Sex-Based Drug Development Market Trends, Competitive Analysis and Segmentations Report

The sex-based drug development market is emerging as a high-potential sector, set on a strong growth trajectory from 2024 to 2034, reports Towards Healthcare a sister firm of Precedence Research.

Ottawa, Oct. 09, 2025 (GLOBE NEWSWIRE) -- The global sex-based drug development market is rising because increasing awareness of gender-specific sexual health disorders, together with regulatory momentum, clinical innovations, and growing demand from both men and women, is driving unprecedented investment and product development in sex-based drugs.

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Key Takeaways:

North America held the largest revenue share of the market.
Asia Pacific is expected to be the fastest-growing region in 2025-2034.
By gender, the men segment dominated the sex-based drug development market in 2024.
By gender, the women segment is expected to grow at the fastest CAGR in the upcoming years.
By drug type, the estrogen therapy segment led the market in 2024.
By drug type, the flibanserin segment is expected to grow significantly during the forecast period.
By disease, the dyspareunia segment held the dominating revenue share of the market in 2024.
By disease, the HSDD segment is expected to grow at the fastest CAGR over the projected period.
By route of administration, the parenteral segment led the sex-based drug development market in 2024.
By route of administration, the topical segment is expected to grow fastest in the projected timeframe.
By distribution channel, the hospital pharmacies segment held a notable revenue share of the market in 2024.
By distribution channel, the online pharmacies segment is expected to grow at the fastest CAGR in the studied years.

Market Overview:

Sexually based drug development is also known as sex specific medicine or gender specific medicine which accepts the significant variance that exists between men's and women's responses to pollution and disease. There is an emerging global burden of diseases affecting sexual health, attending awareness and providing a greater consumer demand for personalised medicines that is significantly driving the development of the sex-based drug market.

In this way, individual cases such as a range of symptoms for men and women at risk for cardiovascular disease are accountable for sex-based clinical decisions. Additionally, the market has been to reinforcing clinical trials for both sexes and restricting sex-based subgroup analyses, which will ultimately help reduce variance in drug responses.

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Major Growth Drivers:

Public awareness and destigmatization of sexual health conditions has led to more people seeking a diagnosis in treatment, opening more markets for HSDD, dyspareunia, and other sexual health conditions. More media coverage, clinical education, and digital health access is reducing barriers.
Regulatory agencies are beginning to approve and fast-track sexual health drugs (for example, flibanserin) and expansion of indications is driving pharmaceutical companies to fund R&D for sex-based drugs.
Advances in drug formulations (more tolerable therapies, hormone vs non-hormone treatments) and route of administrations (parenteral, topical, etc.) are improving patient compliance and outcomes. Convincing more patients to ask for a sexual health treatment.
There is an expansion of providers, reimbursement for sexual health treatments is increasing, and there is an increased number of telemedicine appointments and online pharmacies which is increasing patient access to treatments, especially in emerging markets.

Key Drifts:

What are the current trends directing sex-based drug development?

Drug development for women is increasingly taking a more prioritized role within clinical trials, there has been an expansion of indications (i.e., treating HSDD in pre-menopausal and post-menopausal women).
Non-hormonal therapeutics (i.e., psychoactive agents functioning through neurological pathways) are on the rise in conjunction with hormone-based medicinal treatments, as a move towards safety diversification is initiated.
Specifically, digital health, telemedicine, and online distribution pathways are supporting more patients' access to treatment discreetly, thus, alleviating barriers of stigma in regions of cultural resistance.
Lastly, in emerging markets (Asia Pacific, Latin America), affordability, local manufacturing partnerships, and an increase in income levels are pushing new sex-based treatments into the market.

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Significant Challenge:

Regulatory and Safety Problems in Drug Approvals

For the sex-based drug development market, one of the most significant obstacles is gaining regulatory approval related to providing therapeutic medications for female sexual dysfunction. Safety concerns (i.e., potential side effects from drugs like flibanserin and/or risks in interactions with alcohol or other medications), mixed efficacy signals, and historic underrepresentation of women in clinical research all complicate development and approval. All of these factors also increase costs, delay products to market, and potentially impact clinician and patient confidence.

