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Physician Office Laboratory (POL) Markets, 3rd Edition (Markets for Office-Based Chemistry, Glucose, Coagulation PT, Autoimmune, HIV, Hep, Cardiac Markers, PSA, Flu, HbA1c, Hematology, FOB and Other Tests)

Physician Office Laboratory (POL) Markets, 3rd Edition (Markets for Office-Based Chemistry, Glucose, Coagulation PT, Autoimmune, HIV, Hep, Cardiac Markers, PSA, Flu, HbA1c, Hematology, FOB and Other Tests)

Physician office laboratories are a diverse but significant market for IVD products. The range of POLs is vast: Individual physicians may peform in-office pregnancy and glucose tests, run automated CBCs and chemistry panels or perform moderate complexity infectious disease tests using plate immunoassays and molecular assays.

This report, Physician Office Laboratory Markets is Kalorama's thorough look at this subset market. In terms of data, the report contains:

  • International POL Overview and Country Analysis
  • Corporate Profiles
  • Market Size Estimates for IVD Tests in POL Settings
  • Forecasts to 2018
  • POL Data
  • Important Trends
  • Most Common POL Tests
  • Reimbursement and Regulation
The POL market encompasses a variety of institutions beyond physician practices, including specialty and multispecialty clinics; other primary care and urgent care clinics; and outpatient clinics not located or associated with a hospital (or hospital lab) or outpatient surgical services. In general, the POL market includes tests which are:
  • physically performed in a physician office setting or lab located on the premises of the clinic or practice (not an associated hospital).
  • performed at the time of a consultation with a physician or other healthcare professional (nurse practitioner, pharmacist)
  • reportable to the patient are provide results to be used during the medical visit or same day as the visit
  • used for screening, diagnosis or monitoring purposes
  • not performed by anatomic pathologists or similar pathology practices that operate as physician practices or offices but provide histology, microscopy, and high complexity testing services as outreach (outside patients and samples) and with results not available during the visit or in conjunction with one visit
What competitors are succeeding in this market? What are the most profitable tests, and what growth levels can diagnostic companies expect in the future? How will regulations affect this industry? This report answers these questions. The report takes a bold look into the technologies and trends in physician office testing and laboratories (POLs) with a special focus on the economics of test use in on-site patient care. Among the type of physician conducted tests covered in this market research report:
  • FOB
  • H. pylori
  • Cardiac Markers
  • Hepatitis
  • HIV
  • Histology
  • Microbiology culture
  • Strep A
  • Autoimmune
  • Sed Rate
  • Chemistry Panels
  • Coag PT
  • Lipids
  • Hemato - CBC
  • Glucose
  • HbA1c
  • Rapid Flu
  • Anemia Ferritin, Iron
  • Preg/LH
  • Urinalysis
  • Cancer Markers
  • CRP
  • Hgb
  • Respiratory Viruses
  • STDs
  • Allergy
  • DAU
  • Infectious diseases
  • Microalbumin
  • TDM
  • Other
  • PSA
  • TSH
A truly global report, the 3rd edition this report discusses the POL market in the following countries: Canada, India, US, UK, Germany, Switzerland, Italy, Japan, China, Australia and France.


