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DUBLIN, Jan. 25, 2023 /PRNewswire/ -- The "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 has been added to  ResearchAndMarkets.com's offering.

The global laboratory developed tests market size is expected to reach USD 16.72 billion by 2030, expanding at a CAGR of 6.58% from 2023 to 2030. 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

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 2021
• 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 2021 owing to the introduction of novel LDT products and the high demand for diagnostics tools with the increasing geriatric population

Market Dynamics

Market Drivers

• Increasing Demand for in Vitro Diagnostic Tests That Are Currently Unavailable in the Market
• Increasing Demand for Development of Personalized Medicine
• No Requirement for Any Regulatory Approval.

Market Restraints

• High Cost Associated With the Laboratory-Developed Test
• Efficacy and Safety Issues Related to LDT 

Key Topics Covered:

Chapter 1 Methodology and Scope

Chapter 2 Executive Summary

Chapter 3 Laboratory Developed Tests Market Variables, Trends, & Scope

Chapter 4 Laboratory Developed Tests Market - Segment Analysis, By Technology, 2018 - 2030 (USD Million)

4.1 Laboratory Developed Tests Market: Technology Movement Analysis

4.1.1 Immunoassays

4.1.2 Hematology and Coagulation

4.1.3 Molecular Diagnostics

4.1.4 Microbiology

4.1.5 Clinical Chemistry

4.1.6 Histology/Cytology

4.1.7 Flow Cytometry

4.1.8 Mass Spectroscopy

4.1.9 Others

Chapter 5 Laboratory Developed Tests Market - Segment Analysis, By Application, 2018 - 2030 (USD Million)

5.1 Laboratory Developed Tests Market: Application Movement Analysis

5.1.1 Oncology

5.1.2 Genetic Disorders/Inherited Disease

5.1.4 Immunology

5.1.5 Endocrine

5.1.6 Nutritional And Metabolic Disease

5.1.7 Cardiology

5.1.8 Mental/Behavioral Disorder

5.1.9 Pediatrics-specific Testing

5.1.10 Hematology/General Blood Testing

5.1.11 Bodily Fluid Analysis

5.1.12 Toxicology

5.1.13 Other Diseases

Chapter 6 Regional Business Analysis

Chapter 7 Competitive Analysis

Chapter 8 Company Profiles

Companies Mentioned

• Quest Diagnostics Incorporated
• 23andme, Inc.
• Abbott
• Guardant Health
• NeoGenomics Laboratories
• Siemens Healthcare Private Limited.
• QIAGEN
• Eurofins Scientific
• Illumina, Inc.
• F. Hoffmann-La Roche Ltd.

For more information about this report visit https://www.researchandmarkets.com/r/cav1j3

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SOURCE Research and Markets