1. Overview 8
1.1 Objectives of the Report 8
1.2 Methodology 9
1.3 Scope of the Report 10
1.4 Executive Summary 11
2. IVD Clinical Laboratory Market 16
2.1 Introduction 16
2.2 Independent Clinical Labs 18
2.2.1 Key Players for Independent Clinical Labs 19
2.2.2 Quest Diagnostics and LabCorp 19
2.2.3 Competitive Advantages at Quest and LabCorp 22
2.2.4 Competitive Disadvantages of Quest and LabCorp 24
2.2.5 Revenue Growth of Quest and LabCorp 24
2.2.6 Sector Consolidation 25
2.2.7 Additional Independent Clinical Laboratories 26
2.3 Hospital Market 27
2.3.1 Hospital Market Overview 27
2.3.2 Hospital Lab Testing Drivers 27
2.3.3 Evaluation Models of Laboratory Testing 28
2.3.4 GPOs and IDNs 29
2.3.5 Distributors 29
2.3.6 Clinical Lab Testing Suppliers 30
2.3.7 European Hospital Purchasing Practices 30
2.3.8 Changes in Hospital Funding 31
2.3.9 European Group Purchasing 31
2.4 POL Market 32
2.5 IVD Industry 33
2.5.1 Industry Overview 33
2.5.2 IVD Industry Leading Players Comparison and Review 34
2.5.3 Biotechnology Reagents and Supplies 48
2.5.3.1 Vendor Quality Assurance 49
2.5.3.2 Partnership Support 50
2.5.3.3 Protecting Supply of Raw Materials 51
2.5.3.4 Selecting a Second Source for Chemicals 52
2.5.3.5 Cost Analysis for Reagent Manufacture 52
2.5.3.6 Outsourcing Production of Reagents 53
2.5.4 The Fastest Growing IVD Reagent Markets 53
2.5.5 Automated Instrumentation 53
2.5.6 High Growth Applications Spur Industry Growth 54
2.6 Automated Instrument Platforms Evolution 54
2.7 Reagents and Supplies Market for Clinical Lab Instruments 54
2.8 Spending for Clinical Laboratory Testing 54
2.8.1 Reimbursement Pressure 55
2.8.2 Medicare Part B Spending Trends 57
2.8.3 Strategies for Revenue Growth 58
3. IVD Clinical Laboratory Market 59
3.1 Markets 59
3.1.1 Global Markets 59
3.1.2 Global Drivers of Clinical Laboratory Testing 61
3.1.3 Global Outlook 62
3.1.4 U.S. Market 63
3.1.5 European IVD Market 66
3.1.5.1 German Clinical Laboratory Diagnostic Markets 76
3.1.5.2 U.K. Clinical Laboratory Testing Diagnostic Market 77
3.1.5.2.1 U.K. Competitive Analysis 78
3.1.5.2.2 U.K. Market Access 79
3.1.5.3 French Clinical Laboratory Diagnostic Testing Market 80
3.1.5.4 Italian Clinical Laboratory Diagnostic Market 81
3.1.5.5 Spanish Clinical Laboratory Diagnostic Market 82
3.1.5.6 Finnish Clinical Laboratory Market 83
3.1.5.7 Turkish Clinical Laboratory Market 84
3.1.5.8 Belgium Clinical Laboratory Diagnostic Market 84
3.1.5.9 Swiss Clinical Laboratory Diagnostic Market 85
3.1.5.10 Dutch Clinical Laboratory Diagnostic Market 86
3.1.5.11 Portuguese Clinical Laboratory Diagnostic Market 87
3.1.5.12 Austrian Clinical Laboratory Diagnostic Market 88
3.1.5.13 Greek Clinical Laboratory Diagnostic Market 89
3.1.5.14 Polish Clinical Laboratory Diagnostic Market 90
3.1.5.15 Romanian Clinical Laboratory Diagnostic Market 91
3.1.5.16 Czech Republic Clinical Laboratory Diagnostic Market 92
3.1.5.17 Swedish Clinical Laboratory Diagnostic Market 93
3.1.5.18 Norwegian Clinical Laboratory Diagnostic Market 93
3.1.5.19 Irish Clinical Laboratory Diagnostic Market 94
3.1.5.20 Hungarian Clinical Laboratory Diagnostic Market 94
3.1.5.21 Bulgarian Clinical Laboratory Diagnostic Market 95
3.1.5.22 Slovakian Clinical Laboratory Diagnostic Market 95
3.1.5.23 Lithuanian Clinical Laboratory Diagnostic Market 96
3.1.5.24 Latvian Clinical Laboratory Diagnostic Market 96
3.1.5.25 Estonian Clinical Laboratory Diagnostic Market 97
3.1.5.26 Slovenian Clinical Laboratory Diagnostic Market 97
3.1.6 Asian Markets 98
3.1.6.1 Indian Clinical Laboratory Diagnostic Market 98
3.1.6.1.1 Indian IVD Testing Industry 98
3.1.6.2 Japanese Clinical Laboratory Testing Market 103
3.1.6.3 Chinese Clinical Laboratory Market 103
3.1.7 Clinical Laboratory Smaller Country Markets 111
