Laboratory Developed Tests - Market Research, Industry Trends, Market Share


Published: 09/27/2017
Pages: 375
Full Study Price: US$ 4,500

The market for laboratory-developed tests (LDTs) has been attracting a large amount of attention in recent years. Today, high-risk, complex tests have been developed as LDT, and are used to provide clinical results to both physicians and patients. This report covers the market for laboratory-developed tests, which has been elusive for industry watchers who are seeking resources with which to inform their business planning and competitive activity. Kalorama Information provides its market expertise to estimate the market sizing and forecasts for two areas of laboratory-developed tests.

The Worldwide Market for Laboratory-Developed Tests is Kalorama Information’s unique report that includes unique segmentation for customers that need to identify their specific market segment needs. The two separate but related market areas discussed in this report include the market for clinical lba services that use lab-developed tests, and the market for products which are sold to clinical laboratories that use these products to make LDTs.

The Worldwide Market for Laboratory-Developed Tests uses the term LDTs to incorporate all clinical tests developed by laboratories for their own use. Information presented in this report was derived from publically available information sources such as company reports and announcements, government reports and databases, medical organization reports, medical associations, and other publications. The report’s analysis is based on industry knowledge combined with literature searches and discussions with industry professionals and experts.

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Table Of Contents

  • Executive Summary
    • Overview
    • Scope and Methodology
      • Two Markets: Market for Services and For Test Products Sold to Labs (for use in LDTs)
    • Market Overview
      • kalorama's Analysis of the LDT Market
      • LDT Services Market by Segment (Infectious Disease, Oncology LDT, Genetic Testing, Other LDT)
        • Table Laboratory Developed Test Services Market; Major Clinical (Disease) Segments (2016 2021) (in millions USD)
      • LDT Services Market by Segment (Infectious Disease, Oncology LDT, Genetic Testing, Other LDT)
        • Table Worldwide Market for Products (Instruments and Consumables) Used by Clinical Laboratories for LDTs (2016-2021) (in millions USD)
    • Future Prospects in the Laboratory Development Test Market
      • Status of FDA
  • 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
      • Uniquness of the LDT Market
  • Laboratory Developed Tests - Overview
    • What is a Laboratory Developed Test?
      • Kalorama Definition - LDT
      • 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
        • Table Selected Companies Marketing Histology Stains
        • Table Selected Companies Marketing Microscopes
      • Immunohistochemistry
      • Flow Cytometry
        • Table Selected Companies Marketing Flow Cytometry Platforms
      • 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
        • Table Selected Companies Marketing Mass Spectrometers
      • Sequencing
        • Table Selected Companies Marketing Next Generation Sequencing Platforms to Clinical Laboratories
      • Other Technologies
  • Clinical Applications Where Laboratory Developed Tests are Used
    • Infectious Disease
      • Table Selected Companies/Clinical Laboratories Offering Infectious Disease Test Services Based on LDTs [Excluding microbial identification testing by culture]
    • Oncology
      • Hereditary Risk of Cancer
        • Table Selected Companies/Clinical Laboratories Offering Laboratory Developed Tests for Hereditary
      • Cancer Screening
        • Table Selected Companies/Clinical Laboratories Offering Cancer Screening Test Services Based on LDTs
      • Diagnosis, Prognosis, Treatment Decisions (Personalized Medicine) in Cancer Care
        • Table Selected Companies/Clinical Laboratories Offering Cancer Diagnosis/Prognosis/Personalized Medicine Test Services Based on LDTs
