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The global clinical diagnostics market is continuing to grow at a rate in excess of that for most other segments of the medical device market, and is exhibiting particularly strong growth in emerging countries such as China and India. Molecular diagnostics and point-of-care testing are the most rapidly expanding segments of the market, but other segments including coagulation testing, immunodiagnostics and cellular analysis are also growing at rates above those for the overall market. The report analyzes the key segments of the clinical diagnostics market including clinical chemistry, critical care testing, urinalysis, whole blood glucose testing, immunodiagnostics, hematology and cellular analysis, coagulation testing and molecular diagnostics, and also provides a perspective on the market by clinical application including cancer diagnostics, point-of-care testing, and home and self-testing. In addition, the markets in key countries and regions are analyzed in detail including an assessment of regulatory factors impacting individual countries. Current and forecast market size is provided over the 2009-2015 interval, along with pricing trends in the market and an analysis of competitive factors. The report also analyzes key business transactions in the clinical diagnostics industry, competitor strategies, and strategies for success in clinical diagnostics. The analysis includes in-depth profiles of 25 companies.
Report #IL551 - The Worldwide Clinical Diagnostics Market, 2009-2015
Publication data: May 2010
Contents
EXECUTIVE SUMMARY
1. Introduction
1.1 Technology Trends in Clinical Diagnostics
1.1.1 Molecular Diagnostics
1.1.2 Point-of-Care Testing
1.1.3 Informatics
1.1.4 Microarrays and Lab-on-a-Chip Devices
1.1.5 Laboratory Automation
1.2 Drivers and Limiters of the Clinical Diagnostics Market
1.3 Major Trends in the Clinical Diagnostics Market
1.3.1 Targeted Therapeutics and Diagnostics
1.3.2 Workstation Consolidation
1.3.3 Supplier Consolidation
1.4 Segments of Opportunity and Risk in the Clinical Diagnostics Market
2. INDUSTRY OVERVIEW
2.1 Clinical Chemistry Segment
2.1.1 Trends in General Chemistry Testing
2.1.2 Critical Care Testing
2.1.3 Urinalysis Testing
2.1.4 Whole Blood Glucose Testing
2.2 Immunodiagnostics Market and Subsegments
2.3 Microbiology Segment
2.4 Hematology and Cell Imaging Segments
2.5 Molecular Diagnostics Segment
2.6 Other Clinical Diagnostics Market Segments
2.6.1 Coagulation Testing
2.6.2 Cytology and Histology
2.6.3 Other Subsegments
3. REGULATORY ENVIRONMENT
3.1 The IVD Medical Devices Directive
3.2 U.S. Regulatory Requirements
3.3 Regulatory Requirements in Japan
3.4 Regulatory Requirements in Other Regions
3.4.1 China
3.4.2 India
3.4.3 Other Asian Countries
3.4.4 Africa
3.4.5 Canada
3.4.6 Australia
3.4.7 Latin America
3.5 Status of Harmonization of Regulations Between Countries
4. TECHNOLOGY DEVELOPMENTS
4.1 POC Testing Technology
4.1.1 Impact of Device Miniaturization
4.1.2 Less Invasive and Noninvasive Testing Technologies
4.1.3 Wireless Technologies and POC Testing
4.2 Molecular Diagnostics Technologies
4.2.1 Microarrays in Molecular Diagnostics
4.2.2 Automation of Molecular Testing
4.2.3 Advances in Genotyping, Haplotyping, and Sequencing Technology
4.3 Pharmacogenetic Testing
4.4 Advances in Informatics Technology
4.5 Proteomics Technology
5. MARKET OVERVIEW
5.1 Overview of Sales by Product Segment
5.2 Overview of Sales by Country
5.3 Analysis of Market by Application Segment
5.4 Role of Clinical Diagnostics in Healthcare
5.5 Sites for Clinical Diagnostic Testing
5.6 Major Trends in the Clinical Diagnostics Market
5.7 Characteristics of the Clinical Diagnostics Market by Region
5.7.1 U.S. Market
5.7.2 Japanese Market
5.7.3 German Market
5.7.4 Italian Market
5.7.5 French Market
5.7.6 U.K. Market
5.7.7 Spanish Market
5.7.8 Chinese Market
5.7.9 Indian Market
5.8 Future Impact of Molecular Diagnostics, Pharmacogenetics and Proteomics
5.9 Segments of the Clinical Diagnostics Products Market
6. PRODUCT SEGMENTS
6.1 Clinical Chemistry Products
6.1.1 Integrated testing platforms
6.1.2 High-Throughput Chemistry Systems
6.1.3 Mid-Range Chemistry Systems
6.1.4 Low-Throughput/Alternate Site Chemistry Systems
6.1.5 Urinalysis Products
6.1.6 Critical Care Testing Products
6.1.7 Market Segmentation for Clinical Chemistry Products
6.2 Immunodiagnostic Products
6.2.1 General Purpose Immunodiagnostic Systems
6.2.2 Specialty Immunodiagnostic Systems
6.2.3 Immunoassay-Based Blood Screening Systems
6.2.4 Market Segmentation for Immunodiagnostic Products
6.3 Hematology/Cellular Analysis and Coagulation Testing Products
6.3.1 Conventional Hematology and Integrated Hematology Systems
6.3.2 Dedicated Flow Cytometry Systems
6.3.3 Flow Cytometry Reagents
6.3.4 Coagulation Testing Products
6.3.5 Market Segmentation for Hematology/Flow Cytometry and Coagulation Testing Products
6.4 Cancer Diagnostic Products
6.5 Molecular Diagnostic Products
6.5.1 Infectious Disease Testing Products
6.5.2 Blood Screening (NAT) Products
6.5.3 Genetic Testing Products
6.5.4 Pharmacogenetic Testing Products
6.5.5 Viral Load/Viral Genotyping Products
6.5.6 Molecular Diagnostics Market Segmentation
6.6 POC Testing Products
6.6.1 Bedside Critical Care Testing Products
6.6.2 POC Coagulation/Platelet Function Monitoring Products
6.6.3 Drugs of Abuse Screening Kits
6.6.4 Professional-Use Whole Blood Chemistry Testing Systems
6.6.5 POC Cardiac Marker Testing Products
6.6.6 Rapid Infectious Disease Test Kits
6.6.7 Other POC Products
6.6.8 POC Testing Market Segmentation
6.7 Home and Self-Testing Products
6.7.1 Whole Blood and Minimally Invasive Glucose Testing Products
6.7.2 Home Tests for Monitoring of Glycated Hemoglobin
6.7.3 Coagulation Self-Testing Products
6.7.4 Home Pregnancy and Fertility Products
6.7.5 Home Cholesterol Testing Products
6.7.6 Home Drugs of Abuse Test Kits
6.7.7 Home and Self-Testing Market Segmentation
6.8 Other Clinical Diagnostic Products
7. MARKET ANALYSIS BY END USER
7.1 Traditional Laboratory-Based Testing
7.2 Testing in Other Sites
7.3 Testing in the U.S.
7.4 Testing in Europe
7.5 Testing in Japan
7.6 Testing in China
7.7 Testing in India
7.8 Testing in the Rest of World Region
7.9 Future Trends
8. MARKET ANALYSIS BY COUNTRY
8.1 U.S. Market
8.1.1 Clinical Chemistry Market
8.1.2 Critical Care Testing Market
8.1.3 Urinalysis Market
8.1.4 Blood Glucose Market
8.1.5 Immunodiagnostics Market
8.1.6 Hematology Market
8.1.7 Microbiology Market
8.1.8 Coagulation/Platelet Function Testing Market
