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Global Laboratory-developed Testing Market Research Report 2024
Synopsis
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 Released in 2014, the draft guidance sparked an intense debate over potential LDT regulation.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 global Laboratory-developed Testing market was valued at US$ 3518.7 million in 2023 and is anticipated to reach US$ 4582.6 million by 2030, witnessing a CAGR of 3.8% during the forecast period 2024-2030.
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 aims to provide a comprehensive presentation of the global market for Laboratory-developed Testing, with both quantitative and qualitative analysis, to help readers develop business/growth strategies, assess the market competitive situation, analyze their position in the current marketplace, and make informed business decisions regarding Laboratory-developed Testing.
Report Scope
The Laboratory-developed Testing market size, estimations, and forecasts are provided in terms of revenue ($ millions), considering 2023 as the base year, with history and forecast data for the period from 2019 to 2030. This report segments the global Laboratory-developed Testing market comprehensively. Regional market sizes, concerning products by Type, by Application, and by players, are also provided.
For a more in-depth understanding of the market, the report provides profiles of the competitive landscape, key competitors, and their respective market ranks. The report also discusses technological trends and new product developments.
The report will help the Laboratory-developed Testing companies, new entrants, and industry chain related companies in this market with information on the revenues, sales volume, and average price for the overall market and the sub-segments across the different segments, by company, by Type, by Application, and by regions.
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
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
Chapter Outline
Chapter 1: Introduces the report scope of the report, executive summary of different market segments (by Type, by 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: Introduces executive summary of global market size, regional market size, 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’ competitive landscape, revenue market share, latest development plan, merger, and acquisition information, etc.
Chapter 4: Provides the analysis of various market segments by Type, covering the market size 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 market size and development potential of each market segment, to help readers find the blue ocean market in different downstream markets.
Chapter 6, 7, 8, 9, 10: North America, Europe, Asia Pacific, Latin America, Middle East and Africa segment by country. 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.
Chapter 11: Provides profiles of key players, introducing the basic situation of the main companies in the market in detail, including product sales, revenue, price, gross margin, product introduction, recent development, etc.
Chapter 12: The main points and conclusions of the report.
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 global Laboratory-developed Testing market was valued at US$ 3518.7 million in 2023 and is anticipated to reach US$ 4582.6 million by 2030, witnessing a CAGR of 3.8% during the forecast period 2024-2030.
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 aims to provide a comprehensive presentation of the global market for Laboratory-developed Testing, with both quantitative and qualitative analysis, to help readers develop business/growth strategies, assess the market competitive situation, analyze their position in the current marketplace, and make informed business decisions regarding Laboratory-developed Testing.
Report Scope
The Laboratory-developed Testing market size, estimations, and forecasts are provided in terms of revenue ($ millions), considering 2023 as the base year, with history and forecast data for the period from 2019 to 2030. This report segments the global Laboratory-developed Testing market comprehensively. Regional market sizes, concerning products by Type, by Application, and by players, are also provided.
For a more in-depth understanding of the market, the report provides profiles of the competitive landscape, key competitors, and their respective market ranks. The report also discusses technological trends and new product developments.
The report will help the Laboratory-developed Testing companies, new entrants, and industry chain related companies in this market with information on the revenues, sales volume, and average price for the overall market and the sub-segments across the different segments, by company, by Type, by Application, and by regions.
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
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
Chapter Outline
Chapter 1: Introduces the report scope of the report, executive summary of different market segments (by Type, by 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: Introduces executive summary of global market size, regional market size, 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’ competitive landscape, revenue market share, latest development plan, merger, and acquisition information, etc.
Chapter 4: Provides the analysis of various market segments by Type, covering the market size 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 market size and development potential of each market segment, to help readers find the blue ocean market in different downstream markets.
Chapter 6, 7, 8, 9, 10: North America, Europe, Asia Pacific, Latin America, Middle East and Africa segment by country. 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.
Chapter 11: Provides profiles of key players, introducing the basic situation of the main companies in the market in detail, including product sales, revenue, price, gross margin, product introduction, recent development, etc.
Chapter 12: The main points and conclusions of the report.
