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Global Laboratory-developed Testing Market Size, Manufacturers, Opportunities and Forecast to 2030

April 2024 | 102 pages | ID: G5C6F21A574CEN
APO Research

US$ 3,450.00

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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 Released in 2014, the draft guidance sparked an intense debate over potential LDT regulation.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 estimated at US$ million in 2023 and is projected to reach a revised size of 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, gross margin 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
  • U.S.
  • Canada
  • Europe
  • Germany
  • France
  • U.K.
  • Italy
  • Russia
  • Asia-Pacific
  • China
  • Japan
  • South Korea
  • India
  • Australia
  • China Taiwan
  • Indonesia
  • Thailand
  • Malaysia
  • Latin America
  • Mexico
  • Brazil
  • Argentina
  • Middle East & Africa
  • Turkey
  • Saudi Arabia
  • UAE
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 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: Introduces the report scope of the report, executive summary of global and regional market size and CAGR for the history and forecast period (2019-2024, 2025-2030). 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 2: 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 3: 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 4: Introduces 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 5: Detailed analysis of Laboratory-developed Testing companies' competitive landscape, revenue, market share and ranking, latest development plan, merger, and acquisition information, etc.

Chapter 6: Provides profiles of key players, introducing the basic situation of the main companies in the market in detail, including product introduction, revenue, recent development, etc.

Chapter 7, 8, 9, 10 and 11: North America, Europe, Asia Pacific, Latin America, Middle East & Africa, revenue by country.

Chapter 12: Concluding Insights of the report

Chapter 12: Concluding Insights of the report
1 MARKET OVERVIEW

1.1 Product Definition
1.2 Global Market Growth Prospects
1.3 Global Laboratory-developed Testing Market Size Overview by Region 2019 VS 2023 VS 2030
1.4 Global Laboratory-developed Testing Market Size by Region (2019-2030)
  1.4.1 Global Laboratory-developed Testing Market Size by Region (2019-2024)
  1.4.2 Global Laboratory-developed Testing Market Size by Region (2025-2030)
1.5 Key Regions Laboratory-developed Testing Market Size (2019-2030)
  1.5.1 North America Laboratory-developed Testing Market Size Growth Rate (2019-2030)
  1.5.2 Europe Laboratory-developed Testing Market Size Growth Rate (2019-2030)
  1.5.3 Asia-Pacific Laboratory-developed Testing Market Size Growth Rate (2019-2030)
  1.5.4 Latin America Laboratory-developed Testing Market Size Growth Rate (2019-2030)
  1.5.5 Middle East & Africa Laboratory-developed Testing Market Size Growth Rate (2019-2030)

2 LABORATORY-DEVELOPED TESTING MARKET BY TYPE

2.1 Type Introduction
  2.1.1 Commercial Service
  2.1.2 R&D
2.2 Global Laboratory-developed Testing Market Size by Type
  2.2.1 Global Laboratory-developed Testing Market Size Overview by Type (2019-2030)
  2.2.2 Global Laboratory-developed Testing Historic Market Size Review by Type (2019-2024)
  2.2.3 Global Laboratory-developed Testing Market Size Forecasted by Type (2025-2030)
2.3 Global Laboratory-developed Testing Market Size by Regions
  2.3.1 North America Laboratory-developed Testing Market Size Breakdown by Type (2019-2024)
  2.3.2 Europe Laboratory-developed Testing Market Size Breakdown by Type (2019-2024)
  2.3.3 Asia-Pacific Laboratory-developed Testing Market Size Breakdown by Type (2019-2024)
  2.3.4 Latin America Laboratory-developed Testing Market Size Breakdown by Type (2019-2024)
  2.3.5 Middle East and Africa Laboratory-developed Testing Market Size Breakdown by Type (2019-2024)

