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Non-hormonal Therapies for Women's Health Market by Target Indication, Type of Molecule, Purpose of Therapy, Mechanism of Action, Route of Administration, and Key Geographical Regions: Industry Trends and Global Forecasts, 2021-2030

  • ID: 5359088
  • Report
  • March 2021
  • Region: Global
  • 207 Pages
  • Roots Analysis

FEATURED COMPANIES

  • AbbVie
  • Broadfin Capital
  • First Manhattan Co.
  • Jiangsu Hengrui Medicine
  • New Leaf Venture Partners
  • Sanofi-Aventis

Overview

According to the World Health Organization (WHO), sexual and reproductive health-related conditions represent around one third of all clinical conditions prevalent among women between the ages of 15 and 44 years. The human female reproductive system is complex and governed primarily by two hormones, estrogen and progesterone. Any imbalance in the levels of these hormones materializes in the form of a disease, and/or mood related disorders; in fact, women are more prone to experiencing various forms of anxiety, depression and certain physical symptoms that cannot yet be explained medically, as compared to men. Since hormones are responsible for almost all of the concerns associated with reproductive health, a number of hormone regulating interventions have been developed, and are available, for the treatment/prevention of the clinical conditions that are unique to women. This form of therapy has been proven to be both viable and effective, and have been in use since the 1960s. Such therapies gained better traction as mainstream healthcare solutions after clinical trials were conducted, proving their efficacy, in the late 1990s. Despite the vast success of using hormones as therapeutics, later studies reflected a positive correlation between the use of such interventions and several unwanted side effects, including the risk of developing hormone dependent cancers.

In recent years, the development and introduction of non-hormonal alternatives has revolutionized women’s healthcare. Brisdelle® was the first of such products, approved in 2013 for the management of hot flashes in menopausal women. Till date, 21 non-hormonal therapies (recent examples include Oriahnn™, Phexxi™ and Esmya®) have been approved. Further, several such non-hormonal product candidates are under evaluation across different stages of product development. The inherent advantages of non-hormonal therapies, such as better safety profile, ability to maintain hormonal balance and relatively short treatment courses, over their hormonal counterparts have been demonstrated both in clinical trials and post product approval studies. As a result, such products are currently preferred over hormone-based therapies, and the non-hormonal therapy pipeline is expected to continue to steadily expand over the coming years.It is worth highlighting that significant partnership activity has been observed in this market, with several stakeholders entering into strategic collaborations to support the ongoing product development and commercialization initiatives of such products. In the foreseen future, promising results from the ongoing clinical research initiatives are likely to bring in more investments to support product development activity in this upcoming market segment. Therefore, we are led to anticipate significant growth in this domain in the coming years.

Scope of the Report

The “Non-hormonal Therapies for Women’s Health Market by Target Indication (Bacterial Vaginosis, Contraception, Endometriosis, Postmenopausal Osteoporosis, Uterine Fibroids, Vaginitis and Others), Type of Molecule (Biologic and Small Molecule), Purpose of Therapy (Treatment of Disease and Management of Symptoms), Mechanism of Action (Antagonist, Agonist, Inhibitor and Modulator), Route of Administration (intramuscular, intravaginal, intravenous, oral, subcutaneous, topical, transdermal and others), and Key Geographical Regions (North America, Europe and Asia-Pacific): Industry Trends and Global Forecasts, 2021-2030”report features an extensive study of the current market landscape of non-hormonal therapies, primarily focusing on prescription drugs. The study also includes an elaborate discussion on the future potential of this evolving market. 

