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United States Market for In Vitro Diagnostic Tests (Molecular Assays, Microbiology, Histology, Chemistry, Hematology, Blood Banking, POC and Other Tests)

United States Market for In Vitro Diagnostic Tests

United States Market for In Vitro Diagnostic Tests takes a considered look at the U.S. in vitro diagnostics (IVD) market and examines what current market trends mean for diagnostic manufacturers and investors. This report includes important tools for business planners. Included are market size estimates and forecasts for the following U.S. IVD segments:

  • Clinical Chemistry Market (2015/2020)
  • Identification and Antibiotic Susceptibility Testing (ID/AST) Microbiology (Traditional) Market – Automated ID/AST, Manual/Semi‐Auto ID/AST, Blood Culture, Chromogenic Media, Rapid Micro (2015/2020)
  • Molecular Microbiology / Virology Market – HAIs/BSIs, HIV, Hepatitis, CT/NG, HPV, Respiratory, Mycobacteria/TB, Other (2015/2020)
  • Point-of-Care (POC) Diagnostics Markets – Professional (Drugs of Abuse, Infectious Disease, Pregnancy, Glucose, HbA1c, Lipids, Cardiac Markers, FOB, Critical Care, Coagulation, Hematology, Other), OTC Diabetes, OTC Other (2015/2020)
  • Immunoassays Market – Non Infectious (Cardiac Markers, Tumor Markers, HbA1c, Autoimmune, Allergy, Thyroid, Proteins, Anemia, Fertility, Therapeutic Drugs, Drugs of Abuse, Vitamin D) (2015/2020)
  • Immunoassays Market – Infectious (Hepatitis, HIV, STDs, ToRCH, Respiratory, HAIs/Sepsis, Parasitology, Mycology, Others) (2015/2020)
  • Urinalysis Lab Diagnostics Market (2015/2020)
  • Molecular Diagnostics Market (2015/2020)
  • Coagulation Diagnostics Market (2015/2020)
  • Histology and Cytology Diagnostics Market (2015/2020)
  • Hematology Diagnostics Market (2015/2020)
  • Blood Testing and Typing Diagnostics Market (2015/2020)
  • Clinical Flow Cytometry Market (2015/2020)
The United States represents the world’s largest in vitro diagnostics (IVD) market, projected to outpace other IVD markets in the developed world such as Western Europe and Japan. The report discusses market factors and trends, including:
  • continued expansion of the insured population under the ACA and increased healthcare utilization baselines;
  • demographic aging that increases demand for clinical testing paid for through the country’s leading vehicle for lab payments (Medicare);
  • relatively optimistic macroeconomic indicators vis-à-vis the domestic outlook five years ago or other developed markets in the world;
  • continued product innovation and industry responsiveness to clients’ needs in the world’s largest IVD market.
The report tracks developments, both challenging and positive, in the United States IVD market. Conclusions about the market are made concerning issues such as distribution of market share in IVD market segments, future U.S. IVD market growth, anticipated market obstacles, the growth of the molecular diagnostics market, and core lab IVD market growth.

United States Market for In Vitro Diagnostic Tests profiles in-depth the top tier U.S. IVD market participants. The total combined IVD sales of these top tier companies are estimated by Kalorama to represent nearly 70% of the total U.S. IVD market. The report ranks these firms and notes the IVD strengths of each. Companies discussed include:
  • Danaher Corporation
  • Roche Diagnostics
  • Siemens Healthcare Diagnostics