Regional Analysis:

The leading market share in sex-based drug development belongs to North America due to its sophisticated healthcare system, investment in research and development, and regulatory environment. The U.S. has numerous FDA approvals, along with established reimbursement systems, high prevalence and patient diagnosis of sexual health disorders, and a consumer market that is informed and willing to seek treatment. Distribution channels via hospitals and pharmacies are well known and established, and digital health adoption is strong. Biopharma, academia, and public health partnership supports this status.

Asia Pacific is the area projected for the most growth due to expanding middle-class populations, higher disposable incomes, more accessible healthcare, and more willingness to have conversations around sexual health. Countries such as China, India, Japan, and South Korea are experiencing growth around awareness campaigns, local manufacturing, and foreign investment. Telemedicine and online pharmacy channels provide increased access, particularly in rural areas or where community or cultural beliefs are lessening. Many APAC countries are creating regulatory frameworks to ease the process of bringing new drugs to market.

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Segmental Insights:

By Gender:

The largest share of the market is held by the men’s segment due to it historically having more treatment choices, increased awareness, coverage by health insurance, and regulatory approvals for male sexual dysfunctions (like impotence), compared to female sexual dysfunctions. The use of established drugs (e.g. PDE-5 inhibitors) will continue to drive strong revenue for male patients while the cultural barriers for male patients seeking medical interventions are less than those for female patients.

The women’s segment is currently the smallest share of the total market, but it is expected to have the highest CAGR in the next 5 years. This growth is based on the expansion of indications for medications (such as flibanserin for post-menopausal HSDD), hormone therapies, increased investment in R&D, and the growing societal acceptance that treatment is warranted for conditions that have previously been dismissed or stigmatized in women.

By Type of Drug:

Estrogen therapies are expected to dominate by type of drug, particularly in regard to conditions such as dyspareunia and vaginal atrophy associated with menopause. Estrogen is an option for these conditions with a favorable benefit-to-risk profile because they directly address the decline in hormones and the topical and parenteral formulation provides relief with less systemic adverse effects.

Flibanserin, marketed as Addyi, is also expected to experience significant growth. Given expansion of indications (potentially to post-menopausal women), along with increasing clinical studies supporting its benefit for HSDD, we believe flibanserin will see growth. Its regulatory momentum and increased awareness by both patients and providers will enhance the growth of flibanserin.

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By Disease:

Dyspareunia (painful intercourse) accounted for the largest share of revenue, primarily due to its high prevalence, especially in post-menopausal women, and continued demand for efficacious treatments. Factors fueling its leading position include increasing diagnosis rates, additional drug approvals for vaginal agents, selective estrogen receptor modulator therapies, and increased awareness.

Hypoactive sexual desire disorder is projected to grow the fastest among the disease states due to increased regulatory approvals, improvement of therapeutic alternatives, increased clinical trials, and growing conversion rates of patients who present symptoms or seek treatment. The neurologic component of HSDD, the increasing acceptance of non-hormonal treatments, and enhanced educational outreach would drive this growth as well.

By route of administration:

The parenteral administration (injections, implants) accounted for the largest share of the market share due to consistent delivery of drug levels, bypassing metabolic degradation, and longer duration modalities for hormonal therapies. This route is preferred in clinical settings and hospital pharmacies, for example, for estrogen therapies and other systemic agents.

The topical route (e.g. creams, gels, patches, vaginal inserts) is expected to grow the fastest, especially for female sexual health treatments for dyspareunia and vaginal atrophy, since the topical charges are locally/locally delivered and have fewer systemic side effects which increases comfort and patient adherence.

By distribution channel:

Hospital pharmacies where a significant factor in 2024 as most sexual health medications either require a prescription or prescription monitoring, and hospitals are reliable sources for both physicians prescribed therapies and subsequent patient visits. The use of specialists (urologists, gynaecologists) tends to push distribution towards in-hospital pharmacies.

The fastest-growing distribution channels will be online pharmacies, telehealth platforms, and direct-to-consumer digital models, primarily because these channels are more affordable, private (especially for stigmatized indications), increase access in rural areas, and the younger population continues to prefer digital channels. Some support for this trend continues to be the easing of regulations and acceptance of validated online prescribing.

