Description
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.
Inclusion 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.
Table of Contents
Chapter 1: 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 1-1: Laboratory Developed Test Services Market, Major Clinical (Disease) Segments, 2023–2028 (in $ millions)
- Figure 1-1: Laboratory Developed Test Services Market, Major Clinical (Disease) Segments, 2023–2028 (in $ millions)
LDT Products Market Analysis
- Table 1-2: Worldwide Market for Products (Instruments and Consumables) Used by Clinical Laboratories for LDTs, 2023–2028 (in $ millions)
- Figure 1-2: 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
Chapter 2: 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
Chapter 3: Laboratory Developed Tests – Overview
What is a Laboratory-Developed Test?
Kalorama Definition
- Pre-2025 Definition
- New 2025 Definition
- Table 3-1: 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 3-2: Selected Companies Marketing Histology Stains
- Table 3-3: Selected Companies Marketing Microscopes
Immunohistochemistry
Flow Cytometry
- Table 3-4: Selected Companies Marketing Antibodies for Immunohistochemistry and/or Flow Cytometry Testing in Clinical Laboratories
- Table 3-5: Selected Companies Marketing Flow Cytometry Platforms
Karyotyping
In Situ Hybridization
- Table 3-6: Selected Companies Marketing Probes for FISH-Based Tests in Clinical Laboratories
Polymerase Chain Reaction and Other Nucleic Acid Amplification Technologies
- Table 3-7: 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 3-8: Selected Companies Marketing Mass Spectrometers
Sequencing
- Table 3-9: Selected Companies Marketing Next-Generation Sequencing Platforms to Clinical Laboratories
Other Technologies
Chapter 4: Clinical Applications Where Laboratory-Developed Tests are Used
Infectious Disease
- Table 4-1: Selected Companies Offering Infectious Disease Test Services Based on LDTs (excluding microbial identification testing by culture)
Syndromic Testing
Oncology
Hereditary Risk of Cancer
- Table 4-2: Selected Companies Offering LDTs for Hereditary Risk of Cancer
Cancer Screening
- Table 4-3: Selected Companies Offering Cancer Screening Tests Based on LDTs
Diagnosis, Prognosis, Treatment Decisions (Personalized Medicine) in Cancer Care
- Table 4-4: Selected Companies 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 Offering LDTs for Risk of Disease – Cancer and Beyond
Chromosome Analysis and Non-Invasive Prenatal Testing (NIPT)
- Table 4-6: Selected Companies Offering Non-Invasive Prenatal Testing (NIPT) Chromosome Analysis Based on LDTs
Testing for Inherited Disorders (Prenatal Testing, Postnatal Testing, Carrier Screening)
- Cystic Fibrosis
- Thrombophilia
- Ashkenazi Jewish Genetic Panel
- Other Inherited Disorders Caused by a Single Gene Mutation
- Mitochondrial Disease
- Table 4-7: Selected Companies Offering Genetic Testing for Inherited Disorders (prenatal, postnatal, 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 Companies Offering Direct-to-Consumer Genetic Testing Based on LDTs
Pharmacogenomics
- Table 4-10: Selected Companies Offering Pharmacogenomic Test Services Based on LDTs
Mass Spectrometry-Based Tests for Small Molecules
Other Laboratory Developed Test Applications
- Table 4-11: Selected Companies Offering Autoimmune/Inflammatory Test Services Based on LDTs
- Table 4-12: Selected Companies Offering Cardiovascular Test Services Based on LDTs
- Table 4-13: Selected Companies Offering Neurological Test Services Based on LDTs
- Table 4-14: Selected Companies Offering Other Test Services Based on LDTs
Chapter 5: Market Drivers and Challenges – Laboratory Developed Tests
Regulation of Laboratory Developed Tests: U.S. and Outside the U.S.
