Laboratory-developed Testing Industry Research Report 2024

Laboratory-developed Testing Industry Research Report 2024


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 Released in 2014, the draft guidance sparked an intense debate over potential LDT regulation.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.

According to APO Research, The global Laboratory-developed Testing market was valued at US$ million in 2023 and is anticipated to reach US$ million by 2030, witnessing a CAGR of xx% 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%.

Report Scope

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.

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.

Key Companies & Market Share Insights

In this section, the readers will gain an understanding of the key players competing. This report has studied the key growth strategies, such as innovative trends and developments, intensification of product portfolio, mergers and acquisitions, collaborations, new product innovation, and geographical expansion, undertaken by these participants to maintain their presence. Apart from business strategies, the study includes current developments and key financials. The readers will also get access to the data related to global revenue, price, and sales by manufacturers for the period 2019-2024. This all-inclusive report will certainly serve the clients to stay updated and make effective decisions in their businesses. Some of the prominent players reviewed in the research report include:

Adaptive Biotechnologies Corporation
Quest Diagnostics
Roche
Illumina
Qiagen
Eurofins
Guardant Health
Biotheranostics
Adaptive Biotechnologies
Rosetta Genomics
Biodesix
Helix

Laboratory-developed Testing segment by Type
Commercial Service
R&D

Laboratory-developed Testing Segment by Application
Genetic Testing
Oncology
Infectious Disease
Others

Laboratory-developed Testing Segment 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

Key Drivers & Barriers

High-impact rendering factors and drivers have been studied in this report to aid the readers to understand the general development. Moreover, the report includes restraints and challenges that may act as stumbling blocks on the way of the players. This will assist the users to be attentive and make informed decisions related to business. Specialists have also laid their focus on the upcoming business prospects.

Reasons to Buy This Report

1. This report will help the readers to understand the competition within the industries and strategies for the competitive environment to enhance the potential profit. The report also focuses on the competitive landscape of the global Laboratory-developed Testing market, and introduces in detail the market share, industry ranking, competitor ecosystem, market performance, new product development, operation situation, expansion, and acquisition. etc. of the main players, which helps the readers to identify the main competitors and deeply understand the competition pattern of the market.
2. This report will help stakeholders to understand the global industry status and trends of Laboratory-developed Testing and provides them with information on key market drivers, restraints, challenges, and opportunities.
3. This report will help stakeholders to understand competitors better and gain more insights to strengthen their position in their businesses. The competitive landscape section includes the market share and rank (in volume and value), competitor ecosystem, new product development, expansion, and acquisition.
4. This report stays updated with novel technology integration, features, and the latest developments in the market
5. This report helps stakeholders to gain insights into which regions to target globally
6. This report helps stakeholders to gain insights into the end-user perception concerning the adoption of Laboratory-developed Testing.
7. This report helps stakeholders to identify some of the key players in the market and understand their valuable contribution.

Chapter Outline

Chapter 1: Research objectives, research methods, data sources, data cross-validation;
Chapter 2: 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 3: Provides the analysis of various market segments product types, covering the market size and development potential of each market segment, to help readers find the blue ocean market in different market segments.
Chapter 4: Provides the analysis of various market segments 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 5: 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 6: Detailed analysis of Laboratory-developed Testing companies’ competitive landscape, revenue market share, latest development plan, merger, and acquisition information, etc.
Chapter 7, 8, 9, 10, 11: 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 12: Provides profiles of key players, introducing the basic situation of the main companies in the market in detail, including revenue, gross margin, product introduction, recent development, etc.
Chapter 13: The main points and conclusions of the report.
Chapter 13: The main points and conclusions of the report.


