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 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.
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.
Table of Contents
- 1.Overview8
- 1.1Objectives of the Report8
- 1.2Methodology9
- 1.3Scope of the Report10
- 1.4Executive Summary11
- 2.IVD Clinical Laboratory Market16
- 2.1Introduction16
- 2.2Independent Clinical Labs18
- 2.2.1Key Players for Independent Clinical Labs19
- 2.2.2Quest Diagnostics and LabCorp19
- 2.2.3Competitive Advantages at Quest and LabCorp22
- 2.2.4Competitive Disadvantages of Quest and LabCorp24
- 2.2.5Revenue Growth of Quest and LabCorp24
- 2.2.6Sector Consolidation25
- 2.2.7Additional Independent Clinical Laboratories26
- 2.3Hospital Market27
- 2.3.1Hospital Market Overview27
- 2.3.2Hospital Lab Testing Drivers27
- 2.3.3Evaluation Models of Laboratory Testing28
- 2.3.4GPOs and IDNs29
- 2.3.5Distributors29
- 2.3.6Clinical Lab Testing Suppliers30
- 2.3.7European Hospital Purchasing Practices30
- 2.3.8Changes in Hospital Funding31
- 2.3.9European Group Purchasing31
- 2.4POL Market32
- 2.5IVD Industry33
- 2.5.1Industry Overview33
- 2.5.2IVD Industry Leading Players Comparison and Review34
- 2.5.3Biotechnology Reagents and Supplies48
- 2.5.3.1Vendor Quality Assurance49
- 2.5.3.2Partnership Support50
- 2.5.3.3Protecting Supply of Raw Materials51
- 2.5.3.4Selecting a Second Source for Chemicals52
- 2.5.3.5Cost Analysis for Reagent Manufacture52
- 2.5.3.6Outsourcing Production of Reagents53
- 2.5.4The Fastest Growing IVD Reagent Markets53
- 2.5.5Automated Instrumentation53
- 2.5.6High Growth Applications Spur Industry Growth54
- 2.6Automated Instrument Platforms Evolution54
- 2.7Reagents and Supplies Market for Clinical Lab Instruments54
- 2.8Spending for Clinical Laboratory Testing54
- 2.8.1Reimbursement Pressure55
- 2.8.2Medicare Part B Spending Trends57
- 2.8.3Strategies for Revenue Growth58
- 3.IVD Clinical Laboratory Market59
- 3.1Markets59
- 3.1.1Global Markets59
- 3.1.2Global Drivers of Clinical Laboratory Testing61
- 3.1.3Global Outlook62
- 3.1.4U.S. Market63
- 3.1.5European IVD Market66
- 3.1.5.1German Clinical Laboratory Diagnostic Markets76
- 3.1.5.2U.K. Clinical Laboratory Testing Diagnostic Market77
- 3.1.5.2.1 U.K. Competitive Analysis78
- 3.1.5.2.2 U.K. Market Access79
- 3.1.5.3French Clinical Laboratory Diagnostic Testing Market80
- 3.1.5.4Italian Clinical Laboratory Diagnostic Market81
- 3.1.5.5Spanish Clinical Laboratory Diagnostic Market82
- 3.1.5.6Finnish Clinical Laboratory Market83
- 3.1.5.7Turkish Clinical Laboratory Market84
- 3.1.5.8Belgium Clinical Laboratory Diagnostic Market84
- 3.1.5.9Swiss Clinical Laboratory Diagnostic Market85
- 3.1.5.10Dutch Clinical Laboratory Diagnostic Market86
- 3.1.5.11Portuguese Clinical Laboratory Diagnostic Market87
- 3.1.5.12Austrian Clinical Laboratory Diagnostic Market88
- 3.1.5.13Greek Clinical Laboratory Diagnostic Market89
- 3.1.5.14Polish Clinical Laboratory Diagnostic Market90
- 3.1.5.15Romanian Clinical Laboratory Diagnostic Market91
- 3.1.5.16Czech Republic Clinical Laboratory Diagnostic Market92
- 3.1.5.17Swedish Clinical Laboratory Diagnostic Market93
- 3.1.5.18Norwegian Clinical Laboratory Diagnostic Market93
- 3.1.5.19Irish Clinical Laboratory Diagnostic Market94
