- 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 had the largest number of prevalent cases in 2016, and Oceania is estimated to have had the smallest number (354.2 million and 3.9 million cases, respectively).
- Approved drugs in the benign prostatic hyperplasia space target phosphodiesterase 5, steroid 5a-reductase, alpha 1 adrenergic receptor, and muscarinic acetylcholine receptor. All 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 comprise topline Phase IIb trial results for OPK-88004, and a pre-NDA meeting with the US Food and Drug Administration for Tamsulosin DRS.
- There have been three licensing and asset acquisition deals involving benign prostatic hyperplasia drugs during 2013-18. 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 US parent patents of Xatral (formulation), Cialis (product), Proscar (method of use), and Urief (product) are all set to expire during 2018.
- Cialis’s sales ranked highest among drugs available for BPH during 2012-16. The distribution of clinical trials across Phase I-IV indicates that there is an even distribution of trials for benign prostatic hyperplasia, with 52.3% of trials in Phase I-II, and 47.7% 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 trials.
- GlaxoSmithKline leads industry sponsors with the highest number of clinical trials for benign prostatic hyperplasia, followed by Astellas and Sanofi.
KEY UPCOMING EVENTS
KEY REGULATORY EVENTS
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LICENSING AND ASSET ACQUISITION DEALS
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CLINICAL TRIAL LANDSCAPE
List of Figures
Figure 1: Trends in prevalent cases of benign prostatic hyperplasia, 2016-25
Figure 2: Overview of pipeline drugs for benign prostatic hyperplasia in the US
Figure 3: Pipeline drugs for benign prostatic hyperplasia, by company
Figure 4: Pipeline drugs for benign prostatic hyperplasia, by drug type
Figure 5: Pipeline drugs for benign prostatic hyperplasia, by classifications
Figure 6: Key upcoming events in benign prostatic hyperplasia
Figure 7: Licensing and asset acquisition deals in benign prostatic hyperplasia, 2013-18
Figure 8: Parent patents in benign prostatic hyperplasia
Figure 9: Clinical trials in benign prostatic hyperplasia
Figure 10: Top 10 drugs for clinical trials in benign prostatic hyperplasia
Figure 11: Top 10 companies for clinical trials in benign prostatic hyperplasia
Figure 12: Trial locations in benign prostatic hyperplasia
Figure 13: Benign prostatic hyperplasia trials status
Figure 14: Benign prostatic hyperplasia trials sponsors, by phase
List of Tables
Table 1: Prevalent cases of benign prostatic hyperplasia, 2016-25
Table 2: Prevalence proportions of benign prostatic hyperplasia, 2016-25
Table 3: Marketed drugs for benign prostatic hyperplasia
Table 4: Approvals by country for benign prostatic hyperplasia
Table 5: Pipeline drugs for benign prostatic hyperplasia in the US
Table 6: Historical global sales, by drug ($m), 2012-17
Table 7: Forecasted global sales, by drug ($m), 2018-22