Laboratory Developed Tests Market Size, Share & Trends Analysis Report By Technology (Immunoassay, Molecular Diagnostics), By Application (Oncology, Nutritional & Metabolic Disease), By Region, And Segment Forecasts, 2023 - 2030

Report Overview

The global laboratory developed tests market size was valued at USD 10.04 billion in 2022 and is expected to expand at a compound annual growth rate (CAGR) of 6.58% by 2030. The industry is witnessing growth due to the factors, such as increasing demand for in vitro diagnostic tests that are currently unavailable in the market for laboratory developed tests (LDTs), increasing demand for personalized medicine, and the fact that these tests do not require any regulatory approval. Moreover, these tests are available at lower cost and can aid in developing a wide range of diagnostic tools for various health conditions. This further drives the growth of the industry.

LDTs constitute about 50% of total in-vitro diagnostics devices that are used in some laboratories. The lack of an equivalent IVD on the market is the primary reason labs develop LDTs. However, even after the availability of an approved IVD test may be insufficient due to a lack of specificity and sensitivity. Thus, LDTs play a significant role in bridging gaps in diagnostic demands. This includes testing for rare genetic disorders when designing and commercializing an FDA-approved test that may not be economically feasible. For instance, in May 2022, Guardant Health launched Shield, a blood test that is available as a laboratory-developed test for the detection of early signs of colorectal cancer in the population aged above 45 years.

The COVID-19 pandemic has underlined the significance of reliable and accurate diagnostic diagnostics. Premarket approval is not usually required for LDTs.While the COVID-19 pandemic prompted the quick creation of LDTs to help improve COVID-19 testing capacity, it also raised concerns over the ambiguity of LDT rules and regulations. The pandemic brought to light an often-overlooked fact, the FDA ultimately supervises all diagnostic testing in the United States. The FDA made Emergency Use Authorization (EUA) obligatory for diagnostic LDTs for SARS-CoV-2 in February 2020, a decision overturned by the U.S. Department of Health and Human Services (HHS) in August 2020 to uphold the wider availability of COVID-19 diagnostic tests.

To ensure the quality of the accessible COVID-19 tests, the HHS secretary rescinded this policy in November 2021, reinstating EUA criteria for POC tests. Moreover, the market is growing due to the advantages of LDTs, such as being more cost-efficient, appropriate, and demonstrating higher performance as compared to commercially available IVD assays. The increasing use of LDTs when an FDA-approved IVD is either not accessible or does not match clinical standards. When a survey was conducted in April 2022, 91% of the respondents suggested that the change in regulations will curb innovation for LDTs.

However, the U.S. FDA has regulatory power and enforcement discretion over LDTs. Several LDTs enter the market without being approved by the U.S. FDA or any other regulatory body. For instance, in September 2022, Bionano Genomics launched its first OGM-based LDT for facioscapulohumeral muscular dystrophy. The Clinical Laboratory Improvement Amendments (CLIA) give the Centers for Medicare & Medicaid Services limited authority over the utility or quality of LDTs, including whether or not patients have been harmed as a result of their usage, and instead place more emphasis on analytical performance.

Technology Insights

The molecular diagnostics segment dominated the industry in 2022 and accounted for the largest share of more than 27.20% of the overall revenue. The segment will expand further at a steady CAGR during the forecast period. The growth of the segment is attributed to the increasing geriatric population and an increasing need to provide early disease detection. Moreover, the introduction of accurate and technologically advanced products, such as biochips, companion diagnostics, and microarrays has increased the demand for the early detection of diseases.

The rising prevalence of chronic diseases and the increasing need to control healthcare expenditure are also expected to fuel the growth by boosting the demand for early disease diagnosis & regular monitoring. The genetic/inherited diseases segment is expected to register the second-fastest growth rate during the forecast period. The growth of this segment can be attributed to the increasing prevalence of genetic and inherited disorders and the high demand for prenatal diagnostic tests. There has been a rise in screening tests that are administered to detect abnormalities in newborns. It has been estimated that none of the more than 40 noninvasive prenatal tests are FDA-reviewed but are in the market. Such tests propel the demand for LDTs, further fueling the overall industry growth.

Application Insights

The oncology application segment dominated the industry in 2022 and accounted for the maximum share of more than 20.65% of the overall revenue. Oncology and hereditary illnesses are frequent applications, but broad use is also seen in a variety of other applications, such as toxicology or blood coagulation. For instance, in September 2022, Allelica launched ancestry-specific Polygenic Risk Score (PRS) analysis as an LDT for prostate cancer, coronary artery disease, breast cancer, Alzheimer’s disease, and type 2 diabetes. Moreover, with the increasing prevalence of cancer and the rapid development of cancer diagnosis, the market is undergoing significant growth. For instance, in June 2022, Neogenomics announced data on its LDT RaDaR assay, for the detection of MRD by its subsidiary Inivata Ltd.

The immunoassay segment is expected to grow at the fastest CAGR over the forecast period owing to increased life expectancy, which boosts product demand, as these tests remain the primary mode of diagnosis. Challenges in innovations to improve the tests for Chronic Kidney Diseases (CKDs), heart failures, and osteoporosis are expected to further propel the segment. Improvements in these tests through the introduction of novel markers and novel application of existing markers are promoting segment growth. In addition, alternative sampling methods, the emergence of PoC testing methods, and the introduction of new technologies are likely to further boost segment growth.

Regional Insights

North America dominated the global industry in 2022 and accounted for the maximum share of more than 36.30% of the overall revenue. The region is anticipated to grow at a significant growth rate over the forecast period. The dominance of the region can be attributed to the rising healthcare expenditure, increasing prevalence of chronic diseases, growing geriatric population, and increasing government funding. For instance, according to the U.S. Census Bureau, the geriatric population is around 56 million accounting for 16.9% of the country’s total population. The market for molecular diagnostics in the region is expected to grow at the fastest growth rate over the forecast period subsequently driving the LDT industry growth.

Moreover, key players are focusing on the development of novel products and achieving regulatory approvals, which, in turn, drive the LDT growth. For instance, in August 2022, Biomerica, Inc. launched InFoods, an IBS test developed as an LDT. On the other hand, Asia Pacific is expected to register the fastest growth rate during the forecast period, which can be attributed to the presence of unmet medical needs, increasing scientific research, and positive economic growth. The region shows a high prevalence of cancer and other genetic disorders that require early diagnosis, which propels the demand for the development of novel products. Furthermore, the region has an improved healthcare infrastructure that provides better coverage of LDTs.

Key Companies & Market Share Insights

The industry is expanding at a significant growth rate owing to the strategies adopted by key players focusing on geographic expansion through mergers & acquisitions and product launches. For Instance, in July 2022, Quanterix Corp. launched the first TDTs for the diagnostic evaluation of Alzheimer’s disease for aiding in research applications and clinical diagnostics in the U.S. Some of the prominent key players in the global laboratory developed tests market include:

• Quest Diagnostics Inc.

• 23andme, Inc.

• Abbott

• Guardant Health

• NeoGenomics Laboratories

• Siemens Healthcare Pvt. Ltd.

• QIAGEN

• Eurofins Scientific

• Illumina, Inc.

• F. Hoffmann-La Roche Ltd.

Laboratory Developed Tests Market Report Scope

Global Laboratory Developed Tests Market Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For the purpose of this study, Grand View Research has segmented the global laboratory developed tests market report on the basis of technology, application, and region:

• Technology Outlook (Revenue, USD Million, 2018 - 2030)

  • Immunoassays

  • Hematology & Coagulation

  • Molecular Diagnostics

  • Microbiology

  • Clinical Chemistry

  • Histology/Cytology

  • Flow Cytometry

  • Mass Spectroscopy

  • Others

• Application Outlook (Revenue, USD Million, 2018 - 2030)

  • Oncology

    • Companion Diagnostics

    • Genomics Sequencing & Others

  • Genetic Disorders/Inherited Disease

  • Infectious & Parasitic Diseases

  • Immunology

  • Endocrine

  • Nutritional & Metabolic Disease

  • Cardiology

  • Mental/Behavioral Disorder

  • Pediatrics-specific Testing

  • Hematology/General Blood Testing

  • Bodily Fluid Analysis

  • Toxicology

  • Other Diseases

• Regional Outlook (Revenue, USD Million, 2018- 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • Germany

    • U.K.

    • France

    • Italy

    • Spain

    • Sweden

    • Denmark

    • Norway

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

    • Thailand

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East and Africa (MEA)

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait