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

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

  • September 2017
  • 375 pages
  • ID: 5147466
  • Format: PDF
  • Kalorama Information


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

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 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
• Market for LDT Services in Cancer Screening
• Market for LDT Services for Inherited Disorders
• 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,
• 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) 
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.
Exact Sciences Corporation
Foundation Medicine, Inc.
Genomic Health, Inc.
Genoptix, Inc. Good Start Genetics, Inc. (Acquired By Invitae Corporation)
Grail, Inc.
Guardant Health, Inc.
Illumina, Inc.
Integrated Diagnostics, Inc.
Invitae Corporation
Laboratory Corporation Of America (Labcorp)
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
Rosetta Genomics Ltd.
Sera Prognostics, Inc.
Thermo Fisher Scientific, Inc.
Waters Corporation

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. 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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