1 Preface
1.1 Scope of Report
1.2 Reasons for Doing This Study
1.3 Research Methodology
1.4 Research Process
1.5 Data Source
1.5.1 Secondary Sources
1.5.2 Primary Sources
2 Market Overview
2.1 Product Definition
2.2 Laboratory-developed Testing by Type
2.2.1 Market Value Comparison by Type (2019 VS 2023 VS 2030)
2.2.2 Commercial Service
2.2.3 R&D
2.3 Laboratory-developed Testing by Application
2.3.1 Market Value Comparison by Application (2019 VS 2023 VS 2030)
2.3.2 Genetic Testing
2.3.3 Oncology
2.3.4 Infectious Disease
2.3.5 Others
2.4 Assumptions and Limitations
3 Laboratory-developed Testing Breakdown Data by Type
3.1 Global Laboratory-developed Testing Historic Market Size by Type (2019-2024)
3.2 Global Laboratory-developed Testing Forecasted Market Size by Type (2025-2030)
4 Laboratory-developed Testing Breakdown Data by Application
4.1 Global Laboratory-developed Testing Historic Market Size by Application (2019-2024)
4.2 Global Laboratory-developed Testing Forecasted Market Size by Application (2019-2024)
5 Global Growth Trends
5.1 Global Laboratory-developed Testing Market Perspective (2019-2030)
5.2 Global Laboratory-developed Testing Growth Trends by Region
5.2.1 Global Laboratory-developed Testing Market Size by Region: 2019 VS 2023 VS 2030
5.2.2 Laboratory-developed Testing Historic Market Size by Region (2019-2024)
5.2.3 Laboratory-developed Testing Forecasted Market Size by Region (2025-2030)
5.3 Laboratory-developed Testing Market Dynamics
5.3.1 Laboratory-developed Testing Industry Trends
5.3.2 Laboratory-developed Testing Market Drivers
5.3.3 Laboratory-developed Testing Market Challenges
5.3.4 Laboratory-developed Testing Market Restraints
6 Market Competitive Landscape by Players
6.1 Global Top Laboratory-developed Testing Players by Revenue
6.1.1 Global Top Laboratory-developed Testing Players by Revenue (2019-2024)
6.1.2 Global Laboratory-developed Testing Revenue Market Share by Players (2019-2024)
6.2 Global Laboratory-developed Testing Industry Players Ranking, 2022 VS 2023 VS 2024
6.3 Global Key Players of Laboratory-developed Testing Head office and Area Served
6.4 Global Laboratory-developed Testing Players, Product Type & Application
6.5 Global Laboratory-developed Testing Players, Date of Enter into This Industry
6.6 Global Laboratory-developed Testing Market CR5 and HHI
6.7 Global Players Mergers & Acquisition
7 North America
7.1 North America Laboratory-developed Testing Market Size (2019-2030)
7.2 North America Laboratory-developed Testing Market Growth Rate by Country: 2019 VS 2023 VS 2030
7.3 North America Laboratory-developed Testing Market Size by Country (2019-2024)
7.4 North America Laboratory-developed Testing Market Size by Country (2025-2030)
7.5 United States
7.6 Canada
8 Europe
8.1 Europe Laboratory-developed Testing Market Size (2019-2030)
8.2 Europe Laboratory-developed Testing Market Growth Rate by Country: 2019 VS 2023 VS 2030
8.3 Europe Laboratory-developed Testing Market Size by Country (2019-2024)
8.4 Europe Laboratory-developed Testing Market Size by Country (2025-2030)
8.5 Germany
8.6 France
8.7 U.K.
8.8 Italy
8.9 Russia
8.10 Nordic Countries
9 Asia-Pacific
9.1 Asia-Pacific Laboratory-developed Testing Market Size (2019-2030)
9.2 Asia-Pacific Laboratory-developed Testing Market Growth Rate by Country: 2019 VS 2023 VS 2030
9.3 Asia-Pacific Laboratory-developed Testing Market Size by Country (2019-2024)
9.4 Asia-Pacific Laboratory-developed Testing Market Size by Country (2025-2030)
9.5 China
9.6 Japan
9.7 South Korea
9.8 Southeast Asia
9.9 India
9.10 Australia
10 Latin America
10.1 Latin America Laboratory-developed Testing Market Size (2019-2030)
10.2 Latin America Laboratory-developed Testing Market Growth Rate by Country: 2019 VS 2023 VS 2030
10.3 Latin America Laboratory-developed Testing Market Size by Country (2019-2024)
10.4 Latin America Laboratory-developed Testing Market Size by Country (2025-2030)
10.5 Mexico
10.6 Brazil
11 Middle East & Africa
