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The Worldwide Market for Laboratory-Developed Tests (LDTs), 2023-2028

Best Price Guarantee Length Publisher Published Date SKU
from $5,000 260 Pages Kalorama Information July, 2024 KLI19026538
Best Price Guarantee
Price from $5,000
Length 260 Pages
Publisher Kalorama Information
Published Date July, 2024
SKU KLI19026538

The Worldwide Market for Laboratory-Developed Tests (LDTs), 2023-2028


Kalorama Information’s latest report, The Worldwide Market for Laboratory-Developed Tests (LDTs), 2023-2028, is now available for purchase. This comprehensive study delves into the dynamic landscape of LDTs, exploring both the services market and the market for test products sold to clinical laboratories.

The Worldwide Market for Laboratory-Developed Tests includes comprehensive analysis of the effects of the FDA's new "Medical Devices: Laboratory Developed Tests" rule, passed in April 2024, which subjects LDTs to significantly greater regulatory oversight.

TInclusion Criteria for LDTs:
  • 2023-2024: LDTs are defined as tests developed by laboratories for their own use, distinct from regulated in vitro diagnostic (IVD) kits manufactured by diagnostic companies.
  • From 2025: LDTs are considered IVDs in the U.S. market, subject to phased-in regulations.
    • Key Points:
  • Scope and Methodology:
  • Market data is provided in U.S. dollars for 2023-2028.
  • Revenues of key market players (where available) are analyzed for the preceding three years.
  • Two Interrelated Markets:
  • Clinical laboratory services utilizing LDTs.
  • Products (platforms and consumables) sold to clinical laboratories for LDT development.
  • Global Coverage with Regional Focus:
  • Developed regions (United States, Japan, Western Europe) dominate LDT performance.
  • Focus on Major Clinical Disease Segments
  • Infectious Disease
  • Oncology LDT Services Market
  • Genetic Testing
  • Product Sales Approach:
  • Market data reflects factory sales to end users, considering instrumentation costs embedded in per-test prices.
  • LDTs: Transforming Healthcare:
  • Exciting assays with potential to revolutionize healthcare delivery.
  • AI in LDT Development
  • Discussion of the pivotal role AI could in revolutionizing the way LDT tests are developed, validated, and utilized in clinical settings, particularly in data analysis, assay design, quality control, result interpretation, and regulatory considerations
  • Impact of the COVID-19 Pandemic:
  • Historical “home-brew” or “in-house” LDTs have evolved into high-risk, complex tests.
  • SARS-CoV-2 testing highlights their critical role.
  • Defining LDTs:
  • Broader definition includes all clinical tests developed by laboratories for their own use, beyond the FDA’s narrower view.
For further details and to purchase directly, please contact us.
Sample Report: A sample is available as a PDF upon request.


