성욕 저하 장애(HSDD) : 시장 인사이트, 역학, 시장 예측(2034년)

Key Highlights:

• Hypoactive sexual desire disorder (HSDD) is defined in the DSM-IV-TR as a persistent or recurrent absence of sexual fantasies and desire for sexual activity.
• HSDD treatment involves a multifaceted approach, including sex therapy, psychotherapy, pharmacological interventions, and hormonal therapies. Management strategies for women often include lifestyle modifications, addressing underlying medical or psychiatric conditions, adjusting medications that may affect sexual desire, hormone replacement therapy, and marital or relationship counseling.
• The US Food and Drug Administration (FDA) has approved ADDYI (flibanserin) in 2015 and VYLEESI (bremelanotide) in 2019 for the treatment of acquired, generalized hypoactive sexual desire premenopausal women.
• ADDYI and VYLEESI effectiveness is limited and varies by individual. ADDYI is taken daily and may take several weeks to produce noticeable improvements, while VYLEESI is an on-demand injectable used shortly about 45 minutes before sexual activity. Despite offering different approaches, both medications are only effective in approximately 50-60% of patients, highlighting the ongoing need for more reliable and broadly effective options.
• Freya Pharma Solutions is developing Lybrido, an innovative, on-demand therapy in late-stage trials for FSIAD/HSDD. With seventeen years of research, the Amsterdam-based company targets a major unmet need with a personalized treatment approach
• Some psychological conditions may be associated with the development of HSDD, including depression, anxiety and low self-esteem.
• The HSDD pipeline is severely underdeveloped, reflecting a major unmet need and lack of innovation. Freya Pharma Solutions leads the emerging space, aiming to address both hormonal and psychological drivers of HSDD.
• Successful launch of Lybrido could revitalize the HSDD market, opening opportunities for broader awareness, improved access, and expanded indications.

DelveInsight's "Hypoactive Sexual Desire Disorder (HSDD) - Market Insight, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of HSDD, historical and forecasted epidemiology as well as the HSDD market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The HSDD market report provides current treatment practices, emerging drugs, HSDD share of individual therapies, and current and forecasted HSDD market size from 2020 to 2034, segmented by seven major markets. The report also covers current HSDD treatment practices/algorithms and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.

Geography Covered:

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2020-2034

Hypoactive Sexual Desire Disorder (HSDD) Disease Understanding and Treatment Algorithm

Hypoactive Sexual Desire Disorder (HSDD) Overview

Hypoactive sexual desire disorder is defined in the DSM-IV-TR as a persistent or recurrent absence of sexual fantasies and desire for sexual activity, which causes marked personal distress or interpersonal difficulties. Women can benefit from behavioral and pharmacological interventions. The first barrier to providing this benefit is detection and diagnosis of the disorder. However, the private and personal nature of sexual activity and the potential for feelings of shame, inadequacy, and embarrassment create unique challenges to effective communication about sexual health for both patient and physician. These barriers, combined with lack of awareness of the prevalence and opportunity to treat HSDD on the part of both patient and clinician, are among those responsible for current underdetection and undertreatment. Symptoms of HSDD include decreased spontaneous sexual thoughts or fantasies, decreased responsiveness to stimulation, inability to maintain interest through sex, and loss of desire to initiate sex. Women with HSDD may also avoid situations that could lead to sexual activity.

Hypoactive Sexual Desire Disorder (HSDD) Diagnosis

Hypoactive Sexual Desire Disorder is diagnosed based on a persistent or recurrent lack of sexual desire or thoughts that causes significant distress to the individual and lasts for at least six months. The diagnosis requires ruling out other causes such as medical conditions, medication side effects, psychiatric disorders, or relationship issues. In women, HSDD is now classified under Female Sexual Interest/Arousal Disorder (FSIAD) in the DSM-5, though the term HSDD is still widely used, especially in clinical trials. A detailed sexual and psychosocial history is essential, often supported by validated screening tools such as the Decreased Sexual Desire Screener (DSDS) or the Female Sexual Function Index (FSFI). Clinicians must also assess hormonal status, mental health, and interpersonal factors to determine whether the condition is lifelong or acquired, generalized or situational. Proper diagnosis involves distinguishing HSDD from normal fluctuations in desire and from desire changes secondary to other disorders, ensuring the condition is not better explained by other factors.

Hypoactive Sexual Desire Disorder (HSDD) Treatment

The treatment of Hypoactive Sexual Desire Disorder involves a personalized, multidisciplinary approach that addresses biological, psychological, and relational factors. First-line treatment often includes psychosexual therapy or counseling, particularly when relationship issues, past trauma, or psychological conditions like depression or anxiety contribute to the disorder. Cognitive-behavioral therapy (CBT) and mindfulness-based interventions have also shown benefit in improving sexual desire and reducing distress. Hormonal therapies, such as testosterone supplementation, may be considered off-label in postmenopausal women, though long-term safety and efficacy data are still being evaluated. Treatment plans often combine behavioral strategies, education, and pharmacologic options when appropriate. Lifestyle modifications, such as stress management, regular exercise, and improved sleep, can also support overall sexual health. The choice of therapy depends on individual needs, the underlying cause of HSDD, and whether the patient is pre- or postmenopausal. Regular follow-up is essential to monitor progress and adjust treatment accordingly.

Hypoactive Sexual Desire Disorder (HSDD) Epidemiology

The HSDD epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by the total prevalent cases of HSDD, gender-specific cases of HSDD, age-specific cases of HSDD, and total treated cases of HSDD in the 7MM market covering the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.

• Among the 7MM, the United States has captured the highest patient share of HSDD in 2024.
• HSDD is a common condition across adult age groups, peaking in 45-64 age group, likely due to hormonal changes, menopause-related symptoms, and psychosocial factors.
• HSDD affects approximately 10% of all pre-menopausal women in the United States, or about 6 million women.
• As per the analysis, females are affected more with Hypoactive Sexual Desire Disorder as compared to males.

Hypoactive Sexual Desire Disorder (HSDD) Drug Chapters

The drug chapter segment of the HSDD report encloses a detailed analysis HSDD marketed and emerging pipeline drugs. It also deep dives into HSDD's pivotal clinical trial details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations.

Currently, ADDYI (Sprout Pharmaceuticals) and VYLEESI (Cosette Pharmaceuticals) are the only two FDA-approved medications for treating HSDD. key company for their respective drug candidate include Freya Pharma Solutions (Lybrido), among others. The drug chapter also helps understand the HSDD clinical trial details, expressive pharmacological action, agreements and collaborations, approval, and patent details, and the latest news and press releases.

Marketed Drugs

ADDYI (flibanserin): Sprout Pharmaceuticals

ADDYI is a non-hormonal pill for acquired, generalized HSDD for premenopausal women. Flibanserin selectively targets central serotonin postsynaptic receptors, exhibiting both agonistic and antagonistic effects on 5-HT1A and 5-HT2A, respectively.

The US Food and Drug Administration (FDA) has warned Sprout Pharmaceuticals for the second time concerning its promotion of its HSDD drug ADDYI. The agency also sent a warning letter to a company for conducting a clinical investigation without submitting an investigational new drug application (IND).

VYLEESI (bremelanotide injection): Cosette Pharmaceuticals

VYLEESI is a melanocortin receptor agonist indicated for the treatment of premenopausal women with acquired, generalized HSDD as characterized by low sexual desire that causes marked distress or interpersonal difficulty.

In January 2024, Cosette Pharmaceuticals has completed the acquisition of VYLEESI from Palatin Technologies, which includes 5 Orange Book listed patents with protection up to 2041. Palatin and Cosette will ensure continued patient and healthcare professional access to VYLEESI throughout the transition period.

Emerging Drugs

Lybrido: Freya Pharma Solutions

Lybrido focuses on treatment for patients with HSDD, in which low sexual desire results from a central nervous system that is relatively insensitive to sexual cues. In these individuals, exposure to sexual stimuli (internal or external) fails to trigger activation of the brain's sexual excitatory mechanisms. Lybrido contains sildenafil (a phosphodiesterase type 5 inhibitor) with a time-release coating and an outer testosterone shell. A Phase III trial for Lybrido is currently in preparation.

