With Xiaflex the only FDA approved product for this disease, Endo dominates the market

The Peyronie’s Disease Treatment Market is dominated by a single player, Endo International plc who sells the only FDA approved Peyronie’s disease product. In May 2015, the American Urological Association presented the first ever treatment guidelines for Peyronie’s disease recommending the use of Xiaflex. Furthermore, the company is creating awareness through its “Ask About the Curve” campaign. Also, reimbursement from the U.S. insurance providers will boost the demand for this product. The product is estimated to generate USD 100 million in revenue for Peyronie’s disease by 2018. In Japan, BioSpecifics Technologies Corp. has granted Asahi Kasei Pharma the rights to develop and market XIAFLEX in Japan for Peyronie's disease. Further, the company is also partnering with global companies in Canada, Europe, Mexico, and Brazil for commercializing XIAFLEX for PD.

Peyronie's disease (PD) is condition wherein the penis is curved or bent due to development of plaque or a fibrous scar tissue inside the penis. This condition can cause painful erections and the penis gets bent while it is erected. The bent is towards the side where plaque is being formed i.e. either downwards or upwards. The condition is identified by a major bend or pain. In a few people Peyronie's disease may go away on its own. However, in most cases it may remain stable or worsen. Hence, it is advisable to visit an urologist to avoid consequences in future. Treatment may be needed if the curvature prevents successful sexual intercourse.

Peyronie’s disease is a rare condition observed in about 6 out of 100 men in the age group of 40 to 70 years. Moreover, the Urology Care Foundation also estimates that the number of people affected by this condition can be higher than this as many men are embarrassed and do not see their healthcare provider. It is mostly at times when the men visit the healthcare practitioner for erectile dysfunction treatment and the healthcare practitioner may notice Peyronie’s disease. Lack of awareness among patients has resulted in under reporting of this condition.

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Peyronie's Disease Treatment Options

The exact cause of plaque formation is not known. Hence, treatment is done with the available research and knowledge of plaque formation. There are various treatment options followed for Peyronie’ disease basis on which the market is analyzed. These include drugs, surgery and devices. The drugs market can be analyzed based on the administration route i.e. oral and injectable. Drugs prescribe through oral route include Vitamin E, Potassium amino-benzoate ("Potaba"), Tamoxifen, Colchicine, and Carnitine. Similarly, the injectable drugs include Verapamil, Interferon, and Collagenase. Use of oral drugs is limited as none of the studies conducted so far for Peyroniee’s disease have shown positive results of these drugs over the placebo.

On the other hand injectables show some positive outcomes over placebo. However, more studies are required to establish the efficacy. Studies with collagenase have shown positive outcomes for its use in Peyronie's disease. Therefore, Xiaflex (Collagenase clostridium histolyticum) from BioSpecifics Technologies Corporation is the only FDA approved product indicated for Peyronie's disease in adult men. Approved in 2013, 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 is another good treatment option for Peyronie's disease and moderate-to-severe ED. This device helps straighten the penis. Surgical procedure on the other hand involves grafting the space being emptied on removal of the plaque.

With increasing awareness and research on this disease, new drug molecules could be made available in the market.

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Key Developments

Increasing number of studies and clinical trials related to Peyronie’s disease is expected to offer lucrative opportunities for the market players. For instance, in July 2019, The Journal of Sexual Medicine of the International Society for Sexual Medicine published a study ‘The Effectiveness of 3-D Computed Tomography in the Evaluation of Penile Deformities in Patients with Peyronie's Disease: A Pilot Study’, which concluded that computed tomography failed to offer more information than the evaluation with combined intracavernous injection stimulation test and current limitations and cost increases limit the use of 3D computed tomography in the assessment of Peyronie’s disease.

Similarly, in July 2019, a team of researchers from Memorial Sloan-Kettering Cancer Center (U.S.) found no link between testosterone levels and the magnitude of Peyronie’s disease-associated penile deformity.

Major healthcare associations are focused on presenting new guidelines regarding treatment of Peyronie's disease. For instance, in 2018, the Canadian Urological Association (CUA) presented new guidelines recommending the use of remodeling technique based on Penile Traction Device of Andromedical (ANDROPEYRONIE) in combination with collagenase injections for the treatment of patients with Peyronie's disease.

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