Methyldopa

The menopause market is anticipated to surge significantly in the coming years due to the emergence of new products in the pipeline. In addition, persistently rising cases of menopause in the forecast period will help increase the menopause treatment market. LAS VEGAS, Sept. 12, 2023 /PRNewswire/ -- DelveInsight's Menopause Market Insights report includes a comprehensive understanding of current treatment practices, menopause emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU-4 (Italy, Spain, France, and Germany), the United Kingdom, and Japan]. Key Takeaways from the Menopause Market Report As per DelveInsight analysis, the menopause market size in the 7MM was approximately USD 11 billion in 2022. According to the assessment done by DelveInsight, 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. Leading menopause companies such as Viramal Limited, Simbec Research, Estetra, Mithra Pharmaceuticals, Bayer, Nerre Therapeutics Ltd., Mitsubishi Tanabe Pharma America Inc., MenoGeniX, QUE Oncology, Fervent Pharmaceuticals, and others are developing novel menopause drugs that can be available in the menopause market in the coming years. The promising menopause therapies in the pipeline include Transdermal Estradiol Cream (VML-0203), DONESTA (E4, Estetrol), Elinzanetant (BAY3427080), MT-8554 (Elismetrep), MNGX-100 (Filgrastim/G-CSF), Q-122 (MSX-122), FP-101, and others. Discover which therapies are expected to grab the major menopause market share @ Menopause Market Report Menopause Overview Menopause is a natural biological process that marks the end of a woman's reproductive years. It usually occurs between the ages of 45 and 55, with an average age of around 51. This phase is characterized by a decline in the production of hormones like estrogen and progesterone, leading to the cessation of menstruation and fertility. The primary cause of menopause is the aging of the ovaries, which results in a reduced number of eggs and a decline in hormone production. However, certain medical procedures like hysterectomy, chemotherapy, and radiation therapy can induce menopause prematurely. Menopause brings about a range of symptoms that can vary widely from woman to woman. Common menopause symptoms include hot flashes, night sweats, mood swings, irritability, fatigue, vaginal dryness, and sleep disturbances. These symptoms occur due to the hormonal fluctuations that take place during the transition to menopause. Diagnosing menopause is often based on a woman's age, medical history, and symptoms. A key factor is the absence of menstruation for 12 consecutive months, signaling the end of the reproductive period. In some cases, healthcare providers may recommend blood tests to measure hormone levels, such as follicle-stimulating hormone (FSH) and estrogen, to confirm the onset of menopause. Menopause