Global Laboratory-developed Testing Market Research Report 2024(Status and Outlook)

Global Laboratory-developed Testing Market Research Report 2024(Status and Outlook)



Report Overview:

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 Released in 2014, the draft guidance sparked an intense debate over potential LDT regulation.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 Size was estimated at USD 3671.46 million in 2023 and is projected to reach USD 4592.22 million by 2029, exhibiting a CAGR of 3.80% during the forecast period.

This report provides a deep insight into the global Laboratory-developed Testing market covering all its essential aspects. This ranges from a macro overview of the market to micro details of the market size, competitive landscape, development trend, niche market, key market drivers and challenges, SWOT analysis, Porter’s five forces analysis, value chain analysis, etc.

The analysis helps the reader to shape the competition within the industries and strategies for the competitive environment to enhance the potential profit. Furthermore, it provides a simple framework for evaluating and accessing the position of the business organization. The report structure also focuses on the competitive landscape of the Global Laboratory-developed Testing Market, this report introduces in detail the market share, market performance, product situation, operation situation, etc. of the main players, which helps the readers in the industry to identify the main competitors and deeply understand the competition pattern of the market.

In a word, this report is a must-read for industry players, investors, researchers, consultants, business strategists, and all those who have any kind of stake or are planning to foray into the Laboratory-developed Testing market in any manner.

Global Laboratory-developed Testing Market: Market Segmentation Analysis

The research report includes specific segments by region (country), manufacturers, Type, and Application. Market segmentation creates subsets of a market based on product type, end-user or application, Geographic, and other factors. By understanding the market segments, the decision-maker can leverage this targeting in the product, sales, and marketing strategies. Market segments can power your product development cycles by informing how you create product offerings for different segments.

Key Company

Adaptive Biotechnologies Corporation

Quest Diagnostics

Roche

Illumina

Qiagen

Eurofins

Guardant Health

Biotheranostics

Adaptive Biotechnologies

Rosetta Genomics

Biodesix

Helix

Market Segmentation (by Type)

Commercial Service

R&D

Market Segmentation (by Application)

Genetic Testing

Oncology

Infectious Disease

Others

Geographic Segmentation

North America (USA, Canada, Mexico)

Europe (Germany, UK, France, Russia, Italy, Rest of Europe)

Asia-Pacific (China, Japan, South Korea, India, Southeast Asia, Rest of Asia-Pacific)

South America (Brazil, Argentina, Columbia, Rest of South America)

The Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria, South Africa, Rest of MEA)

Key Benefits of This Market Research:

Industry drivers, restraints, and opportunities covered in the study

Neutral perspective on the market performance

Recent industry trends and developments

Competitive landscape & strategies of key players

Potential & niche segments and regions exhibiting promising growth covered

Historical, current, and projected market size, in terms of value

In-depth analysis of the Laboratory-developed Testing Market

Overview of the regional outlook of the Laboratory-developed Testing Market:

Key Reasons to Buy this Report:

Access to date statistics compiled by our researchers. These provide you with historical and forecast data, which is analyzed to tell you why your market is set to change

This enables you to anticipate market changes to remain ahead of your competitors

You will be able to copy data from the Excel spreadsheet straight into your marketing plans, business presentations, or other strategic documents

The concise analysis, clear graph, and table format will enable you to pinpoint the information you require quickly

Provision of market value (USD Billion) data for each segment and sub-segment

Indicates the region and segment that is expected to witness the fastest growth as well as to dominate the market

Analysis by geography highlighting the consumption of the product/service in the region as well as indicating the factors that are affecting the market within each region

Competitive landscape which incorporates the market ranking of the major players, along with new service/product launches, partnerships, business expansions, and acquisitions in the past five years of companies profiled

Extensive company profiles comprising of company overview, company insights, product benchmarking, and SWOT analysis for the major market players

The current as well as the future market outlook of the industry concerning recent developments which involve growth opportunities and drivers as well as challenges and restraints of both emerging as well as developed regions

Includes in-depth analysis of the market from various perspectives through Porter’s five forces analysis

Provides insight into the market through Value Chain

Market dynamics scenario, along with growth opportunities of the market in the years to come

Chapter Outline

Chapter 1 mainly introduces the statistical scope of the report, market division standards, and market research methods.

