更年期障害市場 - 市場の洞察、疫学、市場予測：2032年

更年期障害は、女性の生殖年齢の終わりを示す自然な生物学的過程です。更年期障害は月経の永久的な停止と定義され、通常45～55歳の間に起こり、平均年齢はおよそ51歳です。更年期障害は、女性が12ヵ月連続で月経がない場合に診断されます。

更年期障害の診断は、主に女性の症状、年齢、病歴の綿密な評価に基づいて行われます。血液検査やその他の検査は、通常、不確かな場合には診断を確定するために、あるいは特定の懸念事項を評価するために行われます。

更年期障害の市場規模は予測期間（2023年～2032年）を通して安定した成長が見込まれます。更年期女性の総数は2022年に主要7ヶ国で約1億人と推定されます。2022年の更年期障害女性数は米国が4,100万件近くと最も多く、主要7ヶ国の他国を上回っています。ほてりと寝汗は、更年期の女性が経験する最も一般的な血管運動症状です。

主要7ヶ国では、2022年の市場規模はほぼ110億米ドルと推定され、そのうちホルモン療法が市場シェアの3分の2近くを占めています。

当レポートでは、主要7ヶ国における更年期障害市場について調査し、市場の概要とともに、疫学、患者動向、新たな治療法、2032年までの市場規模予測、および医療のアンメットニーズなどを提供しています。

目次

第1章 重要な洞察

第2章 レポートのイントロダクション

第3章 各国の更年期障害市場概要

第4章 更年期障害市場概要、クラス別

第5章 更年期障害の疫学の調査手法と市場

第6章 更年期障害のエグゼクティブサマリー

第7章 主要な出来事

第8章 疾患の背景と概要

• イントロダクション
• VMSの危険因子
• 病因
• 種類
• 症状
• 生殖能力の老化の段階化
• 診断
• 更年期障害の治療と管理
• 治療アルゴリズム

第9章 疫学と患者数

• 主な調査結果
• 仮定と根拠：主要7ヶ国
• 主要7ヶ国における更年期障害期の女性の総数
• 米国
• EU4ヶ国と英国
• 日本

第10章 患者動向

第11章 上市済み治療法

第12章 新しい治療法

第13章 更年期障害期：市場分析

• 主な調査結果
• 主要な市場予測の前提条件
• 市場の見通し
• コンジョイント分析
• 主要7ヶ国の更年期障害の総市場規模
• 主要7ヶ国の更年期障害の市場規模、治療法別
• 米国における更年期障害の市場規模
• EU4ヶ国および英国における更年期障害の市場規模
• 日本における更年期障害の市場規模

