Vasomotor Symptoms Market

• Vasomotor Symptoms are cardinal symptoms of menopause. It is characterized by hot flashes and night sweats and may also include heart palpitations and changes in blood pressure.
• Various treatment methods have been used to relieve hot flashes, including lifestyle modification, non-prescription remedies, and prescription therapies.
• In 2023, a significant milestone was achieved in the treatment of vasomotor symptoms (VMS) with the FDA approval of VEOZAH (fezolinetant).
• In February 2024, Mithra Pharmaceuticals announced a significant milestone in its clinical research efforts for DONESTA, a hormone therapy utilizing estetrol (E4) to treat moderate to severe vasomotor symptoms (VMS) associated with menopause. The last patient-out mark was reached in the C301 Endometrial Safety Study, signaling the completion of patient treatments and the initiation of the data management and reporting phase.
• In December 2023, Mithra announced a positive review from the independent Data and Safety Monitoring Board (DSMB) regarding its Phase III program for DONESTA.
• MenoGeniX is actively pursuing partnership opportunities and additional funding to advance clinical trials for MNGX-100, a promising therapy designed for women experiencing moderate to severe hot flashes and other vasomotor symptoms due to natural or surgically induced menopause. The goal is to achieve FDA approval and bring this potential alternative treatment to market.
• Among 7MM, the United States accounts for the highest market size of Vasomotor Symptoms in 2023.
• In the 7MM, the highest number of prevalent cases of Vasomotor Symptoms was observed in the United States.

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DelveInsight's “Vasomotor Symptoms Market Insight, Epidemiology and Market Forecast – 2034” report delivers an in-depth analysis of Vasomotor Symptoms epidemiology, market, and clinical development in Vasomotor Symptoms. In addition to this, the report provides historical and forecasted epidemiology and market data as well as a detailed analysis of the Vasomotor Symptoms market trends in the United States, EU4 (Germany, Spain, Italy, and France) the United Kingdom, and Japan. 

The Vasomotor Symptoms Treatment Market Report provides real-world prescription pattern analysis, emerging drugs assessment, market share, and uptake/adoption pattern of individual therapies, as well as historical and forecasted Vasomotor Symptoms market size from 2020 to 2034 in 7MM. The report also covers current Vasomotor Symptoms treatment market practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s underlying potential. 

Vasomotor Symptoms Treatment Market

Vasomotor Symptoms (VMS) are episodes of profuse heat accompanied by sweating and flushing, which are experienced majorly around the head, neck, chest, and upper back. These are the menopausal symptoms for which women seek treatment most often. VMS, or hot flashes and night sweats, are often considered the cardinal symptoms of menopause. The VMS may also include heart palpitations and changes in blood pressure. At about the age of 40 years, the levels of estrogen and progesterone start to fall in females, and perimenopause (the transition to menopause) begins. As this transition progresses, a female may experience vasomotor symptoms. It has also been observed that the VMS occurs due to constriction or dilation of the blood vessels. The study of Women's Health across the Nation (SWAN) is one of the largest and most ethnically diverse longitudinal studies of the menopausal transition. With the enrollment of thousands of midlife women across five racial/ethnic groups, SWAN followed these women and collected their information regarding vasomotor and other menopause-related symptoms, health behaviors, social and psychological functioning, and a range of physiologic indices, on an annual basis.

The Vasomotor Symptoms report provides an overview of Vasomotor Symptoms pathophysiology, diagnostic approaches, and detailed treatment algorithm along with a real-world scenario of a patient’s journey beginning from the first symptom, the time taken for diagnosis to the entire treatment process.

Further details related to country-based variations in diagnosis are provided in the report...