Chapter 2 is an executive summary of different market segments (by region, 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 Laboratory-developed Testing Market and its likely evolution in the short to mid-term, and long term.

Chapter 3 makes a detailed analysis of the Market's Competitive Landscape of the market and provides the market share, capacity, output, price, latest development plan, merger, and acquisition information of the main manufacturers in the market.

Chapter 4 is the analysis of the whole market industrial chain, including the upstream and downstream of the industry, as well as Porter's five forces analysis.

Chapter 5 introduces the 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 6 provides the analysis of various market segments according to 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 7 provides the analysis of various market segments according to 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 8 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 9 introduces the basic situation of the main companies in the market in detail, including product sales revenue, sales volume, price, gross profit margin, market share, product introduction, recent development, etc.

Chapter 10 provides a quantitative analysis of the market size and development potential of each region in the next five years.

Chapter 11 provides a quantitative analysis of the market size and development potential of each market segment (product type and application) in the next five years.

Chapter 12 is the main points and conclusions of the report.


1 Research Methodology and Statistical Scope
1.1 Market Definition and Statistical Scope of Laboratory-developed Testing
1.2 Key Market Segments
1.2.1 Laboratory-developed Testing Segment by Type
1.2.2 Laboratory-developed Testing Segment by Application
1.3 Methodology & Sources of Information
1.3.1 Research Methodology
1.3.2 Research Process
1.3.3 Market Breakdown and Data Triangulation
1.3.4 Base Year
1.3.5 Report Assumptions & Caveats
2 Laboratory-developed Testing Market Overview
2.1 Global Market Overview
2.1.1 Global Laboratory-developed Testing Market Size (M USD) Estimates and Forecasts (2019-2030)
2.1.2 Global Laboratory-developed Testing Sales Estimates and Forecasts (2019-2030)
2.2 Market Segment Executive Summary
2.3 Global Market Size by Region
3 Laboratory-developed Testing Market Competitive Landscape
3.1 Global Laboratory-developed Testing Sales by Manufacturers (2019-2024)
3.2 Global Laboratory-developed Testing Revenue Market Share by Manufacturers (2019-2024)
3.3 Laboratory-developed Testing Market Share by Company Type (Tier 1, Tier 2, and Tier 3)
3.4 Global Laboratory-developed Testing Average Price by Manufacturers (2019-2024)
3.5 Manufacturers Laboratory-developed Testing Sales Sites, Area Served, Product Type
3.6 Laboratory-developed Testing Market Competitive Situation and Trends
3.6.1 Laboratory-developed Testing Market Concentration Rate
3.6.2 Global 5 and 10 Largest Laboratory-developed Testing Players Market Share by Revenue
3.6.3 Mergers & Acquisitions, Expansion
4 Laboratory-developed Testing Industry Chain Analysis
4.1 Laboratory-developed Testing Industry Chain Analysis
4.2 Market Overview of Key Raw Materials
4.3 Midstream Market Analysis
4.4 Downstream Customer Analysis
5 The Development and Dynamics of Laboratory-developed Testing Market
5.1 Key Development Trends
5.2 Driving Factors
5.3 Market Challenges
5.4 Market Restraints
5.5 Industry News
5.5.1 New Product Developments
