This comprehensive study analyzes the US market for in vitro diagnostic (IVD) products by type, application and end-use segment. Products covered include reagents and related consumables, and instruments and systems for clinical chemistry, immunoassay, blood (hematology, blood banking and hemostasis), nucleic acid, microbiology, cellular (flow cytometry and other), anatomical pathology, effusion and visual inspection, and cytology testing procedures. Endocrine (blood glucose, pregnancy, ovulation and other), infectious disease (sexually transmitted, viral and other), cancer, illicit drug, heart disease, and forensic and identity testing, along with therapeutic drug monitoring, blood grouping and screening, and general health assessment, comprise the IVD applications discussed in the study. A special study section examines IVD demand and growth opportunities in major end-use segments, including hospital laboratories, independent clinical laboratories, outpatient facilities (clinics and physicians' offices), the home health care market and other markets (such as paramedic organizations and forensic laboratories).

Unless otherwise noted, all data appearing in the statistical tables correlate to IVD product demand valued in current US dollars. The term "demand" is equivalent to sales or apparent consumption and includes domestic production plus imports less exports. Tabular details may not add to apparent totals due to independent rounding. In addition, statistical ratios may be rounded for clarity purposes. The source for macroeconomic data and projections appearing in Section II "Market Environment" is The Freedonia Group Consensus Forecasts dated February 2009. Corporate revenues presented in Section VI "Industry Structure" are actual reported statistics or estimates derived from annual reports, SEC filings, security analyst reports, corporate product literature and direct interviews with knowledgeable industry experts.

IVD product information and data were obtained from a variety of primary and secondary sources, including government agencies, trade associations, industry participants, trade journals -- such as American Laboratory , BioPhotonics , IVD Technology , and Medical Device & Diagnostic Industry -- and online databases. Epidemiological statistics were compiled from the US Centers for Disease Control and Prevention, the National Institutes of Health, the National Cancer Institute, the American Cancer Society, the American Heart Association, and the American Diabetes Association. Additional background information was derived from other Freedonia Group studies, including #2418 Biochips (November 2008) and #2323 Patient Monitoring Systems (April 2008).