  • Executive Summary
    • INTRODUCTION
    • TECHNOLOGICAL DYNAMICS IN THE POL
      • Table Annual CLIA Test Waivers by Selected Analyte(s) (Drugs of Abuse and Therapeutic Drugs, Urinalysis, Glucose Monitoring, General Chemistry, Infectious Diseases, Other) (2010-2014)
    • POLMARKETSWORLDWIDE
      • Table Global POL Market by Region/Country (United States, Europe, Japan, ROW) ($ millions) (2014-2019)
      • Table Overview of POLs by Country (U.S., Canada, Australia, China, India, Japan, Philippines, Belgium, Britain, Czech Republic, France, Germany, Greece, Hungary, Italy, Spain, Sweden, Switzerland)
      • The United States of America
        • Table Number of POLs in the United States (Compliance [Moderate and High Complexity], Waiver, Provider-Perfomed Microscopy [PPM], Accreditation [Moderate and High Complexity]) (2005-2013)
        • Table U.S. Physician Office Laboratory (POL) Tests - Ranked by Estimated Volume (2014)
      • Germany
      • Switzerland
      • Japan
    • GLOBAL POLMARKET OVERVIEW
      • Table Global POL Market by Segment ($ millions) (2014-2019) (Allergy, Anemia, Autoimmune, Cardiac Markers, Hematology [CBC], Chemistry, Coagulation [PT], CRP, Drugs of Abuse, D-dimer, ESR, FOB, Glucose, H. pylori, HbA1c, Hepatitis, Hemoglobin/Hematocrit, Histology, HIV, Homocysteine, Lipids, Microalbumin, Microbiology, Pregnancy/Ovulation, PSA, Rapid Flu, Respiratory Viruses, STDs, Strep A, Therapeutic Drugs, TSH, Urinalysis, Other Cancer Markers, Other Infectious Diseases)
    • CONCLUSIONS
  • Introduction
    • BACKGROUND
    • POL DEFINITION
    • THE PROS AND CONS OF POL TESTING
    • REPORT POINT OF VIEW AND METHODOLOGY
  • Market and Technological Dynamics in POL Testing
    • BACKGROUND
    • THE EMERGENCE OF NON-INVASIVE TECHNOLOGIES
      • Saliva and Swab
      • Breath
        • Table Selected Disease Markers in Exhaled Breath (Asthma, Breast cancer, Diabetes, Liver function, Lung cancer, Organ rejection, Renal function, Schizophrenia, Gastrointestinal malabsorption / Irritable Bowel Syndrome (IBS) / Celiac disease and food intolerances / Bacterial overgrowth, Bacterial infection)
      • Optical Techniques
    • BIOSENSORS AND MICROFLUIDICS SUPPORT POC
      • Table Selected Biochip and Biosensor Players, 2014
    • CONNECTIVITY IMPERATIVE FOR POC DEVICES
    • CLIAWAIVED TEST MENU EXPANSION INSTILLS POINTS OF GROWTH IN U.S. POLMARKET
      • Table Traditional CLIA-Waived Tests
      • Table Annual CLIA Test Waivers by Selected Analyte(s) (Drugs of Abuse and Therapeutic Drugs, Urinalysis, Glucose Monitoring, General Chemistry, Infectious Diseases, Other) (2010-2014)
      • Table CLIA-Waived Tests and Analytes
      • Table 2014 CLIA Waivers (Manufacturer and Instrument / Assay)
      • Table Number of POLs in the United States (Compliance [Moderate and High Complexity], Waiver, Provider-Perfomed Microscopy [PPM], Accreditation [Moderate and High Complexity]) (2005-2013)
      • Table U.S. Physician Office Laboratory (POL) Tests - Ranked by Estimated Volume (2014)
    • REIMBURSEMENT CHALLENGES
    • CONCLUSIONS
  • POL Testing in World Markets
    • BACKGROUND
    • OVERVIEW OF THE GLOBAL POLMARKET
      • Table Global POL Market by Region/Country (United States, Europe, Japan, ROW) ($ millions) (2014-2019)
    • PHYSICIAN OFFICE LABS BY COUNTRY
      • Table Overview of POLs by Country (U.S., Canada, Australia, China, India, Japan, Philippines, Belgium, Britain, Czech Republic, France, Germany, Greece, Hungary, Italy, Spain, Sweden, Switzerland)
      • The United States of America
