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 Released in 2014, the draft guidance sparked an intense debate over potential LDT regulation.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.
Market Analysis and Insights: Global Laboratory-developed Testing Market
The global Laboratory-developed Testing market is projected to grow from US$ 3663.8 million in 2024 to US$ 4582.6 million by 2030, at a Compound Annual Growth Rate (CAGR) of 3.8% during the forecast 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%.
Report Covers:
This report presents an overview of global market for Laboratory-developed Testing market size. Analyses of the global market trends, with historic market revenue data for 2019 - 2023, estimates for 2024, and projections of CAGR through 2030.
This report researches the key producers of Laboratory-developed Testing, also provides the revenue of main regions and countries. Highlights of the upcoming market potential for Laboratory-developed Testing, and key regions/countries of focus to forecast this market into various segments and sub-segments. Country specific data and market value analysis for the U.S., Canada, Mexico, Brazil, China, Japan, South Korea, Southeast Asia, India, Germany, the U.K., Italy, Middle East, Africa, and Other Countries.
This report focuses on the Laboratory-developed Testing revenue, market share and industry ranking of main companies, data from 2019 to 2024. Identification of the major stakeholders in the global Laboratory-developed Testing market, and analysis of their competitive landscape and market positioning based on recent developments and segmental revenues. This report will help stakeholders to understand the competitive landscape and gain more insights and position their businesses and market strategies in a better way.
This report analyzes the segments data by Type and by Application, revenue, and growth rate, from 2019 to 2030. Evaluation and forecast the market size for Laboratory-developed Testing revenue, projected growth trends, production technology, application and end-user industry.
Market Segmentation
By Company
Adaptive Biotechnologies Corporation
Quest Diagnostics
Roche
Illumina
Qiagen
Eurofins
Guardant Health
Biotheranostics
Adaptive Biotechnologies
Rosetta Genomics
Biodesix
Helix
Segment by Type
Commercial Service
R&D
Segment by Application
Genetic Testing
Oncology
Infectious Disease
Others
By Region
North America
United States
Canada
Europe
Germany
France
UK
Italy
Russia
Nordic Countries
Rest of Europe
China
Asia (excluding China)
Japan
South Korea
China Taiwan
Southeast Asia
India
Latin America, Middle East & Africa
Brazil
Mexico
Turkey
Israel
GCC Countries
Chapter Outline
Chapter 1: Introduces the report scope of the report, executive summary of different market segments (product type, application, etc), including the market size of each market segment, future development potential, and so on. It offers a high-level view of the current state of the market and its likely evolution in the short to mid-term, and long term.
Chapter 2: Revenue of Laboratory-developed Testing in global and regional level. It provides a quantitative analysis of the market size and development potential of each region and its main countries and introduces the market development, future development prospects, market space, and capacity of each country in the world. This section also introduces the market dynamics, latest developments of the market, the driving factors and restrictive factors of the market, the challenges and risks faced by companies in the industry, and the analysis of relevant policies in the industry.
Chapter 3: Detailed analysis of Laboratory-developed Testing companies鈥� competitive landscape, revenue, market share and industry ranking, latest development plan, merger, and acquisition information, etc.
Chapter 4: Provides the analysis of various market segments by Type, covering the revenue, and development potential of each market segment, to help readers find the blue ocean market in different market segments.
Chapter 5: Provides the analysis of various market segments by Application, covering the revenue, and development potential of each market segment, to help readers find the blue ocean market in different downstream markets.
Chapter 6: North America (US & Canada) by Type, by Application and by country, revenue for each segment.
Chapter 7: Europe by Type, by Application and by country, revenue for each segment.
Chapter 8: China by Type, and by Application, revenue for each segment.
Chapter 9: Asia (excluding China) by Type, by Application and by region, revenue for each segment.
Chapter 10: Middle East, Africa, and Latin America by Type, by Application and by country, revenue for each segment.
Chapter 11: Provides profiles of key companies, introducing the basic situation of the main companies in the market in detail, including product descriptions and specifications, Laboratory-developed Testing revenue, gross margin, and recent development, etc.
