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

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

The physician office laboratory (POL) is usually not broken out in market research reports covering the medical device and diagnostic industry. Numbers are often simply grouped in with hospital and service lab sales. But for marketing strategy, knowing where diagnostic tests occur is as important as the revenue numbers. Now, Kalorama Information shines further light onto the POL testing market with its report, Physician office Laboratory (POL) Testing Markets Worldwide. 

This Kalorama 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. Kalorama Information takes a bold look at the technologies and trends in pol testing and laboratories, with a special focus on the economics of test use in on-site patient care. Physician Office Laboratory (POL) Testing Markets is conservative in its predictions, and offers a calculated look at the future of POL testing. 

Companies in POL Testing

Many physician office laboratory devices exist, and worldwide more than 100 companies market tests using the whole gamut of medical devices and technologies. 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 montior the explosion of people with cardiovascular disease and other chronic conditions. 

Physician office laboratory testing is emerging as a tool in the medical device and diagnostics industry for more efficient diagnosis and patient evaluation. While this quality imperative is most apparent in pay-for-performance systems, it also provide a framework by which public funds can be used more rationally.

What competitors are succeeding in the POL testing market? What are the most profitable POL tests, and what growth levels can diagnostic companies expect in the future? How will regulations affect the medical device and diagnostic industry? Analyst Shara Rosen, author of Kalorama Information's Worldwide Market for In Vitro Diagnostic Tests, now in seven editions, answers these questions. Physician Office Laboratory (POL) Testing Markets examines 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.

Physician Office Laboratory Tests in the Report Include:

  • 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

'Physician office laboratory' is a widely applied term. It encompasses physician practices as small as 2 to 5 doctors that perform a few rapid diagnostic tests, to larger practices of some 200 physicians that operate labs similar to small hospital laboratories. This physician office laboratory definition 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.

Physician Office Laboratory (POL) Testing Markets 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.

Physician Office Laboratory (POL) Testing Markets provides the following:

  • Discussions of the Regulatory Environment for POL testing 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 physician office laboratory 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 Information 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/