3.1.7.1 Canadian Clinical Laboratory Market 111
3.1.7.2 Brazilian Clinical Laboratory Market 112
3.1.7.3 Australian Clinical Laboratory Market 112
3.1.8 ROW Clinical Laboratory Testing Market 113
3.1.9 Overview of Asian Healthcare Market 113
3.1.9.1 Singapore 114
3.1.9.2 Malaysia 115
3.1.9.3 Thailand 116
3.1.9.4 Indonesia 116
3.1.9.5 Philippines 116
3.1.9.6 South Korea 116
3.1.9.7 India 117
3.1.9.8 Hong Kong 117
3.1.9.9 Taiwan 117
3.1.10 Overview of the Latin American Diagnostics Market 118
3.2 Clinical Laboratory Sector 118
3.2.1 Worldwide IVD Sales 118
3.2.1.1 POLs 120
3.2.2 Industry Players 125
3.2.2.1 Manufacturing Companies 125
3.2.3 Market Specialization 126
3.2.4 Revenue and Reimbursement 128
3.2.5 Companies 129
3.3 Outlook for Clinical Laboratory Testing 130
3.3.1 Long-Term Changes 130
3.3.2 Market Drivers 131
3.3.3 The Limits to Growth 132
3.3.4 Hot Sectors in the IVD Market 133
3.3.5 Key Technologies 135
3.3.6 Conclusion 135
4. Clinical Laboratory Instrument Market by Sector 136
4.1 Chemistry Analyzers 136
4.1.1 Ultra-Large Throughput Laboratory Analyzers 136
4.1.2 Large-Throughput Analyzers 143
4.1.3 Mid-Size Clinical Laboratory Analyzers 154
4.1.4 Laboratory Analyzers for the Small Volume Market 158
4.2 Immunochemistry Analyzers 165
4.2.1 Large Immunochemistry Analyzers 165
4.2.2 Small Immunoassay Analyzers 174
4.3 Hematology Analyzers 176
4.4 Point of Care Testing 192
4.6 Cytology Testing 196
4.7 Microbiology Testing 198
4.8 Serology Testing 198
4.9 Esoteric Testing 198
4.10 Anatomic Pathology 199
4.11 Drug Testing 199
5. Important Technology Trends in IVD Instrumentation and Reagents 200
5.1 Technology Innovations in Instrument and Reagent Development 200
5.2 Sensor Systems for Diagnostic Applications 200
5.3 Glucose Measurements 205
5.4 Glucose Test Methods 207
5.5 Cholesterol Measurements 208
5.6 The New Paradigm 209
5.7 Consolidated Workstations 209
5.8 Automation in the Laboratory 211
5.9 Laboratory Information Systems 212
5.10 New User-friendly Interfaces 213
5.11 Biosensor Technology 214
5.12 Data-Management Issues 216
5.12.1 Wireless LANs 216
5.12.2 Cepheid’s POC GBS and BCR/ABL Tests 216
5.12.3 Data and Workflow Management Systems 217
5.12.4 Beckman Central Command 217
6. Business Trends in the Clinical Laboratory Analyzer and Reagents Market 218
6.1 Key Market Developments 218
6.1.1 Decreasing Revenue from Traditional IVD Markets 218
6.1.2 High Growth in POCT and Molecular Diagnostics Arena 218
6.1.3 Move Away from Traditional Kit Testing Methods 219
6.1.4 Integrated Analytical Systems 219
6.1.5 Regulatory Changes 220
6.1.6 Development of a Two-Tier Industry Structure 220
6.1.7 Labor Costs 220
6.1.8 Increasing Value of Companies with High-Margin Technology Platforms 220
6.1.9 The Joining of IVD Testing and Computer Technology 221
6.1.10 User-Friendly User Interfaces 221
6.2 Sector Consolidation 222
6.2.1 IVD Company Consolidation 222
6.2.2 Lab Company Consolidation 225
6.2.2.1 Acquisition Pricing 226
6.2.2.2 A Closer Look at Six Big Lab Deals 226
6.3 Diagnostic Testing Growth Trends 228
6.4 Reagent and Hardware Business in Japan 228
6.5 New Products 228
6.6 Acquisition, License Agreements, Internal Development and Partnerships 229
6.7 Product Testing Depth in Clinical Laboratory Testing 230
6.8 Government Regulation of IVD Devices 230
6.8.1 U.S. Regulation 230
6.8.1.1 Importing Medical Devices into the U.S. 232
6.8.1.2 Exporting Medical Devices from the U.S. 233
6.8.2 U.K. Regulation 233
6.8.3 E.U. Regulation 234
6.8.3.1 France 236
6.8.4 Japanese Regulation 237
6.8.5 Korean Regulation 237
6.8.6 Chinese Regulation 237
6.9 Increased Market Penetration 238
6.10 Costs of Doing Business in Europe 239
6.11 Drivers of European Diagnostics Testing 239
6.12 European Reimbursement Practices 239
6.13 Cost Containment in Europe 240
