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Lateral Flow Technology And The Future Of Point Of Care Diagnostics, 2nd Edition

Lateral flow tests, also known as immunochromatographic strip (ICS) tests, are point of care tests that 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 care. This report, Lateral Flow Technology and the Future of Point of Care Testing, 2nd Edition, takes an in depth look at the market, technologies, and trends in lateral flow point-of-care testing, looking at both self-testing by patients and at point-of-care testing by healthcare professionals.

Lateral flow (LF) devices and tests have been a popular platform for rapid immunoassays since their introduction in the mid-1980s, and since our last look at the market there has been continued interest and innovations. This report profiles over a hundred companies that currently market lateral flow tests. Many of these companies, plus more than ten additional companies, are developing innovations in lateral flow-based devices. Companies profiled in this report use lateral flow technology to develop and market a wide range of rapid tests for market segments of in vitro diagnostic (IVD) tests that can be performed in centralized laboratories.

Every critical aspect of the lateral flow test market is addressed, including the following key topics:

  • The current sales figures for LF productsand realistic projections for 2017
  • The core factors driving LF testing revenues up.
  • Breakout of LF-POC market by Self Test and Professional Breakout of LF-POC market by Key Test Segments (Fertility, Infectious Disease, Cardiac Markers, Oncology, Drugs of Abuse, Other)
  • 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.
  • Regional markets for lateral flow tests (US, Europe, Japan, ROW)
  • Companies launching innovative devices.
  • Obstacles that could trap new entrants.
Growth in lateral flow point-of-care testing is being fueled by many factors fueling growth of the point-of-care market as a whole. These include the globalization of infectious diseases and the associated public health issues, advances in therapies giving physicians more tools for treatment of patients if the doctor is able to rapidly diagnose the problem, the need to monitor an ever-growing group of people with chronic diseases such as cardiovascular diseases, cancer and other chronic conditions, and many other factors. Decentralized testing and the ability to get rapid test results is emerging as a tool for more efficient diagnosis and patient evaluation, and to improve the quality of patient care.

This report provides a realistic assessment acknowledging the reality of payors’ emphasis on cost/benefit analysis for new technologies. Current sales and predictions for 2017 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.

The report offers a quantitative assessment of specific markets, worldwide, in U.S. dollars for 2012 to 2017.


