The Laboratory-developed Testing Market report lists Adaptive Biotechnologies Corporation, Quest Diagnostics, Roche, Illumina, Qiagen, Eurofins, Guardant Health, Biotheranostics, Adaptive Biotechnologies, Rosetta Genomics, Biodesix, Helix among the mentioned manufacturers.

The “Laboratory-developed Testing Market Size” report provides a detailed and insightful analysis of the industry, offering a holistic overview of its various components, key players, and stakeholders. It explores the dynamic nature of the market by evaluating trends, challenges, growth drivers, and emerging opportunities that shape the competitive landscape. This report presents a macro-level analysis, encompassing crucial aspects such as market sizing, segmentation, industry structure, regional distribution, and future growth projections. It assesses market performance across different segments and applications, identifying key factors influencing demand and supply.

Furthermore, the report compiles extensive data on overall market size, including sales volume (in units), revenue generation, and market share distribution among different product types and applications. It also delves into technological advancements, regulatory frameworks, and economic factors that impact market expansion.

Market Analysis and Insights: Global Laboratory-developed Testing 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 Released in 2014, the draft guidance sparked an intense debate over potential LDT regulation.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 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%.
The Global Info Research report includes an overview of the development of the Laboratory-developed Testing industry chain, the market status of Genetic Testing (Commercial Service, R&D), Oncology (Commercial Service, R&D), and key enterprises in developed and developing market, and analysed the cutting-edge technology, patent, hot applications and market trends of Laboratory-developed Testing.
Regionally, the report analyzes the Laboratory-developed Testing markets in key regions. North America and Europe are experiencing steady growth, driven by government initiatives and increasing consumer awareness. Asia-Pacific, particularly China, leads the global Laboratory-developed Testing market, with robust domestic demand, supportive policies, and a strong manufacturing base.

Market segmentation

Laboratory-developed Testing market is split by Type and by Application. For the period 2019-2030, the growth among segments provide accurate calculations and forecasts for sales by Type and by Application in terms of volume and value. This analysis can help you expand your business by targeting qualified niche markets.

The major players covered in the Laboratory-developed Testing market report are:

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

Market segment by Type, covers

  • Commercial Service
  • R&D

Market segment by Application can be divided into

  • Genetic Testing
  • Oncology
  • Infectious Disease
  • Others

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Market segment by region, regional analysis covers

  • North America (United States, Canada and Mexico)
  • Europe (Germany, France, United Kingdom, Russia, Italy, and Rest of Europe)
  • Asia-Pacific (China, Japan, Korea, India, Southeast Asia, and Australia)
  • South America (Brazil, Argentina, Colombia, and Rest of South America)
  • Middle East & Africa (Saudi Arabia, UAE, Egypt, South Africa, and Rest of Middle East & Africa)

The content of the study subjects, includes a total of 15 chapters:

  • Chapter 1, to describe Laboratory-developed Testing product scope, market overview, market estimation caveats and base year.
  • Chapter 2, to profile the top manufacturers of Laboratory-developed Testing, with price, sales, revenue and global market share of Laboratory-developed Testing from 2019 to 2025.
  • Chapter 3, the Laboratory-developed Testing competitive situation, sales quantity, revenue and global market share of top manufacturers are analysed emphatically by landscape contrast.
  • Chapter 4, the Laboratory-developed Testing breakdown data are shown at the regional level, to show the sales quantity, consumption value and growth by regions, from 2019 to 2030.
  • Chapter 5 and 6, to segment the sales by Type and application, with sales market share and growth rate by type, application, from 2019 to 2030.
  • Chapter 7, 8, 9, 10 and 11, to break the sales data at the country level, with sales quantity, consumption value and market share for key countries in the world, from 2017 to 2023.and Laboratory-developed Testing market forecast, by regions, type and application, with sales and revenue, from 2025 to 2030.
  • Chapter 12, market dynamics, drivers, restraints, trends and Porters Five Forces analysis.
  • Chapter 13, the key raw materials and key suppliers, and industry chain of Laboratory-developed Testing.
  • Chapter 14 and 15, to describe Laboratory-developed Testing sales channel, distributors, customers, research findings and conclusion.

