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

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?