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 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 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 Regulatio