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市场调查报告书
商品编码
1887154
治疗性白蛋白市场规模、占有率、成长及全球产业分析:按类型、应用和地区划分的洞察,以及2024年至2032年的预测Therapeutic Albumin Market Size, Share, Growth and Global Industry Analysis By Type & Application, Regional Insights and Forecast to 2024-2032 |
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受严重疾病发病率上升和急诊护理需求增加的推动,全球治疗性白蛋白市场正经历着稳定且持续的增长。根据最新的产业评估,预计2024年全球市场规模将达到44.2亿美元,2025年将成长至47.1亿美元,到2032年将达到75.5亿美元。亚太地区预计将在2024年引领市场,占全球收入的54.52%,这主要得益于该地区疾病的高发生率和血浆衍生产品的广泛应用。
治疗性白蛋白源自人类血浆,用于治疗低血容、烧伤、低白蛋白血症、急性肝衰竭、休克和手术併发症等疾病。其主要功能包括维持渗透压和运输必需分子,因此对于维持体液平衡和支持重症患者復原至关重要。在全球慢性病日益增多的背景下,医疗保健系统扩大采用基于白蛋白的疗法,从而推动了市场的持续成长。
市场概览
市场驱动因素
慢性病的增加是推动市场扩张的最重要因素之一。全球数百万患者患有肾臟疾病、肝衰竭以及促使低白蛋白血症的疾病,迫使医院依赖白蛋白疗法。 2024年4月,美国疾病管制与预防中心 (CDC) 报告称,美国有600万肾臟病患者和450万慢性肝病患者,这推动了急诊和重症监护环境中对白蛋白的需求。
烧伤仍是影响白蛋白医疗需求的重要因素。根据美国烧伤协会统计,2023年有32,540例严重烧伤病例需要住院治疗,其中数千例涉及创伤相关併发症。白蛋白有助于恢復体液平衡,在这些病例中至关重要,从而促进了烧伤治疗市场的成长。
市场限制因子
由于依赖人类血浆,该市场面临供应链和生产方面的挑战。自愿捐血的短缺阻碍了白蛋白的稳定供应。 2024年1月,美国红十字会宣布捐血量下降了40%,促使用于提取白蛋白的血浆供应紧张。这种波动限制了製造商满足不断增长的需求的能力,从而促使价格上涨和全球供应紧张。
市场机会
重组白蛋白技术正在为未来的成长创造新的机会。白蛋白在再生医学、组织工程和细胞疗法中的应用日益广泛,正在扩大其临床应用范围。 2023年3月,Albumedix与HeartSeed合作,将重组人类白蛋白(Recombumin)整合到心臟再生医学中,展示了其在传统重症监护之外的更广泛应用。
植物源性白蛋白的进步,例如Healthgen BIoTechnology于2025年开发的稻米源性HSA,为解决供应短缺和污染风险提供了方案。这些创新增强了可扩展性,并有助于长期市场稳定。
市场趋势
重组白蛋白产品研发的临床试验不断增加,正在重塑产业格局。各公司正利用生物技术驱动的生产方式来解决供体来源白蛋白供应不足的问题。 2024年8月,Silpa Medicare完成了其重组酵母源性白蛋白 "sRbumin" 的I期临床试验,凸显了下一代治疗性白蛋白产品研发的快速进展。这些进步提高了产品的均一性、安全性和全球供应。
依原料划分
2024年,人血白蛋白凭藉其在医院的广泛应用和广泛的临床用途,占了市场主导地位。持续获得批准的产品,例如 Grifols 的 ALBUTEIN FlexBag,进一步巩固了该细分市场的领先地位。
依适应症划分
根据世界卫生组织 (WHO) 的追踪数据,全球每年有 660 万例烧伤病例,烧伤治疗领域持续占主导地位。在印度,每年烧伤病例数达到 600 万至 700 万例,对该地区的需求贡献巨大。
依通路划分
由于白蛋白治疗需要在医院进行,因此医院药局是主要的通路。在美国,约有 170 家医院已将白蛋白引入胸腔外科手术,进一步巩固了其主导地位。
亚太地区
亚太地区预计2024年市场规模将达24.1亿美元,引领全球市场。这主要得益于慢性病高发生、烧伤病例不断增加以及众多主要生产商的存在。中国国家食品药物管理局(NIFDC)批准了一种新的人血白蛋白产品,进一步巩固了该地区的供应基础。
北美
成长主要得益于血浆采集能力的提升及先进生产设施的完善。策略性收购,例如Grifols收购Prometic Plasma Resources,也为扩大供应提供了支援。
欧洲
欧洲凭藉强劲的研发实力,占第二大市场。 Grifols的Preciosa III期临床试验(2024年)证实了熊果素能够提高患者的存活率,从而促进了其临床应用。
拉丁美洲、中东和非洲
成长的驱动因素包括慢性病发病率上升、血浆采集网络扩大以及血浆疗法监管法规的演变。
The global therapeutic albumin market is experiencing steady and sustained expansion, supported by rising incidences of critical medical conditions and increased demand in emergency care. According to the latest industry assessment, the global market was valued at USD 4.42 billion in 2024, is projected to grow to USD 4.71 billion in 2025, and reach USD 7.55 billion by 2032. The Asia Pacific region dominated the market landscape in 2024, capturing 54.52% of global revenue due to high disease prevalence and expanding plasma-based product utilization.