6.14 Hospital Outreach Programs 240
6.15 Electronic Procurement: New Challenges 240
6.16 Competition for Supply Chain Management Solutions 243
6.17 E-Commerce in the Hospital Supply Chain 244
6.17.1 Drivers of E-Commerce Solutions 244
6.17.2 Barriers to E-Commerce Solutions 245
6.18 Top Trends in Laboratory Business Practices 247
6.19 The Value of the New Diagnostics 247
6.20 Converging Technologies—Drugs and Diagnostic Tests Combine for Improved Healthcare 248
6.21 Emerging Technologies in the Downstream Manufacture of Bio-Materials 248
6.22 GMP Readiness 248
6.23 Harnessing Human Resource Capabilities and IT Prowess: Biotechnology in the Future 248
6.24 Partnering with Patient-Based Organizations to Achieve Patient Health Goals 249
6.25 Rumors of the Platform Company’s Demise are Greatly Exaggerated 249
6.26 Who’s Going to Pay for It? 249
7. Company Profiles 252
7.1 Abaxis 252
7.2 Abbott 252
7.3 Adaltis, Inc. 255
7.4 Alfa Wasserman, Inc. (formerly Electro-Nucleonics, Inc. and Schiapparelli Biosystems, Inc.) 255
7.5 Awareness Technology 256
7.6 Beckman Coulter, Inc. 256
7.7 Bio-Reference Laboratories, Inc. 264
7.8 Dade Behring, Inc. 264
7.9 Enzo Biochem, Inc. 265
7.10 Genomic Health, Inc. 265
7.11 Hitachi 265
7.12 Horiba Ltd. 266
7.13 JEOL Ltd. 267
7.14 LabCorp 268
7.15 MEDTOX Scientific, Inc. 268
7.16 Monogram Biosciences, Inc. 269
7.17 Myriad Genetics, Inc. 269
7.18 Nova Biomedical 269
7.19 Olympus America, Inc. Diagnostic Systems Division 270
7.20 Ortho-Clinical Diagnostics, a J&J Company 271
7.21 Psychemedics Corporation 274
7.22 Quest Diagnostics, Inc. 274
7.23 Roche Diagnostics Corp. 275
7.24 Shimadzu 278
7.25 Sysmex Corporation 278
7.26 Thermo Fisher Scientific, Inc. 279
7.27 Vital Scientific, NV 281
LIST OF FIGURES
Figure 2.1: Clinical Laboratory Testing Sector Providers 17
Figure 2.2: Part B Spending on Clinical Laboratory Services, 1991-2007 57
Figure 3.1: IVD Product Demand 63
Figure 3.2: European IVD Market by Clinical Specialty 70
Figure 3.3: Chinese IVD Market, 2006-2012 104
Figure 3.4: Annual Worldwide IVD Market Growth, 2003-2012 119
Figure 3.5: POL Revenue, 2000-2006 121
Figure 3.6: Unweighted Average Medicare Reimbursement for Ten Most Common POL Tests, 2002 vs. 2006 121
Figure 3.7: Total Number of Non-Waived POLs, 2000-2006 122
Figure 3.8: Number of New Tests Granted CLIA-Waived Status, 2000-2006 123
Figure 3.9: High-Volume Waived Tests 124
Figure 6.1: Average Revenue-Multiple Paid to Acquire Labs, 2000-2006 226
Figure 6.2: Hospital Market Share for Outreach Programs 240
LIST OF TABLES
Table 2.1: Total U.S. Clinical Laboratory Revenue from Third Party and Direct Payment, 2005-2012 17
Table 2.2: U.S. Clinical Laboratory Diagnostic Test Market Segments, 2007 18
Table 2.3: Independent Commercial Laboratory Testing Market Value, 2005-2012 18
Table 2.4: Independent Commercial Laboratory Testing Test Volume, 2005-2012 18
Table 2.5: Leading U.S. Reference Laboratories Grouped by Market Capitalization, 2008 19
Table 2.6: Revenue Growth at Quest Diagnostics, 2000-2008 24
Table 2.7: Revenue Growth at LabCorp, 2000-2008 25
Table 2.8: Quest’s Total Volume of Requisitions and Net Revenues from Clinical Laboratory Testing, 2007 25
Table 2.9: Number of Hospital Based Clinical Laboratory Tests in the U.S., 2002-2008 27
Table 2.10: European Cardiovascular Disease Management Expenditures, 2003-2010 31
Table 2.11: U.S. Doctor’s Office Lab Test Dollar Volume and Growth Rates, 2006 32
Table 2.12: Worldwide Alternate Site Clinical Lab Instrument and Reagents Sales, 2005-2012 33
Table 2.13: Thirteen Largest Diagnostic Companies Worldwide, 2007 34
Table 2.14: Products Marketed by Abbott in the Diagnostic Market 39
Table 2.15: Prodesse’s ASRs 49
Table 2.16: Allowed Charges for Top 25 Clinical Laboratory Procedures, 2009 58
