Brooklyn, NY -- (SBWire) -- 11/29/2018 --This report focuses on the global Laboratory Developed Tests (LDT) status, future forecast, growth opportunity, key market and key players. The study objectives are to present the Laboratory Developed Tests (LDT) development in United States, Europe and China.
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 Released in 2014, the draft guidance sparked an intense debate over potential LDT regulation.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.
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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 patients 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,
In 2017, the global Laboratory Developed Tests (LDT) market size was xx million US$ and it is expected to reach xx million US$ by the end of 2025, with a CAGR of xx% during 2018-2025.
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
Critical Care
Haematology
Immunology
Microbiology
Molecular Diagnostics
Other Test Types
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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
United States
Europe
China
Japan
Southeast Asia
India
Central & South America
The study objectives of this report are:
To analyze and study the global Laboratory Developed Tests (LDT) capacity, production, value, consumption, status (2013-2017) and forecast (2018-2025);
Focuses on the key Laboratory Developed Tests (LDT) manufacturers, to study the capacity, production, value, market share and development plans in future.
Focuses on the global key manufacturers, to define, describe and analyze the market competition landscape, SWOT analysis.
To define, describe and forecast the market by type, application and region.
To analyze the global and key regions market potential and advantage, opportunity and challenge, restraints and risks.
To identify significant trends and factors driving or inhibiting the market growth.
To analyze the opportunities in the market for stakeholders by identifying the high growth segments.
To strategically analyze each submarket with respect to individual growth trend and their contribution to the market
To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the market
To strategically profile the key players and comprehensively analyze their growth strategies.
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In this study, the years considered to estimate the market size of Laboratory Developed Tests (LDT) are as follows:
History Year: 2013-2017
Base Year: 2017
Estimated Year: 2018
Forecast Year 2018 to 2025
For the data information by region, company, type and application, 2017 is considered as the base year. Whenever data information was unavailable for the base year, the prior year has been considered.
Key Stakeholders
Laboratory Developed Tests (LDT) Manufacturers
Laboratory Developed Tests (LDT) Distributors/Traders/Wholesalers
Laboratory Developed Tests (LDT) Subcomponent Manufacturers
Industry Association
Downstream Vendors
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