        • Table Non-Practice U.S. POL Sites (Community Clinic, Home Health Agency, Pharmacy, Other Practitioner, Rural Health Clinic, Total) (# of Locations, Est. Test Volume, CLIA-% of Test Volume)
        • Table U.S. POL Test Volume Distribution (Physician Practices Only)
        • Table U.S. Physician Practices and Physicians by Practice Type(Solo/2-Physician Practice, Group Practice (3-5), Group Practice (6-50), Group Practice (51+), Hospital-Based, Medical School/University, Group/Staff HMO, Community Health Center)
        • Table U.S. Physician Office Laboratory (POL) Tests - Ranked by Estimated Volume (2014)
      • Canada - Provinces Determine POL and POCT Coverage
      • Europe-Many Countries, Varied Prospects
      • United Kingdom
      • Germany
      • Italy
      • France
      • Switzerland
      • Japan
      • Australia
      • China
      • India
    • GLOBAL POLMARKET OVERVIEW
      • Table Global POL Market by Segment ($ millions) (2014-2019) (Allergy, Anemia, Autoimmune, Cardiac Markers, Hematology [CBC], Chemistry, Coagulation [PT], CRP, Drugs of Abuse, D-dimer, ESR, FOB, Glucose, H. pylori, HbA1c, Hepatitis, Hemoglobin/Hematocrit, Histology, HIV, Homocysteine, Lipids, Microalbumin, Microbiology, Pregnancy/Ovulation, PSA, Rapid Flu, Respiratory Viruses, STDs, Strep A, Therapeutic Drugs, TSH, Urinalysis, Other Cancer Markers, Other Infectious Diseases)
    • TEST SEGMENT MARKET ANALYSES AND DISCUSSION
      • Diabetes - Glucose
      • Diabetes - HbA1c
        • Table Selected HbA1c Tests and Devices, 2014
      • Diabetes - Microalbumin
        • Table Selected Microalbumin Tests and Devices, 2014
      • Cardiac Markers
        • Table Selected Cardiac Marker Tests and Systems, 2014
      • Secondary Cardiac Markers - CRP, Homocysteine, D-dimer
        • Table Selected CRP Tests and Systems, 2014
      • Lipid Panels and Tests
        • Table Selected Lipid Tests and Systems, 2014
      • Cancer Markers - FOBT, PSA, Others
      • Clinical Chemistry
        • Table Selected Clinical Chemistry Systems, 2014
      • Urinalysis
        • Table Selected Dipstick Urinalysis Systems, 2014
      • Coagulation
        • Table Selected PT/INR Systems, 2014
      • Hematology
        • Table Selected POL Hematology Analyzer Systems, 2014
        • Table Selected POL Hemoglobin and Hematocrit Systems, 2014
      • Histology
      • Infectious Diseases
        • Table Global POL Market for Rapid Infectious Disease Tests(Rapid Flu, HIV, Hepatitis, Strep A, Respiratory Viruses, STDs, Other, Total) (2014-2019) ($ millions)
      • Immunoassay Overview
        • Table Global POL Market for Immunoassays by Segment (2014-2019) ($ millions) (Allergy, Anemia, Autoimune, Cancer Markers, Cardiac Markers, CRP, Drugs of Abuse, Pregnancy/Ovulation, PSA, Therapeutic Drugs, TSH)
        • Table Selected POL Immunoanalyzers, 2014
      • Immunoassays - TSH
      • Immunoassays - Anemia
      • Immunoassays - Allergy
      • Immunoassays - Autoimmune
      • Immunoassays - Drugs of Abuse (DAU)
      • Immunoassays - Therapeutic Drug Monitoring (TDM)
      • Microbiology
      • Molecular
    • CONCLUSIONS
  • Top Tier IVD Players
    • Table Top Tier IVD Player POL Market Shares (%) (Abbott, Alere, Arkray, Beckman Coulter, BD, bioMérieux, Bio-Rad, Horiba, Instrumentation Laboratory, Ortho Clinical, QIAGEN, Radiometer, Roche, Siemens, Sysmex)
    • ABBOTT DIAGNOSTICS
      • Table Abbott Diagnostics Estimated Revenue by IVD Segment - (Core Lab [Chem/Immuno], Hematology, POC, Molecular, Diabetes) ($U.S. Millions) (2011-2013)
      • Point-of-Care Analyzers
      • Hematology
      • Diabetes
    • ALERE
