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.
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.
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.
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.
Epidermolysis Bullosa Therapeutics Market – Taxonomy