United States
- FDA
- Emergency Use Authorization
- Historical Position
- Changes Resulting from COVID Pandemic
- New 2024 Regulations and Implications
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 5-1: Selected Acquisitions of or by Companies/Laboratories with LDTs, 2020-2024
Initial Public Offerings (IPOs) and Financings
- Table 5-2: Selected IPOs of Key Clinical Diagnostics and/or LDT Players, 2018-2022
Future Prospects
Conversion from CLIA Lab Services Offerings to IVD Kits
- Table 5-3: Selected FDA Approved/Cleared Laboratory Developed Tests
Chapter 6: 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 6-1: Laboratory-Developed Test Services Market by Major Clinical (Disease) Segments, 2023–2028 (in $ millions)
- Figure 6-1: Laboratory-Developed Test Services Market by Major Clinical (Disease) Segments, 2023–2028 (in $ millions)
- Figure 6-2: Compound Annual Growth Rate (CAGR) for Laboratory-Developed Test Services Market by Major Clinical (Disease) Segments, 2023–2028 (%)
LDT Services Market by Geography
- Table 6-2: Laboratory Developed Test Services Market by Geographical Distribution, 2023–2028 (in $ millions) (%)
- Figure 6-3: Laboratory Developed Test Services Market by Geographical Distribution, 2023–2028 (in $ millions)
- Figure 6-4: Laboratory Developed Test Services Market, Share by Geographical Distribution, 2023–2028 (%)
- Figure 6-5: 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 6-3: Oncology Laboratory-Developed Test Services Market, Segmented by Clinical Application, 2023-2028 (in $ millions)
- Figure 6-6: Oncology Laboratory-Developed Test Services Market, Segmented by Clinical Application, 2023-2028 (in $ millions)
- Figure 6-7: 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
- Figure 6-8: 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 6-4: Genetic Testing Laboratory-Developed Test Service Market, Segmented by Clinical Application, 2023-2028 (in $ millions)
- Figure 6-9: Genetic Testing Laboratory-Developed Test Service Market, Segmented by Clinical Application, 2023-2028 (in $ millions)
- Figure 6-10: 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
- Figure 6-11: 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 6-5: Infectious Disease Laboratory-Developed Test Service Market, 2023-2028 (in $ millions)
- Figure 6-12: Infectious Disease Laboratory-Developed Test Service Market, 2023-2028 (in $ millions)
- Figure 6-13: Compound Annual Growth Rate (CAGR) for Infectious Disease Laboratory-Developed Test Service Market, 2023-2028 (%)
LDT Infectious Disease Services Market by Geography
- Figure 6-14: Geographical Distribution of the Infectious Disease Laboratory-Developed Test Service Market, by Regional Market Share, 2023 and 2028 (%)
Market for Other Laboratory-Developed Tests
Chapter 7: 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 7-1: Worldwide Market for Products (Instruments and Consumables) Used by Clinical Laboratories for LDTs, 2023-2028 (in $ millions)
- Figure 7-1: Worldwide Market for Products (Instruments and Consumables) Used by Clinical Laboratories for LDTs, 2023-2028 (in $ millions)
- Figure 7-2: 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 7-2: Geographical Distribution of the Market for Products (Instruments and Consumables) Used by Clinical Laboratories for LDTs, 2023-2028 (in $ millions)
- Figure 7-3: Geographical Distribution of the Market for Products (Instruments and Consumables) Used by Clinical Laboratories for LDTs, 2023-2028 (in $ millions)
- Figure 7-4: Geographical Distribution of the Market for Products (Instruments and Consumables) Used by Clinical Laboratories for LDTs, by Regional Market Share, 2023 and 2028 (%)
- Figure 7-5: Compound Annual Growth Rate (CAGR) for Geographical Distribution of the Market for Products (Instruments and Consumables) Used by Clinical Laboratories for LDTs, 2023-2028 (%)
Chapter 8: Company Profiles
23andMe, Inc.