Amongst other elements, the report features:

  • A detailed review of the overall market landscape of non-hormonal therapies, including information on their current phase of development (marketed, clinical, preclinical and discovery), type of molecule (biologic and small molecule),target indication (bacterial vaginosis, contraception, endometriosis, postmenopausal osteoporosis, uterine fibroids, vaginitis and others), purpose of therapy (treatment of disease and management of symptoms), target women population (adult, postmenarchal and premenopausal female, postmenopausal female), mechanism of action (antagonists, agonists, inhibitors and modulators), route of administration (intramuscular, intravaginal, intravenous, oral, subcutaneous, topical, transdermal and others) and special drug designation(s)awarded (if any).
  • A detailed review of the players engaged in the development of non-hormonal therapies, along with information on their year of establishment, company size, location of headquarters and regional landscape.
  • An elaborate discussion on the various commercialization strategies that can be adopted by drug developers engaged in this domain, across different stages of therapy development, including prior to drug launch, at/during drug launch and post-marketing of the drug.
  • Detailed profiles of phase III non-hormonal therapies. Each drug profile features a brief overview of the therapy, along with information on their current development status, route of administration, primary target indication, dosage, mechanism of action, clinical trials, clinical trial results, collaborations and special drug designation(s) received(if any).
  • A detailed geographical clinical trial analysis of completed and ongoing studies of non-hormonal therapies, based on several relevant parameters, such as trial registration year, trial status, trial phase, target indication, geography, type of sponsor, prominent treatment sites and enrolled patient population.
  • An analysis of the various partnerships that have been inked by stakeholders engaged in the development of non-hormonal therapies, during the period pre2013-2020, including research agreements, research and development agreements, contract manufacturing agreements, licensing agreements and other relevant types of deals. It further features a detailed analysis of the investments made, including award/grant, seed financing, venture capital financing, debt financing and others, in companies engaged in this domain.

One of the key objectives of the report was to estimate the existing market size and the future opportunity associated with non-hormonal therapies, over the next decade. Based on multiple parameters, such as target patient population, likely adoption rates and expected pricing, we have provided informed estimates on the evolution of the market for the period 2021-2030. The report also features the likely distribution of the current and forecasted opportunity across [A] target indication (bacterial vaginosis, contraception, endometriosis, postmenopausal osteoporosis, uterine fibroids, vaginitis and others), [B] type of molecule (biologic and small molecule), [C] route of administration (intramuscular, intravaginal, intravenous, oral, subcutaneous, topical, transdermal and others), [D] key geographical regions (North America, Europe and Asia-Pacific). In addition, the chapter presents indication specific value creation analysis. In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

Key Questions Answered

  • Who are the leading industry players engaged in the development of non-hormonal therapies?
  • How many non-hormonal therapy candidates form the current development pipeline? Which key women’s health related disease indications are targeted by such products? 
  • Which commercialization strategies are most commonly adopted by non-hormonal therapy developers, across different stages of product development?
  • Which partnership models are commonly adopted by stakeholders engaged in this domain?
  • What are the key value drivers of the merger and acquisition activity in the non-hormonal therapies industry?
  • Who are the key stakeholders that have actively made investments in the non-hormonal therapies domain?
  • How is the current and future market opportunity likely to be distributed across key market segments?
Note: Product cover images may vary from those shown

FEATURED COMPANIES

  • AbbVie
  • Broadfin Capital
  • First Manhattan Co.
  • Jiangsu Hengrui Medicine
  • New Leaf Venture Partners
  • Sanofi-Aventis

1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Key Questions Answered
1.4. Chapter Outlines

2. EXECUTIVE SUMMARY

3. INTRODUCTION
3.1. Chapter Overview
3.2. Women’s Health and Affiliated Clinical Conditions
3.2.1. Key Milestones in the Treatment of Women’s Health-related Disorders
3.3. Women’s Health-related Conditions
3.4. Available Treatment Modalities
3.4.1. Surgery
3.4.2. Hormonal Therapies
3.4.3. Non-Hormonal Therapies
3.5. Future Perspectives

4. MARKET OVERVIEW
4.1. Chapter Overview
4.2. Non-hormonal Therapies Market: Pipeline
4.2.1. Analysis by Phase of Development
4.2.2. Analysis by Type of Molecule
4.2.3. Analysis by Target Indication
4.2.4. Analysis by Phase of Development and Target Indication
4.2.5. Analysis by Type of Molecule and Target Indication
4.2.6. Analysis by Purpose of Therapy
4.2.7. Analysis by Target Women Population
4.2.8. Analysis by Mechanism of Action
4.2.9. Analysis by Route of Administration
4.3.1. Analysis by Special Designation(s) Awarded

