Polycystic Ovary Syndrome (PCOS) – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2022 To 2032

Polycystic Ovary Syndrome Market Outlook and Forecast

Polycystic Ovary Syndrome (PCOS) – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2022 To 2032

Published Date : 2022-10-12

Updated On : 2023-07-06

Pages : 152

Polycystic Ovary Syndrome (PCOS) Market Outlook

Thelansis’s “Polycystic Ovary Syndrome (PCOS) 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 Polycystic Ovary Syndrome treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).

Polycystic Ovary Syndrome (PCOS) Overview

Polycystic Ovary Syndrome (PCOS) is a prevalent metabolic disorder characterized by hormonal imbalances in women of reproductive age (between 12 and 51 years). It is associated with elevated levels of male hormones, leading to irregular menstrual cycles, ovulation difficulties, and potential challenges with conception. Additionally, PCOS can manifest as abnormal hair growth on the body and face and may have long-term implications, such as an increased risk of heart disease and diabetes. The etiology of PCOS remains incompletely understood; nevertheless, several significant factors have been identified, including:

  1. Excessive Insulin Production: Elevated insulin levels may stimulate the production of androgens, normally present in lower quantities in females, resulting in ovulation problems.
  2. Excessive Androgen Production: The ovaries produce abnormally high levels of androgen hormones, leading to acne and hirsutism (excessive hair growth on the face and body).
  3. Low-Grade Inflammation: Recent studies indicate that females with PCOS experience low-grade inflammation, contributing to increased androgen production and potential cardiovascular issues.
  4. Heredity: There is evidence of a genetic correlation among women affected by PCOS.

Common signs and symptoms of PCOS in females include irregular menstruation (oligomenorrhea), skipped or absent menstruation (amenorrhea), heavy menstrual bleeding (menorrhagia), excessive hair growth on various body areas, acne, weight gain, hair loss, and skin darkening in specific regions. Only a few agents have received approval from the U.S. Food and Drug Administration specifically for treating polycystic ovary syndrome. Several agents are contraindicated during pregnancy. Insulin-sensitizing agents are recommended for most women with PCOS as they positively affect insulin resistance, menstrual irregularities, anovulation, hirsutism, and obesity. Among these agents, metformin has the most extensive data supporting its effectiveness. Additionally, rosiglitazone and pioglitazone have effectively reduced hirsutism and insulin resistance. Metformin and clomiphene, combined, are considered first-line treatments for inducing ovulation. Furthermore, insulin-sensitizing agents, oral contraceptives, spironolactone, and topical eflornithine may be utilized to manage hirsutism in affected patients.

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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Polycystic Ovary Syndrome (PCOS) Competitive Landscape

S. no Asset Company Stage
1 Tildacerfont Spruce Biosciences Phase 2
2 Elagolix AbbVie Phase 2
3 LIK066 Novartis Pharmaceuticals Phase 2
4 DLBS3233 Dexa Medica Group Phase 3
5 D-chiro-inositol and Myoinositol Biosearch S.A. Phase 3
6 Exenatide AstraZeneca Phase 3
7 Saxenda Novo Nordisk A/S Phase 3
8 Saroglitazar Magnesium Zydus Therapeutics Inc. Phase 2

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

Polycystic Ovary Syndrome (PCOS) 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.

Polycystic Ovary Syndrome Market Forecast

1.       Polycystic Ovary Syndrome (PCOS) – 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. Polycystic Ovary Syndrome (PCOS) market scenario 2022
                     1.2.2. Polycystic Ovary Syndrome (PCOS) market scenario 2025
                     1.2.3. Polycystic Ovary Syndrome (PCOS) market scenario 2032

2. Polycystic Ovary Syndrome (PCOS) 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 Polycystic Ovary Syndrome (PCOS)
         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. Polycystic Ovary Syndrome (PCOS) 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 Polycystic Ovary Syndrome (PCOS) management
         2.16.  Market Opportunity for Polycystic Ovary Syndrome (PCOS)
         2.17. KOL Comments on current and upcoming/expected treatment practices in Polycystic Ovary Syndrome (PCOS)

3.       Epidemiology

         3.1.    Epidemiology Overview
         3.2.    Epidemiology by Geography
                     3.2.1. Polycystic Ovary Syndrome (PCOS) Epidemiology in US (2022-2032)
                             3.2.1.1.              Incidence of Polycystic Ovary Syndrome (PCOS)
                             3.2.1.2.              Diagnosed cases
                             3.2.1.3.              Treatable Patient Pool
                             3.2.1.4.              Epidemiology Trends
                     3.2.2. Polycystic Ovary Syndrome (PCOS) Epidemiology in EU-5 (2022-2032)
                             3.2.2.1.              Incidence of Polycystic Ovary Syndrome (PCOS)
                             3.2.2.2.              Diagnosed cases
                             3.2.2.3.              Treatable Patient Pool
                             3.2.2.4.              Epidemiology Trends
                     3.2.3. Polycystic Ovary Syndrome (PCOS) Epidemiology in Japan (2022-2032)
                             3.2.3.1.              Incidence of Polycystic Ovary Syndrome (PCOS)
                             3.2.3.2.              Diagnosed cases
                             3.2.3.3.              Treatable Patient Pool
                             3.2.3.4.              Epidemiology Trends
                     3.2.4. Polycystic Ovary Syndrome (PCOS) Epidemiology in China (2022-2032)
                             3.2.4.1.              Incidence of Polycystic Ovary Syndrome (PCOS)
                             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 Polycystic Ovary Syndrome (PCOS) 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 Polycystic Ovary Syndrome (PCOS) 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 Polycystic Ovary Syndrome (PCOS) 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 Polycystic Ovary Syndrome (PCOS) 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 Polycystic Ovary Syndrome (PCOS) 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 Polycystic Ovary Syndrome (PCOS) 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 Polycystic Ovary Syndrome (PCOS) 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 Polycystic Ovary Syndrome (PCOS) 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 Polycystic Ovary Syndrome (PCOS)
                                      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 Polycystic Ovary Syndrome (PCOS) 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 Polycystic Ovary Syndrome (PCOS)
         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 Polycystic Ovary Syndrome (PCOS) 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