全球氨甲环酸市场规模、份额和趋势分析报告 – 行业概况和 2031 年预测

氨甲环酸市场分析

氨甲环酸市场正在经历显著增长，其在治疗出血性疾病方面的功效及其在各种外科手术中的应用越来越受到认可。正如 PMC 上发表的一篇系统评价所强调的那样，与安慰剂相比，氨甲环酸已被证明可将创伤患者的死亡率降低三分之一，凸显了其在急诊医学中的重要作用。CRASH-2 试验进一步证实了该药物在诱发事件发生后三小时内服用时的有效性，巩固了其作为创伤出血关键干预措施的地位。此外，氨甲环酸的应用范围不仅限于创伤护理；它越来越多地用于选择性手术，包括骨科和牙科手术，它有助于最大限度地减少失血并减少输血需求。越来越多的证据，加上全球创伤病例和外科手术发生率的上升，正在推动整个医疗环境中对氨甲环酸的需求。此外，外用制剂开发等创新正在扩大其用途，为市场参与者提供有利可图的机会。随着医疗保健提供者继续优先考虑患者安全和结果优化，氨甲环酸市场将在未来几年实现持续增长。

氨甲环酸市场规模

2023 年全球氨甲环酸市场规模价值 8185 万美元，预计到 2031 年将达到 1.285 亿美元，2024 年至 2031 年预测期内的复合年增长率为 5.80%。除了对市场价值、增长率、细分、地理覆盖范围和主要参与者等市场情景的见解外，Data Bridge Market Research 策划的市场报告还包括深度专家分析、患者流行病学、管道分析、定价分析和监管框架。

氨甲环酸市场趋势

“外用制剂的引入日益增多”

The tranexamic acid market is witnessing a notable trend toward the development of innovative formulations that enhance its usability and application across various medical fields. One significant advancement is the introduction of topical formulations, such as tranexamic acid sprays, which provide an easy-to-apply, non-invasive option for managing localized bleeding. For instance, Shilpa Medicare Limited's recent launch of the world’s first topical hemostatic spray containing tranexamic acid has been approved by the Central Drugs Standard Control Organization (CDSCO) in India. This formulation is designed for emergency use, making it a lifesaving tool for trauma patients and surgical procedures. Such innovations broaden the scope of tranexamic acid’s applications and improve patient outcomes by facilitating timely intervention. As healthcare providers increasingly adopt these advanced formulations, the tranexamic acid market is set to expand, driven by the demand for effective and user-friendly solutions in bleeding management.

Report Scope and Tranexamic Acid Market Segmentation    

Tranexamic Acid Market Definition

Tranexamic acid is a synthetic derivative of the amino acid lysine, primarily used as an antifibrinolytic agent. It works by inhibiting the activation of plasminogen to plasmin, a process that breaks down fibrin, the protein that helps form blood clots. By preventing this breakdown, tranexamic acid effectively reduces excessive bleeding in various medical situations, including surgical procedures, trauma, and certain bleeding disorders.

Tranexamic Acid Market Dynamics

Drivers

• Increasing Prevalence of Bleeding Disorders

The increasing prevalence of bleeding disorders significantly drives the demand for tranexamic acid as an effective treatment option. According to the World Federation of Hemophilia, approximately 1 in 5,000 to 10,000 male live births are affected by hemophilia A, with an estimated global population of over 400,000 people living with this condition. Additionally, menorrhagia, or heavy menstrual bleeding, affects around 10-30% of women in their reproductive years, highlighting a substantial patient population seeking effective management solutions. Tranexamic acid has emerged as a first-line therapy for treating these conditions due to its proven efficacy in reducing blood loss. Clinical studies have shown that tranexamic acid can reduce menstrual bleeding by up to 60% in women with menorrhagia, enhancing patient quality of life and offering a non-invasive alternative to more aggressive treatments. As awareness of these bleeding disorders grows and healthcare providers increasingly adopt tranexamic acid in their treatment protocols, the market for this drug is poised for continued expansion, making it a critical driver in the healthcare landscape.

• Increasing Number of Surgical Procedures

The increasing number of surgical procedures performed worldwide is a crucial driver of the tranexamic acid market, as effective hemostatic agents are essential in minimizing blood loss and enhancing patient safety. According to a report by the World Health Organization, surgical procedures are projected to rise by 25% by 2030, highlighting the growing demand for reliable patient blood management solutions. Tranexamic acid is particularly valuable in high-risk surgeries, such as orthopedic and cardiac operations, where excessive bleeding can lead to complications and increased healthcare costs. For instance, in orthopedic surgeries, National Institute of Health U.S., studies have shown that the use of tranexamic acid can reduce blood loss, significantly decreasing the necessity for blood transfusions. Furthermore, in cardiac surgery, the administration of tranexamic acid has been associated with reduced rates of postoperative bleeding and improved recovery times. This growing trend towards more surgical interventions, coupled with the proven efficacy of tranexamic acid, underscores its critical role in modern surgical practices and propels its market growth as a vital hemostatic agent.

