Global Laboratory-developed Testing Competitive Landscape Professional Research Report 2025

Research Summary

Laboratory-developed testing (LDT) refers to diagnostic tests that are created, validated, and performed within a specific laboratory for the purpose of providing clinical or medical information. These tests are developed by individual laboratories, often in-house, and are not mass-produced or distributed commercially. LDTs cover a broad spectrum of diagnostic areas, including genetic testing, molecular diagnostics, and specialized clinical assays. Laboratories undertaking the development of these tests are responsible for ensuring their accuracy, reliability, and clinical relevance. While LDTs contribute to innovation in diagnostic capabilities, there are ongoing discussions and regulatory considerations to establish standards and ensure the quality and safety of these tests. The regulatory oversight of LDTs may vary, and regulatory bodies aim to balance the promotion of innovation with the need to safeguard patient interests and maintain the integrity of diagnostic results.

According to DIResearch's in-depth investigation and research, the global Laboratory-developed Testing market size was valued at XX Million USD in 2024 and is projected to reach XX Million USD by 2032, with a CAGR of XX% (2025-2032). Notably, the China market has changed rapidly in the past few years. By 2024, China's market size is expected to be XX Million USD, representing approximately XX% of the global market share. By 2032, it is anticipated to grow further to XX Million USD, contributing XX% to the worldwide market share.

The major global  manufacturers of Laboratory-developed Testing include Adaptive Biotechnologies Corporation, Quest Diagnostics, Roche, Illumina, Qiagen, Eurofins, Guardant Health, Biotheranostics, Adaptive Biotechnologies, Rosetta Genomics, Biodesix, Helix etc. The global players competition landscape in this report is divided into three tiers. The first tier comprises global leading enterprises that command a substantial market share, hold a dominant industry position, possess strong competitiveness and influence, and generate significant revenue. The second tier includes companies with a notable market presence and reputation; these firms actively follow industry leaders in product, service, or technological innovation and maintain a moderate revenue scale. The third tier consists of smaller companies with limited market share and lower brand recognition, primarily focused on local markets and generating comparatively lower revenue.

This report studies the market size, price trends and future development prospects of Laboratory-developed Testing. Focus on analysing the market share, product portfolio, prices, sales, revenue and gross profit margin of global major manufacturers, as well as the market status and trends of different product types and applications in the global Laboratory-developed Testing market. The report data covers historical data from 2020 to 2024, based year in 2025 and forecast data from 2026 to 2032.

The regions and countries in the report include North America, Europe, China, APAC (excl. China), Latin America and Middle East and Africa, covering the Laboratory-developed Testing market conditions and future development trends of key regions and countries, combined with industry-related policies and the latest technological developments, analyze the development characteristics of Laboratory-developed Testing industries in various regions and countries, help companies understand the development characteristics of each region, help companies formulate business strategies, and achieve the ultimate goal of the company's global development strategy.  

The data sources of this report mainly include the National Bureau of Statistics, customs databases, industry associations, corporate financial reports, third-party databases, etc. Among them, macroeconomic data mainly comes from the National Bureau of Statistics, International Economic Research Organization; industry statistical data mainly come from industry associations; company data mainly comes from interviews, public information collection, third-party reliable databases, and price data mainly comes from various markets monitoring database.

Global Key Manufacturers of Laboratory-developed Testing Include:

Adaptive Biotechnologies Corporation

Quest Diagnostics

Roche

Illumina

Qiagen

Eurofins

Guardant Health

Biotheranostics

Adaptive Biotechnologies

Rosetta Genomics

Biodesix

Helix

Laboratory-developed Testing Product Segment Include:

Commercial Service

R&D

Laboratory-developed Testing Product Application Include:

Genetic Testing

Oncology

Infectious Disease

Others

Chapter Scope

Chapter 1: Product Research Range, Product Types and Applications, Market Overview, Market Situation and Trends

Chapter 2: Global Laboratory-developed Testing Industry PESTEL Analysis

Chapter 3: Global Laboratory-developed Testing Industry Porter’s Five Forces Analysis

Chapter 4: Global Laboratory-developed Testing Major Regional Market Size and Forecast Analysis

Chapter 5: Global Laboratory-developed Testing Market Size and Forecast by Type and Application Analysis

Chapter 6: North America Passenger Laboratory-developed Testing Competitive Analysis (Market Size, Key Players and Market Share, Product Type and Application Segment Analysis, Countries Analysis)

Chapter 7: Europe Laboratory-developed Testing Competitive Analysis (Market Size, Key Players and Market Share, Product Type and Application Segment Analysis, Countries Analysis)

Chapter 8: China Laboratory-developed Testing Competitive Analysis (Market Size, Key Players and Market Share, Product Type and Application Segment Analysis, Countries Analysis)

Chapter 9: APAC (Excl. China) Laboratory-developed Testing Competitive Analysis (Market Size, Key Players and Market Share, Product Type and Application Segment Analysis, Countries Analysis)

Chapter 10: Latin America Laboratory-developed Testing Competitive Analysis (Market Size, Key Players and Market Share, Product Type and Application Segment Analysis, Countries Analysis)

Chapter 11: Middle East and Africa Laboratory-developed Testing Competitive Analysis (Market Size, Key Players and Market Share, Product Type and Application Segment Analysis, Countries Analysis)

Chapter 12: Global Laboratory-developed Testing Competitive Analysis of Key Manufacturers (Revenue, Market Share, Regional Distribution and Industry Concentration)

Chapter 13: Key Company Profiles (Product Portfolio, Revenue and Gross Margin)

Chapter 14: Industrial Chain Analysis, Include Raw Material Suppliers, Distributors and Customers

Chapter 15: Research Findings and Conclusion

Chapter 16: Methodology and Data Sources


1 Laboratory-developed Testing Market Overview
1.1 Product Definition and Statistical Scope
1.2 Laboratory-developed Testing Product by Type
1.2.1 Commercial Service
1.2.2 R&D
1.3 Laboratory-developed Testing Product by Application
1.3.1 Genetic Testing
1.3.2 Oncology
1.3.3 Infectious Disease
1.3.4 Others
1.4 Global Laboratory-developed Testing Market Size Analysis (2020-2032)
1.5 Laboratory-developed Testing Market Development Status and Trends
1.5.1 Laboratory-developed Testing Industry Development Status Analysis
1.5.2 Laboratory-developed Testing Industry Development Trends Analysis
2 Laboratory-developed Testing Market PESTEL Analysis
2.1 Political Factors Analysis
2.2 Economic Factors Analysis
2.3 Social Factors Analysis
2.4 Technological Factors Analysis
2.5 Environmental Factors Analysis
2.6 Legal Factors Analysis
3 Laboratory-developed Testing Market Porter's Five Forces Analysis
3.1 Competitive Rivalry
3.2 Threat of New Entrants
3.3 Bargaining Power of Suppliers
3.4 Bargaining Power of Buyers
3.5 Threat of Substitutes
4 Global Laboratory-developed Testing Market Analysis by Regions
4.1 Global Laboratory-developed Testing Overall Market: 2024 VS 2025 VS 2032
4.2 Global Laboratory-developed Testing Revenue and Forecast Analysis (2020-2032)
4.2.1 Global Laboratory-developed Testing Revenue and Market Share by Region (2020-2025)
4.2.2 Global Laboratory-developed Testing Revenue Forecast by Region (2026-2032)
5 Global Laboratory-developed Testing Market Size by Type and Application
5.1 Global Laboratory-developed Testing Market Size by Type (2020-2032)
5.2 Global Laboratory-developed Testing Market Size by Application (2020-2032)
6 North America
6.1 North America Laboratory-developed Testing Market Size and Growth Rate Analysis (2020-2032)
6.2 North America Key Manufacturers Analysis
6.3 North America Laboratory-developed Testing Market Size by Type
6.4 North America Laboratory-developed Testing Market Size by Application
6.5 North America Laboratory-developed Testing Market Size by Country
6.5.1 US
6.5.2 Canada
7 Europe
7.1 Europe Laboratory-developed Testing Market Size and Growth Rate Analysis (2020-2032)
7.2 Europe Key Manufacturers Analysis
7.3 Europe Laboratory-developed Testing Market Size by Type
7.4 Europe Laboratory-developed Testing Market Size by Application
7.5 Europe Laboratory-developed Testing Market Size by Country
7.5.1 Germany
7.5.2 France
7.5.3 United Kingdom
7.5.4 Italy
7.5.5 Spain
7.5.6 Benelux
8 China
8.1 China Laboratory-developed Testing Market Size and Growth Rate Analysis (2020-2032)
8.2 China Key Manufacturers Analysis
8.3 China Laboratory-developed Testing Market Size by Type
8.4 China Laboratory-developed Testing Market Size by Application
9 APAC (excl. China)
9.1 APAC (excl. China) Laboratory-developed Testing Market Size and Growth Rate Analysis (2020-2032)
9.2 APAC (excl. China) Key Manufacturers Analysis
9.3 APAC (excl. China) Laboratory-developed Testing Market Size by Type
9.4 APAC (excl. China) Laboratory-developed Testing Market Size by Application
9.5 APAC (excl. China) Laboratory-developed Testing Market Size by Country
9.5.1 Japan
9.5.2 South Korea
9.5.3 India
9.5.4 Australia
9.5.5 Southeast Asia
10 Latin America
10.1 Latin America Laboratory-developed Testing Market Size and Growth Rate Analysis (2020-2032)
10.2 Latin America Key Manufacturers Analysis
10.3 Latin America Laboratory-developed Testing Market Size by Type
10.4 Latin America Laboratory-developed Testing Market Size by Application
10.5 Latin America Laboratory-developed Testing Market Size by Country
10.5.1 Mexico
10.5.2 Brazil
11 Middle East & Africa
11.1 Middle East & Africa Laboratory-developed Testing Market Size and Growth Rate Analysis (2020-2032)
11.2 Middle East & Africa Key Manufacturers Analysis
11.3 Middle East & Africa Laboratory-developed Testing Market Size by Type
11.4 Middle East & Africa Laboratory-developed Testing Market Size by Application
11.5 Middle East & Africa Laboratory-developed Testing Market Size by Country
11.5.1 Saudi Arabia
11.5.2 South Africa
12 Competition by Manufacturers
12.1 Global Laboratory-developed Testing Market Revenue by Key Manufacturers (2021-2025)
12.2 Laboratory-developed Testing Competitive Landscape Analysis and Market Dynamic
12.2.1 Laboratory-developed Testing Competitive Landscape Analysis
12.2.2 Global Key Manufacturers Headquarter Location and Key Area Sales
12.2.3 Market Dynamic
13 Key Companies Analysis
13.1 Adaptive Biotechnologies Corporation
13.1.1 Adaptive Biotechnologies Corporation Basic Company Profile (Employees, Areas Service, Competitors and Contact Information)
13.1.2 Adaptive Biotechnologies Corporation Laboratory-developed Testing Product Portfolio
13.1.3 Adaptive Biotechnologies Corporation Laboratory-developed Testing Market Data Analysis (Revenue, Gross Margin and Market Share) (2021-2025)
13.2 Quest Diagnostics
13.2.1 Quest Diagnostics Basic Company Profile (Employees, Areas Service, Competitors and Contact Information)
13.2.2 Quest Diagnostics Laboratory-developed Testing Product Portfolio
13.2.3 Quest Diagnostics Laboratory-developed Testing Market Data Analysis (Revenue, Gross Margin and Market Share) (2021-2025)
13.3 Roche
13.3.1 Roche Basic Company Profile (Employees, Areas Service, Competitors and Contact Information)
13.3.2 Roche Laboratory-developed Testing Product Portfolio
13.3.3 Roche Laboratory-developed Testing Market Data Analysis (Revenue, Gross Margin and Market Share) (2021-2025)
13.4 Illumina
13.4.1 Illumina Basic Company Profile (Employees, Areas Service, Competitors and Contact Information)
13.4.2 Illumina Laboratory-developed Testing Product Portfolio
13.4.3 Illumina Laboratory-developed Testing Market Data Analysis (Revenue, Gross Margin and Market Share) (2021-2025)
13.5 Qiagen
13.5.1 Qiagen Basic Company Profile (Employees, Areas Service, Competitors and Contact Information)
13.5.2 Qiagen Laboratory-developed Testing Product Portfolio
13.5.3 Qiagen Laboratory-developed Testing Market Data Analysis (Revenue, Gross Margin and Market Share) (2021-2025)
13.6 Eurofins
13.6.1 Eurofins Basic Company Profile (Employees, Areas Service, Competitors and Contact Information)
13.6.2 Eurofins Laboratory-developed Testing Product Portfolio
13.6.3 Eurofins Laboratory-developed Testing Market Data Analysis (Revenue, Gross Margin and Market Share) (2021-2025)
13.7 Guardant Health
13.7.1 Guardant Health Basic Company Profile (Employees, Areas Service, Competitors and Contact Information)
13.7.2 Guardant Health Laboratory-developed Testing Product Portfolio
13.7.3 Guardant Health Laboratory-developed Testing Market Data Analysis (Revenue, Gross Margin and Market Share) (2021-2025)
13.8 Biotheranostics
13.8.1 Biotheranostics Basic Company Profile (Employees, Areas Service, Competitors and Contact Information)
13.8.2 Biotheranostics Laboratory-developed Testing Product Portfolio
13.8.3 Biotheranostics Laboratory-developed Testing Market Data Analysis (Revenue, Gross Margin and Market Share) (2021-2025)
13.9 Adaptive Biotechnologies
13.9.1 Adaptive Biotechnologies Basic Company Profile (Employees, Areas Service, Competitors and Contact Information)
13.9.2 Adaptive Biotechnologies Laboratory-developed Testing Product Portfolio
13.9.3 Adaptive Biotechnologies Laboratory-developed Testing Market Data Analysis (Revenue, Gross Margin and Market Share) (2021-2025)
13.10 Rosetta Genomics
13.10.1 Rosetta Genomics Basic Company Profile (Employees, Areas Service, Competitors and Contact Information)
13.10.2 Rosetta Genomics Laboratory-developed Testing Product Portfolio
13.10.3 Rosetta Genomics Laboratory-developed Testing Market Data Analysis (Revenue, Gross Margin and Market Share) (2021-2025)
13.11 Biodesix
13.11.1 Biodesix Basic Company Profile (Employees, Areas Service, Competitors and Contact Information)
13.11.2 Biodesix Laboratory-developed Testing Product Portfolio
13.11.3 Biodesix Laboratory-developed Testing Market Data Analysis (Revenue, Gross Margin and Market Share) (2021-2025)
13.12 Helix
13.12.1 Helix Basic Company Profile (Employees, Areas Service, Competitors and Contact Information)
13.12.2 Helix Laboratory-developed Testing Product Portfolio
13.12.3 Helix Laboratory-developed Testing Market Data Analysis (Revenue, Gross Margin and Market Share) (2021-2025)
14 Industry Chain Analysis
14.1 Laboratory-developed Testing Industry Chain Analysis
14.2 Laboratory-developed Testing Industry Raw Material and Suppliers Analysis
14.2.1 Laboratory-developed Testing Key Raw Material Supply Analysis
14.2.2 Raw Material Suppliers and Contact Information
14.3 Laboratory-developed Testing Typical Downstream Customers
14.4 Laboratory-developed Testing Sales Channel Analysis
15 Research Findings and Conclusion
16 Methodology and Data Source
16.1 Methodology/Research Approach
16.2 Research Scope
16.3 Benchmarks and Assumptions
16.4 Date Source
16.4.1 Primary Sources
16.4.2 Secondary Sources
16.5 Data Cross Validation
16.6 Disclaimer

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