Clinical Chemistry Analyzers
Clinical chemistry analysis is one of the most important areas within clinical laboratory analysis. The term clinical chemistry usually refers to determining the concentration or activity of a protein, carbohydrate, lipid, electrolyte, enzyme or small molecule in easily-collected bodily fluids such as blood, serum, plasma or urine. However, it is not necessarily limited to these determinations. The analysis of virtually any biologically-active substance—any place in the body—can loosely be defined as clinical chemistry. In fact, traditional specialization barriers such as microbiology, hematology, blood banking, immunology and even anatomical pathology are rapidly fading, both operationally and instrumentally. But for the sake of defining the subject to a reasonable size, the more traditional scope of clinical chemistry will be the subject of this study.
The purpose of this report is to examine the markets for small lab and highly-automated, large lab platforms, as well as accessory equipment such as reagents, supplies and manufacturers’ original equipment manufacturer (OEM) additional equipment. The emphasis is on those companies and products that are actively developing and marketing chemistry analyzer products for the clinical setting, including hospitals, independent labs, physician’s offices and clinics. Concentration is on the clinical chemistry instrumentation industry market segment in the U.S. and around the world. Particular attention is paid to those areas of the clinical chemistry instrumentation sector that are showing the greatest growth or the most innovation.
Table of Contents
- 1. Overview6
- 1.1Objectives of the Report6
- 1.2Methodology6
- 1.3Scope of the Report7
- 1.4Executive Summary7
- 2.IVD Clinical Chemistry Market9
- 2.1Introduction9
- 3.IVD Clinical Chemistry Market10
- 3.1Markets10
- 3.1.1Global Markets10
- 3.1.2Global Drivers of Clinical Chemistry Testing11
- 3.1.3Global Outlook12
- 3.1.4U.S. Market13
- 3.1.5European Market14
- 3.1.5.1German Clinical Chemistry Diagnostic Markets15
- 3.1.5.2U.K. Clinical Chemistry Testing Diagnostic Market17
- 3.1.5.2.1U.K. Market Statistics18
- 3.1.5.2.2 U.K. Competitive Analysis18
- 3.1.5.2.3 U.K. Market Access19
- 3.1.5.3French Clinical Chemistry Diagnostic Market19
- 3.1.5.4Italian Clinical Chemistry Diagnostic Market20
- 3.1.5.5Spanish Clinical Chemistry Diagnostic Market20
- 3.1.5.6Indian Clinical Chemistry Diagnostic Market20
- 3.1.5.6.1 India's In Vitro Diagnostic Testing Industry20
- 3.1.5.7Scandinavian Clinical Chemistry Market22
- 3.1.5.8Japanese Clinical Chemistry Testing Market23
- 3.1.5.9Country Clinical Chemistry Smaller Markets23
- 3.1.5.9.1 Chinese Clinical Chemistry Market23
- 3.1.5.9.2 Canada Clinical Chemistry Market27
- 3.1.5.9.3 Brazil Clinical Chemistry Market27
- 3.1.5.9.4 Turkey Clinical Chemistry Market27
- 3.1.5.9.5 Australia Clinical Chemistry Market28
- 3.1.5.10Remaining World Clinical Chemistry Testing Market28
- 3.1.5.11Overview of Asian Healthcare Market28
- 3.1.5.11.1 Singapore28
- 3.1.5.11.2 Malaysia29
- 3.1.5.11.3 Thailand29
- 3.1.5.11.4 Indonesia29
- 3.1.5.11.5 Philippines30
- 3.1.5.11.6 South Korea30
- 3.1.5.11.7 India31
- 3.1.5.11.8 Hong Kong31
- 3.1.5.11.9 Taiwan31
- 3.1.5.12Overview of the Latin American Diagnostics Market31
- 3.2Clinical Chemistry Sector32
- 3.2.1Industry-Served Markets32
- 3.2.2Industry Players34
- 3.2.2.1Manufacturing Companies34
- 3.2.3Market Specialization34
- 3.2.4Revenue and Reimbursement36
- 3.2.5Companies37
- 3.3Outlook for Clinical Chemistry Testing38
- 3.3.1Long-Term Changes38
- 3.3.2Market Drivers39
- 3.3.3The Limits to Growth40
- 3.3.4Hot Sectors in the IVD Market40
- 3.3.5Key Technologies40
- 3.3.6Conclusion41
- 3.1Markets10
- 4.Clinical Chemistry Instrument Market by Sector: Size, Growth, Share and Competitors42
- 4.1Ultra-Large Throughput Chemistry Analyzers42
- 4.2 Large-Throughput Analyzers49
- 4.3Mid-Size Clinical Chemistry Analyzers59
- 4.4Chemistry Analyzers for the Small Volume Market63
- 5.Important Technology Trends69
- 5.1Technology Platform Innovations in Point-of-Care Testing69
- 5.2Sensor Systems for Diagnostic Applications69
- 5.3Glucose Measurements71
- 5.4Glucose Test Methods74
- 5.5Cholesterol Measurements74
- 5.6The New Paradigm75
- 5.7Consolidated Workstations75
- 5.8Automation in the Laboratory77
- 5.9Laboratory Information Systems78
- 5.10Biosensor Technology78
- 5.11Data-Management Issues80
- 5.11.1Wireless LANs80
- 5.11.2Data and Workflow Management Systems80
- 5.11.3Beckman Central Command81
- 6.Business Trends in the Clinical Chemistry Analyzer Sector82
- 6.1Key Developments82
- 6.2Sector Consolidation82
- 6.3Diagnostic Testing Growth Trends83
- 6.4Reagent and Hardware Business in Japan84
- 6.5New Products84
- 6.6Acquisition, License Agreements, Internal Development and Partnerships84
- 6.7Product Testing Depth in Clinical Chemistry Testing85
- 6.8Government Regulation85
- 6.8.1U.S. Regulation85
- 6.8.1.1Importing Medical Devices Into the U.S.86
- 6.8.1.2Exporting Medical Devices From the U.S.87
- 6.8.2U.K. Regulation87
- 6.8.3E.U. Regulation89
- 6.8.4Japanese Regulation90
- 6.8.5Korean Regulation91
- 6.8.1U.S. Regulation85
- 6.9Increased Market Penetration91
- 6.10Costs of Doing Business in Europe93
- 6.11Drivers of European Diagnostics Testing93
- 6.12European Reimbursement Practices93
- 6.13Cost Containment in Europe93
- 7.Company Profiles94
- 7.1Abaxis94
- 7.1.1Point-of-Care Blood Chemistry Analyzers94
- 7.1.2Hematology94
- 7.1.3Reagent Discs94
- 7.1.4Orbos Process94
- 7.1.5VetScan Canine Heartworm Antigen Test95
- 7.2Abbott Diagnostics95
- 7.2.1Diagnostic Products95
- 7.2.2Business Analysis97
- 7.2.3TriMark Commentary98
- 7.3Adaltis, Inc.99
- 7.4Alfa Wasserman, Inc. (f/k/a Electro-Nucleonics, Inc. and Schiapparelli Biosystems, Inc.)99
- 7.4.1Background99
- 7.4.2Products100
- 7.5Awareness Technology100
- 7.6Bayer Diagnostics100
- 7.6.1Background101
- 7.6.2General Automated Clinical Chemistry Instruments101
- 7.6.2.1Advia® 2400, 1800, 1650 and 1200 Chemistry Systems101
- 7.6.3Business Analysis103
- 7.6.4TriMark Commentary103
- 7.7Beckman Coulter, Inc.103
- 7.7.1Overview103
- 7.7.2Company History104
- 7.7.3Products104
- 7.7.3.1Clinical Diagnostics Products104
- 7.7.3.1.1 Overview104
- 7.7.3.2Clinical Chemistry Systems105
- 7.7.3.3Clinical Laboratory Automation105
- 7.7.3.4Hemostasis Systems106
- 7.7.3.5Immunodiagnostic Systems106
- 7.7.3.6Primary Care Diagnostics107
- 7.7.3.7Hematology Systems107
- 7.7.3.1Clinical Diagnostics Products104
- 7.7.4TriMark Commentary108
- 7.8Dade Behring, Inc.108
- 7.8.1Products109
- 7.8.2Other Served Markets112
- 7.8.3Business115
- 7.8.4TriMark Commentary116
- 7.9Hitachi116
- 7.9.1Products116
- 7.10 Horiba, Ltd.117
- 7.11JEOL, Ltd.117
- 7.12Olympus America, Inc., Clinical Instruments Division118
- 7.12.1Background118
- 7.12.2Automated General Chemistry Instruments119
- 7.12.3TriMark Commentary119
- 7.13Ortho-Clinical Diagnostics, a Johnson and Johnson Company120
- 7.13.1Background120
- 7.13.2Markets120
- 7.13.3Automated General Chemistry Instruments120
- 7.13.4Business Analysis122
- 7.13.5TriMark Commentary122
- 7.14Roche Diagnostics Corp122
- 7.14.1Background123
- 7.14.2Automated General Chemistry Instruments123
- 7.14.3Business Analysis123
- 7.15Shimadzu124
- 7.15.1Products124
- 7.16Sysmex Corporation125
- 7.17Thermo Electron Corp.125
- 7.18Vital Scientific, NV126
- 7.18.1Background126
- 7.18.2Products127
- 7.18.3Business127
- 7.18.4TriMark Commentary128
- 7.1Abaxis94
- 8.Clinical Chemistry Testing Sector Trends and Forecasts129
- 8.1Home Care Analysis129
- 8.2Non-traditional Collection for Chemistry Testing129
- 8.3New Systems for Critical-Care and Near-Patient Testing129
- 8.4Utility of Near-Patient Testing in Critical-Care Settings129
- 8.5Mergers of Diagnostic Companies129
- 8.6Information Management Advances129
- 8.7Test Ordering Patterns129
- 8.8Patient Satisfaction129
- 8.9Move Away From Central Laboratory130
- 8.10Healthcare Cost Controls130
- 8.11Competition for Services130
- 8.12Drivers of Clinical Chemistry Testing130
- 8.13Confluence of New Technology130
- 8.14New Trends in Clinical Laboratory Testing131
- 8.14.1Trends in Reimbursement Practices131
- 8.14.2Managed Care133
- 8.14.3Changes in Patient Management134
- 8.14.4Focused Testing134
- 8.14.5Satellite Facilities134
- 8.14.6Point-of-Care Testing134
- 8.14.7Regionalization of Laboratory Care135
- 8.15New Chemistry Analyzers136
- 9.Corporate Directory137
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