This Market Spotlight report covers the Benign Prostatic Hyperplasia market, comprising key pipeline and marketed drugs, clinical trials, upcoming events, patent information, a 10-year disease prevalence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.
- The author estimates that in 2016, there were 595.2 million prevalent cases of benign prostatic hyperplasia among males aged 40 years and older worldwide, and forecasts that number to increase to 728.7 million prevalent cases by 2025.
- Asia is estimated to have the largest number of prevalent cases in 2016, and Oceania is estimated to have the smallest number of prevalent cases (354.2 million and 3.9 million cases, respectively).
- Approved drugs in benign prostatic hyperplasia space target phosphodiesterase 5, steroid 5a-reductase, alpha 1 adrenergic receptor, and muscarinic acetylcholine receptor. All the marketed drugs for benign prostatic hyperplasia are administered via the oral route.
- The majority of industry-sponsored drugs in active clinical development for benign prostatic hyperplasia are in Phase II. Therapies in development for benign prostatic hyperplasia focus on a wide variety of targets. These therapies are administered via the rectal, percutaneous catheter/injection, intratumoral, intravenous, and oral routes.
- High-impact upcoming events include topline Phase IIa trial results for OPK-88004, and a pre-NDA meeting with the US Food and Drug Administration for tamsulosin DRS.
- There were three licensing and asset acquisition activities involving benign prostatic hyperplasia drugs during 2012-17. The $8.2m agreement between Aceto and Par Pharmaceuticals in 2014, under which Aceto's subsidiary, Rising Pharmaceuticals purchased three ANDAs from Par Pharmaceuticals through the acquisition of doxercalciferol, paricalcitol and dutasteride capsules, was the only deal with disclosed deal value during this period.
- The US parent patents of Proscar (method of use), Urief (product), Xatral (product) are set to expire in 2018, Zydena (product) in 2019, and Cialis (product) in 2021, which will open the door to generic entries.
- Cialis' sales ranked highest in the benign prostatic hyperplasia space during 2012-16. The clinical trials distribution across Phase I-IV indicates that there is an even distribution of trials for benign prostatic hyperplasia, with 52.1% of trials in Phase I-II, and 47.9% in Phase III-IV.
- The US has a substantial lead in the number of benign prostatic hyperplasia clinical trials globally. Germany leads the major EU markets, while South Korea has the top spot in Asia.
- Clinical trial activity in the benign prostatic hyperplasia space is dominated by completed trials. GlaxoSmithKline has the highest number of completed clinical trials for benign prostatic hyperplasia, with 65 completed trials.
- GlaxoSmithKline leads industry sponsors with the highest number of clinical trials for benign prostatic hyperplasia, followed by Astellas Pharma and Sanofi.
Key Topics Covered:
KEY UPCOMING EVENTS
LICENSING AND ASSET ACQUISITION DEALS
CLINICAL TRIAL LANDSCAPE
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