Index1 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 Growth 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 Study Objectives
1.5 Years Considered
1.6 Years Considered
2 Global Growth Trends
2.1 Global Laboratory-developed Testing Market Perspective (2019-2030)
2.2 Laboratory-developed Testing Growth Trends by Region
2.2.1 Global 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 Top Laboratory-developed Testing Players by Revenue
3.1.1 Global Top Laboratory-developed Testing Players by Revenue (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 Players Covered: Ranking by Laboratory-developed Testing Revenue
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 Laboratory-developed Testing Key Players Head office and Area Served
3.6 Key Players Laboratory-developed Testing Product Solution and Service
3.7 Date of Enter into Laboratory-developed Testing Market
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 Growth Rate by Country: 2019 VS 2023 VS 2030
6.3 North America Laboratory-developed Testing Market Size by Country (2019-2024)
6.4 North America Laboratory-developed Testing Market Size by Country (2025-2030)
6.5 United States
6.6 Canada
7 Europe
7.1 Europe Laboratory-developed Testing Market Size (2019-2030)
7.2 Europe Laboratory-developed Testing Market Growth Rate by Country: 2019 VS 2023 VS 2030
7.3 Europe Laboratory-developed Testing Market Size by Country (2019-2024)
7.4 Europe Laboratory-developed Testing Market Size by Country (2025-2030)
7.5 Germany
7.6 France
7.7 U.K.
7.8 Italy
7.9 Russia
7.10 Nordic Countries
8 Asia-Pacific
8.1 Asia-Pacific Laboratory-developed Testing Market Size (2019-2030)
8.2 Asia-Pacific Laboratory-developed Testing Market Growth Rate by Region: 2019 VS 2023 VS 2030
8.3 Asia-Pacific Laboratory-developed Testing Market Size by Region (2019-2024)
8.4 Asia-Pacific Laboratory-developed Testing Market Size by Region (2025-2030)
8.5 China
8.6 Japan
8.7 South Korea
8.8 Southeast Asia
8.9 India
8.10 Australia
9 Latin America
9.1 Latin America Laboratory-developed Testing Market Size (2019-2030)
9.2 Latin America Laboratory-developed Testing Market Growth Rate by Country: 2019 VS 2023 VS 2030
9.3 Latin America Laboratory-developed Testing Market Size by Country (2019-2024)
9.4 Latin America Laboratory-developed Testing Market Size by Country (2025-2030)
9.5 Mexico
9.6 Brazil
10 Middle East & Africa
10.1 Middle East & Africa Laboratory-developed Testing Market Size (2019-2030)
10.2 Middle East & Africa Laboratory-developed Testing Market Growth Rate by Country: 2019 VS 2023 VS 2030
10.3 Middle East & Africa Laboratory-developed Testing Market Size by Country (2019-2024)
10.4 Middle East & Africa Laboratory-developed Testing Market Size by Country (2025-2030)
10.5 Turkey
10.6 Saudi Arabia
10.7 UAE
11 Key Players Profiles
11.1 Adaptive Biotechnologies Corporation
11.1.1 Adaptive Biotechnologies Corporation Company Detail
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 Development
11.2 Quest Diagnostics
11.2.1 Quest Diagnostics Company Detail
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 Development
11.3 Roche
11.3.1 Roche Company Detail
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 Development
11.4 Illumina
11.4.1 Illumina Company Detail
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 Development
11.5 Qiagen
11.5.1 Qiagen Company Detail
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 Development
11.6 Eurofins
11.6.1 Eurofins Company Detail
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 Development
11.7 Guardant Health
11.7.1 Guardant Health Company Detail
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 Development
11.8 Biotheranostics
11.8.1 Biotheranostics Company Detail
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 Development
11.9 Adaptive Biotechnologies
11.9.1 Adaptive Biotechnologies Company Detail
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 Development
11.10 Rosetta Genomics
11.10.1 Rosetta Genomics Company Detail
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 Development
11.11 Biodesix
11.11.1 Biodesix Company Detail
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 Development
11.12 Helix
11.12.1 Helix Company Detail
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 Development
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
Published By : QY Research
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