Atrophic Vaginitis (Vaginal Atrophy) – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2022 To 2032

Atrophic vaginitis Market Outlook and Forecast

Atrophic Vaginitis (Vaginal Atrophy) – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2022 To 2032

Published Date : 2022-10-01

Updated On : 2023-07-10

Pages : 159

Atrophic Vaginitis (Vaginal Atrophy) Market Outlook

Thelansis’s “Atrophic Vaginitis (Vaginal Atrophy) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2022 To 2032" covers disease overview, epidemiology, drug utilization, prescription share analysis, competitive landscape, clinical practice, regulatory landscape, patient share, market uptake, market forecast, and key market insights under the potential Atrophic Vaginitis (Vaginal Atrophy) treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).

Atrophic Vaginitis (Vaginal Atrophy) Overview

Atrophic vaginitis is an inflammatory condition associated with vaginal atrophy caused by reduced estrogen levels, mainly occurring during menopause. Vaginal atrophy leads to thinning of the vaginal epithelium, decreased vaginal rugae and elasticity, and reduced vaginal secretions. It affects pre-menopausal women and up to 50% of post-menopausal women. The hypoestrogenic state responsible for atrophic vaginitis can result from natural menopause or be induced by medical interventions like surgery, radiation, chemotherapy, or certain medications such as Selective estrogen receptor modulators, Selective estrogen receptor degraders, and antigonadotropins. Lower estrogen levels cause alterations in the vaginal environment, disrupting the normal flora, leading to an overgrowth of skin and rectal pathogens due to decreased Lactobacillus spp. The diagnosis of atrophic vaginitis is typically based on the patient's history and specific physical examination findings. Symptoms include vaginal dryness, burning, pruritis, abnormal vaginal discharge, and painful intercourse. External genitalia signs may include atrophy of the labia majora and minora, dry labia, vulvar dermatoses, vulvar lesions, or sparse pubic hair. Differential diagnoses for atrophic vaginitis include various other conditions affecting the vulvovaginal area and urogenital function. Intravaginal estrogen therapy is the primary pharmacologic treatment, with options such as Conjugated estrogen cream, estradiol cream, estradiol tablet, estradiol vaginal ring, and estradiol transdermal patch. Low-dose local estrogen preparations are recommended to minimize systemic es trogen exposure. Risk factors for atrophic vaginitis include lack of vaginal births and smoking, which can worsen symptoms by reducing vaginal secretions due to vasoconstriction. If left untreated, atrophic vaginitis can lead to persistent itching, scarring from scratching, mucosal abrasions, and unresolved genitourinary complaints.

  • The prevalence of atrophic vaginitis varies, with an estimated 10% to 50% of postmenopausal women and 15% of premenopausal women experiencing symptoms of genitourinary syndrome.

Geography Covered:

North America- the United States and Canada

Europe- EU5 (Germany, France, Italy, Spain, and the United Kingdom)

Other countries- Japan & China

Study Period: 2022-2032

Current Clinical Practice and Treatment Algorithm

This section of the study covers country-specific current clinical practice, the standard of care, and significant limitations around addressing the unmet needs. Retrospective analysis and bench-marking of clinical study outcomes are presented in terms of Pre-treatment & post-treatment clinical and demographic patient characteristics. Essentially, this section will cover the evolution of the current competitive landscape and its impact on the future treatment paradigm.

KOL Insights:

KOLs across 8 MM markets from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs

Market Forecast: Patient Based Forecast Model (MS. Excel Based Automated Dashboard)

- Data Inputs with sourcing

- Market Event and Product Event

- Country-specific Forecast Model

- Market uptake and patient share uptake

- Attribute Analysis

- Analog Analysis

- Disease burden and pricing scenario

- Summary and Insights

NPV/ IRR Calculator-

Optimization of cash flow/ revenue flow concerning all fixed and variable investments throughout the product development process. The rate of return on an investment is a critical indicator to ensure the profitability and break-even of the project.

Competitive Landscape:

The competitive landscape includes country-specific approved as well as pipeline therapies. Any asset/product-specific designation or review such as Orphan drug designation, Fast track, Priority Review, Breakthrough Therapy Designation, Rare Pediatric Disease Designation, and Accelerated Approval are tracked and supplemented with analyst commentary.

