THE WORLDWIDE CLINICAL DIAGNOSTICS MARKET

EXECUTIVE SUMMARY

Exhibit ES-1: Worldwide Clinical Diagnostics Market by Segment 
Exhibit ES-2: U.S. Diagnostic Testing Service Provider Market, 2009 
Exhibit ES-3: Worldwide Market by User Segment 
Exhibit ES-4: Clinical Diagnostics Market by Country/Region 
Exhibit ES-5: Market Segment Growth Rate Comparison 
Exhibit ES-6: Worldwide Sales and Market Share for Leading Suppliers 
Exhibit ES-7: Sales by Segment for Leading Suppliers, 2009 

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 

Exhibit 1.1: 2009 Global Clinical Diagnostic and Diagnostic Imaging Market 
Exhibit 1.2:  Key Factors Driving Adoption of POC Testing 
Exhibit 1.3: Expansion of Clinical Lab Automation in the U.S. 
Exhibit 1.4: High and low-growth product segments of 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 

Exhibit 2.1: Highest Volume Laboratory Tests Performed in the U.S. Medicare Population 
Exhibit 2.2: Chemistry Testing Products 
Exhibit 2.3: Critical Care Testing Products 
Exhibit 2.4: Diabetes Prevalence Trends 
Exhibit 2.5: Automated and Semi-Automated Immunoassay Analyzers 
Exhibit 2.6: Microbiology Test Systems 
Exhibit 2.7: Hematology/cell analysis products 
Exhibit 2.8 Molecular diagnostics products 
Exhibit 2.9 Coagulation testing products 

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 

Exhibit 4.1: Noninvasive, Minimally Invasive and Continuous Glucose Monitoring Technologies 
Exhibit 4.2: Microarrays for Molecular Diagnostics 

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 

Exhibit 5.1: Global Clinical Diagnostic Products Market by Product Segment, 2009-2015 
Exhibit 5.2: Distribution of Global Clinical Diagnostic Products Market by Product Segment, 2009 and 2015 
Exhibit 5.3: Global Clinical Diagnostic Products Market by Country/Region, 2009-2015 
Exhibit 5.4: Distribution of Global Clinical Diagnostic Products Market by Country/Region, 2009 and 2015 
Exhibit 5.5: Global Clinical Diagnostic Products Market Size and Growth by Application Segment, 2009-2015 
Exhibit 5.6: Distribution of global clinical diagnostic products market by application segment, 2009 and 2015 
Exhibit 5.7: Segmentation of Health Care Costs in the U.S. 
Exhibit 5.8: Number of CLIA-registered clinical laboratories by type, 1999 and 2009 
Exhibit 5.9: Worldwide Clinical Diagnostic Products Market by Region 
Exhibit 5.10: Size of the worldwide clinical diagnostic products market by market segment 
Exhibit 5.11: Size of the worldwide clinical chemistry market segments 
Exhibit 5.12: Size of the worldwide immunodiagnostics market segments 
Exhibit 5.13: Microbiology products market 
Exhibit 5.14: Hematology and coagulation testing products market 
Exhibit 5.15: Worldwide molecular diagnostics products market 
Exhibit 5.16: Leading Suppliers in the Global Clinical Diagnostics Market, 2009 
Exhibit 5.17: Niche and Emerging Suppliers in the Global Clinical Diagnostics Market, 2009 

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 

Exhibit 6.1: Clinical chemistry products 
Exhibit 6.2: Clinical Chemistry Market Segmentation by Product Type, 2009 
Exhibit 6.3: General purpose immunodiagnostic products 
Exhibit 6.4: Immunodiagnostics Market by Product Segment, 2009 
Exhibit 6.5: Hematology and coagulation products 
Exhibit 6.6: Hematology/Flow Cytometry/Coagulation Testing Market by Product Segment, 2009 
Exhibit 6.7: Cancer diagnostic products 
Exhibit 6.8: Serum tumor markers and their clinical applications 
Exhibit 6.9: Cancer Diagnostic Products Market by Product Segment, 2009 
Exhibit 6.10: Molecular diagnostic products 
Exhibit 6.11: Molecular Diagnostics Testing Products Market by Product Segment, 2009 
Exhibit 6.12: POC testing products 
Exhibit 6.13: Point-of-Care (POC) Testing Products Market by Product Segment, 2009 
Exhibit 6.14: Home and self-testing products 
Exhibit 6.15: Home and Self-Testing Products Market by Product Segment, 2009 
Exhibit 6.16: 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 