Chapter 12: Analyst's Viewpoints/Conclusions
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1 Report Overview
1.1 Study Scope
1.2 Market Analysis by Type
1.2.1 Global Laboratory-developed Testing Market Size Growth Rate by Type, 2019 VS 2023 VS 2030
1.2.2 Commercial Service
1.2.3 R&D
1.3 Market by Application
1.3.1 Global Laboratory-developed Testing Market Size Growth Rate by Application, 2019 VS 2023 VS 2030
1.3.2 Genetic Testing
1.3.3 Oncology
1.3.4 Infectious Disease
1.3.5 Others
1.4 Assumptions and Limitations
1.5 Study Objectives
1.6 Years Considered
2 Global Growth Trends
2.1 Global Laboratory-developed Testing Market Perspective (2019-2030)
2.2 Global Laboratory-developed Testing Growth Trends by Region
2.2.1 Laboratory-developed Testing Market Size by Region: 2019 VS 2023 VS 2030
2.2.2 Laboratory-developed Testing Historic Market Size by Region (2019-2024)
2.2.3 Laboratory-developed Testing Forecasted Market Size by Region (2025-2030)
2.3 Laboratory-developed Testing Market Dynamics
2.3.1 Laboratory-developed Testing Industry Trends
2.3.2 Laboratory-developed Testing Market Drivers
2.3.3 Laboratory-developed Testing Market Challenges
2.3.4 Laboratory-developed Testing Market Restraints
3 Competition Landscape by Key Players
3.1 Global Revenue Laboratory-developed Testing by Players
3.1.1 Global Laboratory-developed Testing Revenue by Players (2019-2024)
3.1.2 Global Laboratory-developed Testing Revenue Market Share by Players (2019-2024)
3.2 Global Laboratory-developed Testing Market Share by Company Type (Tier 1, Tier 2, and Tier 3)
3.3 Global Key Players of Laboratory-developed Testing, Ranking by Revenue, 2022 VS 2023 VS 2024
3.4 Global Laboratory-developed Testing Market Concentration Ratio
3.4.1 Global Laboratory-developed Testing Market Concentration Ratio (CR5 and HHI)
3.4.2 Global Top 10 and Top 5 Companies by Laboratory-developed Testing Revenue in 2023
3.5 Global Key Players of Laboratory-developed Testing Head office and Area Served
3.6 Global Key Players of Laboratory-developed Testing, Product and Application
3.7 Global Key Players of Laboratory-developed Testing, Date of Enter into This Industry
3.8 Mergers & Acquisitions, Expansion Plans
4 Laboratory-developed Testing Breakdown Data by Type
4.1 Global Laboratory-developed Testing Historic Market Size by Type (2019-2024)
4.2 Global Laboratory-developed Testing Forecasted Market Size by Type (2025-2030)
5 Laboratory-developed Testing Breakdown Data by Application
5.1 Global Laboratory-developed Testing Historic Market Size by Application (2019-2024)
5.2 Global Laboratory-developed Testing Forecasted Market Size by Application (2025-2030)
6 North America
6.1 North America Laboratory-developed Testing Market Size (2019-2030)
6.2 North America Laboratory-developed Testing Market Size by Type
6.2.1 North America Laboratory-developed Testing Market Size by Type (2019-2024)
6.2.2 North America Laboratory-developed Testing Market Size by Type (2025-2030)
6.2.3 North America Laboratory-developed Testing Market Share by Type (2019-2030)
6.3 North America Laboratory-developed Testing Market Size by Application
6.3.1 North America Laboratory-developed Testing Market Size by Application (2019-2024)
6.3.2 North America Laboratory-developed Testing Market Size by Application (2025-2030)
6.3.3 North America Laboratory-developed Testing Market Share by Application (2019-2030)
6.4 North America Laboratory-developed Testing Market Size by Country
6.4.1 North America Laboratory-developed Testing Market Size by Country: 2019 VS 2023 VS 2030
6.4.2 North America Laboratory-developed Testing Market Size by Country (2019-2024)
6.4.3 North America Laboratory-developed Testing Market Size by Country (2025-2030)
6.4.4 U.S.
6.4.5 Canada
7 Europe
7.1 Europe Laboratory-developed Testing Market Size (2019-2030)
7.2 Europe Laboratory-developed Testing Market Size by Type
7.2.1 Europe Laboratory-developed Testing Market Size by Type (2019-2024)
