The global Laboratory Developed Test market size was valued at US$ 3442.2 million in 2023. With growing demand in downstream market, the Laboratory Developed Test is forecast to a readjusted size of US$ 4295.9 million by 2030 with a CAGR of 3.2% during review period.
The research report highlights the growth potential of the global Laboratory Developed Test market. Laboratory Developed Test 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 Test. Market 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 Test 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 Released in 2016, the draft guidance sparked an intense debate over potential LDT regulation.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.
According to our research, the global market for medical devices is estimated at US$ 603 billion in the year 2023, and will be growing at a CAGR of 5% during next six years. The global healthcare spending contributes to occupy 10% of the global GDP and is continuously rising in recent years due to the increasing health needs of the aging population, the growing prevalence of chronic and infectious diseases and the expansion of emerging markets. The medical devices market plays a significant role in the healthcare industry. The market is driven by several factors, including the increasing demand for advanced healthcare services globally, advancements in medical technology, growing geriatric population, rising healthcare expenditure, and increasing awareness about early disease diagnosis and treatment.
Key Features:
The report on Laboratory Developed Test market reflects various aspects and provide valuable insights into the industry.
Market Size and Growth: The research report provide an overview of the current size and growth of the Laboratory Developed Test market. It may include historical data, market segmentation by Type (e.g., Clinical Biochemistry, Hematology), and regional breakdowns.
Market Drivers and Challenges: The report can identify and analyse the factors driving the growth of the Laboratory Developed Test 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 Test 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 Test industry. This include advancements in Laboratory Developed Test technology, Laboratory Developed Test new entrants, Laboratory Developed Test new investment, and other innovations that are shaping the future of Laboratory Developed Test.
Downstream Procumbent Preference: The report can shed light on customer procumbent behaviour and adoption trends in the Laboratory Developed Test market. It includes factors influencing customer ' purchasing decisions, preferences for Laboratory Developed Test product.
Government Policies and Incentives: The research report analyse the impact of government policies and incentives on the Laboratory Developed Test market. This may include an assessment of regulatory frameworks, subsidies, tax incentives, and other measures aimed at promoting Laboratory Developed Test 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 Test market.
Market Forecasts and Future Outlook: Based on the analysis conducted, the research report provide market forecasts and outlook for the Laboratory Developed Test 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 Test market.
Market Segmentation:
Laboratory Developed Test 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
Clinical Biochemistry
Hematology
Immunology
Molecular Diagnostics
Other
Segmentation by application
Hospitals Laboratory
Clinical Research Organizations
Academic Institutes
Specialty Diagnostic Centers
Other
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.
Quest Diagnostics
Thermo Fisher
Waters
Roche
Illumina
Qiagen
23andMe
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 Test Market Size 2019-2030
2.1.2 Laboratory Developed Test Market Size CAGR by Region 2019 VS 2023 VS 2030
2.2 Laboratory Developed Test Segment by Type
2.2.1 Clinical Biochemistry
2.2.2 Hematology
2.2.3 Immunology
2.2.4 Molecular Diagnostics
2.2.5 Other
2.3 Laboratory Developed Test Market Size by Type
2.3.1 Laboratory Developed Test Market Size CAGR by Type (2019 VS 2023 VS 2030)
2.3.2 Global Laboratory Developed Test Market Size Market Share by Type (2019-2024)