第14章 主要なオピニオンリーダーの見解

第15章 SWOT分析

第16章 アンメットニーズ

第17章 市場アクセスと償還

第18章 付録

第19章 レポート調査手法

第20章 DelveInsightのサービス内容

第21章 免責事項

List of Tables

• Table 1: Summary of Menopause Market and Epidemiology (2019-2032)
• Table 2: Key Events
• Table 3: Total Number of Women in Menopause in the 7MM (2019-2032)
• Table 4: Total Number of Cases of Menopause in the US (2019-2032)
• Table 5: Stage-specific Distribution of Women in Menopause in the US (2019-2032)
• Table 6: Age-specific Distribution of Women in Menopause in the US (2019-2032)
• Table 7: Number of Women in Menopause with Vasomotor Symptoms in the US (2019-2032)
• Table 8: Number of Women in Menopause With Moderate-to-severe Vasomotor Symptoms in the US (2019-2032)
• Table 9: Total Number of Cases of Menopause in Germany (2019-2032)
• Table 10: Total Number of Cases of Menopause in France (2019-2032)
• Table 11: Total Number of Cases of Menopause in Italy (2019-2032)
• Table 12: Total Number of Cases of Menopause in Spain (2019-2032)
• Table 13: Total Number of Cases of Menopause in the UK (2019-2032)
• Table 14: Total Number of Women in Menopause in EU4 and the UK (2019-2032)
• Table 15: Stage-specific Distribution of Women in Menopause in Germany (2019-2032)
• Table 16: Stage-specific Distribution of Women in Menopause in France (2019-2032)
• Table 17: Stage-specific Distribution of Women in Menopause in Italy (2019-2032)
• Table 18: Stage-specific Distribution of Women in Menopause in Spain (2019-2032)
• Table 19: Stage-specific Distribution of Women in Menopause in the UK (2019-2032)
• Table 20: Stage-specific Distribution of Women in Menopause in EU4 and the UK (2019-2032)
• Table 21: Age-specific Distribution of Women in Menopause in Germany (2019-2032)
• Table 22: Age-specific Distribution of Women in Menopause in France (2019-2032)
• Table 23: Age-specific Distribution of Women in Menopause in Italy (2019-2032)
• Table 24: Age-specific Distribution of Women in Menopause in Spain (2019-2032)
• Table 25: Age-specific Distribution of Women in Menopause in the UK (2019-2032)
• Table 26: Age-specific Distribution of Women in Menopause in EU4 and the UK (2019-2032)
• Table 27: Number of Women in Menopause with Vasomotor Symptoms in Germany (2019-2032)
• Table 28: Number of Women in Menopause with Vasomotor Symptoms in France (2019-2032)
• Table 29: Number of Women in Menopause with Vasomotor Symptoms in Italy (2019-2032)
• Table 30: Number of Women in Menopause with Vasomotor Symptoms in Spain (2019-2032)
• Table 31: Number of Women in Menopause with Vasomotor Symptoms in the UK (2019-2032)
• Table 32: Number of Women in Menopause with Vasomotor Symptoms in EU4 and the UK (2019-2032)
• Table 33: Number of Women in Menopause With Moderate-to-severe Vasomotor Symptoms in Germany (2019-2032)
• Table 34: Number of Women in Menopause With Moderate-to-severe Vasomotor Symptoms in France (2019-2032)
• Table 35: Number of Women in Menopause With Moderate-to-severe Vasomotor Symptoms in Italy (2019-2032)
• Table 36: Number of Women in Menopause With Moderate-to-severe Vasomotor Symptoms in Spain (2019-2032)
• Table 37: Number of Women in Menopause With Moderate-to-severe Vasomotor Symptoms in the UK (2019-2032)
• Table 38: Number of Women in Menopause With Moderate-to-severe Vasomotor Symptoms in EU4 and the UK (2019-2032)
• Table 39: Total Number of Women in Menopause in Japan (2019-2032)
• Table 40: Stage-specific Distribution of Women in Menopause in Japan (2019-2032)
• Table 41: Age-specific Distribution of Women in Menopause in Japan (2019-2032)
• Table 42: Number of Women in Menopause with Vasomotor Symptoms in Japan (2019-2032)
• Table 43: Number of Women in Menopause With Moderate-to-severe Vasomotor Symptoms in Japan (2019-2032)
• Table 44: Key cross competition: Marketed drugs
• Table 45: Key Cross of Estrogen-based Oral Therapies
• Table 46: Key Cross of Estrogen-based Transdermal Patch
• Table 47: The Key Cross of Estrogen-based Transdermal Spray
• Table 48: The Key Cross of Estrogen-based Transdermal Gel
• Table 49: Key Cross of Estrogen-based Vaginal Ring
• Table 50: Key Cross of Oral Combination Therapies
• Table 51: Key Cross of Transdermal Combination Therapies
• Table 52: Details of Non-hormonal Therapies
• Table 53: Fezolinetant (ESN-364), Clinical Trial Description, 2023
• Table 54: Estradiol + Progesterone, Clinical Trial Description, 2023
• Table 55: Comparison of Emerging Drugs Under Development
• Table 56: Transdermal Estradiol Cream (VML-0203), Clinical Trial Description, 2023
• Table 57: DONESTA (E4, Estetrol), Clinical Trial Description, 2023
• Table 58: Elinzanetant (BAY-3427080), Clinical Trial Description, 2023
• Table 59: MT-8554 (Elismetrep), Clinical Trial Description, 2023
• Table 60: MNGX-100 (Filgrastim/G-CSF), Clinical Trial Description, 2023
• Table 61: Q-122, Clinical Trial Description, 2023
• Table 62: FP-101, Clinical Trial Description, 2023
• Table 63: Key Market Forecast Assumptions for VEOZAH (fezolinetant)
• Table 64: Key Market Forecast Assumptions for DONESTA
• Table 65: Key Market Forecast Assumptions for Elinzanetant (BAY3427080)
• Table 66: Total Market Size of Menopause in the 7MM
• Table 67: Market Size of Menopause by Therapies in the 7MM
• Table 68: Market Size of Menopause by Class in the 7MM
• Table 69: Total Market Size of Menopause in the US
• Table 70: Market Size of Menopause by Therapies in the US
• Table 71: Market Size of Menopause in Germany
• Table 72: Market Size of Menopause in France
• Table 73: Market Size of Menopause in Italy
• Table 74: Market Size of Menopause in Spain
• Table 75: Market Size of Menopause in the UK
• Table 76: Market Size of Menopause in EU4 and the UK
• Table 77: Market Size of Menopause by Therapies in Germany
• Table 78: Market Size of Menopause by Therapies in France
• Table 79: Market Size of Menopause by Therapies in Italy
• Table 80: Market Size of Menopause by Therapies in Spain
• Table 81: Market Size of Menopause by Therapies in the UK
• Table 82: Market Size of Menopause by Therapies in EU4 and the UK
• Table 83: Market Size of Menopause in Japan
• Table 84: Market Size of Menopause by Therapies in Japan

List of Figures

• Figure 1: Risk factors of VMS
• Figure 2: Symptoms of Menopause
• Figure 3: STRAW + 10 Staging System
• Figure 4: Evaluation of Suspected Menopause in Females >40 years
• Figure 5: Treatment of Menopause
• Figure 6: Treatment Algorithm of Hot Flashes
• Figure 7: Treatment of Menopause
• Figure 8: Total Number of Women in Menopause in the 7MM (2019-2032)
• Figure 9: Total Prevalent Cases of Menopause in the US (2019-2032)
• Figure 10: Stage-specific Distribution of Women in Menopause in the US (2019-2032)
• Figure 11: Age-specific Distribution of Women in Menopause in the US (2019-2032)
• Figure 12: Number of Women in Menopause with Vasomotor Symptoms in the US (2019-2032)
• Figure 13: Number of Women in Menopause With Moderate-to-severe Vasomotor Symptoms in the US (2019-2032)
• Figure 14: Total Number of Cases of Menopause in Germany (2019-2032)
• Figure 15: Total Number of Cases of Menopause in France (2019-2032)
• Figure 16: Total Number of Cases of Menopause in Italy (2019-2032)
• Figure 17: Total Number of Cases of Menopause in Spain (2019-2032)
• Figure 18: Total Number of Cases of Menopause in the UK (2019-2032)
• Figure 19: Total Number of Women in Menopause in EU4 and the UK (2019-2032)
• Figure 20: Stage-specific Distribution of Women in Menopause in Germany (2019-2032)
• Figure 21: Stage-specific Distribution of Women in Menopause in France (2019-2032)
• Figure 22: Stage-specific Distribution of Women in Menopause in Italy (2019-2032)
• Figure 23: Stage-specific Distribution of Women in Menopause in Spain (2019-2032)
• Figure 24: Stage-specific Distribution of Women in Menopause in the UK (2019-2032)
• Figure 25: Stage-specific Distribution of Women in Menopause in EU4 and the UK (2019-2032)
• Figure 26: Age-specific Distribution of Women in Menopause in Germany (2019-2032)
• Figure 27: Age-specific Distribution of Women in Menopause in France (2019-2032)
• Figure 28: Age-specific Distribution of Women in Menopause in Italy (2019-2032)
• Figure 29: Age-specific Distribution of Women in Menopause in Spain (2019-2032)
• Figure 30: Age-specific Distribution of Women in Menopause in the UK (2019-2032)
• Figure 31: Age-specific Distribution of Women in Menopause in EU4 and the UK (2019-2032)
• Figure 32: Number of Women in Menopause with Vasomotor Symptoms in Germany (2019-2032)
• Figure 33: Number of Women in Menopause with Vasomotor Symptoms in France (2019-2032)
• Figure 34: Number of Women in Menopause with Vasomotor Symptoms in Italy (2019-2032)
• Figure 35: Number of Women in Menopause with Vasomotor Symptoms in Spain (2019-2032)
• Figure 36: Number of Women in Menopause with Vasomotor Symptoms in the UK (2019-2032)
• Figure 37: Number of Women in Menopause with Vasomotor Symptoms in EU4 and the UK (2019-2032)
• Figure 38: Number of Women in Menopause With Moderate-to-severe Vasomotor Symptoms in Germany (2019-2032)
• Figure 39: Number of Women in Menopause With Moderate-to-severe Vasomotor Symptoms in France (2019-2032)
• Figure 40: Number of Women in Menopause With Moderate-to-severe Vasomotor Symptoms in Italy (2019-2032)
• Figure 41: Number of Women in Menopause With Moderate-to-severe Vasomotor Symptoms in Spain (2019-2032)
• Figure 42: Number of Women in Menopause With Moderate-to-severe Vasomotor Symptoms in the UK (2019-2032)
• Figure 43: Number of Women in Menopause With Moderate-to-severe Vasomotor Symptoms in EU4 and the UK (2019-2032)
• Figure 44: Total Number of Women in Menopause in Japan (2019-2032)
• Figure 45: Stage-specific Distribution of Women in Menopause in Japan (2019-2032)
• Figure 46: Age-specific Distribution of Women in Menopause in Japan (2019-2032)
• Figure 47: Number of Women in Menopause with Vasomotor Symptoms in Japan (2019-2032)
• Figure 48: Number of Women in Menopause With Moderate-to-severe Vasomotor Symptoms in Japan (2019-2032)
• Figure 49: Patient Journey of Menopause
• Figure 50: Total Market Size of Menopause in the 7MM
• Figure 51: Market Size of Menopause by Therapies in the 7MM
• Figure 52: Market Size of Menopause by Class in the 7MM
• Figure 53: Total Market Size of Menopause in the US
• Figure 54: Market Size of Menopause by Therapies in the US
• Figure 55: Market Size of Menopause in Germany
• Figure 56: Market Size of Menopause in France
• Figure 57: Market Size of Menopause in Italy
• Figure 58: Market Size of Menopause in Spain
• Figure 59: Market Size of Menopause in the UK
• Figure 60: Market Size of Menopause in EU4 and the UK
• Figure 61: Market Size of Menopause by Therapies in Germany
• Figure 62: Market Size of Menopause by Therapies in France
• Figure 63: Market Size of Menopause by Therapies in Italy
• Figure 64: Market Size of Menopause by Therapies in Spain
• Figure 65: Market Size of Menopause by Therapies in the UK
• Figure 66: Market Size of Menopause by Therapies in EU4 and the UK
• Figure 67: Market Size of Menopause in Japan
• Figure 68: Market Size of Menopause by Therapies in Japan
• Figure 69: Unmet Needs
• Figure 70: Health Technology Assessment
• Figure 71: Reimbursement Process in Germany
• Figure 72: Reimbursement Process in France
• Figure 73: Reimbursement Process in Spain
• Figure 74: Reimbursement Process in the United Kingdom
• Figure 75: Reimbursement Process in Japan

