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In Vitro Diagnostics

IVD demand in US to reach nearly $25 billion in 2016
US demand for in vitro diagnostic (IVD) products will rise more than six percent annually to nearly $25 billion in 2016. Aging demographic patterns, expanding levels of health insurance coverages, and new product introductions will underlie gains. Growth in the middle aged and elderly population segments will boost overall health care needs, leading to a rising volume of IVD tests. The extension of health insurance coverage attributable to the Affordable Health Care Act of 2010 will make basic and specialized IVD procedures available to a greater number of individuals. Advances in cellular analysis, molecular diagnostic and other advanced technologies will expand applications for IVD products in disease detection, forensic medical, and identity testing.

Clinical chemistry, immunoassay to remain top products
Clinical chemistry and immunoassay will remain the top two IVD methodologies, the former based on sales of personal blood glucose monitors and test strips and the latter due to the penetration of high value-added chemiluminescent products into infectious disease and drug testing markets. Molecular diagnostic products will post the fastest growth in demand among all IVD products based on throughput, accuracy, and speed advantages, especially in the detection of infectious diseases and cancer markers. Diabetes testing will remain the largest IVD application through 2016 and beyond due to increasing blood glucose monitoring among afflicted patients.

Hemostasis tests for cardiac conditions offer best growth
Based on their ability to quantify heart attack and embolism risk prior to occurrence, hemostasis tests for D-dimer and other cardiac parameters will command the best growth among IVD blood testing products. Demand for molecular diagnostic products will expand at a strong pace as next-generation PCR (polymerase chain reaction) and FISH (fluorescence in situ hybridization) penetrate applications involving the analysis, characterization, and therapeutic monitoring of complex infections and tumors. DNA-based forensic, genetic, and identity testing will comprise one of the fastest growing IVD applications through 2016 as the vast potential of law enforcement and genetic screening markets begins to translate into significant revenues. Among other IVD products, cellular analysis and anatomical pathology reagents and instruments will post the best sales gains. Cellular analysis techniques will continue to dominate cervical cancer testing and penetrate additional cancer diagnostic applications. Anatomical pathology will remain the leading IVD technique for biopsy-based cancer and infectious disease detection.

Diabetes testing to benefit clinical chemistry reagents & instruments
Evolving epidemiological trends and patient care approaches will impact favorably on growth opportunities for most types of IVD products. The market for clinical chemistry reagents and instruments will benefit from an increasing number of diabetic patients engaging in self-blood glucose monitoring and the expanding use of general health screening in routine patient examinations. The widening availability of chemiluminescent tests with inherent sensitivity and selectivity advantages will broaden applications for immunoassays in therapeutic drug monitoring, drugs of abuse detection, and infectious disease testing.


