Benign Prostatic Hyperplasia Market

• The United States accounts for the largest Benign prostatic hyperplasia market size, in comparison to EU4 (Germany, Spain, Italy, France), the United Kingdom, and Japan.
• The Benign prostatic hyperplasia market is anticipated to witness a substantial positive shift owing to better uptake of existing drugs, the expected Benign prostatic hyperplasia market launch of Benign prostatic hyperplasia therapies, and raised awareness.
• Benign prostatic hyperplasia is a non-cancerous enlargement of the prostate gland, causing pressure on the urethra, thickening of the bladder wall, and difficulty emptying the bladder fully. This leads to urinary retention and associated symptoms.
• In May 2024, Sumitomo Pharma America (SMPA) announced that the FDA has accepted its supplemental New Drug Application (sNDA) for GEMTESA (vibegron) for the treatment of overactive bladder (OAB) symptoms in men receiving pharmacological therapy for BPH. If approved, vibegron will be the first and only beta-3 agonist for this indication. The FDA aims to make a decision by Q3 of FY2024 under the Prescription Drug User Fee Act (PDUFA).
• Medical therapies for the Benign prostatic hyperplasia treatment market include alpha-blockers, phosphodiesterase-5 inhibitors, 5-alpha reductase inhibitors, and combination medications.
• In 2021, FDA approved Blue Water Biotech’s ENTADFI (finasteride and tadalafil) for the Benign prostatic hyperplasia treatment in men with an enlarged prostate for up to 26 weeks. 

DelveInsight's “Benign prostatic hyperplasia – Market Insights, Epidemiology and Market Forecast – 2034” report delivers an in-depth understanding of Benign prostatic hyperplasia, historical and forecasted epidemiology as well as the Benign prostatic hyperplasia market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

Benign prostatic hyperplasia market report provides real-world prescription pattern analysis, emerging drugs, market share of individual therapies, and historical and forecasted 7MM Benign prostatic hyperplasia market size from 2020 to 2034. The report also covers current Benign prostatic hyperplasia treatment market and unmet medical needs to curate the best opportunities and assess the Benign prostatic hyperplasia treatment market potential.

Benign prostatic hyperplasia Understanding and Treatment Algorithm

Benign prostatic hyperplasia, also known as benign prostatic hypertrophy or obstruction, is a non-cancerous enlargement of the prostate gland, common in older men. It causes the gland to press on the urethra, leading to urinary problems. The exact cause is unclear, but aging and hormonal factors, including estrogen and dihydrotestosterone (DHT), may contribute. Symptoms, which worsen with age, include difficulty urinating and incomplete bladder emptying. Complications like urinary retention, infections, and kidney damage can arise. Diagnosis involves medical history, physical examination, and tests.

Further details related to country-based variations in diagnosis are provided in the report

Benign prostatic hyperplasia Treatment Market

Benign prostatic hyperplasia treatment options include medications like alpha-blockers, phosphodiesterase-5 inhibitors, and 5-alpha-reductase inhibitors, as well as combination therapies. Minimally invasive procedures such as needle ablation and surgery are also available. Combination therapy with an alpha-blocker and a 5-alpha-reductase inhibitor is recommended for some patients. Surgical options involve removing or cutting prostate tissue to alleviate symptoms. 

Benign prostatic hyperplasia Epidemiology

The Benign prostatic hyperplasia epidemiology chapter in the report provides historical as well as forecasted epidemiology in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan from 2024 to 2034. The Benign prostatic hyperplasia epidemiology is segmented with detailed insights into Total Prevalent Cases, Diagnosed and Treatable Cases, Age-specific Prevalent Cases of BPH.

• Benign prostatic hyperplasia is the most common prostate problem for men older than age 50.
• In 7MM, US accounted for the highest total Benign prostatic hyperplasia prevalence.
• As per Delveinsight’s analysis, approximately ~80% of men aged >80 experience lower urinary tract symptoms from Benign prostatic hyperplasia.

Benign prostatic hyperplasia Drugs

The drug chapter segment of the Benign prostatic hyperplasia therapeutics market report encloses a detailed analysis of Benign prostatic hyperplasia marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also deep dives into the Benign prostatic hyperplasia clinical trials details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations. 

Benign prostatic hyperplasia Marketed Drugs

ENTADFI (finasteride and tadalafil): Blue Water Biotech

ENTADFI is a combination of finasteride, a 5α-reductase inhibitor, and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor, indicated to initiate treatment of the signs and symptoms of Benign prostatic hyperplasia in men with an enlarged prostate for up to 26 weeks. Finasteride inhibits Type II 5α-reductase, which converts testosterone to 5αdihydrotestosterone (DHT). By forming a stable enzyme complex, finasteride effectively blocks this conversion. It has no affinity for androgen receptors and reduces 5α-reduced steroid metabolites in blood and urine. Tadalafil is a selective inhibitor of phosphodiesterase 5 (PDE5). PDE5 is found in the smooth muscle of the corpus cavernosum, prostate, and bladder as well as in vascular and visceral smooth muscle, skeletal muscle, urethra, platelets, kidney, lung, cerebellum, heart, liver, testis, seminal vesicle, and pancreas. ENTADFI was approved by the FDA in 2021. 

