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In Vitro Diagnostic Products (US Market & Forecast)

Abstract

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.

Study coverage

Details on these and other findings are contained in Freedonia industry study, In Vitro Diagnostics”, which presents historical demand data for 2001, 2006 and 2011, as well as forecasts for 2016 and 2021 by product, application, and market. This study also considers key market environment factors, evaluates company market share, and profiles 27 competitors in the US IVD industry.

Table of Contents

INTRODUCTION

I. EXECUTIVE SUMMARY

II. 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

III. 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

IV. 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

V. MARKETS

  • General
  • Hospitals
  • Independent Clinical Laboratories
  • Outpatient Facilities
  • Home Health Care Market
  • Physicians' Offices
  • Other Markets

VI. 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

SECTION I -- EXECUTIVE SUMMARY

  • Summary Table

SECTION II -- 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

SECTION III -- 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

SECTION IV -- 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

SECTION V -- 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

SECTION VI -- INDUSTRY STRUCTURE

  • IVD Product Sales by Company, 2011
  • Selected Acquisitions & Divestitures
  • Selected Cooperative Agreements

LIST OF CHARTS

SECTION I

SECTION II -- MARKET ENVIRONMENT

  • National Health Expenditures by Category, 2011

SECTION III -- PRODUCTS

  • IVD Product Demand by Type, 2001-2021
  • IVD Product Demand by Technology, 2011

SECTION IV -- APPLICATIONS

  • IVD Product Demand by Application, 2011

SECTION V -- MARKETS

  • IVD Product Demand by Market, 2011

SECTION VI -- INDUSTRY STRUCTURE

  • IVD Product Market Share, 2011
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