11.1 Middle East & Africa Laboratory-developed Testing Market Size (2019-2030)
11.2 Middle East & Africa Laboratory-developed Testing Market Growth Rate by Country: 2019 VS 2023 VS 2030
11.3 Middle East & Africa Laboratory-developed Testing Market Size by Country (2019-2024)
11.4 Middle East & Africa Laboratory-developed Testing Market Size by Country (2025-2030)
11.5 Turkey
11.6 Saudi Arabia
11.7 UAE
12 Players Profiled
12.1 Adaptive Biotechnologies Corporation
12.1.1 Adaptive Biotechnologies Corporation Company Information
12.1.2 Adaptive Biotechnologies Corporation Business Overview
12.1.3 Adaptive Biotechnologies Corporation Revenue in Laboratory-developed Testing Business (2019-2024)
12.1.4 Adaptive Biotechnologies Corporation Laboratory-developed Testing Product Portfolio
12.1.5 Adaptive Biotechnologies Corporation Recent Developments
12.2 Quest Diagnostics
12.2.1 Quest Diagnostics Company Information
12.2.2 Quest Diagnostics Business Overview
12.2.3 Quest Diagnostics Revenue in Laboratory-developed Testing Business (2019-2024)
12.2.4 Quest Diagnostics Laboratory-developed Testing Product Portfolio
12.2.5 Quest Diagnostics Recent Developments
12.3 Roche
12.3.1 Roche Company Information
12.3.2 Roche Business Overview
12.3.3 Roche Revenue in Laboratory-developed Testing Business (2019-2024)
12.3.4 Roche Laboratory-developed Testing Product Portfolio
12.3.5 Roche Recent Developments
12.4 Illumina
12.4.1 Illumina Company Information
12.4.2 Illumina Business Overview
12.4.3 Illumina Revenue in Laboratory-developed Testing Business (2019-2024)
12.4.4 Illumina Laboratory-developed Testing Product Portfolio
12.4.5 Illumina Recent Developments
12.5 Qiagen
12.5.1 Qiagen Company Information
12.5.2 Qiagen Business Overview
12.5.3 Qiagen Revenue in Laboratory-developed Testing Business (2019-2024)
12.5.4 Qiagen Laboratory-developed Testing Product Portfolio
12.5.5 Qiagen Recent Developments
12.6 Eurofins
12.6.1 Eurofins Company Information
12.6.2 Eurofins Business Overview
12.6.3 Eurofins Revenue in Laboratory-developed Testing Business (2019-2024)
12.6.4 Eurofins Laboratory-developed Testing Product Portfolio
12.6.5 Eurofins Recent Developments
12.7 Guardant Health
12.7.1 Guardant Health Company Information
12.7.2 Guardant Health Business Overview
12.7.3 Guardant Health Revenue in Laboratory-developed Testing Business (2019-2024)
12.7.4 Guardant Health Laboratory-developed Testing Product Portfolio
12.7.5 Guardant Health Recent Developments
12.8 Biotheranostics
12.8.1 Biotheranostics Company Information
12.8.2 Biotheranostics Business Overview
12.8.3 Biotheranostics Revenue in Laboratory-developed Testing Business (2019-2024)
12.8.4 Biotheranostics Laboratory-developed Testing Product Portfolio
12.8.5 Biotheranostics Recent Developments
12.9 Adaptive Biotechnologies
12.9.1 Adaptive Biotechnologies Company Information
12.9.2 Adaptive Biotechnologies Business Overview
12.9.3 Adaptive Biotechnologies Revenue in Laboratory-developed Testing Business (2019-2024)
12.9.4 Adaptive Biotechnologies Laboratory-developed Testing Product Portfolio
12.9.5 Adaptive Biotechnologies Recent Developments
12.10 Rosetta Genomics
12.10.1 Rosetta Genomics Company Information
12.10.2 Rosetta Genomics Business Overview
12.10.3 Rosetta Genomics Revenue in Laboratory-developed Testing Business (2019-2024)
12.10.4 Rosetta Genomics Laboratory-developed Testing Product Portfolio
12.10.5 Rosetta Genomics Recent Developments
12.11 Biodesix
12.11.1 Biodesix Company Information
12.11.2 Biodesix Business Overview
12.11.3 Biodesix Revenue in Laboratory-developed Testing Business (2019-2024)
12.11.4 Biodesix Laboratory-developed Testing Product Portfolio
12.11.5 Biodesix Recent Developments
12.12 Helix
12.12.1 Helix Company Information
12.12.2 Helix Business Overview
12.12.3 Helix Revenue in Laboratory-developed Testing Business (2019-2024)
12.12.4 Helix Laboratory-developed Testing Product Portfolio
12.12.5 Helix Recent Developments
13 Report Conclusion
14 Disclaimer

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