Vasomotor Symptoms Treatment

The North American Menopause Society (NAMS) recommends no treatment until the hot flashes become bothersome to the woman. The decision to begin treatment should be based on the severity of symptoms, an assessment of treatment-related risks, and the woman’s attitudes about menopause and medications. In most women, hot flashes will abate over time without intervention. The treatment methods can include lifestyle modification, non-prescription remedies, hormonal options, and non-hormonal options. The most commonly prescribed hormone is estrogen, used alone or with a progestogen for women with a uterus. Other hormones used include progestogens alone, oral contraceptives, androgen-estrogen, and custom hormonal preparations.

Vasomotor Symptoms Epidemiology

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

• In the 7MM, the highest number of prevalent cases of vasomotor symptoms was observed in the United States.
• In EU4 and the UK, the highest number of prevalent cases of vasomotor symptoms was observed in Germany at nearly 25%.
• Japan comprises nearly 16% of the total prevalent cases of vasomotor symptoms among the 7MM.
• The highest number of prevalent cases of vasomotor symptoms was observed in the age group of 60-65 years. 

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Vasomotor Symptoms Drug Chapters

The drug chapter segment of the Vasomotor Symptoms drugs market report encloses a detailed analysis of Vasomotor Symptoms-marketed drugs and late-stage (Phase III and Phase II) Vasomotor Symptoms pipeline drugs analysis. It also deep dives into the Vasomotor Symptoms pivotal clinical trials details, recent and expected market approvals, patent details, the latest Vasomotor Symptoms news, and recent deals and collaborations. 

Vasomotor Symptoms Marketed Drugs

• VEOZAH (fezolinetant): Astellas

VEOZAH is a neurokinin 3 (NK3) receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms due to menopause. In May 2023, Astellas Pharma announced that the FDA has approved VEOZAH (fezolinetant) 45 mg once daily for the treatment of moderate to severe vasomotor symptoms. VEOZAH blocks neurokinin B (NKB) binding on the kisspeptin/neurokinin B/dynorphin (KNDy) neuron to modulate neuronal activity in the thermoregulatory center of the brain. This helps restore the balance disrupted during menopause which leads to hot flashes and night sweats. The approval is supported by results from the BRIGHT SKY program, which included three Phase III trials enrolling over 3,000 women across the US and Europe. The SKYLIGHT 1 and SKYLIGHT 2 pivotal trials demonstrated the efficacy and safety of fezolinetant for treating moderate to severe VMS due to menopause.

• DUAVEE (conjugated estrogens/bazedoxifene): Pfizer/Ligand Pharmaceuticals

DUAVEE (conjugated estrogens/bazedoxifene) is the first and only therapy to pair conjugated estrogens (CE) with an estrogen agonist/antagonist also known as a selective estrogen receptor modulator (SERM). DUAVEE uses bazedoxifene instead of progestin to help protect the uterine lining against hyperplasia that may result from estrogen alone treatment. It is recommended to administer DUAVEE as an oral tablet for the treatment of vasomotor symptoms associated with menopause, which was approved in the year 2013 by the US FDA. Later in 2014, Pfizer received EMA approval for DUAVEE.

Note: Detailed Marketed therapies assessment will be provided in the final report...

Vasomotor Symptoms Emerging Drugs

• DONESTA (Estetrol): Mithra Pharmaceuticals/Gedeon Richter

DONESTA (estetrol) is a next-generation orally-administrated Estetrol-based hormone therapy product. It is the first native estrogen with selective action in tissues. Estetrol is a natural estrogen produced by the human fetus and passed into maternal blood at relatively high levels during pregnancy. It acts as an estrogen in the nucleus by activating the nuclear estrogen receptor α (ERα) and recruiting the same coregulator activators and repressors as estradiol (E2), or estriol (E3) in a pattern very different from the selective estrogen receptor modulators, tamoxifen, or raloxifene. In bone, vagina, endometrium, brain, and the vascular system, E4 acts in synergy with the endogenous estrogens and provides similar effects. E4, however, exerts much less effect on the liver and the breast than E2 this may reduce some unwanted side effects of endogenous estrogens. Estetrol has a high oral bioavailability and its elimination half-life is approximately 28 hours. Moreover, in contrast to E2, E4 is not metabolized to other active estrogen metabolites. Currently, DONESTA is in the Phase III stage of clinical development for Vasomotor Symptoms.

