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Global Laboratory Developed Test Market Research Report 2024

Global Laboratory Developed Test Market Research Report 2024

Publishing Date : Jan, 2024

License Type :
 

Report Code : 1886481

No of Pages : 84

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Synopsis

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 Released in 2016, the draft guidance sparked an intense debate over potential LDT regulation.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 Test market was valued at US$ 3518.7 million in 2023 and is anticipated to reach US$ 4376.7 million by 2030, witnessing a CAGR of 3.1% during the forecast period 2024-2030.

The global market for medical devices is estimated at US$ 603 billion in the year 2023, and will be growing at a CAGR of 5% during next six years. The global healthcare spending contributes to occupy 10% of the global GDP and is continuously rising in recent years due to the increasing health needs of the aging population, the growing prevalence of chronic and infectious diseases and the expansion of emerging markets. The medical devices market plays a significant role in the healthcare industry.

The market is driven by several factors, including the increasing demand for advanced healthcare services globally, advancements in medical technology, growing geriatric population, rising healthcare expenditure, and increasing awareness about early disease diagnosis and treatment.

This report aims to provide a comprehensive presentation of the global market for Laboratory Developed Test, 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 Test.

Report Scope

The Laboratory Developed Test 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 Test 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.

The report will help the Laboratory Developed Test companies, new entrants, and industry chain related companies in this market with information on the revenues, sales volume, and average price for the overall market and the sub-segments across the different segments, by company, by Type, by Application, and by regions.

By Company (Partial List)

  • Quest Diagnostics
  • Thermo Fisher
  • Waters
  • Roche
  • Illumina
  • Qiagen
  • 23andMe
  • Eurofins
  • Guardant Health
  • Biotheranostics
  • Adaptive Biotechnologies
  • Rosetta Genomics
  • Biodesix
  • Helix

Segment by Type

  • Clinical Biochemistry
  • Hematology
  • Immunology
  • Molecular Diagnostics
  • Other

Segment by Application

  • Hospitals Laboratory
  • Clinical Research Organizations
  • Academic Institutes
  • Specialty Diagnostic Centers
  • Other

By Region

  • North America (United States, 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, Colombia)

Chapter Outline

Chapter 1: Introduces the report scope of the report, executive summary of different market segments (by Type, by 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 market and its likely evolution in the short to mid-term, and long term.
Chapter 2: Introduces executive summary of global market size, regional market size, this section also introduces the market dynamics, latest developments of the market, the driving factors and restrictive factors of the market, the challenges and risks faced by companies in the industry, and the analysis of relevant policies in the industry.
Chapter 3: Detailed analysis of Laboratory Developed Test companies’ competitive landscape, revenue market share, latest development plan, merger, and acquisition information, etc.
Chapter 4: 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 5: 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 6, 7, 8, 9, 10: North America, Europe, Asia Pacific, Latin America, Middle East and Africa segment by country. It 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 11: Provides profiles of key players, introducing the basic situation of the main companies in the market in detail, including product sales, revenue, price, gross margin, product introduction, recent development, etc.
Chapter 12: The main points and conclusions of the report.