  • Executive Summary
    • OVERVIEW
    • SCOPE AND METHODOLOGY
    • MARKET OVERVIEW
      • Table Lateral Flow Rapid Test Sales, Worldwide, 2012 and 2017 ($ millions)
  • Introduction
    • BACKGROUND - POINT-OF-CARE AND RAPID TESTING
    • OVERVIEW OF LATERAL FLOW DEVICES
    • POINT OF VIEW
  • Technical Issues and Innovations For Lateral Flow Devices
    • TECHNICAL ISSUES AND HURDLES WITH LATERAL FLOW DEVICES
    • ALTERNATE TEST SAMPLES
      • Table Selected Companies with Saliva or Oral-Fluid Collection Devices
    • AUTOMATING READING OF LATERAL FLOW TEST RESULTS
      • Table Selected Companies With Readers for Lateral Flow Devices
    • CONNECTIVITY
    • INNOVATIONS WITH LATERAL FLOW DEVICES
      • Table Selected Companies Developing and/or Marketing Innovations in Lateral Flow-Based Tests
    • LATERAL FLOW IN MOLECULAR DIAGNOSTICS [NUCLEIC ACID LATERAL FLOW]
      • Table Selected Companies Using Lateral Flow in Molecular Diagnostics
    • EMERGING TECHNOLOGIES COMPETING AGAINST LATERAL FLOW
      • Table Selected Companies Developing and/or Marketing POC Diagnostic Platforms that May Compete with Lateral Flow Immunoassays
  • Market Issues and Opportunities For Lateral Flow Devices
    • MARKET DRIVERS FOR POINT-OF-CARE TESTING
      • Patent focused drivers
      • Medical/Healthcare related drivers
      • Technology drivers
      • Economic drivers
      • Other drivers
    • ADVANTAGES AND DISADVANTAGES OF LATERAL FLOW POC TESTING
      • Advantages:
      • Disadvantages:
    • EMERGING INTERNATIONAL MARKETS
      • Table Selected Companies Outside of North America, Europe, or Japan Marketing Lateral Flow Diagnostic Tests
  • Market Analysis
    • MARKET OVERVIEW
    • CURRENT MARKETS AND MARKET FORECASTS - LATERAL FLOW POINT-OF-CARE TESTING
      • Self Testing/OTC
      • Professional Lateral Flow Point-of-Care Testing
        • Table Lateral Flow OTC/Self-Test Sales by Test Category, Worldwide, 2012 and 2017(Fertility, Infectious Disease, Cardiac Markers, Oncology, Drugs of Abuse, Other) ($ millions)
        • Table Lateral Flow Professional POC/Rapid Test Sales by Test Category, Worldwide, 2012 and 2017 (Fertility, Infectious Disease, Cardiac Markers, Oncology, Drugs of Abuse, Other) ($ millions)
    • LATERAL FLOW POC TESTING AND RAPID TESTING IN WORLDMARKETS
      • Table Point-of-Care Test Sales by Region 2012 and 2017 (All POC Tests) ($ millions)
      • The United States
      • Europe
      • Rest of World
    • MARKET SEGMENTS BY TEST CATEGORY
      • Table Worldwide POC/Rapid Test Sales by Test Category, 2012 and 2017 (Fertility, Infectious Disease, Cardiac Markers, Oncology, Drugs of Abuse, Other)
      • Fertility (Pregnancy, Ovulation, and Menopause)
        • Table Selected Companies Marketing Fertility LF-Based Tests (Pregnancy, Ovulation, and/or Menopause Tests)
      • Infectious Disease
        • Table Selected Companies Marketing Infectious Disease LF-Based Tests
      • Cardiac Markers
        • Table Selected Companies Marketing LF-Based Cardiac Marker Tests
      • Oncology Markers
        • Table Selected Companies Marketing LF- Oncology LF-Based Tests
      • Drugs of Abuse and Alcohol
        • Table Selected Companies Marketing Drugs of Abuse LF-Based Tests (Includes Alcohol Tests)
      • Other Lateral Flow Point-of-Care Tests
        • Table Selected Companies Marketing Other LF-Based Tests
    • LOCATIONS FOR LATERAL FLOW POINT-OF-CARE TESTING
  • Companies Marketing LF POC/Rapid Test Devices
    • 1 STEP DETECT ASSOCIATES, LLC
    • ACCESS BIO, INC.
    • ACCUBIOTECH CO., LTD.
    • ACCUMED BIOLOGY (SHANGHAI) CO., LTD.
    • ACCUTECH, LLC
    • ALERE INC.
      • Recent Revenue History:
    • Company Overview and POC Products:
      • ALFA SCIENTIFIC DESIGNS, INC.
    • AMEDICA BIOTECH
    • AMERICAN BIO MEDICA CORPORATION
      • Recent Revenue History:
      • Company Overview and POC Products:
    • APACOR LTD.
    • ARTRON LABORATORIES INC.
    • ATLAS LINK BIOTECH CO., LTD.
    • AUGURIX SA/AUGURIX DIAGNOSTICS
    • AUTOBIO DIAGNOSTICS CO., LTD.
    • AZOG, INC.
    • BD (BECTON DICKINSON)
      • Recent Revenue History:
      • Company Overview and POC Products:
    • BECKMAN COULTER, INC. (SUBSIDIARY OF DANAHER CORPORATION)
      • Recent Revenue History:
      • Company Overview and POC Products:
    • BIOCARE DIAGNOSTICS LTD.
    • BIOMERICA, INC.
      • Recent Revenue History
      • Company Overview and POC Products
    • BIOMÉRIEUX SA
      • Recent Revenue History
      • Company Overview and POC Products:
    • BIO-RAD LABORATORIES, INC.
      • Recent Revenue History
      • Company Overview and POC Products
