The global Laboratory-developed Testing market size was valued at US$ 3442.2 million in 2023. With growing demand in downstream market, the Laboratory-developed Testing is forecast to a readjusted size of US$ 4512 million by 2030 with a CAGR of 3.9% during review period.
The research report highlights the growth potential of the global Laboratory-developed Testing market. Laboratory-developed Testing are expected to show stable growth in the future market. However, product differentiation, reducing costs, and supply chain optimization remain crucial for the widespread adoption of Laboratory-developed Testing. 麻豆原创 players need to invest in research and development, forge strategic partnerships, and align their offerings with evolving consumer preferences to capitalize on the immense opportunities presented by the Laboratory-developed Testing market.
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 Released in 2014, the draft guidance sparked an intense debate over potential LDT regulation.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 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%.
Key Features:
The report on Laboratory-developed Testing market reflects various aspects and provide valuable insights into the industry.
麻豆原创 Size and Growth: The research report provide an overview of the current size and growth of the Laboratory-developed Testing market. It may include historical data, market segmentation by Type (e.g., Commercial Service, R&D), and regional breakdowns.
麻豆原创 Drivers and Challenges: The report can identify and analyse the factors driving the growth of the Laboratory-developed Testing market, such as government regulations, environmental concerns, technological advancements, and changing consumer preferences. It can also highlight the challenges faced by the industry, including infrastructure limitations, range anxiety, and high upfront costs.
Competitive Landscape: The research report provides analysis of the competitive landscape within the Laboratory-developed Testing market. It includes profiles of key players, their market share, strategies, and product offerings. The report can also highlight emerging players and their potential impact on the market.
Technological Developments: The research report can delve into the latest technological developments in the Laboratory-developed Testing industry. This include advancements in Laboratory-developed Testing technology, Laboratory-developed Testing new entrants, Laboratory-developed Testing new investment, and other innovations that are shaping the future of Laboratory-developed Testing.
Downstream Procumbent Preference: The report can shed light on customer procumbent behaviour and adoption trends in the Laboratory-developed Testing market. It includes factors influencing customer ' purchasing decisions, preferences for Laboratory-developed Testing product.
Government Policies and Incentives: The research report analyse the impact of government policies and incentives on the Laboratory-developed Testing market. This may include an assessment of regulatory frameworks, subsidies, tax incentives, and other measures aimed at promoting Laboratory-developed Testing market. The report also evaluates the effectiveness of these policies in driving market growth.
Environmental Impact and Sustainability: The research report assess the environmental impact and sustainability aspects of the Laboratory-developed Testing market.
麻豆原创 Forecasts and Future Outlook: Based on the analysis conducted, the research report provide market forecasts and outlook for the Laboratory-developed Testing industry. This includes projections of market size, growth rates, regional trends, and predictions on technological advancements and policy developments.
Recommendations and Opportunities: The report conclude with recommendations for industry stakeholders, policymakers, and investors. It highlights potential opportunities for market players to capitalize on emerging trends, overcome challenges, and contribute to the growth and development of the Laboratory-developed Testing market.
麻豆原创 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 in terms of value.
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 麻豆原创 Introduction
1.2 Years Considered
1.3 Research Objectives
1.4 麻豆原创 Research Methodology
1.5 Research Process and Data Source
1.6 Economic Indicators
1.7 Currency Considered
1.8 麻豆原创 Estimation Caveats
2 Executive Summary
2.1 World 麻豆原创 Overview
2.1.1 Global Laboratory-developed Testing 麻豆原创 Size 2019-2030
2.1.2 Laboratory-developed Testing 麻豆原创 Size CAGR by Region 2019 VS 2023 VS 2030
2.2 Laboratory-developed Testing Segment by Type
2.2.1 Commercial Service
2.2.2 R&D
2.3 Laboratory-developed Testing 麻豆原创 Size by Type
2.3.1 Laboratory-developed Testing 麻豆原创 Size CAGR by Type (2019 VS 2023 VS 2030)
2.3.2 Global Laboratory-developed Testing 麻豆原创 Size 麻豆原创 Share by Type (2019-2024)
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 麻豆原创 Size by Application
2.5.1 Laboratory-developed Testing 麻豆原创 Size CAGR by Application (2019 VS 2023 VS 2030)
2.5.2 Global Laboratory-developed Testing 麻豆原创 Size 麻豆原创 Share by Application (2019-2024)
3 Laboratory-developed Testing 麻豆原创 Size by Player
3.1 Laboratory-developed Testing 麻豆原创 Size 麻豆原创 Share by Players
3.1.1 Global Laboratory-developed Testing Revenue by Players (2019-2024)
3.1.2 Global Laboratory-developed Testing Revenue 麻豆原创 Share by Players (2019-2024)
3.2 Global Laboratory-developed Testing Key Players Head office and Products Offered
3.3 麻豆原创 Concentration Rate Analysis
3.3.1 Competition Landscape Analysis
3.3.2 Concentration Ratio (CR3, CR5 and CR10) & (2022-2024)
3.4 New Products and Potential Entrants
3.5 Mergers & Acquisitions, Expansion
4 Laboratory-developed Testing by Regions
4.1 Laboratory-developed Testing 麻豆原创 Size by Regions (2019-2024)
4.2 Americas Laboratory-developed Testing 麻豆原创 Size Growth (2019-2024)
4.3 APAC Laboratory-developed Testing 麻豆原创 Size Growth (2019-2024)
4.4 Europe Laboratory-developed Testing 麻豆原创 Size Growth (2019-2024)
4.5 Middle East & Africa Laboratory-developed Testing 麻豆原创 Size Growth (2019-2024)
5 Americas
5.1 Americas Laboratory-developed Testing 麻豆原创 Size by Country (2019-2024)
5.2 Americas Laboratory-developed Testing 麻豆原创 Size by Type (2019-2024)
5.3 Americas Laboratory-developed Testing 麻豆原创 Size by Application (2019-2024)
5.4 United States
5.5 Canada
5.6 Mexico
5.7 Brazil
6 APAC
6.1 APAC Laboratory-developed Testing 麻豆原创 Size by Region (2019-2024)
6.2 APAC Laboratory-developed Testing 麻豆原创 Size by Type (2019-2024)
6.3 APAC Laboratory-developed Testing 麻豆原创 Size by Application (2019-2024)
6.4 China
6.5 Japan
6.6 Korea
6.7 Southeast Asia
6.8 India
6.9 Australia
7 Europe
7.1 Europe Laboratory-developed Testing by Country (2019-2024)
7.2 Europe Laboratory-developed Testing 麻豆原创 Size by Type (2019-2024)
7.3 Europe Laboratory-developed Testing 麻豆原创 Size by Application (2019-2024)
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 (2019-2024)
8.2 Middle East & Africa Laboratory-developed Testing 麻豆原创 Size by Type (2019-2024)
8.3 Middle East & Africa Laboratory-developed Testing 麻豆原创 Size by Application (2019-2024)
8.4 Egypt
8.5 South Africa
8.6 Israel
8.7 Turkey
8.8 GCC Countries
9 麻豆原创 Drivers, Challenges and Trends
9.1 麻豆原创 Drivers & Growth Opportunities
9.2 麻豆原创 Challenges & Risks
9.3 Industry Trends
10 Global Laboratory-developed Testing 麻豆原创 Forecast
10.1 Global Laboratory-developed Testing Forecast by Regions (2025-2030)
10.1.1 Global Laboratory-developed Testing Forecast by Regions (2025-2030)
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 (2025-2030)
10.2.1 United States Laboratory-developed Testing 麻豆原创 Forecast
10.2.2 Canada Laboratory-developed Testing 麻豆原创 Forecast
10.2.3 Mexico Laboratory-developed Testing 麻豆原创 Forecast
10.2.4 Brazil Laboratory-developed Testing 麻豆原创 Forecast
10.3 APAC Laboratory-developed Testing Forecast by Region (2025-2030)
10.3.1 China Laboratory-developed Testing 麻豆原创 Forecast
10.3.2 Japan Laboratory-developed Testing 麻豆原创 Forecast
10.3.3 Korea Laboratory-developed Testing 麻豆原创 Forecast
10.3.4 Southeast Asia Laboratory-developed Testing 麻豆原创 Forecast
10.3.5 India Laboratory-developed Testing 麻豆原创 Forecast
10.3.6 Australia Laboratory-developed Testing 麻豆原创 Forecast
10.4 Europe Laboratory-developed Testing Forecast by Country (2025-2030)
10.4.1 Germany Laboratory-developed Testing 麻豆原创 Forecast
10.4.2 France Laboratory-developed Testing 麻豆原创 Forecast
10.4.3 UK Laboratory-developed Testing 麻豆原创 Forecast
10.4.4 Italy Laboratory-developed Testing 麻豆原创 Forecast
10.4.5 Russia Laboratory-developed Testing 麻豆原创 Forecast
10.5 Middle East & Africa Laboratory-developed Testing Forecast by Region (2025-2030)
10.5.1 Egypt Laboratory-developed Testing 麻豆原创 Forecast
10.5.2 South Africa Laboratory-developed Testing 麻豆原创 Forecast
10.5.3 Israel Laboratory-developed Testing 麻豆原创 Forecast
10.5.4 Turkey Laboratory-developed Testing 麻豆原创 Forecast
10.5.5 GCC Countries Laboratory-developed Testing 麻豆原创 Forecast
10.6 Global Laboratory-developed Testing Forecast by Type (2025-2030)
10.7 Global Laboratory-developed Testing Forecast by Application (2025-2030)
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 麻豆原创 Share (2019-2024)
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 麻豆原创 Share (2019-2024)
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 麻豆原创 Share (2019-2024)
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 麻豆原创 Share (2019-2024)
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 麻豆原创 Share (2019-2024)
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 麻豆原创 Share (2019-2024)
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 麻豆原创 Share (2019-2024)
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 麻豆原创 Share (2019-2024)
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 麻豆原创 Share (2019-2024)
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 麻豆原创 Share (2019-2024)
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 麻豆原创 Share (2019-2024)
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 麻豆原创 Share (2019-2024)
11.12.4 Helix Main Business Overview
11.12.5 Helix Latest Developments
12 Research Findings and Conclusion
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*If Applicable.