INTRODUCTION
I. EXECUTIVE SUMMARY
II. MARKET ENVIRONMENT
- General
- Macroeconomic Environment
- Population & Demographic Trends
- Health Care Trends
  - Acute Conditions
  - Chronic Conditions
  - Cancer & AIDS
  - Health Insurance Trends
  - National Health Expenditures
  - Medical Providers
    - Acute Care Hospitals
    - Physicians
    - Outpatient Facilities
  - Patient Activity
    - Hospital Activity
    - Surgical Procedures
    - Outpatient & Home Health Care Activity
- IVD Product Overview
  - Regulation
  - Technology
  - Diagnostic Testing Volume
  - Clinical Laboratory Testing Services
  - Pricing Trends
  - Product Demand Patterns, 1998-2008
  - US Trade
  - International Markets
III. IVD PRODUCTS
- General
- Product Segments
  - Reagents & Consumables
  - Instruments & Systems
- Clinical Chemistry Products
  - Professional Products
    - Reagents & Test Kits
      - Blood Glucose
      - Lipids
      - Electrolytes & Blood Gases
      - Proteins
      - Enzymes
      - Toxicology Reagents
      - Other Clinical Chemistry Reagents
    - Standards & Controls
    - Instruments & Systems
    - Applications
    - Producers
  - Self-Testing Products
    - Blood Glucose Monitoring Products
      - Test Strips & Discs
      - Monitors
    - Other Self-Testing Products
- Immunoassay Products
  - Technology Overview
    - Competitive Immunoassays
    - Noncompetitive Immunoassays
    - Heterogeneous & Homogeneous Immunoassays
    - Labeling Techniques
    - Manual Immunoassays
  - Reagents & Test Kits
    - Enzyme Immunoassays
    - Chemiluminescent Immunoassays
    - Fluorescent Immunoassays
    - Radioimmunoassays
  - Instruments & Systems
  - Applications
    - Drug Testing
      - Therapeutic Drugs
      - Illicit Drugs
    - Infectious Disease Testing
    - Endocrine Condition Testing
    - Cancer Testing
    - Heart Disease Testing
    - Other Applications
  - Producers
- Blood Testing Products
  - Hematology Products
    - Reagents & Consumables
    - Instruments & Systems
    - Applications
    - Producers
  - Blood Banking Products
    - Reagents & Consumables
    - Instruments & Systems
    - Applications
    - Producers
  - Hemostasis Products
    - Reagents & Consumables
    - Instruments & Systems
    - Applications
    - Producers
- Nucleic Acid Testing Products
  - Technology Overview
    - Polymerase Chain Reaction (PCR)
    - Microarrays
    - DNA Sequencing
    - In Situ Hybridization (ISH)
    - Restriction Fragment Length Polymorphisms (RFLPs)
  - Amplified DNA Probes
  - Direct DNA Probes
  - Instruments & Systems
    - PCR Systems
    - Microarray Systems
  - Microarray Products
    - Types of Microarrays
  - IVD Applications
    - Disease Management
    - Forensic Medicine
    - Illicit Drug Testing
  - Consumables
  - Applications
  - Producers
- Microbiology Products
  - Culture Media
  - 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
    - Applications
    - Producers
- Other IVD Products
  - Anatomical Pathology Products
    - Histology Products
    - Immunohistochemistry Products
  - Effusion & Visual Inspection Products
    - Visual Inspection Tests
    - Effusion Tests
    - Applications
    - Producers
  - Cytology Products
    - Reagents, Supplies & Instruments
    - Applications
IV. IVD APPLICATIONS
- General
- Endocrine Conditions
  - Diabetes Monitoring Products
    - Blood Glucose Test Strips
    - Blood Glucose Monitors
    - Other Diabetes Monitoring Products
      - Hemoglobin A1c
      - Microalbumin
      - Ketones
      - All Other Diabetes IVD Products
  - Pregnancy, Ovulation & Fertility Tests
  - Other IVD Products for Endocrine Conditions
- Infectious Diseases
  - Sexually Transmitted Diseases
    - IVD Demand by Methodology
    - IVD Demand by Condition
      - AIDS/HIV
      - Chlamydia
      - Herpes
      - Gonorrhea
      - Other Sexually Transmitted Diseases
  - Other Infectious Diseases
    - IVD Demand by Methodology
    - IVD Demand by Condition
      - Hepatitis
      - All Other Infectious Diseases
  - Cancer
    - IVD Demand by Methodology
    - IVD Demand by Condition
      - Cervical Cancer
      - Breast Cancer
      - Prostate Cancer
      - Colorectal Cancer
    - Other Cancers
  - Drug Testing
    - Therapeutic Drug Monitoring (TDM)
    - Illicit Drug Testing
  - Heart Disease
    - Lipid Profiling
    - Cardiac Markers
    - Blood Proteins
  - Blood Grouping & Screening
    - Blood Typing & Matching
    - Blood & Bleeding Disorders
  - Forensic Medicine & Related Testing
    - Forensic Testing
    - Genetic Testing
    - Identity Testing
  - General Health Screening & Other IVD Applications
    - General Health Screening
    - Disease Detection & Other
V. IVD MARKETS
- General
- Hospitals
- Independent Clinical Laboratories
- Home Health Care
- Outpatient Facilities
- Other Markets
VI. INDUSTRY STRUCTURE
- General
- Market Share
  - Johnson & Johnson
  - Roche Holding
  - Siemens Healthcare Diagnostics
  - Abbott Laboratories
  - Beckman Coulter
  - Becton Dickinson
- Competitive Strategies
- Mergers & Acquisitions
- Cooperative Agreements
- Research & Development
- Marketing & Distribution
- Manufacturing
- Company Profiles
  - 454 Life Sciences, see Roche
  - Abbott Laboratories
  - Applied Biosystems Incorporated, see Life Technologies
  - Bayer AG
  - BD GeneOhm, see Becton Dickinson
  - Beckman Coulter Incorporated
  - Becton, Dickinson and Company
  - Bio-Rad Laboratories Incorporated
  - bioMerieux SA
  - Biosite Incorporated, see Inverness Medical Innovations
  - BioVeris Corporation, see Roche
  - Celera Corporation
  - Cholestech Corporation, see Inverness Medical Innovations
  - Cytopeia Incorporated, see Becton Dickinson
  - Cytyc Corporation, see Hologic
  - Dade Behring Incorporated, see Siemens
  - Danaher Corporation
  - Digene Corporation, see QIAGEN
  - First Check Diagnostics, see Inverness Medical Innovations
  - Gen-Probe Incorporated
  - Hologic Incorporated
  - Inverness Medical Innovations Incorporated
  - Invitrogen Corporation, see Life Technologies
  - Johnson & Johnson
  - Life Technologies Corporation
  - LifeScan Incorporated, see Johnson & Johnson
  - Lumigen Incorporated, see Beckman Coulter
  - Meridian Bioscience Incorporated
  - NimbleGen Systems Incorporated, see Roche
  - Olympus Corporation
  - Oncogene Science Incorporated, see Siemens
  - Ortho-Clinical Diagnostics, see Johnson & Johnson
  - QIAGEN NV
  - Quidel Corporation
  - Redwood Toxicology Laboratory Incorporated, see Inverness Medical Innovations
  - Roche Holding Limited
  - Siemens AG
  - Swiss Precision Diagnostics, see Inverness Medical
  - Innovations
  - Sysmex Corporation
  - Thermo Fisher Scientific Incorporated
  - Third Wave Technologies Incorporated, see Hologic
  - Trinity Biotech plc
  - TriPath, see Becton Dickinson
  - Ventana Medical Systems Incorporated, see Roche
  - Veridex LLC, see Johnson & Johnson
- Other Companies Mentioned in the Study