Exhibit 7.1: Changes to the Clinical Laboratory Fee Schedule in the U.S., 2000-2010 
Exhibit 7.2: Number of Clinical Laboratories in Selected Countries, 2009 
Exhibit 7.3: Segmentation of Laboratory-Based Testing in the U.S., 2009 
Exhibit 7.4: Trends in the Site of Laboratory-Based Testing in the U.S., 1996-2008 
Exhibit 7.5: Estimated distribution of hospital and clinic laboratories in major European Countries, 2009 
Exhibit 7.6: Trends in Health Care Expenditures as a Percentage of GDP, 1998-2006 
Exhibit 7.7: Number of Medical Institutions in China 

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 

Exhibit 8.1: Breakdown of the global clinical diagnostics market by country/region, 2009 
Exhibit 8.2: The U.S. clinical diagnostics market by segment (sales in $millions) 
Exhibit 8.3: The Japan clinical diagnostics market by segment (sales in $millions) 
Exhibit 8.4: The German clinical diagnostics market by segment (sales in $millions) 
Exhibit 8.5: The French clinical diagnostics market by segment (sales in $million) 
Exhibit 8.6: The Italian clinical diagnostics market by segment (sales in $millions) 
Exhibit 8.7: The U.K. clinical diagnostics market by segment (sales in $millions) 
Exhibit 8.8: The Rest of Europe clinical diagnostics market by segment (sales in $millions) 
Exhibit 8.9: The Rest of World clinical diagnostics market by segment (sales in $million) 
Exhibit 8.10: Country/regional markets, clinical chemistry (sales in $million)* 
Exhibit 8.11: Country/regional markets, critical care testing (sales in $million) 
Exhibit 8.12: Country/regional markets, urinalysis (sales in $million) 
Exhibit 8.13: Country/regional markets, whole blood glucose (sales in $million) 
Exhibit 8.14: Country/regional markets, immunodiagnostics (sales in $million) 
Exhibit 8.15: Country/regional markets, hematology/flow cytometry (sales in $million) 
Exhibit 8.16: Country/regional markets, microbiology (sales in $million) 
Exhibit 8.17: Country/regional markets, molecular diagnostics (sales in $million) 
Exhibit 8.18: Country/regional markets, coagulation (sales in $million) 
Exhibit 8.19: Country/regional markets, other (sales in $million) 
Exhibit 8.20: Percentage share per country/region of the global clinical chemistry market, 2009 
Exhibit 8.21: Percentage share per country/region of the global critical care testing market, 2009
Exhibit 8.22: Percentage share per country/region of the global urinalysis market, 2009
Exhibit 8.23: Percentage share per country/region of the global whole blood glucose testing products market, 2009
Exhibit 8.24: Percentage share per country/region of the global immunodiagnostics products market, 2009
Exhibit 8.25: Percentage share per country/region of the global hematology/flow cytometry products market, 2009
Exhibit 8.26: Percentage share per country/region of the global microbiology products market, 2009
Exhibit 8.27: Percentage share per country/region of the global molecular diagnostics market, 2009
Exhibit 8.28: Percentage share per country/region of the global coagulation testing products market, 2009
Exhibit 8.29: Percentage share per country/region of the global other clinical diagnostics products market, 2009

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 

Exhibit 9.1: Worldwide sales by market segment for leading suppliers in the clinical diagnostics market, 2009
Exhibit 9.2: Market segment focus, sales and growth of emerging and niche suppliers in the clinical diagnostics market, 2009

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 

Exhibit 11.1: Market segment participation of the top ten clinical diagnostics companies, 2009

COMPANY DIRECTORY 

*** This is a partial list of companies, for a full listing request it ***

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** Corporate License allows for report sharing within all company locations.