Lateral Flow Technology and the Future of Point of Care Diagnostics

CHAPTER ONE: Executive Summary

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

CHAPTER TWO: Introduction

Background
Rapid Testing in the 21st Century
Point of View

CHAPTER THREE: Technical and Marketing Issues in Lateral Flow Device Commercialization

The Future for Lateral Flow Patents and Innovation
Trends in Nearer the Patient Testing and Decentralization/Central Laboratory Competition
The Emergence of Alternate Test Samples
The Impact of Microfluidics, Biochips, Particles and Beads
The Digital Age—Connectivity
Scale-Up and Manufacturing Issues
International Markets, Lying in Wait
India
Latin America
Asia
Human Genomics—Promise for Molecular- and Cell-Based Disease Assessment

CHAPTER FOUR: Market Analysis

Overview
LF-POC in World Markets
Worldwide
United States
Europe
Japan
Government Programs and Private Initiatives
United States
United Kingdom
Continental Europe
Asia
Privatization

The Major Players
Market Segments by Setting
Self-Test Sector:OTC Tests
POL and Clinic Testing
POC Testing in the Hospital
Home Monitoring of Individuals with Chronic Diseases

Market Segments by Testing Area
Diabetes—Glucose Control Monitoring
Cardiac Markers
Drugs of Abuse
Infectious Diseases
Sepsis
Procalcitonin (PCT)
Endotoxin
Oncology
Fecal Occult Blood
Prostate Specific Antigen (PSA)
Women’s Health, Pregnancy, Fertility

Emerging Tests and Technologies
Commercial Outlook

CHAPTER FIVE: Company Briefs
The Top IVD Companies and Their Lateral Flow Offerings
Becton, Dickinson and Company (BD)
Beckman Coulter Inc.
Biosite Incorporated
Instrumentation Laboratory (IL)
Inverness Medical Innovations, Inc.
Roche Diagnostics


The Second Tier and Their Lateral Flow Offerings
Access Bio, Inc.
Acon Laboratories, Inc./Innovacon
Acrongenomics, Inc.
Addison-Davis Diagnostics, Inc. (ADDI)
ADIATEC
Akers Biosciences, Inc.
ALFA Scientific Designs, Inc.
Amedica Biotech
American Bio Medica Corporation
Ameritek, USA
Amic AB
Analyte Works Ltd. (formerly BioPreventative Ltd.)
Ani Biotech Oy
Asia-Lion Biotechnology Co., Ltd.
ASM Scientific Ltd
Avitar, Inc.
Axis-Shield plc
Binax, Inc.
bioLytical Laboratories Inc.
Biomerica Inc.
Biosafe Medical Technologies, Inc.
BioScan Screening Systems, Inc.
Boditech Med Inc.
BRAHMS
Branan Medical Corporation
Calypte Biomedical Corporation
Care Diagnostica International
Chembio Diagnostic Systems, Inc.
Cholestech Corporation
Chongqing Sungene Pharm. Co., Ltd.
Cibitest GmbH & Co. KG
Cis Biotech, Inc.
Coris BioConcept
Cozart Bioscience Ltd.
Diagenics International Corporation
Diagnostic Chemicals Ltd (DCL)
Enterix, Inc.
ESE Embedded Systems Engineering GmbH
EY Laboratories, Inc.
Genosis PLC
Genzyme Corporation
GlysBy snc
Grant Life Sciences Inc.
Gryphus Diagnostics, LLC
Hema Diagnostic Systems, LLC
ImmunoScience, Inc.
In Veritas Medical Diagnostics (IVMD UK Ltd)
IND Diagnostics Inc,
Innotrac Diagnostics Oy
Instant Technologies, Inc.
LifeAssays AB
Lifestream Technologies, Inc.
MagnaBioSciences LLC
Matritech
MAVAND Solutions GmbH
Medical Services International Inc.
Medifix Limited
MEDIWISS Analytic GmbH
MedMira Inc.
Meridian Bioscience, Inc.
Milenia Biotec GmbH
Mitsubishi Kagaku Iatron, Inc. (MKI)
Mossman Associates, Inc.
Nano-Ditech Corporation
Nanogen Inc.
OraSure Technologies, Inc.
Panbio Limited
Polymedco, Inc.
Preventis GmbH
Pria Diagnostics LLC
Princeton BioMeditech Corporation
Proteome Systems Ltd
Quidel Corporation
r-Biopharm AG
Reagena Ltd
rennesens GmbH
Response Biomedical Corp.
Saliva Diagnostic Systems , Inc. (SDS)
Savyon Diagnostics
Shionogi & Co., Ltd.
Spectral Diagnostics Inc./Nanogen
Standard Diagnostics, Inc.
SureScreen Diagnostics, Ltd.
Synova Healthcare, Inc.
Talecris Biotherapeutics
ThyroTec, Inc.
Trinity Biotech plc
WaveSense, Inc
WayPoint Biomedical, Inc.
Xact Aid, Inc.


List of Exhibits

CHAPTER ONE: Executive Summary

Figure 1-1: Market Summary: Worldwide Lateral Flow POC Sales 2005-2010

CHAPTER THREE: Technical and Marketing Issues in Lateral Flow Device Commercialization
Table 3-1: Selected Innovation in Lateral Flow-Based Tests
Table 3-2: Revenues of Leading U.S. Laboratories by Company/Type (Quest, LabCorp, Other Reference Labs, Hospital Labs, Physician Office Labs) 2005
Table 3-3: Selected Lateral Flow-Ttype Mixed Systems
Table 3-4: Selected Companies Involved in International Marketing Efforts

CHAPTER FOUR: Market Analysis
Table 4-1: Worldwide Lateral Flow OTC/Self Test POC Sales by Test Category (Pregnancy/Ovulation, Infectious Disease, Cholesterol, Drugs of Abuse, Other) 2005-2010
Table 4-2: Worldwide Lateral Flow Professional POC Sales by Test Category (Pregnancy/Ovulation, Infectious Disease, Cardiac Markers, Cholesterol/Lipids, Drugs of Abuse, Other) 2005-2010
Table 4-2: LF POC Test Revenues of Selected IVD Companies 2005
Table 4-3: Selected OTC Tests Available, 2005
Table 4-4: Selected LF-OTC Test Products 2005
Table 4-5: Selected Professional LF Tests on the Market and in Development (Company, Location, Test, Development Status) 2006
Table 4-6: HbA1c Test Market by Segment (Lab vs POC): Average Cost per Test, Number of Tests, and Revenues by Region (U.S., Europe, ROW) 2005
Table 4-7: Worldwide Sales of Selected Lab Based Cardiac IVDs (Cholesterol/ Lipid Markers, CRP/Inflammation Markers, AMI Enzymes, BNP, Homocysteine, D-Dimer) 2005-2010
Table 4-8: Worldwide Sales of OTC POC Cardiac IVDs (Cholesterol/Lipid) 2005-2010
Table 4-9: Worldwide Sales of Selected POC Professional Cardiac IVDs (AMI, Cholesterol/Lipids) 2005-2010
Table 4-10: Selected LF Infectious Disease Tests (Company, Test, Development/Market Status) 2006
Table 4-11: World POC Professional Fecal Occult Blood Test Market by Type (Guaiac vs Immunochemical) 2005-2010
Table 4-12: World POC OTC Fecal Occult Blood Test Market by Type (Guaiac, Immuno, Flushable) 2005-2010
Table 4-13: Selected OTC Fertility Test Kits Available