Hot Flashes - Market Insight, Epidemiology, and Market Forecast - 2034

Key Highlights:

• Hot flashes are sudden episodes of intense warmth, flushing, and sweating, most often linked to menopause. They can disrupt sleep, daily activities, and overall quality of life. Frequent or severe episodes may also contribute to mood changes and long-term health concerns.
• Our secondary research indicates that in the US, approximately 1.3 million women enter menopause each year, of which around 80% experience hot flashes, underscoring the widespread impact of vasomotor symptoms during this transition.
• In EU4 and the UK, more than 50% of postmenopausal women experience vasomotor symptoms, with roughly one-third reporting them as mild and about two-thirds experiencing moderate to severe symptoms, each linked to reduced health utility, higher healthcare use, and greater work and activity impairment.
• VEOZAH (fezolinetant), developed by Astellas Pharma, is the first and only non-hormonal treatment approved by the US Food and Drug Administration (FDA) for the management of hot flashes in menopausal women, marking a significant advancement in non-hormonal therapy options, while other non-hormonal drugs are approved for hot flashes in regions outside the US but not approved by the FDA.
• There are also emerging non-hormonal drugs in the pipeline, including asimadoline (TP0052) by Tioga Pharmaceuticals, NOE-115 by Noema Pharma, and DONESTA by Gedeon Richter, which highlight a growing shift toward innovative therapies that could significantly broaden and reshape the treatment landscape for hot flashes beyond existing options.

DelveInsight's comprehensive report titled "Hot Flashes - Market Insights, Epidemiology, and Market Forecast - 2034" offers a detailed analysis of hot flashes. The report presents historical and projected epidemiological data covering total incident cases of menopause, total diagnosed prevalent cases of hot flashes, severity-specific diagnosed prevalent cases of hot flashes and treated cases of hot flashes. In addition to epidemiology, the market report encompasses various aspects related to the patient population. These aspects include the diagnosis process, prescription patterns, physician perspectives, market accessibility, treatment options, and prospective developments in the market across seven major markets: the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan, spanning from 2020 to 2034.

The report analyzes the existing treatment practices and unmet medical requirements in hot flashes. It evaluates the market potential and identifies potential business prospects for enhancing therapies or interventions. This valuable information enables stakeholders to make well-informed decisions regarding product development and strategic planning for the market.

Hot Flashes Overview

Hot flashes are sudden, intense sensations of heat, often accompanied by flushing, sweating, and sometimes chills, that result from hormonal changes affecting the body's temperature regulation. They are most commonly linked to the menopause transition but can also occur due to medical treatments, hormonal disorders, or other underlying conditions. Severity can vary, ranging from mild discomfort to significant disruption of sleep, daily activities, and work performance. Hot flashes typically begin in midlife for women, coinciding with declining estrogen levels, but can occur earlier in cases of premature menopause or certain medical interventions. While the exact mechanisms are not fully understood, changes in hypothalamic thermoregulation play a key role. Early-onset or unusually severe cases may warrant evaluation for alternative or secondary causes.

Hot Flashes Diagnosis and Treatment Overview

Hot Flashes are diagnosed primarily through clinical evaluation, supported by a thorough patient history and familiarity with menopausal or hormone-related symptoms. There are no definitive laboratory or imaging tests to confirm the diagnosis; however, hormone level assessments may help identify underlying causes such as menopause, premature ovarian insufficiency, or low testosterone in men. Additional testing is guided by the patient's age, medical history, and associated symptoms to rule out secondary conditions like thyroid disease or certain tumors.

Treatment for hot flashes varies widely between individuals, with no single approach universally effective. Most therapies focus on reducing episode frequency and severity, improving sleep, and enhancing quality of life. The optimal regimen often requires collaboration between patient and clinician, considering symptom burden, health status, and treatment preferences. Core options include hormonal therapy, non-hormonal medications such as SSRIs/SNRIs, gabapentin, or the neurokinin-3 receptor (NK-3) antagonist fezolinetant, as well as lifestyle modifications. These may be used alone or in combination. Supportive measures, such as cooling strategies, stress reduction techniques, and cognitive-behavioral therapy, can further help patients manage symptoms and maintain daily function.

Hot Flashes Epidemiology

The epidemiology section of the hot flashes market report offers information on the patient populations, including historical and projected trends for each of the seven major markets. Examining key opinion leader views from physicians or clinical experts can assist in identifying the reasons behind historical and projected trends. The diagnosed patient pool, their trends, and the underlying assumptions are all included in this section of the report.