- 3.1.5.20Hungarian Clinical Laboratory Diagnostic Market94
- 3.1.5.21Bulgarian Clinical Laboratory Diagnostic Market95
- 3.1.5.22Slovakian Clinical Laboratory Diagnostic Market95
- 3.1.5.23Lithuanian Clinical Laboratory Diagnostic Market96
- 3.1.5.24Latvian Clinical Laboratory Diagnostic Market96
- 3.1.5.25Estonian Clinical Laboratory Diagnostic Market97
- 3.1.5.26Slovenian Clinical Laboratory Diagnostic Market97
- 3.1.6Asian Markets98
- 3.1.6.1Indian Clinical Laboratory Diagnostic Market98
- 3.1.6.1.1Indian IVD Testing Industry98
- 3.1.6.2Japanese Clinical Laboratory Testing Market103
- 3.1.6.3Chinese Clinical Laboratory Market103
- 3.1.6.1Indian Clinical Laboratory Diagnostic Market98
- 3.1.7Clinical Laboratory Smaller Country Markets111
- 3.1.7.1Canadian Clinical Laboratory Market111
- 3.1.7.2Brazilian Clinical Laboratory Market112
- 3.1.7.3Australian Clinical Laboratory Market112
- 3.1.8ROW Clinical Laboratory Testing Market113
- 3.1.9Overview of Asian Healthcare Market113
- 3.1.9.1Singapore114
- 3.1.9.2Malaysia115
- 3.1.9.3Thailand116
- 3.1.9.4Indonesia116
- 3.1.9.5Philippines116
- 3.1.9.6South Korea116
- 3.1.9.7India117
- 3.1.9.8Hong Kong117
- 3.1.9.9Taiwan117
- 3.1.10 Overview of the Latin American Diagnostics Market118
- 3.2Clinical Laboratory Sector118
- 3.2.1Worldwide IVD Sales118
- 3.2.1.1POLs120
- 3.2.2Industry Players125
- 3.2.2.1Manufacturing Companies125
- 3.2.3Market Specialization126
- 3.2.4Revenue and Reimbursement128
- 3.2.5Companies129
- 3.2.1Worldwide IVD Sales118
- 3.3Outlook for Clinical Laboratory Testing130
- 3.3.1Long-Term Changes130
- 3.3.2Market Drivers131
- 3.3.3The Limits to Growth132
- 3.3.4Hot Sectors in the IVD Market133
- 3.3.5Key Technologies135
- 3.3.6Conclusion135
- 3.1Markets59
- 4.Clinical Laboratory Instrument Market by Sector136
- 4.1Chemistry Analyzers136
- 4.1.1Ultra-Large Throughput Laboratory Analyzers136
- 4.1.2Large-Throughput Analyzers143
- 4.1.3Mid-Size Clinical Laboratory Analyzers154
- 4.1.4Laboratory Analyzers for the Small Volume Market158
- 4.2Immunochemistry Analyzers165
- 4.2.1Large Immunochemistry Analyzers165
- 4.2.2Small Immunoassay Analyzers174
- 4.3Hematology Analyzers176
- 4.4Point of Care Testing192
- 4.6Cytology Testing196
- 4.7Microbiology Testing198
- 4.8Serology Testing198
- 4.9Esoteric Testing198
- 4.10Anatomic Pathology199
- 4.11Drug Testing199
- 4.1Chemistry Analyzers136
- 5.Important Technology Trends in IVD Instrumentation and Reagents200
- 5.1Technology Innovations in Instrument and Reagent Development200
- 5.2Sensor Systems for Diagnostic Applications200
- 5.3Glucose Measurements205
- 5.4Glucose Test Methods207
- 5.5Cholesterol Measurements208
- 5.6The New Paradigm209
- 5.7Consolidated Workstations209
- 5.8Automation in the Laboratory211
- 5.9Laboratory Information Systems212
- 5.10New User-friendly Interfaces213
- 5.11Biosensor Technology214
- 5.12Data-Management Issues216
- 5.12.1Wireless LANs216
- 5.12.2Cepheid\'s POC GBS and BCR/ABL Tests216
- 5.12.3Data and Workflow Management Systems217
- 5.12.4Beckman Central Command217
- 6.Business Trends in the Clinical Laboratory Analyzer and Reagents Market218
- 6.1Key Market Developments218
- 6.1.1Decreasing Revenue from Traditional IVD Markets218