• In February 2024, Freya Pharma's innovation Lybrido, a dual release combination tablet containing testosterone for sublingual administration, and sildenafil for oral administration, was presented as a very promising future treatment for women diagnosed with Female Sexual Interest/Arousal Disorder (FSIAD) or HSDD.
• In June 2023, Freya Pharma Solutions announced that the US FDA has responded with interest and provided valuable input regarding Freya Pharma's request for advice on the US Clinical Development Program of Lybrido for the treatment of FSIAD or HSDD.

Drug Class Insight

Melanocortin receptor agonist

Melanocortin receptor agonists are a class of drugs that activate melanocortin receptors, particularly the melanocortin-4 receptor (MC4R), which plays a key role in regulating sexual desire through central nervous system pathways. These agents stimulate MC4R in the hypothalamus, enhancing dopaminergic signaling and promoting sexual motivation and arousal. Unlike hormonal treatments, melanocortin agonists act directly on neural circuits involved in sexual behavior, offering a non-hormonal therapeutic approach. The most notable example is bremelanotide (Vyleesi), the first FDA-approved melanocortin receptor agonist for the treatment of acquired, generalized HSDD in premenopausal women. Melanocortin receptor agonists offer a unique, on-demand option for women seeking non-daily, non-hormonal treatment for HSDD, especially those for whom traditional hormone-based therapies are unsuitable.

Serotonin receptor

Serotonin-containing cell bodies are found in the raphe nucleus in the brainstem and in nerve endings distributed diffusely throughout the brain (Julius, 1991). Serotonin has been implicated in sleep, modulation of circadian rhythms, eating, and arousal. Serotonin also has hormone-like effects when released in the bloodstream, regulating smooth muscle contraction and affecting the platelet aggregating and immune systems.

Serotonin receptors are classified into four subtypes: 5-HT1 to 5-HT4, with a further subdivision of the 5-HT1 subtypes. Recall that the 5-HT3 receptor is ionotropic. The other 5-HT receptors exhibit the typical seven transmembrane-spanning segments, and all couple to G proteins to exert their effects. For example, 5-HT1a, 5-HT1b, 5HT1d, and 5HT4 either activate or inhibit adenylyl cyclase. 5-HT1c and 5-HT2 receptors preferentially stimulate activation of phospholipase C to produce increased intracellular levels of diacylglycerol and inositol 1,4,5-trisphosphate.

Hypoactive Sexual Desire Disorder (HSDD) Market Outlook

The therapeutic landscape for HSDD still relies chiefly on behavioral interventions and a pair of centrally acting agents-flibanserin (a daily 5-HT1A agonist/5-HT2A antagonist) and bremelanotide (melanocortin-4 receptor agonist)-both approved only for pre-menopausal women. Although these drugs can improve desire, their modest efficacy, required lifestyle adjustments (night-time dosing for flibanserin; injections for bremelanotide) and notable adverse-effect profiles mean that many patients discontinue or never start pharmacologic therapy. Hormonal approaches (e.g., off-label transdermal testosterone or intranasal oxytocin) offer alternatives for post-menopausal women, yet long-term safety and regulatory acceptance remain unsettled, underscoring the need for newer, more durable solutions.

Encouragingly, pipeline activity is shifting toward multimodal, precision treatments that address both neurochemical imbalance and inhibitory pathways underlying low desire. Late-stage candidates include Lybrido. Three Phase II studies (two for Lybridos and one for Lybrido) have been conducted by company at 16 research sites in the United States. The efficacy and safety of various doses of testosterone, sildenafil, buspirone and combination therapies (testosterone + sildenafil, testosterone + buspirone) were tested in 497 women with HSDD to determine the change in satisfying sexual events (SSEs) over a period of eight weeks.

Despite the advances, only two medications have regulatory approval, and none yet address post-menopausal or male HSDD comprehensively. As awareness for HSDD is growing and as its psychological and relational impact becomes clearer, continued investment in mechanistically targeted trials is essential to deliver safer, more effective, and more inclusive treatments for the millions of individuals affected by HSDD.