    • Genetic Testing
      • Testing for Risk of Disease Moving Beyond Cancer
        • Table Selected Companies/Clinical Laboratories Offering Laboratory Developed Tests for Risk of Disease Cancer and Beyond
      • Chromosome Analysis and Non-Invasive Prenatal Testing (NIPT)
        • Table Selected Companies/Clinical Laboratories Offering Non-Invasive Prenatal Testing (NIPT)/Chromosome Analysis Based on LDTs
      • Testing for Inherited Disorders (Prenatal Testing, Postnatal Testing, Carrier Screening)
        • Table Selected Companies/Clinical Laboratories Offering Genetic Testing for Inherited Disorders (Prenatal Testing, Postnatal Testing, Carrier Screening) Based on LDTs
      • Newborn Screening
      • Other Genetic Testing
        • Table Selected Companies/Clinical Laboratories Offering Newborn Screening or Other Genetic Tests Based on LDTs
      • Direct-to-Consumer Genetic Testing
        • Table Selected Examples of Companies Offering Direct-to-Consumer Genetic Testing Services Based on LDTs
    • Pharmacogenomics
      • Table Selected Companies/Clinical Laboratories Offering Pharmacogenomic Test Services Based on LDTs
    • Mass Spectrometry-Based Tests for Small Molecules
    • Other Laboratory Developed Test Applications
      • Table Selected Companies/Clinical Laboratories Offering Autoimmune/Inflammatory Test Services Based on LDTs
      • Table Selected Companies/Clinical Laboratories Offering Cardiovascular Test Services Based on LDTs
      • Table Selected Companies/Clinical Laboratories Offering Neurological Test Services Based on LDTs
      • Table Selected Companies Offering Other Test Services Based on LDTs
  • Deals - Companies and Laboratories, Laboratory Developed Tests
    • Investments/Financings Companies/Clinical Laboratories with LDTs
      • 2016 and 2017 Investment in LDTs
        • Table Selected Investments and Financing Agreements, Companies/Laboratories with LDTs and Selected Companies Providing Products to Laboratories with LDTs (2014 through August 2017)
    • Mergers and Acquisitions
      • Table Selected Acquisitions of or by Companies/Laboratories with LDTs (2014 through August 2017)
    • Corporate Collaborations
      • Table Selected Agreements Between Diagnostic Companies and Other Diagnostic Companies or Clinical Laboratories Relating to LDTs [Includes IVD Companies and Diagnostic Companies Operating CLIA Laboratories] (2014 through August 2017)
      • Table Selected Agreements Between Diagnostic Companies/Laboratories with LDTs and Pharmaceutical or Biopharmaceutical Companies(Includes Agreements with Selected CROs) (2014 through August 2017)
  • 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
        • Table Selected FDA Approved/Cleared Laboratory Developed Tests
  • 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
      • Table Laboratory Developed Test Services Market; Major Clinical (Disease) Segments (2016 2021) (in millions USD)
      • LDT Services Market by Geography
        • Table Laboratory Developed Test Services Market by Geographical Distribution (2016-2021) (in millions USD)
    • Infectious Disease Laboratory Developed Testing Services Market
      • Markets for LDTs for Infectious Disease Detection and Microbiology
        • Table Infectious Disease Laboratory Developed Test Service Market, (2016-2021)(in millions USD)
      • LDT Infectious Disease Services Market by Geography
        • Table Geographical Distribution of the Infectious Disease Laboratory Developed Test Service Market (2016-2021) [Excluding microbial identification by culture](in millions USD)
        • Table Geographical Distribution of the Infectious Disease Laboratory Microbial Identification Market (Culture) (2016-2021) (in millions USD)
    • Oncology Laboratory Developed Testing Services Market
      • LDT Services Market for Oncology by Segment
        • Table Oncology Laboratory Developed Test Services Market, Segmented by Clinical Application (2016-2021) (in millions USD)
      • 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
        • Table Geographical Distribution of the Oncology Laboratory Developed Test Services Market {Cancer Screening plus Diagnosis/Prognosis/Monitoring] (2016-2021) (in millions USD)