- 6.1.2High Growth in POCT and Molecular Diagnostics Arena218
- 6.1.3Move Away from Traditional Kit Testing Methods219
- 6.1.4Integrated Analytical Systems219
- 6.1.5Regulatory Changes220
- 6.1.6Development of a Two-Tier Industry Structure220
- 6.1.7Labor Costs220
- 6.1.8Increasing Value of Companies with High-Margin Technology Platforms220
- 6.1.9The Joining of IVD Testing and Computer Technology221
- 6.1.10User-Friendly User Interfaces221
- 6.2Sector Consolidation222
- 6.2.1IVD Company Consolidation222
- 6.2.2Lab Company Consolidation225
- 6.2.2.1Acquisition Pricing226
- 6.2.2.2A Closer Look at Six Big Lab Deals226
- 6.3Diagnostic Testing Growth Trends228
- 6.4Reagent and Hardware Business in Japan228
- 6.5New Products228
- 6.6Acquisition, License Agreements, Internal Development and Partnerships229
- 6.7Product Testing Depth in Clinical Laboratory Testing230
- 6.8Government Regulation of IVD Devices230
- 6.8.1U.S. Regulation230
- 6.8.1.1Importing Medical Devices into the U.S.232
- 6.8.1.2Exporting Medical Devices from the U.S.233
- 6.8.2U.K. Regulation233
- 6.8.3E.U. Regulation234
- 6.8.3.1France236
- 6.8.4Japanese Regulation237
- 6.8.5Korean Regulation237
- 6.8.6Chinese Regulation237
- 6.8.1U.S. Regulation230
- 6.9Increased Market Penetration238
- 6.10Costs of Doing Business in Europe239
- 6.11Drivers of European Diagnostics Testing239
- 6.12European Reimbursement Practices239
- 6.13Cost Containment in Europe240
- 6.14Hospital Outreach Programs240
- 6.15Electronic Procurement: New Challenges240
- 6.16Competition for Supply Chain Management Solutions243
- 6.17E-Commerce in the Hospital Supply Chain244
- 6.17.1Drivers of E-Commerce Solutions244
- 6.17.2Barriers to E-Commerce Solutions245
- 6.18Top Trends in Laboratory Business Practices247
- 6.19The Value of the New Diagnostics247
- 6.20Converging Technologies-Drugs and Diagnostic Tests Combine for Improved Healthcare248
- 6.21Emerging Technologies in the Downstream Manufacture of Bio-Materials248
- 6.22GMP Readiness248
- 6.23Harnessing Human Resource Capabilities and IT Prowess: Biotechnology in the Future248
- 6.24Partnering with Patient-Based Organizations to Achieve Patient Health Goals249
- 6.25Rumors of the Platform Company\'s Demise are Greatly Exaggerated249
- 6.26Who\'s Going to Pay for It?249
- 6.1Key Market Developments218
- 7.Company Profiles252
- 7.1Abaxis252
- 7.2Abbott252
- 7.3Adaltis, Inc.255
- 7.4Alfa Wasserman, Inc. (formerly Electro-Nucleonics, Inc. and Schiapparelli Biosystems, Inc.)255
- 7.5Awareness Technology256
- 7.6Beckman Coulter, Inc.256
- 7.7Bio-Reference Laboratories, Inc.264
- 7.8Dade Behring, Inc.264
- 7.9Enzo Biochem, Inc.265
- 7.10Genomic Health, Inc.265
- 7.11Hitachi265
- 7.12Horiba Ltd.266
- 7.13JEOL Ltd.267
- 7.14LabCorp268
- 7.15MEDTOX Scientific, Inc.268
- 7.16Monogram Biosciences, Inc.269
- 7.17Myriad Genetics, Inc.269
- 7.18Nova Biomedical269
- 7.19Olympus America, Inc. Diagnostic Systems Division270
- 7.20Ortho-Clinical Diagnostics, a J&J Company271
- 7.21Psychemedics Corporation274
- 7.22Quest Diagnostics, Inc.274
- 7.23Roche Diagnostics Corp.275
- 7.24Shimadzu278
- 7.25Sysmex Corporation278
- 7.26Thermo Fisher Scientific, Inc.279
- 7.27Vital Scientific, NV281
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