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Physician Office Laboratory (POL) Testing Markets Worldwide: Status
Quo and Future Trends
November 1, 2010
Labs specifically conducted in physician offices are usually not broken out in market
research reports covering the diagnostic industry. Numbers are often simply grouped in
with hospital and service lab sales. But for marketing strategy, knowing where tests
occur is as important as the revenue numbers. Now, Kalorama has once again
rendered this important market segment visible. This report is the second edition of the
report “Physician Office Testing, Worldwide: Status Quo and Future Trends” that was
first published in 2007. The report concentrates on how the market for POL testing has
evolved from 2007 to 2010.
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? Analyst Shara Rosen, author of Kalorama Information’s
Worldwide Market for In Vitro Diagnostic Tests, now in seven editions, 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:
Chemistry Panels
Coag PT
Lipids
Hemato - CBC
Glucose
HbA1c
Rapid Flu
Anemia Ferritin, Iron
Preg/LH
Urinalysis
PSA
TSH
FOB
Cardiac Markers
Hepatitis
HIV

2. Histology
Microbiology culture
Atrep A
Autoimmune
Sed Rate
H. pylori
Cancer Markers
CRP
Hgb
Respiratory Viruses
STDs
Allergy
DAU
Infectious diseases
Microalbumin
TDM
Other
The term physician office lab (POL) is diverse. It encompasses physician practices as
small as 2 to 5 doctors that perform a few rapid tests to large practices of some 200
physicians that operate labs similar to small hospital laboratories. The definition used
here is therefore broad and refers to the market for tests which are: Performed in a
physician office setting, At the time of a consultation between a physician or other
healthcare professional (nurse practitioner, pharmacist, provides a result to be used
during the medical visit and, is used for screening, diagnosis or monitoring purposes.
Growth in physician office testing is fueled by trends in preventative medicine and
proactive approaches in treating the increasing number of diagnosed diabetics; by the
globalization of infectious diseases and the associated public health issues; and by the
need to monitor the explosion of people with cardiovascular disease and other chronic
conditions.
The report offers a quantitative assessment of specific markets, worldwide, in U.S.
dollars for 2009 to 2014. This data is provided in order to set the status quo of tests and
technologies. However the report concentrates on how these will impact the economics
of healthcare over the near term and longer when possible.
This exhaustive report provides:
Discussions of the Regulatory Environment for POLs in various countries and
regions
The Top POL-conducted Tests and average reimbursement level
POL Test Revenues by Type of Test, 2009-2014, for more than 35 test
segments
POL Test Revenues by Region (Europe, Asia, US) , 2009 to 2014
Breakout of the Number of POLSin the US by type (CLIA-waived, non-waived)
Regional POL market environments in top Geographic markets

3. Profiles of the POL Offerings of over 75 Suppliers
SWOT Analysis for Physician Office Testing
Market Analyses for Key POL Testing Areas
The world market for the POL sector of point-of-care diagnostics is provided in U.S.
dollars for the years 2009 - 2014. No adjustments have been made to the market data
for the effects of currency exchange fluctuations or inflation. This may seem
problematic, given the drastic devaluation of the U.S. dollar versus the Japanese Yen,
euro and Swiss Franc. Kalorama has decided to use a constant exchange rate because
it is a more accurate reflection of actual revenue growth in dollars rather than growth
due to exchange rate fluctuations.
CHAPTER ONE: EXECUTIVE SUMMARY
Introduction
Scope and Methodology
Size and Growth of the Market
Market Trends
CHAPTER TWO: INTRODUCTION
Background
POL definition
The Pros and Cons of POL testing
Point of View
CHAPTER THREE: MARKET AND TECHNOLOGICAL DYNAMICS IN POL TESTING
Background
The Emergence of Non-invasive Technologies
o Saliva
o Breath
o Optical Techniques
Miniaturization and Microfluidics Support POC
CLIA Waived Test Menu Expansion Drives U.S. POLs
Connectivity Imperative for POC devices
CHAPTER FOUR: THE ECONOMICS OF POL TESTING
Background
Reimbursement Challenges and Developments
POLs and Clinical Outcomes Management
POL Management Considerations
The Regulatory Environment for POLs
CHAPTER FIVE: POL TESTING IN WORLD MARKETS

