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

Table of Contents

Chapter ONE Executive Summary

• Scope and Methodology
• Size and Growth of the Market
• Market Trends

Chapter TWO Introduction

• Background
• POL Definitions
• Miniaturization, Digitization, and Informatics
• 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
• 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
  • ABAXIS Inc.
  • Accumetrics Incorporated
  • Acrongenomics, Inc.
  • Adeza Biomedical, Inc.
  • ADIATEC
  • 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
  • DNAFORM
  • 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