Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, from 2013 to 2018, generic erosion of established agents--most notably tamsulosin--will cause a decline of more than eight percent in the drug market for benign prostatic hyperplasia and male lower urinary tract symptoms in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan. Generic erosion will offset market growth of more than seven percent that will be driven by the uptake of emerging agents from 2008 to 2013.
The new Pharmacor report entitled Benign Prostatic Hyperplasia and Male Lower Urinary Tract Symptoms finds that the market is saturated with effective, well-established agents. The market is also concentrated as, in 2008, tamsulosin garnered just over half of all major-market sales for benign prostatic hyperplasia. Tamsulosin, the most widely-used alpha blocker for the indication, is marketed by Boehringer Ingelheim as Flomax/Josir/Alna/Pradif/Urolosin and by Astellas as Omix/Omnic/Flomaxtra/Harnal. Generic versions of tamsulosin have been available in Europe and Japan since 2006 and, in the first half of 2010, the drug will be generically available in the United States as well. As a result of generic competition, tamsulosin's annual major-market sales will plummet 41 percent between 2008 and 2013, according to the report.
The report also finds that, while symptom relief remains the primary concern in treating the disease, drug development for benign prostatic hyperplasia has focused on improving dosing convenience and slowing disease progression. Owing to its dosing convenience, GlaxoSmithKline's tamsulosin/dutasteride fixed-dose combination Duodart will likely increase compliance, while Aeterna Zentaris/Sanofi-Aventis/Shionogi's cetrorelix and Aeterna Zentaris/Spectrum Pharmaceuticals/Nippon Kayaku's ozarelix both aim to reduce the size of the prostate and slow disease progression. Additionally, the report finds that drug developers are also focusing on targeting comorbidities, such as erectile dysfunction, with a single agent, namely, Eli Lilly's Cialis.
"If it's approved for the indication, Cialis will be used to treat patients diagnosed with both male lower urinary tract symptoms and erectile dysfunction," said Decision Resources Analyst Benjamin Guikema, Ph.D. "Although we anticipate that, if approved, Cialis would face substantial reimbursement hurdles for the disease through 2018, it has the potential to establish itself as a dominant therapy in the benign prostatic hyperplasia and male lower urinary tract symptoms market if it were to obtain favorable reimbursement in the years after that."
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