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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)

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SKU: KLI5314670 Categories: Diagnostics Market Research, Immunoassays, Molecular & Nucleic Acid Testing, Point-of-Care Diagnostics Pages: 150
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Description

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.

Table of Contents

ONE: EXECUTIVE SUMMARY

Introduction

Technological Dynamics in the POL

POL Markets Worldwide

The United States of America

Germany

Switzerland

Japan

Global POL Market Overview

Conclusions

TWO: INTRODUCTION

Background

POL Definition

The Pros and Cons of POL Testing

Report Point of View and Methodology

THREE: MARKET AND TECHNOLOGICAL DYNAMICS IN POL TESTING

Background

The Emergence of Non-invasive Technologies

Saliva and Swab

Breath

Optical Techniques

Biosensors and Microfluidics Support POC

Connectivity Imperative for POC Devices

CLIA Waived Test Menu Expansion Instills Points of Growth in U.S. POL Market

Reimbursement Challenges

Conclusions

FOUR: POL TESTING IN WORLD MARKETS

Background

Overview of the Global POL Market

Physician Office Labs by Country

The United States of America

Canada – Provinces Determine POL and POCT Coverage

Europe—Many Countries, Varied Prospects

United Kingdom

Germany

Italy

France

Switzerland

Japan

Australia

China

India

Global POL Market Overview

Test Segment Market Analyses and Discussion

Diabetes – Glucose

Diabetes – HbA1c

Diabetes – Microalbumin

Cardiac Markers

Secondary Cardiac Markers – CRP, Homocysteine, D-dimer

Lipid Panels and Tests

Cancer Markers – FOBT, PSA, Others

Clinical Chemistry

Urinalysis

Coagulation

Hematology

Histology

Infectious Diseases

Immunoassay Overview

Immunoassays – TSH

Immunoassays – Anemia

Immunoassays – Allergy

Immunoassays – Autoimmune

Immunoassays – Drugs of Abuse (DAU)

Immunoassays – Therapeutic Drug Monitoring (TDM)

Microbiology

Molecular

Conclusions

FIVE: TOP TIER IVD PLAYERS

Abbott Diagnostics

Point-of-Care Analyzers

Hematology

Diabetes

Alere

Point-of-Care Analyzers

Diabetes

Coagulation

Infectious Disease

Cardiac Markers

Arkray

Beckman Coulter

Becton, Dickinson and Company (BD)

Rapid Flu

bioMérieux

Bio-Rad Laboratories

Horiba Medical

Instrumentation Laboratory

Ortho-Clinical Diagnostics

QIAGEN

Radiometer

Roche Diagnostics

Professional Glucose Testing

Point-of-Care Clinical Chemistry

Siemens Healthcare Diagnostics

HbA1c

Urinalysis

Sysmex Corporation

Hematology

Coagulation

Thermo Fisher Scientific

Infectious Disease

Rapid Flu

SIX: OTHER POL COMPANIES

77 Elektronika

Abaxis

Accriva Diagnostics

ACON Laboratories

Akers Biosciences

Alfa Wassermann Diagnostic Technologies

Axis-Shield

Afinion

NycoCard

Coagulation

Biomerica

Boule Diagnostics

Carolina Liquid Chemistries Corp.

Cepheid

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

OPKO Health

OraSure Technologies

Philips Handheld Diagnostics

Polymedco

Polymer Technology Systems (CHEK Diagnostics)

QBC Diagnostics

Quidel

Trinity Biotech

Vital Diagnostics

LIST OF EXHIBITS

ONE: EXECUTIVE SUMMARY

Table 1-1: Annual CLIA Test Waivers by Selected Analyte(s) (Drugs of Abuse andTherapeutic Drugs, Urinalysis, Glucose Monitoring, General Chemistry,Infectious Diseases, Other) (2010-2014) Table 1-2: Global POL Market by Region/Country (United States, Europe, Japan,ROW) (2014-2019)

Table 1-3: 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)

Table 1-4: Number of POLs in the United States (Compliance [Moderate and HighComplexity], Waiver, Provider-Perfomed Microscopy [PPM], Accreditation[Moderate and High Complexity]) (2005-2013) Table 1-5: U.S. Physician Office Laboratory (POL) Tests – Ranked by EstimatedVolume (2014)

Table 1-6: 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, OtherInfectious Diseases)

THREE: MARKET AND TECHNOLOGICAL DYNAMICS IN POL TESTING

Table 3-1: 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) Table 3-2: Selected Biochip and Biosensor Players, 2014

Table 3-3: Traditional CLIA-Waived Tests

Table 3-4: Annual CLIA Test Waivers by Selected Analyte(s) (Drugs of Abuse andTherapeutic Drugs, Urinalysis, Glucose Monitoring, General Chemistry, InfectiousDiseases, Other) (2010-2014) Table 3-5: CLIA-Waived Tests and Analytes

Table 3-6: 2014 CLIA Waivers (Manufacturer and Instrument / Assay)