  • INTRODUCTION
  • EXECUTIVE SUMMARY
    • Table IVD PRODUCT DEMAND (million dollars)
  • MARKET ENVIRONMENT
    • General
    • Macroeconomic Outlook
      • Table MACROECONOMIC INDICATORS (billion 2005 dollars)
    • Population & Age Distribution
      • Table RESIDENT POPULATION BY AGE GROUP (million)
    • Trends in Health Care
      • Medical Conditions
        • Table ACUTE CONDITIONS BY TYPE (million)
        • Table CHRONIC CONDITIONS BY TYPE (million)
      • Health Insurance Coverage
        • Table HEALTH INSURANCE COVERAGE OF THE US POPULATION (million)
      • National Health Expenditures
        • Table NATIONAL HEALTH EXPENDITURES BY CATEGORY (billion dollars)
        • Table NATIONAL HEALTH EXPENDITURES BY SOURCE (billion dollars)
      • Medical Providers
        • Table HOSPITALS & HOSPITAL BEDS
        • Table NUMBER OF OUTPATIENT FACILITIES BY TYPE
        • Table PHYSICIANS & PHYSICIANS' OFFICES (thousand)
        • Table HOME HEALTH CARE INDICATORS
        • Table NUMBER OF OTHER MEDICAL PROVIDERS BY TYPE
      • Patient Activity
        • Table HOSPITAL ACTIVITY
        • Table SURGICAL PROCEDURES BY SITE (thousand)
        • Table OUTPATIENT EPISODES BY TYPE (million)
    • IVD Market Composition
      • Regulation
      • Technology
      • Trends in IVD Testing
        • Table IVD TESTS BY TECHNOLOGY (million)
        • Table IVD TESTING SITES (thousand)
    • Historical Market Trends
      • Table IVD PRODUCT MARKET, 2001-2011
    • US Trade
      • Table US TRADE IN IVD PRODUCTS (million dollars)
    • World IVD Demand
      • Table WORLD IVD PRODUCT DEMAND BY REGION (million dollars)
  • PRODUCTS
    • General
      • Table IVD PRODUCT DEMAND BY TYPE (million dollars)
    • Product Segments
      • Table IVD PRODUCT DEMAND BY TECHNOLOGY (million dollars)
      • Reagents & Consumables
        • Table IVD REAGENT & CONSUMABLE DEMAND BY TECHNOLOGY (million dollars)
      • Instruments & Systems
        • Table IVD INSTRUMENT & SYSTEM DEMAND BY TECHNOLOGY (million dollars)
    • Clinical Chemistry Products
      • Table CLINICAL CHEMISTRY PRODUCT DEMAND BY TYPE (million dollars)
      • Reagents & Consumables
        • Table CLINICAL CHEMISTRY REAGENT & CONSUMABLE DEMAND BY TYPE (million dollars)
      • Instruments & Systems
        • Table CLINICAL CHEMISTRY INSTRUMENT & SYSTEM DEMAND BY TYPE (million dollars)
      • Applications
        • Table CLINICAL CHEMISTRY PRODUCT DEMAND BY APPLICATION (million dollars)
      • Producers
    • Immunoassay Products
      • Table IMMUNOASSAY PRODUCT DEMAND BY TYPE (million dollars)
      • Reagents & Consumables
        • Table IMMUNOASSAY REAGENT & CONSUMABLE DEMAND BY TYPE (million dollars)
      • Instruments & Systems
        • Table IMMUNOASSAY INSTRUMENT & SYSTEM DEMAND BY TYPE (million dollars)
      • Applications
        • Table IMMUNOASSAY PRODUCT DEMAND BY APPLICATION (million dollars)
      • Producers
    • Molecular Diagnostic Products
      • Table MOLECULAR DIAGNOSTIC PRODUCT DEMAND BY TYPE (million dollars)
      • Technology Overview
      • Reagents & Consumables
        • Table MOLECULAR DIAGNOSTIC REAGENT & CONSUMABLE DEMAND BY TYPE (million dollars)
      • Instruments & Systems
        • Table MOLECULAR DIAGNOSTIC INSTRUMENT & SYSTEM DEMAND BY TYPE (million dollars)
      • Applications
        • Table MOLECULAR DIAGNOSTIC PRODUCT DEMAND BY APPLICATION (million dollars)
      • Producers
    • Blood Testing Products
      • Table BLOOD TESTING PRODUCT DEMAND BY TECHNOLOGY (million dollars)
      • Hematology Products
        • Table HEMATOLOGY PRODUCT DEMAND BY TYPE (million dollars)
        • Table HEMATOLOGY PRODUCT DEMAND BY APPLICATION (million dollars)
      • Blood Bank Products
        • Table BLOOD BANK PRODUCT DEMAND BY TYPE (million dollars)
        • Table BLOOD BANK PRODUCT DEMAND BY APPLICATION (million dollars)
      • Hemostasis Products
        • Table HEMOSTASIS PRODUCT DEMAND BY TYPE (million dollars)
        • Table HEMOSTASIS PRODUCT DEMAND BY APPLICATION (million dollars)
    • Cellular Analysis Products
      • Table CELLULAR ANALYSIS PRODUCT DEMAND BY TECHNOLOGY (million dollars)
      • Flow Cytometry Products
        • Table FLOW CYTOMETRY PRODUCT DEMAND BY TYPE (million dollars)
        • Table FLOW CYTOMETRY PRODUCT DEMAND BY APPLICATION (million dollars)
      • Other Cellular Analysis Products
        • Table OTHER CELLULAR ANALYSIS PRODUCT DEMAND BY TYPE (million dollars)
        • Table OTHER CELLULAR ANALYSIS PRODUCT DEMAND BY APPLICATION (million dollars)
    • Anatomical Pathology Products
      • Table ANATOMICAL PATHOLOGY PRODUCT DEMAND BY TYPE (million dollars)
      • Reagents & Consumables
      • Instruments & Systems
      • Applications
        • Table ANATOMICAL PATHOLOGY PRODUCT DEMAND BY APPLICATION (million dollars)
      • Producers
