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The United States Market for In Vitro Diagnostic Tests: Forecasts to 2018


Attention: There is an updated edition available for this report.

The United States is the world’s largest in vitro diagnostics and nearly half of the global IVD market. While companies seek emerging markets for growth, most healthcare business is generated in the United States and its volume is still a strong advantage of this market.  Most recently the U.S. IVD market weathered interrupted lab and healthcare sector investment in anticipation of the Affordable Care Act and several regulatory and austerity measures on the part of government payers that constricted payments for clinical testing. 

In this report, The United States Market for In Vitro Diagnostic Tests, Kalorama Information analyst Emil Salazar takes a considered look into these trends and what they mean for diagnostic manufacturers and investors. 

As the report notes, there are both challenging developments and postiive trends which make the United States a stable IVD market: The expansion of the insured population under the ACA; demographic aging that increases demand for clinical testing and a medical program that serves as a leading, stable vehicle for payment (Medicare); relatively optimistic macroeconomic indicators vis-à-vis the domestic outlook five years ago or other developed markets in the world; and continued product innovation and industry responsiveness to clients’ needs in the world’s largest IVD market. 

This report includes important tools for business planners, including market size estimates and forecasts for the following IVD segments:

  • Point of Care  (Glucose, Professional, OTC)
  • Histology and Cytology 
  • Clinical Chemistry 
  • Immunoassays (Infectious Disease, Non-Infectious Disease)
  • Molecular Assays (Non-Infectious Disease)
  • Hematology
  • Urinalysis
  • Flow Cytometry
  • Coagulation 
  • Microbiology and Virology (ID/AST, Molecular)
  • Blood Testing
Market sizes, forecasts and shares are provided, as well as a geographic breakdown of the segments, where possible. Changes in technology development, regulatory and reimbursement issues, clinical care, and business environments are discussed. Current market numbers are presented for 2011, with projections given through 2016. The following data points are included in this report:

  • U.S. Health Expenditure
  • U.S. Clinical Lab Expenditure
  • U.S. Infectious Disease Market Opportunities
  • Affordable Care Act (ACA)
  • Clinical Testing under Medicare – Reimbursement Cuts and “Revaluation”
  • Molecular Diagnostics and Medicare Policy
  • Patient Population
  • Healthcare System Utilization
  • Aging
  • Disease Prevalence and Incidence
  • Analyst Conclusions About the Market
Many of the top IVD companies use Kalorama Information products for business planning, which means that this volume can provide a uniform standard for in vitro diagnostic market numbers. This edition greatly expands coverage of the field and tracks the most important developments. See aspects of the industry that might not be available in your company's internal resources. View the market from an independent point of view. Learn about competitors in away that may be invisible to internal personnel. Know the market players - your competitors and potential partners, in proper context and classification. Save countless hours of staff time and other research expenses with the authoritative guide for IVD market estimates and forecasts.

As part of the reports, the following companies are covered:

  • Abbott Diagnostics
  • Alere
  • Beckman Coulter
  • Becton Dickinson
  • Danaher Corporation
  • Hologic
  • Ortho-Clinical Diagnostics / J&J Diabetes Care
  • QIAGEN
  • Roche Diagnostics
  • Siemens Healthcare Diagnostics
  • Sysmex Corporation
  • Thermo Fisher Scientific


