Market Spotlight: Benign Prostatic Hyperplasia (BPH)
Market Spotlight: Benign Prostatic Hyperplasia (BPH)
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This Market Spotlight report covers the Benign Prostatic Hyperplasia (BPH) market, comprising key marketed and pipeline drugs, clinical trials, upcoming and regulatory events, probability of success, and a 10-year disease prevalence forecast, as well as presenting drug-specific revenue forecasts.
Author: Informa Pharma Intelligence
Publisher: Datamonitor Healthcare
- Description
- Contents
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 2021, there were 319.8 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 2021, and Oceania is estimated to have had the smallest number (197.9 million and 2.1 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 two industry-sponsored drugs in active clinical development for BPH, with one drug each in Phase II and Phase III. Therapies in active clinical development for BPH focus on targets such as apoptosis, mitochondria, and phosphodiesterase 5. These therapies are administered via the intratumoral and oral routes.
- An expected PDUFA date for fexapotide is the only high-impact upcoming event for drugs in the BPH space. The overall likelihood of approval of a Phase I urology asset is 9.5%, and the average probability a drug advances from Phase III is 78.3%. Drugs, on average, take 9.6 years from Phase I to approval in the overall urology space.
- There are equal proportions of clinical trials for BPH across all phases of development. 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 44 trials.
- GlaxoSmithKline leads industry sponsors with the highest overall number of clinical trials for BPH, followed by Astellas and Sanofi.
CONTENTS
5 OVERVIEW
6 KEY TAKEAWAYS
7 DISEASE BACKGROUND
8 TREATMENT
8 Watchful waiting
8 Pharmacological treatment
8 Surgical treatment
10 EPIDEMIOLOGY
14 MARKETED DRUGS
17 PIPELINE DRUGS
21 KEY UPCOMING EVENTS
22 KEY REGULATORY EVENTS
22 Nymox Fexapotide Odyssey Reaches FDA
23 PROBABILITY OF SUCCESS
24 REVENUE OPPORTUNITY
26 CLINICAL TRIAL LANDSCAPE
27 Sponsors by status
28 Sponsors by phase
30 BIBLIOGRAPHY
31 APPENDIX
LIST OF FIGURES
12 Figure 1: Trends in prevalent cases of BPH, 2019–28
17 Figure 2: Overview of pipeline drugs for BPH in the US
17 Figure 3: Pipeline drugs for BPH, by company
17 Figure 4: Pipeline drugs for BPH, by drug type
18 Figure 5: Pipeline drugs for BPH, by classification
21 Figure 6: Key upcoming events in BPH
23 Figure 7: Probability of success in the urology pipeline
26 Figure 8: Clinical trials in BPH
26 Figure 9: Top 10 drugs for clinical trials in BPH
27 Figure 10: Top 10 companies for clinical trials in BPH
27 Figure 11: Trial locations in BPH
28 Figure 12: BPH trials status
29 Figure 13: BPH trials sponsors, by phase
LIST OF TABLES
11 Table 1: Prevalent cases of BPH, 2019–28
13 Table 2: Prevalence proportions of BPH, by age
15 Table 3: Marketed drugs for BPH
19 Table 4: Pipeline drugs for BPH in the US
24 Table 5: Historical global sales, by drug ($m), 2017–21
25 Table 6: Forecasted global sales, by drug ($m), 2022–26
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