2.4 Laboratory Developed Test Segment by Application
2.4.1 Hospitals Laboratory
2.4.2 Clinical Research Organizations
2.4.3 Academic Institutes
2.4.4 Specialty Diagnostic Centers
2.4.5 Other
2.5 Laboratory Developed Test Market Size by Application
2.5.1 Laboratory Developed Test Market Size CAGR by Application (2019 VS 2023 VS 2030)
2.5.2 Global Laboratory Developed Test Market Size Market Share by Application (2019-2024)
3 Laboratory Developed Test Market Size by Player
3.1 Laboratory Developed Test Market Size Market Share by Players
3.1.1 Global Laboratory Developed Test Revenue by Players (2019-2024)
3.1.2 Global Laboratory Developed Test Revenue Market Share by Players (2019-2024)
3.2 Global Laboratory Developed Test 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) & (2022-2024)
3.4 New Products and Potential Entrants
3.5 Mergers & Acquisitions, Expansion
4 Laboratory Developed Test by Regions
4.1 Laboratory Developed Test Market Size by Regions (2019-2024)
4.2 Americas Laboratory Developed Test Market Size Growth (2019-2024)
4.3 APAC Laboratory Developed Test Market Size Growth (2019-2024)
4.4 Europe Laboratory Developed Test Market Size Growth (2019-2024)
4.5 Middle East & Africa Laboratory Developed Test Market Size Growth (2019-2024)
5 Americas
5.1 Americas Laboratory Developed Test Market Size by Country (2019-2024)
5.2 Americas Laboratory Developed Test Market Size by Type (2019-2024)
5.3 Americas Laboratory Developed Test Market 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 Test Market Size by Region (2019-2024)
6.2 APAC Laboratory Developed Test Market Size by Type (2019-2024)
6.3 APAC Laboratory Developed Test Market 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 Test by Country (2019-2024)
7.2 Europe Laboratory Developed Test Market Size by Type (2019-2024)
7.3 Europe Laboratory Developed Test Market 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 Test by Region (2019-2024)
8.2 Middle East & Africa Laboratory Developed Test Market Size by Type (2019-2024)
8.3 Middle East & Africa Laboratory Developed Test Market Size by Application (2019-2024)
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 Test Market Forecast
10.1 Global Laboratory Developed Test Forecast by Regions (2025-2030)
10.1.1 Global Laboratory Developed Test Forecast by Regions (2025-2030)
10.1.2 Americas Laboratory Developed Test Forecast
10.1.3 APAC Laboratory Developed Test Forecast
10.1.4 Europe Laboratory Developed Test Forecast
10.1.5 Middle East & Africa Laboratory Developed Test Forecast
10.2 Americas Laboratory Developed Test Forecast by Country (2025-2030)
10.2.1 United States Laboratory Developed Test Market Forecast
10.2.2 Canada Laboratory Developed Test Market Forecast
10.2.3 Mexico Laboratory Developed Test Market Forecast
10.2.4 Brazil Laboratory Developed Test Market Forecast
10.3 APAC Laboratory Developed Test Forecast by Region (2025-2030)
10.3.1 China Laboratory Developed Test Market Forecast
10.3.2 Japan Laboratory Developed Test Market Forecast
10.3.3 Korea Laboratory Developed Test Market Forecast
10.3.4 Southeast Asia Laboratory Developed Test Market Forecast
10.3.5 India Laboratory Developed Test Market Forecast
10.3.6 Australia Laboratory Developed Test Market Forecast
10.4 Europe Laboratory Developed Test Forecast by Country (2025-2030)
10.4.1 Germany Laboratory Developed Test Market Forecast
10.4.2 France Laboratory Developed Test Market Forecast
10.4.3 UK Laboratory Developed Test Market Forecast
10.4.4 Italy Laboratory Developed Test Market Forecast
10.4.5 Russia Laboratory Developed Test Market Forecast
10.5 Middle East & Africa Laboratory Developed Test Forecast by Region (2025-2030)
10.5.1 Egypt Laboratory Developed Test Market Forecast
10.5.2 South Africa Laboratory Developed Test Market Forecast
10.5.3 Israel Laboratory Developed Test Market Forecast
10.5.4 Turkey Laboratory Developed Test Market Forecast
10.5.5 GCC Countries Laboratory Developed Test Market Forecast
10.6 Global Laboratory Developed Test Forecast by Type (2025-2030)
10.7 Global Laboratory Developed Test Forecast by Application (2025-2030)
11 Key Players Analysis
11.1 Quest Diagnostics
