A laboratory-developed test (LDT) is a
kind of in-vitro diagnostic test that faces a limitation of being
developed, manufactured and processed within an individual laboratory.
In the United States, the federal government regulates the development,
manufacturing and use of LDTs through the Centers for Medicare and
Medicaid Services (CMS) and the Clinical Laboratory Improvement
Amendments (CLIA). In July 2014, the United States Food and Drug
Administration (FDA) announced to start regulating some LDTs. A number
of LDTs are commercially available for the analysis of substances such
as DNA, proteins, glucose and cholesterol in sample taken from human
beings. There are many hospitals and laboratories that prefer to offer
their own LDTs, even though FDA-approved in-vitro diagnostic tests are
available on the market for the same analyte. LDT developers cannot sell
their proprietary tests to hospitals, clinical laboratories and
physician offices directly, and hence, adopt a business model wherein
they enter into partnerships with diagnostic service providers and
pathology labs that collect the sample and ship it to them.
Globally, the market for
laboratory-developed testing is expanding year on year at double digit
rate. Continued developments in technology leading to the introduction
of new LDTs, growing demand for personalized treatment and consistent
rise in overall patient population are among the major factors driving
the market for laboratory-developed testing. In October 2011, Sequenom,
Inc. introduced a laboratory developed non-invasive prenatal test,
MaterniT21 (now MaterniT21 PLUS) for the determination of fetal
chromosomal aneuploidies by analyzing the fetal cell-free DNA
circulating in the maternal blood. NIPTs are contributing significantly
in the overall growth of laboratory-developed testing market. FDA
approved in-vitro diagnostic tests that are considered safe and accurate
than LDTs, are expected to affect the laboratory-developed testing
market growth to some extent.
In terms of geography, the global market
for laboratory-developed testing can be categorized into four major
regions, namely, North America, Europe, Asia-Pacific and Rest of the
World (RoW). North America represented the largest regional market for
laboratory-developed testing in 2013. Reimbursement coverage for major
LDTs has been one of the major reasons responsible for North America
holding leading position in terms of laboratory-developed testing market
across the globe. Europe was the second largest market for
laboratory-developed testing after North America in 2013. In
Asia-Pacific region, the laboratory-developed testing market is expected
to grow under the influence of factors such as the presence of a large
pool of patients suffering from various diseases and emerging economy of
countries including India, and China. In RoW region, Latin America,
Middle East and Africa are the most potential markets. Continuously
improving healthcare infrastructure of these regions is expected to play
a key role in driving the growth of laboratory-developed testing
market.
Sequenom, Inc., Quest Diagnostics,
Laboratory Corporation of America Holdings (LabCorp), ARUP Laboratories,
Myriad Genetic Laboratories Inc., Precision Therapeutics Inc., RedPath
Integrated Pathology, Inc. and CardioDx are some major diagnostic
laboratories that are engaged in the business of laboratory-developed
testing. Sequenom Laboratories, a business subsidiary of Sequenom, Inc.
offers a variety of LDTs related to non-invasive prenatal and women’s
health and other diseases such as cancer, autoimmune and neurological
disorders. MaterniT21 PLUS, HerediT CF, SensiGene RHD and RetnaGene AMD
are the LDTs being developed and marketed by Sequenom Laboratories. Some
other examples of LDTs include Corus CAD by CardioDx, ChemoFx assay by
Precision Therapeutics Inc. and PathfinderTG by RedPath Integrated
Pathology, Inc.
This report is a complete study of
current trends in the market, industry growth drivers, and restraints.
It provides market projections for the coming years. It includes
analysis of recent developments in technology, Porter’s five force model
analysis and detailed profiles of top industry players. The report also
includes a review of micro and macro factors essential for the existing
market players and new entrants along with detailed value chain
analysis.
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