Company Overview
Financials
- Table 8-1: Revenues for 23andMe, 2021–2023 (in $ millions)
Adaptive Biotechnologies Corporation
Company Overview
Financials
- Table 8-2: Revenues for Adaptive Biotechnologies, 2021–2023 (in $ millions)
Agendia NV
Company Overview
Financials
Agilent Technologies Inc.
Company Overview
Financials
- Table 8-3: Revenues for Agilent Technologies, 2021–2023 (in $ millions)
Ambry Genetics Corp.
Company Overview
Financials
BGI
Company Overview
Financials
- Table 8-4: Revenues for BGI, 2021–2023 (in $ millions)
Biodesix, Inc.
Company Overview
Financials
- Table 8-5: Revenues for Biodesix, 2021–2023 (in $ millions)
Biotheranostics, Inc.
Company Overview
Financials
Bruker Corporation
Company Overview
Financials
- Table 8-6: Revenues for Bruker, 2021–2023 (in $ millions)
CareDx, Inc.
Company Overview
Financials
- Table 8-6: Revenues for CareDx, 2021–2023 (in $ millions)
CENTOGENE AG
Company Overview
Financials
- Table 8-7: Revenues for CENTOGENE, 2021–2023 (in $ millions)
Epic Sciences, Inc.
Company Overview
Financials
Eurofins
Company Overview
Financials
- Table 8-8: Revenues for Eurofins, 2021–2023 (in $ millions)
Foundation Medicine, Inc.
Company Overview
Financials
Guardant Health, Inc.
Company Overview
Financials
- Table 8-9: Revenues for Guardant Health, 2021–2023 (in $ millions)
Helix
Company Overview
Financials
Illumina, Inc.
Company Overview
Financials
- Table 8-10: Revenues for Illumina, 2021–2023 (in $ millions)
Invitae Corporation/LabCorp
Company Overview
Financials
- Table 8-11: Revenues for Invitae, 2021–2023 (in $ millions)
Laboratory Corporation of America (LabCorp)
Company Overview
Financials
- Table 8-12: Revenues for LabCorp, 2021–2023 (in $ millions)
LungLife AI
Company Overview
Financials
MDxHealth
Company Overview
Financials
- Table 8-13: Revenues for MDxHealth, 2021–2023 (in $ millions)
Myriad Genetics, Inc.
Company Overview
Financials
- Table 8-14: Revenues for Myriad Genetics, 2021–2023 (in $ millions)
Natera, Inc.
Company Overview
Financials
- Table 8-15: Revenues for Natera, 2021–2023 (in $ millions)
NeoGenomics
Company Overview
Financials
- Table 8-16: Revenues for NeoGenomics, 2021–2023 (in $ millions)
OPKO Health, Inc./OPKO Diagnostics
Company Overview
Financials
- Table 8-17: Revenues for OPKO Health, 2021–2023 (in $ millions)
PacBio
Company Overview
Financials
- Table 8-18: Revenues for PacBio, 2021–2023 (in $ millions)
QIAGEN N.V.
Company Overview
Financials
- Table 8-19: Revenues for QIAGEN, 2021–2023 (in $ millions)
Quest Diagnostics
Company Overview
Financials
- Table 8-20: Revenues for Quest Diagnostics, 2021–2023 (in $ millions)
Revvity
Company Overview
Financials
- Table 8-21: Revenues for Revvity, 2021–2023 (in $ millions)
Roche Diagnostics
Company Overview
Financials
- Table 8-22: Revenues for Roche, 2021–2023 (in $ millions)
SCIEX Pte Ltd.
Company Overview
Financials
- Table 8-23: Revenues for Danaher, 2021–2023 (in $ millions)
Thermo Fisher Scientific, Inc.
Company Overview
Financials
- Table 8-24: Revenues for Thermo Fisher Scientific, 2021–2023 (in $ millions)
Waters Corporation
Company Overview
Financials
- Table 8-25: Revenues for Waters Corp., 2021–2023 (in $ millions)
