With Xiaflex the only FDAapproved product for this disease, Endo dominates the market
The Peyronie’sDisease Treatment Market is dominated by a single player, EndoInternational plc who sells the only FDA approved Peyronie’s disease product.In May 2015, the American Urological Association presented the first evertreatment guidelines for Peyronie’s disease recommending the use of Xiaflex.Furthermore, the company is creating awareness through its “Ask About theCurve” campaign. Also, reimbursement from the U.S. insurance providers willboost the demand for this product. The product is estimated to generate USD 100million in revenue for Peyronie’s disease by 2018. In Japan, BioSpecificsTechnologies Corp. has granted Asahi Kasei Pharma the rights to develop andmarket XIAFLEX in Japan for Peyronie's disease. Further, the company is alsopartnering with global companies in Canada, Europe, Mexico, and Brazil forcommercializing XIAFLEX for PD.
Peyronie's disease (PD) iscondition wherein the penis is curved or bent due to development of plaque or afibrous scar tissue inside the penis. This condition can cause painfulerections and the penis gets bent while it is erected. The bent is towards theside where plaque is being formed i.e. either downwards or upwards. Thecondition is identified by a major bend or pain. In a few people Peyronie'sdisease may go away on its own. However, in most cases it may remain stable orworsen. Hence, it is advisable to visit an urologist to avoid consequences infuture. Treatment may be needed if the curvature prevents successful sexualintercourse.
Peyronie’s disease is a rarecondition observed in about 6 out of 100 men in the age group of 40 to 70years. Moreover, the Urology Care Foundation also estimates that the number ofpeople affected by this condition can be higher than this as many men areembarrassed and do not see their healthcare provider. It is mostly at timeswhen the men visit the healthcare practitioner for erectile dysfunctiontreatment and the healthcare practitioner may notice Peyronie’s disease. Lackof awareness among patients has resulted in under reporting of this condition.
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Peyronie's Disease TreatmentOptions
The exact cause of plaqueformation is not known. Hence, treatment is done with the available researchand knowledge of plaque formation. There are various treatment options followedfor Peyronie’ disease basis on which the market is analyzed. These includedrugs, surgery and devices. The drugs market can be analyzed based on theadministration route i.e. oral and injectable. Drugs prescribe through oralroute include Vitamin E, Potassium amino-benzoate ("Potaba"),Tamoxifen, Colchicine, and Carnitine. Similarly, the injectable drugs includeVerapamil, Interferon, and Collagenase. Use of oral drugs is limited as none ofthe studies conducted so far for Peyroniee’s disease have shown positiveresults of these drugs over the placebo.
On the other hand injectablesshow some positive outcomes over placebo. However, more studies are required toestablish the efficacy. Studies with collagenase have shown positive outcomesfor its use in Peyronie's disease. Therefore, Xiaflex (Collagenase clostridiumhistolyticum) from BioSpecifics Technologies Corporation is the only FDAapproved product indicated for Peyronie's disease in adult men. Approved in2013, Xiaflex is marketed in the U.S. by Endo International plc. In Europe,Collagenase clostridium histolyticum is available by the brand name Xiapex.
A penile prosthetic device isanother good treatment option for Peyronie's disease and moderate-to-severe ED.This device helps straighten the penis. Surgical procedure on the other handinvolves grafting the space being emptied on removal of the plaque.
With increasing awareness andresearch on this disease, new drug molecules could be made available in themarket.
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Key Developments
Increasing number of studies andclinical trials related to Peyronie’s disease is expected to offer lucrativeopportunities for the market players. For instance, in July 2019, The Journalof Sexual Medicine of the International Society for Sexual Medicine published astudy ‘The Effectiveness of 3-D Computed Tomography in the Evaluation of PenileDeformities in Patients with Peyronie's Disease: A Pilot Study’, whichconcluded that computed tomography failed to offer more information than theevaluation with combined intracavernous injection stimulation test and currentlimitations and cost increases limit the use of 3D computed tomography in theassessment of Peyronie’s disease.
Similarly, in July 2019, a teamof researchers from Memorial Sloan-Kettering Cancer Center (U.S.) found no linkbetween testosterone levels and the magnitude of Peyronie’s disease-associatedpenile deformity.
Major healthcare associations arefocused on presenting new guidelines regarding treatment of Peyronie's disease.For instance, in 2018, the Canadian Urological Association (CUA) presented newguidelines recommending the use of remodeling technique based on PenileTraction Device of Andromedical (ANDROPEYRONIE) in combination with collagenaseinjections for the treatment of patients with Peyronie's disease.
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