Market Executive Summary

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 Released in 2016, the draft guidance sparked an intense debate over potential LDT regulation.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 market for Laboratory Developed Test was estimated to be worth US$ 3518.7 million in 2023 and is forecast to a readjusted size of US$ 4376.7 million by 2030 with a CAGR of 3.1% during the forecast period 2024-2030.

According to our research, 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.

Report Scope

This report aims to provide a comprehensive presentation of the global market for Laboratory Developed Test, focusing on the total sales revenue, key companies market share and ranking, together with an analysis of Laboratory Developed Test by region & country, by Type, and by Application.

The Laboratory Developed Test market size, estimations, and forecasts are provided in terms of sales revenue ($ millions), considering 2023 as the base year, with history and forecast data for the period from 2019 to 2030. 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.

Global Laboratory Developed Test Companies Covered

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

Global Laboratory Developed Test Market, by Region

North America (U.S., Canada, Mexico)

Europe (Germany, France, UK, Italy, etc.)

Asia Pacific (China, Japan, South Korea, Southeast Asia, India, etc.)

South America (Brazil, etc.)

Middle East and Africa (Turkey, GCC Countries, Africa, etc.)

Global Laboratory Developed Test Market, Segment by Type

Clinical Biochemistry

Hematology

Immunology

Molecular Diagnostics

Other

Global Laboratory Developed Test Market, Segment by Application

Hospitals Laboratory

Clinical Research Organizations

Academic Institutes

Specialty Diagnostic Centers

Other

Chapter Outline

Chapter 1: Introduces the report scope of the report, global total market size. This chapter also provides 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 2: Detailed analysis of Laboratory Developed Test manufacturers competitive landscape, revenue market share, latest development plan, merger, and acquisition information, etc.

Chapter 3: 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 4: 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 5: Revenue of Laboratory Developed Test in regional level. It provides a quantitative analysis of the market size and development potential of each region and introduces the market development, future development prospects, market space, and market size of each country in the world.

Chapter 6: Revenue of Laboratory Developed Test in country level. It provides sigmate data by Type, and by Application for each country/region.

Chapter 7: Provides profiles of key players, introducing the basic situation of the main companies in the market in detail, including product revenue, gross margin, product introduction, recent development, etc.

Chapter 8: Analysis of industrial chain, including the upstream and downstream of the industry.

Chapter 9: Conclusion.