  • Executive Summary
    • Introduction
    • Market Metrics – Utilization
      • Table U.S. Commercially Insured Members' Encounters with Ambulatory Physicians (per 1,000 Members) (2005-2014)
    • Market Metrics – Aging
      • Table Historical and Projected U.S. Aged Populations (60+) (% Share of Total Population, Population in Millions) (1950-2050)
    • Market Metrics – Disease
    • Market Metrics – U.S. Total Health and Clinical Lab Expenditures and Payers
    • Market Metrics – U.S. Clinical Testing by Channel
    • Impacts of the Affordable Care Act
    • Impacts of PAMA and LDT Reform
    • U.S. IVD Market
      • Table U.S. IVD Market by Segment (2015/2020) ($ millions)
    • Top Tier U.S. IVD Market Participants and Rankings
      • Table U.S. IVD Market Rankings by Estimated 2015 Revenue – Top 15 Companies
    • Conclusions
  • Introduction to U.S. Health Care
    • The United States and In Vitro Diagnostics
      • Table U.S. IVD Market (2015/2020) ($ billions)
    • U.S. Patient Population
      • Healthcare System Utilization
        • Table U.S. Hospital Inpatient Admissions and Outpatient Visits Per 1,000 Persons (1994-2013)
        • Table U.S. Commercially Insured Members' Encounters with Ambulatory Physicians (per 1,000 Members) (2005-2014)
      • 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. Cancer Incidence – Aggregate, Lung, Colon, Prostate, Breast (per 100,000 persons) (2002-2012)
        • Table Selected Notifiable Infectious Disease Incidences in the United States (per 100,000 persons) (2003-2013)
    • Health Insurance in the United States and the Affordable Care Act
      • U.S. Health Expenditure
        • Table U.S. National Health Expenditure by Payer (Out of Pocket, Private Health Insurance, Medicare, Medicaid) (2013-2020)
      • U.S. Clinical Lab Expenditure
        • Table U.S. Clinical Laboratory Market by Segment Hospital, Independent, Physician Office ($ millions) (2013-2020)
      • Affordable Care Act (ACA)
    • Clinical Testing under Medicare – Reimbursement Cuts and Market Based Pricing
      • Protecting Access to Medicare Act of 2014 (PAMA)
    • Molecular Diagnostics and Medicare Policy
    • Laboratory DevelopedTests (LDTs) InvigorateMarket, Challenge Regulators
    • U.S. Healthcare Infrastructure and Testing Channels
      • Hospitals
      • Independent Labs
      • Physician Office Laboratories
      • Self Testing
      • Retail Clinics
    • Conclusions
  • U.S. IVD Market Analysis
    • Clinical Chemistry
      • Table U.S. Clinical Chemistry Market (2015/2020) ($ millions)
    • Microbiology and Virology – ID/AST and Molecular
      • Table U.S. ID/AST Microbiology Market (2015/2020) ($ millions)
      • Table U.S. ID/AST Microbiology Market – Automated ID/AST, Manual/Semi Auto ID/AST, Blood Culture, Chromogenic Media, Rapid Micro (2015/2020) ($ millions)
      • Table U.S. Molecular Microbiology / Virology Market (2015/2020) ($ millions)
      • Table U.S. Molecular Microbiology / Virology Market – HAIs/BSIs, HIV, Hepatitis, CT/NG, HPV, Respiratory, Mycobacteria/TB, Other (2015/2020) ($ millions)
    • Point of Care Testing
      • Table U.S. Point of Care (POC) Diagnostics Markets – Professional (Drugs of Abuse, Infectious Disease, Pregnancy, Glucose, HbA1c, Lipids, Cardiac Markers, FOB, Critical Care, Coagulation, Hematology, Other), OTC Diabetes, OTC Other (2015/2020) ($ millions)
      • Table U.S. Point of Care (POC) Diagnostics Markets – Professional, OTC Diabetes, OTC Other (2015/2020) ($ millions)
    • Immunoassays
      • Table U.S. Immunoassays Markets – Infectious and Non Infectious (2015/2020) ($ millions)
      • Table U.S. Immunoassays Market – Non Infectious (Cardiac Markers, Tumor Markers, HbA1c, Autoimmune, Allergy, Thyroid, Proteins, Anemia, Fertility, Therapeutic Drugs, Drugs of Abuse, Vitamin D) (2015/2020) ($ millions)
      • Table U.S. Immunoassays Market – Infectious (Hepatitis, HIV, STDs, ToRCH, Respiratory, HAIs/Sepsis, Parasitology, Mycology, Others)
    • Urinalysis
      • Table U.S. Urinalysis Lab Diagnostics Market (2015/2020) ($ millions)
    • Molecular Diagnostics
      • Table U.S. Molecular Diagnostics Market (2015/2020) ($ millions)
    • Coagulation
