The laboratory developed test market generated US$ 7.3 Bn in global revenue at the end of 2021, and it is predicted to grow at a CAGR of 6.4% to reach a market worth of US$ 14.4 Bn by the end of 2032. Clinical biochemistry tests are anticipated to account for a market value share of 31.5% by 2032, according to Persistence Market Research. In 2021, the revenue from laboratory-developed tests represented around 3.7% of the market for clinical laboratory services globally. From 2017 to 2021, the market for laboratory-developed tests grew at a CAGR of 4.7%.
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The demand for laboratory-developed tests is expected to rise over the next few years as a result of factors including increased healthcare costs for genetic and chronic illnesses as well as an increase in the number of cancer cases in the general population.
How is the expansion of the laboratory developed test industry Affected?
“Product Recalls Affect Market Development”
Healthcare diagnostic product recalls are a regular procedure intended to either eliminate a current failing or minimise any prospective problems. A wide range of ailments, including infectious infections as COVID-19, genetic problems, and many cancers, have been treated by laboratory derived tests (LDTs).
LDTs, however, cannot be contrasted with FDA-approved diagnostics due to the fact that they were not previously centrally registered or tracked. Between a test created in a lab and a diagnosis that has FDA approval, insurance coverage and eHealth make no distinction. There is no useable database that contains all LDTs.
CLIA and FDA Laboratory Developed Tests are Subject to Strict Control.
To provide accurate and reliable results, the Clinical Laboratory Improvement Amendments programme (CLIA) regulates labs that conduct tests on patient samples. According to the FDA, LDT is a test that is created and utilised within a single laboratory.
LDTs are frequently referred to as “home brew” tests because they are created internally. According to the FFDCA, LDTs are regarded as “devices” that are analogous to IVDs and are as a result governed by the FDA.
The FDA modified the tests that were created in laboratories. The following significant adjustments to the agency’s policy were made, per a statement: The agency gave all serology test developers precise performance threshold parameters for specificity and sensitivity.
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Key Segments Covered in Laboratory Developed Test Industry Research
Laboratory Developed Test Market by Test Type:
- Clinical Biochemistry
- Critical Care
- Haematology
- Immunology
- Microbiology
- Molecular Diagnostics
- Others
Laboratory Developed Test Market by Application:
- Oncology
- Genetics
- Infectious Diseases
- Autoimmune Disorders
- Neurology
Laboratory Developed Test Market by End User:
- Hospital Laboratories
- Specialty Diagnostics Centers
- Clinical Research Organizations
- Research Institutes
Laboratory Developed Test Market by Region:
- North America Laboratory Developed Test Market
- Latin America Laboratory Developed Test Market
- Europe Laboratory Developed Test Market
- South Asia Laboratory Developed Test Market
- East Asia Laboratory Developed Test Market
- Oceania Laboratory Developed Test Market
- Middle East & Africa Laboratory Developed Test Market
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