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.

Table of Contents

1. Key Insights

2. Report Introduction

3. Country-wise Menopause Market Overview

• 3.1. Country-wise Market Share (%) Distribution of Menopause in 2019
• 3.2. Country-wise Market Share (%) Distribution of Menopause in 2032

4. Menopause Market Overview by Class

• 4.1. Market Share (%) Distribution of Menopause by Class in 2019
• 4.2. Market Share (%) Distribution of Menopause by Class in 2032

5. Methodology of Menopause Epidemiology and Market

6. Executive Summary of Menopause

7. Key Events

8. Disease Background and Overview

• 8.1. Introduction
• 8.2. Risk factors of VMS
• 8.3. Etiology
• 8.4. Types
• 8.5. Symptoms
• 8.6. Staging of Reproductive Aging
• 8.7. Diagnosis
  • 8.7.1. Diagnosis Algorithm
  • 8.7.2. Diagnostic Guidelines
    • 8.7.2.1. NICE Recommendations for Diagnosis of Perimenopause and Menopause
    • 8.7.2.2. The North American Menopause Society Recommendations for Clinical Care of Midlife Women
• 8.8. Treatment and Management of Menopause
• 8.9. Treatment Algorithm
  • 8.9.1. Treatment Algorithm
  • 8.9.2. Treatment and Management Guidelines
    • 8.9.2.1. The United States Preventive Services Task Force (USPSTF) Recommendations
    • 8.9.2.2. The American College of Obstetricians and Gynecologists Guidelines
    • 8.9.2.3. The North American Menopause Society Recommendations for Clinical Care of Midlife Women
    • 8.9.2.4. The American Academy of Family Physicians
    • 8.9.2.5. National Institute for Health and Care Excellence (NICE) Recommendations for Diagnosis of Perimenopause and Menopause

9. Epidemiology and Patient Population

• 9.1. Key Findings
• 9.2. Assumptions and Rationale: The 7MM
  • 9.2.1. Number of Women in Menopause
  • 9.2.2. Age-specific Distribution of Women in Menopause
  • 9.2.3. Vasomotor Symptoms of Women in Menopause
  • 9.2.4. Moderate-to-severe VMS in Women in Menopause
  • 9.2.5. Treatment Rate for Women in Menopause
• 9.3. Total Number of Women in Menopause in the 7MM
• 9.4. The United States
  • 9.4.1. Total Number of Women in Menopause
  • 9.4.2. Stage-specific Distribution of Women in Menopause
  • 9.4.3. Age-specific Distribution of Women in Menopause
  • 9.4.4. Number of Women in Menopause with Vasomotor Symptoms
  • 9.4.5. Number of Women in Menopause with Moderate-to-severe Vasomotor Symptoms
• 9.5. EU4 and the UK
  • 9.5.1. Germany
    • 9.5.1.1. Total Number of Women in Menopause
    • 9.5.1.2. Stage-specific Distribution of Women in Menopause
    • 9.5.1.3. Age-specific Distribution of Women in Menopause
    • 9.5.1.4. Number of Women in Menopause with Vasomotor Symptoms
    • 9.5.1.5. Number of Women in Menopause with Moderate-to-severe Vasomotor Symptoms
  • 9.5.2. France
    • 9.5.2.1. Total Number of Women in Menopause
    • 9.5.2.2. Stage-specific Distribution of Women in Menopause
    • 9.5.2.3. Age-specific Distribution of Women in Menopause
    • 9.5.2.4. Number of Women in Menopause with Vasomotor Symptoms
    • 9.5.2.5. Number of Women in Menopause with Moderate-to-severe Vasomotor Symptoms
  • 9.5.3. Italy
    • 9.5.3.1. Total Number of Women in Menopause
    • 9.5.3.2. Stage-specific Distribution of Women in Menopause
    • 9.5.3.3. Age-specific Distribution of Women in Menopause
    • 9.5.3.4. Number of Women in Menopause with Vasomotor Symptoms
    • 9.5.3.5. Number of Women in Menopause with Moderate-to-severe Vasomotor Symptoms
  • 9.5.4. Spain
    • 9.5.4.1. Total Number of Women in Menopause
    • 9.5.4.2. Stage-specific Distribution of Women in Menopause
    • 9.5.4.3. Age-specific Distribution of Women in Menopause
    • 9.5.4.4. Number of Women in Menopause with Vasomotor Symptoms
    • 9.5.4.5. Number of Women in Menopause with Moderate-to-severe Vasomotor Symptoms
  • 9.5.5. The UK
    • 9.5.5.1. Total Number of Women in Menopause
    • 9.5.5.2. Stage-specific Distribution of Women in Menopause
    • 9.5.5.3. Age-specific Distribution of Women in Menopause
    • 9.5.5.4. Number of Women in Menopause with Vasomotor Symptoms
    • 9.5.5.5. Number of Women in Menopause with Moderate-to-severe Vasomotor Symptoms
• 9.6. Japan
  • 9.6.1. Total Number of Women in Menopause
  • 9.6.2. Stage-specific Distribution of Women in Menopause
  • 9.6.3. Age-specific Distribution of Women in Menopause
  • 9.6.4. Number of Women in Menopause with Vasomotor Symptoms
  • 9.6.5. Number of Women in Menopause with Moderate-to-severe Vasomotor Symptoms

10. Patient Journey

11. Marketed Therapies

• 11.1. Key Cross Competition
• 11.2. Marketed Drugs by Class
• 11.3. DUAVEE/DUAVIVE (bazedoxifene acetate/conjugated estrogens): Pfizer/Ligand Pharmaceuticals
  • 11.3.1. Product Description
  • 11.3.2. Regulatory Milestones
  • 11.3.3. Other Developmental Activities
  • 11.3.4. Safety and Efficacy
  • 11.3.5. Product Profile
• 11.4. VEOZAH (fezolinetant): Astellas Pharma
  • 11.4.1. Product Description
  • 11.4.2. Regulatory Milestones
  • 11.4.3. Other Developmental Activities
  • 11.4.4. Clinical Development
  • 11.4.5. Clinical Trials Information
  • 11.4.6. Safety and Efficacy
  • 11.4.7. Product Profile
• 11.5. BIJUVA / BIJUVE (estradiol and progesterone): TherapeuticsMD
  • 11.5.1. Product Description
  • 11.5.2. Regulatory Milestones
  • 11.5.3. Other Development Activities
  • 11.5.4. Clinical Development
  • 11.5.5. Clinical Trials Information
  • 11.5.6. Safety and Efficacy
  • 11.5.7. Product Profile