3 LABORATORY-DEVELOPED TESTING MARKET BY APPLICATION

3.1 Type Introduction
  3.1.1 Genetic Testing
  3.1.2 Oncology
  3.1.3 Infectious Disease
  3.1.4 Others
3.2 Global Laboratory-developed Testing Market Size by Application
  3.2.1 Global Laboratory-developed Testing Market Size Overview by Application (2019-2030)
  3.2.2 Global Laboratory-developed Testing Historic Market Size Review by Application (2019-2024)
  3.2.3 Global Laboratory-developed Testing Market Size Forecasted by Application (2025-2030)
3.3 Global Laboratory-developed Testing Market Size by Regions
  3.3.1 North America Laboratory-developed Testing Market Size Breakdown by Application (2019-2024)
  3.3.2 Europe Laboratory-developed Testing Market Size Breakdown by Application (2019-2024)
  3.3.3 Asia-Pacific Laboratory-developed Testing Market Size Breakdown by Application (2019-2024)
  3.3.4 Latin America Laboratory-developed Testing Market Size Breakdown by Application (2019-2024)
  3.3.5 Middle East and Africa Laboratory-developed Testing Market Size Breakdown by Application (2019-2024)

4 GLOBAL MARKET DYNAMICS

4.1 Laboratory-developed Testing Industry Trends
4.2 Laboratory-developed Testing Industry Drivers
4.3 Laboratory-developed Testing Industry Opportunities and Challenges
4.4 Laboratory-developed Testing Industry Restraints

5 COMPETITIVE INSIGHTS BY COMPANY

5.1 Global Top Players by Laboratory-developed Testing Revenue (2019-2024)
5.2 Global Laboratory-developed Testing Industry Company Ranking, 2022 VS 2023 VS 2024
5.3 Global Laboratory-developed Testing Key Company Headquarters & Area Served
5.4 Global Laboratory-developed Testing Company, Product Type & Application
5.5 Global Laboratory-developed Testing Company Commercialization Time
5.6 Market Competitive Analysis
  5.6.1 Global Laboratory-developed Testing Market CR5 and HHI
  5.6.2 Global Top 5 and 10 Laboratory-developed Testing Players Market Share by Revenue in 2023
  5.6.3 2023 Laboratory-developed Testing Tier 1, Tier 2, and Tier

6 COMPANY PROFILES

6.1 Adaptive Biotechnologies Corporation
  6.1.1 Adaptive Biotechnologies Corporation Comapny Information
  6.1.2 Adaptive Biotechnologies Corporation Business Overview
  6.1.3 Adaptive Biotechnologies Corporation Laboratory-developed Testing Revenue, Global Share and Gross Margin (2019-2024)
  6.1.4 Adaptive Biotechnologies Corporation Laboratory-developed Testing Product Portfolio
  6.1.5 Adaptive Biotechnologies Corporation Recent Developments
6.2 Quest Diagnostics
  6.2.1 Quest Diagnostics Comapny Information
  6.2.2 Quest Diagnostics Business Overview
  6.2.3 Quest Diagnostics Laboratory-developed Testing Revenue, Global Share and Gross Margin (2019-2024)
  6.2.4 Quest Diagnostics Laboratory-developed Testing Product Portfolio
  6.2.5 Quest Diagnostics Recent Developments
6.3 Roche
  6.3.1 Roche Comapny Information
  6.3.2 Roche Business Overview
  6.3.3 Roche Laboratory-developed Testing Revenue, Global Share and Gross Margin (2019-2024)
  6.3.4 Roche Laboratory-developed Testing Product Portfolio
  6.3.5 Roche Recent Developments
6.4 Illumina
  6.4.1 Illumina Comapny Information
  6.4.2 Illumina Business Overview
  6.4.3 Illumina Laboratory-developed Testing Revenue, Global Share and Gross Margin (2019-2024)
  6.4.4 Illumina Laboratory-developed Testing Product Portfolio
  6.4.5 Illumina Recent Developments
6.5 Qiagen
  6.5.1 Qiagen Comapny Information
  6.5.2 Qiagen Business Overview
  6.5.3 Qiagen Laboratory-developed Testing Revenue, Global Share and Gross Margin (2019-2024)
  6.5.4 Qiagen Laboratory-developed Testing Product Portfolio
  6.5.5 Qiagen Recent Developments
6.6 Eurofins
  6.6.1 Eurofins Comapny Information
  6.6.2 Eurofins Business Overview
  6.6.3 Eurofins Laboratory-developed Testing Revenue, Global Share and Gross Margin (2019-2024)
  6.6.4 Eurofins Laboratory-developed Testing Product Portfolio
  6.6.5 Eurofins Recent Developments
6.7 Guardant Health
  6.7.1 Guardant Health Comapny Information
  6.7.2 Guardant Health Business Overview
  6.7.3 Guardant Health Laboratory-developed Testing Revenue, Global Share and Gross Margin (2019-2024)
  6.7.4 Guardant Health Laboratory-developed Testing Product Portfolio
  6.7.5 Guardant Health Recent Developments
6.8 Biotheranostics
  6.8.1 Biotheranostics Comapny Information
  6.8.2 Biotheranostics Business Overview
  6.8.3 Biotheranostics Laboratory-developed Testing Revenue, Global Share and Gross Margin (2019-2024)
  6.8.4 Biotheranostics Laboratory-developed Testing Product Portfolio
  6.8.5 Biotheranostics Recent Developments
6.9 Adaptive Biotechnologies
  6.9.1 Adaptive Biotechnologies Comapny Information
  6.9.2 Adaptive Biotechnologies Business Overview
  6.9.3 Adaptive Biotechnologies Laboratory-developed Testing Revenue, Global Share and Gross Margin (2019-2024)
  6.9.4 Adaptive Biotechnologies Laboratory-developed Testing Product Portfolio
  6.9.5 Adaptive Biotechnologies Recent Developments
6.10 Rosetta Genomics
  6.10.1 Rosetta Genomics Comapny Information
  6.10.2 Rosetta Genomics Business Overview
  6.10.3 Rosetta Genomics Laboratory-developed Testing Revenue, Global Share and Gross Margin (2019-2024)
  6.10.4 Rosetta Genomics Laboratory-developed Testing Product Portfolio
  6.10.5 Rosetta Genomics Recent Developments
6.11 Biodesix
  6.11.1 Biodesix Comapny Information
  6.11.2 Biodesix Business Overview
  6.11.3 Biodesix Laboratory-developed Testing Revenue, Global Share and Gross Margin (2019-2024)
  6.11.4 Biodesix Laboratory-developed Testing Product Portfolio
  6.11.5 Biodesix Recent Developments
6.12 Helix
  6.12.1 Helix Comapny Information
  6.12.2 Helix Business Overview
  6.12.3 Helix Laboratory-developed Testing Revenue, Global Share and Gross Margin (2019-2024)
  6.12.4 Helix Laboratory-developed Testing Product Portfolio
  6.12.5 Helix Recent Developments