In February 2023, Gedeon Richter Plc. and Mithra Pharmaceuticals announced that they signed a license agreement for the commercialization of DONESTA. The territories covered by the agreement are geographical Europe, the CIS countries, Latin America, Australia, and New Zealand. According to Mithra's news release in February 2024, the company is on schedule to file for DONESTA, a treatment for vasomotor symptoms of menopause in both the U.S. and Europe during the fourth quarter of 2024.

• MNGX-100: MenoGeniX

MNGX-100 contains a naturally occurring human protein called G-CSF, also known as granulocyte colony-stimulating factor. It is recommended to inject subcutaneously for the treatment of Vasomotor Symptoms associated with postmenopause. This cytokine (a cell signaling molecule) stimulates the production of neutrophils, a type of white blood cell. MenoGeniX believes that G-CSF is acting on the hypothalamus, the body's thermostat, to counteract the effect of pro-inflammatory cytokines that are often elevated in individuals experiencing menopausal symptoms. MenoGeniX's initial clinical trial results strongly suggest that MNGX-100 will be well-tolerated and will lead to a durable reduction in hot flash frequency and severity. MenoGeniX is currently scaling up for its clinical trial supported by the National Institute on Aging (NIA) of the National Institutes of Health (NIH) for the clinical development of MNGX-100 for the treatment of menopausal hot flashes. The grant funding will support a Phase Ib/IIa clinical trial evaluating the safety and efficacy of multiple doses of MNGX-100 in 60 women with naturally occurring or surgically induced menopause.

Note: Detailed emerging therapies assessment will be provided in the final report...

Vasomotor Symptoms Market Outlook

The Vasomotor Symptoms market outlook is promising, driven by new approvals and innovative therapies in development. The recent FDA approval of VEOZAH (fezolinetant) by Astellas introduces a novel non-hormonal treatment option, significantly enhancing the therapeutic landscape for moderate to severe VMS. This follows the success of DUAVEE (conjugated estrogens/bazedoxifene), which has been a key player since its approval in 2013. Emerging therapies like Mithra’s DONESTA and MenoGeniX’s MNGX-100, both offering unique mechanisms of action, are expected to further diversify and expand the market. With significant unmet needs in VMS, these advancements are likely to drive market growth and improve outcomes for women affected by menopausal symptoms.

Key Vasomotor Symptoms Companies, such as Mithra Pharmaceuticals and MenoGeniX are evaluating their lead candidates in different stages of clinical development, respectively. They aim to investigate their products for the treatment of Vasomotor Symptoms.

• The Vasomotor Symptoms Market Size shall grow during the forecast period owing to increased awareness among patients, updated diagnosis and treatment guidelines, and growth in the diseased population.
• Among 7MM, the United States accounts for the highest Vasomotor Symptoms Market Size in 2023.
• Among the EU4 and the UK, Germany had the highest Vasomotor Symptoms Market Size in 2023, while Spain had the lowest Vasomotor Symptoms Market Size.

Vasomotor Symptoms Drugs Uptake

DONESTA (estetrol), currently in Phase III development for vasomotor symptoms, is poised for strong drug uptake due to its innovative profile and patient-friendly oral administration. As the first native estrogen with selective tissue action, DONESTA offers a promising alternative to traditional hormone therapies by minimizing unwanted side effects, particularly on the liver and breast. Its high oral bioavailability and convenient dosing further enhance its appeal, making it a likely favorable option among patients and healthcare providers. Given its advanced stage in the development process and its potential to fill a significant gap in the VMS treatment landscape, DONESTA is expected to see robust adoption upon approval.

