Menopause - Market Insights, Epidemiology and Market Forecast - 2032

Key Highlights:

• The Menopause market is projected to witness consistent growth throughout the forecast period (2023-2032). The total number of women in menopause were estimated to be around 100 million in 2022 in the 7MM.
• DelveInsight's analysis reveals that the United States had the highest number of women in menopause in 2022, nearly 41 million cases, surpassing other countries in the 7MM.
• The distribution of women in menopause across different stages includes peri-menopause, post-menopause, and premature menopause. In the US, a highest number of women were found to be in the post-menopause stage.
• Hot flashes and night sweats are the most prevalent vasomotor symptoms experienced by women through menopause.
• In the 7MM, a market size of nearly USD 11,000 million in 2022 was estimated of which hormonal therapies generated nearly two-third of the market share.
• The total market size of the Menopause is anticipated to upsurge during the forecast period due to the expected entry of emerging therapies that includes DONESTA, BAY3427080, and VEOZAH.

DelveInsight's "Menopause - Market Insights, Epidemiology and Market Forecast - 2032" report delivers an in-depth understanding of the Menopause, historical and forecasted epidemiology and the Menopause market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The Menopause market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM, Menopause market size from 2019 to 2032. The report also covers current Menopause treatment practices/algorithms and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Geography Covered:

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

Study Period: 2019-2032

Disease Understanding and Treatment Algorithm

Menopause Overview

Menopause is a natural biological process that marks the end of a woman's reproductive years. It is defined as the permanent cessation of menstruation, typically occurring between 45 and 55, with an average age of around 51. Menopause is diagnosed when a woman has gone through 12 consecutive months without a menstrual period.

Menopause Diagnosis

The diagnosis of menopause is primarily based on a woman's symptoms, age, and a thorough evaluation of her medical history. Blood tests and other investigations are typically used to confirm the diagnosis if there is uncertainty or to evaluate specific concerns.

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

Menopause Treatment

The treatment for menopause aims to alleviate the symptoms and improve the quality of life for women experiencing the hormonal changes associated with this stage of life. The treatment options can vary depending on the severity of symptoms and individual preferences. The goal of treatment during menopause is to make the transition more comfortable and reduce any associated symptoms. Several treatments are available to meet those two goals, including hormone therapy, medications, and natural remedies.

Hormone replacement therapy (HRT) or menopausal hormone therapy (MHT) is a common treatment for reducing menopause symptoms. Generally, this involves taking estrogen, progestin, or a combination of the two hormones. This can be an oral pill, injection, gel, patch, or vaginal ring. At present, almost 100 different combinations of estrogen-only, progestin, and combination hormone therapies are available.

Although Hormonal Therapy (HT) effectively treats vasomotor symptoms, it increases the risk of breast cancer, coronary artery disease, stroke, and others. Therefore, many women are ineligible for HT and its associated risks, reducing their usage.

Non-hormonal therapies such as selective serotonin reuptake inhibitors (SSRIs) and selective norepinephrine reuptake inhibitors (SNRIs) commonly prescribed for depression, gabapentin utilized for neuropathic pain and sleep issues, as well as various herbal supplements, offer a range of benefits for women seeking relief during menopause without relying on hormone-based treatments. Non-hormonal therapies avoid the potential side effects of hormonal treatments, such as increased risk of blood clots or breast cancer. Additionally, these therapies can be suitable for women who have undergone certain medical procedures or have a history of certain conditions where hormone use is not recommended. Until 2023, only one non-hormonal therapy, Brisdelle (paroxetine), an SSRI, had received approval (in 2013) from the US FDA; however, its generic version had already entered the market.

Menopause Epidemiology

As the market is derived using the patient-based model, the Menopause epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total number of women in menopause, stage-specific distribution of women in menopause, age-specific distribution of women in menopause, number of women in menopause with vasomotor symptoms, and number of women in menopause with moderate-to-severe vasomotor symptoms in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan, from 2019 to 2032. The total number of women in menopause in the 7MM comprised approximately 100 million cases in 2022 and are projected to increase during the forecast period.

