The "The Market for Clinical LDT Services and LDT Supplies" report has been added to ResearchAndMarkets.com's offering.
In this report, laboratory developed tests (LDTs) include all clinical tests developed by laboratories for their own use, in contrast to in vitro diagnostic (IVD) kits that are manufactured and sold by diagnostic companies for use by many different clinical labs. Clinical laboratories can develop LDTs based on any diagnostic test technology used in the clinical lab. For some technologies, such as chemistry tests or immunoassays, automated platforms with large test menus are commercially available.
As a result, in some labs, development and use of LDTs based on these technologies may be less than the number of LDTs based on newer technologies such as next generation sequencing. However, laboratories may develop tests on widely used technologies such as immunoassays to offer tests for rare diseases. Clinical laboratories may also perform tests on types of specimens that are not included in the approved labeling for a test or may have other reasons why they decide to develop an LDT.
Laboratory developed tests (LDTs) are not a new or recent phenomenon but due to the incredible need for testing of SARS-CoV-2, there has been a flood of new tests and the regulatory guidance has changed dramatically.
Historically, these tests were called "home-brew tests" or "in-house tests." Also, historically, these tests were low-volume, simple and well characterized tests for low-risk diagnostic applications. Today, high-risk, complex tests have been developed as LDTs, and are being used to provide clinical results to physicians and their patients.
This is a unique report with a unique segmentation to help customers find the right segment for their needs. Two separate but related markets are discussed in this report: the market for clinical laboratory services using laboratory developed tests, and the market for products (platforms and consumables) sold to clinical laboratories who use these products to make LDTs.
Both are large and rapidly growing markets. Chemistry Tests, Immunoassays Histology Stains, Flow Cytometry, Karyotyping, ISH, Gene Signatures, Microarrays are among the technologies used in lab develop tests. This report examines each technology category.
This significant activity in the development of new LDTs, growing revenues from current LDTs, and large addressable markets for many of the emerging LDTs has attracted the interest of investors and also other companies looking for acquisitions.
There have also been a significant number of acquisitions in recent years. Consolidation among companies and laboratories offering LDTs is expected to continue in the future. This is not a new trend in the clinical laboratory market. Major companies such as Quest Diagnostics and LabCorp have made numerous acquisitions to reach their current market positions. Smaller clinical laboratories have also been making acquisitions. In the segment of this market focusing on companies and laboratories offering services based on LDTs, many new companies continue to be founded providing a continuing stream of smaller companies trying to grow, and that may grow by acquisitions or may be acquired.
Laboratory developed tests is an exciting field and market in which assays are being developed that may have the potential to transform certain aspects of healthcare. There are great number of companies in the LDT market. New LDTs are being developed and introduced, and some segments of this market (especially the market for cancer diagnosis, prognosis, personalized medicine, and monitoring patients) have become very competitive. Some companies will not survive, but there are also examples of successful companies. This field has attracted considerable interest from investors and from companies making acquisitions.
Key Topics Covered:
Chapter One: Executive Summary
- Overview
- Scope and Methodology
- Two Markets: Market for Services and for Test Products Sold to Labs (for use in LDTs)
- Market Overview
- Analysis of the LDT Market
- LDT Services Market by Segment (Infectious Disease, Oncology LDT, Genetic Testing, Other LDT) (in millions USD)
- LDT Services Market by Segment (Infectious Disease, Oncology LDT, Genetic Testing, Other LDT) Market Drivers and Challenges)
- Future Progress
- Status of FDA Regulation
Chapter Two: Introduction
- Laboratory-Developed Tests Versus In Vitro Diagnostic Tests
- IVD
- LDTs
- Why Do Laboratories Use Laboratory-Developed Tests?
- Laboratory Developed Tests Markets Clinical Laboratories Performing LDTs
- Instrument and Reagent Manufacturers Supplying Labs
- Point of View and Methodology
- Uniqueness of the LDT Market
Chapter 3: Laboratory-Developed Tests
- Overview
- What is an LDT?
- Kalorama Definition
- Regulatory Approval and LDTs
- General purpose reagent:
- Analyte specific reagent (ASR): Use of Diagnostic Technologies
- Chemistry Tests
- Immunoassays
- Histology Stains
- Immunohistochemistry
- Flow Cytometry
- Karyotyping
- In Situ Hybridization
- Polymerase Chain Reaction and Other Nucleic Acid Amplification Technologies
- Microarrays
- Protein Microarrays
- DNA Microarrays
- Chromosomal Microarrays
- Tissue Microarrays
- Mass Spectrometry
- Sequencing
Chapter Four: Clinical Applications
- Companies
- Syndromic Testing
- COVID-19 Laboratory Developed Tests
- 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 Tests
- Other LDT Applications
Chapter 5: Market Drivers and Challenges
- Technology
- Status of FDA-Approved and Ce-Marked Tests
- Changes Resulting From COVID-19 Pandemic
- Clinical Market Drivers
- Competition
- Personalized Medicine and Companion Diagnostics
- Regulation of Laboratory Developed Tests US and Outside The US
- FDA
- Directive 98/79/EC
- Reimbursement
- CMTP and Greek Park Collaborative
- Association for Molecular Pathology
- Mergers and Acquisitions
- Future Prospects
- Conversion From Clia Lab Services offerings To Ivd Kits
Chapter 6: Laboratory Developed Test Market Analysis Clinical Laboratories Performing LDTs
- LDT Market Worldwide
- The Number of LDTs On The Market
- Small Versus Large Volume
- LDT Services Market By Segment
- LDT Services 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
- 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
- Market for Other Laboratory Developed Tests
Chapter 7: Laboratory Developed Test Market Analysis Instrument and Reagent Manufacturers
- Uniqueness of Market Analysis On LDT Product and Reagents
- LDT Products and Reagents By Segment (Pcr, Mass Spectrometry, Ngs. Microarrays and Other)
- Geographic Distribution of Product and Reagents Used for LDT Market
Chapter 8: Company Profiles
- 23andme, Inc.
- Adaptive Biotechnologies Corporation
- Admera Health
- 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
- Laboratory Corporation of America (Labcorp)
- LunglifeAI
- MDXHealth
- Myriad Genetics, Inc.
- Natera, Inc.
- Neogenomics
- Opko Health, Inc./Opko Diagnostics
- Pacific Biosciences of California, Inc.
- Perkin Elmer, Inc.
- Qiagen N.V.
- Quest Diagnostics
- Roche Diagnostics
- Rosetta Genomics Ltd.
- SCIEX Pte Ltd.
- Thermo Fisher Scientific, Inc.
- Waters Corporation
For more information about this report visit https://www.researchandmarkets.com/r/88eilb
View source version on businesswire.com: https://www.businesswire.com/news/home/20201216005456/en/
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