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

Report
260 Pages
July 2024
Region: Global
Kalorama Information
ID: 5989186

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 a 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.

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
The uniqueness of the LDT Market

CHAPTER 3: LABORATORY DEVELOPED TESTS - OVERVIEW

WHAT IS A LABORATORY-DEVELOPED TEST?
Publisher 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
Directive 98/79/EC
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
Dako
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)
PERKINELMER, INC.
Company Overview
Financials
Table 8-19: Revenues for PerkinElmer, 2021-2023 (in $ millions)
QIAGEN N.V.
Company Overview
Financials
Table 8-20: Revenues for QIAGEN, 2021-2023 (in $ millions)
QUEST DIAGNOSTICS
Company Overview
Financials
Table 8-21: Revenues for Quest Diagnostics, 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)

Samples

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Companies Mentioned

23Andme, Inc.
Adaptive Biotechnologies Corporation
Agendia Nv
Agilent Technologies Inc.
Ambry Genetics Corp.
BGI
Biodesix, Inc.
Biotheranostics, Inc.
Bruker Corporation
Caredx, Inc.
Centogene AG
Dako
Epic Sciences, Inc.
Eurofins
Foundation Medicine, Inc.
Guardant Health, Inc.
Helix
Illumina, Inc.
Invitae Corporation/Labcorp
Laboratory Corporation of America (Labcorp)
Lunglife AI
Mdxhealth
Myriad Genetics, Inc.
Natera, Inc.
Neogenomics
Opko Health, Inc./Opko Diagnostics
Pacbio
Perkinelmer, Inc.
Qiagen N.V.
Quest Diagnostics
Roche Diagnostics
Sciex Pte Ltd.
Thermo Fisher Scientific, Inc.
Waters Corporation

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Inclusion Criteria for LDTs:

Key Points:

Scope and Methodology:

Two Interrelated Markets:

Global Coverage with Regional Focus:

Focus on Major Clinical Disease Segments

Product Sales Approach:

LDTs: Transforming Healthcare:

AI in LDT Development

Impact of the COVID-19 Pandemic:

Defining LDTs:

Table of Contents

Samples

Companies Mentioned

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