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Questions answered in the Laboratory-developed Testing market research report:

  • What is the Laboratory-developed Testing market size?
  • What are the market driving factors behind the Laboratory-developed Testing market?
  • What are the market trends and forecast for the global Laboratory-developed Testing market?
  • What are the trends and forecasts based on market research and analysis of Laboratory-developed Testing market segmentation by type, application, and geography?
  • Which are the major global Laboratory-developed Testing companies?
  • What is the CAGR and Revenue expected in future?

Detailed TOC of Global Laboratory-developed Testing Market 2025 by Manufacturers, Regions, Type and Application, Forecast to 2030

1 Laboratory-developed Testing Market Overview

1.1 Introduction

1.2 Market Analysis by Type

1.2.1 Overview: Global Revenue by Type: 2017 Versus 2021 Versus 2030

1.3 Market Analysis by Application

1.4 Global Market Size & Forecast

1.4.1 Global Sales in Value (2017 & 2021 & 2030)

1.4.2 Global Sales in Volume (2019-2030)

1.4.3 Global Price (2019-2030)

1.5 Global Production Capacity Analysis

1.5.1 Global Total Production Capacity (2019-2030)

1.5.2 Global Production Capacity by Geographic Region

1.6 Market Drivers, Restraints and Trends

1.6.1 Laboratory-developed Testing Market Drivers

1.6.2 Laboratory-developed Testing Market Restraints

1.6.3 Laboratory-developed Testing Trends Analysis

2 Manufacturers Profiles

2.1 Manufacture 1

2.1.1 Manufacture 1 Details

2.1.2 Manufacture 1 Major Business

2.1.3 Manufacture 1 Laboratory-developed Testing Product and Services

2.1.4 Manufacture 1 Laboratory-developed Testing Sales, Price, Revenue, Gross Margin and Market Share (2019, 2020, 2021, and 2025)

2.2 Manufacture 2

2.2.1 Manufacture 2 Details

2.2.2 Manufacture 2 Major Business

2.2.3 Manufacture 2 Laboratory-developed Testing Product and Services

2.2.4 Manufacture 2 Laboratory-developed Testing Sales, Price, Revenue, Gross Margin and Market Share (2019, 2020, 2021, and 2025)

2.3 Manufacture 3

2.3.1 Manufacture 3 Details

2.3.2 Manufacture 3 Major Business

2.3.3 Manufacture 3 Laboratory-developed Testing Product and Services

2.3.4 Manufacture 3 Laboratory-developed Testing Sales, Price, Revenue, Gross Margin and Market Share (2019, 2020, 2021, and 2025)

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3 Laboratory-developed Testing Breakdown Data by Manufacturer

