Oct 17, 2017   SOURCE: PR NewsWire

Worldwide Laboratory-Developed Tests Market 2017: Services (Labs Performing LDTs) and Equipment (Instruments and Reagents Used in LDTs)

DUBLIN, October 17, 2017 /PRNewswire/ --

The "The Worldwide Market for Laboratory-Developed Tests: Services (Labs Performing LDTs) and Equipment (Instruments and Reagents Used in LDTs)" report has been added to Research and Markets' offering.

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This is a unique report with a unique segmentation to help customers find the right segment for their needs. Two separate but related markets are discussed in this report: the market for clinical laboratory services using laboratory developed tests, and the market for products (platforms and consumables) sold to clinical laboratories who uses these products to make LDTs. Both are large and rapidly growing markets.

Laboratory-developed tests, or LDTs, have been attracting a lot of attention in recent years, but they are not a new or recent phenomenon. Historically, these tests were called home-brew tests or in-house tests. Also historically, these tests were low-volume, simple and well characterized tests for low-risk diagnostic applications. Today, high-risk, complex tests have been developed as LDTs, and are being used to provide clinical results to physicians and their patients.

This market has been elusive for industry watchers seeking a resource to inform business planning and competitive activity. Expertise has been put in the in vitro diagnostics market to work with this volume which estimates market sizing and forecasts for two key areas of lab-developed tests.

The Market for Lab-Developed Test Services and the Market for Instruments and Reagents Sold to Labs

A Rapidly Moving, Highly Dynamic Market.

Chemistry Tests, Immunoassays Histology Stains, Flow Cytometry, Karyotyping, ISH, Gene Signatures, Microarrays are among the technologies used in lab develop tests. This report examines each technology category.

There are great number of companies in the LDT market. New LDTs are being developed and introduced, and some segments of this market (especially the market for cancer diagnosis, prognosis, personalized medicine, and monitoring patients) have become very competitive. Some companies will not survive, but there are also examples of successful companies. This field has attracted considerable interest from investors and from companies making acquisitions.

Tracking FDA Actions and Statements and Industry Reaction

There has been considerable discussion in recent years about regulation of this market, and the FDA proposed a draft guidance calling for more FDA oversight of these tests. However, at this time, the likely outcome of this discussion is not clear. However, some LDTs available today have already been FDA cleared or approved, and others are likely to be developed into in vitro diagnostic (IVD) tests that a company can ship widely to clinical laboratories. Early examples of this are discussed in the report.

In this report, laboratory developed tests (LDTs) include all clinical tests developed by laboratories for their own use, in contrast to in vitro diagnostic (IVD) kits that are manufactured and sold by diagnostic companies for use by many different clinical labs. For LDTs, clinical labs do have to purchase instruments and reagents, but these products are not FDA approved/cleared or CE-IVD marked kits (or other kits approved by regulatory authorities of a specific company) that contain everything required to do a test that was developed by the diagnostic company.

Key Topics Covered:

1: Executive Summary

    --  Overview
    --  Scope And Methodology
    --  Two Markets: Market For Services And For Test Products Sold To Labs (For
        Use In LDTs)
    --  Market Overview
    --  Analysis Of The LDTMarket
    --  LDT Services Market By Segment (Infectious Disease, Oncology LDT,
        Genetic Testing, Other LDT)
    --  LDT Services Market By Segment (Infectious Disease, Oncology LDT,
        Genetic Testing, Other LDT)
    --  Future Prospects In The Laboratory Development Test Market
    --  Status Of FDA Regulation

2: Introduction

    --  Laboratory Develop Tests Versus In Vitro Diagnostic Tests Ivd
    --  LDTs Why Do Laboratories Use Laboratory Developed Tests?
    --  Laboratory Developed Test Markets - Clinical Laboratories Performing
        Laboratory Developed Tests Versus
    --  Instrument And Reagent Manufacturers
    --  Point-Of-View And Methodology
    --  Uniqueness Of The LDTMarket

3: Laboratory Developed Tests - Overview

    --  What Is A Laboratory Developed Test?
    --  Regulatory Approval And LDTs
    --  Other Important Terminology
    --  General Purpose Reagent:
    --  Analyte Specific Reagent (ASR):
    --  Use Of Diagnostic Technologies As Laboratory Developed Tests
    --  Chemistry Tests
    --  Immunoassays
    --  Histology Stains
    --  Immunohistochemistry
    --  Flow Cytometry
    --  Karyotyping
    --  In Situ Hybridization
    --  Polymerase Chain Reaction And Other Nucleic Acid Amplification
        Technologies
    --  Analysis Of Gene Expression Patterns (Gene Signatures)
    --  Microarrays
    --  Protein Microarrays
    --  Dna Microarrays
    --  Chromosomal Microarrays
    --  Tissue Microarrays
    --  Mass Spectrometry
    --  Sequencing

