Laboratory-developed Testing - Global Market Share and Ranking, Overall Sales and Demand Forecast 2024-2030

Publication ID:

PB503243951

Publication Date:

March 15, 2024

Pages:

109

Publisher:

MRRPB5

Countries:

Global [1]

USD 3,950.00

Pharmaceutical Manufacturing [2]

Healthcare [3]

Pharma & Healthcare [4]

Description:

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 Released in 2014, the draft guidance sparked an intense debate over potential LDT regulation.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 global market for Laboratory-developed Testing was estimated to be worth US$ 3518.7 million in 2023 and is forecast to a readjusted size of US$ 4582.6 million by 2030 with 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%.
Report Scope
This report aims to provide a comprehensive presentation of the global market for Laboratory-developed Testing, focusing on the total sales revenue, key companies market share and ranking, together with an analysis of Laboratory-developed Testing by region & country, by Type, and by Application.
The Laboratory-developed Testing market size, estimations, and forecasts are provided in terms of sales revenue ($ millions), considering 2023 as the base year, with history and forecast data for the period from 2019 to 2030. 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.
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
U.S.
Canada
Europe
Germany
France
U.K.
Italy
Russia
Asia-Pacific
China
Japan
South Korea
China Taiwan
Southeast Asia
India
Latin America
Mexico
Brazil
Argentina
Middle East & Africa
Turkey
Saudi Arabia
U.A.E
Chapter Outline
Chapter 1: Introduces the report scope of the report, global total market size. This chapter also provides the market dynamics, latest developments of the market, the driving factors and restrictive factors of the market, the challenges and risks faced by manufacturers in the industry, and the analysis of relevant policies in the industry.
Chapter 2: Detailed analysis of Laboratory-developed Testing manufacturers competitive landscape, revenue market share, latest development plan, merger, and acquisition information, etc.
Chapter 3: 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 4: 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 5: Revenue of Laboratory-developed Testing in regional level. It provides a quantitative analysis of the market size and development potential of each region and introduces the market development, future development prospects, market space, and market size of each country in the world.
Chapter 6: Revenue of Laboratory-developed Testing in country level. It provides sigmate data by Type, and by Application for each country/region.
Chapter 7: Provides profiles of key players, introducing the basic situation of the main companies in the market in detail, including product revenue, gross margin, product introduction, recent development, etc.
Chapter 8: Analysis of industrial chain, including the upstream and downstream of the industry.
Chapter 9: Conclusion.

Please Note - This is an on demand report and will be delivered in 2 business days (48 hours) post payment.

Table Of Contents:

1 Market Overview
1.1 Laboratory-developed Testing Product Introduction
1.2 Global Laboratory-developed Testing Market Size Forecast
1.3 Laboratory-developed Testing Market Trends & Drivers
1.3.1 Laboratory-developed Testing Industry Trends
1.3.2 Laboratory-developed Testing Market Drivers & Opportunity
1.3.3 Laboratory-developed Testing Market Challenges
1.3.4 Laboratory-developed Testing Market Restraints
1.4 Assumptions and Limitations
1.5 Study Objectives
1.6 Years Considered
2 Competitive Analysis by Company
2.1 Global Laboratory-developed Testing Players Revenue Ranking (2023)
2.2 Global Laboratory-developed Testing Revenue by Company (2019-2024)
2.3 Key Companies Laboratory-developed Testing Manufacturing Base Distribution and Headquarters
2.4 Key Companies Laboratory-developed Testing Product Offered
2.5 Key Companies Time to Begin Mass Production of Laboratory-developed Testing
2.6 Laboratory-developed Testing Market Competitive Analysis
2.6.1 Laboratory-developed Testing Market Concentration Rate (2019-2024)
2.6.2 Global 5 and 10 Largest Companies by Laboratory-developed Testing Revenue in 2023
2.6.3 Global Top Companies by Company Type (Tier 1, Tier 2, and Tier 3) & (based on the Revenue in Laboratory-developed Testing as of 2023)
2.7 Mergers & Acquisitions, Expansion
3 Segmentation by Type
3.1 Introduction by Type
3.1.1 Commercial Service
3.1.2 R&D
3.2 Global Laboratory-developed Testing Sales Value by Type
3.2.1 Global Laboratory-developed Testing Sales Value by Type (2019 VS 2023 VS 2030)
3.2.2 Global Laboratory-developed Testing Sales Value, by Type (2019-2030)
3.2.3 Global Laboratory-developed Testing Sales Value, by Type (%) (2019-2030)
4 Segmentation by Application
4.1 Introduction by Application
4.1.1 Genetic Testing
4.1.2 Oncology
4.1.3 Infectious Disease
4.1.4 Others
4.2 Global Laboratory-developed Testing Sales Value by Application
4.2.1 Global Laboratory-developed Testing Sales Value by Application (2019 VS 2023 VS 2030)
4.2.2 Global Laboratory-developed Testing Sales Value, by Application (2019-2030)
4.2.3 Global Laboratory-developed Testing Sales Value, by Application (%) (2019-2030)
5 Segmentation by Region
5.1 Global Laboratory-developed Testing Sales Value by Region
5.1.1 Global Laboratory-developed Testing Sales Value by Region: 2019 VS 2023 VS 2030
5.1.2 Global Laboratory-developed Testing Sales Value by Region (2019-2024)
5.1.3 Global Laboratory-developed Testing Sales Value by Region (2025-2030)
5.1.4 Global Laboratory-developed Testing Sales Value by Region (%), (2019-2030)
5.2 North America
5.2.1 North America Laboratory-developed Testing Sales Value, 2019-2030
5.2.2 North America Laboratory-developed Testing Sales Value by Country (%), 2023 VS 2030
5.3 Europe
5.3.1 Europe Laboratory-developed Testing Sales Value, 2019-2030
5.3.2 Europe Laboratory-developed Testing Sales Value by Country (%), 2023 VS 2030
5.4 Asia Pacific
5.4.1 Asia Pacific Laboratory-developed Testing Sales Value, 2019-2030
5.4.2 Asia Pacific Laboratory-developed Testing Sales Value by Country (%), 2023 VS 2030
5.5 South America
5.5.1 South America Laboratory-developed Testing Sales Value, 2019-2030
5.5.2 South America Laboratory-developed Testing Sales Value by Country (%), 2023 VS 2030
5.6 Middle East & Africa
5.6.1 Middle East & Africa Laboratory-developed Testing Sales Value, 2019-2030
5.6.2 Middle East & Africa Laboratory-developed Testing Sales Value by Country (%), 2023 VS 2030
6 Segmentation by Key Countries/Regions
6.1 Key Countries/Regions Laboratory-developed Testing Sales Value Growth Trends, 2019 VS 2023 VS 2030
6.2 Key Countries/Regions Laboratory-developed Testing Sales Value
6.3 United States
6.3.1 United States Laboratory-developed Testing Sales Value, 2019-2030
6.3.2 United States Laboratory-developed Testing Sales Value by Type (%), 2023 VS 2030
6.3.3 United States Laboratory-developed Testing Sales Value by Application, 2023 VS 2030
6.4 Europe
6.4.1 Europe Laboratory-developed Testing Sales Value, 2019-2030
6.4.2 Europe Laboratory-developed Testing Sales Value by Type (%), 2023 VS 2030
6.4.3 Europe Laboratory-developed Testing Sales Value by Application, 2023 VS 2030
6.5 China
6.5.1 China Laboratory-developed Testing Sales Value, 2019-2030
6.5.2 China Laboratory-developed Testing Sales Value by Type (%), 2023 VS 2030
6.5.3 China Laboratory-developed Testing Sales Value by Application, 2023 VS 2030
6.6 Japan
6.6.1 Japan Laboratory-developed Testing Sales Value, 2019-2030
6.6.2 Japan Laboratory-developed Testing Sales Value by Type (%), 2023 VS 2030
6.6.3 Japan Laboratory-developed Testing Sales Value by Application, 2023 VS 2030
6.7 South Korea
6.7.1 South Korea Laboratory-developed Testing Sales Value, 2019-2030
6.7.2 South Korea Laboratory-developed Testing Sales Value by Type (%), 2023 VS 2030
