Laboratory Developed Tests Market To Reach $19.85 Billion By 2030

Laboratory Developed Tests Market Growth & Trends

The global laboratory developed tests market size is expected to reach USD 19.85 billion by 2030, expanding at a CAGR of 7.05% from 2024 to 2030, according to a new report by Grand View Research, Inc. The growth of the industry is attributed to the increasing prevalence of chronic and genetic diseases, infectious & autoimmune diseases, and rising awareness among the population about healthy living. The laboratory-developed tests (LDTs) are generated and utilized in the laboratories, and LDTs are released into the market without FDA approval or any other independent regulatory assessment. LDTs are most typically employed in molecular diagnostics, which includes tests that target a variety of different chemicals in addition to genetics.

For instance, in July 2022, Quest Diagnostics launched a lab-based molecular diagnostic test for the diagnosis of monkeypox virus infections. Moreover, immunoassay is gaining immense adoption and acceptability with the development of novel tests. For instance, in December 2021, OPKO Health, Inc., announced the FDA approval of the 4Kscore test, an LDT in which, four immunoassays are combined into a single numerical score that takes into account the patient’s age, biopsy history, and the results of a digital rectal exam. Although LDTs do not require FDA approval as they are not marketed to others, they need to go through rigorous validation procedures. However, the increasing global prevalence of cancer is a key factor driving the industry's growth.

According to GLOBOCAN, in 2020, there were an estimated 19.3 million new cancer cases globally, out of which, 2.3 million were breast cancer cases. Lung cancer was the most common cause of death among cancer patients, representing an unmet need for faster and more accurate diagnostic tools in the segment. In January 2021, the British In Vitro Diagnostics Association urged NHS England for the development of a commissioning framework for molecular diagnostics in oncology. Key players focus on product launches and geographical expansion to gain a higher industry share. For instance, in May 2022, Guardant Health launched Shield, a blood test that is available as an LDT for the detection of early signs of colorectal cancer in the adult population aged above 45 years

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Laboratory Developed Tests Market Report Highlights

• The molecular diagnostic technology segment dominated the industry and accounted for the largest share of the overall revenue in 2023

• The segment growth was attributed to the increased need to provide diagnostics tests for a number of diseases

• The oncology application segment is expected to grow lucratively over the forecast period due to the increasing prevalence of cancer

• The market is expected to grow significantly owing to the introduction of innovative services that can address the growing demands of the target audience

• North America dominated the industry in 2023 owing to the introduction of novel LDT products and the high demand for diagnostics tools with the increasing geriatric population

Laboratory Developed Tests Market Segmentation

Grand View Research has segmented the global laboratory developed tests market report based on technology, application, and region:

Laboratory Developed Tests Technology Outlook (Revenue, USD Billion, 2018 - 2030)

• Immunoassays

• Hematology & Coagulation

• Molecular Diagnostics

• Microbiology

• Clinical Chemistry

• Histology/Cytology

• Flow Cytometry

• Mass Spectroscopy

• Others

Laboratory Developed Tests Application Outlook (Revenue, USD Billion, 2018 - 2030)

• Oncology

  • Companion Diagnostics

  • Genomics Sequencing & Other

• 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

Laboratory Developed Tests Regional Outlook (Revenue, USD Billion, 2018 - 2030)

• North America

  • U.S.

  • Canada

• Europe

  • Germany

  • UK

  • France

  • Italy

  • Spain

  • Denmark

  • Sweden

  • Norway

• Asia Pacific

  • China

  • Japan

  • India

  • South Korea

  • Australia

  • Thailand

• Latin America

  • Brazil

  • Mexico

  • Argentina

• Middle East and Africa (MEA)

  • South Africa

  • Saudi Arabia

  • Kuwait

  • UAE

List of Key Players in Laboratory Developed Tests Market

• Quest Diagnostics Incorporated.

• 23andMe, Inc.

• Abbott

• Guardant Health

• NeoGenomics Laboratories.

• Siemens Healthineers AG

• QIAGEN

• Illumina, Inc.

• F. Hoffmann-La Roche Ltd.