4: Clinical Applications Where Laboratory Developed Tests Are Used

    --  Infectious Disease
    --  Oncology
    --  Hereditary Risk Of Cancer
    --  Cancer Screening
    --  Diagnosis, Prognosis, Treatment Decisions (Personalized Medicine) In
        Cancer Care
    --  Genetic Testing
    --  Testing For Risk Of Disease - Moving Beyond Cancer
    --  Chromosome Analysis And Non-Invasive Prenatal Testing (Nipt)
    --  Testing For Inherited Disorders (Prenatal Testing, Postnatal Testing,
        Carrier Screening)
    --  Newborn Screening
    --  Other Genetic Testing
    --  Direct-To-Consumer Genetic Testing
    --  Pharmacogenomics
        --  Table 4-10: Selected Companies/Clinical Laboratories Offering
            Pharmacogenomic Test Services Based On LDTs
    --  Mass Spectrometry-Based Tests For Small Molecules
    --  Other Laboratory Developed Test Applications
        --  Table 4-11: Selected Companies/Clinical Laboratories Offering
            Autoimmune/Inflammatory Test Services Based On LDTs
        --  Table 4-12: Selected Companies/Clinical Laboratories Offering
            Cardiovascular Test Services Based On LDTs
        --  Table 4-13: Selected Companies/Clinical Laboratories Offering
            Neurological Test Services Based On LDTs 107
        --  Table 4-14: Selected Companies Offering Other Test Services Based On
            LDTs

5: Deals - Companies And Laboratories, Laboratory Developed Tests

    --  Investments/Financings - Companies/Clinical Laboratories With LDTs
    --  2016 And 2017 Investment In LDTs

6: Market Drivers And Challenges - Laboratory Developed Tests

    --  Technology
    --  Status Of FDA-Approved And CE-Marked Tests
    --  Clinical Market Drivers
    --  Competition
    --  A Large Amount Of Companies
    --  Personalized Medicine And Companion Diagnostics
    --  Foundation Medicine
    --  Thermo Fisher Oncomine
    --  Regulation Of Laboratory Developed Tests - Us And Outside The Us
    --  FDA
    --  Directive 98/79/Ec
    --  Reimbursement
    --  Cmtp And Greek Park Collaborative
    --  Association For Molecular Pathology
    --  Future Prospects
    --  Conversion From Clia Lab Services Offerings To Ivd Kits

7: Laboratory Developed Test Market Analysis - Clinical Laboratories Performing LDTs

    --  Worldwide Laboratory Developed Testing Service Market
    --  The Number Of LDTs On The Market
    --  Small Versus Large Volume
    --  LDT Services Market By Segment
    --  LDT Services Market By Geography
    --  Infectious Disease Laboratory Developed Testing Services Market
    --  Markets For LDTs For Infectious Disease Detection And Microbiology
    --  LDT Infectious Disease Services Market By Geography
    --  Oncology Laboratory Developed Testing Services Market
    --  LDT Services Market For Oncology By Segment
    --  Hereditary Risk Of Cancertesting Servicesmarket
    --  Cancer Screening Services Market
    --  Diagnosis, Prognosis, Treatment Decisions (Personalized Medicine) In
        Cancer Care
    --  Geographical Distribution Of The Oncology Laboratory Developed Test
        Service Market
    --  Genetic Testing Laboratory Developed Testing Services Market
    --  LDT Genetic Test Market By Segment
    --  LDT Market By Geography
    --  Market For Other Laboratory Developed Tests

8: Laboratory Developed Test Market Analysis - Instrument And Reagent Manufacturers

    --  Uniquness Of Market Analysis On LDTProduct And Reagents
    --  LDTProducts And Reagents By Segment (Pcr, Mass Spectrometry, Ngs.
        Microarrays And Other)
    --  Geographic Distribution Of Product And Reagants Used For LDTMarket

9: Company Profiles

    --  23Andme, Inc.
    --  Adaptive Biotechnologies Corporation
    --  Admera Health
    --  Agendia NV
    --  Agilent Technologies Inc.
    --  Altheadx, Inc.
    --  Ambry Genetics Corp.
    --  Applied Proteomics, Inc.
    --  Athena Diagnostics, Inc. (A Quest Diagnostics Business)
    --  BGI
    --  Biodesix, Inc.
    --  Biotheranostics, Inc.
    --  Bruker Corporation
    --  Cancer Genetics, Inc.
    --  Cardiodx, Inc.
    --  Caredx, Inc.
    --  Caris Life Sciences
    --  Castle Biosciences, Inc.
    --  Centogene AG
    --  Color Genomics, Inc.
    --  Cynvenio Biosystems, Inc.
    --  Epic Sciences, Inc.
    --  Eurofins
    --  Exact Sciences Corporation
    --  Foundation Medicine, Inc.
    --  Genomic Health, Inc.
    --  Genoptix, Inc.
    --  Good Start Genetics, Inc. (Acquired By Invitae Corporation)
    --  Grail, Inc.
    --  Guardant Health, Inc.
    --  Helix
    --  Illumina, Inc.
    --  Integrated Diagnostics, Inc.
    --  Invitae Corporation
    --  Laboratory Corporation Of America (Labcorp)
    --  MDXhealth
    --  Multiplicom NV (Part Of Agilent Technologies)
    --  Myriad Genetics, Inc.
    --  Nantomics (Member Of The Nantworks Ecosystem Of Companies)
    --  Natera, Inc.
    --  Neogenomics, Inc./Neogenomics Laboratories
    --  OPKO Health, Inc./Opko Diagnostics
    --  Pacific Biosciences Of California, Inc.
    --  Perkinelmer, Inc.
    --  Qiagen N.V.
    --  Quest Diagnostics
    --  Roche
    --  Rosetta Genomics Ltd.
    --  Sciex
    --  Sera Prognostics, Inc.
    --  Thermo Fisher Scientific, Inc.

    --  Waters Corporation

For more information about this report visit https://www.researchandmarkets.com/research/h8f8z4/the_worldwide

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