1. Market Research
  2. > Healthcare
  3. > Health Services Market Trends
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

Summary

Table of Contents

Search Inside

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) 
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

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.

Get Industry Insights. Simply.

  • Latest reports & slideshows with insights from top research analysts
  • 150+ Million searchable statistics with tables, figures & datasets
  • More than 25,000 trusted sources
  • Single User License — provides access to the report by one individual.
  • Department License — allows you to share the report with up to 5 users
  • Site License — allows the report to be shared amongst all employees in a defined country
  • Corporate License — allows for complete access, globally.

ReportLinker may already be registered as a supplier with your company. If you want to Order by PO, check with us first and we'll let you know if we are a registered supplier and what the vendor number is. Otherwise, we'll provide you with the necessary information to register ReportLinker as a vendor.

Ahmad helps you find the right report:
Testimonials

The research specialist advised us on the best content for our needs and provided a great report and follow-up, thanks very much we shall look at ReportLinker in the future.

Kate Merrick

Global Marketing Manager at
Eurotherm by Schneider Electric

We were impressed with the support that ReportLinker’s research specialists’ team provided. The report we purchased was useful and provided exactly what we want.

Category Manager at
Ikea

ReportLinker gave access to reliable and useful data while avoiding dispersing resources and spending too much time on unnecessary research.

Executive Director at
PwC Advisory

The customer service was fast, responsive, and 100% professional in all my dealings (...) If we have more research needs, I'll certainly prioritize working with ReportLinker!

Scott Griffith

Vice President Marketing at
Maurice Sporting Goods

The research specialist provided prompt, helpful instructions for accessing ReportLinker's product. He also followed up to make sure everything went smoothly and to ensure an easy transition to the next stage of my research

Jessica P Huffman

Research Associate at
American Transportation Research Institute

Excellent customer service. Very responsive and fast.

Director, Corporate Strategy at
Ingredion

I reached out to ReportLinker for a detailed market study on the Air Treatment industry. The quality of the report, the research specialist’s willingness to solve my queries exceeded my expectations. I would definitely recommend ReportLinker for in-depth industry information.

Mariana Mendoza

Global Platform Senior Manager at
Whirlpool Corporation

Thanks! I like what you've provided and will certainly come back if I need to do further research works.

Bee Hin Png

CEO at
LDR Pte Ltd

The research specialist advised us on the best content for our needs and provided a great report and follow-up, thanks very much we shall look at ReportLinker in the future.

Kate Merrick

Global Marketing Manager at
Eurotherm by Schneider Electric

FAQ
  • How we can help
    • I am not sure if the report I am interested in will fulfill my needs. Can you help me?
    • Yes, of course. You can call us at +33(0) 4 37 65 17 03 or drop us an email at researchadvisor@reportlinker.com to let us know more about your requirements.
    • We buy reports often - can ReportLinker get me any benefits?
    • Yes. Set up a call with a Senior Research Advisor to learn more - researchadvisor@reportlinker.com or +33(0) 4 37 65 17 03.
    • I have had negative experiences with market research reports before. How can you avoid this from happening again?
    • We advise all clients to read the TOC and Summary and list your questions so that we can get more insight for you before you make any purchase decision. A research advisor will accompany you so that you can compare samples and reports from different sources, and choose the study that is right for you.

  • Report Delivery
    • How and when I will receive my Report?
    • Most reports are delivered right away in a pdf format, while others are accessed via a secure link and access codes. Do note that sometimes reports are sent within a 12 hour period, depending on the time zones. However, you can contact us to escalate this. Should you need a hard copy, you can check if this option is offered for the particular report, and pay the related fees.
  • Payment conditions
    • What payment methods do you accept?
      1. Credit card : VISA, American Express, Mastercard, or
      2. You can download an invoice to pay by wire transfer, check, or via a Purchase Order from your company, or
      3. You can pay via a Check made out in US Dollars, Euros, or British Pounds for the full amount made payable to ReportLinker
    • What are ReportLinker’s Payment Terms?
    • All payments must normally be submitted within 30 days. However, you can let us know if you need extended time.
    • Are Taxes and duties included?
    • All companies based in France must pay a 20% tax per report. The same applies to all individuals based in the EU. All EU companies must supply their VAT number when purchasing to avoid this charge.
    • I’m not satisfied. Can I be refunded?
    • No. Once your order has been processed and the publisher has received a notification to send you the report, we cannot issue any refund or cancel any order. As these are not ‘traditional’ products that can be returned, reports that are dispatched are considered to be ‘consumed’.
  • User license
    • The license that you should acquire depends on the number of persons that need to access the report. This can range from Single User (only one person will have the right to read or access the report), or Department License (up to 5 persons), to Site License (a group of persons based in the same company location), or Corporate License (the entire company personnel based worldwide). However, as publishers have different terms and conditions, we can look into this for you.
Purchase Reports From Reputable Market Research Publishers

Neurodiagnostics Market Research Report by Product, by Indication, by End User, by State - United States Forecast to 2026 - Cumulative Impact of COVID-19

  • $ 2249
  • June 2021
  • 79 pages

Neurodiagnostics Market Research Report by Product (Clinical Testing Instrument, Diagnostic & Imaging System, and Reagent & Consumable), by Indication (Epilepsy, Headache Disorder, and Neurodegenerative ...

  • United States
  • Sleep Aid
  • Marketing Research
  • Industry analysis
  • Medical Technology Density

ref:plp2017

Reportlinker.com © Copyright 2021. All rights reserved.

ReportLinker simplifies how Analysts and Decision Makers get industry data for their business.

Make sure you don’t miss any news and follow us on