11.1.1 Quest Diagnostics Company Information
11.1.2 Quest Diagnostics Laboratory Developed Test Product Offered
11.1.3 Quest Diagnostics Laboratory Developed Test Revenue, Gross Margin and Market Share (2019-2024)
11.1.4 Quest Diagnostics Main Business Overview
11.1.5 Quest Diagnostics Latest Developments
11.2 Thermo Fisher
11.2.1 Thermo Fisher Company Information
11.2.2 Thermo Fisher Laboratory Developed Test Product Offered
11.2.3 Thermo Fisher Laboratory Developed Test Revenue, Gross Margin and Market Share (2019-2024)
11.2.4 Thermo Fisher Main Business Overview
11.2.5 Thermo Fisher Latest Developments
11.3 Waters
11.3.1 Waters Company Information
11.3.2 Waters Laboratory Developed Test Product Offered
11.3.3 Waters Laboratory Developed Test Revenue, Gross Margin and Market Share (2019-2024)
11.3.4 Waters Main Business Overview
11.3.5 Waters Latest Developments
11.4 Roche
11.4.1 Roche Company Information
11.4.2 Roche Laboratory Developed Test Product Offered
11.4.3 Roche Laboratory Developed Test Revenue, Gross Margin and Market Share (2019-2024)
11.4.4 Roche Main Business Overview
11.4.5 Roche Latest Developments
11.5 Illumina
11.5.1 Illumina Company Information
11.5.2 Illumina Laboratory Developed Test Product Offered
11.5.3 Illumina Laboratory Developed Test Revenue, Gross Margin and Market Share (2019-2024)
11.5.4 Illumina Main Business Overview
11.5.5 Illumina Latest Developments
11.6 Qiagen
11.6.1 Qiagen Company Information
11.6.2 Qiagen Laboratory Developed Test Product Offered
11.6.3 Qiagen Laboratory Developed Test Revenue, Gross Margin and Market Share (2019-2024)
11.6.4 Qiagen Main Business Overview
11.6.5 Qiagen Latest Developments
11.7 23andMe
11.7.1 23andMe Company Information
11.7.2 23andMe Laboratory Developed Test Product Offered
11.7.3 23andMe Laboratory Developed Test Revenue, Gross Margin and Market Share (2019-2024)
11.7.4 23andMe Main Business Overview
11.7.5 23andMe Latest Developments
11.8 Eurofins
11.8.1 Eurofins Company Information
11.8.2 Eurofins Laboratory Developed Test Product Offered
11.8.3 Eurofins Laboratory Developed Test Revenue, Gross Margin and Market Share (2019-2024)
11.8.4 Eurofins Main Business Overview
11.8.5 Eurofins Latest Developments
11.9 Guardant Health
11.9.1 Guardant Health Company Information
11.9.2 Guardant Health Laboratory Developed Test Product Offered
11.9.3 Guardant Health Laboratory Developed Test Revenue, Gross Margin and Market Share (2019-2024)
11.9.4 Guardant Health Main Business Overview
11.9.5 Guardant Health Latest Developments
11.10 Biotheranostics
11.10.1 Biotheranostics Company Information
11.10.2 Biotheranostics Laboratory Developed Test Product Offered
11.10.3 Biotheranostics Laboratory Developed Test Revenue, Gross Margin and Market Share (2019-2024)
11.10.4 Biotheranostics Main Business Overview
11.10.5 Biotheranostics Latest Developments
11.11 Adaptive Biotechnologies
11.11.1 Adaptive Biotechnologies Company Information
11.11.2 Adaptive Biotechnologies Laboratory Developed Test Product Offered
11.11.3 Adaptive Biotechnologies Laboratory Developed Test Revenue, Gross Margin and Market Share (2019-2024)
11.11.4 Adaptive Biotechnologies Main Business Overview
11.11.5 Adaptive Biotechnologies Latest Developments
11.12 Rosetta Genomics
11.12.1 Rosetta Genomics Company Information
11.12.2 Rosetta Genomics Laboratory Developed Test Product Offered
11.12.3 Rosetta Genomics Laboratory Developed Test Revenue, Gross Margin and Market Share (2019-2024)
11.12.4 Rosetta Genomics Main Business Overview
11.12.5 Rosetta Genomics Latest Developments
11.13 Biodesix
11.13.1 Biodesix Company Information
11.13.2 Biodesix Laboratory Developed Test Product Offered
11.13.3 Biodesix Laboratory Developed Test Revenue, Gross Margin and Market Share (2019-2024)
11.13.4 Biodesix Main Business Overview
11.13.5 Biodesix Latest Developments
11.14 Helix
11.14.1 Helix Company Information
11.14.2 Helix Laboratory Developed Test Product Offered
11.14.3 Helix Laboratory Developed Test Revenue, Gross Margin and Market Share (2019-2024)
11.14.4 Helix Main Business Overview
11.14.5 Helix Latest Developments
12 Research Findings and Conclusion
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