Enzyme
replacement therapy involves intravenous administration of enzymes in
order to correct the deficiency of enzymes that causes a specific
disease condition called lysosomal storage disease. Enzyme
replacement therapy is used in Fabry Disease, Gaucher disease,
lysosomal acid lipase deficiency, mucopolysaccharidosis, Hunter
syndrome, and Pompe disease. Enzymes are obtained from sources such
as human cells, animal cells, and recombinant DNA technology. Enzyme
replacement, although does not provide permanent cure, helps prevents
permanent damage to the body caused due to deficiency of a specific
enzyme. Treatment consists of weekly or monthly doses depending upon
the disease. For instance, in order to address enzyme deficiency in
Gaucher disease, modified version of glucocerebrosidase is
administered intravenously every two weeks. Enzyme replacement is
associated with fewer side effects than other treatment methods.
However, enzyme replacement therapy may be inconvenient for some
patients such as children and geriatric population due to intravenous
administration. It may result in local infusion reaction or
hypersensitive reactions in the form of local rash, fever, edema,
bronchospasm or hypotension.
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Market
Dynamics
Although
lysosomal storage disease is a rare disorder, a significant number of
people are affected with this disease. According to study published
in Molecular Genetics and Metabolism Reports in December 2017,
lysosomal storage disease has incidence rate of 1 in 4000 to 1 13,000
live births. Lysosomal storage disease consists of 60 genetic
abnormalities with problematic enzyme function. Being an orphan
disease condition, regulatory agencies offer the benefit of rapid
approval and ease in approval process. This in turn, is expected to
expand the overall enzyme replacement therapy market with
introduction of new therapies by various key players. For instance,
in November 2017, The FDA approved Mepsevii (vestronidase alfa),
which is first authorized treatment for pediatric and adult patients
suffering from an inherited metabolic condition called
mucopolysaccharidosis type VII (MPS VII). FDA granted Mepsevii with
fast-track approval and orphan drug status to incentivize the
development. Financial help by NGOs such as National Gaucher Society
help patient receive enzyme replacement therapy that are costly.
Regional
Insights
On
the basis of geography, the global enzyme replacement therapy market
is segmented into North America, Latin America, Europe, Asia Pacific,
Middle East, and Africa. North America is expected to lead the market
during forecast period, followed by Europe. According to study
published in journal Hematology, in March 2017, incidence of Gaucher
Disease in the general population varied from 0.39 to 5.80 per
100?000, and its prevalence varied from 0.70 to 1.75 per 100?000.
Ease in access and government support for research and development is
expected to aid growth of the enzyme replacement therapy market.
Competitive
Landscape
Key
players operating in the global enzyme replacement therapy market
include Shire plc, Amicus Therapeutics, Genzyme Corporation, Pfizer
Inc., BioMarin Pharmaceutical, Inc., Sigma-Tau Pharmaceuticals, Inc.,
Essential Pharmaceuticals Limited, Merck KGa, and AbbVie Inc.
Market
Taxonomy
On
the basis of enzyme type, the global enzyme replacement therapy
market is segmented into -:
-
Agalsidase Beta
-
Velaglucerase Alfa
-
Imiglucerase
-
Taliglucerase
-
Alglucosidase Alfa
-
Laronidase
-
Idursulfase
-
Galsulfase
-
Pegademase
-
Others
On
the basis of indication, the global enzyme replacement therapy market
is segmented into -:
-
Fabry Disease
-
Gaucher Disease
-
Pompe Disease
-
Scheie Syndrome
-
Hunter Disease
-
Maroteaux-Lamy Syndrome
-
Others
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