Atrophic Vaginitis - Market Insight, Epidemiology, and Market Forecast - 2034

Key Highlights:

• The United States leads the atrophic vaginitis market, surpassing the EU4 (Germany, Spain, Italy, France), the UK, and Japan in atrophic vaginitis market size. The total atrophic vaginitis market for therapies across the seven major markets (7MM) is growing at a CAGR of 1.6%, largely driven by conventional treatments. This trend underscores the ongoing reliance on established therapies, while also highlighting opportunities for innovation in treatment options.
• Atrophic vaginitis, caused by reduced estrogen levels during menopause, leads to vaginal dryness, itching, and pain during intercourse. It is typically treated with estrogen therapies or non-hormonal moisturizers.
• According to DelveInsight's estimates, in the year 2023, there were approximately 99 million prevalent cases of atrophic vaginitis across the seven major markets (7MM). These cases are expected to rise significantly from 2020 to 2034, driven by an increasing post-menopausal population, greater awareness among women, a growing emphasis on women's health, and improved healthcare access globally.
• According to the 2023 estimates, 50% of atrophic vaginitis cases were classified as moderate to severe, yet fewer than 40% of affected women sought medical treatment. This highlights a significant gap in the management of the condition, emphasizing the need for increased awareness and access to effective therapies.
• Currently, only two drugs have been approved by the US FDA for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy (VVA), due to menopause- OSPHENA (ospemifene) and IMVEXXY (estradiol vaginal inserts) developed by companies like Duchesnay and TherapeuticsMD, respectively.
• Currently, there is no complete cure for atrophic vaginitis, and the pipeline for new treatments remains limited, underscoring a significant unmet need in managing this condition.

DelveInsight's "Atrophic Vaginitis Market Insights, Epidemiology and Market Forecast - 2034" report delivers an in-depth understanding of the indication atrophic vaginitis, historical and forecasted epidemiology as well as the atrophic vaginitis market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

The atrophic vaginitis market report provides real-world prescription pattern analysis, approved drugs, market share of individual therapies, and historical and forecasted 7MM atrophic vaginitis market size from 2020 to 2034. The report also covers current atrophic vaginitis treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's underlying potential.

Atrophic Vaginitis Treatment Market

Atrophic Vaginitis Overview, Country-Specific Treatment Guidelines and Diagnosis

Atrophic vaginitis is a condition characterized by thinning, dryness, and loss of elasticity in the vaginal lining, usually due to decreased estrogen levels during menopause. Menopause, occurring around age 50, results in reduced hormone production, cessation of menstrual periods, and symptoms indicative of vaginal atrophy. Symptoms include vaginal dryness, itching, burning, and pain during intercourse, along with potential urinary issues. The severity can range from mild discomfort to significant pain and impairment. Challenges in managing atrophic vaginitis include the social stigma associated with discussing intimate health issues, potential side effects of treatments, and limited access to care or affordability of therapies. Diagnosis typically involves a detailed medical history, physical examination, and pelvic exam, with additional tests to rule out other conditions.

The atrophic vaginitis market report provides an overview of atrophic vaginitis pathophysiology, diagnostic approaches, and detailed treatment algorithm along with a real-world scenario of a patient's journey beginning from the first symptom, the time taken for diagnosis to the entire treatment process.

Atrophic Vaginitis Treatment

Treatment for atrophic vaginitis focuses on alleviating symptoms and restoring vaginal health. Of the patients diagnosed with atrophic vaginitis, more than 2/3rd manage their disease with over the counter treatment modalities. The current treatment approaches for atrophic vaginitis, also known as vaginal atrophy, encompasses a variety of options.

Topical estrogen therapy, which includes creams, rings, or tablets applied directly to the vagina, helps replenish local estrogen levels and is often the first line of treatment.

Systemic hormone replacement therapy (HRT), administered orally or through transdermal patches, addresses broader menopausal symptoms including vaginal atrophy.

Vaginal DHEA (dehydroepiandrosterone), a hormone therapy, also shows promise in improving vaginal tissue health.

Additionally, selective estrogen receptor modulators (SERMs) like ospemifene mimic estrogen's beneficial effects on vaginal tissue. Lifestyle changes, such as staying sexually active, avoiding irritants, and maintaining good hygiene, can further help manage symptoms. Recently, laser therapy using fractional CO2 lasers has emerged as a newer approach to stimulate collagen production and enhance vaginal health.

Atrophic Vaginitis Epidemiology

The atrophic vaginitis epidemiology chapter in the report provides historical as well as forecasted prevalence in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan from 2024 to 2034. The atrophic vaginitis epidemiology is segmented with detailed insights into Total Prevalent Cases, Total Diagnosed Prevalent Cases, Severity-specific Cases, and Total Patients Taking Prescription Treatment Cases for Atrophic Vaginitis in the 7MM [2020-2034].

• As per DelveInsight's estimates, in the year 2023, the total prevalent cases of atrophic vaginitis were 99 million cases in the 7MM, which might rise by 2034 at a CAGR of XX%.
• In the US, only a quarter of patients get diagnosed in a year due to differential diagnosis
• EU4 and the UK, accounted for 47.4% of the total diagnosed prevalent cases of atrophic vaginitis in the year 2023.
• According to the 2023 estimates, 50% of atrophic vaginitis cases were classified as moderate to severe, yet fewer than 40% of affected women sought medical treatment.

Atrophic Vaginitis Drug Chapters

The drug chapter segment of the atrophic vaginitis market report encloses a detailed analysis of atrophic vaginitis marketed drugs. It also deep dives into the atrophic vaginitis pivotal clinical trial details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations.