Table 3.1: Worldwide IVD Testing Market, 2008 59
Table 3.2: Worldwide Distribution of IVD Testing, 2008 59
Table 3.3: Global Clinical Laboratory Market Sales, 1998-2012 60
Table 3.4: Thirteen Largest Diagnostic Companies Worldwide, 2007 61
Table 3.5: U.S. Clinical Laboratory Testing Market, 2003-2012 64
Table 3.6: U.S. Clinical Laboratory Diagnostic Test Market Segments, 2007 64
Table 3.7: U.S. Clinical Diagnostic POCT and Rapid Test Market Segments, 2007 65
Table 3.8: U.S. Individual Clinical Chemistry Laboratory Diagnostic Test Markets, 2007 65
Table 3.9: European Clinical Laboratory Testing IVD Reagents and Instruments Market, 2000-2012 66
Table 3.10: European Clinical Laboratory Diagnostic Testing Reagents and Instruments Market by Analyte, 2006 66
Table 3.11: European Clinical Chemistry Testing IVD Reagents and Instruments Market, 2000-2012 67
Table 3.12: European Clinical Laboratory Testing Diagnostics by Country Market, 2008 68
Table 3.13: European Rapid POCT by Country Market, 2008 69
Table 3.14: European Patient Self Testing OTC Diagnostics by Country Market, 2006 69
Table 3.15: German Clinical Laboratory Testing Diagnostics Products Market Sales, 2003-2012 76
Table 3.16: German Clinical Diagnostic Rapid Test Market Segments, 2008 76
Table 3.17: U.K. Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 77
Table 3.18: U.K. Clinical Diagnostic Rapid Test Market Segments, 2008 78
Table 3.19: Major U.K. IVD Manufacturers 79
Table 3.20: U.S. IVD Manufacturers Doing Business in the U.K. 79
Table 3.21: Other European Companies that Manufacture IVD Products in the U.K. 79
Table 3.22: French Clinical IVD Testing Diagnostics Products Market Sales, 2003-2012 80
Table 3.23: French Clinical Diagnostic Rapid Test Market Segments, 2008 80
Table 3.24: Italian Laboratory Diagnostics Products Market Sales, 2003-2012 81
Table 3.25: Italian Clinical Diagnostic Rapid Test Market Segments, 2008 82
Table 3.26: Spanish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 82
Table 3.27: Spanish Clinical Diagnostic Rapid Test Market Segments, 2008 83
Table 3.28: Finnish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 83
Table 3.29: Turkish Clinical Laboratory Testing Market, 2000-2012 84
Table 3.30: Belgium Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 84
Table 3.31: Belgium Clinical Reagents and Instruments Market, 2006 85
Table 3.32: Swiss Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 85
Table 3.33: Swiss Clinical Reagents and Instruments Market, 2006 86
Table 3.34: Dutch Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 86
Table 3.35: Dutch Clinical Reagents and Instruments Market, 2006 87
Table 3.36: Portuguese Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 87
Table 3.37: Portuguese Clinical Reagents and Instruments Market, 2006 88
Table 3.38: Austrian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 88
Table 3.39: Austrian Clinical Reagents and Instruments Market, 2006 89
Table 3.40: Greek Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 89
Table 3.41: Greek Clinical Reagents and Instruments Market, 2006 90
Table 3.42: Polish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 90
Table 3.43: Polish Clinical Reagents and Instruments Market, 2006 91
Table 3.44: Romanian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 91
Table 3.45: Romanian Clinical Reagents and Instruments Market, 2006 92
Table 3.46: Czech Republic Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 92
Table 3.47: Swedish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 93
Table 3.48: Norwegian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 93
Table 3.49: Irish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 94
Table 3.50: Hungarian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 94
Table 3.51: Bulgarian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 95
Table 3.52: Slovakian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 95
Table 3.53: Lithuanian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 96
Table 3.54: Latvian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 96
Table 3.55: Estonian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 97
Table 3.56: Slovenian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 97
Table 3.57: Indian IVD Market for Instruments and Reagents, 2004-2012 98
Table 3.58: Number of Automated Clinical Labs in India, 2004-2012 98
Table 3.59: Indian IVD Market, 2008 99
Table 3.60: Japanese Clinical Laboratory Testing Instrument and Reagents Market, 2003-2012 103
Table 3.61: Chinese Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 104
Table 3.62: Chinese IVD Market, 2008 104
Table 3.63: Proportion of Medical Expenses Paid Privately 106
Table 3.64: Chinese International IVD Manufacturers 107
Table 3.65: Chinese Domestic IVD Manufacturers 108
Table 3.66: Chinese IVD Distributors 110
Table 3.67: Canadian Clinical Laboratory Testing Market, 2000-2008 111
Table 3.68: Brazilian Clinical Laboratory Testing Market, 2000-2008 112
Table 3.69: Australian Clinical Laboratory Testing Market, 2000-2008 112
Table 3.70: ROW Clinical Laboratory Testing Market, 2000-2008 113
Table 3.71: Number of Clinical Laboratories in Latin America 118
Table 3.72: Twenty Most Common Laboratory Tests Offered at Family Physician Offices 125
Table 3.73: Important New Waived Tests 125
Table 3.74: Principal Marketers of Automated Clinical Laboratory Instruments 126
Table 3.75: Key Market Drivers of Automated Clinical Laboratory Instruments 131
Table 3.76: Key Market Limits of Automated Clinical Laboratory Instruments 133
Table 4.1: Ultra-Large Clinical Laboratory Analyzers 143
Table 4.2: JEOL Analyzer Comparison 151
Table 4.3: Large Clinical Laboratory Analyzers 154
Table 4.4: Mid-size Clinical Laboratory Analyzers 158
Table 4.5: Small Clinical Laboratory Analyzers 164
Table 4.6: Large Immunochemistry Analyzers 173
Table 4.7: Small Immunoassay Analyzers 176
Table 4.8: Linearity and Precision of Abbott CELL-DYN Hematology Analyzers 178
Table 4.9: Accuracy of the Automated Differential of Abbott CELL-DYN Analyzers 179
Table 4.10: Linearity and Precision of Siemens Hematology Analyzers 180
Table 4.11: Accuracy of the Automated Differential of Siemens Hematology Analyzers 181
Table 4.12: Linearity and Precision of Beckman Coulter Hematology Instruments 183
Table 4.13: Accuracy of the Automated Differential of Beckman Coulter Hematology Analyzers 183
Table 4.14: Linearity and Precision of Horiba ABX Hematology Analyzers 185
Table 4.15: Accuracy of the Horiba ABX Hematology Analyzers 186
Table 4.16: Linearity and Precision of Sysmex Hematology Analyzers 189
Table 4.17: Accuracy of the Sysmex Hematology Analyzers 189
Table 4.18: Comparison of Linearity and Precision of Top-of-the-Line Hematology Analyzers 190
Table 4.19: Comparison of Accuracy of the Top-of-the-Line Hematology Analyzers 190
Table 4.20: Hematology Analyzers with a Five-Part WBC Differential 191
Table 4.21: Hematology Analyzers with a Three-Part WBC Differential 191
Table 4.22: Point of Care Testing 193
Table 4.23: Number of ER Visits in U.S. Hospitals, 1997-2007 195
Table 4.24: Number of POCT in U.S., 2000-2012 195
Table 4.25: PAP Tests in Top European Markets 197
Table 4.26: PAP Tests in Top Asian Markets 197
Table 5.1: Normal Glucose Values—Fasting State 207
Table 5.2: Applications for Wireless LAN Technology 216
Table 7.1: Products Marketed by Abbott in the Diagnostics Market 253
Table 7.2: Comparison of JEOL Analyzers 267
Table 7.3: The VITROS ECiQ Immunodiagnostic System 273
Table 7.4: Sysmex Marketing Summary for China 279 |