Clinical Trial Assessment-

Detailed clinical trial data analysis and critical product positioning include trial design, primary outcomes, secondary outcomes, dosing and schedules, inclusion and exclusion criteria, recruitment status and essentially covers the reported adverse events. Majorly the trial analysis helps determine the potential of the critical assets and their probable filing and launch date.

Unmet Medical Needs Overview-

This report presents the most important clinical unmet needs in the treatment, according to Thelansis research and analysis. Other essential unmet needs identified through our study include decreased cost burden on patients, improved administration convenience, and improved patient compliance.

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Atrophic Vaginitis (Vaginal Atrophy) Competitive Landscape

S. no Asset Company Stage
1 Estradiol Vaginal Cream 0.01% Actavis Inc. Phase 3
2 Estradiol Alvogen Pine Brook LLC Phase 3
3 Estradiol Vaginal Cream, 0.01% Mylan Pharmaceuticals Inc Phase 3

KOLs across 8 MM market from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs.

COUNTRY No. Of KOLs
USA 17
GERMANY 4
UK 4
SPAIN 3
FRANCE 2
ITALY 3
JAPAN 3
CHINA 4

Atrophic Vaginitis (Vaginal Atrophy) Market Forecast: Patient Based Forecast Model (MS. Excel Based Automated Dashboard)

Data Inputs with sourcing, Market Event, Product Event, Country specific Forecast Model, Market uptake and patient share uptake, Attribute Analysis, Analog Analysis, Disease burden, and pricing scenario, Summary, and Insights.

Atrophic vaginitis Market Forecast

1.       Atrophic Vaginitis (Vaginal Atrophy) – Key Findings Summary

         1.1.    Clinical findings
                     1.1.1. Disease overview
                     1.1.2. Therapeutic practices
                     1.1.3. Future outlook
         1.2.    Commercial findings
                     1.2.1. Atrophic Vaginitis (Vaginal Atrophy) market scenario 2022
                     1.2.2. Atrophic Vaginitis (Vaginal Atrophy) market scenario 2025
                     1.2.3. Atrophic Vaginitis (Vaginal Atrophy) market scenario 2032

2. Atrophic Vaginitis (Vaginal Atrophy) Overview

         2.1.    Disease Introduction
         2.2.    Pathophysiology
         2.3.    Signs and Symptoms
         2.4.    Risk Factors
         2.5.    Etiology
         2.6.    Classification
         2.7.    Pathogenesis
         2.8.    Diagnosis
         2.9.    Complications
         2.10. Treatment Algorithm
                     2.10.1.    Treatment in US (guidelines)
                     2.10.2.    Treatment in EU-5 (guidelines)
                     2.10.3.    Treatment in Japan (guidelines)
                     2.10.4.    Treatment in China (guidelines)
         2.11. Treatment Goals for Atrophic Vaginitis (Vaginal Atrophy)
         2.12. Referral Patterns
                     2.12.1.    Referral Scenario in US
                     2.12.2.    Referral Scenario in EU-5
                     2.12.3.    Referral Scenario in Japan
                     2.12.4.    Referral Scenario in China
         2.13. Atrophic Vaginitis (Vaginal Atrophy) Prognosis
         2.14. Healthcare burden
                     2.14.1.    Healthcare burden in US
                     2.14.2.    Healthcare burden in EU-5
                     2.14.3.    Healthcare burden in Japan
                     2.14.4.    Healthcare burden in China
         2.15.  Unmet Needs in Atrophic Vaginitis (Vaginal Atrophy) management
         2.16.  Market Opportunity for Atrophic Vaginitis (Vaginal Atrophy)
         2.17. KOL Comments on current and upcoming/expected treatment practices in Atrophic Vaginitis (Vaginal Atrophy)

