Report cover image

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

Publisher Kalorama Information
Published Jul 01, 2024
Length 260 Pages
SKU # KLI19026538

Description

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.

Table of Contents

260 Pages
    • Overview
    • Scope and Methodology
    • Market Overview
    • Market Drivers and Challenges Facing LDT Market
    • Future Prospects in the Laboratory-Development Test Market
    • 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
    • What is a Laboratory-Developed Test?
    • Other Important Terminology
    • Use of Diagnostic Technologies as Laboratory-Developed Tests
    • Infectious Disease
    • Oncology
    • Genetic Testing
    • Pharmacogenomics
    • Mass Spectrometry-Based Tests for Small Molecules
    • Other Laboratory Developed Test Applications
    • Regulation of Laboratory Developed Tests: U.S. and Outside the U.S.
    • Technology
    • Clinical Market Drivers
    • Competition
    • Personalized Medicine and Companion Diagnostics
    • Reimbursement
    • Mergers and Acquisitions
    • Initial Public Offerings (IPOs) and Financings
    • Future Prospects
    • Worldwide Laboratory Developed Testing Service Market
    • LDT Services Market by Segment
    • Oncology Laboratory Developed Testing Services Market
    • Genetic Testing Laboratory-Developed Testing Services Market
    • Infectious Disease Laboratory Developed Testing Services Market
    • Market for Other Laboratory-Developed Tests
    • Uniqueness of Market Analysis on LDT Products and Reagents
    • LDT Products and Reagents by Market Segment (PCR, Mass Spectrometry, NGS. Microarrays and Other)
    • 23andMe, Inc.
    • Adaptive Biotechnologies Corporation
    • Agendia NV
    • Agilent Technologies Inc.
    • Ambry Genetics Corp.
    • BGI
    • Biodesix, Inc.
    • Biotheranostics, Inc.
    • Bruker Corporation
    • CareDx, Inc.
    • CENTOGENE AG
    • 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

Pricing

Currency Rates
How Do Licenses Work?

How Do Licenses Work?

The primary function of a report license is to define how many people within a company are authorized to use the purchased report. This is separate to how a report might be delivered. Unless specifically identified otherwise, the purchase option is Single User. Below is a helpful description of that license, along with a sampling of others most commonly offered.

  • This license allows only one user to have access to and to use/read the report. It is not one user at a time or one user group; it is an individual who will be reading and utilizing the report.

  • This license allows for the entire purchasing company to read and use the report. This is the license level that would allow for a report to be placed on an internal company shared drive for access by all employees of that direct company. This license does not extend to parent or sister company use.

  • This license is designed to allow an entire department within a company full access to a report. The departmental license is a great option for companies that have more than one location and the department is spread out all over the country/world

  • This license is for companies that have one location where they want the report to be accessible by all employees within that physical location.

  • This is the most flexible of the licensing options. Some publishers will allow you to get a license for a preset number of people (typically 5). These licenses are ideal for small work groups.

License options are at the discretion of each publisher. As such, not all licenses indicated above are available for every product. If you are uncertain of the best license for your needs or would like a license that is not proactively available, please contact us and we will be happy to assist.

Request A Sample
Head shot

Questions or Comments?

Our team has the ability to search within reports to verify it suits your needs. We can also help maximize your budget by finding sections of reports you can purchase.
Chat Now
Contact Us