Hypoactive Sexual Desire Disorder (HSDD) Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2025-2034. The landscape of HSDD treatment has experienced a profound transformation with the uptake of novel medicines. These innovative therapies are redefining standards of care.

Hypoactive Sexual Desire Disorder (HSDD) Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, and Phase II stage. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers detailed information on collaborations, acquisitions and mergers, licensing, and patent details for HSDD emerging therapies.

KOL- Views

To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Some of the leaders like MD, Professor and Vice Chair of the Department of Rheumatology and Director, PhD, and others. Their opinion helps to understand and validate current and emerging therapies and treatment patterns or HSDD market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Delveinsight's analysts connected with 15+ KOLs to gather insights; however, interviews were conducted with 5+ KOLs in the 7MM. Centers such as the Washington University School of Medicine, University Medical Center Hamburg-Eppendorf, and University Graduate School of Medicine etc. were contacted. Their opinion helps understand and validate HSDD epidemiology and market trends.

Qualitative Analysis

We perform qualitative and market intelligence analysis using various approaches, such as SWOT and conjoint analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, designation, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

The analyst analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry.

In efficacy, the trial's primary and secondary outcome measures are evaluated.

Further, the therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials.

Market Access and Reimbursement

Reimbursement may be referred to as the negotiation of a price between a manufacturer and a payer that allows the manufacturer access to the market. It is provided to reduce the high costs and make the essential drugs affordable. Health technology assessment (HTA) plays an important role in reimbursement decision-making and recommending the use of a drug. These recommendations vary widely throughout the seven major markets, even for the same drug. In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs, including Medicare, Medicaid, Health Insurance Program (CHIP), and the state and federal health insurance marketplaces, are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs) and third-party organizations that provide services and educational programs to aid patients are also present.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of currently used therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report:

• The report covers a descriptive overview of HSDD, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into HSDD epidemiology and treatment.
• Additionally, an all-inclusive account of both the current and emerging therapies for HSDD is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of the HSDD market; historical and forecasted is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM HSDD market.

Hypoactive Sexual Desire Disorder (HSDD) Report Insights

Hypoactive Sexual Desire Disorder (HSDD) Report Insights

• Patient Population
• Therapeutic Approaches
• HSDD Pipeline Analysis
• HSDD Market Size and Trends
• Market Opportunities
• Impact of Upcoming Therapies

Hypoactive Sexual Desire Disorder (HSDD) Report Key Strengths

• Ten Years Forecast
• 7MM Coverage
• HSDD Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake

Hypoactive Sexual Desire Disorder (HSDD) Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs:

• What was the HSDD market share (%) distribution in 2020 and what it would look like in 2034?
• What would be the HSDD total market size as well as market size by therapies across the 7MM during the study period (2020-2034)?
• What are the key findings about the market across the 7MM and which country will have the largest HSDD market size during the study period (2020-2034)?
• At what CAGR, the HSDD market is expected to grow at the 7MM level during the study period (2020-2034)?
• What would be the HSDD market growth till 2034?
• What are the disease risks, burdens, and unmet needs of HSDD?
• What is the historical HSDD patient pool in the United States, EU4 (Germany, France, Italy, and Spain), and the UK, and Japan?
• What will be the growth opportunities across the 7MM concerning the patient population of HSDD?
• Amon the 7MM which country would have the most prevalent cases of HSDD?
• At what CAGR the population is expected to grow across the 7MM during the study period (2020-2034)?
• How many companies are developing therapies for the treatment of HSDD?
• How many emerging therapies are in the mid-stage and late stage of development for the treatment of HSDD?
• What are the key collaborations (industry-industry, industry-academia), Mergers and acquisitions, and licensing activities related to HSDD therapies?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• What are the key designations that have been granted for the emerging therapies for HSDD?
• What are the 7MM historical and forecasted market of HSDD?

Reasons to buy:

• The report will help in developing business strategies by understanding trends shaping and driving the HSDD market.
• To understand the future market competition in the HSDD market and insightful review of the SWOT analysis of HSDD.
• Organize sales and marketing efforts by identifying the best opportunities for HSDD in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Organize sales and marketing efforts by identifying the best opportunities for the HSDD market.
• To understand the future market competition in the HSDD.

