Global Laboratory-developed Testing Market 2025 by Company, Regions, Type and Application, Forecast to 2031
Description
According to our (Global Info Research) latest study, the global Laboratory-developed Testing market size was valued at US$ 3899 million in 2024 and is forecast to a readjusted size of USD 5017 million by 2031 with a CAGR of 3.7% during review period.
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 Released in 2014, the draft guidance sparked an intense debate over potential LDT regulation.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 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 15%.
This report is a detailed and comprehensive analysis for global Laboratory-developed Testing market. Both quantitative and qualitative analyses are presented by company, by region & country, by Type and by Application. As the market is constantly changing, this report explores the competition, supply and demand trends, as well as key factors that contribute to its changing demands across many markets. Company profiles and product examples of selected competitors, along with market share estimates of some of the selected leaders for the year 2025, are provided.
Key Features:
Global Laboratory-developed Testing market size and forecasts, in consumption value ($ Million), 2020-2031
Global Laboratory-developed Testing market size and forecasts by region and country, in consumption value ($ Million), 2020-2031
Global Laboratory-developed Testing market size and forecasts, by Type and by Application, in consumption value ($ Million), 2020-2031
Global Laboratory-developed Testing market shares of main players, in revenue ($ Million), 2020-2025
The Primary Objectives in This Report Are:
To determine the size of the total market opportunity of global and key countries
To assess the growth potential for Laboratory-developed Testing
To forecast future growth in each product and end-use market
To assess competitive factors affecting the marketplace
This report profiles key players in the global Laboratory-developed Testing market based on the following parameters - company overview, revenue, gross margin, product portfolio, geographical presence, and key developments. Key companies covered as a part of this study include Adaptive Biotechnologies Corporation, Quest Diagnostics, Roche, Illumina, Qiagen, Eurofins, Guardant Health, Biotheranostics, Adaptive Biotechnologies, Rosetta Genomics, etc.
This report also provides key insights about market drivers, restraints, opportunities, new product launches or approvals.
Market segmentation
Laboratory-developed Testing market is split by Type and by Application. For the period 2020-2031, the growth among segments provides accurate calculations and forecasts for Consumption Value by Type and by Application. This analysis can help you expand your business by targeting qualified niche markets.
Market segment by Type
Commercial Service
R&D
Market segment by Application
Genetic Testing
Oncology
Infectious Disease
Others
Market segment by players, this report covers
Adaptive Biotechnologies Corporation
Quest Diagnostics
Roche
Illumina
Qiagen
Eurofins
Guardant Health
Biotheranostics
Adaptive Biotechnologies
Rosetta Genomics
Biodesix
Helix
Market segment by regions, regional analysis covers
North America (United States, Canada and Mexico)
Europe (Germany, France, UK, Russia, Italy and Rest of Europe)
Asia-Pacific (China, Japan, South Korea, India, Southeast Asia and Rest of Asia-Pacific)
South America (Brazil, Rest of South America)
Middle East & Africa (Turkey, Saudi Arabia, UAE, Rest of Middle East & Africa)
The content of the study subjects, includes a total of 13 chapters:
Chapter 1, to describe Laboratory-developed Testing product scope, market overview, market estimation caveats and base year.
Chapter 2, to profile the top players of Laboratory-developed Testing, with revenue, gross margin, and global market share of Laboratory-developed Testing from 2020 to 2025.
Chapter 3, the Laboratory-developed Testing competitive situation, revenue, and global market share of top players are analyzed emphatically by landscape contrast.
Chapter 4 and 5, to segment the market size by Type and by Application, with consumption value and growth rate by Type, by Application, from 2020 to 2031
Chapter 6, 7, 8, 9, and 10, to break the market size data at the country level, with revenue and market share for key countries in the world, from 2020 to 2025.and Laboratory-developed Testing market forecast, by regions, by Type and by Application, with consumption value, from 2026 to 2031.
Chapter 11, market dynamics, drivers, restraints, trends, Porters Five Forces analysis.
Chapter 12, the key raw materials and key suppliers, and industry chain of Laboratory-developed Testing.
Chapter 13, to describe Laboratory-developed Testing research findings and conclusion.
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 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 15%.