Therapeutic albumin is derived from human plasma and used to treat conditions such as hypovolemia, burns, hypoalbuminemia, acute liver failure, shock, and surgical complications. Its primary functions include maintaining oncotic pressure and transporting essential molecules, making it crucial for managing fluid imbalance and supporting patient recovery in severe illnesses. With chronic diseases rising globally, healthcare systems continue to expand their use of albumin-based therapies, driving consistent market growth.
Market Snapshot
Market Drivers
Increasing chronic disease burden is one of the most influential forces behind the market's expansion. Millions of patients globally suffer from kidney disease, liver failure, and conditions leading to hypoalbuminemia, driving hospitals to rely on albumin therapy. In April 2024, the CDC reported 6.0 million kidney disease cases and 4.5 million chronic liver disease cases in the U.S., strengthening demand for albumin in acute and critical care.
Burn injuries continue to significantly impact medical demand for albumin. As per the American Burn Association, 32,540 severe burn cases required inpatient hospitalization in 2023, including thousands with trauma-related complications. Albumin, which aids fluid balance restoration, is indispensable in such cases, contributing to the growth of the burn indication segment.
Market Restraints
The market faces supply chain and production challenges due to dependence on human-derived plasma. Shortages in voluntary blood donation hinder consistent albumin availability. In January 2024, the American Red Cross announced a 40% decline in blood donations, tightening plasma supply for albumin extraction. Such fluctuations limit manufacturers' ability to meet rising demand and contribute to price increases and global supply constraints.
Market Opportunities
Recombinant albumin technology is creating new opportunities for future growth. The rising adoption of albumin in regenerative medicine, tissue engineering, and cell therapy is broadening its clinical utility. In March 2023, Albumedix partnered with Heartseed to integrate recombinant human albumin (Recombumin) into cardiac regenerative therapy, demonstrating expanding applications beyond traditional critical care.
Advancements in plant-derived albumin, such as rice-based HSA developed by Healthgen Biotechnology in 2025, offer solutions to supply shortages and contamination risks. These innovations enhance scalability and support long-term market stability.
Market Trends
Increasing clinical trials to develop recombinant albumin products are shaping industry trends. Companies are addressing supply limitations of donor-derived albumin through biotechnology-led production. In August 2024, Shilpa Medicare completed Phase 1 trials of sRbumin, a recombinant yeast-derived albumin, highlighting rapid progress toward next-generation therapeutic albumin products. Such advancements enhance consistency, safety, and global availability.
By Source
The human-derived albumin segment dominated in 2024 due to widespread adoption in hospitals and broad clinical applicability. Continuous approvals-such as Grifols' ALBUTEIN FlexBag-strengthen segment leadership.
By Indication
The burn segment remains dominant, supported by 6.6 million thermal burn cases annually worldwide as tracked by WHO. Rising burn incidence in India, reaching 6-7 million cases per year, contributes significantly to regional demand.
By Distribution Channel
Hospital pharmacies lead due to the intensive, hospital-based nature of albumin treatments. Albumin usage in thoracic surgeries, adopted by nearly 170 U.S. hospitals, reinforces this dominance.
Asia Pacific
Valued at USD 2.41 billion in 2024, Asia Pacific leads the global market due to high chronic disease prevalence, increasing burn injuries, and the presence of major manufacturers. China's NIFDC approval for new human albumin products is strengthening regional supply.
North America
Growth is driven by rising plasma collection capabilities and advanced production facilities. Strategic acquisitions-such as Grifols' purchase of Prometic Plasma Resources-support supply expansion.
Europe
Europe holds the second-largest share, driven by strong R&D efforts. Grifols' PRECIOSA Phase 3 trial in 2024 demonstrated survival benefits of Albutein, boosting clinical adoption.
Latin America & Middle East/Africa
Growth is supported by rising chronic disease rates, expanding plasma collection networks, and regulatory advancements for plasma therapeutics.
Conclusion
The therapeutic albumin market is poised for solid expansion-growing from USD 4.42 billion in 2024 to USD 4.71 billion in 2025, and ultimately reaching USD 7.55 billion by 2032. Rising chronic diseases, burn incidences, biotechnology innovations, and expanding regenerative medicine applications will drive the market's future trajectory.
Segmentation By Source
By Indication
By Distribution Channel
By Region