Table 3-7: Number of POLs in the United States (Compliance [Moderate and HighComplexity], Waiver, Provider-Perfomed Microscopy [PPM], Accreditation[Moderate and High Complexity]) (2005-2013) Table 3-8: U.S. Physician Office Laboratory (POL) Tests – Ranked by EstimatedVolume (2014)

FOUR: POL TESTING IN WORLD MARKETS

Table 4-1: Global POL Market by Region/Country (United States, Europe, Japan,ROW) (2014-2019)

Table 4-2: 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)

Table 4-3: 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 4-4: U.S. POL Test Volume Distribution (Physician Practices Only)

Table 4-5: U.S. Physician Practices and Physicians by Practice Type(Solo/2-PhysicianPractice, Group Practice (3-5), Group Practice (6-50), Group Practice (51+),Hospital-Based, Medical School/University, Group/Staff HMO, CommunityHealth Center)

Table 4-6: U.S. Physician Office Laboratory (POL) Tests – Ranked by EstimatedVolume (2014)

Table 4-7: 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, OtherInfectious Diseases)

Table 4-8: Selected HbA1c Tests and Devices, 2014

Table 4-9: Selected Microalbumin Tests and Devices, 2014

Table 4-10: Selected Cardiac Marker Tests and Systems, 2014

Table 4-11: Selected CRP Tests and Systems, 2014

Table 4-12: Selected Lipid Tests and Systems, 2014

Table 4-13: Selected Clinical Chemistry Systems, 2014

Table 4-14: Selected Dipstick Urinalysis Systems, 2014

Table 4-15: Selected PT/INR Systems, 2014

Table 4-16: Selected POL Hematology Analyzer Systems, 2014

Table 4-17: Selected POL Hemoglobin and Hematocrit Systems, 2014

Table 4-18: Global POL Market for Rapid Infectious Disease Tests(Rapid Flu, HIV,

Hepatitis, Strep A, Respiratory Viruses, STDs, Other, Total) (2014-2019)

Table 4-19: Global POL Market for Immunoassays by Segment (2014-2019) (Allergy,Anemia, Autoimune, Cancer Markers, Cardiac Markers, CRP, Drugs of Abuse,Pregnancy/Ovulation, PSA, Therapeutic Drugs, TSH)

Table 4-20: Selected POL Immunoanalyzers, 2014

FIVE: TOP TIER IVD PLAYERS

Table 5-1: 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)

Table 5-2: Abbott Diagnostics: Estimated Revenue by IVD Segment – (Core Lab[Chem/Immuno], Hematology, POC, Molecular, Diabetes) (2011-2013)

Table 5-3: Alere: Revenue by IVD Segment – (Professional POC – Cardiology,Infectious Disease, Toxicology, Diabetes, Other; Consumer [OTC] Diagnostics)(2011-2013)

Table 5-4: Beckman Coulter: Estimated Revenue by IVD Segment – (ClinicalChemistry, Immunoassays, Hematolgy, Flow Cytometry) (2011-2013)

Table 5-5: Becton Dickinson: Estimated Revenue by IVD Segment – (Histology,Molecular, Microbiology [ID/AST, Media, Rapid Tests, Blood Culture], FlowCytometry) (FY 2011-2013)

Table 5-6: bioMérieux: Estimated Revenue by IVD Segment – (Microbiology,Immunoassays, Molecular, Industrial [Applied], Other) (FY 2011-2013)

Table 5-7: Ortho-Clinical Diagnostics: Estimated Revenue by Product Group –(Immunoassays, Chemistry, Blood Banking) (2011-2013)

Table 5-8: QIAGEN: Estimated Revenue by Segment – (HPV, Other MolecularClinical, Applied Testing, Pharma, Academia) (2011-2013)

Table 5-9: Roche Diagnostics: Estimated Revenue by Segment – (ProfessionalDiagnostics, Diabetes Care, Molecular Diagnostics, Tissue Diagnostics)(2011-2013)

Table 5-10: Siemens Healthcare Diagnostics: Estimated Revenue by Segment –(Hematology, Coagulation, Chemistry/Immunoassays, Microbiology, Urinalysis,Blood Gases) (2011-2013)

Table 5-11: Sysmex Corporation: Estimated Revenue by Segment – (Hematology,Coagulation, Urinalysis, Chemistry/Immuno, Other IVD) (2011-2013)

Table 5-12: Thermo Fisher Scientific: Estimated Revenue by Segment – (ClinicalProducts, Immunoassays [Phadia], Microbiology, Histology, TransplantDiagnostics) (2011-2013)

SIX: OTHER POL COMPANIES

Table 6-1: Abaxis: Estimated Revenue by Business Segment Segment – (Piccolo /Clinical IVD, VetScan Chemistry, Veterinary Hematology, Other)(CY 2011-2013)

Table 6-2: Cepheid: Estimated Revenue by Business Segment Segment – (NorthAmerican Clinical, North American Non-Clinical, International Clinical,International Non-Clinical) (2011-2013)

 

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