  • Executive Summary
    • Overview
    • Scope and Methodology
      • Two Markets: The Market for Services and the Market for Test Products Sold to Labs
    • Market Overview
      • LDT Services Market Analysis
        • Table Laboratory Developed Test Services Market, Major Clinical (Disease) Segments, 2023-2028 (in $ millions)
        • Table Laboratory Developed Test Services Market, Major Clinical (Disease) Segments, 2023-2028 (in $ millions)
      • LDT Products Market Analysis
        • Table Worldwide Market for Products (Instruments and Consumables) Used by Clinical Laboratories for LDTs, 2023-2028 (in $ millions)
        • Table Worldwide Market for Products (Instruments and Consumables) Used by Clinical Laboratories for LDTs, 2023-2028 (in $ millions)
    • Market Drivers and Challenges Facing LDT Market
    • Future Prospects in the Laboratory-Development Test Market
      • New FDA Regulation in 2024
      • LDT Business Landscape
  • Introduction
    • Laboratory-Developed Tests Versus In Vitro Diagnostic Tests
      • LDTs
      • IVDs
    • Why Do Laboratories Use Laboratory-Developed Tests?
    • Laboratory Developed Test Markets - Clinical Laboratories Performing Laboratory-Developed Tests Versus Instrument and Reagent Manufacturers
    • Methodology
      • Uniqueness of the LDT Market
  • Laboratory Developed Tests - Overview
    • What is a Laboratory-Developed Test?
      • Kalorama Definition
        • Table FDA Enforcement Discretion of New Regulation Phaseout Stage, by IVD Category, 2024
      • 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 Antibodies for Immunohistochemistry and/or Flow Cytometry Testing in Clinical Laboratories
        • Table Selected Companies Marketing Flow Cytometry Platforms
      • Karyotyping
      • In Situ Hybridization
        • Table Selected Companies Marketing Probes for FISH-Based Tests in Clinical Laboratories
      • Polymerase Chain Reaction and Other Nucleic Acid Amplification Technologies
        • Table 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 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 Offering Infectious Disease Test Services Based on LDTs (excluding microbial identification testing by culture)
      • Syndromic Testing
    • Oncology
      • Hereditary Risk of Cancer
        • Table Selected Companies Offering LDTs for Hereditary Risk of Cancer
      • Cancer Screening
        • Table Selected Companies Offering Cancer Screening Tests Based on LDTs
      • Diagnosis, Prognosis, Treatment Decisions (Personalized Medicine) in Cancer Care
        • Table Selected Companies Offering Cancer Diagnosis/Prognosis/Personalized Medicine Test Services Based on LDTs
    • Genetic Testing
      • Testing for Risk of Disease - Moving Beyond Cancer
        • Table Selected Companies Offering LDTs for Risk of Disease - Cancer and Beyond
      • Chromosome Analysis and Non-Invasive Prenatal Testing (NIPT)
        • Table Selected Companies Offering Non-Invasive Prenatal Testing (NIPT) Chromosome Analysis Based on LDTs
      • Testing for Inherited Disorders (Prenatal Testing, Postnatal Testing, Carrier Screening)
        • Table Selected Companies Offering Genetic Testing for Inherited Disorders (prenatal, postnatal, 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 Companies Offering Direct-to-Consumer Genetic Testing Based on LDTs
    • Pharmacogenomics
      • Table Selected Companies Offering Pharmacogenomic Test Services Based on LDTs
    • Mass Spectrometry-Based Tests for Small Molecules
    • Other Laboratory Developed Test Applications
      • Table Selected Companies Offering Autoimmune/Inflammatory Test Services Based on LDTs
      • Table Selected Companies Offering Cardiovascular Test Services Based on LDTs
      • Table Selected Companies Offering Neurological Test Services Based on LDTs
      • Table Selected Companies Offering Other Test Services Based on LDTs
  • Market Drivers and Challenges - Laboratory Developed Tests
    • Regulation of Laboratory Developed Tests: U.S. and Outside the U.S.
      • United States
      • Europe
      • Rest of World
    • Technology
      • Status of FDA-approved and CE-marked Tests
      • AI in LDT Development
    • Clinical Market Drivers
    • Competition
    • Personalized Medicine and Companion Diagnostics
    • Reimbursement
      • The Protecting Access to Medicare Act (PAMA)
