The "Worldwide Market for Laboratory-Developed Tests (LDTs), 2023-2028" report has been added to ResearchAndMarkets.com's offering.

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 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.

Key Topics Covered:

CHAPTER 1: EXECUTIVE SUMMARY

• 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
  • LDTs
  • IVDs
• WHY DO LABORATORIES USE LABORATORY-DEVELOPED TESTS?
• LABORATORY-DEVELOPED TEST MARKETS - CLINICAL LABORATORIES PERFORMING LABORATORY-DEVELOPED TESTS VERSUS INSTRUMENT AND REAGENT MANUFACTURERS

CHAPTER 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
  • 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
  
  
  • Syndromic Testing
• 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)
  • Cystic Fibrosis
  • Thrombophilia
  • Ashkenazi Jewish Genetic Panel
  • Other Inherited Disorders Caused by a Single Gene Mutation
  • Mitochondrial Disease
  • 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
  • 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
• 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 Marke
  • 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
• Adaptive Biotechnologies
• Agendia
• Agilent Technologies Inc.
• Ambry Genetics.
• BGI
• Biodesix
• Biotheranostics
• Bruker
• Caredx
• Centogene
• Dako
• Epic Sciences
• Eurofins
• Foundation Medicine
• Guardant Health
• Helix
• Illumina
• Invitae Corporation/Labcorp
• Laboratory Corporation of America (Labcorp)
• Lunglife AI
• Mdxhealth
• Myriad Genetics
• Natera, Inc.
• Neogenomics
• Opko Health, Inc./Opko Diagnostics
• Pacbio
• Perkinelmer, Inc.
• Qiagen N.V.
• Quest Diagnostics
• Roche Diagnostics
• Sciex Pte Ltd.
• Thermo Fisher Scientific
• Waters Corporation

For more information about this report visit https://www.researchandmarkets.com/r/4g3j6q

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240820105053/en/