Worldwide Laboratory-Developed Tests Market 2017: Services (Labs Performing LDTs) and Equipment (Instruments and Reagents Used in LDTs)

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.

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. Expertise has been put 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

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There has been considerable discussion in recent years about regulation of this market, and the FDA proposed a draft guidance calling for more FDA oversight of these tests.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.

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.

Key Topics Covered:

1: Executive Summary

2: Introduction

3: Laboratory Developed Tests - Overview

4: Clinical Applications Where Laboratory Developed Tests Are Used

5: Deals - Companies And Laboratories, Laboratory Developed Tests

6: Market Drivers And Challenges - Laboratory Developed Tests

7: Laboratory Developed Test Market Analysis - Clinical Laboratories Performing LDTs

8: Laboratory Developed Test Market Analysis - Instrument And Reagent Manufacturers

9: Company Profiles

For more information about this report visit https://www.researchandmarkets.com/research/h8f8z4/the_worldwide

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