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DelveInsight’s “Benign Prostatic Hyperplasia Market Insights, Epidemiology, and Market Forecast-2034″ report offers an in-depth understanding of the Benign Prostatic Hyperplasia, historical and forecasted epidemiology as well as the Benign Prostatic Hyperplasia market trends in the United States, EU4 (Germany, Spain, Italy, France) the United Kingdom and Japan.

To Know in detail about the Benign Prostatic Hyperplasia market outlook, drug uptake, treatment scenario and epidemiology trends, Click here; Benign Prostatic Hyperplasia Market Forecast

Some of the key facts of the Benign Prostatic Hyperplasia Market Report:

• The Benign Prostatic Hyperplasia market size is anticipated to grow with a significant CAGR during the study period (2020-2034).

• In June 2026, The FDA has granted approval for a feasibility study of the NanoKnife System, which will evaluate irreversible electroporation (IRE) as a potential treatment for lower urinary tract symptoms (LUTS) resulting from benign prostatic hyperplasia (BPH).

• In March 2026, Prodeon Medical has obtained U.S. Food and Drug Administration (FDA) 510(k) clearance for its Urocross Expander System, a temporary implant technology designed to treat lower urinary tract symptoms (LUTS) linked to benign prostatic hyperplasia (BPH).

• In January 2026, Butterfly Medical, a company developing a proprietary non-surgical treatment for benign prostatic hyperplasia (BPH), has announced the successful completion of the final 12-month follow-up for all participants in its international pivotal clinical trial. This landmark study aims to assess the safety and effectiveness of the Butterfly Prostatic Retraction Device, a first-line interventional therapy (FIT) for BPH.

• In December 2025, Zenflow, Inc. announced that the FDA has approved its Zenflow Spring Implant and Delivery System for the treatment of symptoms related to benign prostatic hyperplasia (BPH). This first-line interventional therapy is designed to widen the urethra while maintaining natural anatomy through a proprietary spring-like implant. The company also highlighted that this is the first FDA-approved BPH treatment performed in an outpatient setting using the Zenflow Spring Scope, which received FDA 510(k) clearance earlier this year.

• In August 2025, Jyong Biotech Ltd. (Nasdaq: MENS), a Taiwan-based, science-driven biotechnology company focused on developing and commercializing innovative plant-derived drugs for urinary system disorders, with initial market focus on the U.S., EU, and Asia, announced its participation in the 22nd Urological Association of Asia Congress held alongside the 47th Annual Meeting of the Taiwan Urological Association from August 14–17, 2025. The company presented topline results from multiple clinical studies of its proprietary drug candidates: BOTRESO® for benign prostatic hyperplasia (BPH) and lower urinary tract symptoms (LUTS), and MCS‑8 (PCP) for potential prostate cancer prevention.

• In April 2025, The investigational ProVee Urethral Expander System for benign prostatic hyperplasia (BPH) met all safety and effectiveness endpoints in a Phase 3 study, as reported at the 2025 American Urological Association Annual Meeting. Steven A. Kaplan, MD, presented data from the ProVIDE trial (NCT05186740), a Phase 3, prospective, multicenter, randomized, double-blind, sham-controlled study assessing the safety, performance, and effectiveness of ProVee. Patients were randomly assigned in a 2:1 ratio to receive either ProVee or a sham procedure (simulated delivery with no stent deployed). The study included men aged 45 and older with moderate-to-severe symptomatic BPH, an International Prostate Symptom Score (IPSS) of at least 13, and an IPSS V/S of at least 1 at baseline.

• In April 2025, The investigational ProVee Urethral Expander System for benign prostatic hyperplasia (BPH) met all safety and effectiveness endpoints in a Phase 3 study, as reported at the 2025 American Urological Association Annual Meeting. Steven A. Kaplan, MD, presented data from the ProVIDE trial (NCT05186740), a Phase 3, prospective, multicenter, randomized, double-blind, sham-controlled study assessing the safety, performance, and effectiveness of ProVee. Patients were randomly assigned in a 2:1 ratio to receive either ProVee or a sham procedure (simulated delivery with no stent deployed). The study included men aged 45 and older with moderate-to-severe symptomatic BPH, an International Prostate Symptom Score (IPSS) of at least 13, and an IPSS V/S of at least 1 at baseline.

