October 11, 2007
The Clinical Chemistry Analyzers Market: Technology Trends, Business Challenges and Competitive Landscape
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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 describe the specific segments of the global clinical chemistry instrumentation market. Specifically, this study examines 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 content
2. IVD Clinical Chemistry Market 2.1 Introduction
3. IVD Clinical Chemistry Market 3.1 Markets 3.1.1 Global Markets 3.1.2 Global Drivers of Clinical Chemistry Testing 3.1.3 Global Outlook 3.1.4 U.S. Market 3.1.5 European Market 22.214.171.124 German Clinical Chemistry Diagnostic Markets 126.96.36.199 U.K. Clinical Chemistry Testing Diagnostic Market 188.8.131.52.1 U.K. Market Statistics 184.108.40.206.2 U.K. Competitive Analysis 220.127.116.11.3 U.K. Market Access 18.104.22.168 French Clinical Chemistry Diagnostic Market 22.214.171.124 Italian Clinical Chemistry Diagnostic Market 126.96.36.199 Spanish Clinical Chemistry Diagnostic Market 188.8.131.52 Indian Clinical Chemistry Diagnostic Market 184.108.40.206.1 India's In Vitro Diagnostic Testing Industry 220.127.116.11 Scandinavian Clinical Chemistry Market 18.104.22.168 Japanese Clinical Chemistry Testing Market 22.214.171.124 Country Clinical Chemistry Smaller Markets 126.96.36.199.1 Chinese Clinical Chemistry Market 188.8.131.52.2 Canada Clinical Chemistry Market 184.108.40.206.3 Brazil Clinical Chemistry Market 220.127.116.11.4 Turkey Clinical Chemistry Market 18.104.22.168.5 Australia Clinical Chemistry Market 22.214.171.124.6 Mexico IVD Market 126.96.36.199 Remaining World Clinical Chemistry Testing Market 188.8.131.52 Overview of Asian Healthcare Market 184.108.40.206.1 Singapore 220.127.116.11.2 Malaysia 18.104.22.168.3 Thailand 22.214.171.124.4 Indonesia 126.96.36.199.5 Philippines 188.8.131.52.6 South Korea 184.108.40.206.7 India 220.127.116.11.8 Hong Kong 18.104.22.168.9 Taiwan 22.214.171.124 Overview of the Latin American Diagnostics Market 3.2 Clinical Chemistry Sector 3.2.1 Industry-Served Markets 3.2.2 Industry Players 126.96.36.199 Manufacturing Companies 3.2.3 Market Specialization 3.2.4 Revenue and Reimbursement 3.2.5 Companies 3.3 Outlook for Clinical Chemistry Testing 3.3.1 Long-Term Changes 3.3.2 Market Drivers 3.3.3 The Limits to Growth 3.3.4 Hot Sectors in the IVD Market 3.3.5 Key Technologies 3.3.6 Conclusion
4. Clinical Chemistry Instrument Market by Sector: Size, Growth, Share and Competitors 4.1 Ultra-Large Throughput Chemistry Analyzers 4.2 Large-Throughput Analyzers 4.3 Mid-Size Clinical Chemistry Analyzers 4.4 Chemistry Analyzers for the Small-Volume Market
5. Important Technology Trends 5.1 Technology Platform Innovations in Point-of-Care Testing 5.2 Sensor Systems for Diagnostic Applications 5.3 Glucose Measurements 5.4 Glucose Test Methods 5.5 Cholesterol Measurements 5.6 The New Paradigm 5.7 Consolidated Workstations 5.8 Automation in the Laboratory in Response to Labor Shortages 5.9 Laboratory Information Systems 5.10 Biosensor Technology 5.11 Data-Management Issues 5.11.1 Wireless LANs 5.11.2 Data and Workflow Management Systems 5.11.3 Beckman Central Command 5.12 Connectivity Platforms 5.12.1 Laboratory Data Linking Software and Interface to the Laboratory Information System 5.12.2 AbbottLink Analyzer Connections 5.12.3 Beckman Coulter DL2000 Data Manager v6.5 5.12.4 bioMerieux Inc. ENQ 5.12.5 Ortho-Clinical Diagnostics Inc. Software Version 1.02
6. Business Trends in the Clinical Chemistry Analyzer Sector 6.1 Key Developments 6.2 Sector Consolidation 6.3 Diagnostic Testing Growth Trends 6.4 Reagent and Hardware Business in Japan 6.5 New Products 6.6 Acquisition, License Agreements, Internal Development and Partnerships 6.7 Product Testing Depth in Clinical Chemistry Testing 6.8 Government Regulation 6.8.1 U.S. Regulation 188.8.131.52 Importing Medical Devices to the U.S. 184.108.40.206 Exporting Medical Devices from the U.S. 6.8.2 U.K. Regulation 6.8.3 E.U. Regulation 6.8.4 Japanese Regulation 6.8.5 Korean Regulation 6.9 Increased Market Penetration 6.10 Costs of Doing Business in Europe 6.11 Drivers of European Diagnostics Testing 6.12 European Reimbursement Practices 6.13 Cost Containment in Europe 6.14 Medicare Reimbursement Trends
7. Company Profiles 7.1 Abaxis 7.1.1 Point-of-Care Blood Chemistry Analyzers 7.1.2 Hematology 7.1.3 Reagent Discs 7.1.4 Orbos Process 7.1.5 VetScan Canine Heartworm Antigen Test 7.2 Abbott Diagnostics 7.2.1 Diagnostic Products 7.2.2 Business Analysis 7.2.3 Commentary 7.3 Adaltis, Inc. 7.4 Alfa Wasserman, Inc. (f/k/a Electro-Nucleonics, Inc. and Schiapparelli Biosystems, Inc.) 7.4.1 Background 7.4.2 Products 7.5 Awareness Technology 7.6 Bayer Diagnostics 7.6.1 Background 7.6.2 General Automated Clinical Chemistry Instruments 220.127.116.11 ADVIA(R) 2400, 1800, 1650 and 1200 Chemistry Systems 7.6.3 Business Analysis 7.6.4 Commentary 7.7 Beckman Coulter, Inc. 7.7.1 Overview 7.7.2 Company History 7.7.3 Products 18.104.22.168 Clinical Diagnostics Products 22.214.171.124.1 Overview 126.96.36.199 Clinical Chemistry Systems 188.8.131.52 Clinical Laboratory Automation 184.108.40.206 Hemostasis Systems 220.127.116.11 Immunodiagnostic Systems 18.104.22.168 Primary Care Diagnostics 22.214.171.124 Hematology Systems 7.7.4 Commentary 7.8 Dade Behring, Inc. 7.8.1 Products 7.8.2 Other Served Markets 7.9 Hitachi 7.9.1 Products 7.10 Horiba, Ltd. 7.11 JEOL, Ltd. 7.12 Olympus America, Inc. Clinical Instruments Division 7.12.1 Background 7.12.2 Automated General Chemistry Instruments 7.12.3 Commentary 7.13 Ortho-Clinical Diagnostics, a Johnson & Johnson Company 7.13.1 Background 7.13.2 Markets 7.13.3 Automated General Chemistry Instruments 7.13.4 Commentary 7.14 Roche Diagnostics Corp 7.14.1 Background 7.14.2 Automated General Chemistry Instruments 7.14.3 Business Analysis 7.15 Shimadzu 7.15.1 Products 7.16 Sysmex Corporation 7.17 Thermo Electron Corp. 7.18 Vital Scientific, NV 7.18.1 Background 7.18.2 Products
8. Clinical Chemistry Testing Sector Trends and Forecasts 8.1 Home Care Analysis 8.2 Non-traditional Collection for Chemistry Testing 8.3 New Systems for Critical-Care and Near-Patient Testing 8.4 Utility of Near-Patient Testing in Critical-Care Settings 8.5 Mergers of Diagnostic Companies 8.6 Information Management Advances 8.7 Test Ordering Patterns 8.8 Patient Satisfaction 8.9 Move Away From Central Laboratory 8.10 Healthcare Cost Controls 8.11 Competition for Services 8.12 Drivers of Clinical Chemistry Testing 8.13 Confluence of New Technology 8.14 New Trends in Clinical Laboratory Testing 8.14.1 Trends in Reimbursement Practices 8.14.2 Managed Care 8.14.3 Changes in Patient Management 8.14.4 Focused Testing 8.14.5 Satellite Facilities 8.14.6 Point-of-Care Testing 8.14.7 Regionalization of Laboratory Care 8.15 New Chemistry Analyzers 8.16 Multiplexing Technology
9. Clinical Chemistry Product Introductions 9.1 Clinical Chemistry Analyzer Product Launches 9.2 Clinical Chemistry Reagent Product Launches
10. Corporate Directory
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