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 Released in 2014, the draft guidance sparked an intense debate over potential LDT regulation.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

According to this study, over the next five years the Laboratory-developed Testing market will register a 5.0% CAGR in terms of revenue, the global market size will reach US$ 4030 million by 2024, from US$ 3010 million in 2019. In particular, this report presents the global market share (sales and revenue) of key companies in Laboratory-developed Testing business, shared in Chapter 3.

This report presents a comprehensive overview, market shares, and growth opportunities of Laboratory-developed Testing market by product type, application, key manufacturers and key regions and countries.

This study considers the Laboratory-developed Testing value and volume generated from the sales of the following segments:

Segmentation by product type: breakdown data from 2014 to 2019, in Section 2.3: and forecast to 2024 in section 11.7.
Clinical Biochemistry
Critical Care
Haematology
Immunology
Microbiology
Molecular Diagnostics
Other Test Types
Segmentation by application: breakdown data from 2014 to 2019, in Section 2.4: and forecast to 2024 in section 11.8.
Academic Institutes
Clinical Research organizations
Hospitals laboratory
Specialty Diagnostic Centers
Other Type of Facilities

This report also splits the market by region: Breakdown data in Chapter 4, 5, 6, 7 and 8.
Americas
United States
Canada
Mexico
Brazil
APAC
China
Japan
Korea
Southeast Asia
India
Australia
Europe
Germany
France
UK
Italy
Russia
Spain
Middle East & Africa
Egypt
South Africa
Israel
Turkey
GCC Countries

The report also presents the market competition landscape and a corresponding detailed analysis of the major vendor/manufacturers in the market. The key manufacturers covered in this report: Breakdown data in in Chapter 3.
Adaptive Biotechnologies Corporation
Quest Diagnostics
Roche
Illumina
Qiagen
Eurofins
Guardant Health
Biotheranostics
Adaptive Biotechnologies
Rosetta Genomics
Biodesix
Helix

In addition, this report discusses the key drivers influencing market growth, opportunities, the challenges and the risks faced by key manufacturers and the market as a whole. It also analyzes key emerging trends and their impact on present and future development.

Research objectives
To study and analyze the global Laboratory-developed Testing consumption (value & volume) by key regions/countries, product type and application, history data from 2014 to 2018, and forecast to 2024.
To understand the structure of Laboratory-developed Testing market by identifying its various subsegments.
Focuses on the key global Laboratory-developed Testing manufacturers, to define, describe and analyze the sales volume, value, market share, market competition landscape, SWOT analysis and development plans in next few years.
To analyze the Laboratory-developed Testing with respect to individual growth trends, future prospects, and their contribution to the total market.
To share detailed information about the key factors influencing the growth of the market (growth potential, opportunities, drivers, industry-specific challenges and risks).
To project the consumption of Laboratory-developed Testing submarkets, with respect to key regions (along with their respective key countries).
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.