• The alpha blockers approved by the US FDA include terazosin (HYTRIN), doxazosin (CARDURA), tamsulosin (FLOMAX), alfuzosin (UROXATRAL), and silodosin (RAPAFLO).

• The key driver of the BPH market’s growth is the increasing prevalence of risk factors such as obesity, cardiovascular diseases, type 2 diabetes, and the rising aging population.

• Benign prostatic hyperplasia is the most prevalent prostate condition among men over 50.

• Among the seven major markets (7MM), the United States had the highest total prevalence of BPH.

• According to DelveInsight’s analysis, nearly 80% of men over the age of 80 experience lower urinary tract symptoms due to benign prostatic hyperplasia.

• Key Benign Prostatic Hyperplasia Companies: AiViva BioPharma, Chong Kun Dang, EMS, Urotronic Inc., Resurge Therapeutics Inc, Antev, Nymox Pharmaceutical, GlaxoSmithKline, Dongkook Pharmaceutical, RECORDATI GROUP, Astellas Pharma Inc, Eli Lilly and Company, Sophiris Bio Corp, Bayer, Sophiris Bio Corp, Warner Chilcott, Nymox Corporation, QLT Inc., NeoTract, Inc., Xintian Pharmaceutical, and others

• Key Benign Prostatic Hyperplasia Therapies: AIV007, CKD-846, DTT106, Paclitaxel, RT-310, Teverelix trifluoroacetate, Fexapotide, GI198745, DKF-313, Silodosin, ASP4901, Tadalafil, PRX302, Levitra (Vardenafil, BAY38-9456), PRX302, WC3055, NX-1207, QLT0074, Tamsulosin Hydrochloride, Ningmitai capsule, and others

• The Benign Prostatic Hyperplasia epidemiology based on age-specific cases analyzed that Benign Prostatic Hyperplasia is more common in older males as compared to those below 40 years

• The Benign Prostatic Hyperplasia market is expected to surge due to the disease’s increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Benign Prostatic Hyperplasia pipeline products will significantly revolutionize the Benign Prostatic Hyperplasia market dynamics.

Benign Prostatic Hyperplasia Overview

Benign prostatic hyperplasia (BPH), also known as prostate gland enlargement, is a common condition that affects aging men. It occurs when the prostate gland, which surrounds the urethra (the tube that carries urine from the bladder out of the body), gradually enlarges. The prostate gland’s enlargement can cause compression of the urethra, leading to various urinary symptoms.

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Benign Prostatic Hyperplasia Epidemiology

The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2020 to 2034. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends.

Benign Prostatic Hyperplasia Epidemiology Segmentation:

The Benign Prostatic Hyperplasia market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:

• Total Prevalence of Benign Prostatic Hyperplasia

• Prevalent Cases of Benign Prostatic Hyperplasia by severity

• Gender-specific Prevalence of Benign Prostatic Hyperplasia

• Diagnosed Cases of Episodic and Chronic Benign Prostatic Hyperplasia

Download the report to understand which factors are driving Benign Prostatic Hyperplasia epidemiology trends @ Benign Prostatic Hyperplasia Epidemiology Forecast

Benign Prostatic Hyperplasia Drugs Uptake and Pipeline Development Activities

The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Benign Prostatic Hyperplasia market or expected to get launched during the study period. The analysis covers Benign Prostatic Hyperplasia market uptake by drugs, patient uptake by therapies, and sales of each drug.

Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share.

The report also covers the Benign Prostatic Hyperplasia Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.

Benign Prostatic Hyperplasia Therapies and Key Companies

• AIV007: AiViva BioPharma

• CKD-846: Chong Kun Dang

• DTT106: EMS

• Paclitaxel: Urotronic Inc.

• RT-310: Resurge Therapeutics Inc

• Teverelix trifluoroacetate Antev

• Fexapotide: Nymox Pharmaceutical

• GI198745: GlaxoSmithKline

• DKF-313: Dongkook Pharmaceutical

• Silodosin: RECORDATI GROUP

• ASP4901: Astellas Pharma Inc

• Tadalafil: Eli Lilly and Company

• PRX302: Sophiris Bio Corp

• Levitra (Vardenafil, BAY38-9456): Bayer

• PRX302: Sophiris Bio Corp

• WC3055: Warner Chilcott

• NX-1207: Nymox Corporation

• QLT0074: QLT Inc.

• Tamsulosin Hydrochloride: NeoTract, Inc.

