Global Laboratory Developed Test Market Research Report 2024
Published on: 2024-01-04 | No of Pages : 400 | Industry : Medical
Publisher : MRA | Format : PDF
Global Laboratory Developed Test Market Research Report 2024
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 Released in 2016, the draft guidance sparked an intense debate over potential LDT regulation.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.
According to MRAResearch’s new survey, global Laboratory Developed Test market is projected to reach US$ 4376.7 million in 2033, increasing from US$ 3518.7 million in 2022, with the CAGR of 3.1% during the period of 2023 to 2033. Influencing issues, such as economy environments, COVID-19 and Russia-Ukraine War, have led to great market fluctuations in the past few years and are considered comprehensively in the whole Laboratory Developed Test market research.
The leading players in laboratory-developed testing include Quest Diagnostics, Roche, Illumina, Qiagen, and Eurofins, with the top three accounting for approximately 15% of the market.
North America is the largest market with more than 65% of the market, followed by Europe with about 17%.
Report Scope
This report, based on historical analysis (2018-2022) and forecast calculation (2023-2033), aims to help readers to get a comprehensive understanding of global Laboratory Developed Test market with multiple angles, which provides sufficient supports to readers’ strategy and decision making.
Quest Diagnostics
Thermo Fisher
Waters
Roche
Illumina
Qiagen
23andMe
Eurofins
Guardant Health
Biotheranostics
Adaptive Biotechnologies
Rosetta Genomics
Biodesix
Helix
Segment by Type
Clinical Biochemistry
Hematology
Immunology
Molecular Diagnostics
Other
Hospitals Laboratory
Clinical Research Organizations
Academic Institutes
Specialty Diagnostic Centers
Other
By Region
North America
United States
Canada
Europe
Germany
France
UK
Italy
Russia
Nordic Countries
Rest of Europe
Asia-Pacific
China
Japan
South Korea
Southeast Asia
India
Australia
Rest of Asia
Latin America
Mexico
Brazil
Rest of Latin America
Middle East & Africa
Turkey
Saudi Arabia
UAE
Rest of MEA
The Laboratory Developed Test report covers below items
Chapter 1Product Basic Information (Definition, Type and Application)
Chapter 2Global market size, regional market size. Market Opportunities and Challenges
Chapter 3Companies’ Competition Patterns
Chapter 4Product Type Analysis
Chapter 5Product Application Analysis
Chapter 6 to 10Country Level Value Analysis
Chapter 11Companies' Outline
Chapter 12Market Conclusions
Chapter 13Research Methodology and Data Source
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.
According to MRAResearch’s new survey, global Laboratory Developed Test market is projected to reach US$ 4376.7 million in 2033, increasing from US$ 3518.7 million in 2022, with the CAGR of 3.1% during the period of 2023 to 2033. Influencing issues, such as economy environments, COVID-19 and Russia-Ukraine War, have led to great market fluctuations in the past few years and are considered comprehensively in the whole Laboratory Developed Test market research.
The leading players in laboratory-developed testing include Quest Diagnostics, Roche, Illumina, Qiagen, and Eurofins, with the top three accounting for approximately 15% of the market.
North America is the largest market with more than 65% of the market, followed by Europe with about 17%.
Report Scope
This report, based on historical analysis (2018-2022) and forecast calculation (2023-2033), aims to help readers to get a comprehensive understanding of global Laboratory Developed Test market with multiple angles, which provides sufficient supports to readers’ strategy and decision making.
By Company
Quest Diagnostics
Thermo Fisher
Waters
Roche
Illumina
Qiagen
23andMe
Eurofins
Guardant Health
Biotheranostics
Adaptive Biotechnologies
Rosetta Genomics
Biodesix
Helix
Segment by Type
Clinical Biochemistry
Hematology
Immunology
Molecular Diagnostics
Other
Segment by Application
Hospitals Laboratory
Clinical Research Organizations
Academic Institutes
Specialty Diagnostic Centers
Other
By Region
North America
United States
Canada
Europe
Germany
France
UK
Italy
Russia
Nordic Countries
Rest of Europe
Asia-Pacific
China
Japan
South Korea
Southeast Asia
India
Australia
Rest of Asia
Latin America
Mexico
Brazil
Rest of Latin America
Middle East & Africa
Turkey
Saudi Arabia
UAE
Rest of MEA
The Laboratory Developed Test report covers below items
Chapter 1Product Basic Information (Definition, Type and Application)
Chapter 2Global market size, regional market size. Market Opportunities and Challenges
Chapter 3Companies’ Competition Patterns
Chapter 4Product Type Analysis
Chapter 5Product Application Analysis
Chapter 6 to 10Country Level Value Analysis
Chapter 11Companies' Outline
Chapter 12Market Conclusions
Chapter 13Research Methodology and Data Source