This section focuses on the uptake rate of potential Vasomotor Symptoms drugs expected to be launched in the market during 2020–2034, which depends on the Vasomotor Symptoms competitive landscape, safety, and efficacy data along with order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.

Vasomotor Symptoms Pipeline Development Activities

The Vasomotor Symptoms therapeutics market report provides insights into Vasomotor Symptoms clinical trials within Phase III and Phase II stages. It also analyzes key Vasomotor Symptoms Companies involved in developing targeted therapeutics.

Pipeline Development Activities

The Vasomotor Symptoms therapeutics market report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Vasomotor Symptoms emerging therapies.

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KOL Views

To keep up with the real-world scenario in current and emerging market trends, we take opinions from Key Industry leaders working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility, including medical/scientific writers, doctors, professors, and Others.

DelveInsight’s analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as the University of Pittsburgh, Massachusetts General Hospital/Harvard Medical School, etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or Vasomotor Symptoms market trends.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

In efficacy, the trial’s primary and secondary outcome measures are evaluated; for instance, in event-free survival, one of the most important primary outcome measures is event-free survival and overall survival. 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. In addition, the scoring is also based on the probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Vasomotor Symptoms Therapeutics Market Access and Reimbursement

Reimbursement may be referred to as the negotiation of a price between a manufacturer and 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 Vasomotor Symptoms therapeutics market 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.

Vasomotor Symptoms Treatment Market Report Scope

• The Vasomotor Symptoms therapeutics market report covers a segment of key events, an executive summary, descriptive overview, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, and disease progression along treatment guidelines.
• Additionally, an all-inclusive account of emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
• A detailed review of the Vasomotor symptoms market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The Vasomotor Symptoms therapeutics market report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM Vasomotor Symptoms drugs market.

Vasomotor Symptoms Treatment Market Report Insights

• Vasomotor Symptoms Patient Population
• Vasomotor Symptoms Therapeutic Approaches
• Vasomotor symptoms Pipeline Drugs Analysis
• Vasomotor symptoms Market Size and Trends
• Existing and future Vasomotor Symptoms Drugs Market Opportunity

Vasomotor Symptoms Treatment Market Report Key Strengths

• 11 Years Vasomotor Symptoms Market Forecast
• 7MM Coverage
• Vasomotor Symptoms Epidemiology Segmentation
• Key Cross Competition
• Conjoint analysis
• Vasomotor Symptoms Drugs Uptake
• Key Vasomotor Symptoms Market Forecast Assumptions

Vasomotor Symptoms Treatment Market Report Assessment

• Current Vasomotor Symptoms Treatment Market Practices
• Vasomotor Symptoms Unmet Needs
• Vasomotor Symptoms Pipeline Drugs Analysis Profiles
• Vasomotor Symptoms Drugs Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)
• Vasomotor Symptoms Market Drivers
• Vasomotor Symptoms Market Barriers

FAQs

• What is the historical and forecasted Vasomotor Symptoms patient pool/patient burden in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
• What was the Vasomotor Symptoms market size, the Vasomotor Symptoms market size by therapies, market share (%) distribution in 2020, and what would it look like in 2034? What are the contributing factors/key catalysts for this growth?
• Which combination treatment approaches will have a significant impact on the Vasomotor Symptoms drug treatment market size?
• What are the emerging options for the Vasomotor Symptoms treatment?
• How many companies are developing therapies for the treatment of Vasomotor Symptoms?
• What are the recent novel therapies, targets, Vasomotor Symptoms Mechanisms of Action, and technologies developed to overcome the limitations of existing therapies?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies?

Reasons to Buy

• The Vasomotor Symptoms therapeutics market report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Vasomotor Symptoms Market.
• Insights on patient burden/disease Vasomotor Symptoms Prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing market opportunities 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 approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Patient-based forecast model which uses bottom-up forecasting techniques is accepted as a gold standard in pharma forecasting.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders’ perspectives 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.

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