-
Report details
-
21
Figures
-
61
Tables
-
Chapter 1: Executive Summary
-
Overview
-
Scope and Methodology
-
Two Markets: The Market for Services and the Market for Test Products Sold to…
-
Market Overview
-
LDT Services Market Analysis
-
LDT Products Market Analysis
-
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
-
Why Do Laboratories Use Laboratory-Developed Tests?
-
Laboratory Developed Test Markets – Clinical Laboratories Performing Laboratory-…
-
Methodology
-
Uniqueness of the LDT Market
-
Chapter 3: Laboratory Developed Tests - Overview
-
What is a Laboratory-Developed Test?
-
Kalorama Definition
-
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
-
Immunohistochemistry
-
Flow Cytometry
-
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
-
Sequencing
-
Other Technologies
-
Chapter 4: Clinical Applications Where Laboratory-Developed Tests are Used
-
Infectious Disease
-
Oncology
-
Hereditary Risk of Cancer
-
Cancer Screening
-
Diagnosis, Prognosis, Treatment Decisions (Personalized Medicine) in Cancer Care
-
Genetic Testing
-
Testing for Risk of Disease – Moving Beyond Cancer
-
Chromosome Analysis and Non-Invasive Prenatal Testing (NIPT)
-
Testing for Inherited Disorders (Prenatal Testing, Postnatal Testing, Carrier…
-
Newborn Screening
-
Other Genetic Testing
-
Direct-to-Consumer Genetic Testing
-
Pharmacogenomics
-
Mass Spectrometry-Based Tests for Small Molecules
-
Other Laboratory Developed Test Applications
-
Chapter 5: 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
-
Initial Public Offerings (IPOs) and Financings
-
Future Prospects
-
Conversion from CLIA Lab Services Offerings to IVD Kits
-
Chapter 6: Laboratory-Developed Test Market Analysis – Clinical Laboratories…
-
Worldwide Laboratory Developed Testing Service Market
-
The Number of LDTs on the Market
-
Small versus Large Volume
-
LDT Services Market by Segment
-
LDT Services Market by Geography
-
Oncology Laboratory Developed Testing Services Market
-
LDT Services Market for Oncology by Segment
-
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 Mark…
-
Genetic Testing Laboratory-Developed Testing Services Market
-
LDT Genetic Test Market by Segment
-
LDT Genetic Testing LDT Market by Geography
-
Infectious Disease Laboratory Developed Testing Services Market
-
Markets for LDTs for Infectious Disease Detection and Microbiology
-
LDT Infectious Disease Services Market by Geography
-
Market for Other Laboratory-Developed Tests
-
Chapter 7: Laboratory-Developed Test Market Analysis – Instrument and Reagent…
-
Uniqueness of Market Analysis on LDT Products and Reagents
-
LDT Products and Reagents by Market Segment (PCR, Mass Spectrometry, NGS. Microa…
-
Geographic Distribution of Product and Reagents Used for LDT Market
-
Chapter 8: Company Profiles
-
23andMe, Inc.
-
Company Overview
-
Financials
-
Adaptive Biotechnologies Corporation
-
Company Overview
-
Financials
-
Agendia NV
-
Company Overview
-
Financials
-
Agilent Technologies Inc.
-
Company Overview
-
Financials
-
Ambry Genetics Corp.
-
Company Overview
-
Financials
-
BGI
-
Company Overview
-
Financials
-
Biodesix, Inc.
-
Company Overview
-
Financials
-
Biotheranostics, Inc.
-
Company Overview
-
Financials
-
Bruker Corporation
-
Company Overview
-
Financials
-
CareDx, Inc.
-
Company Overview
-
Financials
-
CENTOGENE AG
-
Company Overview
-
Financials
-
Epic Sciences, Inc.
-
Company Overview
-
Financials
-
Eurofins
-
Company Overview
-
Financials
-
Foundation Medicine, Inc.
-
Company Overview
-
Financials
-
Guardant Health, Inc.
-
Company Overview
-
Financials
-
Helix
-
Company Overview
-
Financials
-
Illumina, Inc.
-
Company Overview
-
Financials
-
Invitae Corporation/LabCorp
-
Company Overview
-
Financials
-
Laboratory Corporation of America (LabCorp)
-
Company Overview
-
Financials
-
LungLife AI
-
Company Overview
-
Financials
-
MDxHealth
-
Company Overview
-
Financials
-
Myriad Genetics, Inc.
-
Company Overview
-
Financials
-
Natera, Inc.
-
Company Overview
-
Financials
-
NeoGenomics
-
Company Overview
-
Financials
-
OPKO Health, Inc./OPKO Diagnostics
-
Company Overview
-
Financials
-
PacBio
-
Company Overview
-
Financials
-
QIAGEN N.V.
