側方流動技術および将来のポイントオブケア診断

Abstract

Lateral flow tests, also known as immunochromatographic strip (ICS) tests, offer dramatic benefits in the diagnostic process that point towards a robust market. LF tests reduce the time spent waiting for test results from hours to minutes, require less training for operators, and reduce the cost of both device development and manufacturing.

Rapid point of care testing devices will play an increasingly important role in the decentralization of medicine, where testing is moving away from hospitals and to pharmacies and even shopping malls, a trend that will fuel exponential growth. Despite these certain trends, competition is heavy and there are issues and trends affecting this market that new entrants need to be aware of.

Kalorama' s Lateral Flow - A Perspective on the Past and Future of Rapid Clinical Tests' is your guide to this increasingly crowded LF testing market place. Kalorama' s report cuts through the hype about the lateral flow point of care marketplace and provides a realistic assessment of this growing field. Every critical aspect of the LF market is addressed, including the following key topics:

• The current sales figures and realistic projections for 2010.
• The core factors driving LF testing revenues up.
• The growing number of need-to-know companies in Lateral Flow Test devices.
• The trends to watch that could increase sales predictions.
• Expected gains to be made by LF POC devices over lab-based immunoassays across categories.
• Obstacles that could trap new entrants.
• An interview with the original developer of LF testing technology with his take on where this market is headed.

This report cuts through the hype about LF-POC and provides a realistic assessment acknowledging the reality of payors' emphasis on cost/benefit analysis for new technologies. Current sales and predictions for 2010 sales are provided for the diabetes, oncology, cardiac marker, pregnancy and other LF test markets.

Kalorama' s unique and thorough research process provides an exhaustive analysis of this evolving market. Information was gathered using both primary and secondary research including comprehensive research of secondary sources such as company literature, databases, investment reports, and medical and business journals. For the purpose of this study, Kalorama Information conducted telephone and email interviews with key industry officials, consultants, health care providers, and government personnel. These sources were the primary basis in gathering information specifically relating to revenue and market share data presented in this report. Specific interviews with device company representatives included marketing directors, division managers, and product development representatives.

In addition to superior coverage of the overall market, specific company profiles are included for the following device makers:

• Becton, Dickinson and Company (BD)
• Beckman Coulter Inc.
• Biosite Incorporated
• Instrumentation Laboratory (IL)
• Inverness Medical Innovations, Inc.
• Roche Diagnostics
• The Second Tier
• Acon Laboratories, Inc./Innovacon
• Acrongenomics, Inc.
• Addison-Davis Diagnostics, Inc. (ADDI)
• ADIATEC
• Akers Biosciences, Inc.
• ALFA Scientific Designs, Inc.
• Amedica Biotech
• 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.

Table of Contents

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