Physician Office Laboratory (POL) Testing Markets Worldwide: Status Quo and Future Trends

Date: November 22, 2010
Pages: 250
Price:
US$ 3,995.00
Publisher: Kalorama Information
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: P72B25ACBA8EN
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Physician Office Laboratory (POL) Testing Markets Worldwide: Status Quo and Future Trends
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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.

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. The report is conservative in its predictions and offers a calculated look into the future, based on events taking place in the present.

The term physician office lab (POL) is as wide and diverse as one can imagine. 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)
  • Complete discussions of the POL environments in top geographic markets.
  • Profiles of the POL Offerings of over 75 suppliers.
  • Market Analyses for Key POL Testing Areas.
  • including:
    • Chemistry panels
    • Coag PT
    • Lipids
    • Hemato - CBC
    • Glucose
    • HbA1c
    • Rapid Flu
    • Anemia ferritin, iron
    • Preg/LH
    • Urinalysis
    • PSA
    • TSH
    • FOB
    • Cardiac Markers
    • Hepatitis
    • HIV
    • 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 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
Saliva
Breath
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

Background
Overview of the POL Market, Worldwide
  Specific Country Information
  The United States of America
  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
  Diabetes - Glucose
  Diabetes - HbA1c
  Diabetes - Microalbumin
  Cardiac Markers
  Lipid Panels and Miscellaneous Cardiac Markers
  Cancer Markers
  Clinical Chemistry
  Coagulation
  Hematology
  Histology
  Infectious Diseases
  Public Health in Developing Countries
  Immunoassays
  Thyroid Function
  Anemia
  Allergy
  Autoimmune
  Drugs of Abuse (DAU)
  Therapeutic Drug Monitoring (TDM)
  Microbiology
  Molecular
  Women’s Health / Pregnancy/Fertility
Commercial Outlook

CHAPTER SEVEN: TOP COMPANIES

Abbott Diagnostics
Alere Inc.
ARKRAY
Bayer Diabetes Care
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.
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

TABLE OF EXHIBITS

CHAPTER ONE: EXECUTIVE SUMMARY

Table 1-1: Historic Exchange Rate Data
Table 1-2: Worldwide POL Diagnostic Reagent Sales by country, 2009-2014 ($ million)

CHAPTER THREE: MARKET AND TECHNOLOGICAL DYNAMICS IN POL TESTING

Table 3-1: Selected Innovations in non-invasive testing, 2010
Table 3-2: Selected disease markers in exhaled breath
Table 3-3: Selected biochip and biosensor innovations, 2010
Table 3-4: Traditional CLIA waived tests
Table 3-5: Selected Waived Test Categories 2010
Table 3-6: Selected Waived Instruments and Devices 2010
Table 3-7: POLs in the U.S., 2000-2010
Table 3-8: Tests performed in-office
Table 3-9: Tests sent out to a laboratory

CHAPTER FOUR: THE ECONOMICS OF POL TESTING

Table 4-1: Selected chemistry and hematology POL systems

CHAPTER FIVE: POL TESTING IN WORLD MARKETS

Table 5-1: Worldwide POL Diagnostic Reagent Sales by Country, 2009-2014 ($ million)
Table 5-2: Overview of POLs by Country
Table 5-3: Distribution of lab tests in physician offices
Table 5-4: Top 25 POL Tests, U.S., 2009

CHAPTER SIX: MARKET ANALYSIS

Table 6-1: Worldwide POL Diagnostic Reagent Sales by test segment, 2009-2014 ($ million)
Table 6-2: POC Test Revenues of Selected Companies, Global, Estimated
Table 6-3: Selected Disease Statistics, Worldwide, 2008
Table 6-4: Selected Blood Glucose Test Devices on the Market, 2010
Table 6-5: Selected HbA1c Tests and Devices, 2010
Table 6-6: Selected Microalbumin Tests, waived
Table 6-7: Selected Cardiac Market Tests and Systems
Table 6-8: Worldwide Sales, Selected Cardiac Marker IVDs, 2009
Table 6-9: Selected Rapid CRP Diagnostics
Table 6-10: Selected Lipid Panel Tests
Table 6-11: Selected Small Footprint Chemistry Systems, 2009
Table 6-12: Selected CLIA Waived PT Devices
Table 6-13: Selected Platelet Function Tests
Table 6-14: Selected Small Footprint Hematology Systems, 2010
Table 6-15: Selected POC Hemoglobin Test Systems
Table 6-16: Worldwide POL Infectious Disease Rapid Test Sales, 2009-2014 ($ million)
Table 6-17: Worldwide POL Immunoassay Test Sales, 2009-2014 ($ million)
Table 6-18: Selected Compact Immunoassay Systems, 2010
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