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)
