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

Nov 1, 2010
250 Pages - Pub ID: KLI2807838
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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
  • 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
  • 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.

All Kalorama reports advertise the single user price. Use is limited to one user. We also feature department and global pricing for reports that we be utilized by more than one user at your company. Please consult ask your sales representative or select the correct license on our website.

For Kalorama's take on the healthcare news of the week, based on our analysis of healthcare markets, follow Kalorama Information's Key Point Blog at http://kaloramakeypoint.blogspot.com/

TABLE OF CONTENTS

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
      • 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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