Atrophic Vaginitis Marketed Drugs

OSPHENA / SENSHIO (ospemifene): Shionogi / Duchesnay

OSPHENA / SENSHIO (ospemifene) is a selective estrogen receptor modulator (SERM) marketed by Shionogi and Duchesnay. Ospemifene is primarily used to treat moderate to severe dyspareunia (pain during sexual intercourse) due to vulvar and vaginal atrophy (VVA) in postmenopausal women.

In some regions, it is also approved for treating moderate to severe vaginal dryness due to VVA.

IMVEXXY (estradiol vaginal inserts): TherapeuticsMD

IMVEXXY's mechanism of action is the re-estrogenization of the tissue in and around the vagina. IMVEXXY's distinctive formulation ensures that it dissolves completely without mess, so patients can use it any time of day by placing the soft gel capsule in the lower part of the vagina to treat the vulva and vagina. IMVEXXY is administered daily for two weeks followed by only twice a week dosing. Nine out of 10 patients who participated in a clinical trial reported that IMVEXXY was "easy to use."

The FDA approval of IMVEXXY is based on the results of a Phase III, randomized, double-blind, placebo-controlled study that evaluated the safety and efficacy of IMVEXXY (4 mcg and 10 mcg) compared to placebo from baseline to week 12.

Atrophic Vaginitis Market Outlook

The Atrophic Vaginitis market size in the seven major markets is projected to experience significant growth from 2024, driven by a notable increase in prevalent cases and the necessity for innovative therapies that can provide more effective, long-term relief for the millions of women affected by atrophic vaginitis. The compound annual growth rate (CAGR) is expected to be 1.0%.

• The United States accounts for the largest Atrophic Vaginitis market size, in comparison to EU4 (Germany, Spain, Italy, France), the United Kingdom, and Japan.
• Among EU4 and the UK, Germany had the largest Atrophic Vaginitis market size accounting for approximately USD 223 million, followed by Italy, with Spain having the smallest Atrophic Vaginitis market size in 2023.
• In Japan, the total Atrophic Vaginitis market size was USD 400 million in 2023, which is expected to rise during the study period (2020-2034).
• In 2023, over-the-counter products dominated 60% of the atrophic vaginitis market, while prescription medications, particularly hormonal treatments, held the remaining 40%. OSPHENA emerged as a strong performer, capturing a market value of USD 100 million. However, the rise of generics poses a significant challenge to future Atrophic Vaginitis market growth.

Atrophic Vaginitis Drug Uptake

This section focuses on the uptake rate of potential Atrophic Vaginitis drugs expected to be launched in the 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 Atrophic Vaginitis companies 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.

Atrophic Vaginitis Activities

This section in Atrophic Vaginitis market report provides insights into different therapeutic candidates. It also analyzes key Atrophic Vaginitis companies involved in developing targeted therapeutics.

Pipeline Development Activities

This section in Atrophic Vaginitis market report covers information on collaborations, acquisitions and mergers, licensing, and patent details for emerging therapies.

Atrophic Vaginitis KOL Views

To keep up with the real-world scenario in current Atrophic Vaginitis 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 treatment patterns of atrophic vaginitis. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the Atrophic Vaginitis 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 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.

In efficacy, the trial's primary and secondary outcome measures are evaluated; for instance, in event-free survival, one of the most important primary outcome measures is event-free survival and overall survival.

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.

Atrophic Vaginitis Market Access and Reimbursement

The Atrophic Vaginitis market report 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 Atrophic Vaginitis Market Report

• The Atrophic Vaginitis market report covers a segment of key events, an executive summary, descriptive overview of atrophic vaginitis, 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 the current 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 atrophic vaginitis 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 Atrophic Vaginitis market 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 atrophic vaginitis.

Atrophic Vaginitis Market Report Insights

• Atrophic Vaginitis Patient Population
• Atrophic Vaginitis Therapeutic Approaches
• Atrophic vaginitis Pipeline Analysis
• Atrophic vaginitis Market Size
• Atrophic Vaginitis Market Trends
• Existing and future Atrophic Vaginitis Market Opportunity

Atrophic Vaginitis Market Report Key Strengths

• Eleven Years Forecast
• 7MM Coverage
• atrophic vaginitis Epidemiology Segmentation
• Inclusion of Country specific treatment guidelines
• KOL's feedback on approved therapies
• Key Cross Competition
• Conjoint analysis
• Atrophic Vaginitis Drugs Uptake
• Key Atrophic Vaginitis Market Forecast Assumptions

Atrophic Vaginitis Market Report Assessment

• Current Atrophic Vaginitis Treatment Practices
• Atrophic Vaginitis Unmet Needs
• Atrophic Vaginitis Pipeline Product Profiles
• Atrophic Vaginitis Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)
• Atrophic Vaginitis Marker Drivers
• Atrophic Vaginitis Market Barriers

FAQs:

• What is the growth rate of the 7MM atrophic vaginitis treatment market?
• What was the total Atrophic Vaginitis market size, the 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 Atrophic Vaginitis therapies?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
• What are the current options for the treatment of atrophic vaginitis?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved Atrophic Vaginitis therapies?

Reasons to buy Atrophic Vaginitis Market Report

• The Atrophic Vaginitis market report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the atrophic vaginitis Market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years
• Understand the existing Atrophic Vaginitis 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.
• Detailed analysis and ranking of class-wise potential current 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 therapies, 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 market so that the upcoming Atrophic Vaginitis companies can strengthen their development and launch strategy.