Note: Detailed current therapies assessment will be provided in the full report of Benign prostatic hyperplasia

Benign prostatic hyperplasia Emerging Drugs

GEMTESA (vibegron): Sumitomo Pharma

Vibegron, a once-daily beta-3 adrenergic receptor (β3) agonist, is currently under investigation for the treatment of overactive bladder (OAB) symptoms in men who are receiving pharmacological therapy for BPH. URO-901-3005 is a Phase III study, evaluating safety and efficacy of vibegron in approximately 1,100 men with OAB symptoms and BPH. In May 2024, FDA accepted Sumitomo Pharma's supplemental New Drug Application (sNDA) for Vibegron, and the PDUFA action date is set for Q3 of FY2024.

Note: Detailed emerging therapies assessment will be provided in the final report.

Benign prostatic hyperplasia Market Outlook

Key Benign prostatic hyperplasia companies, such as Sumitomo Pharma, and others are evaluating their leading companies in different stages of Benign prostatic hyperplasia clinical trials, respectively. They aim to investigate Benign prostatic hyperplasia drugs for the Benign prostatic hyperplasia treatment.

• The primary catalyst propelling the Benign prostatic hyperplasia therapeutics market forward is the surge in risk factors, including obesity, heart and circulatory ailments, type 2 diabetes, and the expanding geriatric demographic
• Among EU4 and the UK, UK accounted for the highest Benign prostatic hyperplasia market size in 2023.
• The US FDA approved alpha blockers include terazosin (HYTRIN), doxazosin (CARDURA), tamsulosin (FLOMAX), alfuzosin (UROXATRAL), and silodosin (RAPAFLO).
• The global Benign prostatic hyperplasia therapeutics market is expected to grow due to factors like population demographics, technological advancements, and increased research efforts.

Benign prostatic hyperplasia Drugs Uptake

This section focuses on the uptake rate of potential Benign prostatic hyperplasia drugs expected to be launched in the Benign prostatic hyperplasia market during 2024–2034, which depends on the competitive landscape, safety, and efficacy data along with order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake. 

Further detailed analysis of emerging therapies drug uptake in the report…

Benign prostatic hyperplasia Activities

The report provides insights into therapeutic candidate in Phase III stage. It also analyzes key players involved in developing targeted therapeutics. 

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for emerging Benign prostatic hyperplasia therapies. 

KOL Views

To keep up with the real-world scenario in current and emerging market trends, we take opinions from Key Industry leaders working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts were contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility.

DelveInsight’s analysts connected with 10+ KOLs to gather insights; however, interviews were conducted with 5+ KOLs in the 7MM. Their opinion helps understand and validate current and emerging treatment patterns of Benign prostatic hyperplasia. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. 

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided. 

Benign prostatic hyperplasia Market Access and Reimbursement

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of currently used therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Benign prostatic hyperplasia market report

• The report covers a segment of key events, an executive summary, descriptive overview of Benign prostatic hyperplasia, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, and disease progression along with country specific treatment guidelines.
• Additionally, an all-inclusive account of both the current and emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
• A detailed review of the Benign prostatic hyperplasia market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM Benign prostatic hyperplasia market.

Benign prostatic hyperplasia Market Report Insights

• Patient Population
• Therapeutic Approaches
• Benign prostatic hyperplasia Pipeline Analysis
• Benign prostatic hyperplasia Market Size and Trends
• Existing and future Market Opportunity 

Benign prostatic hyperplasia Market Report Key Strengths

• Eleven Years Forecast
• 7MM Coverage 
• Benign prostatic hyperplasia Epidemiology Segmentation
• Inclusion of Country specific treatment guidelines
• KOL’s feedback on approved and emerging therapies 
• Key Cross Competition 
• Conjoint analysis
• Drugs Uptake and Key Market Forecast Assumptions

Benign prostatic hyperplasia Market Report Assessment

• Current Benign prostatic hyperplasia Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs

• What is the growth rate of the 7MM Benign prostatic hyperplasia treatment market?
• What was the total Benign prostatic hyperplasia market size, the Benign prostatic hyperplasia market size by therapies, market share (%) distribution in 2020, and what would it look like in 2034? What are the contributing factors/key catalysts for this growth?
• Is there any unexplored patient setting that can open the window for growth in the future?
• What are the pricing variations among different geographies for approved and off-label therapies?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends? Although multiple expert guidelines recommend testing for targetable mutations before therapy initiation, why do barriers to testing remain high?
• What are the current and emerging Benign prostatic hyperplasia drugs for the treatment of Benign prostatic hyperplasia? 
• How many Benign prostatic hyperplasia companies are developing therapies for Benign prostatic hyperplasia treatment?
• What are the recent novel therapies, targets, Benign prostatic hyperplasia mechanisms of action, and technologies developed to overcome the limitations of existing therapies? 
• Patient/physician acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved Benign prostatic hyperplasia drugs?

Reasons to buy

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Benign prostatic hyperplasia Market.
• Insights on patient burden/Benign prostatic hyperplasia prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label Benign prostatic hyperplasia drugs, and patient assistance programs.
• To understand Key Opinion Leaders’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing Benign prostatic hyperplasia market so that the upcoming players can strengthen their development and launch strategy.

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