    • Microbiology Products
      • Table MICROBIOLOGY PRODUCT DEMAND BY TYPE (million dollars)
      • Reagents & Consumables
      • Instruments & Systems
      • Applications
        • Table MICROBIOLOGY PRODUCT DEMAND BY APPLICATION (million dollars)
      • Producers
    • Other IVD Products
      • Table OTHER IVD PRODUCT DEMAND BY TECHNOLOGY (million dollars)
      • Effusion & Visual Inspection Products
        • Table EFFUSION & VISUAL INSPECTION PRODUCT DEMAND BY TYPE (million dollars)
        • Table EFFUSION & VISUAL INSPECTION PRODUCT DEMAND BY APPLICATION (million dollars)
      • Cytology Products
        • Table CYTOLOGY PRODUCT DEMAND BY TYPE (million dollars)
        • Table CYTOLOGY PRODUCT DEMAND BY APPLICATION (million dollars)
  • APPLICATIONS
    • General
      • Table IVD PRODUCT DEMAND BY APPLICATION (million dollars)
    • Infectious Disease Testing
      • Table INFECTIOUS DISEASE TESTING IVD PRODUCT DEMAND BY TYPE, TECHNOLOGY, & CONDITION (million dollars)
      • Sexually Transmitted Diseases
        • Table SEXUALLY TRANSMITTED DISEASE (STD) TESTING IVD PRODUCT DEMAND BY TYPE, TECHNOLOGY, & CONDITION (million dollars)
      • Other Infectious Diseases
        • Table OTHER INFECTIOUS DISEASE TESTING IVD PRODUCT DEMAND BY TYPE, TECHNOLOGY, & CONDITION (million dollars)
    • Cancer Testing
      • Table CANCER TESTING IVD PRODUCT DEMAND BY TYPE, TECHNOLOGY, & CONDITION (million dollars)
      • Cervical Cancer
      • Breast Cancer
      • Prostate Cancer
      • Colorectal Cancer
      • Other Cancers
      • Producers
    • Diabetes Testing
      • Table DIABETES TESTING IVD PRODUCT DEMAND BY TYPE (million dollars)
      • Reagents & Consumables
      • Instruments & Systems
    • Heart Disease Testing
      • Table HEART DISEASE TESTING IVD PRODUCT DEMAND BY TYPE, TECHNOLOGY, & CONDITION (million dollars)
      • Lipid Profiling
      • Cardiac Markers
      • Blood Proteins
    • Blood Grouping & Screening
      • Table BLOOD GROUPING & SCREENING IVD PRODUCT DEMAND BY TYPE, TECHNOLOGY, & APPLICATION (million dollars)
      • Blood Typing & Matching
      • Blood & Bleeding Disorders
    • Drug Testing
      • Table DRUG TESTING IVD PRODUCT DEMAND BY TYPE, TECHNOLOGY, & FUNCTION (million dollars)
      • Therapeutic Drug Monitoring
      • Drugs-of-Abuse Testing
    • Forensic Medicine
      • Table FORENSIC MEDICINE IVD PRODUCT DEMAND BY TYPE, TECHNOLOGY, & FUNCTION (million dollars)
      • DNA Analysis
      • Identity Testing
      • Other Applications
    • Other IVD Applications
      • Table OTHER APPLICATIONS IVD PRODUCT DEMAND BY TYPE, TECHNOLOGY, & FUNCTION (million dollars)
      • Disease Detection
      • General Health Screening
      • Pregnancy & Ovulation Testing
  • MARKETS
    • General
      • Table IVD PRODUCT DEMAND BY MARKET (million dollars)
    • Hospitals
      • Table HOSPITAL IVD PRODUCT DEMAND BY TYPE & TECHNOLOGY (million dollars)
    • Independent Clinical Laboratories
      • Table INDEPENDENT CLINICAL LABORATORY IVD PRODUCT DEMAND BY TYPE & TECHNOLOGY (million dollars)
    • Outpatient Facilities
      • Table OUTPATIENT FACILITY IVD PRODUCT DEMAND BY TYPE & TECHNOLOGY (million dollars)
    • Home Health Care Market
      • Table HOME HEALTH CARE IVD PRODUCT DEMAND BY TYPE & TECHNOLOGY (million dollars)
    • Physicians' Offices
      • Table PHYSICIANS' OFFICE IVD PRODUCT DEMAND BY TYPE & TECHNOLOGY (million dollars)
    • Other Markets
      • Table OTHER MARKETS IVD PRODUCT DEMAND BY TYPE & TECHNOLOGY (million dollars)
  • INDUSTRY STRUCTURE
    • General
      • Table IVD PRODUCT SALES BY COMPANY, 2011 (million dollars)
    • Market Share
    • Competitive Strategies
    • Mergers & Acquisitions
      • Table SELECTED ACQUISITIONS & DIVESTITURES
    • Cooperative Agreements
      • Table SELECTED COOPERATIVE AGREEMENTS
    • Research & Development
    • Marketing & Distribution
    • Manufacturing
    • Company Profiles
      • Abbott Laboratories
      • Affymetrix Incorporated
      • Agilent Technologies Incorporated
      • Alere Incorporated
      • ARKRAY Incorporated
      • Bayer AG
      • Becton, Dickinson and Company
      • bioMerieux SA
      • Bio-Rad Laboratories Incorporated
      • CombiMatrix Corporation
      • Danaher Corporation
      • Gen-Probe Incorporated
      • Hologic Incorporated
      • Illumina Incorporated
      • Johnson & Johnson
      • Life Technologies Corporation
      • Meridian Bioscience Incorporated
      • Myriad Genetics Incorporated
      • PerkinElmer Incorporated
      • QIAGEN NV
      • Quest Diagnostics Incorporated
      • Roche Holding Limited
      • Sequenom Incorporated
      • Siemens AG
      • Sysmex Corporation
      • Thermo Fisher Scientific Incorporated
      • Trinity Biotech plc

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