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 Released in 2014, the draft guidance sparked an intense debate over potential LDT regulation.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鈥檚 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 global Laboratory-developed Testing market size was valued at US$ 3770 million in 2023 and is forecast to a readjusted size of USD 4851 million by 2030 with a CAGR of 3.7% during review period.
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 2024, are provided.
Key Features:
Global Laboratory-developed Testing market size and forecasts, in consumption value ($ Million), 2019-2030
Global Laboratory-developed Testing market size and forecasts by region and country, in consumption value ($ Million), 2019-2030
Global Laboratory-developed Testing market size and forecasts, by Type and by Application, in consumption value ($ Million), 2019-2030
Global Laboratory-developed Testing market shares of main players, in revenue ($ Million), 2019-2024
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 2019-2030, 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 segmentation
Laboratory-developed Testing market is split by Type and by Application. For the period 2018-2029, 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 2019 to 2024.
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 2019 to 2030.
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 2019 to 2024.and Laboratory-developed Testing market forecast, by regions, by Type and by Application, with consumption value, from 2024 to 2030.
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.
Please Note - This is an on demand report and will be delivered in 2 business days (48 Hours) post payment.
1 Market Overview
1.1 Product Overview and Scope
1.2 Market Estimation Caveats and Base Year
1.3 Classification of Laboratory-developed Testing by Type
1.3.1 Overview: Global Laboratory-developed Testing Market Size by Type: 2019 Versus 2023 Versus 2030
1.3.2 Global Laboratory-developed Testing Consumption Value Market Share by Type in 2023
1.3.3 Commercial Service
1.3.4 R&D
1.4 Global Laboratory-developed Testing Market by Application
1.4.1 Overview: Global Laboratory-developed Testing Market Size by Application: 2019 Versus 2023 Versus 2030
1.4.2 Genetic Testing
1.4.3 Oncology
1.4.4 Infectious Disease
1.4.5 Others
1.5 Global Laboratory-developed Testing Market Size & Forecast
1.6 Global Laboratory-developed Testing Market Size and Forecast by Region
1.6.1 Global Laboratory-developed Testing Market Size by Region: 2019 VS 2023 VS 2030
1.6.2 Global Laboratory-developed Testing Market Size by Region, (2019-2030)
1.6.3 North America Laboratory-developed Testing Market Size and Prospect (2019-2030)
1.6.4 Europe Laboratory-developed Testing Market Size and Prospect (2019-2030)
1.6.5 Asia-Pacific Laboratory-developed Testing Market Size and Prospect (2019-2030)
1.6.6 South America Laboratory-developed Testing Market Size and Prospect (2019-2030)
1.6.7 Middle East & Africa Laboratory-developed Testing Market Size and Prospect (2019-2030)
2 Company Profiles
2.1 Adaptive Biotechnologies Corporation
2.1.1 Adaptive Biotechnologies Corporation Details
2.1.2 Adaptive Biotechnologies Corporation Major Business
2.1.3 Adaptive Biotechnologies Corporation Laboratory-developed Testing Product and Solutions
2.1.4 Adaptive Biotechnologies Corporation Laboratory-developed Testing Revenue, Gross Margin and Market Share (2019-2024)
2.1.5 Adaptive Biotechnologies Corporation Recent Developments and Future Plans
2.2 Quest Diagnostics
2.2.1 Quest Diagnostics Details
2.2.2 Quest Diagnostics Major Business
2.2.3 Quest Diagnostics Laboratory-developed Testing Product and Solutions
2.2.4 Quest Diagnostics Laboratory-developed Testing Revenue, Gross Margin and Market Share (2019-2024)
2.2.5 Quest Diagnostics Recent Developments and Future Plans
2.3 Roche
2.3.1 Roche Details
2.3.2 Roche Major Business
2.3.3 Roche Laboratory-developed Testing Product and Solutions
2.3.4 Roche Laboratory-developed Testing Revenue, Gross Margin and Market Share (2019-2024)
2.3.5 Roche Recent Developments and Future Plans
2.4 Illumina
2.4.1 Illumina Details
2.4.2 Illumina Major Business
2.4.3 Illumina Laboratory-developed Testing Product and Solutions
2.4.4 Illumina Laboratory-developed Testing Revenue, Gross Margin and Market Share (2019-2024)
2.4.5 Illumina Recent Developments and Future Plans
2.5 Qiagen
2.5.1 Qiagen Details
2.5.2 Qiagen Major Business
2.5.3 Qiagen Laboratory-developed Testing Product and Solutions
2.5.4 Qiagen Laboratory-developed Testing Revenue, Gross Margin and Market Share (2019-2024)
2.5.5 Qiagen Recent Developments and Future Plans
2.6 Eurofins
2.6.1 Eurofins Details
2.6.2 Eurofins Major Business
2.6.3 Eurofins Laboratory-developed Testing Product and Solutions
2.6.4 Eurofins Laboratory-developed Testing Revenue, Gross Margin and Market Share (2019-2024)
2.6.5 Eurofins Recent Developments and Future Plans
2.7 Guardant Health
2.7.1 Guardant Health Details
2.7.2 Guardant Health Major Business
2.7.3 Guardant Health Laboratory-developed Testing Product and Solutions
2.7.4 Guardant Health Laboratory-developed Testing Revenue, Gross Margin and Market Share (2019-2024)
2.7.5 Guardant Health Recent Developments and Future Plans
2.8 Biotheranostics
2.8.1 Biotheranostics Details
2.8.2 Biotheranostics Major Business
2.8.3 Biotheranostics Laboratory-developed Testing Product and Solutions
2.8.4 Biotheranostics Laboratory-developed Testing Revenue, Gross Margin and Market Share (2019-2024)
2.8.5 Biotheranostics Recent Developments and Future Plans
2.9 Adaptive Biotechnologies
2.9.1 Adaptive Biotechnologies Details
2.9.2 Adaptive Biotechnologies Major Business
2.9.3 Adaptive Biotechnologies Laboratory-developed Testing Product and Solutions
2.9.4 Adaptive Biotechnologies Laboratory-developed Testing Revenue, Gross Margin and Market Share (2019-2024)
2.9.5 Adaptive Biotechnologies Recent Developments and Future Plans
2.10 Rosetta Genomics
2.10.1 Rosetta Genomics Details
2.10.2 Rosetta Genomics Major Business
2.10.3 Rosetta Genomics Laboratory-developed Testing Product and Solutions
2.10.4 Rosetta Genomics Laboratory-developed Testing Revenue, Gross Margin and Market Share (2019-2024)
2.10.5 Rosetta Genomics Recent Developments and Future Plans
2.11 Biodesix
2.11.1 Biodesix Details
2.11.2 Biodesix Major Business
2.11.3 Biodesix Laboratory-developed Testing Product and Solutions
2.11.4 Biodesix Laboratory-developed Testing Revenue, Gross Margin and Market Share (2019-2024)
2.11.5 Biodesix Recent Developments and Future Plans
2.12 Helix
2.12.1 Helix Details
2.12.2 Helix Major Business
2.12.3 Helix Laboratory-developed Testing Product and Solutions
2.12.4 Helix Laboratory-developed Testing Revenue, Gross Margin and Market Share (2019-2024)
2.12.5 Helix Recent Developments and Future Plans
3 Market Competition, by Players
3.1 Global Laboratory-developed Testing Revenue and Share by Players (2019-2024)
3.2 Market Share Analysis (2023)
3.2.1 Market Share of Laboratory-developed Testing by Company Revenue
3.2.2 Top 3 Laboratory-developed Testing Players Market Share in 2023
3.2.3 Top 6 Laboratory-developed Testing Players Market Share in 2023
3.3 Laboratory-developed Testing Market: Overall Company Footprint Analysis
3.3.1 Laboratory-developed Testing Market: Region Footprint
3.3.2 Laboratory-developed Testing Market: Company Product Type Footprint
3.3.3 Laboratory-developed Testing Market: Company Product Application Footprint
3.4 New Market Entrants and Barriers to Market Entry
3.5 Mergers, Acquisition, Agreements, and Collaborations
4 Market Size Segment by Type
4.1 Global Laboratory-developed Testing Consumption Value and Market Share by Type (2019-2024)
4.2 Global Laboratory-developed Testing Market Forecast by Type (2025-2030)
5 Market Size Segment by Application
5.1 Global Laboratory-developed Testing Consumption Value Market Share by Application (2019-2024)
5.2 Global Laboratory-developed Testing Market Forecast by Application (2025-2030)
6 North America
6.1 North America Laboratory-developed Testing Consumption Value by Type (2019-2030)
6.2 North America Laboratory-developed Testing Market Size by Application (2019-2030)
6.3 North America Laboratory-developed Testing Market Size by Country
6.3.1 North America Laboratory-developed Testing Consumption Value by Country (2019-2030)
6.3.2 United States Laboratory-developed Testing Market Size and Forecast (2019-2030)
6.3.3 Canada Laboratory-developed Testing Market Size and Forecast (2019-2030)
6.3.4 Mexico Laboratory-developed Testing Market Size and Forecast (2019-2030)
7 Europe
7.1 Europe Laboratory-developed Testing Consumption Value by Type (2019-2030)
7.2 Europe Laboratory-developed Testing Consumption Value by Application (2019-2030)
7.3 Europe Laboratory-developed Testing Market Size by Country
7.3.1 Europe Laboratory-developed Testing Consumption Value by Country (2019-2030)
7.3.2 Germany Laboratory-developed Testing Market Size and Forecast (2019-2030)
7.3.3 France Laboratory-developed Testing Market Size and Forecast (2019-2030)
7.3.4 United Kingdom Laboratory-developed Testing Market Size and Forecast (2019-2030)
7.3.5 Russia Laboratory-developed Testing Market Size and Forecast (2019-2030)
7.3.6 Italy Laboratory-developed Testing Market Size and Forecast (2019-2030)
8 Asia-Pacific
8.1 Asia-Pacific Laboratory-developed Testing Consumption Value by Type (2019-2030)
8.2 Asia-Pacific Laboratory-developed Testing Consumption Value by Application (2019-2030)
8.3 Asia-Pacific Laboratory-developed Testing Market Size by Region
8.3.1 Asia-Pacific Laboratory-developed Testing Consumption Value by Region (2019-2030)
8.3.2 China Laboratory-developed Testing Market Size and Forecast (2019-2030)
8.3.3 Japan Laboratory-developed Testing Market Size and Forecast (2019-2030)
8.3.4 South Korea Laboratory-developed Testing Market Size and Forecast (2019-2030)
8.3.5 India Laboratory-developed Testing Market Size and Forecast (2019-2030)
8.3.6 Southeast Asia Laboratory-developed Testing Market Size and Forecast (2019-2030)
8.3.7 Australia Laboratory-developed Testing Market Size and Forecast (2019-2030)
9 South America
9.1 South America Laboratory-developed Testing Consumption Value by Type (2019-2030)
9.2 South America Laboratory-developed Testing Consumption Value by Application (2019-2030)
9.3 South America Laboratory-developed Testing Market Size by Country
9.3.1 South America Laboratory-developed Testing Consumption Value by Country (2019-2030)
9.3.2 Brazil Laboratory-developed Testing Market Size and Forecast (2019-2030)
9.3.3 Argentina Laboratory-developed Testing Market Size and Forecast (2019-2030)
10 Middle East & Africa
10.1 Middle East & Africa Laboratory-developed Testing Consumption Value by Type (2019-2030)
10.2 Middle East & Africa Laboratory-developed Testing Consumption Value by Application (2019-2030)
10.3 Middle East & Africa Laboratory-developed Testing Market Size by Country
10.3.1 Middle East & Africa Laboratory-developed Testing Consumption Value by Country (2019-2030)
10.3.2 Turkey Laboratory-developed Testing Market Size and Forecast (2019-2030)
10.3.3 Saudi Arabia Laboratory-developed Testing Market Size and Forecast (2019-2030)
10.3.4 UAE Laboratory-developed Testing Market Size and Forecast (2019-2030)
11 Market Dynamics
11.1 Laboratory-developed Testing Market Drivers
11.2 Laboratory-developed Testing Market Restraints
11.3 Laboratory-developed Testing Trends Analysis
11.4 Porters Five Forces Analysis
11.4.1 Threat of New Entrants
11.4.2 Bargaining Power of Suppliers
11.4.3 Bargaining Power of Buyers
11.4.4 Threat of Substitutes
11.4.5 Competitive Rivalry
12 Industry Chain Analysis
12.1 Laboratory-developed Testing Industry Chain
12.2 Laboratory-developed Testing Upstream Analysis
12.3 Laboratory-developed Testing Midstream Analysis
12.4 Laboratory-developed Testing Downstream Analysis
13 Research Findings and Conclusion
14 Appendix
14.1 Methodology
14.2 Research Process and Data Source
14.3 Disclaimer
Adaptive Biotechnologies Corporation
Quest Diagnostics
Roche
Illumina
Qiagen
Eurofins
Guardant Health
Biotheranostics
Adaptive Biotechnologies
Rosetta Genomics
Biodesix
Helix
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*If Applicable.