This section also presents the total prevalence rate of hot flashes in menopause, supported by relevant tables and graphs to provide a clear and concise understanding of the data. Additionally, the report discloses the assumptions made during the analysis, ensuring data interpretation and presentation transparency. This epidemiological data is valuable for understanding the disease burden and its impact on the patient population across various regions.

Key Findings

• In the US, among women who experience hot flashes, approximately one-third report them as mild, while about two-thirds experience moderate to severe symptoms, indicating a significant burden that can affect daily functioning and quality of life.
• In Germany, an estimated 1.6 million women transition into menopause each year, and 72% experience hot flashes, highlighting a substantial health and quality-of-life burden that underscores the need for greater awareness, supportive workplace policies, and expanded treatment options for vasomotor symptoms.
• In Italy, the prevalence rate of hot flashes in menopause is 52%, meaning more than half of women face hot flashes, highlighting a substantial public health concern and the need for broader access to effective management strategies.
• In Japan, the prevalence rate of hot flashes in menopause is 16%, meaning fewer than one in five women experience these symptoms, highlighting the lowest rate among the 7MM and offering unique insights into potential cultural, lifestyle, or biological factors influencing symptom occurrence.

Hot Flashes Market Outlook

The hot flashes therapeutics market is further expected to increase by the major drivers, such as the rising prevalent population, technological advancements, and upcoming therapies in the forecast period (2025-2034).

Hot flashes are managed primarily through hormonal therapy, which helps regulate the hormonal fluctuations driving symptoms. The most widely used treatments include estrogen therapy, often combined with progestin in women with a uterus, and the newly FDA-approved VEOZAH (fezolinetant), the first non-hormonal, NK-3 receptor antagonist for hot flashes. VEOZAH offers targeted relief by modulating hypothalamic thermoregulation, significantly reducing frequency and severity in clinical trials, with a favorable safety profile. Additional options include non-hormonal medications such as Selective Serotonin Reuptake Inhibitors (SSRIs)/ Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs), gabapentin, and clonidine, as well as lifestyle modifications and cognitive-behavioral therapy. VEOZAH represents a major advancement, expanding treatment options beyond hormones and addressing the needs of women who cannot or choose not to use hormonal therapy.

With ongoing research and continued dedication, the future holds promise for even more effective treatments and, ultimately, a potential cure for this challenging condition. According to DelveInsight, the hot flashes market in the 7MM is expected to change significantly during the forecast period (2025-2034).

Hot Flashes Drug Chapters

Marketed Drugs

VEOZAH (fezolinetant): Astellas Pharma

VEOZAH, developed by Astellas Pharma and generically known as fezolinetant, is the first and only FDA-approved non-hormonal oral therapy for managing hot flashes in menopausal women. By targeting neurokinin-3 receptors in the brain, it addresses the underlying thermoregulatory dysfunction caused by hormonal changes, rather than simply masking symptoms.

• In May 2023, the US FDA approved VEOZAH (fezolinetant) for the treatment of moderate to severe vasomotor symptoms due to menopause, marking it as the first non-hormonal neurokinin-3 (NK3) receptor antagonist approved for this indication.
• In December 2023, the European Medicines Agency (EMA) approved VEOZAH (fezolinetant) for the treatment of moderate to severe vasomotor symptoms due to menopause.

LYNKUET (elinzanetant): Bayer

LYNKUET, generically known as elinzanetant, is an innovative, first-in-class, non-hormonal oral therapy in development for managing hot flashes in menopausal women. By dual-blocking neurokinin-1 and neurokinin-3 receptors in the brain, it directly targets the central thermoregulatory disruptions triggered by hormonal changes. This mechanism offers the potential to treat the underlying cause of symptoms, positioning LYNKUET as a promising next-generation option beyond conventional symptom relief.

• In July 2025, Bayer reported that the UK's Medicines and Healthcare products Regulatory Agency (MHRA) authorized LYNKUET (elinzanetant) for the treatment of moderate to severe vasomotor symptoms, also known as hot flashes, associated with menopause. This marks the first approval of a dual neurokinin-targeted therapy, blocking both NK-1 and NK-3 receptors, for this indication in the UK.

Emerging Drugs

DONESTA (estetrol): Estetra/ Gedeon Richter

DONESTA, developed by Gedeon Richter, is an investigational therapy for the treatment of hot flashes and other menopause-related symptoms. It is an estetrol-containing, non-hormonal selective estrogen receptor modulator (SERM)-like product designed to target the underlying mechanisms of thermoregulatory dysfunction in menopause, with the aim of providing a safer and more targeted alternative to conventional hormone-based therapies.

In February 2025, the European Medicines Agency (EMA) accepted Gedeon Richter's Marketing Authorization Application (MAA) for DONESTA (estetrol-containing mono product) for the management of menopausal symptoms, marking the start of the formal regulatory evaluation process in the European Union.

Asimadoline (TP0052): Tioga Pharmaceuticals

Asimadoline (TP0052), developed by Tioga Pharmaceuticals, is an oral, non-hormonal investigational therapy being explored for the treatment of vasomotor symptoms such as hot flashes in post-menopausal women. It acts as a selective κ-opioid receptor agonist, targeting neurochemical pathways involved in thermoregulation, with the goal of addressing the underlying mechanisms driving symptom generation rather than merely reducing their external manifestations.

• Asimadoline (TP0052) currently in Phase II for the treatment of vasomotor symptoms associated with menopause, including hot flashes. However, since the trial's commencement, no further updates have been publicly reported.

NOE-115: Noema Pharma

NOE-115, developed by Noema Pharma, is an innovative, oral, non-hormonal investigational therapy designed to treat vasomotor symptoms, including hot flashes and night sweats, in postmenopausal women. As a broad-spectrum monoamine modulator, it targets multiple neurotransmitter pathways to potentially address the root neurochemical drivers of thermoregulatory disruption, offering symptom relief as well as improvements in weight control, energy levels, and cognitive function.

• In May 2024, Noema Pharma reported dosing of the first patient in a Phase IIa open-label trial of NOE-115.
• NOE-115 is currently in the Phase II of clinical trial.

Hot Flashes Market Segmentation

DelveInsight's "Hot Flashes - Market Insights, Epidemiology, and Market Forecast - 2034" report provides a detailed outlook of the current and future hot flashes market, segmented within countries, by therapies, and by classes. Further, the market of each region is then segmented by each therapy to provide a detailed view of the current and future market share of all therapies.

Hot Flashes Market Size by Countries

The hot flashes market size is assessed separately for various countries, including the US, EU4 (Germany, France, Italy, and Spain), the UK, and Japan. In 2024, the United States held a significant share of the overall 7MM (Seven Major Markets) hot flashes market, primarily attributed to the country's higher prevalence of the condition and the elevated cost of the available treatments. This dominance is projected to persist, especially with the potential early introduction of new products.

Hot Flashes Drugs Uptake

This section focuses on the sales uptake of potential hot flashes drugs that have recently been launched or are anticipated to be launched in the hot flashes market between 2025 and 2034. It estimates the market penetration of hot flashes drugs for a given country, examining their impact within and across classes and segments. It also touches upon the financial and regulatory decisions contributing to the probability of success (PoS) of the drugs in the hot flashes market.

The emerging hot flashes therapies are analyzed based on various attributes such as efficacy and safety in randomized clinical trials, order of entry and other market dynamics, and the unmet need they fulfill in the hot flashes market.

Hot Flashes Market Access and Reimbursement

DelveInsight's "Hot Flashes - Market Insights, Epidemiology, and Market Forecast - 2034" report provides a descriptive overview of the market access and reimbursement scenario of hot flashes. This section includes a detailed analysis of the country-wise healthcare system for each therapy, enlightening the market access, reimbursement policies, and health technology assessments.

KOL Views

To keep up with current hot flashes market trends and to fill gaps in secondary findings, we interview KOLs' and SMEs' working in the hot flashes domain. Their opinion helps understand and validate current and emerging therapies and treatment patterns or hot flashes market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the hot flashes unmet needs.

Hot Flashes: KOL Insights

DelveInsight's analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. These KOLs were from organizations, institutes, and hospitals, such as University of Texas MD Anderson Cancer Center, US; University Medical Center Hamburg-Eppendorf, Germany; PSL Research University, France; University of Campania "Luigi Vanvitelli, Italy; Complutense University, Spain; Liverpool John Moores University, UK; Keio University School of Medicine, Japan; among others.

As per KOLs from the US, "Hot flashes significantly impact quality of life during menopause, with symptoms varying widely in frequency and severity. Experts emphasize that non-hormonal treatments, such as neurokinin receptor antagonists, are reshaping management by targeting the underlying thermoregulatory pathways. Leading voices also highlight the importance of personalized approaches, given the diverse symptom profiles and treatment needs among menopausal women."

As per KOLs from Germany, "Despite advances in menopausal care, a significant unmet need remains for effective, non-hormonal therapies that address hot flashes without increasing risks related to hormone replacement. Experts stress the importance of integrating multidisciplinary support, including mental health and lifestyle interventions, to better manage the broad impact of vasomotor symptoms."

