Lateral flow (LF) 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 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)
• The trends to watch that could increase sales predictions.
• Need-to-know companies in Lateral Flow Test devices.
• 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)
• 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.

Table Of Contents

CHAPTER ONE: EXECUTIVE SUMMARY
Overview
Scope and Methodology
Market Overview

CHAPTER TWO: INTRODUCTION
Background - PointofCare and Rapid Testing
Overview of Lateral Flow Devices
Point of View

CHAPTER THREE: TECHNICAL ISSUES AND INNOVATIONS FOR LATERAL FLOW DEVICES
Technical Issues and Hurdles with Lateral Flow Devices
Alternate Test Samples
Automating Reading of Lateral Flow Test Results
Connectivity
Innovations with Lateral Flow Devices
Lateral Flow in Molecular Diagnostics [Nucleic Acid Lateral Flow]
Emerging Technologies Competing Against Lateral Flow

CHAPTER FOUR: ISSUES AND TRENDS
Patent focused drivers
Medical/Healthcare related drivers
Technology drivers
Economic drivers
Other drivers
Advantages and Disadvantages of Lateral Flow POC Testing

Advantages:
Disadvantages:



CHAPTER FIVE: MARKET ANALYSIS
Market Overview
Current Markets and Market Forecasts -
Lateral Flow PointofCare Testing

Self Testing/OTC
Professional Lateral Flow PointofCare Testing


Lateral Flow POC Testing and Rapid Testing in World Markets

The United States
Europe
Rest of World


Market Segments by Test Category

Fertility (Pregnancy, Ovulation, and Menopause)
Infectious Disease

HIV POC Testing
Influenza
Tuberculosis


Cardiac Markers
Oncology Markers
Drugs of Abuse and Alcohol
Other Lateral Flow PointofCare Tests


Locations for Lateral Flow PointofCare Testing

CHAPTER SIX: 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:


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


bioMerieux sa

Recent Revenue History
Company Overview and POC Products:
Recent Revenue History
Company Overview and POC Products


BioScan Screening Systems, Inc
BioSino BioTechnology and Science Inc.
Blue Cross Biomedical Co., Ltd.
BNTX Inc
Boson Biotech Co., Ltd.
Branan Medical Corporation
BÃœHLMANN Laboratories AG
Calypte Biomedical Corporation

Recent Revenue History
Company Overview and POC Products
Recent Revenue History
Company Overview and POC Products


Dr. Fooke Laboratorien GmbH
DRG International, Inc.

Recent Revenue History


Embryotech Laboratories
Enterix Inc. (A Quest Diagnostics Company)
Eurospital Spa
Express Diagnostics International
EY Laboratories, Inc.
First Check Diagnostics Corp. (Subsidiary of Alere)
First Diagnostic LLC
GenBio
Germaine Laboratories
Healgen Scientific LLC
Hema Diagnostic Systems, LLC (HDS)
Hemosure, Inc.
Hightop Biotech Co., Ltd.
IDenta Corporation
ImmunoMycologics, Inc.
ImmunoScience, Inc.
Immunostics, Inc
InBios International, Inc.
Instant Technologies, Inc.
InTec Products, Inc.
International ImmunoDiagnostics
Jant Pharmacal Corporation
Jei Daniel Biotech Corp.
Labsystems Diagnostics Group (Formerly Ani Biotech Oy)
Labtest
LifeSign LLC
Liming BioProducts Co., Ltd.
MagnaBioSciences, LLC
MAVAND Solutions GmbH
Medisensor, Inc.
Mediwatch Plc
Medix Biochemica
MedMira Inc.

Recent Revenue History
Company Overview and POC Products
Recent Revenue History
Company Overview and POC Products
Recent Revenue History
Company Overview and POC Products


Polymed Therapeutics, Inc.
Precheck Bio, Inc.
Prestige Diagnostics
Preventis GmbH
Princeton Biomeditech Corporation
Quidel Corporation

Recent Revenue History
Company Overview and POC Products


RBiopharm AG
Real World Diagnostics
Redwood Toxicology Laboratory, Inc.
ReLIA Diagnostics, Inc.
RENESA UG

Recent Revenue History
Company Overview and POC Products


Reszon Diagnostics International Sdn. Bhd.
SA Scientific
Savyon Diagnostics
Screening Devices Canada, Inc.
Sekisui Medical 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.
WAMA Diagnostica
Zhuhai Encode Medical Engineering Co., Ltd.

CHAPTER SEVEN: COMPANIES ENTERING LF POC/RAPID TEST MARKET OR LAUNCHING NOVEL TESTS
Alverix, Inc.
Arbor Vita Corporation
Axxin
BioAMD Ltd.
BioMedomics
Corgenix Medical Corporation
Epinex Diagnostics, Inc.
Genisphere, LLC
GenPrime, Inc.
Mesa Tech International, Inc.
TwistDx, Ltd.
Venaxis, Inc. (Formerly Aspen BioPharma, Inc.)
LIST OF EXHIBITS

CHAPTER ONE: EXECUTIVE SUMMARY
Table 11: Lateral Flow Rapid Test Sales, Worldwide, 2012 and 2017

CHAPTER THREE: TECHNICAL ISSUES AND INNOVATIONS FOR LATERAL FLOW DEVICES
Table 31: Selected Companies with Saliva or OralFluid Collection Devices
Table 32: Selected Companies With Readers for Lateral Flow Devices
Table 33: Selected Companies Developing and/or Marketing Innovations in LFT
Table 34: Selected Companies Using Lateral Flow in Molecular Diagnostics
Table 35: Selected Companies Developing and/or Marketing POC Diagnostic Platforms that May Compete with Lateral Flow Immunoassays

CHAPTER FOUR: ISSUES AND TRENDS
Table 41: Selected Companies Outside of North America, Europe, or Japan Marketing Lateral Flow Diagnostic Tests

CHAPTER FIVE: MARKET ANALYSIS
Table 51: Lateral Flow OTC/SelfTest Sales by Test Category, Worldwide, 2012 and 2017 (Fertility, Infectious Disease, Cardiac Markers, Oncology, Drugs of Abuse, Other)
Table 52: Lateral Flow Professional POC/Rapid Test Sales by Test Category, Worldwide, 2012 and 2017 (Fertility, Infectious Disease, Cardiac Markers, Oncology, Drugs of Abuse, Other)
Table 53: PointofCare Test Sales by Region, 2012 and 2017 (All POC Tests)
Table 54: Worldwide POC/Rapid Test Sales by Test Category, 2012 and 2017 (Fertility, Infectious Disease, Cardiac Markers, Oncology, Drugs of Abuse, Other)
Table 55: Selected Companies Marketing Fertility LFBased Tests
Table 56: Selected Companies Marketing Infectious Disease LFBased Tests
Table 57: Selected Companies Marketing LFBased Cardiac Marker Tests
Table 58: Selected Companies Marketing LF Oncology LFBased Tests
Table 59: Selected Companies Marketing Drugs of Abuse LFBased Tests
Table 510: Selected Companies Marketing Other LFBased Tests

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