Epidemiology Segmentation DelveInsight estimates that there were approximately 100 million total women in menopause in the 7MM in 2022. For the age-specific analysis, the 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 the age-group 51-60 years and the lowest in <40 years with 64 million and 3.4 million cases, respectively in 2022. The menopause market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into: 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 Number of Women in Menopause with Moderate-to-Severe Vasomotor Symptoms Menopause Treatment Market The North American Menopause Society (NAMS) suggests waiting until the hot flashes become troublesome to the woman before seeking treatment. The intensity of symptoms, an assessment of treatment-related risks, and the woman's views towards menopause and drugs should all be considered before starting treatment. Duavee (bazedoxifene acetate/conjugated estrogens) is the first and only medicine that combines CE with an estrogen agonist/antagonist, commonly known as a selective estrogen receptor modulator (SERM), for the treatment of menopausal VMS. Duavee employs bazedoxifene rather than progestin to help protect the uterine lining from hyperplasia that may occur as a result of estrogen-only treatment. Many women use non-prescription therapies to address disorders such as hot flashes, such as isoflavones, black cohosh, and progesterone-containing hormone lotions. The clinical evidence for the efficacy and long-term safety of these therapies is insufficient. Furthermore, most over-the-counter medications for hot flashes are classified as nutritional supplements and, as such, are not regulated by the US Food and Drug Administration. Prescription medications for various purposes that have demonstrated some benefit in alleviating hot flashes are available for women who have hot flashes but cannot undergo hormone therapy. Certain prescription antidepressants may reduce hot flashes in women, including those with a history of breast cancer. Others include gabapentin, clonidine, and methyldopa. The NAMS recommends that women who need relief from mild menopause-related hot flashes first consider lifestyle changes such as manipulating the environment to keep the core body temperature cool, getting regular exercise, quitting smoking, and using relaxation techniques such as paced respiration. To know more about menopause treatment, visit @ Menopause Treatment Drugs Key Menopause Therapies and Companies Transdermal Estradiol Cream (VML-0203): Viramal Limited/Simbec Research DONESTA (E4, Estetrol): Estetra/Mithra Pharmaceuticals Elinzanetant (BAY3427080): Bayer|Nerre Therapeutics Ltd. MT-8554 (Elismetrep): Mitsubishi Tanabe Pharma America Inc. MNGX-100 (Filgrastim/G-CSF): MenoGeniX Q-122 (MSX-122): QUE Oncology FP-101: Fervent Pharmaceuticals Learn