Opportunities

• Rising Awareness of Trauma Management

Rising awareness of trauma management has created a significant market opportunity for tranexamic acid, especially given its critical role in emergency medicine. Increased recognition of the importance of timely intervention in trauma cases has led to the incorporation of tranexamic acid in treatment protocols for traumatic hemorrhage, which is a leading cause of preventable death. For instance, findings from the CRASH-2 trial demonstrated that administering tranexamic acid within three hours of injury can reduce mortality from bleeding by approximately 15%, making it a vital therapeutic option in trauma care. The growing emphasis on early and effective hemorrhage control has prompted emergency medical services and hospitals to prioritize the use of tranexamic acid in their protocols, enhancing its adoption in critical situations. Furthermore, training initiatives and awareness campaigns aimed at improving trauma care practices continue to advocate for the use of tranexamic acid, further expanding its market potential as a key intervention in saving lives during emergencies.

• Growing Investments in Healthcare Infrastructure

Growing investments in healthcare infrastructure, particularly in emerging markets, present a substantial market opportunity for tranexamic acid, as these improvements enhance access to essential medications. For instance, countries such as India and Brazil are significantly increasing their healthcare expenditures to modernize hospitals and expand access to quality care. As healthcare facilities upgrade and expand their capabilities, the demand for effective treatment options for bleeding control is likely to rise, particularly in surgical and trauma settings where tranexamic acid plays a critical role. Furthermore, initiatives aimed at improving emergency care and surgical outcomes will lead to higher utilization rates of this hemostatic agent. This trend towards enhanced healthcare infrastructure improves patient outcomes and creates a conducive environment for the increased adoption of tranexamic acid, driving its market growth in these regions.

Restraints/Challenges

• Lengthy and Complex Regulatory Processes

Regulatory hurdles represent a significant challenge in the tranexamic acid market, as obtaining approval for new indications often involves a lengthy and complex process that can vary widely across different countries. For instance, while tranexamic acid is already established for use in managing bleeding during surgery, its approval for newer indications, such as preventing blood loss in trauma patients or treating heavy menstrual bleeding, requires extensive clinical trials and comprehensive documentation to satisfy varying regulatory standards. In the U.S., the FDA mandates rigorous premarket evaluation, including randomized controlled trials, to assess safety and efficacy for any new indication, which can take years and incur substantial costs. Similarly, in Europe, the European Medicines Agency (EMA) requires a detailed assessment under the European Medicines Agency's regulatory framework, including compliance with the Medical Device Regulation (MDR) when applicable. These differing regulatory requirements can lead to significant delays in bringing tranexamic acid to market for new uses, hindering the market growth in diverse clinical settings.

• Adverse Effects and Safety Concerns

Adverse effects and safety concerns pose a significant challenge in the tranexamic acid market, as, despite its general safety profile, the drug is associated with potential adverse events that can deter its use in certain populations. One of the most notable concerns is the increased risk of thromboembolic events, such as deep vein thrombosis and pulmonary embolism, particularly among patients with pre-existing risk factors, including obesity or a history of vascular disorders. Such hesitancy can result in underutilization of tranexamic acid, especially in settings where alternative hemostatic agents are available and perceived as safer. Consequently, the safety profile of tranexamic acid can significantly influence clinicians' decision-making processes, potentially limiting its adoption in critical surgical and trauma care settings, which ultimately impacts its market growth.

This market report provides details of new recent developments, trade regulations, import-export analysis, production analysis, value chain optimization, market share, impact of domestic and localized market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on the market contact Data Bridge Market Research for an Analyst Brief, our team will help you take an informed market decision to achieve market growth.

Tranexamic Acid Market Scope

The market is segmented on the basis of type, form, application, end users, and distribution channel. The growth amongst these segments will help you analyse meagre growth segments in the industries and provide the users with a valuable market overview and market insights to help them make strategic decisions for identifying core market applications.

Type

• USP25
• BP2000
• Other

Form

• Tablets
• Injections
• Oral Liquid

Application

• Trauma
• Craniocerebral Trauma
• Menorrhagia
• Postpartum Hemorrhage
• Surgery
• Whitening Cosmetics
• Others

End Users

• Clinics
• Hospitals
• Diagnostic Centers
• Others

Distribution Channel

• Hospital Pharmacy
• Retail Pharmacy
• Online Pharmacy

Tranexamic Acid Market Regional Analysis

The market is analysed and market size insights and trends are provided by country, type, form, application, end users, and distribution channel as referenced above.

市场报告涉及的国家包括北美洲的美国、加拿大和墨西哥、欧洲的德国、法国、英国、荷兰、瑞士、比利时、俄罗斯、意大利、西班牙、土耳其、欧洲其他地区、亚太地区（APAC）的中国、日本、印度、韩国、新加坡、马来西亚、澳大利亚、泰国、印度尼西亚、菲律宾、亚太地区（APAC）的其他地区、沙特阿拉伯、阿联酋、南非、埃及、以色列、中东和非洲（MEA）的其他地区、南美洲的巴西、阿根廷和南美洲其他地区。

北美预计将引领全球氨甲环酸市场，主要原因是医疗保健领域的大量投资预计将刺激市场扩张。在该地区，美国预计将占据领先地位，这主要是因为其在医疗保健解决方案和创新治疗方案方面的技术进步迅速。此外，美国越来越重视早期疾病检测和个性化医疗，这进一步增强了对氨甲环酸的需求，有助于该地区在该市场占据主导地位。

预计亚太地区将在 2024 年至 2031 年期间经历显著增长，这主要得益于仿制药和品牌阿奇霉素的供应，使患者更容易获得。生物制药领域的快速发展促进了创新疗法的发展，进一步推动了市场扩张。该地区研发活动的增加为药物发现和改进营造了充满活力的环境。此外，医疗保健行业的持续发展，以及政府的大力支持和旨在提高医疗保健可及性和可负担性的举措，将推动亚太地区氨甲环酸市场的整体增长。

报告的国家部分还提供了影响单个市场因素和国内市场监管变化，这些因素和变化会影响市场的当前和未来趋势。下游和上游价值链分析、技术趋势和波特五力分析、案例研究等数据点是用于预测单个国家市场情景的一些指标。此外，在提供国家数据的预测分析时，还考虑了全球品牌的存在和可用性以及它们因来自本地和国内品牌的大量或稀缺竞争而面临的挑战、国内关税和贸易路线的影响。  

氨甲环酸市场份额

市场竞争格局按竞争对手提供详细信息。详细信息包括公司概况、公司财务状况、产生的收入、市场潜力、研发投资、新市场计划、全球影响力、生产基地和设施、生产能力、公司优势和劣势、产品发布、产品宽度和广度、应用主导地位。以上提供的数据点仅与公司对市场的关注有关。

在市场上运营的氨甲环酸市场领导者是：

• Venkatasai 生命科学公司（印度）
• 上海盛欣医药化工有限公司 (中国)
• VBShilpa（印度）
• 湖南洞庭药业有限公司 (中国)
• 海南葫芦娃药业有限公司 (中国)
• 葛兰素史克公司（英国）
• Aurobindo Pharma（印度）
• Dr. Reddy's Laboratories Ltd.（印度）
• 鲁冰花（印度）
• 太阳制药工业有限公司 (印度)
• Viatris Inc.（美国）
• Teva Pharmaceutical Industries Ltd.（以色列）
• Hikma Pharmaceuticals PLC（英国）
• 百特（美国）
• 山德士集团（瑞士）
• 辉瑞公司（美国）
• 诺华公司（瑞士）
• 安进公司 (美国)
• Zydus Cadila（印度）

氨甲环酸市场最新动态

• 2024 年 5 月，女性健康倡导者 Maxwellia 宣布推出 Evana 重度经期缓解剂 500 毫克片剂（含氨甲环酸）和 Ultravana 经期止痛剂 250 毫克肠溶片剂（含萘普生），以帮助女性应对重度和痛经。Evana 是一种抗纤维蛋白溶解剂，用于减少月经量过多 (HMB)，可将血流量减少高达 60%。它是唯一专门用于缓解重度经期出血的药房品牌
• 2024 年 1 月，专注于提供基本注射药物的专业制药公司 Avenacy 宣布在美国推出氨甲环酸注射液 USP，作为 Cyklokapron 的治疗仿制药，经美国食品药品管理局批准。该注射剂适用于血友病患者的短期使用（2 至 8 天），以减少或预防出血，并最大限度地减少拔牙期间和拔牙后进行替代治疗的需要
• 2022 年 9 月，Shilpa Medicare Limited 宣布成功创新了世界上第一种含有氨甲环酸的局部止血喷雾剂，该喷雾剂已获得中央药品标准控制组织 (CDSCO) 的批准。这种突破性的喷雾剂配方易于使用、便携、易于涂抹，可作为救生工具。它已在人类和强大的猪创伤模型中进行了临床验证

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