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

  • ID: 4401303
  • Report
  • 375 pages
  • Kalorama Information
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FEATURED COMPANIES

  • 23Andme, Inc.
  • Applied Proteomics, Inc.
  • Cardiodx, Inc.
  • Cynvenio Biosystems, Inc.
  • Grail, Inc.
  • Myriad Genetics, Inc.
  • MORE

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

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.

As Part of the Market Analysis, the Report Offers the Following Data:

  • Market for LDT Services in Infectious Disease, 2017 to 2022
  • Market for LDT Services in Cancer Screening, 2017 to 2022
  • Market for LDT Services for Inherited Disorders, 2017 to 2022
  • Investment in LDT Companies, 2016 and 2017
  • Status of FDA Regulation of LDT
  • Selected Companies/Clinical Laboratories Offering Infectious Disease Test Services Based on LDTs
  • Companies/Clinical Laboratories Offering Cancer Screening Test Services Based on LDTs
  • Companies/Clinical Laboratories Offering Genetic Testing for Inherited Disorders
  • Market for Products and Reagents Sold to Labs for Use in LDTs, 2017 to 2022
  • Market for Products and Reagents Used in LDTs by Type
  • Market for Products and Reagents  Used in LDTs by Region.
  • M&A Activity: Acquisitions of or by Companies/Laboratories with LDTs
  • Agreements Between Diagnostic Companies with LDTs and Pharmaceutical Companies
  • Direct to Consumer (DTC) Offerings
  • Important Conclusions About the Market
  • Company Profiles

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.  The clinical lab uses these reagents to develop and validate the LDT before the test can be used for diagnostic purposes.   The information presented in this report is derived from publicly available information sources such as company reports and announcements, government reports and databases, medical organization reports, medical associations, and other publications.  The analysis is based on the author's industry knowledge combined with literature searches and discussions with industry professionals and experts in the areas of point-of-care tests, decentralized healthcare and healthcare economics.

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FEATURED COMPANIES

  • 23Andme, Inc.
  • Applied Proteomics, Inc.
  • Cardiodx, Inc.
  • Cynvenio Biosystems, Inc.
  • Grail, Inc.
  • Myriad Genetics, Inc.
  • MORE

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)
    • Table 1-1: 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 1-2: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 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
    • Table 3-1: Selected Companies Marketing Histology Stains
    • Table 3-2: Selected Companies Marketing Microscopes
  • Immunohistochemistry
  • Flow Cytometry
    • Table 3-3: Selected Companies Marketing Antibodies For Immunohistochemistry And/Or Flow Cytometry Testing In Clinical Laboratories
    • Table 3-4: Selected Companies Marketing Flow Cytometry Platforms
  • Karyotyping
  • In Situ Hybridization
    • Table 3-5: Selected Companies Marketing Probes For Fish Based Tests In Clinical Laboratories
  • Polymerase Chain Reaction And Other Nucleic Acid Amplification Technologies
    • Table 3-6: Selected Companies Marketing Open PCR Platforms That Can Be Used By Clinical Laboratories For LDTs
  • Analysis Of Gene Expression Patterns (Gene Signatures)
  • Microarrays
  • Protein Microarrays
  • Dna Microarrays
  • Chromosomal Microarrays
  • Tissue Microarrays
  • Mass Spectrometry
    • Table 3-7: Selected Companies Marketing Mass Spectrometers
  • Sequencing
    • Table 3-8: Selected Companies Marketing Next Generation Sequencing Platforms To Clinical Laboratories

4: Clinical Applications Where Laboratory Developed Tests Are Used

  • Infectious Disease
    • Table 4-1: Selected Companies/Clinical Laboratories Offering Infectious Disease Test Services Based On LDTs [Excluding Microbial Identification Testing By Culture]
  • Oncology
  • Hereditary Risk Of Cancer
  • Cancer Screening
    • Table 4-3: Selected Companies/Clinical Laboratories Offering Cancer Screening Test Services Based On LDTs
  • Diagnosis, Prognosis, Treatment Decisions (Personalized Medicine) In Cancer Care
    • Table 4-4: 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 4-5: Selected Companies/Clinical Laboratories Offering Laboratory Developed Tests For Risk Of Disease - Cancer And Beyond
  • Chromosome Analysis And Non-Invasive Prenatal Testing (Nipt)
    • Table 4-6: 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 4-7: 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 4-8: Selected Companies/Clinical Laboratories Offering Newborn Screening Or Other Genetic Tests Based On LDTs
  • Direct-To-Consumer Genetic Testing
    • Table 4-9: Selected Examples Of Companies Offering Direct-To-Consumer Genetic Testing Services Based On LDTs
  • 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
    • Table 5-1: 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 5-2: Selected Acquisitions Of Or By Companies/Laboratories With LDTs (2014 Through August 2017)
    • Corporate Collaborations
    • Table 5-3: 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 5-4: Selected Agreements Between Diagnostic Companies/Laboratories With LDTs And Pharmaceutical Or Biopharmaceutical Companies(Includes Agreements With Selected Cros) (2014 Through August 2017)

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
    • Table 6-1: Selected Fda Approved/Cleared Laboratory Developed Tests