5.5.2 Mergers & Acquisitions
5.5.3 Expansions
5.5.4 Collaboration/Supply Contracts
5.6 Industry Policies
6 Laboratory-developed Testing Market Segmentation by Type
6.1 Evaluation Matrix of Segment Market Development Potential (Type)
6.2 Global Laboratory-developed Testing Sales Market Share by Type (2019-2024)
6.3 Global Laboratory-developed Testing Market Size Market Share by Type (2019-2024)
6.4 Global Laboratory-developed Testing Price by Type (2019-2024)
7 Laboratory-developed Testing Market Segmentation by Application
7.1 Evaluation Matrix of Segment Market Development Potential (Application)
7.2 Global Laboratory-developed Testing Market Sales by Application (2019-2024)
7.3 Global Laboratory-developed Testing Market Size (M USD) by Application (2019-2024)
7.4 Global Laboratory-developed Testing Sales Growth Rate by Application (2019-2024)
8 Laboratory-developed Testing Market Segmentation by Region
8.1 Global Laboratory-developed Testing Sales by Region
8.1.1 Global Laboratory-developed Testing Sales by Region
8.1.2 Global Laboratory-developed Testing Sales Market Share by Region
8.2 North America
8.2.1 North America Laboratory-developed Testing Sales by Country
8.2.2 U.S.
8.2.3 Canada
8.2.4 Mexico
8.3 Europe
8.3.1 Europe Laboratory-developed Testing Sales by Country
8.3.2 Germany
8.3.3 France
8.3.4 U.K.
8.3.5 Italy
8.3.6 Russia
8.4 Asia Pacific
8.4.1 Asia Pacific Laboratory-developed Testing Sales by Region
8.4.2 China
8.4.3 Japan
8.4.4 South Korea
8.4.5 India
8.4.6 Southeast Asia
8.5 South America
8.5.1 South America Laboratory-developed Testing Sales by Country
8.5.2 Brazil
8.5.3 Argentina
8.5.4 Columbia
8.6 Middle East and Africa
8.6.1 Middle East and Africa Laboratory-developed Testing Sales by Region
8.6.2 Saudi Arabia
8.6.3 UAE
8.6.4 Egypt
8.6.5 Nigeria
8.6.6 South Africa
9 Key Companies Profile
9.1 Adaptive Biotechnologies Corporation
9.1.1 Adaptive Biotechnologies Corporation Laboratory-developed Testing Basic Information
9.1.2 Adaptive Biotechnologies Corporation Laboratory-developed Testing Product Overview
9.1.3 Adaptive Biotechnologies Corporation Laboratory-developed Testing Product Market Performance
9.1.4 Adaptive Biotechnologies Corporation Business Overview
9.1.5 Adaptive Biotechnologies Corporation Laboratory-developed Testing SWOT Analysis
9.1.6 Adaptive Biotechnologies Corporation Recent Developments
9.2 Quest Diagnostics
9.2.1 Quest Diagnostics Laboratory-developed Testing Basic Information
9.2.2 Quest Diagnostics Laboratory-developed Testing Product Overview
9.2.3 Quest Diagnostics Laboratory-developed Testing Product Market Performance
9.2.4 Quest Diagnostics Business Overview
9.2.5 Quest Diagnostics Laboratory-developed Testing SWOT Analysis
9.2.6 Quest Diagnostics Recent Developments
9.3 Roche
9.3.1 Roche Laboratory-developed Testing Basic Information
9.3.2 Roche Laboratory-developed Testing Product Overview
9.3.3 Roche Laboratory-developed Testing Product Market Performance
9.3.4 Roche Laboratory-developed Testing SWOT Analysis
9.3.5 Roche Business Overview
9.3.6 Roche Recent Developments
9.4 Illumina
9.4.1 Illumina Laboratory-developed Testing Basic Information
9.4.2 Illumina Laboratory-developed Testing Product Overview
9.4.3 Illumina Laboratory-developed Testing Product Market Performance
9.4.4 Illumina Business Overview
9.4.5 Illumina Recent Developments
9.5 Qiagen
9.5.1 Qiagen Laboratory-developed Testing Basic Information
9.5.2 Qiagen Laboratory-developed Testing Product Overview
9.5.3 Qiagen Laboratory-developed Testing Product Market Performance
