Benign prostatic hyperplasia (BPH), also known as benign prostatic hypertrophy or benign prostatic obstruction, is a common problem in aging men. It refers to the nonmalignant enlargement of the prostate. The enlarged prostate gland presses against the urethra, and the bladder wall thickens. The bladder may eventually become weak, leading to urinary retention (inability to empty completely). Urinary retention and narrowing of the urethra are the causes of problems associated with BPH.

Key Takeaways

• Datamonitor Healthcare estimates that in 2019, there were 305.5 million prevalent cases of benign prostatic hyperplasia (BPH) among males aged 40 years and older worldwide, and forecasts that number to increase to 373.8 million prevalent cases by 2028.
• Asia is estimated to have had the largest number of prevalent cases in 2019, and Oceania is estimated to have had the smallest number (188.5 million and 2.0 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.
• There are only three industry-sponsored drugs in active clinical development for BPH, with one drug each in Phase II, Phase III, and the NDA/BLA stage.
• Therapies in active clinical development for BPH focus on targets such as apoptosis, mitochondria, steroid 5a-reductase, and phosphodiesterase 5. These therapies are administered via the intratumoral and oral routes.
• The only high-impact upcoming event in the BPH space is an estimated PDUFA date for Tad-Fin. The overall likelihood of approval of a Phase I urology asset is 9.7%, and the average probability a drug advances from Phase III is 77.3%. Drugs, on average, take 9.0 years from Phase I to approval in the overall urology space.
• 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 54% of trials in Phase I–II, and 46% in Phase III–IV.
• The US has a substantial lead in the number of BPH clinical trials globally. Germany leads the major European 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 65 trials.
• GlaxoSmithKline leads industry sponsors with the highest overall number of clinical trials for BPH, followed by Astellas and Sanofi.