123
3.1.9.6 South Korea 123
3.1.9.7 India 124
3.1.9.8 Hong Kong 124
3.1.9.9 Taiwan 124
3.1.10 Overview of the Latin American Diagnostics Market 125
3.2 Clinical Laboratory Sector 125
3.2.1 Worldwide IVD Sales 125
3.2.1.1 POLs 127
3.2.2 Industry Players 132
3.2.2.1 Manufacturing Companies 132
3.2.3 Market Specialization 134
3.2.4 Revenue and Reimbursement 136
3.2.5 Companies 136
3.3 Outlook for Clinical Laboratory Testing 137
3.3.1 Long-Term Changes 137
3.3.2 Market Drivers 139
3.3.3 The Limits to Growth 139
3.3.4 Hot Sectors in the IVD Market 139
3.3.5 Key Technologies 141
3.3.6 Conclusion 141
4. Clinical Laboratory Instrument Market by Sector 142
4.1 Chemistry Analyzers 142
4.1.1 Ultra-Large Throughput Laboratory Analyzers 142
4.1.2 Large-Throughput Analyzers 149
4.1.3 Mid-Size Clinical Laboratory Analyzers 160
4.1.4 Laboratory Analyzers for the Small Volume Market 164
4.2 Immunochemistry Analyzers 169
4.2.1 Large Immunochemistry Analyzers 169
4.2.2 Small Immunoassay Analyzers 178
4.3 Hematology Analyzers 180
4.4 POCT 194
4.4.1 U.S. POC Markets 199
4.4.2 European POCT Market 201
4.4.2.1 German POC Diagnostic Markets 204
4.4.2.2 U.K. POCT Diagnostic Market 207
4.4.2.2.1 U.K. Market Statistics 207
4.4.2.2.2 U.K. Competitive Analysis 208
4.4.2.2.3 U.K. Market Access 209
4.4.2.3 French POC Diagnostic Market 209
4.4.2.4 Italian POC Diagnostic Market 210
4.4.2.5 Spanish POC Diagnostic Market 211
4.4.2.6 Scandinavian POC Market 211
4.4.3 Japanese POCT Market 211
4.4.4 Chinese POC Market 212
4.4.5 Canadian POC Market 214
4.4.6 Brazilian POC Market 215
4.4.7 Turkish POC Market 215
4.4.8 Australian POC Market 216
4.5 ROW POCT Market 216
4.6 Cytology Testing 217
4.7 Microbiology Testing 219
4.8 Serology Testing 219
4.9 Esoteric Testing 219
4.10 Anatomic Pathology 220
4.11 Drug Testing 220
5. Important Technology Trends in IVD Instrumentation and Reagents 221
5.1 Technology Innovations in Instrument and Reagent Development 221
5.2 Sensor Systems for Diagnostic Applications 221
5.3 Glucose Measurements 223
5.4 Glucose Test Methods 226
5.5 Cholesterol Measurements 227
5.6 The New Paradigm 227
5.7 Consolidated Workstations 227
5.8 Automation in the Laboratory 229
5.9 Laboratory Information Systems 230
5.10 New User-friendly Interfaces 231
5.11 Biosensor Technology 232
5.12 Data-Management Issues 233
5.12.1 Wireless LANs 234
5.12.2 Cepheid’s POC GBS and BCR/ABL Tests 234
5.12.3 Data and Workflow Management Systems 235
5.12.4 Beckman Central Command 235
6. Business Trends in the Clinical Laboratory Analyzer and Reagents Market 236
6.1 Key Market Developments 236
6.1.1 Decreasing Revenue from Traditional IVD Markets 236
6.1.2 High Growth in POCT and Molecular Diagnostics Arena 236
6.1.3 Move Away from Traditional Kit Testing Methods 237
6.1.4 Integrated Analytical Systems 237
6.1.5 Regulatory Changes 237
6.1.6 Development of a Two-Tier Industry Structure 238
6.1.7 Labor Costs 238
6.1.8 Increasing Value of Companies with High-Margin Technology Platforms 238
6.1.9 The Joining of IVD Testing and Computer Technology 239
6.1.10 User-Friendly User Interfaces 239
6.2 Sector Consolidation 240
6.2.1 IVD Company Consolidation 240
6.2.2 Lab Company Consolidation 243
6.2.2.1 Acquisition Pricing 244
6.2.2.2 A Closer Look at Six Big Lab Deals 244
6.3 Diagnostic Testing Growth Trends 246
6.4 Reagent and Hardware Business in Japan 246
6.5 New Products 247
6.6 Acquisition, License Agreements, Internal Development and Partnerships 247
6.7 Product Testing Depth in Clinical Laboratory Testing 251
6.8 Government Regulation of IVD Devices 251
6.8.1 U.S. Regulation 251
6.8.1.1 Importing Medical Devices into the U.S. 252
6.8.1.2 Exporting Medical Devices from the U.S. 253
6.8.2 U.K. Regulation 253
6.8.3 E.U. Regulation 255
6.8.3.1 France 256
6.8.4 Japanese Regulation 257
6.8.5 Korean Regulation 257
6.8.6 Chinese Regulation 257