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary of Hypoactive Sexual Desire Disorder (HSDD)

4. Key Events

5. HSDD Epidemiology and Market Forecast Methodology

6. HSDD Market Overview at a Glance

• 6.1. Market Share (%) Distribution of HSDD by Therapies in 2024
• 6.2. Market Share (%) Distribution of HSDD by Therapies in 2034

7. Disease Background and Overview: Hypoactive Sexual Desire Disorder (HSDD)

• 7.1. Introduction
• 7.2. Signs and Symptoms
• 7.3. Causes
• 7.4. Diagnosis

8. Treatment and Management

• 8.1. Treatment Guidelines and Recommendations

9. Epidemiology and Patient Population of HSDD in the 7MM

• 9.1. Key Findings
• 9.2. Assumptions and Rationale
• 9.3. Total Prevalent Cases of HSDD in the 7MM
• 9.4. The United States
  • 9.4.1. Total Prevalent Cases of HSDD in the United States [2020-2034]
  • 9.4.2. Gender-specific Cases of HSDD in the United States [2020-2034]
  • 9.4.3. Age-specific Cases of HSDD in the United States [2020-2034]
  • 9.4.4. Total Treated Cases of HSDD in the United States [2020-2034]
• 9.5. EU4 and the UK
  • 9.5.1. Total Prevalent Cases of HSDD in EU4 and the UK [2020-2034]
  • 9.5.2. Gender-specific Cases of HSDD in EU4 and the UK [2020-2034]
  • 9.5.3. Age-specific Cases of HSDD in EU4 and the UK [2020-2034]
  • 9.5.4. Total Treated Cases of HSDD in EU4 and the UK [2020-2034]
• 9.6. Japan
  • 9.6.1. Total Prevalent Cases of HSDD in Japan [2020-2034]
  • 9.6.2. Gender-specific Cases of HSDD in Japan [2020-2034]
  • 9.6.3. Age-specific Cases of HSDD in Japan [2020-2034]
  • 9.6.4. Total Treated Cases of HSDD in Japan [2020-2034]

10. Patient Journey

11. Marketed Therapies

• 11.1. Key Competitors
• 11.2. ADDYI (Flibanserin): Sprout Pharmaceuticals
  • 11.2.1. Product Description
  • 11.2.2. Regulatory milestones
  • 11.2.3. Other Developmental Activity
  • 11.2.4. Clinical Developmental Activities
  • 11.2.5. Safety and efficacy

12. Emerging Therapies

• 12.1. Key Competitors
• 12.2. Lybrido: Freya Pharma Solutions
  • 12.2.1. Product Description
  • 12.2.2. Regulatory milestones
  • 12.2.3. Other Developmental Activity
  • 12.2.4. Clinical Developmental Activities
  • 12.2.5. Safety and efficacy

13. Hypoactive Sexual Desire Disorder (HSDD): Seven Major Market Analysis

• 13.1. Key Findings
• 13.2. Key Market Forecast Assumptions
  • 13.2.1. Cost Assumptions and Rebate
  • 13.2.2. Pricing Trends
  • 13.2.3. Analogue Assessment
  • 13.2.4. Launch Year and Therapy Uptake
• 13.3. Market Outlook
• 13.4. Total Market Size of HSDD in the 7MM
• 13.5. United States Market Size
  • 13.5.1. Total Market Size of HSDD in the United States
  • 13.5.2. Market Size of HSDD by Therapies in the United States
• 13.6. EU4 and the UK Market Size
  • 13.6.1. Total Market Size of HSDD in EU4 and the UK
  • 13.6.2. Market size of HSDD by Therapies in EU4 and the UK
• 13.7. Japan Market Size
  • 13.7.1. Total Market Size of HSDD in Japan
  • 13.7.2. Market Size of HSDD by Therapies in Japan

14. Unmet Needs

15. SWOT Analysis

16. KOL Views

17. Market Access and Reimbursement

18. Appendix

• 18.1. Bibliography
• 18.2. Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight