Photopheresis is a type of apheresis, which is a popular therapeutic option used in treatment of various autoimmune diseases, solid organ transplant rejections such as kidney and liver, acute and chronic graft versus host disease (GVHD), and advanced cutaneous T-cell lymphoma. Extracorporeal photopheresis (ECP) was first approved by the US FDA in 1988, as a leukapheresis-based therapeutic procedure.
Today, ECP is also known as extracorporeal photoimmunotherapy, and is available at several specialized centers worldwide. With growing need for blood products in transfusion processes, the market of apheresis is gaining traction. Following plasmapheresis, which is the currently the largest apheresis segment, photopheresis is a significant market as well. Among all other segments of this industry, photopheresis represents the fastest growing market since the past few years. Rising blood disorders affecting global population is primarily driving the market. As photopheresis products are recognized for their established efficiency in the treatment of CTCL, the market for ECP will witness steady growth in the near future.
In photopheresis, WBCs are collected after exposure to photosensitizer, UVA radiation, and 8-MOP. The mechanism is based on the principle of activation of 8-MOP by UVA, which ultimately causes DNA cross linkage. Performed via IV, the process of ECP commences in three key stages, including leukapheresis, photoactivation, and reinfusion. The third step involves the infusion of treated cell product back to the patient. As far as devices or equipment for photopheresis are concerned, several open and closed systems are available in the market. However, the US FDA has approved only closed systems, which allow the integration of drug photoactivation and reinfusion. As a result, closed systems assure lesser risk of contamination, infection, and flaws during reinfusion.
While advanced cutaneous T-cell lymphoma (TTCL) treatment predominantly involves use of photopheresis products, ECP also finds application in various other diseases, including atopic dermatitis, scleroderma, diabetes mellitus type I, bullosa acquisita, lupus erythematosus, and Crohn disease. Research has reaffirmed the efficacy of EPC in treatment of aforementioned disorders. In addition, photopheresis products have also been found to be applicable in some other diseases as well, including multiple sclerosis, rheumatoid arthritis, psoriasis, and nephrogenic systemic fibrosis.
ECP is being used in treatment of various dermatogenic disorders, including scleroderma, scleromyxedema, oral lichen planus, and recalcitrant pemphigus vulgaris and foliaceous. Studies also provide evidences for the application of adjunctive photopheresis in face transplantation and prophylaxis against heart transplant rejection. Moreover, ECP has been found effective against refractory chronic lung transplant rejection and persistent acute lung transplant rejection.
Recently, a key specialty pharmaceutical player in Switzerland, Mallinckrodt plc announced Switzerland's Federal Department of Home Affairs - FDHA’s approval for the reimbursement of ECP treatment for Switzerland-based patients, who are suffering from bronchiolitis obliterans syndrome (BOS), following lung transplantation. This approval highlights the potential application of ECP as a restoring therapy for BOS patients in Switzerland.
Increasing applications of photopheresis in the medical world are bolstering the market in developed regions. However, developing economies are still in a nascent stage of mass adoption of photopheresis in treatment of diseases. Therakos, Inc. is one of the top players in market. Mac Molds is a leading manufacturer of photopheresis systems.
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