Epidermolysis Bullosa Therapeutics
Market – Regional Analysis
On the basis of region, the
global Epidermolysis
Bullosa Therapeutics Market is segmented into North America, Latin America,
Europe, Asia Pacific, Middle East, and Africa.
Epidermolysis Bullosa (EB) is a
rare, genetic disorder of skin tissues. People suffering from EB have fragile
skin, which is susceptible to blisters leading to wounds that are difficult to
heal. Symptoms related to this disorder includes, blistering of skin, deformity
or loss of fingernails and toenails, internal blistering including on the
throat, esophagus, stomach, intestines and urinary tract, skin thickening on
palms and soles of the feet (hyperkeratosis) and scalp blistering, scarring,
and hair loss (scarring alopecia).
Epidermolysis Bullosa
Therapeutics Market Drivers
Development of various pipeline
drugs for treatment of EB is a major factor expected to drive the epidermolysis
bullosa therapeutics market growth. For instance, Fibrocell Technologies, Inc.
is undergoing clinical trial for its drug FCX-007 for the treatment of EB. This
drug is under clinical phase II and is expected to be completed in December
2033.
Moreover, TWi Biotechnology, Inc.
is conducting phase II clinical trial for the drug AC-203 to treat skin lesions
in EB and is expected to complete the study in February 2019.
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Furthermore, Amryt Research
Limited is conducting clinical trial phase III for its drug Oleogel-S10, which
is intended for the treatment of wounds in EB that is expected to complete in
September 2020.
Furthermore, in May 2018, Abeona
Therapeutics Inc. announced updated clinical data from the Phase I/II trial of
EB-101, a gene-corrected skin graft cell therapy for patients suffering from
recessive dystrophic epidermolysis bullosa (RDEB). The EB-101 has been granted
Regenerative Medicine Advanced Therapy (RMAT) designation in January 2018,
Orphan Drug Designation and Rare Pediatric Disease Designation from the US Food
and Drug Administration (US FDA) and European Medicines Agency (EMA) in 2017.
Therefore, large number of drugs
in the pipeline is providing growth opportunities for the players in
epidermolysis bullosa therapeutics market during the forecast period.
Epidermolysis Bullosa
Therapeutics Market Restraints
Withdrawal of drugs failing to
meet expectations is expected to restrain growth of EB therapeutics market. For
instance, in September 2017, Rival Amicus Therapeutics, withdrew its AP101 drug
which was in phase III clinical study. AP101 drug was a water based cream,
which is only supposed to be applied when dressings are changed every three or
four days, as recommended for EB patients. Such water-based cream required
patients to change dressings daily and the company indicated this might be the
reason for its failure to hit targets for wound closure in patients within
three months.
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North America region is expected
to witness growth in the EB therapeutics market due to inorganic growth
strategies adopted by key players. For instance, in August 2015, Amicus
Therapeutics, a biotechnology company involved in developing drugs for orphan
diseases acquired Scioderm, Inc., a company involved in developing innovative
therapies for treating diseases. This acquisition aims to accelerate clinical
development of Zorblisa, drug of Amicus Therapeutics, which is under
preclinical investigation for commercialization, for the treatment of
epidermolysis bullosa.
Strategies used by key players
such as collaboration in Asia Pacific region is also expected to drive growth
of the EB therapeutics market in the region. For instance, in August 2018,
RegeneRx Biopharmaceuticals, Inc., entered into a joint venture with YuYang
DNU, a Korean company to develop its product- RGN-137 on a global basis for the
orphan indication, epidermolysis bullosa (EB) which is under preclinical study.
Furthermore, YuYang will invest about US$17.8 million in cash for its clinical
development.
Key players operating in
epidermolysis bullosa therapeutics market include Birken AG, Fibrocell Science,
Inc., RegeneRx Biopharmaceuticals, Inc., GlaxoSmithKline Plc., InMed
Pharmaceuticals Inc., Karus Therapeutics Limited, ProQR Therapeutics N.V.,
Scioderm, Inc., Stratatech Corporation, TWi Biotechnology Inc., Amryt Research
Limited, and WAVE Life Sciences Ltd.
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