• The number of women in menopause in the US in 2022 accounted for nearly 40% of total number of cases for Menopause in the 7MM. During the study period, these numbers are expected to rise at a significant CAGR.
• The stage-specific distribution of women in menopause typically includes three stages: premenopausal, perimenopausal, and postmenopausal. DelveInsight estimated that among the different stages of menopause, women in post-menopause stage (40-65 years) were highest in number (6,503,051 cases) in 2022 in the 7MM.
• For the age-specific analysis, number of cases of menopause were distributed across various age groups, such as <40 years, 40-50 years, 51-60 years, and 61-65 years, in the 7MM. As per the analysis, the highest number of cases were estimated in age-group 51-60 years and lowest in <40 years with 64 million and 3.4 million cases, respectively in 2022.
• The most common vasomotor symptoms experienced during menopause are hot flashes and night sweats.
• In the US, 34% of all menopause cases in the US exhibited moderate-to-severe vasomotor symptoms in 2022.
• Japan accounted for 18% of the number of women in menopause in the 7MM in 2022, with 18 million cases.

Menopause Drug Chapters

The drug chapter segment of the Menopause report encloses a detailed analysis of Menopause marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also understands the Menopause clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.

Marketed Drugs

DUAVEE/DUAVIVE (bazedoxifene acetate/conjugated estrogens): Pfizer/Ligand Pharmaceuticals

DUAVEE (bazedoxifene acetate/conjugated estrogens) 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 provides the benefits of estrogen while minimizing the potential risks by including bazedoxifene, which helps protect against endometrial hyperplasia. With its convenient once-daily dosing, DUAVEE offers a convenient and reliable solution for managing menopausal symptoms, allowing women to regain control of their lives and embrace this new phase with confidence and comfort.

VEOZAH (fezolinetant): Astellas Pharma

VEOZAH is a neurokinin 3 (NK3) receptor antagonist indicated for treating moderate-to-severe VMS due to menopause. VEOZAH offers a safe and non-hormonal option, addressing the challenges and discomfort associated with menopause and providing optimal support for women experiencing menopause.

Note: Detailed marketed therapies assessment will be provided in the final report of Menopause.

Emerging Drugs

Transdermal Estradiol Cream (VML-0203): Viramal Limited/Simbec Research

Transdermal estradiol cream, also known as VML-0203, is a formulation of estradiol, which is a type of estrogen hormone. Estradiol creams are commonly used in hormone replacement therapy (HRT) for women experiencing menopause. The product is delivered transdermally for the systemic benefit and vaginally for localized symptoms. They are expected to demonstrate improved bioavailability, and through an easy-to-use cosmetic-grade cream formula, they are patient-friendly daily solutions to support healthier aging.

DONESTA (estetrol): Estetra/Mithra Pharmaceuticals

DONESTA (Estetrol-E4) is Mithra's next-generation, orally-administered, E4-based hormone therapy (HT) candidate for vasomotor menopausal symptoms (VMS) relief. Estetrol (E4) is a natural estrogen produced in large quantities by the human fetal liver. The role of E4 in embryonic physiology and/or human pregnancy has not yet been determined. Estetrol (E4) is the first NEST (native estrogen with selective action in tissues).

DONESTA Phase II study yielded positive topline results for VMS. Currently, DONESTA is in the Phase III stage of clinical development for vasomotor symptoms.

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

Drug Class Insights

Drug classes commonly used for menopause management include Hormone Replacement Therapy (HRT), Selective Estrogen Receptor Modulators (SERMs), Antidepressants, Gabapentin, and Vaginal Estrogens. HRT, consisting of estrogen alone or in combination with progestin, effectively addresses symptoms like hot flashes, night sweats, and vaginal dryness, but carries risks. SERMs like raloxifene help prevent bone loss but don't relieve menopausal symptoms. Antidepressants such as SSRIs and SNRIs, as well as gabapentin, can reduce hot flashes and improve sleep quality. Vaginal estrogens are localized treatments for vaginal dryness. Treatment selection should be individualized based on symptoms, medical history, and preferences, and healthcare providers should guide women in determining the most suitable drug class and treatment plan while considering potential risks and benefits.

Menopause Market Outlook

Hot flushes are the most bothersome and prevalent menopause-related symptom, affecting up to 85% of menopausal women with different severity, frequency, and duration. Hot flashes associated with menopause are treated using two main categories of drugs: hormonal therapies and non-hormonal therapies.

The market is expected to experience positive growth with the approval of potential drugs like DONESTA (E4, Estetrol), VEOZAH (fezolinetant), and Elinzanetant (BAY3427080).