      • Association for Molecular Pathology
    • Mergers and Acquisitions
      • Table Selected Acquisitions of or by Companies/Laboratories with LDTs, 2020-2024
    • Initial Public Offerings (IPOs) and Financings
      • Table Selected IPOs of Key Clinical Diagnostics and/or LDT Players, 2018-2022
    • 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 by Major Clinical (Disease) Segments, 2023-2028 (in $ millions)
      • Table Laboratory-Developed Test Services Market by Major Clinical (Disease) Segments, 2023-2028 (in $ millions)
      • Table Compound Annual Growth Rate (CAGR) for Laboratory-Developed Test Services Market by Major Clinical (Disease) Segments, 2023-2028 (%)
      • LDT Services Market by Geography
        • Table Laboratory Developed Test Services Market by Geographical Distribution, 2023-2028 (in $ millions) (%)
        • Table Laboratory Developed Test Services Market by Geographical Distribution, 2023-2028 (in $ millions)
        • Table Laboratory Developed Test Services Market, Share by Geographical Distribution, 2023-2028 (%)
        • Table Compound Annual Growth Rate (CAGR) for Laboratory Developed Test Services Market by Geographical Distribution, 2023-2028 (%)
    • Oncology Laboratory Developed Testing Services Market
      • LDT Services Market for Oncology by Segment
        • Table Oncology Laboratory-Developed Test Services Market, Segmented by Clinical Application, 2023-2028 (in $ millions)
        • Table Oncology Laboratory-Developed Test Services Market, Segmented by Clinical Application, 2023-2028 (in $ millions)
        • Table Compound Annual Growth Rate (CAGR) for Oncology Laboratory-Developed Test Services Market, Segmented by Clinical Application, 2023-2028 (%)
      • Hereditary Risk of Cancer Testing Services Market
      • 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), by Regional Market Share, 2023 and 2028 (%)
    • 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, 2023-2028 (in $ millions)
        • Table Genetic Testing Laboratory-Developed Test Service Market, Segmented by Clinical Application, 2023-2028 (in $ millions)
        • Table Compound Annual Growth Rate (CAGR) for Genetic Testing Laboratory-Developed Test Service Market, Segmented by Clinical Application, 2023-2028 (%)
      • LDT Genetic Testing LDT Market by Geography
        • Table Geographical Distribution of the Genetic Testing Laboratory-Developed Test Service Market, by Regional Market Share, 2023 and 2028 (%)
    • Infectious Disease Laboratory Developed Testing Services Market
      • Markets for LDTs for Infectious Disease Detection and Microbiology
        • Table Infectious Disease Laboratory-Developed Test Service Market, 2023-2028 (in $ millions)
        • Table Infectious Disease Laboratory-Developed Test Service Market, 2023-2028 (in $ millions)
        • Table Compound Annual Growth Rate (CAGR) for Infectious Disease Laboratory-Developed Test Service Market, 2023-2028 (%)
      • LDT Infectious Disease Services Market by Geography
        • Table Geographical Distribution of the Infectious Disease Laboratory-Developed Test Service Market, by Regional Market Share, 2023 and 2028 (%)
    • Market for Other Laboratory-Developed Tests
  • Laboratory-Developed Test Market Analysis - Instrument and Reagent Manufacturers
    • Uniqueness of Market Analysis on LDT Products and Reagents
    • LDT Products and Reagents by Market Segment (PCR, Mass Spectrometry, NGS. Microarrays and Other)
      • Table Worldwide Market for Products (Instruments and Consumables) Used by Clinical Laboratories for LDTs, 2023-2028 (in $ millions)
      • Table Worldwide Market for Products (Instruments and Consumables) Used by Clinical Laboratories for LDTs, 2023-2028 (in $ millions)
      • Table Compound Annual Growth Rate (CAGR) for Worldwide Market for Products (Instruments and Consumables) Used by Clinical Laboratories for LDTs, 2023-2028 (%)
      • Geographic Distribution of Product and Reagents Used for LDT Market
        • Table Geographical Distribution of the Market for Products (Instruments and Consumables) Used by Clinical Laboratories for LDTs, 2023-2028 (in $ millions)
        • Table Geographical Distribution of the Market for Products (Instruments and Consumables) Used by Clinical Laboratories for LDTs, 2023-2028 (in $ millions)
