U.S. Laboratory Developed Tests (LDTs) Market - Focused Insights 2024-2029

U.S. LABORATORY DEVELOPED TESTS MARKET ANALYSIS

The U.S. laboratory developed tests (LDTs) market was valued at USD 2.52 billion in 2023 and is expected to reach USD 3.08 billion by 2029, growing at a CAGR of 3.40% during the forecast period. The demand for laboratory developed tests is rising due to multiple factors, including the awareness of infection control and prevention, increased healthcare expenditure, and growing chronic disorders.

The study considers a detailed scenario of the present laboratory developed tests market and its market dynamics for 2024−2029 in the U.S. It covers a detailed overview of several market growth enablers, restraints, and trends. The report offers both the demand and supply aspects of the market. It profiles and examines leading companies and other prominent players operating in the market.

MARKET DEFINITION

Laboratory developed tests (LDTs) are in vitro diagnostic products (IVDs) intended for clinical use and designed, manufactured, and used within a single clinical laboratory that meets certain laboratory requirements. LDTs play an important role in healthcare.

MARKET TRENDS

Increase In Chronic and Infectious Diseases: The burden of infectious diseases and chronic disorders is constantly growing in the U.S. and worldwide. In the U.S., 45% of Americans suffer from at least one chronic disease, and this number is likely to grow. And 17% of the population in the U.S. is aged 65 and above. Chronic disorders include different types of cancers, diabetes, cardiovascular disorders, and others. Infectious diseases such as diphtheria, Ebola, flu, HIV/AIDS, etc, and outbreaks such as the virus COVID-19 which is consistently impacting the growth of the infectious disease testing market. The LDTs market has great potential to obstruct the path of rising disease incidences by early diagnosis and treatment monitoring based on diagnostics.

Increasing Product Offerings Related To Genetic Health Risks: Manufacturers of laboratory-developed tests across the U.S. will have plenty of lucrative offers in the coming years. Vendors have begun recognizing the value of R&D spending in providing a diversified product line. For instance, 23andMe and Virgin Groups merged to become a publicly traded company that will transform personalized healthcare and therapeutic advancements using human genetics. Many companies are taking extensive measures to make their product offerings more versatile through innovations, such as providing data on genetic health risks, traits, and ancestry.

The U.S. LABORATORY DEVELOPED TESTS MARKET INSIGHTS

• The molecular diagnostics test type segment is growing significantly, with the fastest-growing CAGR of 3.89% during the forecast period in the U.S. laboratory developed tests (LDTs) market. The presence of favorable reimbursement policies coupled with rising government support in funding and initiatives to develop diagnostics tests is anticipated to drive the U.S. molecular diagnostics growth.
• By application, the oncology segment dominated the market by occupying over 39% share in the U.S. laboratory developed tests (LDTs) market in 2023. The segmental growth can be attributed to the increasing prevalence of cancer diseases and high expenditure on healthcare.
• LDTs are not FDA-approved for marketing. Some of the reagents, controls, and equipment used in these tests may be manufactured (and are FDA-approved). The reagents in these instances are called Analyte Specific Reagents, or ASRs. In addition, some tests are developed as proprietary tests. The test is marketed to other labs and healthcare providers as a service, and samples must be sent to the lab that developed the test for analysis.
• Laboratories must constantly monitor the tests and test systems to ensure that the results generated remain as accurate, precise, sensitive, and specific as those initially validated. Federal and state governments and laboratory accrediting organizations also regulate these processes and examine them regularly.

VENDOR LANDSCAPE

The U.S. laboratory developed tests (LDTs) market report contains exclusive data on 27 vendors. The laboratory developed test (LDT) sector is experiencing a notable uptick in investment and innovation. This surge can be attributed to the growing precision and effectiveness of LDTs in detecting and diagnosing various diseases. Some independent laboratories, such as LabCorp and Quest Diagnostics, operate as two significant independents across the United States. These independent laboratories are domestic market players and hold a higher market share. Apart from that, several international independent clinical laboratories are present nationwide and compete with domestic small and mid-sized vendors. In the current landscape, high competition in the U.S. clinical laboratory tests market exists among LabCorp, Quest Diagnostics, Sonic Healthcare, and OPKO Health.