4. Background
Overview of the POL Market, Worldwide
o Specific Country Information
 The United States
 Europe — Many Countries and Systems
 Japan
 China
 India
 Australia
CHAPTER SIX: MARKET ANALYSIS
Market Overview
The Major Players
Disease Burden and POL Testing Needs
Test Segment Market Analysis
o Diabetes - Glucose
o Diabetes - HbA1c
o Diabetes - Microalbumin
o Cardiac Markers
o Lipid Panels and Miscellaneous Cardiac Markers
o Cancer Markers
o Clinical Chemistry
o Coagulation
o Hematology
o Histology
o Infectious Diseases
o Public Health in Developing Countries
o Immunoassays
o Thyroid Function
o Anemia
o Allergy
o Autoimmune
o Drugs of Abuse (DAU)
o Therapeutic Drug Monitoring (TDM)
o Microbiology
o Molecular
o Women’s Health / Pregnancy/Fertility
Commercial Outlook
CHAPTER SEVEN: TOP COMPANIES
Abbott Diagnostics
Alere Inc.
ARKRAY
Bayer Diabetes Care

5. Becton, Dickinson and Company (BD)
Beckman Coulter Inc.
bioMérieux Inc.
Bio-Rad Laboratories Inc.
Horiba Medical
Instrumentation Laboratory (IL)
Lifescan Inc.
Ortho Clinical Diagnostics (OCD)
Phadia AB
QIAGEN N.V.
Radiometer A/S
Roche Diagnostics
Siemens Healthcare Diagnostics
Sysmex Corporation
CHAPTER EIGHT: “NEW FRONTIER” COMPANIES IN THE POL MARKET
3M Medical Diagnostics
77 Elektronika Kft.
Abaxis, Inc.
A/C Diagnostics
Accumetrics
Acon Laboratories, Inc.
Acrongenomics Inc.
Akers Biosciences, Inc.
Alfa Wassermann Diagnostic Technologies, LLC
Ani Biotech Oy
Axis-Shield plc
Biomerica Inc.
BioVei Incorporated
Carolina Liquid Chemistries Corp.
Celerus Diagnostics
Cepheid
Chembio Diagnostic Systems, Inc.
Chempaq A/S
Claros Diagnostics, Inc.
CoaguSense, Inc.
diaDexus, Inc.
Diaglobal GmbH
Diazyme Laboratories
DxNA
Eiken Chemical Co., Ltd
Enigma Diagnostics Limited
Enterix Inc.
ESA Biosciences Inc.
HandyLab, Inc.

6. Helena Laboratories
HemoCue AB
Idaho Technology
Innovative Biosensors
International Technidyne Corp (ITC)
LifeAssays AB
LifeSign LLC
MACHEREY-NAGEL GmbH & Co.
Meridian Bioscience, Inc.
Micronics Inc.
Nanosphere, Inc.
OraSure Technologies, Inc.
Oxonica Diagnostics
Philips Handheld Immunoassays
Pocared Diagnostics Ltd
Polymedco, Inc.
Polymer Technology Systems, Inc.
QBC Diagnostics, Inc.
QuantRx Biomedical Corporation
Quidel Corporation
Quotient Diagnostics
Randox
Response Biomedical Corp.
Rheonix Inc.
Screening Devices Canada, Inc.
SQI Diagnostics Inc.
Trinity Biotech plc
TwistDx, Ltd.
Veredus Laboratories Pte
Vital Diagnostics
CHAPTER NINE: THE FUTURE OF THE POL MARKET: SWOT ANALYSIS
Strengths
Weaknesses
Opportunities
Threats
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