        • Table Geographical Distribution of the Market for Products (Instruments and Consumables) Used by Clinical Laboratories for LDTs, by Regional Market Share, 2023 and 2028 (%)
        • Table Compound Annual Growth Rate (CAGR) for Geographical Distribution of the Market for Products (Instruments and Consumables) Used by Clinical Laboratories for LDTs, 2023-2028 (%)
  • Company Profiles
    • 23andMe, Inc.
      • Company Overview
      • Financials
        • Table Revenues for 23andMe, 2021-2023 (in $ millions)
    • Adaptive Biotechnologies Corporation
      • Company Overview
      • Financials
        • Table Revenues for Adaptive Biotechnologies, 2021-2023 (in $ millions)
    • Agendia NV
      • Company Overview
      • Financials
    • Agilent Technologies Inc.
      • Company Overview
      • Financials
        • Table Revenues for Agilent Technologies, 2021-2023 (in $ millions)
    • Ambry Genetics Corp.
      • Company Overview
      • Financials
    • BGI
      • Company Overview
      • Financials
        • Table Revenues for BGI, 2021-2023 (in $ millions)
    • Biodesix, Inc.
      • Company Overview
      • Financials
        • Table Revenues for Biodesix, 2021-2023 (in $ millions)
    • Biotheranostics, Inc.
      • Company Overview
      • Financials
    • Bruker Corporation
      • Company Overview
      • Financials
        • Table Revenues for Bruker, 2021-2023 (in $ millions)
    • CareDx, Inc.
      • Company Overview
      • Financials
        • Table Revenues for CareDx, 2021-2023 (in $ millions)
    • CENTOGENE AG
      • Company Overview
      • Financials
        • Table Revenues for CENTOGENE, 2021-2023 (in $ millions)
    • Epic Sciences, Inc.
      • Company Overview
      • Financials
    • Eurofins
      • Company Overview
      • Financials
        • Table Revenues for Eurofins, 2021-2023 (in $ millions)
    • Foundation Medicine, Inc.
      • Company Overview
      • Financials
    • Guardant Health, Inc.
      • Company Overview
      • Financials
        • Table Revenues for Guardant Health, 2021-2023 (in $ millions)
    • Helix
      • Company Overview
      • Financials
    • Illumina, Inc.
      • Company Overview
      • Financials
        • Table Revenues for Illumina, 2021-2023 (in $ millions)
    • Invitae Corporation/LabCorp
      • Company Overview
      • Financials
        • Table Revenues for Invitae, 2021-2023 (in $ millions)
    • Laboratory Corporation of America (LabCorp)
      • Company Overview
      • Financials
        • Table Revenues for LabCorp, 2021-2023 (in $ millions)
    • LungLife AI
      • Company Overview
      • Financials
    • MDxHealth
      • Company Overview
      • Financials
        • Table Revenues for MDxHealth, 2021-2023 (in $ millions)
    • Myriad Genetics, Inc.
      • Company Overview
      • Financials
        • Table Revenues for Myriad Genetics, 2021-2023 (in $ millions)
    • Natera, Inc.
      • Company Overview
      • Financials
        • Table Revenues for Natera, 2021-2023 (in $ millions)
    • NeoGenomics
      • Company Overview
      • Financials
        • Table Revenues for NeoGenomics, 2021-2023 (in $ millions)
    • OPKO Health, Inc./OPKO Diagnostics
      • Company Overview
      • Financials
        • Table Revenues for OPKO Health, 2021-2023 (in $ millions)
    • PacBio
      • Company Overview
      • Financials
        • Table Revenues for PacBio, 2021-2023 (in $ millions)
    • PerkinElmer, Inc.
      • Company Overview
      • Financials
        • Table Revenues for PerkinElmer, 2021-2023 (in $ millions)
    • QIAGEN N.V.
      • Company Overview
      • Financials
        • Table Revenues for QIAGEN, 2021-2023 (in $ millions)
    • Quest Diagnostics
      • Company Overview
      • Financials
        • Table Revenues for Quest Diagnostics, 2021-2023 (in $ millions)
    • Roche Diagnostics
      • Company Overview
      • Financials
        • Table Revenues for Roche, 2021-2023 (in $ millions)
    • SCIEX Pte Ltd.
      • Company Overview
      • Financials
        • Table Revenues for Danaher, 2021-2023 (in $ millions)
    • Thermo Fisher Scientific, Inc.
      • Company Overview
      • Financials
        • Table Revenues for Thermo Fisher Scientific, 2021-2023 (in $ millions)
    • Waters Corporation
      • Company Overview
      • Financials
        • Table Revenues for Waters Corp., 2021-2023 (in $ millions)

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