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 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.

This report attempts to answer the following questions:

• Which companies are the key players?
• What are the opportunities in clinical laboratory instrumentation and reagent markets?
• What is happening with the information revolution in lab instruments?
• What are the developing trends?
• Where are the new market growth areas?
• What are the most favored lab analysis technology platforms?
• Where is the laboratory analyzer instrument technology taking us?
• How is immunological technology blending with more established laboratory procedures?
• What are the business trends in the IVD industry?

This analysis reviews the market for clinical laboratory instrumentation used in clinical practice. It defines the dollar volume of sales in each major regional market, as well as 25 individual European country markets, and it analyzes the factors that influence the size and the growth of the individual market segments. The report details market sizes and growth rates for the U.S. and world markets. The study surveys some of the leading companies known to be marketing, manufacturing or developing products for the clinical laboratory instrumentation and reagent market for those sectors covered here. Each company is discussed in depth with a section on the history of the company, product lines, business and marketing analysis, and a subjective commentary of the position of the company in its market. The unique benefits of this report are:

• In-depth analysis of the major sectors of the clinical laboratory instrumentation and reagent sectors, 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 the various key sector players have forged, as well as describing financings of these market participants, giving insight into potential market collaborations.

• Examination of new technology platforms in the U.S., Japan and Europe that seek to dominate this mature market, and to identify lead positions and potential future growth areas.
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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
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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
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