Global Laboratory-developed Testing Market Size, Status and Forecast 2020-2026

Twenty-five years ago, the Food and Drug Administration (FDA) asserted in a draft document that "home brew" tests-now commonly referred to as laboratory-developed tests (LDTs)-are subject to the same regulatory oversight as other in vitro diagnostics (IVDs)4. In 2010, the FDA began work on developing a proposed framework for future LDT oversight. Released in 2014, the draft guidance sparked an intense debate over potential LDT regulation. While the proposed guidance has not been implemented, many questions regarding LDT oversight remain unresolved.

A laboratory developed test (LDT) is a type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory.

LDTs can be used to measure or detect a wide variety of analytes (substances such as proteins, chemical compounds like glucose or cholesterol, or DNA), in a sample taken from a human body. Some LDTs are relatively simple tests that measure single analytes, such as a test that measures the level of sodium. Other LDTs are complex and may measure or detect one or more analytes. For example, some tests can detect many DNA variations from a single blood sample, which can be used to help diagnose a genetic disease. Various levels of chemicals can be measured to help diagnose a patient’s state of health, such as levels of cholesterol or sodium.

While the uses of an LDT are often the same as the uses of FDA-cleared or approved in vitro diagnostic tests, some labs may choose to offer their own test. For example, a hospital lab may run its own vitamin D assay, even though there is an FDA-cleared test for vitamin D currently on the market.
The leading manufactures mainly are Quest Diagnostics, Roche, Illumina, Qiagen,
Eurofins. Quest Diagnostics is the largest manufacturer; its revenue of global market exceeds 5% in 2016. The next is Roche and Illumina.
Market Analysis and Insights: Global Laboratory-developed Testing Market
In 2019, the global Laboratory-developed Testing market size was US$ 3256.2 million and it is expected to reach US$ 4240 million by the end of 2026, with a CAGR of 3.8% during 2021-2026.
Global Laboratory-developed Testing Scope and Market Size
Laboratory-developed Testing market is segmented by Type, and by Application. Players, stakeholders, and other participants in the global Laboratory-developed Testing market will be able to gain the upper hand as they use the report as a powerful resource. The segmental analysis focuses on revenue and forecast by Type and by Application in terms of revenue and forecast for the period 2015-2026.
Segment by Type, the Laboratory-developed Testing market is segmented into Clinical Biochemistry, Critical Care, Haematology, Immunology, Microbiology, Molecular Diagnostics, Other Test Types, etc.
Segment by Application, the Laboratory-developed Testing market is segmented into Academic Institutes, Clinical Research organizations, Hospitals laboratory, Specialty Diagnostic Centers, Other Type of Facilities, etc.
Regional and Country-level Analysis
The Laboratory-developed Testing market is analysed and market size information is provided by regions (countries).
The key regions covered in the Laboratory-developed Testing market report are North America, Europe, China, Japan, Southeast Asia, India and Central & South America, etc.
The report includes country-wise and region-wise market size for the period 2015-2026. It also includes market size and forecast by Type, and by Application segment in terms of revenue for the period 2015-2026.

Competitive Landscape

and Laboratory-developed Testing Market Share Analysis
Laboratory-developed Testing market competitive landscape provides details and data information by vendors. The report offers comprehensive analysis and accurate statistics on revenue by the player for the period 2015-2020. It also offers detailed analysis supported by reliable statistics on revenue (global and regional level) by player for the period 2015-2020. Details included are company description, major business, company total revenue and the revenue generated in Laboratory-developed Testing business, the date to enter into the Laboratory-developed Testing market, Laboratory-developed Testing product introduction, recent developments, etc.
The major vendors include Adaptive Biotechnologies Corporation, Quest Diagnostics, Roche, Illumina, Qiagen, Eurofins, Guardant Health, Biotheranostics, Adaptive Biotechnologies, Rosetta Genomics, Biodesix, Helix, etc.

This report focuses on the global Laboratory-developed Testing status, future forecast, growth opportunity, key market and key players. The study objectives are to present the Laboratory-developed Testing development in North America, Europe, China, Japan, Southeast Asia, India and Central & South America.

The key players covered in this study

Adaptive Biotechnologies Corporation
Quest Diagnostics
Roche
Illumina
Qiagen
Eurofins
Guardant Health
Biotheranostics
Adaptive Biotechnologies
Rosetta Genomics
Biodesix
Helix

Market segment by Type, the product can be split into

Clinical Biochemistry
Critical Care
Haematology
Immunology
Microbiology
Molecular Diagnostics
Other Test Types

Market segment by Application, split into

Academic Institutes
Clinical Research organizations
Hospitals laboratory
Specialty Diagnostic Centers
Other Type of Facilities

Market segment by Regions/Countries, this report covers

North America
Europe
China
Japan
Southeast Asia
India
Central & South America

The study objectives of this report are:

To analyze global Laboratory-developed Testing status, future forecast, growth opportunity, key market and key players.
To present the Laboratory-developed Testing development in North America, Europe, China, Japan, Southeast Asia, India and Central & South America.
To strategically profile the key players and comprehensively analyze their development plan and strategies.
To define, describe and forecast the market by type, market and key regions.

In this study, the years considered to estimate the market size of Laboratory-developed Testing are as follows:
History Year: 2015-2019

Base Year:

2019

Estimated Year:

2020
Forecast Year 2020 to 2026
For the data information by region, company, type and application, 2019 is considered as the base year. Whenever data information was unavailable for the base year, the prior year has been considered.

Frequently Asked Questions