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

$4,200.00 – $8,400.00

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SKU: KLI5093826 Categories: Diagnostics Market Research, Point-of-Care Diagnostics Pages: 210
  • Description
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  • Latest reports

Description

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.

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

bioMérieux 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

BÜHLMANN 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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