9.5.4 Qiagen Business Overview
9.5.5 Qiagen Recent Developments
9.6 Eurofins
9.6.1 Eurofins Laboratory-developed Testing Basic Information
9.6.2 Eurofins Laboratory-developed Testing Product Overview
9.6.3 Eurofins Laboratory-developed Testing Product Market Performance
9.6.4 Eurofins Business Overview
9.6.5 Eurofins Recent Developments
9.7 Guardant Health
9.7.1 Guardant Health Laboratory-developed Testing Basic Information
9.7.2 Guardant Health Laboratory-developed Testing Product Overview
9.7.3 Guardant Health Laboratory-developed Testing Product Market Performance
9.7.4 Guardant Health Business Overview
9.7.5 Guardant Health Recent Developments
9.8 Biotheranostics
9.8.1 Biotheranostics Laboratory-developed Testing Basic Information
9.8.2 Biotheranostics Laboratory-developed Testing Product Overview
9.8.3 Biotheranostics Laboratory-developed Testing Product Market Performance
9.8.4 Biotheranostics Business Overview
9.8.5 Biotheranostics Recent Developments
9.9 Adaptive Biotechnologies
9.9.1 Adaptive Biotechnologies Laboratory-developed Testing Basic Information
9.9.2 Adaptive Biotechnologies Laboratory-developed Testing Product Overview
9.9.3 Adaptive Biotechnologies Laboratory-developed Testing Product Market Performance
9.9.4 Adaptive Biotechnologies Business Overview
9.9.5 Adaptive Biotechnologies Recent Developments
9.10 Rosetta Genomics
9.10.1 Rosetta Genomics Laboratory-developed Testing Basic Information
9.10.2 Rosetta Genomics Laboratory-developed Testing Product Overview
9.10.3 Rosetta Genomics Laboratory-developed Testing Product Market Performance
9.10.4 Rosetta Genomics Business Overview
9.10.5 Rosetta Genomics Recent Developments
9.11 Biodesix
9.11.1 Biodesix Laboratory-developed Testing Basic Information
9.11.2 Biodesix Laboratory-developed Testing Product Overview
9.11.3 Biodesix Laboratory-developed Testing Product Market Performance
9.11.4 Biodesix Business Overview
9.11.5 Biodesix Recent Developments
9.12 Helix
9.12.1 Helix Laboratory-developed Testing Basic Information
9.12.2 Helix Laboratory-developed Testing Product Overview
9.12.3 Helix Laboratory-developed Testing Product Market Performance
9.12.4 Helix Business Overview
9.12.5 Helix Recent Developments
10 Laboratory-developed Testing Market Forecast by Region
10.1 Global Laboratory-developed Testing Market Size Forecast
10.2 Global Laboratory-developed Testing Market Forecast by Region
10.2.1 North America Market Size Forecast by Country
10.2.2 Europe Laboratory-developed Testing Market Size Forecast by Country
10.2.3 Asia Pacific Laboratory-developed Testing Market Size Forecast by Region
10.2.4 South America Laboratory-developed Testing Market Size Forecast by Country
10.2.5 Middle East and Africa Forecasted Consumption of Laboratory-developed Testing by Country
11 Forecast Market by Type and by Application (2025-2030)
11.1 Global Laboratory-developed Testing Market Forecast by Type (2025-2030)
11.1.1 Global Forecasted Sales of Laboratory-developed Testing by Type (2025-2030)
11.1.2 Global Laboratory-developed Testing Market Size Forecast by Type (2025-2030)
11.1.3 Global Forecasted Price of Laboratory-developed Testing by Type (2025-2030)
11.2 Global Laboratory-developed Testing Market Forecast by Application (2025-2030)
11.2.1 Global Laboratory-developed Testing Sales (K Units) Forecast by Application
11.2.2 Global Laboratory-developed Testing Market Size (M USD) Forecast by Application (2025-2030)
12 Conclusion and Key Findings

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