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
    • Table 7-1: Laboratory Developed Test Services Market; Major Clinical (Disease) Segments (2016 - 2021)151(In Millions USD)
  • LDT Services Market By Geography
    • Table 7-2: 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 7-3: Infectious Disease Laboratory Developed Test Service Market, (2016-2021)(In Millions USD)
  • LDT Infectious Disease Services Market By Geography
    • Table 7-4: Geographical Distribution Of The Infectious Disease Laboratory Developed Test Service Market (2016-2021) [Excluding Microbial Identification By Culture](In Millions USD)
    • Table 7-5: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 7-6: 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 7-7: 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 7-8: Genetic Testing Laboratory Developed Test Service Market, Segmented By Clinical Application (2016-2021) (In Millions USD)
  • LDT Market By Geography
    • Table 7-9: Geographical Distribution Of The Genetic Testing Laboratory Developed Test Service Market (2016-2021) (Millions USD)
  • 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)
    • Table 8-1: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 LDTMarket
    • Table 8-2: Geographical Distribution Of The Market For Products (Instruments And Consumables) Used By Clinical Laboratories For LDTs (2016-2021) (In Millions USD)

9: Company Profiles

  • 23Andme, Inc.
  • Adaptive Biotechnologies Corporation
  • Admera Health
  • Agendia NV
  • Agilent Technologies Inc.
    • Recent Revenue History
    • Agilent Technologies Revenues (2014, 2015, 2016)
    • 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:
    • Bruker Corporation Revenues (2013 - 2016)
    • Company Overview:
  • Cancer Genetics, Inc.
    • Recent Revenue History
    • Cancer Genetics Revenues (2014, 2015, 2016)
    • Company Overview
      1. Collaborations With Universities Or Other Non-Profit Organizations
      2. Collaborations With Other Companies
  • Cardiodx, Inc.
  • Caredx, Inc.
    • Recent Revenue History
    • Caredx Revenues (2014, 2015, 2016)
    • Company Overview
  • Caris Life Sciences
  • Castle Biosciences, Inc.
  • Centogene AG
  • Color Genomics, Inc.
  • Cynvenio Biosystems, Inc.
  • Epic Sciences, Inc.
  • Eurofins
    • Recent Revenue History
    • Eurofins Health Revenues (2014 To 2016)
    • Company Overview
  • Exact Sciences Corporation
    • Recent Revenue History
    • Exact Sciences Revenues (2014, 2015, 2016)
    • Company Overview
  • Foundation Medicine, Inc.
    • Recent Revenue History
    • Foundation Medicine Revenues (2014, 2015, 2016)
    • Company Overview
  • Genomic Health, Inc.
    • Recent Revenue History
    • Genomic Health Revenues (2014 To 2016)
    • Company Overview
  • Genoptix, Inc.
  • Good Start Genetics, Inc. (Acquired By Invitae Corporation)
  • Grail, Inc.
  • Guardant Health, Inc.
  • Helix
  • Illumina, Inc.
    • Recent Revenue History
    • Illumina (2014, 2015, 2016)
    • Company Overview
  • Integrated Diagnostics, Inc.
  • Invitae Corporation
    • Recent Revenue History
    • Invitae Corporation Revenues (2014, 2015, 2016)
    • Company Overview
  • Laboratory Corporation Of America (Labcorp)
    • Recent Revenue History
    • Laboratory Corporation Of America (Labcorp) Revenues (2014, 2015, 2016)
    • Company Overview
  • MDXhealth
    • Recent Revenue History:
    • Mdxhealth Revenues (2014, 2015, 2016)
    • Company Overview
  • Multiplicom NV (Part Of Agilent Technologies)
  • Myriad Genetics, Inc.
    • Recent Revenue History
    • Myriad Genetics Revenues (2015, 2016, 2017)
    • Company Overview
  • Nantomics (Member Of The Nantworks Ecosystem Of Companies)
  • Natera, Inc.
    • Recent Revenue History:
    • Natera Revenues (2014, 2015, 2016)
    • Company Overview
  • Neogenomics, Inc./Neogenomics Laboratories
    • Recent Revenue History
    • Neogenomics Revenues (2014, 2015, 2106)
    • Company Overview
  • OPKO Health, Inc./Opko Diagnostics
    • Recent Revenue History
    • Opko Health (2014, 2015, 2106)
    • Company Overview
  • Pacific Biosciences Of California, Inc.
    • Recent Revenue History
    • Pacific Biosciences Revenues (2014, 2105, 2016)
    • Company Overview
  • Perkinelmer, Inc.
    • Recent Revenue History:
    • Perkinelmer Revenues (2015 Through 2017)
    • Company Overview:
  • Qiagen N.V.
    • Recent Revenue History
    • Qiagen (2014, 2015, 2106)
    • Company Overview
  • Quest Diagnostics
    • Recent Revenue History
    • Quest Diagnostics Revenues (2014, 2015, 2016)
    • Company Overview
  • Roche
    • Recent Revenue History
    • Roche Revenues (2015 - 2016) (MCHF)
    • Roche Revenues (2015 - 2016) (MUSD)
    • Company Overview
  • Rosetta Genomics Ltd.
    • Recent Revenue History:
    • Rosetta Genomics Revenues (2014 To 2016)
    • Company Overview:
  • Sciex
  • Sera Prognostics, Inc.
  • Thermo Fisher Scientific, Inc.
    • Recent Revenue History
    • Thermo Fisher Scientific Revenues (2014-2016)
    • Company Overview
  • Waters Corporation
    • Recent Revenue History:
    • Waters Corporation Revenues (2014, 2015, 2016)
    • Company Overview
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  • 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
Note: Product cover images may vary from those shown
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Note: Product cover images may vary from those shown
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