8.1.9 Molecular Diagnostics Market
8.1.10 Other Product Market Segments
8.2 Japanese Market
8.2.1 Clinical Chemistry Market
8.2.2 Critical Care Testing Market
8.2.3 Urinalysis Market
8.2.4 Blood Glucose Market
8.2.5 Immunodiagnostics Market
8.2.6 Hematology Market
8.2.7 Microbiology Market
8.2.8 Coagulation Testing Market
8.2.9 Molecular Diagnostics Market
8.2.10 Other Product Market Segments
8.3 German Market
8.3.1 Clinical Chemistry Market
8.3.2 Critical Care Testing Market
8.3.3 Urinalysis Market
8.3.4 Blood Glucose Market
8.3.5 Immunodiagnostics Market
8.3.6 Hematology Market
8.3.7 Microbiology Market
8.3.8 Coagulation Testing Market
8.3.9 Molecular Diagnostics Market
8.3.10 Other Product Market Segments
8.4 French Market
8.4.1 Clinical Chemistry Market
8.4.2 Critical Care Testing Market
8.4.3 Urinalysis Market
8.4.4 Blood Glucose Market
8.4.5 Immunodiagnostics Market
8.4.6 Hematology Market
8.4.7 Microbiology Market
8.4.8 Coagulation Testing Market
8.4.9 Molecular Diagnostics Market
8.4.10 Other Product Market Segments
8.5 Italian Market
8.5.1 Clinical Chemistry Market
8.5.2 Critical Care Testing Market
8.5.3 Urinalysis Market
8.5.4 Blood Glucose Market
8.5.5 Immunodiagnostics Market
8.5.6 Hematology Market
8.5.7 Microbiology Market
8.5.8 Coagulation Testing Market
8.5.9 Molecular Diagnostics Market
8.5.10 Other Product Market Segments
8.6 U.K. Market
8.7 Rest of Europe and Rest of World Markets
8.7.1 Rest of Europe
8.7.2 China
8.7.3 India
8.7.4 Rest of World
8.8 Country Markets by Testing Discipline
9. COMPANY ANALYSIS
9.1 Overview of Clinical Diagnostic Product Suppliers
9.1.1 Industry Leaders
9.1.2 Niche Suppliers and Emerging Companies
9.2 Mergers and Acquisitions in the Clinical Diagnostics Industry
9.3 Perspectives and Strategies of Key Suppliers
9.3.1 Siemens Diagnostics
9.3.2 Abbott Diagnostics
9.3.3 Roche Diagnostics
10. COMPANY PROFILES
10.1 Abbott Laboratories
10.2 A. Menarini Diagnostics
10.3 Arkray
10.4 Bayer Diabetes Care
10.5 Beckman Coulter
10.6 BD
10.7 bioMerieux
10.8 Bio-Rad Laboratories
10.9 Cepheid
10.10 Cytyc/Hologic
10.11 DiaSorin
10.12 Digene/Qiagen
10.13 Gen-Probe
10.14 Home Diagnostics
10.15 Instrumentation Laboratory
10.16 Inverness Medical Innovations
10.16.1 Biosite
10.16.2 HemoSense
10.16.3 Cholestech
10.17 Meridian
10.18 NOVA Biomedical
10.19 Ortho Clinical Diagnostics/LifeScan
10.20 Radiometer A/S
10.21 Roche Diagnostics
10.22 Siemens Diagnostics
10.23 Stago
10.24 Sysmex
10.25 Tosoh
11. STRATEGIES FOR SUCCESS
11.1 Consolidation and Information Technology
11.2 Targeting of High Growth/High-Value Segments
11.3 Technology Strategies
11.4 Marketing and Distribution Strategies for the Clinical Diagnostics Market
COMPANY DIRECTORY
| Description
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Catalog No.
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Pricing
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| The Worldwide Clinical Diagnostics Market, 2009-2015
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Report #551
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$4,750*
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*outside U.S. add $75. California residents add applicable sales tax
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