PUBLISHER: Grand View Research | PRODUCT CODE: 1474896
PUBLISHER: Grand View Research | PRODUCT CODE: 1474896
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