6.9 Increased Market Penetration 258
6.10 Costs of Doing Business in Europe 260
6.11 Drivers of European Diagnostics Testing 260
6.12 European Reimbursement Practices 260
6.13 Cost Containment in Europe 260
6.14 Hospital Outreach Programs 260
6.15 Electronic Procurement: New Challenges 261
6.16 Competition for Supply Chain Management Solutions 263
6.17 E-Commerce in the Hospital Supply Chain 264
6.17.1 Drivers of E-Commerce Solutions 265
6.17.2 Barriers to E-Commerce Solutions 265
6.18 Top Trends in Laboratory Business Practices 268
6.19 The Value of the New Diagnostics 268
6.20 Converging Technologies—Drugs and Diagnostic Tests Combine for Improved Healthcare 269
6.21 Emerging Technologies in the Downstream Manufacture of Bio-Materials 269
6.22 GMP Readiness 269
6.23 Harnessing Human Resource Capabilities and IT Prowess: Biotechnology in the Future 269
6.24 Partnering with Patient-Based Organizations to Achieve Patient Health Goals 269
6.25 Rumors of the Platform Company’s Demise are Greatly Exaggerated 270
6.26 Who’s Going to Pay for It? 270
7. Company Profiles 273
7.1 Abaxis 273
7.2 Abbott Diagnostics 274
7.3 Adaltis, Inc. 278
7.4 Alfa Wasserman, Inc. (formerly Electro-Nucleonics, Inc. and Schiapparelli Biosystems, Inc.) 279
7.5 Awareness Technology 280
7.6 Bayer Diagnostics 280
7.7 Beckman Coulter, Inc. 281
7.8 Bio-Reference Laboratories, Inc. 286
7.9 Clarient, Inc. 286
7.10 Dade Behring, Inc. 287
7.11 Enzo Biochem, Inc. 295
7.12 Genomic Health, Inc. 295
7.13 Hitachi 296
7.14 Horiba Ltd. 296
7.15 JEOL Ltd. 297
7.16 LabCorp 297
7.17 Medtox Scientific, Inc. 298
7.18 Monogram Biosciences, Inc. 298
7.19 Myriad Genetics, Inc. 299
7.20 Nova Biomedical 299
7.21 Olympus America, Inc. Diagnostic Systems Division 299
7.22 Ortho-Clinical Diagnostics, a J&J Company 301
7.23 Psychemedics Corporation 303
7.24 Quest Diagnostics, Inc. 304
7.25 Roche Diagnostics Corp. 304
7.26 Shimadzu 307
7.27 Sysmex Corporation 307
7.28 Thermo Fisher Scientific, Inc. 308
7.29 Vital Scientific, NV 308
LIST OF FIGURES
Figure 2.1: Clinical Laboratory Testing Sector Providers 18
Figure 2.2: Part B Spending on Clinical Laboratory Services, 1991-2005 63
Figure 3.1: European IVD Market by Clinical Specialty 76
Figure 3.2: Chinese IVD Market, 1995-2004 112
Figure 3.3: Annual Worldwide IVD Market Growth, 2003-2005 126
Figure 3.4: POL Revenue, 2000-2006 128
Figure 3.5: Unweighted Average Medicare Reimbursement for Ten Most Common POL Tests, 2002 vs. 2006 128
Figure 3.6: Total Number of Non-Waived POLs, 2000-2006 129
Figure 3.7: Number of New Tests Granted CLIA-Waived Status, 2000-2006 129
Figure 3.8: High-Volume Waived Tests 130
Figure 3.9: U.S. Revenue for Six Largest IVD Vendors, 2005 132
Figure 3.10: U.S. Revenue Change for Six Largest IVD Vendors, 2005 133
Figure 6.1: Average Revenue-Multiple Paid to Acquire Labs, 2000-2006 244
Figure 6.2: Hospital Market Share for Outreach Programs 261
LIST OF TABLES
Table 2.1: Total U.S. Clinical Laboratory Revenue from Third Party and Direct Payment, 2005-2012 18
Table 2.2: U.S. Clinical Laboratory Diagnostic Test Market Segments, 2005 19
Table 2.3: Independent Commercial Laboratory Testing Market Value, 2005-2012 19
Table 2.4: Independent Commercial Laboratory Testing Test Volume, 2005-2012 19
Table 2.5: Leading U.S. Reference Laboratories Grouped by Market Capitalization, 2006 20
Table 2.6: Revenue Growth at Quest Diagnostics, 2000-2006 25
Table 2.7: Revenue Growth at LabCorp, 2000-2006 25
Table 2.8: Quest Diagnostics Revenue from Managed Care Contracts, 2004-2006 26
Table 2.9: LabCorp Revenue from Managed Care Contracts, 2004-2006 26
Table 2.10: Quest’s Total Volume of Requisitions and Net Revenues from Clinical Laboratory Testing, 2005 26
Table 2.11: Number of Hospital Based Clinical Laboratory Tests in the U.S., 2002-2008 28
Table 2.12: European Cardiovascular Disease Management Expenditures, 2003-2010 32
Table 2.13: U.S. Doctor’s Office Lab Test Dollar Volume and Growth Rates, 2006 34
Table 2.14: Worldwide Alternate Site Clinical Lab Instrument and Reagents Sales, 2005-2012 34
Table 2.15: Top IVD Manufacturers, 2005 36
Table 2.16: Products Marketed by Abbott in the Diagnostic Market 41
Table 2.17: Prodesse’s ASRs 57
Table 2.18: Hospital Laboratory Share of Part B Medicare Spending, 1996-2005 64
Table 2.19: Medicare Spending on Clinical Lab Services, 1991-2005 64
Table 2.20: Medicare Part B Spending Per Medicare Enrollee, 1998-2005 65
Table 2.21: Allowed Charges for Top 25 Clinical Laboratory Procedures, 2005 65
Table 3.1: Worldwide IVD Testing Market, 2006 67
Table 3.2: Worldwide Distribution of IVD Testing, 2006 67
Table 3.3: Global Clinical Laboratory Market Sales, 1998-2010 68
Table 3.4: Top 15 IVD Manufacturers’ Worldwide Revenue 69
Table 3.5: U.S. Clinical Laboratory Testing Market, 2003-2012 71
Table 3.6: U.S. Clinical Laboratory Diagnostic Test Market Segments, 2006 72
Table 3.7: U.S. Clinical Laboratory Diagnostic Testing Reagents and Instruments Market by Analyte, 2006 72
Table 3.8: U.S. Individual Clinical Chemistry Laboratory Diagnostic Test Markets, 2006 72
Table 3.9: European Clinical Laboratory Testing IVD Reagents and Instruments Market, 2000-2012 73
Table 3.10: European Clinical Laboratory Diagnostic Testing Reagents and Instruments Market by Analyte, 2006 73
Table 3.11: European Clinical Chemistry Testing Reagents and Instruments Market, 2006 74
Table 3.12: European Clinical Laboratory Testing Diagnostics by Country Market, 2006 74
Table 3.13: European Rapid POCT by Country Market, 2006 75
Table 3.14: European Patient Self Testing OTC Diagnostics by Country Market, 2006 75
Table 3.15: German Clinical Laboratory Testing Diagnostics Products Market Sales, 2003-2012 82
Table 3.16: German Clinical Reagents and Instruments Market, 2003 82
Table 3.17: U.K. Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 84
Table 3.18: U.K. Clinical Reagents and Instruments Market, 2006 84
Table 3.19: Major U.K. IVD Manufacturers 85
Table 3.20: U.S. IVD Manufacturers Doing Business in the U.K. 85
Table 3.21: Other European Companies that Manufacture IVD Products in the U.K. 86
Table 3.22: French Clinical IVD Testing Diagnostics Products Market Sales, 2003-2012 87
Table 3.23: French Clinical Reagents and Instruments Market, 2006 87
Table 3.24: Italian Laboratory Diagnostics Products Market Sales, 2003-2012 88
Table 3.25: Italian Clinical Reagents and Instruments Market, 2006 88
Table 3.26: Spanish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 89
Table 3.27: Spanish Clinical Reagents and Instruments Market, 2006 89
Table 3.28: Finnish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 90
Table 3.29: Finnish Clinical Reagents and Instruments Market, 2006 90
Table 3.30: Turkish Clinical Laboratory Testing Market, 2003-2012 91
Table 3.31: Belgium Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 91
Table 3.32: Belgium Clinical Reagents and Instruments Market, 2006 92
Table 3.33: Swiss Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 92
Table 3.34: Swiss Clinical Reagents and Instruments Market, 2006 93
Table 3.35: Dutch Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 93
Table 3.36: Dutch Clinical Reagents and Instruments Market, 2006 93
Table 3.37: Portuguese Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 94
Table 3.38: Portuguese Clinical Reagents and Instruments Market, 2006 94
Table 3.39: Austrian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 95
Table 3.40: Austrian Clinical Reagents and Instruments Market, 2006 95
Table 3.41: Greek Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 96
Table 3.42: Greek Clinical Reagents and Instruments Market, 2006 96
Table 3.43: Polish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 97
