Laboratory-developed Testing Market (Updated Version Available)

Report Overview
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 Released in 2014, the draft guidance sparked an intense debate over potential LDT regulation.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.



This research report gives detailed data about the major factors influencing the growth of the Laboratory-developed Testing market at the national and local level forecast of the market size, in terms of value, market share by region, and segment; regional market positions; segment and country opportunities for growth; Key company profiles, SWOT, product portfolio and growth strategies. It studies the market\'s essential sides such as top participants, expansion strategies, business models, and other market features to improve market insight.

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 2021-2028.

COVID-19 Impact
Report covers Impact of Coronavirus COVID-19: Since the COVID-19 virus outbreak in December 2019, the disease has spread to almost every country around the globe with the World Health Organization declaring it a public health emergency. The global impacts of the coronavirus disease 2019 (COVID-19) are already starting to be felt, and will significantly affect the Laboratory-developed Testing market in 2020. The outbreak of COVID-19 has brought effects on many aspects, like flight cancellations; travel bans and quarantines; restaurants closed; all indoor/outdoor events restricted; over forty countries state of emergency declared; massive slowing of the supply chain; stock market volatility; falling business confidence, growing panic among the population, and uncertainty about future.


First, this report covers the present status and the future prospects of the global Laboratory-developed Testing market for 2015-2028.
Market Segmentation
The Laboratory-developed Testing market is segmented on the basis of type, application, end-use industry, and region & country.
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 by Order Type

Clinical Biochemistry

Critical Care

Haematology

Immunology

Microbiology

Molecular Diagnostics

Other Test Types




In Market segmentation by applications :

Academic Institutes

Clinical Research organizations

Hospitals laboratory

Specialty Diagnostic Centers

Other Type of Facilities




Market Segment as follows:
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 - 2028?
• What are the driving forces in the Laboratory-developed Testing market for the forecast period 2021 - 2028?
• 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?

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