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

  • ID: 2860819
  • Report
  • May 2007
  • Region: Global
  • 212 Pages
  • Kalorama Information
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Many in the clinical and manufacturing community have their eyes on the Physician Office Laboratory (POL) as an outlet both to improve patient compliance and outcomes and to open new market opportunities. Studies are emerging on the clinical outcomes and cost-benefit of nearer-the-patient testing, but little certain is known about POLs as a distribution channel for diagnostics products.

Kalorama's Physician Office Laboratory (POL) Testing Markets Worldwide: Status Quo and Future Trends takes a bold look into the technologies and trends in physician office laboratories (POLs)—with a special focus on the economics of test use in on-site patient care—and quantifies the market for this type of testing worldwide and in specific regions.

This exhaustive report provides:

  • Discussions of the Regulatory Environment for POLs in various countries and regions.
  • CMA reimbursement rates and average costs for the top POL tests.
  • POL Test Revenues by Type of Test, 2006-2011, for more than 35 test segments.
  • POL Test Revenues by Region, 2006 to 2011.
  • Estimates and Overview of the number of POLs in various countries.
  • Complete discussions of the POL environments in top geographic markets.
  • Market Analyses for 15 POL Testing Areas.
  • Profiles of the POL offerings of over 110 suppliers.
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.

This broad definition is used because near patient testing is shaped by the nature of the healthcare system in place and the culture of a specific region or country. A precise estimation of the IVD company revenues assigned to the POL market is a somewhat precarious exercise. Most POL rapid tests are carried by catalogue vendors such as VWR and Thermo-Fisher and by distributors specializing POL sales. In the case of large POLs, the sale of small chemistry, hematology and immunoassay analyzers is often handled by an IVD company representative; otherwise distributors serve most other POLs.

The estimates provided in this report refer to factory sales to the end user or distributor and not retail pricing or reimbursement payments. The estimate was established using U.S. CMS physician service data (2005), company reports, industry publications, various other government and private market research resources, and as part of Kalorama's trusted information-gathering process, extensive contact with professional including industry professionals and conference attendees to verify information and forecasts.

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Executive Summary

- Scope and Methodology

- Size and Growth of the Market

- Market Trends



- Background

- POL Definitions

- Miniaturization, Digitization, and Informatics

- The Pros and Cons of POL Testing

- Point of View


Market and Technological Dynamics in POL Testing

- Background

- The Emergence of Non-Invasive Technologies

- Pharmacodiagnostics (PGx) on demand

- Lab-on-a-Chip

- The Wireless Revolution

- Connectivity Imperative

Chapter Four

The Economics of POL Testing

- Background

- POLs and Clinical Outcomes Management

- A POL Is More than Just Device Installation

- The Regulatory Environment

- Reimbursement Issues and Trends

Chapter Five

POL Status Quo

- Background

- Overview of the Worldwide POL Market

- World Segments and POL Market Evolution

- The United States

- Europe—A Hodgepodge

- Germany

- France

- Switzerland

- Other EU Countries

- Japan

- China

- India

- The Rest of the World

- The Future of POLs

Chapter Six

Market Analysis

- Overview

- Home Monitoring of Individuals with Chronic Diseases

- The Major Players

- POL Test Segments

- Diabetes

- Glucose

- Glycohemoglobin (HbA1c)

- Cardiac Markers

- Clinical Chemistry

- Hematology

- Coagulation

- Infectious Disease

- Immunoassays

- Thyroid Function

- Anemia

- Allergy

- Autoimmune

- Cancer Markers

- Pharmacodiagnostics

- Women’s Health / Pregnancy/Fertility

- Emerging Tests and Technologies

- Commercial Outlook

Chapter Seven

Company Profiles

- The Top IVD Companies and Their POL Offerings

- Abbott Labs

- ARKRAY (formerly Kyoto Daiichi)

- Bayer Diabetes Care

- Becton, Dickinson and Company (BD)

- Beckman Coulter Inc.

- Bio-Rad Laboratories Inc.

- Instrumentation Laboratory (IL)

- Inverness Medical Innovations, Inc.

- Ortho Clinical Diagnostics (OCD)

- Roche Diagnostics

- Siemens Medical Solutions Diagnostics / Bayer Diagnostics

- Sysmex Corporation

- POC Companies and New Frontiers


- Accumetrics Incorporated

- Acrongenomics, Inc.

- Adeza Biomedical, Inc.


- Advance Nanotech, Inc.

- AESKU.Diagnostics GmbH

- Akers Biosciences, Inc.

- Ambri Ltd.

- Ani Biotech Oy

- Ark Therapeutics Limited

- AspenBio Pharma, Inc.

- Avitar, Inc.

- Axis-Shield plc

- Binax, Inc.

- BioCurex Inc.

- bioLytical Laboratories Inc.

- Biomerica Inc.

- Biosafe Medical Technologies, Inc.

- BioScan Screening Systems, Inc.

- Biosite Incorporated

- Boditech Med Inc.

- Boule Diagnostics International AB

- Calypte Biomedical Corporation

- Careside Medical LLC

- Chembio Diagnostics, Inc.

- Chempaq A/S

- Cholestech Corporation

- Chongqing Sungene Pharm. Co., Ltd.

- Claros Diagnostics, Inc.

- Cozart Bioscience Ltd.

