Laboratory-developed Testing Market (Updated Version Available)

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 Released in 2014, the draft guidance sparked an intense debate over potential LDT regulation.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.
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 report offers detailed coverage of Laboratory-developed Testing industry and main market trends. The market research includes historical and forecast market data, demand, application details, price trends, and company shares of the leading Laboratory-developed Testing by geography. The report splits the market size, by volume and value, on the basis of application type and geography.

The report forecast global Laboratory-developed Testing market to grow to reach xxx Million USD in 2020 with a CAGR of xx% during the period 2021-2025.

First, this report covers the present status and the future prospects of the global Laboratory-developed Testing market for 2015-2025.
And in this report, we analyze global market from 5 geographies: Asia-Pacific[China, Southeast Asia, India, Japan, Korea, Western Asia], Europe[Germany, UK, France, Italy, Russia, Spain, Netherlands, Turkey, Switzerland], North America[United States, Canada, Mexico], Middle East & Africa[GCC, North Africa, South Africa], South America[Brazil, Argentina, Columbia, Chile, Peru].

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

At the same time, we classify Laboratory-developed Testing according to the type, application by geography. More importantly, the report includes major countries market based on the type and application.

Market Segment as follows:
Market by Order Type
Clinical Biochemistry
Critical Care
Haematology
Immunology
Microbiology
Molecular Diagnostics
Other Test Types
Market by Application
Academic Institutes
Clinical Research organizations
Hospitals laboratory
Specialty Diagnostic Centers
Other Type of Facilities

By Region
Asia-Pacific[China, Southeast Asia, India, Japan, Korea, Western Asia]
Europe[Germany, UK, France, Italy, Russia, Spain, Netherlands, Turkey, Switzerland]
North America[United States, Canada, Mexico]
Middle East & Africa[GCC, North Africa, South Africa]
South America[Brazil, Argentina, Columbia, Chile, Peru]

The research provides answers to the following key questions:
• What is the estimated growth rate and market share and size of the Laboratory-developed Testing market for the forecast period 2021 - 2025?
• What are the driving forces in the Laboratory-developed Testing market for the forecast period 2021 - 2025?
• Who are the prominent market players and how have they gained a competitive edge over other competitors?
• What are the market trends influencing the progress of the Laboratory-developed Testing industry worldwide?
• What are the major challenges and threats restricting the progress of the industry?
• What opportunities does the market hold for the prominent market players?