2018 Market Spotlight: Benign Prostatic Hyperplasia (BPH) – GlaxoSmithKline Leads Industry Sponsors with the Highest Number of Overall Clinical Trials for BPH, Followed by Astellas & Sanofi – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Market Spotlight: Benign Prostatic Hyperplasia (BPH)” report has been added to ResearchAndMarkets.com’s offering.

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

• The author estimates that in 2016, there were 595.2 million prevalent cases of benign prostatic hyperplasia (BPH) 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 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 majority of industry-sponsored drugs in active clinical development for BPH are in Phase II, with just 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 release of topline Phase IIb trial results for OPK-88004 is the only high-impact upcoming event in the BPH space. The overall likelihood of approval of a Phase I urology asset is 15.8%, and the average probability a drug advances from Phase III is 80%. Drugs, on average, take 8.1 years from Phase I to approval in the overall urology space.
• There have been three licensing and asset acquisition deals involving BPH 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 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 around 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 65 trials.
• GlaxoSmithKline leads industry sponsors with the highest number of overall clinical trials BPH, followed by Astellas and Sanofi

Key Topics Covered

OVERVIEW

KEY TAKEAWAYS

DISEASE BACKGROUND

TREATMENT

Watchful waiting

Pharmacological treatment

Surgical treatment

EPIDEMIOLOGY

MARKETED DRUGS

Approvals by country

PIPELINE DRUGS

KEY UPCOMING EVENTS

KEY REGULATORY EVENTS

Four Drugs Set For EU Approval, EMA Holds Fire On Pacritinib

Device Debut: Procept Biorobotics Expects To Make A Splash With AquaBeam

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

Boston Scientific Scores March M&A Double Whammy With NxThera

Teleflex Adds Minimally Invasive BPH System With NeoTract Buy

PARENT PATENTS

REVENUE 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, 2017-26

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: Key upcoming events in BPH

Figure 7: Probability of success in the BPH pipeline

Figure 8: Licensing and asset acquisition deals in BPH, 2013-18

Figure 9: Parent patents in BPH

Figure 10: Clinical trials in BPH

Figure 11: Top 10 drugs for clinical trials in BPH

Figure 12: Top 10 companies for clinical trials in BPH

Figure 13: Trial locations in BPH

Figure 14: BPH trials status

Figure 15: BPH trials sponsors, by phase

LIST OF TABLES

Table 1: Prevalent cases of BPH, 2017-26

Table 2: Prevalence proportions of BPH, by age, 2017-26

Table 3: Marketed drugs for BPH

Table 4: Approvals by country for BPH

Table 5: Pipeline drugs for BPH in the US

Table 6: Historical global sales, by drug ($m), 2013-17

Table 7: Forecasted global sales, by drug ($m), 2018-22

For more information about this report visit https://www.researchandmarkets.com/r/b8h23z

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