Laboratory developed test (LDT) is known as a type of in-vitro diagnostic test. Laboratory developed test is designed, manufactured and used within a single laboratory. Laboratory developed test is considered as testing services developed in clinical laboratories, hospitals, and academic institutes according to their own procedures. The laboratory developed test is often created in response to unfulfilled clinical needs. Laboratory developed test is basically used for early and precise diagnosis, monitoring and guiding the treatment of the patient. It is also used to diagnose and access the diseases and disorders for which the FDA approved kits are not available. The laboratory developed test are used solely within the laboratory as it’s not allowed to sold or distributed to healthcare facilities or other labs. Currently, the clinical laboratories are regulated by the Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA) and are expected to change by the U.S. FDA regulatory framework in upcoming years.
The laboratory developed test involve novel and complex test methods and interpretative approaches, for the rare diseases and disorder diagnosis which boost the laboratory developed test market over the forecast period.
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The global laboratory development test market is expected to register a significant CAGR over a forecast period. The non-availability of specialized tests for rare diseases such as genetic tests and molecular tests is expected to boost the global market of laboratory developed test. Sometimes the existing test may not apply to a particular disorder, and so modification of the test is required at the lab level which also anticipated to propel the global laboratory developed test market. The increasing funding for the research and development activities for diagnosis of rare diseases and disorders by the various regulatory authority bodies and some state governments, also expected to fuel the growth of the global laboratory development test market.
However, the higher cost of laboratory developed test due to high cost of reagents and devices, may hamper the growth of the global laboratory development test market. The delay by the U.S. Food and Drug Administration (FDA) for the regulatory guidance on laboratory developed tests, may also hinder the growth of the global laboratory development test market. The lack of skilled personnel to perform the specialized laboratory developed test, may also restrain the growth of the global laboratory development test market over a forecast period.
On the basis of regional presence, the global laboratory development test market is segmented into five key regions: North America, Latin America, Europe, Asia-Pacific, and Middle East & Africa.
The North America is dominating and contributed the leading shares to the global laboratory development test market in terms of revenue and expected to register a significant growth over a forecast period due to the developed laboratory infrastructure and availability of skilled personnel in the region. The Europe has also contributed the moderate shares and registered a healthy growth rate to the global laboratory development test market followed by North America. The APEJ has become the lucrative market for laboratory development test and anticipated to register significant shares over the forecast period due to the increasing research and development activities along with the growing medical tourism in the region. The Latin America and MEA are at a nascent stage to the global laboratory development test market and expected to show a moderate growth over a forecast period.
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Some of the market players in disposable diabetes devices Market globally include Citrano Medical Laboratories, Hendry Regional Medical Center Clinical Laboratory, Parkview Medical Center/Resp Care, Desert Regional Medical Center Clinical Lab, Southwest Healthcare System Clinical Laboratory, Sharp Cornado Hosp & Healthcare Center, Bristol Bay Area Health Corporation, Med Plus LLC, United Medical Labs Inc., and South Texas Clinical Laboratory LLP.