Benign Prostatic Hyperplasia - Drug Pipeline Analysis and Market Forecasts to 201611 May 2010 • by Natalie Aster
GlobalData, the industry analysis specialist’s new report, “Benign Prostatic Hyperplasia - Drug Pipeline Analysis and Market Forecasts to 2016” is an essential source of information and analysis on the global benign prostatic hyperplasia market. The report identifies the key trends shaping and driving the global benign prostatic hyperplasia market. The report also provides insight on the prevalent competitive landscape and the emerging players expected to bring significant shift in the market positioning of the existing market leaders. Most importantly, the report provides valuable insight on the pipeline products within the global benign prostatic hyperplasia sector. This report is built using data and information sourced from proprietary databases, primary and secondary research and in house analysis by GlobalData’s team of industry experts.
The Benign Prostatic Hyperplasia Therapeutics Market is Forecast to Show Modest Growth Until 2016
GlobalData’s analysis suggests that the global benign prostatic hyperplasia (BPH) market was worth $3,798m in 2009. It is forecast to grow at a compound annual growth rate (CAGR) of 4.5% for the next seven years to reach $5,166m by 2016. This growth rate is primarily attributable to the strong current treatment options as well as a strong pipeline rich in first-in-class molecules. This growth will be further supported by the high incidence rate of the disease and the introduction of first-in-class and me-too therapies with improved clinical benefits.
Benign Prostatic Hyperplasia Market has Strong Competition Between the Several Generics and Few Branded Products
GlobalData analyzed the current competitive landscape for BPH market and found the competition to be strong. There are more than five marketed products for the treatment of BPH, which include finasteride, dutasteride, tamsulosin, doxazosin, alfuzosin, terazosin and silodosin. Competition in the BPH market is driven not only by product characteristics such as their efficacy and safety profile, but also by market characteristics such as the number of competitors, pricing and the introduction of generics.
The BPH market has witnessed a number of patent expiries of major marketed products such as finasteride (Proscar), tamsulosin (Flomax, Harnal) and dutasteride (Avodart) in the US. These major products are likely to be substituted by lower priced generics in the near future. The substitution of these products with cheaper generics will trigger a price war scenario and competition in the BPH market will intensify in the future.
Recently, Duodart, a fixed dose combination of dutasteride and tamsulosin, has received marketing authorization application (MAA) approval in Europe and new drug application (NDA) approval the US. The drug has an improved efficacy and safety profile over the currently marketed products. This implies that Duodart will provide strong competition for the currently marketed products. The competition in the BPH market will further intensify with the launch of strong pipeline candidates which have improved therapeutic outcomes.
Strong Clinical Pipeline with Several First-in-Class Molecules
GlobalData analyzed the BPH pipeline and found it to be strong. The pipeline for BPH consists of more than 15 molecules currently in different stages of development. More than 75% of the BPH pipeline is accounted for by first-in-class molecules. Most of these molecules hold promise with a novel mechanism of action while having an improved efficacy and safety profile. Among the first-in-class molecules, two are in their late stage of development (Phase III) and most of them are in the Phase II clinical stage. Although the BPH pipeline does not have as many me-too molecules, Cialis is one of the most promising molecules in this class which is being studied in Phase III, and it is expected to be launched in the near future. A strong clinical pipeline coupled with moderate unmet need in the BPH market is expected to help sustain the market’s growth rate during the forecast period.
Benign Prostatic Hyperplasia Market has Moderate Unmet Need
GlobalData has found that the global BPH market is a lucrative market with moderate levels of unmet need. The BPH market has a number of products with high to medium efficacy and moderate safety profiles. Although most marketed products have an acceptable efficacy and safety profile, there is an underlying opportunity to improve the therapeutic outcomes. Treatment options such as finasteride, dutasteride, tamsulosin, doxazosin, alfuzosin, terazosin and silodosin have medium to high efficacy in the improvement of BPH symptoms, peak urine flow rate, prostate volume and in decreasing the risk of need for surgery. The safety profiles of these marketed products are moderate and can have adverse effects such as erectile dysfunction, retrograde ejaculation, impotency, decreased libido and breast disorders. In summation, the unmet need in BPH market is moderate and can be fulfilled by products that target underserved patient populations and offer an improved efficacy profile while being safe.
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