-
Company Overview
-
Financials
-
Quest Diagnostics
-
Company Overview
-
Financials
-
Revvity
-
Company Overview
-
Diagnostics
-
Sequencing /Genomics
-
Liquid Biopsy
-
Histology
-
Prenatal Business
-
Lab Services
-
Financials
-
Roche Diagnostics
-
Company Overview
-
Financials
-
SCIEX Pte Ltd.
-
Company Overview
-
Financials
-
Thermo Fisher Scientific, Inc.
-
Company Overview
-
Financials
-
Waters Corporation
-
Company Overview
-
Financials
|
The Worldwide Market for Laboratory-Developed Tests (LDTs), 2023-2028
26 Jul 2024
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.
Page Count: 260
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
-
LDT Products Market Analysis
-
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
-
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
-
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
-
Immunohistochemistry
-
Flow Cytometry
-
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
-
Sequencing
-
Other Technologies
-
Chapter 4: Clinical Applications Where Laboratory-Developed Tests are Used
-
Infectious Disease
-
Oncology
-
Hereditary Risk of Cancer
-
Cancer Screening
-
Diagnosis, Prognosis, Treatment Decisions (Personalized Medicine) in Cancer Care
-
Genetic Testing
-
Testing for Risk of Disease – Moving Beyond Cancer
-
Chromosome Analysis and Non-Invasive Prenatal Testing (NIPT)
-
Testing for Inherited Disorders (Prenatal Testing, Postnatal Testing, Carrier Screening)
-
Newborn Screening
-
Other Genetic Testing
-
Direct-to-Consumer Genetic Testing
-
Pharmacogenomics
-
Mass Spectrometry-Based Tests for Small Molecules
-
Other Laboratory Developed Test Applications
-
Chapter 5: 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
-
Initial Public Offerings (IPOs) and Financings
-
Future Prospects
-
Conversion from CLIA Lab Services Offerings to IVD Kits
-
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
-
LDT Services Market by Geography
-
Oncology Laboratory Developed Testing Services Market
-
LDT Services Market for Oncology by Segment
-
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
-
Genetic Testing Laboratory-Developed Testing Services Market
-
LDT Genetic Test Market by Segment
-
LDT Genetic Testing LDT Market by Geography
-
Infectious Disease Laboratory Developed Testing Services Market
-
Markets for LDTs for Infectious Disease Detection and Microbiology
-
LDT Infectious Disease Services Market by Geography
-
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)
-
Geographic Distribution of Product and Reagents Used for LDT Market
-
Chapter 8: Company Profiles
-
23andMe, Inc.
-
Company Overview
-
Financials
-
Adaptive Biotechnologies Corporation
-
Company Overview
-
Financials
-
Agendia NV
-
Company Overview
-
Financials
-
Agilent Technologies Inc.
-
Company Overview
-
Financials
-
Ambry Genetics Corp.
-
Company Overview
-
Financials
-
BGI
-
Company Overview
-
Financials
-
Biodesix, Inc.
-
Company Overview
-
Financials
-
Biotheranostics, Inc.
-
Company Overview
-
Financials
-
Bruker Corporation
-
Company Overview
-
Financials
-
CareDx, Inc.
-
Company Overview
-
Financials
-
CENTOGENE AG
-
Company Overview
-
Financials
-
Epic Sciences, Inc.
-
Company Overview
-
Financials
-
Eurofins
-
Company Overview
-
Financials
-
Foundation Medicine, Inc.
-
Company Overview
-
Financials
-
Guardant Health, Inc.
-
Company Overview
-
Financials
-
Helix
-
Company Overview
-
Financials
-
Illumina, Inc.
-
Company Overview
-
Financials
-
Invitae Corporation/LabCorp
-
Company Overview
-
Financials
-
Laboratory Corporation of America (LabCorp)
-
Company Overview
-
Financials
-
LungLife AI
-
Company Overview
-
Financials
-
MDxHealth
-
Company Overview
-
Financials
-
Myriad Genetics, Inc.
-
Company Overview
-
Financials
-
Natera, Inc.
-
Company Overview
-
Financials
-
NeoGenomics
-
Company Overview
-
Financials
-
OPKO Health, Inc./OPKO Diagnostics
-
Company Overview
-
Financials
-
PacBio
-
Company Overview
-
Financials
-
QIAGEN N.V.
-
Company Overview
-
Financials
-
Quest Diagnostics
-
Company Overview
-
Financials
-
Revvity
-
Company Overview
-
Diagnostics
-
Sequencing /Genomics
-
Liquid Biopsy
-
Histology
-
Prenatal Business
-
Lab Services
-
Financials
-
Roche Diagnostics
-
Company Overview
-
Financials
-
SCIEX Pte Ltd.
-
Company Overview
-
Financials
-
Thermo Fisher Scientific, Inc.
-
Company Overview
-
Financials
-
Waters Corporation
-
Company Overview
-
Financials
|
More information about this product
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