• Ningmitai capsule: Xintian Pharmaceutical

Discover more about therapies set to grab major Benign Prostatic Hyperplasia market share @ Benign Prostatic Hyperplasia Treatment Market

Benign Prostatic Hyperplasia Market Drivers

• Rising prevalence of benign prostatic hyperplasia due to the growing aging male population.

• Increasing awareness and early diagnosis of lower urinary tract symptoms (LUTS).

• Growing demand for minimally invasive and office-based treatment options.

• Continuous advancements in medical devices, laser therapies, and robotic technologies.

• Expanding adoption of novel pharmaceuticals with improved efficacy and safety profiles.

• Favorable reimbursement policies for BPH diagnosis and treatment in developed markets.

Benign Prostatic Hyperplasia Market Barriers

• High cost of advanced minimally invasive procedures and surgical devices.

• Availability of low-cost generic medications, limiting the uptake of newer therapies.

• Risk of treatment-related complications, including urinary incontinence.

• Preference for conservative management in patients with mild or moderate symptoms.

• Limited awareness and access to advanced treatment options in emerging economies.

• Stringent regulatory requirements for approval of novel drugs and medical devices.

• Variability in reimbursement coverage across different countries and healthcare systems.

Scope of the Benign Prostatic Hyperplasia Market Report

• Study Period: 2020–2034

• Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]

• Key Benign Prostatic Hyperplasia Companies: AiViva BioPharma, Chong Kun Dang, EMS, Urotronic Inc., Resurge Therapeutics Inc, Antev, Nymox Pharmaceutical, GlaxoSmithKline, Dongkook Pharmaceutical, RECORDATI GROUP, Astellas Pharma Inc, Eli Lilly and Company, Sophiris Bio Corp, Bayer, Sophiris Bio Corp, Warner Chilcott, Nymox Corporation, QLT Inc., NeoTract, Inc., Xintian Pharmaceutical, and others

• Key Benign Prostatic Hyperplasia Therapies: AIV007, CKD-846, DTT106, Paclitaxel, RT-310, Teverelix trifluoroacetate, Fexapotide, GI198745, DKF-313, Silodosin, ASP4901, Tadalafil, PRX302, Levitra (Vardenafil, BAY38-9456), PRX302, WC3055, NX-1207, QLT0074, Tamsulosin Hydrochloride, Ningmitai capsule, and others

• Benign Prostatic Hyperplasia Therapeutic Assessment: Benign Prostatic Hyperplasia current marketed and Benign Prostatic Hyperplasia emerging therapies

• Benign Prostatic Hyperplasia Market Dynamics: Benign Prostatic Hyperplasia market drivers and Benign Prostatic Hyperplasia market barriers

• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies

• Benign Prostatic Hyperplasia Unmet Needs, KOL’s views, Analyst’s views, Benign Prostatic Hyperplasia Market Access and Reimbursement

To know more about Benign Prostatic Hyperplasia companies working in the treatment market, visit @ Benign Prostatic Hyperplasia Clinical Trials and Therapeutic Assessment

Table of Contents

1. Benign Prostatic Hyperplasia Market Report Introduction

2. Executive Summary for Benign Prostatic Hyperplasia

3. SWOT analysis of Benign Prostatic Hyperplasia

4. Benign Prostatic Hyperplasia Patient Share (%) Overview at a Glance

5. Benign Prostatic Hyperplasia Market Overview at a Glance

6. Benign Prostatic Hyperplasia Disease Background and Overview

7. Benign Prostatic Hyperplasia Epidemiology and Patient Population

8. Country-Specific Patient Population of Benign Prostatic Hyperplasia

9. Benign Prostatic Hyperplasia Current Treatment and Medical Practices

10. Benign Prostatic Hyperplasia Unmet Needs

11. Benign Prostatic Hyperplasia Emerging Therapies

12. Benign Prostatic Hyperplasia Market Outlook

13. Country-Wise Benign Prostatic Hyperplasia Market Analysis (2020–2034)

14. Benign Prostatic Hyperplasia Market Access and Reimbursement of Therapies

15. Benign Prostatic Hyperplasia Market Drivers

16. Benign Prostatic Hyperplasia Market Barriers

17. Benign Prostatic Hyperplasia Appendix

18. Benign Prostatic Hyperplasia Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

About DelveInsight

DelveInsight is a leading Healthcare Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.

It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate the business growth and overcome challenges with a practical approach.

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