7.2.2 Europe Laboratory-developed Testing Market Size by Type (2025-2030)
7.2.3 Europe Laboratory-developed Testing Market Share by Type (2019-2030)
7.3 Europe Laboratory-developed Testing Market Size by Application
7.3.1 Europe Laboratory-developed Testing Market Size by Application (2019-2024)
7.3.2 Europe Laboratory-developed Testing Market Size by Application (2025-2030)
7.3.3 Europe Laboratory-developed Testing Market Share by Application (2019-2030)
7.4 Europe Laboratory-developed Testing Market Size by Country
7.4.1 Europe Laboratory-developed Testing Market Size by Country: 2019 VS 2023 VS 2030
7.4.2 Europe Laboratory-developed Testing Market Size by Country (2019-2024)
7.4.3 Europe Laboratory-developed Testing Market Size by Country (2025-2030)
7.4.3 Germany
7.4.4 France
7.4.5 U.K.
7.4.6 Italy
7.4.7 Russia
7.4.8 Nordic Countries
8 China
8.1 China Laboratory-developed Testing Market Size (2019-2030)
8.2 China Laboratory-developed Testing Market Size by Type
8.2.1 China Laboratory-developed Testing Market Size by Type (2019-2024)
8.2.2 China Laboratory-developed Testing Market Size by Type (2025-2030)
8.2.3 China Laboratory-developed Testing Market Share by Type (2019-2030)
8.3 China Laboratory-developed Testing Market Size by Application
8.3.1 China Laboratory-developed Testing Market Size by Application (2019-2024)
8.3.2 China Laboratory-developed Testing Market Size by Application (2025-2030)
8.3.3 China Laboratory-developed Testing Market Share by Application (2019-2030)
9 Asia (excluding China)
9.1 Asia Laboratory-developed Testing Market Size (2019-2030)
9.2 Asia Laboratory-developed Testing Market Size by Type
9.2.1 Asia Laboratory-developed Testing Market Size by Type (2019-2024)
9.2.2 Asia Laboratory-developed Testing Market Size by Type (2025-2030)
9.2.3 Asia Laboratory-developed Testing Market Share by Type (2019-2030)
9.3 Asia Laboratory-developed Testing Market Size by Application
9.3.1 Asia Laboratory-developed Testing Market Size by Application (2019-2024)
9.3.2 Asia Laboratory-developed Testing Market Size by Application (2025-2030)
9.3.3 Asia Laboratory-developed Testing Market Share by Application (2019-2030)
9.4 Asia Laboratory-developed Testing Market Size by Region
9.4.1 Asia Laboratory-developed Testing Market Size by Region: 2019 VS 2023 VS 2030
9.4.2 Asia Laboratory-developed Testing Market Size by Region (2019-2024)
9.4.3 Asia Laboratory-developed Testing Market Size by Region (2025-2030)
9.4.4 Japan
9.4.5 South Korea
9.4.6 China Taiwan
9.4.7 Southeast Asia
9.4.8 India
9.4.9 Australia
10 Middle East, Africa, and Latin America
10.1 Middle East, Africa, and Latin America Laboratory-developed Testing Market Size (2019-2030)
10.2 Middle East, Africa, and Latin America Laboratory-developed Testing Market Size by Type
10.2.1 Middle East, Africa, and Latin America Laboratory-developed Testing Market Size by Type (2019-2024)
10.2.2 Middle East, Africa, and Latin America Laboratory-developed Testing Market Size by Type (2025-2030)
10.2.3 Middle East, Africa, and Latin America Laboratory-developed Testing Market Share by Type (2019-2030)
10.3 Middle East, Africa, and Latin America Laboratory-developed Testing Market Size by Application
10.3.1 Middle East, Africa, and Latin America Laboratory-developed Testing Market Size by Application (2019-2024)
10.3.2 Middle East, Africa, and Latin America Laboratory-developed Testing Market Size by Application (2025-2030)
10.3.3 Middle East, Africa, and Latin America Laboratory-developed Testing Market Share by Application (2019-2030)
10.4 Middle East, Africa, and Latin America Laboratory-developed Testing Market Size by Country
10.4.1 Middle East, Africa, and Latin America Laboratory-developed Testing Market Size by Country: 2019 VS 2023 VS 2030
10.4.2 Middle East, Africa, and Latin America Laboratory-developed Testing Market Size by Country (2019-2024)
10.4.3 Middle East, Africa, and Latin America Laboratory-developed Testing Market Size by Country (2025-2030)