As per KOLs from Japan, "The relatively low reported prevalence of hot flashes may mask under diagnosis and cultural stigma around menopause symptoms. Specialists highlight the need for increased awareness and accessible treatment options, especially non-hormonal therapies, to meet the unique clinical and social challenges faced by Japanese women during menopause."

Competitive Intelligence Analysis

We conduct a competitive and market intelligence analysis of the hot flashes. Market, utilizing various Competitive Intelligence tools such as SWOT analysis and market entry strategies. The inclusion of these analyses is contingent upon data availability, ensuring a comprehensive and well-informed assessment of the market landscape and competitive dynamics.

Hot Flashes Pipeline Development Activities

The report offers an analysis of therapeutic candidates in Phase II and III stages and examines companies involved in developing targeted therapeutics for hot flashes. It provides valuable insights into the advancements and progress of potential treatments in clinical development for this condition.

Pipeline Development Activities

The report covers information on collaborations, acquisition and merger, licensing, patent details, and other information for emerging hot flashes therapies.

Hot Flashes Report Insights

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

Hot Flashes Report Key Strengths

• 10 Years Forecast
• The 7MM Coverage
• Hot Flashes Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Hot Flashes Market
• Hot Flashes Drugs Uptake

Hot Flashes Report Assessment

• Hot Flashes Current Treatment Practices
• Unmet Needs
• Hot Flashes Product Profiles
• Hot Flashes Market Attractiveness

Key Questions:

• How common is hot flashes?
• What are the key findings of hot flashes epidemiology across the 7MM, and which country will have the highest number of patients during the study period (2020-2034)?
• What are the currently available treatments for hot flashes?
• What are the disease risk, burden, and unmet needs of hot flashes?
• At what CAGR is the hot flashes market and its epidemiology is expected to grow in the 7MM during the forecast period (2025-2034)?
• How would the unmet needs impact the hot flashes market dynamics and subsequently influence the analysis of the related trends?
• What would be the forecasted patient pool of hot flashes in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
• Among EU4 and the UK, which country will have the highest number of patients during the forecast period (2025-2034)?
• How many companies are currently developing therapies for the treatment of hot flashes?

Reasons to buy:

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the hot flashes market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• To understand the existing market opportunity in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of current treatment in the US, EU4 (Germany, France, Italy, and Spain), the UK, and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the attribute analysis section to provide visibility around leading classes.
• Highlights of Market Access and Reimbursement policies of approved therapies, barriers to accessibility of off-label expensive therapies, and patient assistance programs.
• To understand the perspective of Key Opinion Leaders around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.

Frequently Asked Questions:

1. What are the treatment goals for hot flashes?

The primary treatment goals for hot flashes are to reduce the frequency and severity of vasomotor symptoms, alleviate associated discomfort such as night sweats and sleep disturbances, and improve overall quality of life. Additional objectives include addressing underlying hormonal or neurological causes, minimizing side effects from therapies, and providing long-lasting symptom relief. Treatments aim to enable women to maintain daily functioning and well-being while reducing the need for frequent medication adjustments or invasive interventions.

2. What are the challenges in managing hot flashes?

Managing hot flashes presents several challenges, including wide variability in symptom severity and patient response to treatment. Hormonal therapies, while effective, may not be suitable for all due to contraindications or safety concerns. Non-hormonal options often provide only partial relief and may require ongoing adjustments. Additionally, underreporting and cultural stigma can delay diagnosis, while limited awareness among healthcare providers can hinder personalized treatment. Access to comprehensive care and long-term management strategies remains inconsistent, complicating effective symptom control.

3. What are the key factors driving the growth of the hot flashes market?

Key factors driving the growth of the hot flashes market include increasing awareness of menopausal health issues, a growing aging female population, and greater demand for effective non-hormonal treatment options. The approval and adoption of novel therapies like neurokinin receptor antagonists, advancements in personalized medicine, and expanding healthcare access also fuel market expansion. Additionally, ongoing research, improved patient education, and supportive regulatory environments enhance treatment availability and uptake.

4. How will the hot flashes market and epidemiology forecast report benefit the clients?

The hot flashes market and epidemiology forecast report provides clients with comprehensive insights into disease prevalence, patient demographics, and market trends. It enables identification of unmet needs, assessment of competitive landscapes, and strategic planning for product development and market access. The report supports informed decision-making by offering analysis of regulatory frameworks, emerging therapies, and forecasted growth, helping stakeholders optimize investments and policy strategies.