Table of Contents
INTRODUCTION
EXECUTIVE SUMMARY
MARKET ENVIRONMENT
General
Macroeconomic Outlook
Population & Age Distribution
Trends in Health Care
Medical Conditions
Acute Conditions
Chronic Conditions
Health Insurance Coverage
National Health Expenditures
Spending Categories
Funding Sources
Medical Providers
Hospitals
Outpatient Facilities
Physicians & Physicians' Offices
Home Health Care Providers
Other Medical Providers
Patient Activity
Hospital Activity
Surgical Procedures
Outpatient Activity
IVD Market Composition
Regulation
510(k) Pre-Market Notification
Pre-Market Approval (PMA)
Current Good Manufacturing Practices (cGMPs)
Packaging
Post-Marketing Surveillance
Laboratory Regulations
Medicare & Medicaid
Technology
Trends in IVD Testing
IVD Tests by Technology
IVD Testing Sites
Historical Market Trends
US Trade
World IVD Demand
PRODUCTS
General
Product Segments
Reagents & Consumables
Instruments & Systems
Clinical Chemistry Products
Reagents & Consumables
Blood Glucose
Lipids
Electrolytes & Blood Gases
Proteins
Enzymes
Toxicology Reagents
Other Reagents
Standards & Controls
Instruments & Systems
Clinical Chemistry Analyzers
Blood Glucose Monitors
Applications
Producers
Immunoassay Products
Reagents & Consumables
Enzyme Immunoassays
Chemiluminescent Immunoassays
Fluorescent Immunoassays
Radioimmunoassays
Instruments & Systems
Applications
Producers
Molecular Diagnostic Products
Technology Overview
Polymerase Chain Reaction (PCR)
Microarrays
DNA Sequencing
In Situ Hybridization
Restriction Fragment Length Polymorphisms (RFLPs)
Reagents & Consumables
Amplified DNA Probe Assays
Direct DNA Probes
Microarrays
Other Reagents & Consumables
Instruments & Systems
PCR Systems
Other Molecular Diagnostic Systems
Applications
Producers
Blood Testing Products
Hematology Products
Reagents & Consumables
Instruments & Systems
Applications
Producers
Blood Bank Products
Reagents & Consumables
Instruments & Systems
Applications
Producers
Hemostasis Products
Reagents & Consumables
Instruments & Systems
Applications
Producers
Cellular Analysis Products
Flow Cytometry Products
Reagents & Consumables
Instruments & Systems
Applications
Producers
Other Cellular Analysis Products
Reagents & Consumables
Instruments & Systems
Applications
Producers
Anatomical Pathology Products
Reagents & Consumables
Instruments & Systems
Applications
Producers
Microbiology Products
Reagents & Consumables
Instruments & Systems
Applications
Producers
Other IVD Products
Effusion & Visual Inspection Products
Reagents & Consumables
Instruments & Systems
Applications
Producers
Cytology Products
Reagents & Consumables
Instruments & Systems
Applications
Producers
APPLICATIONS
General
Infectious Disease Testing
Sexually Transmitted Diseases
AIDS/HIV
Chlamydia
Herpes Simplex (HSV)
Gonorrhea
Other Sexually Transmitted Diseases
Other Infectious Diseases
Hepatitis
All Other Infectious Diseases
Cancer Testing
Cervical Cancer
Breast Cancer
Prostate Cancer
Colorectal Cancer
Other Cancers
Producers
Diabetes Testing
Reagents & Consumables
Blood Glucose Test Strips & Related Consumables
Other Reagents & Consumables
Instruments & Systems
Heart Disease Testing
Lipid Profiling
Cardiac Markers
Blood Proteins
Blood Grouping & Screening
Blood Typing & Matching
Blood & Bleeding Disorders
Drug Testing
Therapeutic Drug Monitoring
Drugs-of-Abuse Testing
Forensic Medicine
DNA Analysis
Identity Testing
Other Applications
Other IVD Applications
Disease Detection
General Health Screening
Pregnancy & Ovulation Testing
MARKETS
General
Hospitals
Independent Clinical Laboratories
Outpatient Facilities
Home Health Care Market
Physicians' Offices
Other Markets
INDUSTRY STRUCTURE
General
Market Share
Competitive Strategies
Mergers & Acquisitions
Cooperative Agreements
Research & Development
Marketing & Distribution
Manufacturing
Company Profiles
Abbott Laboratories
Affymetrix Incorporated
Agilent Technologies Incorporated
Alere Incorporated
ARKRAY Incorporated
Axis-Shield, see Alere
Bayer AG
BD Diagnostics Infectious Disease, see Becton Dickinson
Beckman Coulter, see Danaher
Becton, Dickinson and Company
Bioline, see Meridian Bioscience
bioMerieux SA
Bio-Rad Laboratories Incorporated
Caliper Life Sciences, see PerkinElmer
Celera, see Quest Diagnostics
chemagen Biopolymer-Technologie, see PerkinElmer
CombiMatrix Corporation
Danaher Corporation
Focus Diagnostics, see Quest Diagnostics
Gen-Probe Incorporated
HemoCue, see Quest Diagnostics
Hologic Incorporated
Illumina Incorporated
Inverness Medical Innovations, see Alere
Johnson & Johnson