5. COMPETITIVE LANDSCAPE
5.1. Chapter Overview
5.2. Non-hormonal Therapies Market: List of Developers
5.2.1. Analysis by Year of Establishment
5.2.2. Analysis by Company Size
5.2.3. Analysis by Geography
5.3. Key Players: Analysis by Number of Product Candidates
5.4. Big Pharma Initiatives

6. KEY COMMERCIALIZATION STRATEGIES
6.1. Chapter Overview
6.2. Successful Drug Launch Strategy: Publisher Framework
6.3. Successful Drug Launch Strategy: Product Differentiation
6.4. Commonly Adopted Commercialization Strategies based on the Development Stage of the Product
6.5. Approved Non-hormonal Prescription Drugs
6.6. Key Commercialization Strategies Adopted by Companies Focused on Women’s Health
6.6.1. Strategies Adopted Before Therapy Approval
6.6.1.1. Participation in Global Events
6.6.1.2. Collaboration with Industry Stakeholders and Other Pharmaceutical Firms
6.6.1.3. Expansion of Target Indication
6.6.2. Strategies Adopted During / Post Therapy Approval
6.6.2.1. Geographical Expansion
6.6.2.2. Participation in Global Events
6.6.2.3. Patient Assistance Programs
6.6.2.4. Awareness Through Product Websites
6.6.2.5. Collaboration with Industry Stakeholders and Other Pharmaceutical Firms
6.6.2.6. Aligning with Government Initiatives to Ensure High Adoption Rate
6.7. Concluding Remarks

7. DRUG PROFILES (PHASE III)
7.1. Chapter Overview
7.2. Relugolix
7.3. DARE-BV1 (Clindamycin gel)
7.4. Ovaprene®
7.5. Yselty® (Linzagolix)
7.6. Fezolinetant
7.7. BAY1002670 (Vilaprisan)
7.8. Abaloparatide-TD
7.9. Terconazole (0.4%)
7.10. SCY-078 (Ibrexafungerp)
7.11. VT-1161 (Oteseconazole)
7.12. MV140 (Uromune)
7.13. Orilissa™ (Elagolix)
7.14. EVO100 (Amphora)

8. CLINICAL TRIAL ANALYSIS
8.1. Chapter Overview
8.2. Scope and Methodology
8.3. Non-hormonal Therapies: Clinical Trial Analysis
8.3.1. Analysis by Trial Registration Year
8.3.2. Analysis by Trial Status
8.3.3. Analysis by Trial Phase
8.3.4. Analysis by Trial Registration Year and Trial Status
8.3.5. Analysis by Target Patient Segment
8.3.6. Analysis by Target Indication
8.3.7. Analysis by Type of Sponsor
8.3.8. Analysis by Geography
8.3.8.1. Analysis by Geography (Pre-2017 and Post 2017)
8.4. Non-Hormonal Therapies: Analysis by Enrolled Patient Population
8.4.1. Analysis by Trial Registration Year
8.4.2. Analysis by Trial Status
8.4.3. Analysis by Trial Phase
8.4.4. Analysis by Geography
8.4.4.1. Analysis by Geography (Pre-2017 and Post 2017)
8.5. Analysis by Study Design
8.6. Concluding Remarks
8.6.1. Emerging Molecules to Watch
8.6.2. Most Important Trials to Watch

9. RECENT DEVELOPMENTS
9.1. Chapter Overview
9.2. Partnership Models
9.3. Non-hormonal Therapies: Recent Partnerships
9.3.1. Analysis by Year of Partnership
9.3.2. Analysis by Type of Partnership
9.3.3. Analysis by Target Indication
9.3.4. Most Active Players: Analysis by Number of Partnerships
9.3.5. Geographical Analysis
9.3.5.1. Intercontinental and Intracontinental Agreements
9.4. Types of Funding
9.5. Non-Hormonal Therapies: Funding and Investment Analysis
9.5.1. Analysis by Number of Funding Instances
9.5.2. Analysis by Amount Invested
9.5.3. Analysis by Type of Funding
9.5.4. Analysis by Type of Funding and Year
9.5.5. Analysis by Funding Amount and Year
9.5.6. Regional Analysis by Amount Invested
9.5.7. Most Active Players
9.6. Concluding Remarks