3.       Epidemiology

         3.1.    Epidemiology Overview
         3.2.    Epidemiology by Geography
                     3.2.1. Atrophic Vaginitis (Vaginal Atrophy) Epidemiology in US (2022-2032)
                             3.2.1.1.              Incidence of Atrophic Vaginitis (Vaginal Atrophy)
                             3.2.1.2.              Diagnosed cases
                             3.2.1.3.              Treatable Patient Pool
                             3.2.1.4.              Epidemiology Trends
                     3.2.2. Atrophic Vaginitis (Vaginal Atrophy) Epidemiology in EU-5 (2022-2032)
                             3.2.2.1.              Incidence of Atrophic Vaginitis (Vaginal Atrophy)
                             3.2.2.2.              Diagnosed cases
                             3.2.2.3.              Treatable Patient Pool
                             3.2.2.4.              Epidemiology Trends
                     3.2.3. Atrophic Vaginitis (Vaginal Atrophy) Epidemiology in Japan (2022-2032)
                             3.2.3.1.              Incidence of Atrophic Vaginitis (Vaginal Atrophy)
                             3.2.3.2.              Diagnosed cases
                             3.2.3.3.              Treatable Patient Pool
                             3.2.3.4.              Epidemiology Trends
                     3.2.4. Atrophic Vaginitis (Vaginal Atrophy) Epidemiology in China (2022-2032)
                             3.2.4.1.              Incidence of Atrophic Vaginitis (Vaginal Atrophy)
                             3.2.4.2.              Diagnosed cases
                             3.2.4.3.              Treatable Patient Pool
                             3.2.4.4.              Epidemiology Trends
         3.3.    Epidemiology Trends (World-wide)

4.       Market Outlook

         4.1.    US Atrophic Vaginitis (Vaginal Atrophy) Market Forecast 2022-2032
                     4.1.1. Market Progression (Futuristic)
                     4.1.2. Market Trends and Expectations
                             4.1.2.1.              Worst case scenario
                             4.1.2.2.              Base Case Scenario
                             4.1.2.3.              Best Case Scenario
                     4.1.3. Drivers and Barriers
         4.2.    UK Atrophic Vaginitis (Vaginal Atrophy) Market Forecast 2022-2032
                     4.2.1. Market Progression (Futuristic)
                     4.2.2. Market Trends and Expectations
                             4.2.2.1.              Worst case scenario
                             4.2.2.2.              Base Case Scenario
                             4.2.2.3.              Best Case Scenario
                     4.2.3. Drivers and Barriers
         4.3.    France Atrophic Vaginitis (Vaginal Atrophy) Market Forecast 2022-2032
                     4.3.1. Market Progression (Futuristic)
                     4.3.2. Market Trends and Expectations
                             4.3.2.1.              Worst case scenario
                             4.3.2.2.              Base Case Scenario
                             4.3.2.3.              Best Case Scenario
                     4.3.3. Drivers and Barriers
         4.4.    Germany Atrophic Vaginitis (Vaginal Atrophy) Market Forecast 2022-2032
                     4.4.1. Market Progression (Futuristic)
                     4.4.2. Market Trends and Expectations
                             4.4.2.1.              Worst case scenario
                             4.4.2.2.              Base Case Scenario
                             4.4.2.3.              Best Case Scenario
                     4.4.3. Drivers and Barriers
         4.5.    Italy Atrophic Vaginitis (Vaginal Atrophy) Market Forecast 2022-2032
                     4.5.1. Market Progression (Futuristic)
                     4.5.2. Market Trends and Expectations
                             4.5.2.1.              Worst case scenario
                             4.5.2.2.              Base Case Scenario
                             4.5.2.3.              Best Case Scenario
                     4.5.3. Drivers and Barriers
         4.6.    Spain Atrophic Vaginitis (Vaginal Atrophy) Market Forecast 2022-2032
                     4.6.1. Market Progression (Futuristic)
                     4.6.2. Market Trends and Expectations
                             4.6.2.1.              Worst case scenario
                             4.6.2.2.              Base Case Scenario
                             4.6.2.3.              Best Case Scenario
                     4.6.3. Drivers and Barriers
         4.7.    Japan Atrophic Vaginitis (Vaginal Atrophy) Market Forecast 2022-2032
                     4.7.1. Market Progression (Futuristic)
                     4.7.2. Market Trends and Expectations
                             4.7.2.1.              Worst case scenario
                             4.7.2.2.              Base Case Scenario
                             4.7.2.3.              Best Case Scenario
                     4.7.3. Drivers and Barriers
         4.8.    China Atrophic Vaginitis (Vaginal Atrophy) Market Forecast 2022-2032
                     4.8.1. Market Progression (Futuristic)
                     4.8.2. Market Trends and Expectations
                             4.8.2.1.              Worst case scenario
                             4.8.2.2.              Base Case Scenario
                             4.8.2.3.              Best Case Scenario
                     4.8.3. Drivers and Barriers
         4.9.    Key Expected Milestones (world-wide) Impacting the Market