      • Table U.S. Coagulation Diagnostics Market (2015/2020) ($ millions)
    • Histology
      • Table U.S. Histology and Cytology Diagnostics Market (2015/2020) ($ millions)
    • Hematology
      • Table U.S. Hematology Diagnostics Market (2015/2020) ($ millions)
    • Blood Testing and Typing
      • Table U.S. Blood Testing and Typing Diagnostics Market (2015/2020) ($ millions)
    • Flow Cytometry
      • Table U.S. Clinical Flow Cytometry Market (2015/2020) ($ millions)
    • Total U.S. IVD Market
      • Table U.S. IVD Market by Segment (2015/2020) ($ millions)
  • Top Tier U.S. IVD Market Players
    • Abbott Diagnostics
      • Table Abbott Diagnostics Revenue (2012-2015) ($ millions)
      • Core Lab
      • Hematology
      • Molecular
      • Blood Testing
      • Mass Spectrometry ID/AST
      • Diabetes Testing
      • Point of Care (POC) Diagnostics
    • Alere
      • Table Alere Revenue (2012-2015) ($ millions)
      • Critical Care
      • Lipids and Cardiac Markers
      • Diabetes Testing
      • Coagulation
      • Toxicology / Drugs of Abuse
      • Infectious Diseases
    • Beckman Coulter (Danaher)
      • Table Beckman Coulter Revenue (2012-2015) ($ millions)
      • Immunoassays
      • Clinical Chemistry
      • Hematology
      • Microbiology
      • Urinalysis
      • Flow Cytometry
      • Molecular
    • Becton, Dickinson and Company (BD)
      • Table BD Revenue (FY 2012-FY 2015) ($ millions)
      • Microbiology
      • Mass Spectrometry
      • Immunoassays
      • Molecular
      • Histology/Cytology
      • Flow Cytometry
    • bioMérieux
      • Table bioMérieux Revenue (2012-2015) ($ millions)
      • Microbiology
      • Mass Spectrometry
      • Immunoassays
      • Molecular
      • Sequencing
    • Bio Rad Laboratories
      • Table Bio Rad Laboratories Revenue (2012-2015) ($ millions)
      • Microbiology
      • Hemoglobinopathy and Diabetes Testing
      • Immunoassays
      • Blood Typing and Testing
      • Tissue Typing
      • Sequencing
    • Cepheid
      • Table Cepheid Revenue (2012-2015) ($ millions)
      • Molecular Hospital Acquired Infection (HAI) Testing
      • Molecular Sexual Health and Women's Health Testing
      • Molecular Critical Infectious Disease Testing
      • Molecular Oncology Testing
    • Danaher Corporation
      • Table Danaher Diagnostics Group Subsidiary Revenue (Beckman Coulter, Radiometer, Leica Biosystems) (2012-2015) ($ millions)
      • Histology
      • Point of Care Testing
    • Hologic
      • Table Hologic Revenue (FY 2012-FY 2015) ($ millions)
      • Molecular Cytology / Histology (HPV)
      • Other Molecular (STIs, HIV, HCV, TB, Respiratory)
      • Microbiology (AccuProbe Molecular Culture ID Tests)
      • Blood Testing (Molecular PROCLEIX Tests)
    • Johnson & Johnson (Incl. Janssen Diagnostics)
      • Table Johnson & Johnson Diagnostics Revenue (2012-2015) ($ millions)
    • Ortho Clinical Diagnostics
      • Core Lab
      • Blood Testing and Typing
    • QIAGEN
      • Table QIAGEN Revenue (2012-2015) ($ millions)
      • Molecular Infectious Disease
      • Companion Diagnostics
      • Immunoassays
      • Next Generation Sequencing
    • Roche Diagnostics
      • Table Roche Diagnostics Revenue (2012-2015) ($ millions)
      • Professional Diagnostics
      • Immunoassays
      • Point of Care Diagnostics
      • Diabetes Care
      • Tissue Diagnostics
      • Molecular Diagnostics
      • Blood Testing
      • Sequencing
      • Microbiology (GeneWeave)
    • Siemens Healthcare Diagnostics
      • Table Siemens Healthcare Diagnostics Revenue (FY 2012-FY 2015) ($ millions)
      • Clinical Chemistry
      • Immunoassays
      • Hematology
      • Molecular Diagnostics and Histology
      • Urinalysis
      • Coagulation
      • Point of Care Diagnostics
    • Sysmex Corporation
      • Table Sysmex Corporation Revenue (FY 2012-FY 2015) ($ millions)
      • Hematology
      • Coagulation
      • Urinalysis
    • Thermo Fisher Scientific
      • Table Thermo Fisher Scientific Revenue (2012-2015) ($ millions)
      • Immunoassays
      • Drug Testing
      • Histology
      • Mass Spectrometry
      • Microbiology
      • Molecular
      • Sequencing

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