  • Executive Summary
    • INTRODUCTION
      • Table Historic Exchange Rate Data
    • SIZE AND GROWTH OF THE MARKET
      • Table Worldwide POL Diagnostic Reagent Sales by country, 2009-2014 ($ million)
    • MARKET TRENDS
  • Introduction
    • BACKGROUND
    • POL DEFINITION
    • THE PROS AND CONS OF POL TESTING
    • POINT OF VIEW
  • Market and Technological Dynamics in POL Testing
    • BACKGROUND
    • THE EMERGENCE OF NON-INVASIVE TECHNOLOGIES
      • Table Selected Innovations in Non-Invasive Testing, 2010
      • Table Selected Disease Markers in Exhaled Breath
    • MINIATURIZATION AND MICROFLUIDICS SUPPORT POC
      • Table Selected Biochip and Biosensor Innovations, 2010
    • CLIA WAIVED TEST MENU EXPANSION DRIVES U.S. POLS
      • Table Traditional CLIA waived Tests
      • Table Selected Waived Test Categories 2010
      • Table Selected Waived Instruments and Devices 2010
      • Table POLs in the U.S., 2000-2010
      • Table Tests performed in-office
      • Table Tests sent out to a laboratory
    • CONNECTIVITY IMPERATIVE FOR POC DEVICES
  • The Economics of POL Testing
    • BACKGROUND
    • REIMBURSEMENT CHALLENGES AND DEVELOPMENTS
    • POLS AND CLINICAL OUTCOMES MANAGEMENT
    • POL MANAGEMENT CONSIDERATIONS
    • THE REGULATORY ENVIRONMENT FOR POLS
      • Table Selected chemistry and hematology POL systems
  • POL Testing in World Markets
    • BACKGROUND
    • OVERVIEW OF THE POL MARKET, WORLDWIDE
      • Table Worldwide POL Diagnostic Reagent Sales by Country, 2009-2014 ($ million)
    • SPECIFIC COUNTRY INFORMATION
      • Table Overview of POLs by Country
      • Table Distribution of lab tests in physician offices
      • Table Top 25 POL Tests, U.S., 2009
  • Market Analysis
    • MARKET OVERVIEW
      • Table Worldwide POL Diagnostic Reagent Sales by test segment, 2009-2014 ($ million)
    • THE MAJOR PLAYERS
      • Table POC Test Revenues of Selected Companies, Global, Estimated
    • DISEASE BURDEN AND POL TESTING NEEDS
      • Table Selected Disease Statistics, Worldwide, 2008
    • TEST SEGMENT MARKET ANALYSIS
      • Table Selected Blood Glucose Test Devices on the Market, 2010
      • Table Selected HbA1c Tests and Devices, 2010
      • Table Selected Microalbumin Tests, waived
      • Table Selected Cardiac Market Tests and Systems
      • Table Worldwide Sales, Selected Cardiac Marker IVDs, POLs, 2009
      • Table Selected Rapid CRP Diagnostics
      • Table Selected Lipid Panel Tests
      • Table Selected Small Footprint Chemistry Systems, 2009
      • Table Selected CLIA Waived PT Devices
      • Table Selected Platelet Function Tests
      • Table Selected Small Footprint Hematology Systems, 2010
      • Table Selected POC Hemoglobin Test Systems
      • Table Worldwide POL Infectious Disease Rapid Test Sales, 2009-2014 ($ million)
      • Table Worldwide POL Immunoassay Test Sales, 2009-2014 ($ million)
      • Table Selected Compact Immunoassay Systems, 2010
    • COMMERCIAL OUTLOOK
  • Company Directory
    • THE TOP IVD COMPANIES AND THEIR POL OFFERINGS
    • ABBOTT DIAGNOSTICS
      • Table Recent Revenue History
    • ALERE INC.
      • Table Recent Revenue History: $ million (* estimated)
    • ARKRAY (formerly Kyoto Daiichi)
    • BAYER DIABETES CARE
      • Table Recent Revenue History: (million)
    • BECTON, DICKINSON AND COMPANY (BD)
      • Table Recent Revenue History
    • BECKMAN COULTER INC.
      • Table Recent Revenue History: ($ million)
      • Table Segments, ($ Million)
    • BIOMÉRIEUX INC.
      • Table Recent Revenue History
    • BIO-RAD LABORATORIES INC.
      • Table Recent Revenue History: ($ million) * = estimated
    • HORIBA MEDICAL
    • INSTRUMENTATION LABORATORY (IL)
      • Table Recent Revenue History: ($ millions, estimated)
    • LIFESCAN INC.
      • Table Recent Revenue History: (in millions)
    • ORTHO CLINICAL DIAGNOSTICS (OCD)
      • Table Recent Revenue History: (in millions)
      • Table Segments In 2009
    • PHADIA AB
      • Table Recent Revenue History: 2007 $347.5 million
    • QIAGEN N.V.
      • Table Recent Revenue History: ($ million)
    • RADIOMETER A/S
    • ROCHE DIAGNOSTICS
      • Table Recent Revenue History (in millions)
      • Table Segments (In Millions, Estimated)
    • SIEMENS HEALTHCARE DIAGNOSTICS
      • Table Recent Revenue History: $ million
      • Table Segments ($ Million)
    • SYSMEX CORPORATION
      • Table Recent Revenue History: ($ million)
      • Table Segments (Million)
  • "New Frontier" Companies in the POL Market
    • 3M MEDICAL DIAGNOSTICS
    • 77 ELEKTRONIKA KFT.
    • ABAXIS, INC.
      • Table Recent Revenue History:
    • A/C DIAGNOSTICS
    • ACCUMETRICS
      • Table Recent Revenue History: 2006 $5.0 million
    • ACON LABORATORIES, INC.
    • ACRONGENOMICS INC.
    • AKERS BIOSCIENCES, INC.
    • ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, LLC
    • ANI BIOTECH OY
    • AXIS-SHIELD PLC
      • Table Recent Revenue History (in millions)
    • BIOMERICA INC.
      • Table Recent Revenue History: (estimated)
    • BIOVEI INCORPORATED
    • CAROLINA LIQUID CHEMISTRIES CORP.
    • CELERUS DIAGNOSTICS
    • CEPHEID
      • Table Recent Revenue History: ($ million, clinical product sales)
    • CHEMBIO DIAGNOSTIC SYSTEMS, INC.
      • Table Recent Revenue History: 2006 $6.5 million
    • CHEMPAQ A/S
    • CLAROS DIAGNOSTICS, INC.
    • COAGUSENSE, INC.
    • DIADEXUS, INC.
    • DIAGLOBAL GMBH
    • DIAZYME LABORATORIES
    • DXNA
    • EIKEN CHEMICAL CO., LTD
      • Table Recent Revenue History: not all clinical diagnostics
    • ENIGMA DIAGNOSTICS LIMITED
    • ENTERIX INC.
    • ESA BIOSCIENCES INC.
    • HANDYLAB, INC.
    • HELENA LABORATORIES
    • HEMOCUE AB
    • IDAHO TECHNOLOGY
    • INNOVATIVE BIOSENSORS
    • INTERNATIONAL TECHNIDYNE CORP (ITC)
    • LIFEASSAYS AB
    • LIFESIGN LLC
    • MACHEREY-NAGEL GMBH & CO.
    • MERIDIAN BIOSCIENCE, INC.
      • Table Recent Revenue History: ($ million)
    • MICRONICS INC.
    • NANOSPHERE, INC.
      • Table Recent Revenue History: product sales
    • ORASURE TECHNOLOGIES, INC.
      • Table Recent Revenue History: ($ million )
    • OXONICA DIAGNOSTICS
    • PHILIPS HANDHELD IMMUNOASSAYS
    • POCARED DIAGNOSTICS LTD
    • POLYMEDCO, INC.
    • POLYMER TECHNOLOGY SYSTEMS, INC.
    • QBC DIAGNOSTICS, INC.
    • QUANTRX BIOMEDICAL CORPORATION
    • QUIDEL CORPORATION
      • Table Recent Revenue History:
    • QUOTIENT DIAGNOSTICS
    • RANDOX
    • RESPONSE BIOMEDICAL CORP.
      • Table Recent Revenue History: Clinical product sales
    • RHEONIX INC.
    • SCREENING DEVICES CANADA, INC.
    • SQI DIAGNOSTICS INC.
    • TRINITY BIOTECH PLC
      • Table Recent Revenue History: (million, estimated)
    • TWISTDX, LTD.
    • VEREDUS LABORATORIES PTE
    • VITAL DIAGNOSTICS
  • The Future of the POL Market: SWOT Analysis
    • STRENGTHS
    • WEAKNESSES
    • OPPORTUNITIES
    • THREATS

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