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.
Pemphigus Vulgaris Treatment Market Drivers
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.
Pemphigus Vulgaris Treatment Market Regional Analysis
Government agencies are indulged in research and development of new drugs for pemphigus vulgaris treatment. For instance, National Institute of Allergy and Infectious Diseases (NIAID), an agency of the U.S. Department of Health and Human Services (HHS), is conducting a Phase 1 trial to check use of Polyclonal T regulatory cells in treatment of pemphigus vulgaris. The study started in September 2017, and is estimated to be completed by September 2020. Therefore, active research and development by key players in the region is expected to support North America 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 National Organization for Rare Disorders (NORD), a U.S.-based non-profit organization, pemphigus vulgaris is more prevalent in Europe and the U.S. compared to other regions of the world. Owing to this, people in these regions are expected to be greatly affected by new drug discoveries and also contribute more to the overall expenditure for pemphigus vulgaris treatment in the near future. This in turn is expected to fuel global pemphigus vulgaris treatment market growth over the forecast period.
Pemphigus Vulgaris Treatment Market Restraints
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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Pemphigus Vulgaris Treatment Market Key Players
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
Pemphigus Vulgaris Treatment Market Taxonomy
The global pemphigus vulgaris treatment market is segmented on the basis of drugs route of administration, distribution channel, and region.
By Route of Administration
By Distribution Channel
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