more about the FDA-approved drugs for menopause @ Drugs for Menopause Treatment Menopause Market Dynamics The menopause market dynamics are undergoing significant shifts as societal awareness of women's health and well-being continues to grow. With an aging population and increasing focus on women's empowerment, there's a heightened demand for innovative products and services addressing the physical and emotional challenges associated with menopause. This has spurred a surge in research and development, leading to the creation of a diverse range of hormone replacement therapies, herbal supplements, lifestyle apps, and personalized health plans. As more women seek effective and holistic solutions, companies are embracing a more consumer-centric approach, tailoring their offerings to individual needs and preferences. Additionally, discussions around menopause are becoming less taboo, allowing for open dialogue and information-sharing, further shaping the menopause market dynamics by fostering a supportive ecosystem for women navigating this life stage. However, despite the potential for growth, this menopause market is not without its barriers. Stringent regulatory processes for hormonal treatments and supplements, coupled with concerns about product safety and efficacy, pose challenges for menopause market entrants. Additionally, cultural stigmas and misinformation surrounding menopause still exist in certain societies, inhibiting open discussions and the adoption of new solutions. Economic disparities and limited access to healthcare further compound these issues, preventing equal menopause market penetration. Overcoming these barriers requires a multi-faceted approach, involving education, regulatory reforms, and inclusive product development, to truly tap into the menopause market's potential. Scope of the Menopause Market Report Therapeutic Assessment: Menopause current marketed and emerging therapies Menopause Market Dynamics: Attribute Analysis of Emerging Menopause Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's Views, Analyst's Views, Menopause Market Access and Reimbursement Discover more about menopause drugs in development @ Menopause Clinical Trials Table of Contents Related Reports Hot Flashes Pipeline Hot Flashes Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key hot flashes companies, including Veru Healthcare, Fervent Pharmaceuticals, Ogeda, Bayer, Lundbeck A/S, TherapeuticsMD, MenoGeniX, Mitsubishi Tanabe Pharma, QUE Oncology, Pherin Pharmaceuticals, among others. Hot Flashes Market Hot Flashes Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key hot flashes companies, including Veru Healthcare, Fervent Pharmaceuticals, Ogeda, Bayer, Lundbeck A/S, TherapeuticsMD, MenoGeniX, Mitsubishi Tanabe Pharma, QUE Oncology, among others. Menopause Global Market Menopause Market