Browse More Insights of Towards Healthcare:

The global sexually transmitted infections (STI) market is valued at US$ 69.67 billion in 2024, growing to US$ 78.09 billion in 2025, and is projected to reach approximately US$ 214.36 billion by 2034, reflecting a CAGR of 12.08% between 2025 and 2034.

The global women’s health app market is estimated at US$ 4.89 billion in 2024, expanding to US$ 5.76 billion in 2025, with projections indicating it could reach around US$ 25.18 billion by 2034, at a robust CAGR of 17.81% over the forecast period.

The global progesterone market stands at US$ 1.52 billion in 2024, expected to grow to US$ 1.72 billion in 2025, and projected to reach roughly US$ 5.05 billion by 2034, achieving a CAGR of 12.74% between 2025 and 2034.

The global women’s digital health market is valued at US$ 3.17 billion in 2024, increasing to US$ 3.82 billion in 2025, and is expected to reach US$ 20.92 billion by 2034, growing at a CAGR of 20.54% during the forecast period.

Regionally, Europe’s women’s digital health market is estimated at US$ 1.03 billion in 2024, projected to grow to US$ 1.24 billion in 2025, and expected to reach US$ 6.69 billion by 2034, reflecting a CAGR of 20.24%.

The Asia-Pacific women’s digital health the market is valued at US$ 724.17 million in 2024, rising to US$ 889.14 million in 2025, and forecast to reach US$ 5.69 billion by 2034, expanding at a CAGR of 22.74%.

The global natural fertility supplements market is estimated at US$ 2.32 billion in 2024, growing to US$ 2.54 billion in 2025, and is projected to reach US$ 6.54 billion by 2034, achieving a CAGR of 9.44%.

The global fertility market is valued at US$ 36.57 billion in 2024, expanding to US$ 39.88 billion in 2025, and expected to reach US$ 87.05 billion by 2034, reflecting a CAGR of 9.06%.

Finally, the global infertility treatment market is estimated at US$ 1.70 billion in 2024 and is projected to reach US$ 3.65 billion by 2034, growing at a CAGR of 7.9% from 2024 to 2034.

Recent Developments:

On July 24, 2025, FDA grants priority review to expanded indication of Addyi for treating HSDD in postmenopausal women. Sprout Pharmaceuticals’ supplemental application is under priority review, which could enable Addyi to serve a substantial unmet population of women beyond reproductive age.
On May 18, 2025, Boehringer Ingelheim presents new Phase III pooled data for flibanserin in pre-menopausal women with HSDD. The DAISY and VIOLET trials showed increased satisfying sexual events, improved desire, and reduced distress versus placebo; side effects were generally mild to moderate.

Key Players List:

Pfizer
Reckitt Benckiser Group PLC
Roche
Novartis
Karex Berhad
Tenga
Doc Johnson Enterprises
Eli Lilly
Mankind Pharma

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Segments Covered in the Report

By Gender

Men
Women

By Drug Type

Flibanserin
Bremelanotide
Ospemifene
Estrogen Therapy
Others

By Disease

Hypoactive Sexual Desire Disorder (HSDD)
Dyspareunia
Others

By Route of Administration

Oral
Parenteral
Topical

By Distribution Channel

Hospital Pharmacies
Drug Stores & Retail Pharmacies
Online Pharmacies

By Region

North America
- U.S.
- Canada
Asia Pacific
- China
- Japan
- India
- South Korea
- Thailand
Europe
- Germany
- UK
- France
- Italy
- Spain
- Sweden
- Denmark
- Norway
Latin America
- Brazil
- Mexico
- Argentina
Middle East and Africa (MEA)
- South Africa
- UAE
- Saudi Arabia
- Kuwait

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Towards Healthcare is a leading global provider of technological solutions, clinical research services, and advanced analytics, with a strong emphasis on life science research. Dedicated to advancing innovation in the life sciences sector, we build strategic partnerships that generate actionable insights and transformative breakthroughs. As a global strategy consulting firm, we empower life science leaders to gain a competitive edge, drive research excellence, and accelerate sustainable growth.

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