    • BIOSCAN SCREENING SYSTEMS, INC.
    • BIOSINO BIO-TECHNOLOGY AND SCIENCE INC.
    • BLUE CROSS BIO-MEDICAL CO., LTD.
    • BNTX INC.
    • BOSON BIOTECH CO., LTD.
    • BRANAN MEDICAL CORPORATION
    • BÜHLMANN LABORATORIES AG
    • CALYPTE BIOMEDICAL CORPORATION
      • Recent Revenue History
      • Company Overview and POC Products
    • CARE DIAGNOSTICA
    • CARE PRODUCTS, INC.
    • CERTEST BIOTEC
    • CHEMBIO DIAGNOSTICS, INC.
      • Recent Revenue History
      • Company Overview and POC Products
    • CHEMTRON BIOTECH, INC.
    • CLARITY DIAGNOSTICS (DIAGNOSTIC TEST GROUP, LLC)
    • CLINICAL INNOVATIONS, LLC
    • CONCATENO (SUBSIDIARY OF ALERE)
    • CONFIRM BIOSCIENCES
    • CONTRAVAC, INC.
    • CORE TECHNOLOGY CO., LTD.
    • CORIS BIOCONCEPT
    • CTK BIOTECH, INC.
    • DEVONMEDICAL PRODUCTS
    • DFI CO., LTD.
    • DIAGENICS SE
    • DIAGENICS INTERNATIONAL CORPORATION
    • DIALABGMBH
    • DIASOURCE IMMUNOASSAYS
    • DR. FOOKE LABORATORIEN GMBH
    • DRG INTERNATIONAL, INC.
    • EKF DIAGNOSTICS HOLDINGS PLC
      • Recent Revenue History
      • Company Overview and POC Products
    • EMBRYOTECH LABORATORIES
    • ENTERIX INC. (AQUEST DIAGNOSTICS COMPANY)
    • EUROSPITAL SPA
    • EXPRESS DIAGNOSTICS INTERNATIONAL
    • EY LABORATORIES, INC.
    • FIRST CHECK DIAGNOSTICS CORP. (SUBSIDIARY OF ALERE)
    • FIRST DIAGNOSTIC LLC
    • GENBIO
    • GERMAINE LABORATORIES
    • HAMAMATSU PHOTONICS K.K.
    • HEALGEN SCIENTIFIC LLC
    • HEMA DIAGNOSTIC SYSTEMS, LLC (HDS)
    • HEMOSURE, INC.
    • HIGHTOP BIOTECH CO., LTD.
    • IDENTA CORPORATION
    • IMMUNO-MYCOLOGICS, INC.
    • IMMUNOSCIENCE, INC.
    • IMMUNOSTICS, INC.
    • INBIOS INTERNATIONAL, INC.
    • INSTANT TECHNOLOGIES, INC.
    • INTEC PRODUCTS, INC.
    • INTERNATIONAL IMMUNO-DIAGNOSTICS
    • JANT PHARMACAL CORPORATION
    • JEI DANIEL BIOTECH CORP.
    • LABSYSTEMS DIAGNOSTICS GROUP (FORMERLY ANI BIOTECH OY)
    • LABTEST
    • LIFESIGN LLC
    • LIMING BIO-PRODUCTS CO., LTD.
    • MAGNABIOSCIENCES, LLC
    • MAVAND SOLUTIONS GMBH
    • MEDISENSOR, INC.
    • MEDIWATCH PLC
    • MEDIX BIOCHEMICA
    • MEDMIRA INC.
      • Recent Revenue History
      • Company Overview and POC Products
    • MERIDIAN BIOSCIENCE, INC.
      • Recent Revenue History
      • Company Overview and POC Products
    • MICROPOINT BIOSCIENCE, INC.
    • MP BIOMEDICALS, LLC
    • NANO-DITECH CORPORATION
    • NANTONG EGENS BIOTECHNOLOGY CO., LTD.
    • NEWSCEN COAST BIO-PHARMACEUTICAL CO., LTD.
    • NEXSCREEN LLC
    • NOBEL MEDICAL INC.
    • OASIS DIAGNOSTICS CORPORATION
    • OMEGA DIAGNOSTICS GROUP PLC
    • OPERON
    • ORASURE TECHNOLOGIES, INC.
      • Recent Revenue History
      • Company Overview and POC Products
    • PAN PROBE BIOTECH, INC.
    • PERFECT EASE BIOTECH CO., LTD.
    • POLYMEDCO, INC.
    • POLYMED THERAPEUTICS, INC.
    • PRECHECK BIO, INC.
    • PRESTIGE DIAGNOSTICS
    • PREVENTIS GMBH
    • PRINCETON BIOMEDITECH CORPORATION
    • QUIDEL CORPORATION
      • Recent Revenue History
      • Company Overview and POC Products
    • QUIKTEST USA, INC.
    • RAPID PATHOGEN SCREENING, INC.
    • R-BIOPHARM AG
    • REAGENA GROUP REAGENA OY LTD. REAGENA INTERNATIONAL OY, LTD.
    • REALWORLD DIAGNOSTICS
    • REDWOOD TOXICOLOGY LABORATORY, INC.
    • RELIA DIAGNOSTICS, INC.
    • RENESA UG
    • RESPONSE BIOMEDICAL CORPORATION
      • Recent Revenue History
      • Company Overview and POC Products
    • RESZON DIAGNOSTICS INTERNATIONAL SDN. BHD.
    • SA SCIENTIFIC
    • SAVYON DIAGNOSTICS
    • SCREENING DEVICES CANADA, INC.
    • SEKISUI DIAGNOSTICS, LLC
    • SEKISUIMEDICAL CO., LTD.
    • SERASCIENCE
    • SICHUAN MAKER BIOTECHNOLOGY CO., LTD.
    • STANDARD DIAGNOSTICS (PART OF ALERE)
    • SURESCREEN DIAGNOSTICS
    • SYNTRON BIORESEARCH, INC.
    • SYSTAGENIX WOUND MANAGEMENT
    • TECHLAB, INC.
    • TECO DIAGNOSTICS
    • THERADIAG
    • TRINITY BIOTECH PLC
      • Recent Revenue History
      • Company Overview and POC Products
    • TURKLAB MEDICAL DEVICES INC.
    • UCP BIOSCIENCES, INC.
    • US DIAGNOSTICS, INC.
    • VEDA.LAB SA
    • VIRICELL S.L.
    • WAMADIAGNOSTICA
    • ZHUHAI ENCODEMEDICAL ENGINEERING CO., LTD.
  • Companies Entering LF POC/Rapid Test Market or Developing Novel Technologies for LF Tests
    • ALVERIX, INC.
    • ARBOR VITA CORPORATION
    • AXXIN
    • BIO-AMD LTD.
    • BIOMEDOMICS
    • CORGENIX MEDICAL CORPORATION
    • EPINEX DIAGNOSTICS, INC.
    • GENISPHERE, LLC
    • GENPRIME, INC.
    • INTRINSIC LIFESCIENCES
    • MESA TECH INTERNATIONAL, INC.
    • TWISTDX, LTD.
    • VENAXIS, INC. (FORMERLY ASPEN BIOPHARMA, INC.)

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