Pemphigus Vulgaris is an autoimmune disorder in which painful blisters are formed on the mucus membrane and skin. The disorder is rare and affects mouth, nose, throat, lungs, eyes, and sometimes genitals. The disorder is caused when the body produces antibodies against self-cells, although the exact cause and mechanism is unknown. Formation of Immunoglobulin G (IgG) antibodies against self desmosomal adhesion proteins, present on epidermal keratinocytes, results in blister formation. Its diagnosis involves biopsy (tissue sampling), blood tests for pemphigus specific antibodies, and endoscopy. The treatment involves administration of immunosuppressant drugs and corticosteroids.
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New drug approvals is expected to drive the global pemphigus vulgaris treatment market growth over the forecast period. For instance, in June 2018, the U.S. Food and Drug Administration (FDA) approved the use of Rituximab for the treatment of pemphigus vulgaris. Rituximab is a humanized anti-cd20 monoclonal antibody and acts to reduce the number of skin lesions. The drug acts by targeting cd20 antigen, expressed on cells of B cell lineage and kills B cells. Rituximab acts by inhibiting cell proliferation and inducing cell apoptosis. Rituximab has minimal immunogenicity and can be reused.
Moreover, active research and development by key manufacturers is expected to have positive impact on the global pemphigus vulgaris treatment market growth. For instance, F. Hoffmann-La Roche AG, in collaboration with Genentech, Inc., is conducting a Phase-3 clinical trial (estimated study completion by November 2019) to check the efficacy and safety of drug rituximab as compared to Mycophenolate Mofetil. Rituximab is a U.S.FDA approved drug for the treatment of pemphigus vulgaris and Mycophenolate Mofetil is a drug which, according to National Centre for Biotechnology Information (NCBI), is found to be an effective adjuvant that increases the immunosuppressive effect.
Moreover, Principia Biopharma, a U.S.-based late stage biopharmaceutical company, is conducting Phase-3 clinical trial (estimated study completion by December 2019) for PRN1008 drug, which is a covalent inhibitor of BTK (Bruton’s tyrosine kinase), in pemphigus vulgaris patients. Treatment with PRN1008 was found to inhibit the B cell activation and antibody mediated immune cell activation. These factors are expected to support the global pemphigus vulgaris treatment market growth over the forecast period.
Argenx SE, a Netherlands-based biopharmaceutical company, is conducting Phase-2 clinical trial (estimated study completion by August 2019) to check the efficacy of ARGX-113 in treatment of pemphigus vulgaris. ARGX-113 is an antibody Fc fragment (crystallizable fragment), which acts against neonatal Fc Receptor, involved in IgG half-life prolonging pathway and ultimately leading to persistence of autoantibodies, thus mediating the removal of autoantibodies from the system. Therefore, increasing number of clinical trials to develop new therapies for pemphigus vulgaris is expected to fuel the Europe pemphigus vulgaris treatment market growth over the forecast period.
According to the U.S. National Library of Medicine, in rare cases, use of nonsteroidal anti-inflammatory drugs is a cause of pemphigus vulgaris. This restricts the use of anti-inflammatory agents in the pemphigus, which is characterized by blisters containing inflammatory mediators. Moreover, Rituximab, the only U.S. FDA approved drug used for treatment of pemphigus vulgaris, has side effects such as joint or muscle pain, anemia, kidney problems, muscle spasms, and in rare cases allergic reactions. Such side effects are expected to restrain the global pemphigus vulgaris treatment market growth over the forecast period.
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Some of the key players operating in the global pemphigus vulgaris treatment market include, Principia Biopharma, Argenx SE, Alexion Inc., Genentech, Inc., Novartis International AG, GlaxoSmithKline plc. Vifor Pharma Management Ltd., and F. Hoffmann-La Roche AG