6.7.3 South Korea Laboratory-developed Testing Sales Value by Application, 2023 VS 2030
6.8 Southeast Asia
6.8.1 Southeast Asia Laboratory-developed Testing Sales Value, 2019-2030
6.8.2 Southeast Asia Laboratory-developed Testing Sales Value by Type (%), 2023 VS 2030
6.8.3 Southeast Asia Laboratory-developed Testing Sales Value by Application, 2023 VS 2030
6.9 India
6.9.1 India Laboratory-developed Testing Sales Value, 2019-2030
6.9.2 India Laboratory-developed Testing Sales Value by Type (%), 2023 VS 2030
6.9.3 India Laboratory-developed Testing Sales Value by Application, 2023 VS 2030
7 Company Profiles
7.1 Adaptive Biotechnologies Corporation
7.1.1 Adaptive Biotechnologies Corporation Profile
7.1.2 Adaptive Biotechnologies Corporation Main Business
7.1.3 Adaptive Biotechnologies Corporation Laboratory-developed Testing Products, Services and Solutions
7.1.4 Adaptive Biotechnologies Corporation Laboratory-developed Testing Revenue (US$ Million) & (2019-2024)
7.1.5 Adaptive Biotechnologies Corporation Recent Developments
7.2 Quest Diagnostics
7.2.1 Quest Diagnostics Profile
7.2.2 Quest Diagnostics Main Business
7.2.3 Quest Diagnostics Laboratory-developed Testing Products, Services and Solutions
7.2.4 Quest Diagnostics Laboratory-developed Testing Revenue (US$ Million) & (2019-2024)
7.2.5 Quest Diagnostics Recent Developments
7.3 Roche
7.3.1 Roche Profile
7.3.2 Roche Main Business
7.3.3 Roche Laboratory-developed Testing Products, Services and Solutions
7.3.4 Roche Laboratory-developed Testing Revenue (US$ Million) & (2019-2024)
7.3.5 Illumina Recent Developments
7.4 Illumina
7.4.1 Illumina Profile
7.4.2 Illumina Main Business
7.4.3 Illumina Laboratory-developed Testing Products, Services and Solutions
7.4.4 Illumina Laboratory-developed Testing Revenue (US$ Million) & (2019-2024)
7.4.5 Illumina Recent Developments
7.5 Qiagen
7.5.1 Qiagen Profile
7.5.2 Qiagen Main Business
7.5.3 Qiagen Laboratory-developed Testing Products, Services and Solutions
7.5.4 Qiagen Laboratory-developed Testing Revenue (US$ Million) & (2019-2024)
7.5.5 Qiagen Recent Developments
7.6 Eurofins
7.6.1 Eurofins Profile
7.6.2 Eurofins Main Business
7.6.3 Eurofins Laboratory-developed Testing Products, Services and Solutions
7.6.4 Eurofins Laboratory-developed Testing Revenue (US$ Million) & (2019-2024)
7.6.5 Eurofins Recent Developments
7.7 Guardant Health
7.7.1 Guardant Health Profile
7.7.2 Guardant Health Main Business
7.7.3 Guardant Health Laboratory-developed Testing Products, Services and Solutions
7.7.4 Guardant Health Laboratory-developed Testing Revenue (US$ Million) & (2019-2024)
7.7.5 Guardant Health Recent Developments
7.8 Biotheranostics
7.8.1 Biotheranostics Profile
7.8.2 Biotheranostics Main Business
7.8.3 Biotheranostics Laboratory-developed Testing Products, Services and Solutions
7.8.4 Biotheranostics Laboratory-developed Testing Revenue (US$ Million) & (2019-2024)
7.8.5 Biotheranostics Recent Developments
7.9 Adaptive Biotechnologies
7.9.1 Adaptive Biotechnologies Profile
7.9.2 Adaptive Biotechnologies Main Business
7.9.3 Adaptive Biotechnologies Laboratory-developed Testing Products, Services and Solutions
7.9.4 Adaptive Biotechnologies Laboratory-developed Testing Revenue (US$ Million) & (2019-2024)
7.9.5 Adaptive Biotechnologies Recent Developments
7.10 Rosetta Genomics
7.10.1 Rosetta Genomics Profile
7.10.2 Rosetta Genomics Main Business
7.10.3 Rosetta Genomics Laboratory-developed Testing Products, Services and Solutions
7.10.4 Rosetta Genomics Laboratory-developed Testing Revenue (US$ Million) & (2019-2024)
7.10.5 Rosetta Genomics Recent Developments
7.11 Biodesix
7.11.1 Biodesix Profile
7.11.2 Biodesix Main Business
7.11.3 Biodesix Laboratory-developed Testing Products, Services and Solutions
7.11.4 Biodesix Laboratory-developed Testing Revenue (US$ Million) & (2019-2024)
7.11.5 Biodesix Recent Developments
7.12 Helix
7.12.1 Helix Profile
7.12.2 Helix Main Business
7.12.3 Helix Laboratory-developed Testing Products, Services and Solutions
7.12.4 Helix Laboratory-developed Testing Revenue (US$ Million) & (2019-2024)
7.12.5 Helix Recent Developments
8 Industry Chain Analysis
8.1 Laboratory-developed Testing Industrial Chain
8.2 Laboratory-developed Testing Upstream Analysis
8.2.1 Key Raw Materials
8.2.2 Raw Materials Key Suppliers
8.2.3 Manufacturing Cost Structure
8.3 Midstream Analysis
8.4 Downstream Analysis (Customers Analysis)
8.5 Sales Model and Sales Channels
8.5.1 Laboratory-developed Testing Sales Model
8.5.2 Sales Channel
8.5.3 Laboratory-developed Testing Distributors
9 Research Findings and Conclusion
10 Appendix
10.1 Research Methodology
10.1.1 Methodology/Research Approach
10.1.2 Data Source
10.2 Author Details
10.3 Disclaimer

Companies Mentioned:

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

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