Index

1 Report Overview
1.1 Study Scope
1.2 Market Analysis by Type
1.2.1 Global Laboratory Developed Test Market Size Growth Rate by Type: 2019 VS 2023 VS 2030
1.2.2 Clinical Biochemistry
1.2.3 Hematology
1.2.4 Immunology
1.2.5 Molecular Diagnostics
1.2.6 Other
1.3 Market by Application
1.3.1 Global Laboratory Developed Test Market Growth by Application: 2019 VS 2023 VS 2030
1.3.2 Hospitals Laboratory
1.3.3 Clinical Research Organizations
1.3.4 Academic Institutes
1.3.5 Specialty Diagnostic Centers
1.3.6 Other
1.4 Study Objectives
1.5 Years Considered
1.6 Years Considered
2 Global Growth Trends
2.1 Global Laboratory Developed Test Market Perspective (2019-2030)
2.2 Laboratory Developed Test Growth Trends by Region
2.2.1 Global Laboratory Developed Test Market Size by Region: 2019 VS 2023 VS 2030
2.2.2 Laboratory Developed Test Historic Market Size by Region (2019-2024)
2.2.3 Laboratory Developed Test Forecasted Market Size by Region (2025-2030)
2.3 Laboratory Developed Test Market Dynamics
2.3.1 Laboratory Developed Test Industry Trends
2.3.2 Laboratory Developed Test Market Drivers
2.3.3 Laboratory Developed Test Market Challenges
2.3.4 Laboratory Developed Test Market Restraints
3 Competition Landscape by Key Players
3.1 Global Top Laboratory Developed Test Players by Revenue
3.1.1 Global Top Laboratory Developed Test Players by Revenue (2019-2024)
3.1.2 Global Laboratory Developed Test Revenue Market Share by Players (2019-2024)
3.2 Global Laboratory Developed Test Market Share by Company Type (Tier 1, Tier 2, and Tier 3)
3.3 Players Covered: Ranking by Laboratory Developed Test Revenue
3.4 Global Laboratory Developed Test Market Concentration Ratio
3.4.1 Global Laboratory Developed Test Market Concentration Ratio (CR5 and HHI)
3.4.2 Global Top 10 and Top 5 Companies by Laboratory Developed Test Revenue in 2023
3.5 Laboratory Developed Test Key Players Head office and Area Served
3.6 Key Players Laboratory Developed Test Product Solution and Service
3.7 Date of Enter into Laboratory Developed Test Market
3.8 Mergers & Acquisitions, Expansion Plans
4 Laboratory Developed Test Breakdown Data by Type
4.1 Global Laboratory Developed Test Historic Market Size by Type (2019-2024)
4.2 Global Laboratory Developed Test Forecasted Market Size by Type (2025-2030)
5 Laboratory Developed Test Breakdown Data by Application
5.1 Global Laboratory Developed Test Historic Market Size by Application (2019-2024)
5.2 Global Laboratory Developed Test Forecasted Market Size by Application (2025-2030)
6 North America
6.1 North America Laboratory Developed Test Market Size (2019-2030)
6.2 North America Laboratory Developed Test Market Growth Rate by Country: 2019 VS 2023 VS 2030
6.3 North America Laboratory Developed Test Market Size by Country (2019-2024)
6.4 North America Laboratory Developed Test Market Size by Country (2025-2030)
6.5 United States
6.6 Canada
7 Europe
7.1 Europe Laboratory Developed Test Market Size (2019-2030)
7.2 Europe Laboratory Developed Test Market Growth Rate by Country: 2019 VS 2023 VS 2030
7.3 Europe Laboratory Developed Test Market Size by Country (2019-2024)
7.4 Europe Laboratory Developed Test Market Size by Country (2025-2030)
7.5 Germany
7.6 France
7.7 U.K.
7.8 Italy
7.9 Russia
7.10 Nordic Countries
8 Asia-Pacific
8.1 Asia-Pacific Laboratory Developed Test Market Size (2019-2030)
8.2 Asia-Pacific Laboratory Developed Test Market Growth Rate by Region: 2019 VS 2023 VS 2030
8.3 Asia-Pacific Laboratory Developed Test Market Size by Region (2019-2024)
8.4 Asia-Pacific Laboratory Developed Test Market Size by Region (2025-2030)
8.5 China
8.6 Japan
8.7 South Korea
8.8 Southeast Asia
8.9 India
8.10 Australia
9 Latin America
9.1 Latin America Laboratory Developed Test Market Size (2019-2030)
9.2 Latin America Laboratory Developed Test Market Growth Rate by Country: 2019 VS 2023 VS 2030
9.3 Latin America Laboratory Developed Test Market Size by Country (2019-2024)
9.4 Latin America Laboratory Developed Test Market Size by Country (2025-2030)
9.5 Mexico
9.6 Brazil
10 Middle East & Africa
10.1 Middle East & Africa Laboratory Developed Test Market Size (2019-2030)
10.2 Middle East & Africa Laboratory Developed Test Market Growth Rate by Country: 2019 VS 2023 VS 2030
