Global Laboratory-developed Testing Market Growth (Status and Outlook) 2023-2029

Global Laboratory-developed Testing Market Growth (Status and Outlook) 2023-2029

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 Released in 2014, the draft guidance sparked an intense debate over potential LDT regulation.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.
LPI (LP Information)' newest research report, the “Laboratory-developed Testing Industry Forecast” looks at past sales and reviews total world Laboratory-developed Testing sales in 2022, providing a comprehensive analysis by region and market sector of projected Laboratory-developed Testing sales for 2023 through 2029. With Laboratory-developed Testing sales broken down by region, market sector and sub-sector, this report provides a detailed analysis in US$ millions of the world Laboratory-developed Testing industry.
This Insight Report provides a comprehensive analysis of the global Laboratory-developed Testing landscape and highlights key trends related to product segmentation, company formation, revenue, and market share, latest development, and M&A activity. This report also analyzes the strategies of leading global companies with a focus on Laboratory-developed Testing portfolios and capabilities, market entry strategies, market positions, and geographic footprints, to better understand these firms’ unique position in an accelerating global Laboratory-developed Testing market.
This Insight Report evaluates the key market trends, drivers, and affecting factors shaping the global outlook for Laboratory-developed Testing and breaks down the forecast by type, by application, geography, and market size to highlight emerging pockets of opportunity. With a transparent methodology based on hundreds of bottom-up qualitative and quantitative market inputs, this study forecast offers a highly nuanced view of the current state and future trajectory in the global Laboratory-developed Testing.
The global Laboratory-developed Testing market size is projected to grow from US$ 3442.2 million in 2022 to US$ 4512 million in 2029; it is expected to grow at a CAGR of 3.9% from 2023 to 2029.
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%.
This report presents a comprehensive overview, market shares, and growth opportunities of Laboratory-developed Testing market by product type, application, key players and key regions and countries.
Market Segmentation:
Segmentation by type
Commercial Service
R&D
Segmentation by application
Genetic Testing
Oncology
Infectious Disease
Others
This report also splits the market by region:
Americas
United States
Canada
Mexico
Brazil
APAC
China
Japan
Korea
Southeast Asia
India
Australia
Europe
Germany
France
UK
Italy
Russia
Middle East & Africa
Egypt
South Africa
Israel
Turkey
GCC Countries
The below companies that are profiled have been selected based on inputs gathered from primary experts and analyzing the company's coverage, product portfolio, its market penetration.
Adaptive Biotechnologies Corporation
Quest Diagnostics
Roche
Illumina
Qiagen
Eurofins
Guardant Health
Biotheranostics
Adaptive Biotechnologies
Rosetta Genomics
Biodesix
Helix

Please note: The report will take approximately 2 business days to prepare and deliver.