• The total market size of Menopause in the 7MM was around USD 11,000 million in 2022. This is estimated to increase by 2032 at a significant CAGR.
• In 2022, hormonal therapy covered around 63% of the total 7MM. By 2032, its market is expected to decrease due to the emergence of non-hormonal therapies.
• Among the 7MM, the US captured the highest market in 2022, covering a total of 61% market.
• In 2022, EU4 and the UK captured nearly 38% of the total market in the 7MM.
• Among the forecasted emerging therapies, Elinzanetant (BAY3427080) is expected to capture the highest market in the 7MM by 2032.

Menopause Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to launch in the market during 2019-2032. For example, for Donesta (E4, Estetrol), in the US we expect the drug uptake to be Slow-medium with a probability-adjusted peak share of around 8%, and years to the peak is expected to be 9 years from the year of launch.

Further detailed analysis of emerging therapies drug uptake in the report…

Menopause Pipeline Development Activities

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

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Menopause 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 the secondary research. Industry Experts were contacted for insights on Menopause evolving treatment landscape, patient reliance on conventional therapies, patient's therapy switching acceptability, and drug uptake along with challenges related to accessibility, including KOL from Department of Obstetrics and Gynecology, Yale School of Medicine; Department of Epidemiology, University of North Carolina at Chapel Hil; Italian Association for Applied Sexology and Psychology (AISPA), Milan; and others.

DelveInsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Their opinion helps to understand and validate current and emerging therapies and treatment patterns or Menopause market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

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, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

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 route of administration, order of entry and designation, 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.

Market Access and Reimbursement

The high cost of therapies for the treatment is a major factor restraining the growth of the global drug market. Because of the high cost, the economic burden is increasing, leading the patient to escape from proper treatment. Menopause treatment and medical services are eligible for reimbursement with a flexible spending account (FSA), health savings account (HSA), or health reimbursement arrangement (HRA). Menopause treatment and medical services reimbursement are not eligible with a limited-purpose flexible spending account (LPFSA) or a dependent care flexible spending account (DCFSA).

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved 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 segment of key events, an executive summary, descriptive overview of Menopause, 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, disease progression, and treatment guidelines.
• Additionally, an all-inclusive account of the current and emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will impact the current treatment landscape.
• A detailed review of the Menopause market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind the approach is included in the report covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preference that help shape and drive the 7MM Menopause market.

Menopause Report Insights

• Patient Population
• Therapeutic Approaches
• Menopause Pipeline Analysis
• Menopause Market Size and Trends
• Existing and Future Market Opportunity

Menopause Report Key Strengths

• Ten Years Forecast
• The 7MM Coverage
• Menopause Epidemiology Segmentation
• Key Cross Competition
• Conjoint Analysis
• Drugs Uptake and Key Market Forecast Assumptions

Menopause Report Assessment

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

Key Questions

Market Insights

• What was the Menopause total market size, the market size by therapies, and market share (%) distribution in 2019, and how would it all look in 2032? What are the contributing factors for this growth?
• What unmet needs are associated with the current treatment market of Menopause?
• What will be the impact of the DUAVEE patent expiry in the market?
• How will DONESTA compete with the existing therapies for Menopause during the study period?
• Which drug is going to be the largest contributor in 2032?
• What are the pricing variations among different geographies for approved and off-label therapies?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights

• What are the disease risk, burdens, and unmet needs of Menopause? What will be the growth opportunities across the 7MM concerning the patient population of Menopause?
• What is the historical and forecasted Menopause patient pool in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
• Why do only limited patients appear for diagnosis?
• Which type of Menopause is more prevalent and why?
• What factors are affecting the diagnosis of the indication?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

• What are the current options for treating Menopause? What are the current guidelines for treating Menopause in the US and Europe?
• How many companies are developing therapies for treating Menopause?
• How many emerging therapies are in the mid-stage and late stage of development for treating Menopause?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
• What are the key designations that have been granted for the emerging therapies for Menopause?
• What is the cost burden of approved therapies on the patient?
• 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? Focus on reimbursement policies.
• What are the 7MM historical and forecasted markets of Menopause?

Reasons to Buy:

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the Menopause 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 approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies that will 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 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 need of the existing market so that the upcoming players can strengthen their development and launch strategy.