LIST OF TABLES

SECTION I -- EXECUTIVE SUMMARY
- Summary Table
SECTION II -- MARKET ENVIRONMENT
- 1 Macroeconomic Indicators
- 2 Population & Demographics
- 3 Acute Conditions by Type
- 4 Chronic Conditions by Type
- 5 Cancer & AIDS Indicators
- 6 Health Insurance Coverage of the US Population, 1998-2008
- 7 National Health Expenditures by Type & Source
- 8 Acute Care Hospitals
- 9 Physicians & Physicians' Offices
- 10 Outpatient Facilities
- 11 Hospital Activity
- 12 Surgical Procedures
- 13 Outpatient & Home Health Care Activity
- 14 Diagnostic Testing Volume
- 15 Clinical Laboratory Testing Sites & Revenues
- 16 IVD Product Demand, 1998-2008
- 17 US Trade in IVD Products
- 18 World IVD Product Demand by Region
SECTION III -- IVD PRODUCTS
- 1 IVD Demand by Product Group
- 2 IVD Product Demand by Methodology
- 3 IVD Reagent & Consumable Demand by Methodology
- 4 IVD Instrument & System Demand by Methodology
- 5 Clinical Chemistry Product Demand by Segment
- 6 Professional Clinical Chemistry Product Demand by Type
- 7 Common Clinical Chemistry Tests
- 8 Professional Clinical Chemistry Product Demand by Application
- 9 Self-Testing Clinical Chemistry Product Demand by Type
- 10 Self-Testing Clinical Chemistry Product Demand by Application
- 11 Immunoassay Product Demand by Type
- 12 Immunoassay Product Demand by Application
- 13 Blood Testing Product Demand by Methodology
- 14 Hematology Product Demand by Type
- 15 Hematology Product Demand by Application
- 16 Blood Banking Product Demand by Type
- 17 Blood Banking Product Demand by Application
- 18 Hemostasis Product Demand by Type
- 19 Hemostasis Product Demand by Application
- 20 Nucleic Acid Testing Product Demand by Type
- 21 Nucleic Acid Testing Product Demand by Application
- 22 Microbiology Product Demand by Type
- 23 Microbiology Product Demand by Application
- 24 Cellular Analysis Product Demand by Methodology
- 25 Flow Cytometry Product Demand by Type
- 26 Flow Cytometry Product Demand by Application
- 27 Other Cellular Analysis Product Demand by Type
- 28 Other Cellular Analysis Product Demand by Application
- 29 Other IVD Product Demand by Methodology
- 30 Anatomical Pathology Product Demand by Type
- 31 Anatomical Pathology Product Demand by Application
- 32 Effusion & Visual Inspection Product Demand by Type
- 33 Effusion & Visual Inspection Product Demand by Application
- 34 Cytology Product Demand by Type
- 35 Cytology Product Demand by Application
SECTION IV -- IVD APPLICATIONS
- 1 IVD Product Demand by Application
- 2 Endocrine Testing -- IVD Product Demand by Methodology & Condition
- 3 Infectious Disease Testing -- IVD Product Demand by Condition
- 4 Sexually Transmitted Disease (STD) Testing - IVD Product Demand by Methodology
- 5 Sexually Transmitted Disease (STD) Testing - IVD Product Demand by Condition
- 6 Other Infectious Disease Testing -- IVD Demand by Methodology
- 7 Cancer Testing -- IVD Product Demand by Methodology
- 8 Cancer Testing -- IVD Product Demand by Condition
- 9 Drug Testing -- IVD Product Demand by Methodology & Type
- 10 Heart Disease Testing -- IVD Product Demand by Methodology
- 11 Blood Grouping & Screening -- IVD Product Demand by Methodology
- 12 Forensic & Related Testing -- IVD Product Demand by Methodology
- 13 General Health Screening & Other Applications - IVD Product Demand by Methodology & Procedure
SECTION V -- IVD MARKETS
- 1 IVD Product Demand by Market
- 2 Hospital Laboratory IVD Product Demand
- 3 Independent Clinical Laboratory IVD Product Demand
- 4 Home IVD Product Demand
- 5 Outpatient IVD Product Demand
- 6 Other Markets: IVD Product Demand
SECTION VI -- INDUSTRY STRUCTURE
- 1 US IVD Product Sales by Company, 2008
- 2 Selected Acquisitions & Divestitures
- 3 Selected Cooperative Agreements

LIST OF CHARTS

SECTION III -- IVD PRODUCTS
- 1 IVD Product Demand by Methodology, 2008
SECTION IV -- IVD APPLICATIONS
- 1 IVD Product Demand by Application, 2008
SECTION V -- IVD MARKETS
- 1 IVD Product Demand by Market, 2008
SECTION VI -- INDUSTRY STRUCTURE
- 1 US IVD Product Sales, Market Share by Company, 2008

Pharmaceutical Market Research

In Vitro Diagnostics