12. Emerging Therapies

• 12.1. Key Cross Competition
• 12.2. Transdermal Estradiol Cream (VML-0203): Viramal Limited/Simbec Research
  • 12.2.1. Product Description
  • 12.2.2. Clinical Development
  • 12.2.3. Clinical Trials Information
  • 12.2.4. Product Profile
• 12.3. DONESTA (E4, Estetrol): Estetra/Mithra Pharmaceuticals
  • 12.3.1. Product Description
  • 12.3.2. Other Developmental Activity
  • 12.3.3. Clinical Development
  • 12.3.4. Clinical Trials Information
  • 12.3.5. Safety and Efficacy
  • 12.3.6. Product Profile
  • 12.3.7. Analysts' Views
• 12.4. Elinzanetant (BAY3427080): Bayer|Nerre Therapeutics Ltd.
  • 12.4.1. Product Description
  • 12.4.2. Other Developmental Activity
  • 12.4.3. Clinical Development
  • 12.4.4. Clinical Trials Information
  • 12.4.5. Safety and Efficacy
  • 12.4.6. Product Profile
  • 12.4.7. Analysts' Views
• 12.5. MT-8554 (Elismetrep): Mitsubishi Tanabe Pharma America Inc.
  • 12.5.1. Product Description
  • 12.5.2. Clinical Development
  • 12.5.3. Clinical Trials Information
  • 12.5.4. Safety and Efficacy
  • 12.5.5. Product Profile
• 12.6. MNGX-100 (Filgrastim/G-CSF): MenoGeniX
  • 12.6.1. Product Description
  • 12.6.2. Other Developmental Activity
  • 12.6.3. Clinical Development
  • 12.6.4. Clinical Trials Information
  • 12.6.5. Safety and Efficacy
  • 12.6.6. Product Profile
• 12.7. Q-122 (MSX-122): QUE Oncology
  • 12.7.1. Product Description
  • 12.7.2. Clinical Development
  • 12.7.3. Clinical Trials Information
  • 12.7.4. Product Profile
• 12.8. FP-101: Fervent Pharmaceuticals
  • 12.8.1. Product Description
  • 12.8.2. Clinical Development
  • 12.8.3. Clinical Trials Information
  • 12.8.4. Product Profile

13. Menopause: Market Analysis

• 13.1. Key Findings
• 13.2. Key Market Forecast Assumptions
• 13.3. Market Outlook
• 13.4. Conjoint Analysis
• 13.5. Total Market Size of Menopause in the 7MM
• 13.6. Market Size of Menopause by Therapies in the 7MM
• 13.7. Market Size of Menopause in the United States
  • 13.7.1. Total Market Size of Menopause
  • 13.7.2. Market Size of Menopause by Therapies
• 13.8. Market Size of Menopause in EU4 and the UK
  • 13.8.1. Germany
    • 13.8.1.1. Total Market Size of Menopause
    • 13.8.1.2. Market size of Menopause by Therapies
  • 13.8.2. France
    • 13.8.2.1. Total Market Size of Menopause
    • 13.8.2.2. Market size of Menopause by Therapies
  • 13.8.3. Italy
    • 13.8.3.1. Total Market Size of Menopause
    • 13.8.3.2. Market size of Menopause by Therapies
  • 13.8.4. Spain
    • 13.8.4.1. Total Market Size of Menopause
    • 13.8.4.2. Market size of Menopause by Therapies
  • 13.8.5. The UK
    • 13.8.5.1. Total Market Size of Menopause
    • 13.8.5.2. Market size of Menopause by Therapies
• 13.9. Market Size of Menopause in Japan
  • 13.9.1. Total Market Size of Menopause
  • 13.9.2. Market size of Menopause by Therapies

14. Key Opinion Leaders' Views

15. SWOT Analysis

16. Unmet Needs

17. Market Access and Reimbursement

• 17.1. The United States
  • 17.1.1. Centre for Medicare and Medicaid Services (CMS)
• 17.2. In EU4 and the UK
  • 17.2.1. Germany
  • 17.2.2. France
  • 17.2.3. Italy
  • 17.2.4. Spain
  • 17.2.5. The United Kingdom
• 17.3. Japan
  • 17.3.1. MHLW

18. Appendix

• 18.1. Bibliography
• 18.2. Acronyms and Abbreviations

19. Report Methodology

20. DelveInsight Capabilities

21. Disclaimer