  • Executive Summary
    • INTRODUCTION
    • MARKET METRICS - SYSTEM UTILIZATION
      • Table U.S. Hospital Inpatient Admissions and Outpatient Visits Per 1,000 Persons (1991-2011)
    • MARKET METRICS -AGING
      • Table Historical and Projected U.S. Aged Populations (60+) (% Share of Total Population, Population in Millions) (1950-2050)
    • MARKET METRICS -DISEASE
      • Table U.S. Infectious Disease Market Opportunities Ranked
    • MARKET METRICS -U.S.TOTAL HEALTH AND CLINICAL LAB EXPENDITURES AND PAYERS
    • MARKET METRICS -U.S. CLINICAL TESTING BY CHANNEL
    • IMPACTS OF THE AFFORDABLE CAREACT
    • IMPACTS OF CLFS CUTS AND MOLECULAR REIMBURSEMENT REFORM
    • U.S. IVDMARKET
      • Table U.S. IVD Market by Segment
    • TOP TIER U.S. IVDMARKET PARTICIPANTS AND RANKINGS
      • Table U.S. IVD Market Rankings by Estimated 2013 Revenue - Top 12 Companies
    • CONCLUSIONS
  • Introduction to U.S. Health Care
    • THE UNITED STATES AND IN VITRO DIAGNOSTICS
      • U.S. PATIENT POPULATION
      • Healthcare System Utilization
        • Table U.S. Hospital Inpatient Admissions and Outpatient Visits Per 1,000 Persons (1991-2011)
      • Aging
        • Table Historical and Projected U.S. Aged Populations (60+) (% Share of Total Population, Population in Millions) (1950-2050)
      • Disease Prevalence and Incidence
        • Table U.S. Adult Diabetes Prevalence - Age-Adjusted and Crude Rates (%) (2002-2012)
        • Table U.S. Cancer Incidence - Aggregate, Lung, Colon, Prostate, Breast (per 100,000 persons) (2000-2010)
        • Table Selected Notifiable Infectious Disease Incidences in the United States (per 100,000 persons) (2001-2011)
        • Table U.S. Infectious Disease Market Opportunities Ranked
    • HEALTH INSURANCE IN THE UNITED STATES AND THE AFFORDABLE CARE ACT (ACA)
      • U.S. Health Expenditure
        • Table U.S. National Health Expenditure by Payer (Out-of-Pocket, Private Health Insurance, Medicare, Medicaid) (2002-2022)
      • U.S. Clinical Lab Expenditure
        • Table U.S. Clinical Laboratory Market by Segment - Hospital, Independent, Physician Office ($ millions) (2008-2018)
      • Affordable Care Act (ACA)
      • Clinical Testing under Medicare - Reimbursement Cuts and "Revaluation"
      • Molecular Diagnostics and Medicare Policy
    • U.S. HEALTHCARE INFRASTRUCTURE AND TESTING CHANNELS
      • Hospitals
      • Independent Labs
      • Physician Office Laboratories (POLs)
      • Self-Testing
      • Retail Clinics
      • Other Labs
    • CONCLUSIONS
  • U.S. IVD Market Analysis
    • CLINICAL CHEMISTRY
    • MICROBIOLOGY AND VIROLOGY, ID/AST AND MOLECULAR
    • POINT OF CARE TESTING
    • IMMUNOASSAYS
    • URINALYSIS
    • MOLECULAR DIAGNOSTICS
    • COAGULATION
    • HISTOLOGY
    • HEMATOLOGY
    • BLOOD TESTING AND TYPING
    • FLOW CYTOMETRY
    • TOTAL U.S. IVDMARKET
      • Table U.S. IVD Market by Segment
  • Top Tier U.S. IVD Market Players
    • ABBOTT DIAGNOSTICS
      • Table Abbott Diagnostics Estimated Revenue by IVD Segment - (Core Lab [Chem/Immuno], Hematology, POC, Molecular, Diabetes) ($U.S. Millions) (2011-2013)
      • Core Lab
      • Molecular
      • Diabetes
    • ALERE
      • Table Alere Revenue by IVD Segment - (Professional POC - Cardiology, Infectious Disease, Toxicology, Diabetes, Other; Consumer [OTC] Diagnostics) ($U.S. Millions) (2011-2013)
      • Critical Care
      • Infectious Disease
      • Consumer Diagnostics
    • BECKMAN COULTER
      • Table Beckman Coulter Estimated Revenue by IVD Segment - (Clinical Chemistry, Immunoassays, Hematolgy, Flow Cytometry) ($U.S. Millions) (2011-2013)
      • Clinical Chemistry
      • Immunoassays
      • Hematology
      • Flow Cytometry
    • BECTON, DICKINSON AND COMPANY (BD)
      • Table Becton Dickinson Estimated Revenue by IVD Segment - (Histology, Molecular, Microbiology [ID/AST, Media, Rapid Tests, Blood Culture], Flow Cytometry) ($U.S. Millions) (FY 2011-2013)
      • Molecular
      • Rapid Tests
      • Flow Cytometry
    • DANAHER CORPORATION
      • Table Danaher Corporation Estimated Revenue by Subsidiary Group - (Beckman Coulter, Radiometer, Leica Biosystems, Leica Microsystems, AB Sciex, Molecular Diagnostics) ($U.S. Millions) (FY 2011-2013)
      • Histology
      • Point-of-Care Testing
    • HOLOGIC (INCL. GEN-PROBE)
      • Table Hologic Estimated Revenue by Product Group - (HPV, ThinPrep, Gen-Probe Clinical Molecular, Gen-Probe Blood Banking) ($U.S. Millions) (FY 2011-2013)
      • Molecular Diagnostics / Histology
    • ORTHO-CLINICAL DIAGNOSTICS (AND J&J DIABETES CARE)
      • Table Ortho-Clinical Diagnostics / J&J Diabetes Care Estimated Revenue by Product Group - (OTC Diabetes [SMBG], Immunoassays, Chemistry, Blood Banking) ($U.S. Millions) (2011-2013)
      • Blood Banking
    • QIAGEN
      • Table QIAGEN Estimated Revenue by Segment - (HPV, Other Molecular Clinical, Applied Testing, Pharma, Academia) ($U.S. Millions) (2011-2013)
      • Companion Diagnostics / Cancer Markers
      • Infectious Disease
      • Immunoassays
    • ROCHE DIAGNOSTICS
      • Table Roche Diagnostics Estimated Revenue by Segment - (Professional Diagnostics, Diabetes Care, Molecular Diagnostics, Tissue Diagnostics) ($U.S. Millions) (2011-2013)
      • Professional Diagnostics
      • Diabetes Care
      • Molecular Diagnostics
    • SIEMENS HEALTHCARE DIAGNOSTICS
      • Table Siemens Healthcare Diagnostics Estimated Revenue by Segment - (Hematology, Coagulation, Chemistry/Immunoassays, Microbiology, Urinalysis, Blood Gases) ($U.S. Millions) (2011-2013)
      • Clinical Chemistry/Immunoassays
      • Immunoassays
      • Microbiology
      • Companion Diagnostics
      • Urinalysis
      • Coagulation
      • Point-of-Care Diagnostics
    • SYSMEX CORPORATION
      • Table Sysmex Corporation Estimated Revenue by Segment - (Hematology, Coagulation, Urinalysis, Chemistry/Immuno, Other IVD) ($U.S. Millions) (2011-2013)
      • Hematology
      • Coagulation
    • THERMO FISHER SCIENTIFIC
      • Table Thermo Fisher Scientific Estimated Revenue by Segment - (Clinical Products, Immunoassays [Phadia], Microbiology, Histology, Transplant Diagnostics) ($U.S. Millions) (2011-2013)
      • Immunoassays
      • Microbiology
      • Molecular Diagnostics

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