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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