Insights, Competitive Landscape, and Market Forecast – 2028 report deliver an in-depth understanding of the disease, market trends, market drivers, market barriers, and key menopause companies including ISIDEN, Novapharm, Arkopharma, Pileje, Thermamex, ÉLERTÉ Laboratories, Serelys Pharma, Besins Healthcare, Bayer, ITALFARMACO S.p.A, Pfizer Inc, Mylan NV, Teva Pharmaceuticals, TherapeuticsMD, Inc, Novo Nordisk, Novartis, Millicent Pharma, PADAGIS LLC, Vertical Pharmaceuticals LLC, Amgen, among others. Vasomotor Symptoms of Menopause Pipeline Vasomotor Symptoms of Menopause Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key vasomotor symptoms of menopause companies, including Mithra Pharmaceuticals, Acer Therapeutics, QUE Oncology, Bayer, Endoceutics, Astellas Pharma, Mitsubishi Tanabe Pharma, MenoGenix, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

近日，罗氏公布2023H1业绩，在制药业务板块，其眼科产品VEGF-A/Ang2双抗Vabysmo（Faricimab，法瑞西单抗）收入增长迅猛，今年上半年销售收入达9.57亿瑞士法郎（约10.5亿美元），同比增长500%。VabysmoVabysmo是一款双特异性抗体，同时靶向作用于血管内皮生长因子A（VEGF-A）和血管生成素2（Ang-2）这两条不同的信号通路。从生物学机制上看，VEGF-A和Ang-2信号会使血管不稳定，诱导形成新生血管和促进炎症。Vabysmo在阻断VEGF/VEGFR信号有效控制新生血管形成的同时，也能抑制Ang-2信号来改善血管稳定性和减轻视网膜炎症。与单纯抗VEGF疗法相比，Vabysmo用于治疗多种视网膜疾病可以实现减少眼部注射给药频率，改善患者的远期视力结局。Vabysmo是首款针对眼科疾病获批的双特异性抗体，是首个在治疗糖尿病性黄斑水肿（DME）和湿性年龄相关性黄斑变性（wAMD）的III期研究中达到4个月间隔给药的药物。Vabysmo在2022年1月底首次获FDA批准上市，仅一年后便成长为一款重磅炸弹。FDA已于今年5月受理其用于治疗视网膜静脉阻塞（RVO）的新适应症上市申请。目前，Vabysmo正在加速放量，罗氏预计Vabysmo今年销售额有望达到20亿美元。除了Vabysmo外，抗VEGF的眼科用药还有哪些？目前研发进展如何？DME和AMD简介DME是糖尿病性视网膜病变（DR）的一种并发症。糖尿病患者因为血糖过高，对眼部血管造成损伤，会导致血液和/或体液渗入视网膜，就会造成糖尿病性视网膜病变（DR）的发生，表现视网膜部分区域的肿胀和血液供给阻断。如果血管损伤和渗漏发生在视网膜的中央区域，就会引起黄斑水肿，即糖尿病性黄斑水肿。DME如果不加以干预治疗，会严重威胁到视力，影响生活质量。AMD是一种会影响到人们需要清晰中央视力的日常活动（比如阅读）的眼部疾病，该疾病进展到晚期则称为新生血管性年龄相关性黄斑变性（nAMD），或者叫做湿性年龄相关性黄斑变性（wAMD），病理表现为新生和异常的血管在黄斑下不受控制地生长，导致肿胀、出血和/或纤维化，如果不加以治疗，通常会导致中央视力的永久性丧失。AMD变化过程来源：参考来源2AMD是60岁以上人群视力损害和严重视力丧失的主要原因之一。2020年全球有1.96亿AMD患者，预计到2040年将达到2.88亿。AMD被称为“不死的癌症”，在VEGF靶向药物出现之前，其治疗手段有限，大多依靠激光、手术、经瞳孔温热疗法、光动力疗法等来稳定病情，但这些疗法难以改善视力并且存在种种弊端。自从抗VEGF眼科用药被开发出来后，彻底改变了AMD以及DME的治疗现状。VEGF作用机制及获批药物VEGF即血管内皮生长因子，是细胞内刺激血管生成的信号蛋白，具备促进血管新生和再生的功能。VEGF家族包括VEGF-A、VEGF-B、VEGF-C、VEGF-D、VEGF-E和胎盘生长因子（PIGF），具有促进血管通透性增加、细胞外基质变性、血管内皮细胞迁移、增殖和血管形成等作用。VEGF的高表达与AMD、DR及息肉状脉络膜血管病变（PCV）等新生血管性视网膜疾病的发生发展密切相关，以VEGF作为靶点的药物治疗能从发病机制上抑制视网膜疾病的发生发展。当前已获批的靶向VEGF类药物主要有抗VEGF单抗、融合蛋白，以及双靶点抗VEGF药物。其中单抗类有罗氏/诺华的雷珠单抗（Ranibizumab，Lucentis）、诺华的Brolucizumab（Beovu）；融合蛋白类有拜耳/再生元的阿柏西普（Aflibercept，Elyea）、康弘药业的康柏西普（Conbercept）；双靶点抗VEGF药物有罗氏的Vabysmo。雷珠单抗雷珠单抗由罗氏旗下基因泰克和诺华联合开发，主要机制是结合并阻断VEGF受体，减少血管内皮细胞增殖、血管渗漏和新血管生成，并促进已有的新生血管消退。雷珠单抗于2006年获FDA批准上市，是全球首个获批用于眼科的抗VEGF药物。雷珠单抗的获批使抗VEGF疗法在很大程度上取代了以前的治疗策略。自上市以来，雷珠单抗全球销售额基本维持在30亿美元。2014年全球销售额达到顶峰，超40亿美元，近年来销售额出现下滑趋势。阿柏西普阿柏西普是一种新型玻璃体内注射用VEGF抑制剂，是一种重组融合蛋白，由人VEGF受体1和2的胞外区与人体免疫球蛋白G1（IgG1）的可结晶片段融合而成。它是全球首个完全人源的重组融合蛋白，可同时阻断VEGF-A、VEGF-B以及胎盘生长因子（PIGF），作用靶点更广，可有效结合VEGF二聚体，同时有着更长的作用时间，更持久的疗效，注射间隔可延长至3-4个月。