Table 3.44: Polish Clinical Reagents and Instruments Market, 2006 97
Table 3.45: Romanian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 98
Table 3.46: Romanian Clinical Reagents and Instruments Market, 2006 98
Table 3.47: Czech Republic Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 99
Table 3.48: Swedish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 99
Table 3.49: Norwegian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 100
Table 3.50: Irish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 100
Table 3.51: Hungarian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 101
Table 3.52: Bulgarian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 101
Table 3.53: Slovakian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 102
Table 3.54: Lithuanian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 102
Table 3.55: Latvian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 103
Table 3.56: Estonian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 103
Table 3.57: Slovenian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 104
Table 3.58: Indian IVD Market for Instruments and Reagents, 2004-2012 104
Table 3.59: Number of Automated Clinical Labs in India, 2004-2012 105
Table 3.60: Indian IVD Market, 2006 105
Table 3.61: Market Sales of IVD Equipment and Reagents by Company in India, 2004 and 2005 108
Table 3.62: Japanese Clinical Laboratory Testing Instrument and Reagents Market, 2003-2012 111
Table 3.63: Chinese Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 112
Table 3.64: Chinese IVD Market 112
Table 3.65: Proportion of Medical Expenses Paid Privately 114
Table 3.66: Chinese International IVD Manufacturers 115
Table 3.67: Chinese Domestic IVD Manufacturers 116
Table 3.68: Chinese IVD Distributors 118
Table 3.69: Canadian Clinical Laboratory Testing Market, 2000-2008 119
Table 3.70: Brazilian Clinical Laboratory Testing Market, 2000-2008 120
Table 3.71: Australian Clinical Laboratory Testing Market, 2000-2008 120
Table 3.72: ROW Clinical Laboratory Testing Market, 2000-2008 121
Table 3.73: Number of Clinical Laboratories in Latin America 125
Table 3.74: Twenty Most Common Laboratory Tests Offered at Family Physician Offices 131
Table 3.75: Important New Waived Tests 132
Table 3.76: Principal Marketers of Automated Clinical Laboratory Instruments 133
Table 4.1: Ultra-Large Clinical Laboratory Analyzers 149
Table 4.2: JEOL Analyzer Comparison 157
Table 4.3: Large Clinical Laboratory Analyzers 160
Table 4.4: Mid-size Clinical Laboratory Analyzers 163
Table 4.5: Small Clinical Laboratory Analyzers 168
Table 4.6: Large Immunochemistry Analyzers 177
Table 4.7: Small Immunoassay Analyzers 180
Table 4.8: Linearity and Precision of Abbott CELL-DYN Hematology Analyzers 182
Table 4.9: Accuracy of the Automated Differential of Abbott CELL-DYN Analyzers 183
Table 4.10: Linearity and Precision of Bayer Hematology Analyzers 184
Table 4.11: Accuracy of the Automated Differential of Bayer Hematology Analyzers 184
Table 4.12: Linearity and Precision of Beckman Coulter Hematology Instruments 186
Table 4.13: Accuracy of the Automated Differential of Beckman Coulter Hematology Analyzers 186
Table 4.14: Linearity and Precision of Horiba ABX Hematology Analyzers 188
Table 4.15: Accuracy of the Horiba ABX Hematology Analyzers 189
Table 4.16: Linearity and Precision of Sysmex Hematology Analyzers 191
Table 4.17: Accuracy of the Sysmex Hematology Analyzers 192
Table 4.18: Comparison of Linearity and Precision of Top-of-the-Line Hematology Analyzers 192
Table 4.19: Comparison of Accuracy of the Top-of-the-Line Hematology Analyzers 193
Table 4.20: Hematology Analyzers with a Five-Part WBC Differential 193
Table 4.21: Hematology Analyzers with a Three-Part WBC Differential 194
Table 4.22: POCT 195
Table 4.23: Number of ER Visits in U.S. Hospitals, 1996-2005 197
Table 4.24: Number of POCT in U.S., 2000-2011 198
Table 4.25: Global POC Revenues, 1998-2008 199
Table 4.26: Worldwide Distribution of POCT, 2005 199
Table 4.27: U.S. POCT Market, 2000-2011 200
Table 4.28: U.S. Clinical Diagnostic Test Market Segments, Revenue from Clinical Laboratory Testing, 2005 200
Table 4.29: U.S. POCT by Distribution Location, 2005 200
Table 4.30: U.S. Clinical Diagnostic POCT and Rapid Test Market Segments, 2005 201
Table 4.31: Drivers of European Diagnostics Testing 202
Table 4.32: Regional Comparison of Healthcare and IVD for Eastern Europe 203
Table 4.33: European IVD Reagent Testing Market, 2000-2012 203
Table 4.34: European Testing Diagnostics Market, 2004 203
Table 4.35: Top Dozen Country IVD Testing Markets and POC Share, 2004 204
Table 4.36: German POCT Diagnostics Products Market Sales, 2002-2007 204
Table 4.37: German Patient Care Central Lab Test Market, 2000-2008 205
Table 4.38: German Alternate Site Testing Market (POL), 2000-2008 205
Table 4.39: German Hospital POC Market, 2000-2008 205
Table 4.40: German Clinical Diagnostic Test Market Segments; Sales from Clinical Laboratory Testing, 2004 206
Table 4.41: German Clinical Diagnostic Rapid Test Market Segments 206
Table 4.42: U.K. POC Diagnostics Products Market Sales, 1998-2007 207
Table 4.43: Major U.K. IVD Manufacturers 208
Table 4.44: U.S. IVD Manufacturers Doing Business in the U.K. 208
Table 4.45: Other European Companies that Manufacture IVD Products in the U.K. 209
Table 4.46: French POC Diagnostics Products Market Sales, 1998-2007 210
Table 4.47: Italian POC Diagnostics Products Market Sales, 1998-2007 210
Table 4.48: Spanish POC Diagnostics Products Market Sales, 1998-2007 211
Table 4.49: Scandinavian POC Diagnostics Products Market Sales, 2000-2008 211
Table 4.50: Japanese POCT Market, 2000-2008 212
Table 4.51: Chinese POC Diagnostics Products Market Sales, 2000-2008 212
Table 4.52: Canadian POCT Market, 2000-2008 214
Table 4.53: Brazilian POCT Market, 2000-2008 215
Table 4.54: Turkish POCT Market, 2000-2008 215
Table 4.55: Australian POCT Market, 2000-2008 216
Table 4.56: ROW POCT Market, 2000-2007 216
Table 4.57: PAP Tests in Top European Markets 218
Table 4.58: PAP Tests in Top Asian Markets 218
Table 5.1: Normal Glucose Values—Fasting State 225
Table 5.2: Applications for Wireless LAN Technology 234
Table 7.1: Products Marketed by Abbott in the Diagnostics Market 277
Table 7.2: Products Marketed by Dade Behring in the Diagnostics Market 288
Table 7.3: Clinically Significant Tests Available From Dade 292
Table 7.4: Comparison of JEOL Analyzers 297
Table 7.5: The VITROS ECiQ Immunodiagnostic System 302
Table 7.6: Sysmex Marketing Summary for China 308
Other selected research from the 'Markets' category:
Molecular Diagnostics Markets
The technologies that constitute molecular diagnostics--like first-generation amplification, DNA probes, fluorescent in situ hybridization (FISH), second-generation biochips and microfluidics, next-generation signal detection, biosensors, and molecular labels... Learn More
RNA Interference Markets
This study defines the dollar volume of sales, both worldwide and in the U.S., and analyzes the factors that influence market size and growth for RNAi testing. Learn More
Other selected research from the 'Laboratory Testing' category:
Mass Spectroscopy for Clinical Laboratory Analysis
Mass spectroscopy is a clinical laboratory analysis technique used in determining the basic composition and structure of a sample or molecule. The process involves bending a charged beam of vaporized... Learn More
Clinical Laboratory Testing Volume 1: Reagents and Instruments
This study concentrates on the clinical laboratory instrumentation industry market segment and the companion reagents sector in the U.S. and around the world. Learn More