10. MARKET FORECAST AND OPPORTUNITY ANALYSIS
10.1. Chapter Overview
10.2. Scope and Limitations
10.3. Key Assumptions and Forecast Methodology
10.4. Global Non-hormonal Therapiesfor Women’s Health Market
10.4.1. Non-hormonal Therapies Market: Analysis by Target Indication
10.4.2. Non-hormonal Therapies Market: Analysis by Type of Molecule
10.4.3. Non-hormonal Therapies Market: Analysis by Route of Administration
10.4.4. Non-hormonal Therapies Market: Analysis by Geography
10.5. Non-hormonal Therapies for Women’s Health Market: Value Creation Analysis
10.5.1. Bacterial Vaginosis
10.5.2. Contraception
10.5.3. Endometriosis
10.5.4. Postmenopausal Osteoporosis
10.5.5. Uterine Fibroids
10.5.6. Vasomotor Symptoms
10.6. Non-hormonal Therapies for Women’s Health Market: Product Wise Sales Forecasts
10.6.1. Nuvessa™ (Metronidazole)
10.6.1.1. Target Patient Population
10.6.1.2. Sales Forecast
10.6.1.3. Net Present Value
10.6.2. VivaGel™ (SPL 7013)
10.6.2.1. Target Patient Population
10.6.2.2. Sales Forecast
10.6.2.3. Net Present Value
10.6.3. Solosec™ (Secnidazole)
10.6.3.1. Target Patient Population
10.6.3.2. Sales Forecast
10.6.3.3. Net Present Value
10.6.4. Tymlos™ (Abaloparatide)
10.6.4.1. Target Patient Population
10.6.4.2. Sales Forecast
10.6.4.3. Net Present Value
10.6.5. Orilissa™
10.6.5.1. Target Patient Population
10.6.5.2. Sales Forecast
10.6.5.3. Net Present Value
10.6.6. Osphena® (Ospemifene)
10.6.6.1. Target Patient Population
10.6.6.2. Sales Forecast
10.6.6.3. Net Present Value
10.6.7. Evenity™(Romosozumab-aqqg)
10.6.7.1. Target Patient Population
10.6.7.2. Sales Forecast
10.6.7.3. Net Present Value
10.6.8. Esmya® and Fibristal® (Ulipristal acetate)
10.6.8.1. Target Patient Population
10.6.8.2. Sales Forecast
10.6.8.3. Net Present Value
10.6.9. Phexxi™ (Amphora)
10.6.9.1. Target Patient Population
10.6.9.2. Sales Forecast
10.6.9.3. Net Present Value
10.6.10. Oriahnn™
10.6.10.1. Target Patient Population
10.6.10.2. Sales Forecast
10.6.10.3. Net Present Value
10.6.11. Relugolix
10.6.11.1. Target Patient Population
10.6.11.2. Sales Forecast
10.6.11.3. Net Present Value
10.6.12. DARE-BV1 (Clindamycin gel)
10.6.12.1. Target Patient Population
10.6.12.2. Sales Forecast
10.6.12.3. Net Present Value
10.6.13. Ovaprene®
10.6.13.1. Target Patient Population
10.6.13.2. Sales Forecast
10.6.13.3. Net Present Value
10.6.14. Yselty® (Linzagolix)
10.6.14.1. Target Patient Population
10.6.14.2. Sales Forecast
10.6.14.3. Net Present Value
10.6.15. Fezolinetant
10.6.15.1. Target Patient Population
10.6.15.2. Sales Forecast
10.6.15.3. Net Present Value
10.6.16. BAY1002670 (Vilaprisan)
10.6.16.1. Target Patient Population
10.6.16.2. Sales Forecast
10.6.16.3. Net Present Value
10.6.17. Abaloparatide-TD
10.6.17.1. Target Patient Population
10.6.17.2. Sales Forecast
10.6.17.3. Net Present Value
10.6.18. Terconazole(0.4%)
10.6.18.1. Target Patient Population
10.6.18.2. Sales Forecast
10.6.18.3. Net Present Value
10.6.19. SCY-078 (Ibrexafungerp)
10.6.19.1. Target Patient Population
10.6.19.2. Sales Forecast
10.6.19.3. Net Present Value
10.6.20. VT-1161 (Oteseconazole)
10.6.20.1. Target Patient Population
10.6.20.2. Sales Forecast
10.6.20.3. Net Present Value
10.6.21. MV140 (Uromune)
10.6.21.1. Target Patient Population
10.6.21.2. Sales Forecast
10.6.21.3. Net Present Value
10.6.22. EVO100
10.6.22.1. Target Patient Population
10.6.22.2. Sales Forecast
10.6.22.3. Net Present Value

