Market Spotlight: Benign Prostatic Hyperplasia (BPH)

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Report
30 Pages
January 2021
Region: Global
Citeline
ID: 4462137

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

Key Takeaways

The publisher 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 I, Phase II, and Phase III.
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 overall likelihood of approval of a Phase I urology asset is 11.4%, 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.

OVERVIEWKEY TAKEAWAYSDISEASE BACKGROUND

TREATMENT

Watchful waiting
Pharmacological treatment
Surgical treatment

EPIDEMIOLOGYMARKETED DRUGSPIPELINE DRUGS

KEY REGULATORY EVENTS

UK's NICE Backs Funding For Olympus Plasma System For BPH
UK's NICE Recommends Boston Scientific’s Rezum Steam Treatment For BPH

PROBABILITY OF SUCCESSREVENUE OPPORTUNITY

CLINICAL TRIAL LANDSCAPE

Sponsors by status
Sponsors by phase
Recent events

BIBLIOGRAPHY

Prescription information

APPENDIX

LIST OF FIGURES

Figure 1: Trends in prevalent cases of BPH, 2019–28
Figure 2: Overview of pipeline drugs for BPH in the US
Figure 3: Pipeline drugs for BPH, by company
Figure 4: Pipeline drugs for BPH, by drug type
Figure 5: Pipeline drugs for BPH, by classification
Figure 6: Probability of success in the urology pipeline
Figure 7: Clinical trials in BPH
Figure 8: Top 10 drugs for clinical trials in BPH
Figure 9: Top 10 companies for clinical trials in BPH
Figure 10: Trial locations in BPH
Figure 11: BPH trials status
Figure 12: BPH trials sponsors, by phase

LIST OF TABLES

Table 1: Prevalent cases of BPH, 2019–28
Table 2: Prevalence proportions of BPH, by age
Table 3: Marketed drugs for BPH
Table 4: Pipeline drugs for BPH in the US
Table 5: Historical global sales, by drug ($m), 2015–19
Table 6: Forecasted global sales, by drug ($m), 2021–25

Table of Contents

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