- Diagnostic Chemicals Ltd (DCL)

- Diaglobal GmbH

- Digital Bio Technology/ InCyto


- Ekips Technologies

- Enterix, Inc.

- Epocal Inc.

- ESA Biosciences Inc.

- Farallon Medical, Inc.

- GenBio

- Genzyme Corporation

- Grant Life Sciences Inc.

- Gryphus Diagnostics, LLC

- Helena Laboratories

- Hema Diagnostic Systems, LLC

- HemoCue AB

- HemoSense, Inc.

- Hitachi High-Technologies Corporation

- Home Access Health Corporation

- Hypoguard, USA Inc.

- ImmunoScience, Inc.

- Innotrac Diagnostics Oy

- International Technidyne Corp (ITC)

- LifeAssays AB

- Lifestream Technologies, Inc.

- Mast Group Ltd.

- Matritech

- MedCap Corp.

- Medical Services International Inc.

- MedMira Inc.

- Menssana Research, Inc.

- Meretek Diagnostics Inc.

- Meridian Bioscience, Inc.

- Micronics, Inc.

- Milenia Biotec GmbH

- Mitsubishi Kagaku Iatron, Inc. (MKI)

- Mobidiag Oy

- Monash University

- Mossman Associates, Inc.

- N-Dia, Inc.

- OraSure Technologies, Inc.

- Orion Diagnostica OY

- Panbio Limited

- Philips Medical Systems

- PlaCor, Inc.

- PointCare Technologies, Inc.

- Polymedco, Inc.

- Polymer Technology Systems, Inc.

- Princeton BioMeditech Corporation

- PortaScience, Inc.

- Proteome Systems Ltd

- Provalis Diagnostics / Bayer Diabetes Care

- QBC Diagnostics, Inc.

- Quest Diagnostics

- Quidel Corporation

- Rapid Pathogen Screening

- rennesens GmbH

- Response Biomedical Corp.

- SA Scientific

- Sphere Medical Ltd.

- StatSure Diagnostic Systems, Inc.

- SureScreen Diagnostics, Ltd.

- Synova Healthcare, Inc.

- SYNTRON Bioresearch, Inc.

- ThyroTec, Inc.

- Trinity Biotech plc

- Veredus Laboratories Pte

- Wadsworth Center

- Zonda, Inc.

List of Exhibits

CHAPTER ONE: Executive Summary

- Figure 1-1: Market Summary: Worldwide POL Diagnostic Reagent Sales

2006 and 2011

CHAPTER THREE: Market and Technological Dynamics in POL Testing

- Table 3-1: Selected New Biochip Products (Company, Target, Product) 2007

- Table 3-2: General Practitioner’s Use of EMRs in Europe and the United

States by Country

Chapter Four: The Economics of POL Testing

- Table 4-1: Selected Chemistry and Hematology POL Systems (Company, Testing Area, Details, Status)

- Table 4-2: Main Categories of CLIA-Waived Tests and Their Corresponding CPT Codes

- Table 4-3: Common POL Tests, Their CLIA Status, CPT Code, Average Cost, and Reimbursement Rate

Chapter Five: POL Status Quo

- Table 5-1: Old-Age Dependency Ratios (Elderly as a Percentage of Working-Age Population) Comparative Projections by Country 2000 vs 2025

- Table 5-2: Worldwide POL Diagnostic Reagent Sales by Region (U.S., Europe, Japan, ROW) 2006-2011

- Table 5-4: Physician Office Laboratories in the United States (Number of Labs, waived POLs, non-waived POLs) 1995 to 2006

- Table 5-5: Top 25 POL Tests in the United States (CPT Code, Test, Status, Allowed Payment, Allowed Services, Reimbursement Fee) 2005

Chapter Six: Market Analysis

- Table 6-1: Worldwide Lab-Type POL Diagnostic Test Reagent Sales by

Segment (15 Test Segments) 2006-2011

- Table 6-2: Worldwide Rapid POL Diagnostic Test Reagent Sales by

Segment (21 Test Segments) 2006-2011

- Table 6-3: POC Test Revenues of Selected Companies (40 Companies) Estimated 2005/06 Gobal Revenues and Area of Focus

- Table 6-4: Selected Blood Glucose Test Devices on the Market (Company,

Location, Product, Market Status)

- Table 6-5: Worldwide Sales of Selected Cardiac IVDs (Cardiac Markers, BNP, Cholesterol Panels, Lipids, hsCRP, CRP, Homocystine) 2006

- Table 6-6: Selected Whole Blood Chemistry System Manufacturers

- Table 6-7: World Market for Rapid Infectious Disease Testing in POLs and

Clinics by Analyte (Hepatitis, Strep A, Influenza, Respiratory

Viruses, HIV, Other) 2006

- Table 6-8: Top 10 CLIA-Waived Infectious Disease Tests in the POL

- Table 6-9: Worldwide POL Lab-Type Immunoassay Revenues by Test Type (Thyroid, Allergy, Anemia, Cancer Markers, CRP, hsCRP,

Autoimmune, Homocystine) 2006

- Table 6-10: Worldwide POL Rapid Immunoassay Revenues by Test Type (HbA1c, Cholesterol Panel, PSA, Pregnance/LH, Flu, Hepatitis, HIV, TSH, Cardiac/Troponin, Strep A, BNP, Respiratory Viruses, Other

Infectious Disease, Drugs of Abuse) 2006
Note: Product cover images may vary from those shown