This report is a detailed and comprehensive analysis for global Laboratory-developed Testing market. Both quantitative and qualitative analyses are presented by company, by region & country, by Type and by Application. As the market is constantly changing, this report explores the competition, supply and demand trends, as well as key factors that contribute to its changing demands across many markets. Company profiles and product examples of selected competitors, along with market share estimates of some of the selected leaders for the year 2025, are provided.
Key Features:
Global Laboratory-developed Testing market size and forecasts, in consumption value ($ Million), 2020-2031
Global Laboratory-developed Testing market size and forecasts by region and country, in consumption value ($ Million), 2020-2031
Global Laboratory-developed Testing market size and forecasts, by Type and by Application, in consumption value ($ Million), 2020-2031
Global Laboratory-developed Testing market shares of main players, in revenue ($ Million), 2020-2025
The Primary Objectives in This Report Are:
To determine the size of the total market opportunity of global and key countries
To assess the growth potential for Laboratory-developed Testing
To forecast future growth in each product and end-use market
To assess competitive factors affecting the marketplace
This report profiles key players in the global Laboratory-developed Testing market based on the following parameters - company overview, revenue, gross margin, product portfolio, geographical presence, and key developments. Key companies covered as a part of this study include Adaptive Biotechnologies Corporation, Quest Diagnostics, Roche, Illumina, Qiagen, Eurofins, Guardant Health, Biotheranostics, Adaptive Biotechnologies, Rosetta Genomics, etc.
This report also provides key insights about market drivers, restraints, opportunities, new product launches or approvals.
Market segmentation
Laboratory-developed Testing market is split by Type and by Application. For the period 2020-2031, the growth among segments provides accurate calculations and forecasts for Consumption Value by Type and by Application. This analysis can help you expand your business by targeting qualified niche markets.
Market segment by Type
Commercial Service
R&D
Market segment by Application
Genetic Testing
Oncology
Infectious Disease
Others
Market segment by players, this report covers
Adaptive Biotechnologies Corporation
Quest Diagnostics
Roche
Illumina
Qiagen
Eurofins
Guardant Health
Biotheranostics
Adaptive Biotechnologies
Rosetta Genomics
Biodesix
Helix
Market segment by regions, regional analysis covers
North America (United States, Canada and Mexico)
Europe (Germany, France, UK, Russia, Italy and Rest of Europe)
Asia-Pacific (China, Japan, South Korea, India, Southeast Asia and Rest of Asia-Pacific)
South America (Brazil, Rest of South America)
Middle East & Africa (Turkey, Saudi Arabia, UAE, Rest of Middle East & Africa)
The content of the study subjects, includes a total of 13 chapters:
Chapter 1, to describe Laboratory-developed Testing product scope, market overview, market estimation caveats and base year.
Chapter 2, to profile the top players of Laboratory-developed Testing, with revenue, gross margin, and global market share of Laboratory-developed Testing from 2020 to 2025.
Chapter 3, the Laboratory-developed Testing competitive situation, revenue, and global market share of top players are analyzed emphatically by landscape contrast.
Chapter 4 and 5, to segment the market size by Type and by Application, with consumption value and growth rate by Type, by Application, from 2020 to 2031
Chapter 6, 7, 8, 9, and 10, to break the market size data at the country level, with revenue and market share for key countries in the world, from 2020 to 2025.and Laboratory-developed Testing market forecast, by regions, by Type and by Application, with consumption value, from 2026 to 2031.
Chapter 11, market dynamics, drivers, restraints, trends, Porters Five Forces analysis.
Chapter 12, the key raw materials and key suppliers, and industry chain of Laboratory-developed Testing.
Chapter 13, to describe Laboratory-developed Testing research findings and conclusion.
Table of Contents
111 Pages
- 1 Market Overview
- 2 Company Profiles
- 3 Market Competition, by Players
- 4 Market Size Segment by Type
- 5 Market Size Segment by Application
- 6 North America
- 7 Europe
- 8 Asia-Pacific
- 9 South America
- 10 Middle East & Africa
- 11 Market Dynamics
- 12 Industry Chain Analysis
- 13 Research Findings and Conclusion
- 14 Appendix
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