10.4.4 Brazil
10.4.5 Mexico
10.4.6 Turkey
10.4.7 Saudi Arabia
10.4.8 Israel
10.4.9 GCC Countries
11 Key Players Profiles
11.1 Adaptive Biotechnologies Corporation
11.1.1 Adaptive Biotechnologies Corporation Company Details
11.1.2 Adaptive Biotechnologies Corporation Business Overview
11.1.3 Adaptive Biotechnologies Corporation Laboratory-developed Testing Introduction
11.1.4 Adaptive Biotechnologies Corporation Revenue in Laboratory-developed Testing Business (2019-2024)
11.1.5 Adaptive Biotechnologies Corporation Recent Developments
11.2 Quest Diagnostics
11.2.1 Quest Diagnostics Company Details
11.2.2 Quest Diagnostics Business Overview
11.2.3 Quest Diagnostics Laboratory-developed Testing Introduction
11.2.4 Quest Diagnostics Revenue in Laboratory-developed Testing Business (2019-2024)
11.2.5 Quest Diagnostics Recent Developments
11.3 Roche
11.3.1 Roche Company Details
11.3.2 Roche Business Overview
11.3.3 Roche Laboratory-developed Testing Introduction
11.3.4 Roche Revenue in Laboratory-developed Testing Business (2019-2024)
11.3.5 Roche Recent Developments
11.4 Illumina
11.4.1 Illumina Company Details
11.4.2 Illumina Business Overview
11.4.3 Illumina Laboratory-developed Testing Introduction
11.4.4 Illumina Revenue in Laboratory-developed Testing Business (2019-2024)
11.4.5 Illumina Recent Developments
11.5 Qiagen
11.5.1 Qiagen Company Details
11.5.2 Qiagen Business Overview
11.5.3 Qiagen Laboratory-developed Testing Introduction
11.5.4 Qiagen Revenue in Laboratory-developed Testing Business (2019-2024)
11.5.5 Qiagen Recent Developments
11.6 Eurofins
11.6.1 Eurofins Company Details
11.6.2 Eurofins Business Overview
11.6.3 Eurofins Laboratory-developed Testing Introduction
11.6.4 Eurofins Revenue in Laboratory-developed Testing Business (2019-2024)
11.6.5 Eurofins Recent Developments
11.7 Guardant Health
11.7.1 Guardant Health Company Details
11.7.2 Guardant Health Business Overview
11.7.3 Guardant Health Laboratory-developed Testing Introduction
11.7.4 Guardant Health Revenue in Laboratory-developed Testing Business (2019-2024)
11.7.5 Guardant Health Recent Developments
11.8 Biotheranostics
11.8.1 Biotheranostics Company Details
11.8.2 Biotheranostics Business Overview
11.8.3 Biotheranostics Laboratory-developed Testing Introduction
11.8.4 Biotheranostics Revenue in Laboratory-developed Testing Business (2019-2024)
11.8.5 Biotheranostics Recent Developments
11.9 Adaptive Biotechnologies
11.9.1 Adaptive Biotechnologies Company Details
11.9.2 Adaptive Biotechnologies Business Overview
11.9.3 Adaptive Biotechnologies Laboratory-developed Testing Introduction
11.9.4 Adaptive Biotechnologies Revenue in Laboratory-developed Testing Business (2019-2024)
11.9.5 Adaptive Biotechnologies Recent Developments
11.10 Rosetta Genomics
11.10.1 Rosetta Genomics Company Details
11.10.2 Rosetta Genomics Business Overview
11.10.3 Rosetta Genomics Laboratory-developed Testing Introduction
11.10.4 Rosetta Genomics Revenue in Laboratory-developed Testing Business (2019-2024)
11.10.5 Rosetta Genomics Recent Developments
11.11 Biodesix
11.11.1 Biodesix Company Details
11.11.2 Biodesix Business Overview
11.11.3 Biodesix Laboratory-developed Testing Introduction
11.11.4 Biodesix Revenue in Laboratory-developed Testing Business (2019-2024)
11.11.5 Biodesix Recent Developments
11.12 Helix
11.12.1 Helix Company Details
11.12.2 Helix Business Overview
11.12.3 Helix Laboratory-developed Testing Introduction
11.12.4 Helix Revenue in Laboratory-developed Testing Business (2019-2024)
11.12.5 Helix Recent Developments
12 Analyst's Viewpoints/Conclusions
13 Appendix
13.1 Research Methodology
13.1.1 Methodology/Research Approach
13.1.2 Data Source
13.2 Disclaimer
13.3 Author Details
Adaptive Biotechnologies Corporation
Quest Diagnostics
Roche
Illumina
Qiagen
Eurofins
Guardant Health
Biotheranostics
Adaptive Biotechnologies
Rosetta Genomics
Biodesix
Helix
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*If Applicable.