Leica Microsystems, see Danaher
LifeScan, see Johnson & Johnson
Life Technologies Corporation
Lumigen, see Danaher
Meridian Bioscience Incorporated
Myriad Genetics Incorporated
Ortho-Clinical Diagnostics, see Johnson & Johnson
PerkinElmer Incorporated
Phoenix Bio-Tech, see Trinity Biotech
QIAGEN NV
Quest Diagnostics Incorporated
Roche Holding Limited
Sequenom Incorporated
Siemens AG
Sysmex Corporation
Thermo Fisher Scientific Incorporated
Third Wave Technologies, see Hologic
Trinity Biotech plc
TriPath Imaging, see Becton Dickinson
Veridex, see Johnson & Johnson
List of Tables
EXECUTIVE SUMMARY
Summary Table
MARKET ENVIRONMENT
Macroeconomic Indicators
Resident Population by Age Group
Acute Conditions by Type
Chronic Conditions by Type
Health Insurance Coverage of the US Population
National Health Expenditures by Category
National Health Expenditures by Source
Hospitals & Hospital Beds
Number of Outpatient Facilities by Type
Physicians & Physicians' Offices
Home Health Care Indicators
Number of Other Medical Providers by Type
Hospital Activity
Surgical Procedures by Site
Outpatient Episodes by Type
IVD Tests by Technology
IVD Testing Sites
IVD Product Market, 2001-2011
US Trade in IVD Products
World IVD Product Demand by Region
PRODUCTS
IVD Product Demand by Type
IVD Product Demand by Technology
IVD Reagent & Consumable Demand by Technology
IVD Instrument & System Demand by Technology
Clinical Chemistry Product Demand by Type
Clinical Chemistry Reagent & Consumable Demand by Type
Clinical Chemistry Instrument & System Demand by Type
Clinical Chemistry Product Demand by Application
Immunoassay Product Demand by Type
Immunoassay Reagent & Consumable Demand by Type
Immunoassay Instrument & System Demand by Type
Immunoassay Product Demand by Application
Molecular Diagnostic Product Demand by Type
Molecular Diagnostic Reagent & Consumable Demand by Type
Molecular Diagnostic Instrument & System Demand by Type
Molecular Diagnostic Product Demand by Application
Blood Testing Product Demand by Technology
Hematology Product Demand by Type
Hematology Product Demand by Application
Blood Bank Product Demand by Type
Blood Bank Product Demand by Application
Hemostasis Product Demand by Type
Hemostasis Product Demand by Application
Cellular Analysis Product Demand by Technology
Flow Cytometry Product Demand by Type
Flow Cytometry Product Demand by Application
Other Cellular Analysis Product Demand by Type
Other Cellular Analysis Product Demand by Application
Anatomical Pathology Product Demand by Type
Anatomical Pathology Product Demand by Application
Microbiology Product Demand by Type
Microbiology Product Demand by Application
Other IVD Product Demand by Technology
Effusion & Visual Inspection Product Demand by Type
Effusion & Visual Inspection Product Demand by Application
Cytology Product Demand by Type
Cytology Product Demand by Application
APPLICATIONS
IVD Product Demand by Application
Infectious Disease Testing IVD Product Demand by Type, Technology, & Condition
Sexually Transmitted Disease (STD) Testing IVD Product Demand by Type, Technology, & Condition
Other Infectious Disease Testing IVD Product Demand by Type, Technology, & Condition
Cancer Testing IVD Product Demand by Type, Technology, & Condition
Diabetes Testing IVD Product Demand by Type
Heart Disease Testing IVD Product Demand by Type, Technology, & Condition
Blood Grouping & Screening IVD Product Demand by Type, Technology, & Application
Drug Testing IVD Product Demand by Type, Technology, & Function
Forensic Medicine IVD Product Demand by Type, Technology, & Function
Other Applications IVD Product Demand by Type, Technology, & Function
MARKETS
IVD Product Demand by Market
Hospital IVD Product Demand by Type & Technology
Independent Clinical Laboratory IVD Product Demand by Type & Technology
Outpatient Facility IVD Product Demand by Type & Technology
Home Health Care IVD Product Demand by Type & Technology
Physicians' Office IVD Product Demand by Type & Technology
Other Markets IVD Product Demand by Type & Technology
INDUSTRY STRUCTURE
IVD Product Sales by Company, 2011
Selected Acquisitions & Divestitures
Selected Cooperative Agreements
List of Charts
MARKET ENVIRONMENT
National Health Expenditures by Category, 2011
PRODUCTS
IVD Product Demand by Type, 2001-2021
IVD Product Demand by Technology, 2011
APPLICATIONS
IVD Product Demand by Application, 2011
MARKETS
IVD Product Demand by Market, 2011
INDUSTRY STRUCTURE
IVD Product Market Share, 2011
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