10.3 Middle East & Africa Laboratory Developed Test Market Size by Country (2019-2024)
10.4 Middle East & Africa Laboratory Developed Test Market Size by Country (2025-2030)
10.5 Turkey
10.6 Saudi Arabia
10.7 UAE
11 Key Players Profiles
11.1 Quest Diagnostics
11.1.1 Quest Diagnostics Company Detail
11.1.2 Quest Diagnostics Business Overview
11.1.3 Quest Diagnostics Laboratory Developed Test Introduction
11.1.4 Quest Diagnostics Revenue in Laboratory Developed Test Business (2019-2024)
11.1.5 Quest Diagnostics Recent Development
11.2 Thermo Fisher
11.2.1 Thermo Fisher Company Detail
11.2.2 Thermo Fisher Business Overview
11.2.3 Thermo Fisher Laboratory Developed Test Introduction
11.2.4 Thermo Fisher Revenue in Laboratory Developed Test Business (2019-2024)
11.2.5 Thermo Fisher Recent Development
11.3 Waters
11.3.1 Waters Company Detail
11.3.2 Waters Business Overview
11.3.3 Waters Laboratory Developed Test Introduction
11.3.4 Waters Revenue in Laboratory Developed Test Business (2019-2024)
11.3.5 Waters Recent Development
11.4 Roche
11.4.1 Roche Company Detail
11.4.2 Roche Business Overview
11.4.3 Roche Laboratory Developed Test Introduction
11.4.4 Roche Revenue in Laboratory Developed Test Business (2019-2024)
11.4.5 Roche Recent Development
11.5 Illumina
11.5.1 Illumina Company Detail
11.5.2 Illumina Business Overview
11.5.3 Illumina Laboratory Developed Test Introduction
11.5.4 Illumina Revenue in Laboratory Developed Test Business (2019-2024)
11.5.5 Illumina Recent Development
11.6 Qiagen
11.6.1 Qiagen Company Detail
11.6.2 Qiagen Business Overview
11.6.3 Qiagen Laboratory Developed Test Introduction
11.6.4 Qiagen Revenue in Laboratory Developed Test Business (2019-2024)
11.6.5 Qiagen Recent Development
11.7 23andMe
11.7.1 23andMe Company Detail
11.7.2 23andMe Business Overview
11.7.3 23andMe Laboratory Developed Test Introduction
11.7.4 23andMe Revenue in Laboratory Developed Test Business (2019-2024)
11.7.5 23andMe Recent Development
11.8 Eurofins
11.8.1 Eurofins Company Detail
11.8.2 Eurofins Business Overview
11.8.3 Eurofins Laboratory Developed Test Introduction
11.8.4 Eurofins Revenue in Laboratory Developed Test Business (2019-2024)
11.8.5 Eurofins Recent Development
11.9 Guardant Health
11.9.1 Guardant Health Company Detail
11.9.2 Guardant Health Business Overview
11.9.3 Guardant Health Laboratory Developed Test Introduction
11.9.4 Guardant Health Revenue in Laboratory Developed Test Business (2019-2024)
11.9.5 Guardant Health Recent Development
11.10 Biotheranostics
11.10.1 Biotheranostics Company Detail
11.10.2 Biotheranostics Business Overview
11.10.3 Biotheranostics Laboratory Developed Test Introduction
11.10.4 Biotheranostics Revenue in Laboratory Developed Test Business (2019-2024)
11.10.5 Biotheranostics Recent Development
11.11 Adaptive Biotechnologies
11.11.1 Adaptive Biotechnologies Company Detail
11.11.2 Adaptive Biotechnologies Business Overview
11.11.3 Adaptive Biotechnologies Laboratory Developed Test Introduction
11.11.4 Adaptive Biotechnologies Revenue in Laboratory Developed Test Business (2019-2024)
11.11.5 Adaptive Biotechnologies Recent Development
11.12 Rosetta Genomics
11.12.1 Rosetta Genomics Company Detail
11.12.2 Rosetta Genomics Business Overview
11.12.3 Rosetta Genomics Laboratory Developed Test Introduction
11.12.4 Rosetta Genomics Revenue in Laboratory Developed Test Business (2019-2024)
11.12.5 Rosetta Genomics Recent Development
11.13 Biodesix
11.13.1 Biodesix Company Detail
11.13.2 Biodesix Business Overview
11.13.3 Biodesix Laboratory Developed Test Introduction
11.13.4 Biodesix Revenue in Laboratory Developed Test Business (2019-2024)
11.13.5 Biodesix Recent Development
11.14 Helix
11.14.1 Helix Company Detail
11.14.2 Helix Business Overview
11.14.3 Helix Laboratory Developed Test Introduction
11.14.4 Helix Revenue in Laboratory Developed Test Business (2019-2024)
11.14.5 Helix Recent Development
12 Analyst's Viewpoints/Conclusions
13 Appendix
13.1 Research Methodology
13.1.1 Methodology/Research Approach
13.1.2 Data Source
13.2 Disclaimer
13.3 Author Details

Published By : QY Research

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