      • Table Alere Revenue by IVD Segment - (Professional POC - Cardiology, Infectious Disease, Toxicology, Diabetes, Other; Consumer [OTC] Diagnostics) ($U.S. Millions) (2011-2013)
      • Point-of-Care Analyzers
      • Diabetes
      • Coagulation
      • Infectious Disease
      • Cardiac Markers
    • ARKRAY
    • BECKMAN COULTER
      • Table Beckman Coulter Estimated Revenue by IVD Segment - (Clinical Chemistry, Immunoassays, Hematolgy, Flow Cytometry) ($U.S. Millions) (2011-2013)
    • BECTON, DICKINSON AND COMPANY (BD)
      • Table Becton Dickinson Estimated Revenue by IVD Segment - (Histology, Molecular, Microbiology [ID/AST, Media, Rapid Tests, Blood Culture], Flow Cytometry) ($U.S. Millions) (FY 2011-2013)
      • Rapid Flu
    • BIOMÉRIEUX
      • Table bioMérieux Estimated Revenue by IVD Segment - (Microbiology, Immunoassays, Molecular, Industrial [Applied], Other) ($U.S. Millions) (FY 2011-2013)
    • BIO-RAD LABORATORIES
    • HORIBA MEDICAL
    • INSTRUMENTATION LABORATORY
    • ORTHO-CLINICAL DIAGNOSTICS
      • Table Ortho-Clinical Diagnostics Estimated Revenue by Product Group - (Immunoassays, Chemistry, Blood Banking) ($U.S. Millions) (2011-2013)
    • QIAGEN
      • Table QIAGEN Estimated Revenue by Segment - (HPV, Other Molecular Clinical, Applied Testing, Pharma, Academia) ($U.S. Millions) (2011-2013)
    • RADIOMETER
    • ROCHE DIAGNOSTICS
      • Table Roche Diagnostics Estimated Revenue by Segment - (Professional Diagnostics, Diabetes Care, Molecular Diagnostics, Tissue Diagnostics) ($U.S. Millions) (2011-2013)
      • Professional Glucose Testing
      • Point-of-Care Clinical Chemistry
    • SIEMENS HEALTHCARE DIAGNOSTICS
      • Table Siemens Healthcare Diagnostics Estimated Revenue by Segment - (Hematology, Coagulation, Chemistry/Immunoassays, Microbiology, Urinalysis, Blood Gases) ($U.S. Millions) (2011-2013)
      • HbA1c
      • Urinalysis
    • SYSMEX CORPORATION
      • Table Sysmex Corporation Estimated Revenue by Segment - (Hematology, Coagulation, Urinalysis, Chemistry/Immuno, Other IVD) ($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) ($U.S. Millions) (2011-2013)
      • Infectious Disease
      • Rapid Flu
  • Other POL Companies
    • 77 ELEKTRONIKA
    • ABAXIS
      • Table Abaxis Estimated Revenue by Business Segment Segment - (Piccolo/Clinical IVD, VetScan Chemistry, Veterinary Hematology, Other) ($U.S. Millions) (CY 2011-2013)
    • ACCRIVA DIAGNOSTICS
    • ACON LABORATORIES
    • AKERS BIOSCIENCES
    • ALFAWASSERMANN DIAGNOSTIC TECHNOLOGIES
    • AXIS-SHIELD
      • Afinion
      • NycoCard
      • Coagulation
    • BIOMERICA
    • BOULE DIAGNOSTICS
    • CAROLINA LIQUID CHEMISTRIES CORP.
    • CEPHEID
      • Table Cepheid Estimated Revenue by Business Segment Segment - (North American Clinical, North American Non-Clinical, International Clinical, International Non-Clinical) ($U.S. Millions) (2011-2013)
    • CHEMBIO DIAGNOSTIC SYSTEMS
    • COAGUSENSE
    • DIAZYME LABORATORIES
    • DXNA
    • EIKEN CHEMICAL
    • EKF DIAGNOSTICS
    • ENIGMA DIAGNOSTICS
    • ENTERIX
    • GLYCOMARK
    • HELENA LABORATORIES
    • HITACHI CHEMICAL
    • LABYSYSTEMS DIAGNOSTICS
    • LIFEASSAYS
    • LIFESIGN (PRINCETON BIOMEDITECH)
    • MACHEREY-NAGEL
    • MAGELLAN DIAGNOSTICS
    • MERIDIAN BIOSCIENCE
    • MICRONICS
    • MINDRAY
    • NANOSPHERE
    • OPKOHEALTH
    • ORASURE TECHNOLOGIES
    • PHILIPS HANDHELD DIAGNOSTICS
    • POLYMEDCO
    • POLYMER TECHNOLOGY SYSTEMS (CHEK DIAGNOSTICS)
    • QBC DIAGNOSTICS
    • QUIDEL
    • TRINITY BIOTECH
    • VITAL DIAGNOSTICS

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