7 NORTH AMERICA

7.1 North America Laboratory-developed Testing Market Size Growth Rate (CAGR) by Country: 2019 VS 2023 VS 2030
7.2 North America Laboratory-developed Testing Market Size by Country (2019-2024)
7.3 North America Laboratory-developed Testing Market Size Forecast by Country (2025-2030)

8 EUROPE

8.1 Europe Laboratory-developed Testing Market Size Growth Rate (CAGR) by Country: 2019 VS 2023 VS 2030
8.2 Europe Laboratory-developed Testing Market Size by Country (2019-2024)
8.3 Europe Laboratory-developed Testing Market Size Forecast by Country (2025-2030)

9 ASIA-PACIFIC

9.1 Asia-Pacific Laboratory-developed Testing Market Size Growth Rate (CAGR) by Country: 2019 VS 2023 VS 2030
9.2 Asia-Pacific Laboratory-developed Testing Market Size by Country (2019-2024)
9.3 Asia-Pacific Laboratory-developed Testing Market Size Forecast by Country (2025-2030)

10 LATIN AMERICA

10.1 Latin America Laboratory-developed Testing Market Size Growth Rate (CAGR) by Country: 2019 VS 2023 VS 2030
10.2 Latin America Laboratory-developed Testing Market Size by Country (2019-2024)
10.3 Latin America Laboratory-developed Testing Market Size Forecast by Country (2025-2030)

11 MIDDLE EAST & AFRICA

11.1 Middle East & Africa Laboratory-developed Testing Market Size Growth Rate (CAGR) by Country: 2019 VS 2023 VS 2030
11.2 Middle East & Africa Laboratory-developed Testing Market Size by Country (2019-2024)
11.3 Middle East & Africa Laboratory-developed Testing Market Size Forecast by Country (2025-2030)

12 CONCLUDING INSIGHTS

13 APPENDIX

13.1 Reasons for Doing This Study
13.2 Research Methodology
13.3 Research Process
13.4 Authors List of This Report
13.5 Data Source
  13.5.1 Secondary Sources
  13.5.2 Primary Sources


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