    • Genetic Testing Laboratory Developed Testing Services Market
      • LDT Genetic Test Market by Segment
        • Table Genetic Testing Laboratory Developed Test Service Market, Segmented by Clinical Application (2016-2021) (in millions USD)
      • LDT Market by Geography
        • Table Geographical Distribution of the Genetic Testing Laboratory Developed Test Service Market (2016-2021) (millions USD)
    • Market for Other Laboratory Developed Tests
  • Laboratory Developed Test Market Analysis Instrument and Reagent Manufacturers
    • Uniquness of Market Analysis on LDT Product and Reagents
    • LDT Products and Reagents by Segment (PCR, Mass Spectrometry, NGS. Microarrays and Other)
      • Table Worldwide Market for Products (Instruments and Consumables) Used by Clinical Laboratories for LDTs (2016-2021) (in millions USD)
      • Geographic Distribution of Product and Reagants Used for LDT Market
        • Table Geographical Distribution of the Market for Products (Instruments and Consumables) Used by Clinical Laboratories for LDTs (2016-2021) (in millions USD)
  • Company Profiles
    • 23andMe, Inc.
    • Adaptive Biotechnologies Corporation
    • Admera Health
    • Agendia NV
    • AgilentTechnologies Inc.
      • Recent Revenue History
      • Company Overview
    • AltheaDx, Inc.
    • Ambry Genetics Corp.
    • Applied Proteomics, Inc.
    • Athena Diagnostics, Inc. (A Quest Diagnostics Business)
    • BGI
    • Biodesix, Inc.
    • bioTheranostics, Inc.
    • Bruker Corporation
      • Recent Revenue History:
      • Company Overview:
    • Cancer Genetics, Inc.
      • Recent Revenue History
      • Company Overview
      • Collaborations with Universities or Other Non-Profit Organizations
      • Collaborations with Other Companies
    • CardioDx, Inc.
    • CareDx, Inc.
      • Recent Revenue History
      • Company Overview
    • Caris Life Sciences
    • Castle Biosciences, Inc.
    • CENTOGENE AG
    • Color Genomics, Inc.
    • Cynvenio Biosystems, Inc.
    • Epic Sciences, Inc.
    • Eurofins
      • Recent Revenue History
      • Company Overview
    • Exact Sciences Corporation
      • Recent Revenue History
      • Company Overview
    • Foundation Medicine, Inc.
      • Recent Revenue History
      • Company Overview
    • Genomic Health, Inc.
      • Recent Revenue History
      • Company Overview
    • Genoptix, Inc.
    • Good Start Genetics, Inc. (Acquired by Invitae Corporation)
    • GRAIL, Inc.
    • Guardant Health, Inc.
    • Helix
    • Illumina, Inc.
      • Recent Revenue History
      • Company Overview
    • Integrated Diagnostics, Inc.
    • Invitae Corporation
      • Recent Revenue History
      • Company Overview
    • Laboratory Corporation of America (LabCorp)
      • Recent Revenue History
      • Company Overview
    • MDxHealth
      • Recent Revenue History:
      • Company Overview
    • Multiplicom NV (Part of Agilent Technologies)
    • Myriad Genetics, Inc.
      • Recent Revenue History
      • Company Overview
    • NANTOMICS (Member of the NantWorks ecosystem of companies)
    • Natera, Inc.
      • Recent Revenue History:
      • Company Overview
    • NeoGenomics, Inc./NeoGenomics Laboratories
      • Recent Revenue History
      • Company Overview
    • OPKO Health, Inc./OPKO Diagnostics
      • Recent Revenue History
      • Company Overview
    • Pacific Biosciences of California, Inc.
      • Recent Revenue History
      • Company Overview
    • PerkinElmer, Inc.
      • Recent Revenue History:
      • Company Overview:
    • QIAGEN N.V.
      • Recent Revenue History
      • Company Overview
    • Quest Diagnostics
      • Recent Revenue History
      • Company Overview
    • Roche
      • Recent Revenue History
      • Company Overview
    • Rosetta Genomics Ltd.
      • Recent Revenue History:
      • Company Overview:
    • SCIEX
    • Sera Prognostics, Inc.
    • Thermo Fisher Scientific, Inc.
      • Recent Revenue History
      • Company Overview
    • Waters Corporation
      • Recent Revenue History:
      • Company Overview: