The global Laboratory-developed Testing market size is predicted to grow from US$ 3833 million in 2025 to US$ 4834 million in 2031; it is expected to grow at a CAGR of 3.9% from 2025 to 2031.
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 Released in 2014, the draft guidance sparked an intense debate over potential LDT regulation.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%.
The “Laboratory-developed Testing Industry Forecast” looks at past sales and reviews total world Laboratory-developed Testing sales in 2024, providing a comprehensive analysis by region and market sector of projected Laboratory-developed Testing sales for 2025 through 2031. With Laboratory-developed Testing sales broken down by region, market sector and sub-sector, this report provides a detailed analysis in US$ millions of the world Laboratory-developed Testing industry.
This Insight Report provides a comprehensive analysis of the global Laboratory-developed Testing landscape and highlights key trends related to product segmentation, company formation, revenue, and market share, latest development, and M&A activity. This report also analyses the strategies of leading global companies with a focus on Laboratory-developed Testing portfolios and capabilities, market entry strategies, market positions, and geographic footprints, to better understand these firms’ unique position in an accelerating global Laboratory-developed Testing market.
This Insight Report evaluates the key market trends, drivers, and affecting factors shaping the global outlook for Laboratory-developed Testing and breaks down the forecast by Type, by Application, geography, and market size to highlight emerging pockets of opportunity. With a transparent methodology based on hundreds of bottom-up qualitative and quantitative market inputs, this study forecast offers a highly nuanced view of the current state and future trajectory in the global Laboratory-developed Testing.
This report presents a comprehensive overview, market shares, and growth opportunities of Laboratory-developed Testing market by product type, application, key players and key regions and countries.
Segmentation by Type:
Commercial Service
R&D
Segmentation by Application:
Genetic Testing
Oncology
Infectious Disease
Others
This report also splits the market by region:
Americas
United States
Canada
Mexico
Brazil
APAC
China
Japan
Korea
Southeast Asia
India
Australia
Europe
Germany
France
UK
Italy
Russia
Middle East & Africa
Egypt
South Africa
Israel
Turkey
GCC Countries
The below companies that are profiled have been selected based on inputs gathered from primary experts and analyzing the company's coverage, product portfolio, its market penetration.
Adaptive Biotechnologies Corporation
Quest Diagnostics
Roche
Illumina
Qiagen
Eurofins
Guardant Health
Biotheranostics
Adaptive Biotechnologies
Rosetta Genomics
Biodesix
Helix
Please Note - This is an on demand report and will be delivered in 2 business days (48 hours) post payment.
1 Scope of the Report
1.1 Market Introduction
1.2 Years Considered
1.3 Research Objectives
1.4 Market Research Methodology
1.5 Research Process and Data Source
1.6 Economic Indicators
1.7 Currency Considered
1.8 Market Estimation Caveats
2 Executive Summary
2.1 World Market Overview
2.1.1 Global Laboratory-developed Testing Market Size (2020-2031)
2.1.2 Laboratory-developed Testing Market Size CAGR by Region (2020 VS 2024 VS 2031)
2.1.3 World Current & Future Analysis for Laboratory-developed Testing by Country/Region (2020, 2024 & 2031)
2.2 Laboratory-developed Testing Segment by Type
2.2.1 Commercial Service
2.2.2 R&D
2.3 Laboratory-developed Testing Market Size by Type
2.3.1 Laboratory-developed Testing Market Size CAGR by Type (2020 VS 2024 VS 2031)
2.3.2 Global Laboratory-developed Testing Market Size Market Share by Type (2020-2025)
2.4 Laboratory-developed Testing Segment by Application
2.4.1 Genetic Testing
2.4.2 Oncology
2.4.3 Infectious Disease
2.4.4 Others
2.5 Laboratory-developed Testing Market Size by Application
2.5.1 Laboratory-developed Testing Market Size CAGR by Application (2020 VS 2024 VS 2031)
2.5.2 Global Laboratory-developed Testing Market Size Market Share by Application (2020-2025)
3 Laboratory-developed Testing Market Size by Player
3.1 Laboratory-developed Testing Market Size Market Share by Player
3.1.1 Global Laboratory-developed Testing Revenue by Player (2020-2025)
3.1.2 Global Laboratory-developed Testing Revenue Market Share by Player (2020-2025)
3.2 Global Laboratory-developed Testing Key Players Head office and Products Offered
3.3 Market Concentration Rate Analysis
3.3.1 Competition Landscape Analysis
3.3.2 Concentration Ratio (CR3, CR5 and CR10) & (2023-2025)
3.4 New Products and Potential Entrants
3.5 Mergers & Acquisitions, Expansion
4 Laboratory-developed Testing by Region
4.1 Laboratory-developed Testing Market Size by Region (2020-2025)
4.2 Global Laboratory-developed Testing Annual Revenue by Country/Region (2020-2025)
4.3 Americas Laboratory-developed Testing Market Size Growth (2020-2025)
4.4 APAC Laboratory-developed Testing Market Size Growth (2020-2025)
4.5 Europe Laboratory-developed Testing Market Size Growth (2020-2025)
4.6 Middle East & Africa Laboratory-developed Testing Market Size Growth (2020-2025)
5 Americas
5.1 Americas Laboratory-developed Testing Market Size by Country (2020-2025)
5.2 Americas Laboratory-developed Testing Market Size by Type (2020-2025)
5.3 Americas Laboratory-developed Testing Market Size by Application (2020-2025)
5.4 United States
5.5 Canada
5.6 Mexico
5.7 Brazil
6 APAC
6.1 APAC Laboratory-developed Testing Market Size by Region (2020-2025)
6.2 APAC Laboratory-developed Testing Market Size by Type (2020-2025)
6.3 APAC Laboratory-developed Testing Market Size by Application (2020-2025)
6.4 China
6.5 Japan
6.6 South Korea
6.7 Southeast Asia
6.8 India
6.9 Australia
7 Europe
7.1 Europe Laboratory-developed Testing Market Size by Country (2020-2025)
7.2 Europe Laboratory-developed Testing Market Size by Type (2020-2025)
7.3 Europe Laboratory-developed Testing Market Size by Application (2020-2025)
7.4 Germany
7.5 France
7.6 UK
7.7 Italy
7.8 Russia
8 Middle East & Africa
8.1 Middle East & Africa Laboratory-developed Testing by Region (2020-2025)
8.2 Middle East & Africa Laboratory-developed Testing Market Size by Type (2020-2025)
8.3 Middle East & Africa Laboratory-developed Testing Market Size by Application (2020-2025)
8.4 Egypt
8.5 South Africa
8.6 Israel
8.7 Turkey
8.8 GCC Countries
9 Market Drivers, Challenges and Trends
9.1 Market Drivers & Growth Opportunities
9.2 Market Challenges & Risks
9.3 Industry Trends
10 Global Laboratory-developed Testing Market Forecast
10.1 Global Laboratory-developed Testing Forecast by Region (2026-2031)
10.1.1 Global Laboratory-developed Testing Forecast by Region (2026-2031)
10.1.2 Americas Laboratory-developed Testing Forecast
10.1.3 APAC Laboratory-developed Testing Forecast
10.1.4 Europe Laboratory-developed Testing Forecast
10.1.5 Middle East & Africa Laboratory-developed Testing Forecast
10.2 Americas Laboratory-developed Testing Forecast by Country (2026-2031)
10.2.1 United States Market Laboratory-developed Testing Forecast
10.2.2 Canada Market Laboratory-developed Testing Forecast
10.2.3 Mexico Market Laboratory-developed Testing Forecast
10.2.4 Brazil Market Laboratory-developed Testing Forecast
10.3 APAC Laboratory-developed Testing Forecast by Region (2026-2031)
10.3.1 China Laboratory-developed Testing Market Forecast
10.3.2 Japan Market Laboratory-developed Testing Forecast
10.3.3 Korea Market Laboratory-developed Testing Forecast
10.3.4 Southeast Asia Market Laboratory-developed Testing Forecast
10.3.5 India Market Laboratory-developed Testing Forecast
10.3.6 Australia Market Laboratory-developed Testing Forecast
10.4 Europe Laboratory-developed Testing Forecast by Country (2026-2031)
10.4.1 Germany Market Laboratory-developed Testing Forecast
10.4.2 France Market Laboratory-developed Testing Forecast
10.4.3 UK Market Laboratory-developed Testing Forecast
10.4.4 Italy Market Laboratory-developed Testing Forecast
10.4.5 Russia Market Laboratory-developed Testing Forecast
10.5 Middle East & Africa Laboratory-developed Testing Forecast by Region (2026-2031)
10.5.1 Egypt Market Laboratory-developed Testing Forecast
10.5.2 South Africa Market Laboratory-developed Testing Forecast
10.5.3 Israel Market Laboratory-developed Testing Forecast
10.5.4 Turkey Market Laboratory-developed Testing Forecast
10.6 Global Laboratory-developed Testing Forecast by Type (2026-2031)
10.7 Global Laboratory-developed Testing Forecast by Application (2026-2031)
10.7.1 GCC Countries Market Laboratory-developed Testing Forecast
11 Key Players Analysis
11.1 Adaptive Biotechnologies Corporation
11.1.1 Adaptive Biotechnologies Corporation Company Information
11.1.2 Adaptive Biotechnologies Corporation Laboratory-developed Testing Product Offered
11.1.3 Adaptive Biotechnologies Corporation Laboratory-developed Testing Revenue, Gross Margin and Market Share (2020-2025)
11.1.4 Adaptive Biotechnologies Corporation Main Business Overview
11.1.5 Adaptive Biotechnologies Corporation Latest Developments
11.2 Quest Diagnostics
11.2.1 Quest Diagnostics Company Information
11.2.2 Quest Diagnostics Laboratory-developed Testing Product Offered
11.2.3 Quest Diagnostics Laboratory-developed Testing Revenue, Gross Margin and Market Share (2020-2025)
11.2.4 Quest Diagnostics Main Business Overview
11.2.5 Quest Diagnostics Latest Developments
11.3 Roche
11.3.1 Roche Company Information
11.3.2 Roche Laboratory-developed Testing Product Offered
11.3.3 Roche Laboratory-developed Testing Revenue, Gross Margin and Market Share (2020-2025)
11.3.4 Roche Main Business Overview
11.3.5 Roche Latest Developments
11.4 Illumina
11.4.1 Illumina Company Information
11.4.2 Illumina Laboratory-developed Testing Product Offered
11.4.3 Illumina Laboratory-developed Testing Revenue, Gross Margin and Market Share (2020-2025)
11.4.4 Illumina Main Business Overview
11.4.5 Illumina Latest Developments
11.5 Qiagen
11.5.1 Qiagen Company Information
11.5.2 Qiagen Laboratory-developed Testing Product Offered
11.5.3 Qiagen Laboratory-developed Testing Revenue, Gross Margin and Market Share (2020-2025)
11.5.4 Qiagen Main Business Overview
11.5.5 Qiagen Latest Developments
11.6 Eurofins
11.6.1 Eurofins Company Information
11.6.2 Eurofins Laboratory-developed Testing Product Offered
11.6.3 Eurofins Laboratory-developed Testing Revenue, Gross Margin and Market Share (2020-2025)
11.6.4 Eurofins Main Business Overview
11.6.5 Eurofins Latest Developments
11.7 Guardant Health
11.7.1 Guardant Health Company Information
11.7.2 Guardant Health Laboratory-developed Testing Product Offered
11.7.3 Guardant Health Laboratory-developed Testing Revenue, Gross Margin and Market Share (2020-2025)
11.7.4 Guardant Health Main Business Overview
11.7.5 Guardant Health Latest Developments
11.8 Biotheranostics
11.8.1 Biotheranostics Company Information
11.8.2 Biotheranostics Laboratory-developed Testing Product Offered
11.8.3 Biotheranostics Laboratory-developed Testing Revenue, Gross Margin and Market Share (2020-2025)
11.8.4 Biotheranostics Main Business Overview
11.8.5 Biotheranostics Latest Developments
11.9 Adaptive Biotechnologies
11.9.1 Adaptive Biotechnologies Company Information
11.9.2 Adaptive Biotechnologies Laboratory-developed Testing Product Offered
11.9.3 Adaptive Biotechnologies Laboratory-developed Testing Revenue, Gross Margin and Market Share (2020-2025)
11.9.4 Adaptive Biotechnologies Main Business Overview
11.9.5 Adaptive Biotechnologies Latest Developments
11.10 Rosetta Genomics
11.10.1 Rosetta Genomics Company Information
11.10.2 Rosetta Genomics Laboratory-developed Testing Product Offered
11.10.3 Rosetta Genomics Laboratory-developed Testing Revenue, Gross Margin and Market Share (2020-2025)
11.10.4 Rosetta Genomics Main Business Overview
11.10.5 Rosetta Genomics Latest Developments
11.11 Biodesix
11.11.1 Biodesix Company Information
11.11.2 Biodesix Laboratory-developed Testing Product Offered
11.11.3 Biodesix Laboratory-developed Testing Revenue, Gross Margin and Market Share (2020-2025)
11.11.4 Biodesix Main Business Overview
11.11.5 Biodesix Latest Developments
11.12 Helix
11.12.1 Helix Company Information
11.12.2 Helix Laboratory-developed Testing Product Offered
11.12.3 Helix Laboratory-developed Testing Revenue, Gross Margin and Market Share (2020-2025)
11.12.4 Helix Main Business Overview
11.12.5 Helix Latest Developments
12 Research Findings and Conclusion
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*If Applicable.