11. CONCLUDING REMARKS

12. APPENDIX 1: TABULATED DATA

13. APPENDIX 2: LIST OF COMPANIES

Note: Product cover images may vary from those shown
  • AbbVie
  • Actavis
  • Adjuvant Capital
  • Aisling Capital
  • Allergan
  • Amgen
  • Amplity Health
  • Arcadia Securities
  • Aspire Capital Fund
  • Astellas Pharma
  • Avomeen
  • Azure Biotech
  • Bayer
  • BB Biotech
  • Boehringer Ingelheim
  • Broadfin Capital
  • Brookline Capital Markets
  • Cantor Fitzgerald
  • Ceek Women's Health
  • Celmatix
  • Chugai Pharmaceutical
  • Cidara Therapeutics
  • DAFNA Capital Management
  • Daré Bioscience
  • Duchesnay
  • Eli Lilly
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Evofem Biosciences
  • Evotec
  • Exeltis
  • Ferring Pharmaceuticals
  • First Manhattan Co.
  • Forest Laboratories
  • Fougera Pharmaceuticals
  • Gedea Biotech 
  • Gedeon Richter
  • Ghost Tree Capital
  • Great Point Partners
  • Guggenheim Securities
  • H.C. Wainwright & Co.
  • Hammock Pharmaceuticals (acquired by Element Nutritional Sciences)
  • Hansoh Pharma
  • Health Decisions
  • Hennepin Life Sciences
  • Inmunotek
  • Inovio Pharmaceuticals
  • Intralytix, the Eliava Foundation 
  • ITF Pharma
  • Jiangsu Hengrui Medicine
  • KaNDy Therapeutics (acquired by Bayer)
  • Kindeva Drug Delivery
  • Kissei Pharmaceutical
  • Korea Investment Partners (KIP)
  • Ladenburg Thalmann
  • Ligand Pharmaceuticals
  • Lupin Pharmaceuticals
  • Medtech4Health
  • Merck Sharp & Dohme
  • Milana Pharm
  • Mitsubishi Tanabe Pharma
  • Medical Research Commercialisation Fund (MRCF)
  • Mycovia Pharmaceuticals
  • Myovant Sciences
  • National Holdings
  • National Securities Corporation
  • Neurocrine Biosciences
  • New Enterprise Associates
  • New Leaf Venture Partners
  • NovaDigm Therapeutics
  • Novartis Pharmaceuticals
  • Noven Pharmaceuticals
  • ObsEva
  • Ogeda
  • Omega Funds
  • Oxford Finance
  • PDL BioPharma
  • Pfizer
  • Prosight Capital
  • Puissance Capital
  • QUE Oncology
  • Radius Health
  • Repros Therapeutics (acquired by Allergan)
  • Roche
  • Sanofi-Aventis
  • SCYNEXIS
  • Shionogi
  • Sofinnova Ventures
  • Sphera Global Healthcare Fund
  • Square 1 Bank 
  • Starpharma
  • Strategic Science & Technologies
  • Sumitomo Dainippon Pharma
  • Swelife
  • Symbiomix Therapeutics (acquired by Lupin)
  • Takeda Pharmaceutical
  • TriLogic Pharma
  • Uniseed
  • Venrock Healthcare Capital Partners
  • Vinnova Financing
  • Vinnova Grants 
  • WBB Securities
  • Woodford Investment Management
  • Xanodyne Pharmaceuticals
  • Yaso Therapeutics
Note: Product cover images may vary from those shown

 

 

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