自2011年获FDA批准上市用于wADM的治疗后，目前阿柏西普在眼科领域已有五个适应症获批，包括DME、nAMD，RVO、以及病理性近视性脉络膜新生血管（myopic CNV）引发的视力损害。阿柏西普上市的第一年销售额就达到了8.38亿美元；2021年，全球销售额更是达到93.85亿美元，市场占比已接近50%，成为名副其实的重磅炸弹。同一年，雷珠单抗销售额只有35.1亿美元。2022年，阿柏西普全球销售额为96.47亿美元，同比增长4%。目前，阿柏西普是全球销售量最高的抗VEGF眼科药物。康柏西普康柏西普是由康弘药业自主研发的一款抗VEGF受体与人免疫球蛋白Fc段基因重组的融合蛋白。自2013年在国内获批以来，康柏西普已经批准了3个适应症。BrolucizumabBrolucizumab是诺华研发的一款人源化单链抗体片段（scFv），分子量为26kDa，具有体积小、组织渗透性强、对VEGF-A异构体有强大抑制作用及高度亲和力。在临床试验HAWK和HARRIER试验中的数据显示，Brolucizumab分别以87%和83％的概率，以12周的给药间隔成功维持至48周，即疗效可持续12周。Brolucizumab于2019年10月获FDA批准上市，用于wAMD的治疗。Evaluate Pharma预测，Brolucizumab到2024年全球销售额有望达到13.2亿美元。眼科领域在研抗VEGF药物雷珠单抗和阿柏西普的专利均已于2020年到期，2021年9月，FDA批准了Biogen/三星Bioepis联合研发的雷珠单抗生物类似药SB11。国内也有很多它们的仿制药在研。去年4月，齐鲁制药提交了阿柏西普生物类似药QL1207的上市申请；今年1月，齐鲁制药提交的雷珠单抗生物类似药QL1205的上市申请获受理。一旦批准上市，国内眼科抗VEGF生物药领域将进入创新药和仿制药混战的局面，市场竞争加剧。另外，尽管抗VEGF疗法取得了巨大的成功，但是单靶VEGF抑制剂对VEGF激活的抑制作用，会促使其他促血管生成因子的上调表达，这不利于药物发挥疗效，对导致DME、wAMD炎症的减轻作用有限。因此，这类患者面临较大未满足的临床需求，需要更优疗效、更小风险和更加便捷的药物。近年来双靶点药物已逐渐成为抗VEGF药物治疗眼科疾病的重要研发方向之一。目前，双靶点抗VEGF药物只有罗氏的Vabysmo获批上市。部分在研的抗VEGF眼科创新型药物来源：药渡数据库在双靶点抗VEGF药物研发中，荣昌生物的RC28-E、信达生物的IBI302以及Adverum Biotechnologies的ADVM-022研发进度靠前。RC28-ERC28-E是荣昌开发的首创VEGF/FGF（成纤维细胞生长因子）双靶标融合蛋白药物。RC28-E由VEGFR1、VEGFR2和FGFR1的胞外结构域与人IgG1融合而成，其中IgG1片段可延长药物在血清中的半衰期，从而减少给药频率。RC28-E独特的结构设计有效避免了单靶VEGF抑制剂的缺陷，并且其人源化设计可有效延长半衰期，从而减少给药频率并减轻患者不适。在Ib期剂量扩大试验中，结果显示，RC28-E在wAMD患者中展现出良好的耐受性和安全性，显著改善了患者的视力和病情。并且，对于此前接受抗VEGF药物治疗和眼底息肉状脉络膜血管病变（PCV）的患者，RC28-E均展现出疗效。目前RC28-E正在进行III期临床研究，旨在评估RC28-E治疗wAMD患者的有效性和安全性。据华安证券研报预测，倘若RC28-E的wAMD、DME这两个适应症能在2026年初上市，预估2026年、2027年国内销售额合计约可达到2.1亿元和5.41亿元。IBI302IBI302是信达于2012年从圆祥生命科技引进一款创新性双靶向特异性重组全人源融合蛋白。IBI302的N末端可与VEGF家族结合并阻断其介导的信号通路，从而抑制血管上皮细胞增殖和血管生成，降低血管通透性和减少渗漏；IBI302的C末端可以特异性结合C3b和C4b并抑制二者介导的补体激活经典途径和补体激活替代途径，减少补体介导的炎症反应。通过以上两种机制，IBI302可以实现治疗和控制nAMD的目的。在I期临床研究中，结果表明，IBI302具有良好的安全性和耐受性，患者接受治疗后视力明显改善且视网膜水肿也有所减少。2023年7月28日，信达在药物临床试验登记与信息公示平台登记了一项III期临床试验，旨在评估IBI302对比阿柏西普治疗nAMD的有效性和安全性。ADVM-022ADVM-022是一款玻璃体内注射治疗wAMD的一次性基因疗法。它使用Adverum独有的AAV.7m8载体，携带表达编码Aflibercept的转基因。Aflibercept是已经获批治疗湿性AMD的重组蛋白疗法，它将IgG与VEGF受体的细胞外域融合在一起，通过与VEGF-A结合，阻断VEGF-A的信号传导。与其它需要进行视网膜下注射的基因疗法不同，ADVM-022只需要一次玻璃体内注射，旨在提供长期疗效，降低频繁抗VEGF药物注射带来的治疗负担，并且改善患者的视力。毫无疑问，抗VEGF药物在眼科的应用，无论对眼底病，还是整个眼科的发展都是一个里程碑式的变革，对眼底疾病的治疗产生了巨大影响，也为其他慢性眼病的治疗提供了强大的参考和启示。据光大证券发布的研究报告，我国VEGF类药品眼科渗透率仅1.15%，而美国市场的渗透率约为6-7%。假设到2025年，我国VEGF药品在眼科的渗透率和使用频率达到美国的水平，届时我国VEGF药品眼科市场空间将超过百亿，由此可见抗VEGF药物市场巨大的潜力和价值。目前在该赛道，国内还是一片蓝海，药品研发速度以及创新性和差异化，是脱颖而出的关键。参考来源罗氏2023H1财报.Macular Degeneration Breakthroughs.https://www.verywellhealth.com/macular-degeneration-emerging-treatments-5071096.刘正,王业青,张晓梅.眼部新生血管与抗血管内皮生长因子治疗[J].国际眼科杂志,2007(03):779-781.Li Y, Baccouche B, Olayinka O, Serikbaeva A, Kazlauskas A. The Role of the Wnt Pathway in VEGF/Anti-VEGF-Dependent Control of the Endothelial Cell Barrier. Invest Ophthalmol Vis Sci. 2021;62(12):17. doi:10.1167/iovs.62.12.17.欧阳灵艺,邢怡桥. 抗VEGF药物在湿性年龄相关性黄斑变性中的应用进展[J]. 国际眼科杂志,2020,20(01):74-78.END👇关注药渡数据媒体矩阵