Los Angeles, CA -- (SBWire) -- 01/07/2019 --This report studies the global Laboratory-developed Testing market status and forecast, categorizes the global Laboratory-developed Testing market size (value & volume) by key players, type, application, and region. This report focuses on the top players in North America, Europe, Asia-Pacific, South America, and Middle East & Africa.
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 Released in 2014, the draft guidance sparked an intense debate over potential LDT regulation.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.
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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.
There are mainly two type product of Laboratory-developed Testing market: Commercial Service and R&D. Commercial Service accounts the largest proportion; however, R&D still have high growth rate.
Geographically, the global Laboratory-developed Testing market has been segmented into North America, Europe, China, Japan, Southeast Asia, India and Other Regions. The North America held the largest share in the global Laboratory-developed Testing products market, its revenue of global market exceeds 68% in 2017. The next is Europe and Japan
The global Laboratory-developed Testing market is valued at 3010 million US$ in 2017 and will reach 4060 million US$ by the end of 2025, growing at a CAGR of 3.8% during 2018-2025.
The major manufacturers covered in this report
Adaptive Biotechnologies Corporation
Quest Diagnostics
Roche
Illumina
Qiagen
Eurofins
Guardant Health
Biotheranostics
Adaptive Biotechnologies
Rosetta Genomics
Biodesix
Helix
Geographically, this report studies the key regions, focuses on product sales, value, market share and growth opportunity in these regions, covering
North America
Europe
China
Japan
Southeast Asia
India
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Global Laboratory-Developed Testing Market Will Reach 4060 Million US$ by the End of 2025
QYResearch is a leading market research publisher which pursuits high product quality with the belief that quality is the soul of business and consulting group has accumulated creative design methods on many high-quality markets investigation and research team with rich experience.