The Worldwide Market for Laboratory-Developed Tests: Services (Labs Performing LDTs) and Equipment (Instruments and Reagents Used in LDTs)

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Published Sep 27, 2017 | 375 Pages | Pub ID: KLI15485878

The Worldwide Market for Laboratory-Developed Tests: Services (Labs Performing LDTs) and Equipment (Instruments and Reagents Used in LDTs)

Laboratory-developed tests, or LDTs, have been attracting a lot of attention in recent years, but they are not a new or recent phenomenon.  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 market has been elusive for industry watchers seeking a resource to inform business planning and competitive activity.    Kalorama Information has put its expertise in the in vitro diagnostics market to work with this volume which estimates market sizing and forecasts for two key areas of lab-developed tests.

The Market for Lab-Developed Test Services and the Market for Instruments and Reagents Sold to Labs

The Worldwide Market for Laboratory-Developed Tests 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 uses these products to make LDTs.  Both are large and rapidly growing markets.    As part of the market analysis, the report offers the following data:
Market for LDT Services in Infectious Disease, 2017 to 2022
Market for LDT Services in Cancer Screening, 2017 to 2022
Market for LDT Services for Inherited Disorders, 2017 to 2022
Investment in LDT Companies, 2016 and 2017
Status of FDA Regulation of LDT
 Selected Companies/Clinical Laboratories Offering Infectious Disease Test Services Based on LDTs
Companies/Clinical Laboratories Offering Cancer Screening Test Services Based on LDTs  
Companies/Clinical Laboratories Offering Genetic Testing for Inherited Disorders 
Market for Products and Reagents Sold to Labs for Use in LDTs, 2017 to 2022
Market for Products and Reagents Used in LDTs by Type
Market for Products and Reagents  Used in LDTs by Region.
M&A Activity: Acquisitions of or by Companies/Laboratories with LDTs 
Agreements Between Diagnostic Companies with LDTs and Pharmaceutical Companies 
Direct to Consumer (DTC) Offerings
Important Conclusions About the Market
Company Profiles

A Rapidly Moving, Highly Dynamic Market

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.  

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. 

Tracking FDA Actions and Statements and Industry Reaction

There has been considerable discussion in recent years about regulation of this market, and the FDA proposed a draft guidance calling for more FDA oversight of these tests.  However, at this time, the likely outcome of this discussion is not clear.  However, some LDTs available today have already been FDA cleared or approved, and others are likely to be developed into in vitro diagnostic (IVD) tests that a company can ship widely to clinical laboratories.  Early examples of this are discussed in the report.

Comprehensive Research

There is no other resource that tackles this subject as comprehenisve as Kalorama Information's.  The report is a global report and includes forecast breakouts both in the service and product segments for; The United States, Europe, Asia, Japan, Latin America, China, Rest of World.

Companies Profiled Include:

  • 23andMe, Inc.    
  • Adaptive Biotechnologies Corporation    
  • Admera Health    
  • Agendia Nv    
  • Agilenttechnologies Inc.    
  • Altheadx, Inc.    
  • Ambry Genetics Corp.  
  • Applied Proteomics, Inc.  
  • Athena Diagnostics, Inc. (A Quest Diagnostics Business)    
  • BGI 
  • Biodesix, Inc.    
  • Biotheranostics, Inc.    
  • Bruker Corporation    
  • Cancer Genetics, Inc.    
  • Cardiodx, Inc.    
  • Caredx, Inc.    
  • Caris Life Sciences    
  • Castle Biosciences, Inc.    
  • Centogene Ag 
  • Color Genomics, Inc. 
  • Cynvenio Biosystems, Inc. 
  • Epic Sciences, Inc. 
  • Eurofins 
  • Exact Sciences Corporation 
  • Foundation Medicine, Inc. 
  • Genomic Health, Inc. 
  • Genoptix, Inc. Good Start Genetics, Inc. (Acquired By Invitae Corporation) 
  • Grail, Inc. 
  • Guardant Health, Inc. 
  • Helix 
  • Illumina, Inc. 
  • Integrated Diagnostics, Inc. 
  • Invitae Corporation 
  • Laboratory Corporation Of America (Labcorp) 
  • Mdxhealth 
  • Multiplicom Nv (Part Of Agilent Technologies) 
  • Myriad Genetics, Inc. 
  •  Nantomics (Member Of The Nantworks Ecosystem Of Companies) 
  • Natera, Inc. 
  •  Neogenomics, Inc./Neogenomics Laboratories 
  •  Opko Health, Inc./Opko Diagnostics 
  • Pacific Biosciences Of California, Inc. 
  • Perkin Elmer, Inc. 
  •  Qiagen N.V. 
  • Quest Diagnostics 
  •  Roche 
  •  Rosetta Genomics Ltd. 
  •  Sciex 
  • Sera Prognostics, Inc. 
  • Thermo Fisher Scientific, Inc. 
  •  Waters Corporation 

Scope of the Report

In this report, The Worldwide Market for Laboratory-Developed Tests: Services, 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.  For LDTs, clinical labs do have to purchase instruments and reagents, but these products are not FDA approved/cleared or CE-IVD marked kits (or other kits approved by regulatory authorities of a specific company) that contain everything required to do a test that was developed by the diagnostic company.  The clinical lab uses these reagents to develop and validate the LDT before the test can be used for diagnostic purposes.   The information presented in this report is derived from publicly available information sources such as company reports and announcements, government reports and databases, medical organization reports, medical associations, and other publications.  The analysis is based on the author's industry knowledge combined with literature searches and discussions with industry professionals and experts in the areas of point-of-care tests, decentralized healthcare and healthcare economics.

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