5.       Competitive Landscape

         5.1.    Pipeline Therapies Overview
                     5.1.1. Phase III Therapies
                                      5.1.1.1.                     Current Status
                                      5.1.1.2.                     Trial details, results
                                      5.1.1.3.                     Approval Timeline
                                      5.1.1.4.                     Likelihood of approval
                                      5.1.1.5.                     Expected Product Positioning
                             5.1.1.2.              All other Phase III Therapies …..
                             5.1.1.3.              Attribute Analysis of Phase III molecules
                     5.1.2.  Phase II and Phase I/II Therapies
                                      5.1.2.1.                     Current Status
                                      5.1.2.2.                     Trial details, results
                                      5.1.2.3.                     Approval Timelines
                     5.1.3. List of active Pre-clinical Therapies
                                      5.1.3.1.                     Status in Atrophic Vaginitis (Vaginal Atrophy)
                                      5.1.3.2.                     Company positioning
                             5.1.3.2.              All other pre-clinical therapies
                     5.1.4. List of Inactive/discontinued assets
                             5.1.4.1.              Business impact of discontinuations on current pipeline
                     5.1.5. Potential winners from Atrophic Vaginitis (Vaginal Atrophy) Pipeline
                             5.1.5.1.              Potential Blockbusters across the pipeline

6.       Regulatory/Approval Scenario

         6.1.    Regulatory/Approval Framework in US
                     6.1.1. Policy Framework
                     6.1.2. Payer Expectations
         6.2.    Regulatory/Approval Framework in UK
                     6.2.1. Policy Framework
                     6.2.2. Payer Expectations
         6.3.    Regulatory/Approval Framework in France
                     6.3.1. Policy Framework
                     6.3.2. Payer Expectations
         6.4.    Regulatory/Approval Framework in Germany
                     6.4.1. Policy Framework
                     6.4.2. Payer Expectations
         6.5.    Regulatory/Approval Framework in Italy
                     6.5.1. Policy Framework
                     6.5.2. Payer Expectations
         6.6.    Regulatory/Approval Framework in Spain
                     6.6.1. Policy Framework
                     6.6.2. Payer Expectations
         6.7.       Regulatory/Approval Framework in Japan
                     6.7.1. Policy Framework
                     6.7.2. Payer Expectations
         6.8.       Regulatory/Approval Framework in China
                     6.8.1. Policy Framework
                     6.8.2. Payer Expectations

7.       Clinical Trial Assessment – Current and Future Paradigm

         7.1.    Distribution of Primary Endpoints across trials
         7.2.    Distribution of Secondary Endpoints across trials
         7.3.    Evolution and acceptance of surrogate endpoints
         7.4.    Key Investigator initiated trials
         7.5.    Attrition analysis
                     7.5.1. Suspended/Discontinued Assets
                     7.5.2. Failed Trials, Reasons and Business Impact
                     7.5.3. Terminated Trials, Reasons and Business Impact
                     7.5.4. Withdrawn Trials, Reasons and Business Impact
         7.6.    Trial enrollment scenario and challenges
         7.7.    Clinical Trial Guidance (across geographies)

8.       Thelansis Commentary

         8.1.    Key Unmet needs in Atrophic Vaginitis (Vaginal Atrophy)
         8.2.    Possible Best-case Clinical Trial Strategies
         8.3.    Possible Best Case Targeted Product Profile (TPP)
         8.4.    Possible Best-case Market positioning strategies
         8.5.    Possible Best-case Market Access Strategies
         8.6.    Possible Best-case LCM Strategies
         8.7.    Overall View on Atrophic Vaginitis (Vaginal Atrophy) Market in Dollar Value

9.       Report Methodology

         9.1.    Secondary research
         9.2.    Primary research
         9.3.    Data collation
         9.4.    Insight Generation

10.   About Thelansis

         10.1.    Our Capabilities
         10.2.    Our Services
         10.3.    Our Contacts
         10.4.    Disclaimer