3.1 Global Laboratory-developed Testing Sales in Volume by Manufacturer (2019, 2020, 2021, and 2025)

3.2 Global Laboratory-developed Testing Revenue by Manufacturer (2019, 2020, 2021, and 2025)

3.3 Key Manufacturer Market Position in Laboratory-developed Testing

3.4 Market Concentration Rate

3.4.1 Top 3 Laboratory-developed Testing Manufacturer Market Share in 2021

3.4.2 Top 6 Laboratory-developed Testing Manufacturer Market Share in 2021

3.5 Global Laboratory-developed Testing Production Capacity by Company: 2021 VS 2025

3.6 Manufacturer by Geography: Head Office and Laboratory-developed Testing Production Site

3.7 New Entrant and Capacity Expansion Plans

3.8 Mergers & Acquisitions

4 Laboratory-developed Testing Market Analysis by Region

4.1 Global Market Size by Region

4.1.1 Global Sales in Volume by Region (2019-2030)

4.1.2 Global Revenue by Region (2019-2030)

4.2 North America Laboratory-developed Testing Revenue (2019-2030)

4.3 Europe Laboratory-developed Testing Revenue (2019-2030)

4.4 Asia-Pacific Revenue (2019-2030)

4.5 South America Revenue (2019-2030)

4.6 Middle East and Africa Revenue (2019-2030)

5 Laboratory-developed Testing Market Segment by Type

5.1 Global Sales in Volume by Type (2019-2030)

5.2 Global Revenue by Type (2019-2030)

5.3 Global Price by Type (2019-2030)

6 Laboratory-developed Testing Market Segment by Application

6.1 Global Sales in Volume by Application (2019-2030)

6.2 Global Revenue by Application (2019-2030)

6.3 Global Price by Application (2019-2030)

7 North America by Country, by Type, and by Application

7.1 North America Laboratory-developed Testing Sales by Type (2019-2030)

7.2 North America Laboratory-developed Testing Sales by Application (2019-2030)

7.3 North America Laboratory-developed Testing Market Size by Country

7.3.1 North America Laboratory-developed Testing Sales in Volume by Country (2019-2030)

7.3.2 North America Laboratory-developed Testing Revenue by Country (2019-2030)

7.3.3 United States Market Size and Forecast (2019-2030)

7.3.4 Canada Market Size and Forecast (2019-2030)

7.3.5 Mexico Market Size and Forecast (2019-2030)

8 Europe by Country, by Type, and by Application

8.1 Europe Laboratory-developed Testing Sales by Type (2019-2030)

8.2 Europe Laboratory-developed Testing Sales by Application (2019-2030)

8.3 Europe Laboratory-developed Testing Market Size by Country

8.3.1 Europe Laboratory-developed Testing Sales in Volume by Country (2019-2030)

8.3.2 Europe Laboratory-developed Testing Revenue by Country (2019-2030)

8.3.3 Germany Market Size and Forecast (2019-2030)

8.3.4 France Market Size and Forecast (2019-2030)

8.3.5 United Kingdom Market Size and Forecast (2019-2030)

8.3.6 Russia Market Size and Forecast (2019-2030)

8.3.7 Italy Market Size and Forecast (2019-2030)

9 Asia-Pacific by Region, by Type, and by Application

9.1 Asia-Pacific Laboratory-developed Testing Sales by Type (2019-2030)

9.2 Asia-Pacific Laboratory-developed Testing Sales by Application (2019-2030)

9.3 Asia-Pacific Laboratory-developed Testing Market Size by Region

9.3.1 Asia-Pacific Laboratory-developed Testing Sales in Volume by Region (2019-2030)

9.3.2 Asia-Pacific Laboratory-developed Testing Revenue by Region (2019-2030)

9.3.3 China Market Size and Forecast (2019-2030)

9.3.4 Japan Market Size and Forecast (2019-2030)

9.3.5 Korea Market Size and Forecast (2019-2030)

9.3.6 India Market Size and Forecast (2019-2030)

9.3.7 Southeast Asia Market Size and Forecast (2019-2030)

9.3.8 Australia Market Size and Forecast (2019-2030)

10 South America by Region, by Type, and by Application

10.1 South America Laboratory-developed Testing Sales by Type (2019-2030)

10.2 South America Laboratory-developed Testing Sales by Application (2019-2030)

10.3 South America Laboratory-developed Testing Market Size by Country

10.3.1 South America Laboratory-developed Testing Sales in Volume by Country (2019-2030)

10.3.2 South America Laboratory-developed Testing Revenue by Country (2019-2030)

10.3.3 Brazil Market Size and Forecast (2019-2030)

10.3.4 Argentina Market Size and Forecast (2019-2030)

11 Middle East & Africa by Country, by Type, and by Application

11.1 Middle East & Africa Laboratory-developed Testing Sales by Type (2019-2030)

11.2 Middle East & Africa Laboratory-developed Testing Sales by Application (2019-2030)

11.3 Middle East & Africa Laboratory-developed Testing Market Size by Country

11.3.1 Middle East & Africa Laboratory-developed Testing Sales in Volume by Country (2019-2030)

11.3.2 Middle East & Africa Laboratory-developed Testing Revenue by Country (2019-2030)

11.3.3 Turkey Market Size and Forecast (2019-2030)

11.3.4 Egypt Market Size and Forecast (2019-2030)

11.3.5 Saudi Arabia Market Size and Forecast (2019-2030)

11.3.6 South Africa Market Size and Forecast (2019-2030)

12 Raw Material and Industry Chain

12.1 Raw Material of Laboratory-developed Testing and Key Manufacturers

12.2 Manufacturing Costs Percentage of Laboratory-developed Testing

12.3 Laboratory-developed Testing Production Process

12.4 Laboratory-developed Testing Industrial Chain

13 Sales Channel, Distributors, Traders and Dealers

13.1 Sales Channel

13.1.1 Direct Marketing

13.1.2 Indirect Marketing

13.2 Laboratory-developed Testing Typical Distributors

13.3 Laboratory-developed Testing Typical Customers

14 Research Findings and Conclusion

15 Appendix

15.1 Methodology

15.2 Research Process and Data Source

15.3 Disclaimer

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