This Market Spotlight report covers the Benign Prostatic Hyperplasia market, comprising key marketed and pipeline drugs, clinical trials, upcoming and regulatory events, probability of success, patent information, a 10-year disease prevalence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.

Key Takeaways

• Datamonitor Healthcare estimates that in 2017, there were 293.2 million prevalent cases of benign prostatic hyperplasia (BPH) among males aged 40 years and older worldwide, and forecasts that number to increase to 358.7 million prevalent cases by 2026.
• Asia is estimated to have had the largest number of prevalent cases in 2017, and Oceania is estimated to have had the smallest number (180.1 million and 1.9 million cases, respectively).
• Approved drugs in the BPH space target phosphodiesterase 5, steroid 5a-reductase, alpha 1 adrenergic receptor, and muscarinic acetylcholine receptor. All marketed drugs for BPH are administered via the oral route.
• The largest proportion of industry-sponsored drugs in active clinical development for BPH are in Phase II, with two drugs in Phase III.
• Therapies in development for BPH focus on a wide variety of targets. These therapies are administered via the rectal, percutaneous catheter/injection, intratumoral, intravenous, and oral routes.
• The overall likelihood of approval of a Phase I urology asset is 15.9%, and the average probability a drug advances from Phase III is 80%. Drugs, on average, take 8.5 years from Phase I to approval in the overall urology space.
• There have been only four licensing and asset acquisition deals involving BPH drugs during 2014–19. The $8.2m agreement between Aceto and Par Pharmaceutical in 2014, under which Aceto’s subsidiary, Rising Pharmaceuticals, purchased three ANDAs from Par Pharmaceutical through the acquisition of doxercalciferol, paricalcitol, and dutasteride capsules, was the only deal with a disclosed value.
• The distribution of clinical trials across Phase I–IV indicates that just over half of trials for BPH have been in the early and midphases of development, with 52% of trials in Phase I–II, and 48% in Phase III–IV.
• The US has a substantial lead in the number of BPH clinical trials globally. Germany leads the major EU markets, while South Korea has the top spot in Asia.
• Clinical trial activity in the BPH space is dominated by completed trials. GlaxoSmithKline has the highest number of completed clinical trials for BPH, with 64 trials.
• GlaxoSmithKline leads industry sponsors with the highest overall number of clinical trials for BPH, followed by Astellas and Sanofi.