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市场调查报告书
商品编码
1880600
人类纤维蛋白原浓缩物市场规模、占有率、成长及全球产业分析:依类型、应用和地区划分的洞察与预测(2024-2032 年)Human Fibrinogen Concentrates Market Size, Share, Growth and Global Industry Analysis By Type & Application, Regional Insights and Forecast to 2024-2032 |
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由于外科手术的增加、人们对先进止血疗法的认识不断提高以及血浆衍生技术的持续进步,全球人类纤维蛋白原浓缩物市场正在快速扩张。根据最新估计,2024 年全球市场规模约为 7.687 亿美元,预计到 2025 年将达到 8.534 亿美元。预计到 2032 年,市场规模将加速成长至 19.011 亿美元,预测期内复合年增长率 (CAGR) 为 12.1%。欧洲在全球市场占主导地位,2024 年市占率达到 48.39%,这得益于其强大的生产能力、监管审批以及外科手术和出血性疾病的高发生率。
人类纤维蛋白原浓缩物是一种重要的血浆衍生止血产品,用于快速恢復因创伤、手术或先天性纤维蛋白原缺乏症(例如无纤维蛋白原血症)而导致严重出血患者的纤维蛋白原水平。全球手术负担的不断加重仍然是推动市场需求的主要因素。例如,全印度医学科学研究所 (AIIMS) 报告称,2022 年 9 月印度进行了超过 25 万例全膝关节置换手术,显示市场对可靠的止血解决方案的需求日益增长。 LFB、CSL、Octapharma AG 和 Grifols S.A. 等领先企业持续投资于研发、产品线拓展和临床试验,以巩固其全球影响力。 2024 年 2 月,Grifols 公布了 Biotest 的纤维蛋白原浓缩物 BT524 的 III 期临床试验的积极结果,证明其在治疗获得性纤维蛋白原缺乏症 (AFD) 方面的疗效。
市场推动因素
主要推动因素之一是全球外科手术数量的快速增长,这归因于人口老化、慢性病增多、不健康的生活方式以及创伤病例的增加。随着外科手术变得越来越复杂,对快速有效的术中止血液的需求也相应增长。根据美国国立卫生研究院 (NIH) 发布的 "2024 年全球心臟外科手术量报告" ,高收入国家平均每年每 10 万人进行 123.2 例心臟手术。减少术中和术后併发症的需求日益增长,显着加速了纤维蛋白原浓缩物相对于新鲜冷冻血浆 (FFP) 和冰冻血浆等传统选择的应用。
市场限制因子
然而,人类纤维蛋白原浓缩物的高成本仍然是一个主要阻碍因素,尤其是在新兴经济体。复杂的生产流程、对捐献血浆的需求以及严格的监管规程都显着增加了生产成本。例如,1克FIBRINOREL的商业价格约为185.4美元,限制了其在低收入地区的普及。有限的保险覆盖范围进一步阻碍了其在发展中国家的应用,并减缓了其市场渗透速度。
市场机会
全球和区域製造商之间不断扩大的策略联盟正在创造强劲的成长机会。製药公司、生技公司和血浆分离专家之间的合作能够加快产品开发速度并深化市场渗透。 2024年6月,Plasmagen Biosciences与CSL Behring合作,开始在印度生产和销售Hemocomplettan P,这标誌着在改善发展中国家市场可及性方面迈出了重要一步。除了不断扩大的研发管线外,政府为改善外科基础设施所做的努力预计也将支持长期成长。
市场挑战
供应链的复杂性仍然是一项重大挑战。人类纤维蛋白原浓缩物需要强大的供体网络、严格的冷链物流、高技能人员以及严格的批次放行监管。这些因素为新生产商设置了很高的进入门槛,减缓了竞争扩张速度,并限制了全球供应。
产业趋势
一个关键的新兴趋势是转向研发管线创新,以缩短给药时间、实现剂量标准化并改善临床疗效。传统的冷冻纤维蛋白原补充剂受限于剂量差异和耗时的解冻过程。像 Grifols 的 BT524 这样的新产品,预计将于 2025 年在 III 期临床试验中达到其主要目标,在治疗获得性纤维蛋白原缺乏症 (AFD) 方面具有更可预测的疗效和更快速的给药方式。这些进步有望重新定义全球临床实践。
市场区隔概览
依应用领域
预计到2024年,获得性纤维蛋白原缺乏症和外科手术领域将成为市场主导,这主要得益于创伤病例的增加以及全球外科手术数量的增长。作为参考,2020-2021年澳洲共进行了12,700例冠状动脉绕道手术(CABG)。先天性纤维蛋白原缺乏症仍是第二大区隔市场,这主要归功于其较高的盛行率(每百万人口1-30例)以及人们对该疾病的认识和诊断率的不断提高。
依最终使用者
预计到2024年,医院领域将占最大市场占有率,这得益于其先进的基础设施和庞大的手术量。根据世界卫生组织统计,全球每年进行的外科手术数量超过3亿例,增加了医院对纤维蛋白原浓缩物的依赖。
欧洲
欧洲将占最大的区域市场占有率,到2024年市场规模将达到3.72亿美元,这得益于该地区强大的行业地位以及对诸如Octapharma的Fibriga等产品的早期应用。
北美
成长的推动因素是出血性疾病发生率的上升(据估计,美国约有33,000人患有血友病)以及健全的医疗保健生态系统。
亚太地区
亚太地区未来成长潜力巨大,这得益于人口老化、慢性病增多以及基础设施建设,例如旨在升级100家医院的 "2024 100-4-100" 计画。
拉丁美洲、中东和非洲
儘管这些地区的市场占有率较小,但它们正受益于人们意识的提高和医疗保健投资的增加。
The global human fibrinogen concentrates market is expanding rapidly as surgical volumes rise, awareness of advanced hemostatic therapies grows, and plasma-derived technologies continue to evolve. According to the latest estimates, the global market size stood at USD 768.7 million in 2024, is projected to reach USD 853.4 million in 2025, and is expected to accelerate to USD 1,901.1 million by 2032, growing at a strong CAGR of 12.1% during the forecast period. Europe dominated the global market with a 48.39% share in 2024, supported by strong manufacturing capabilities, regulatory approvals, and a high prevalence of surgical and bleeding-related disorders.
Human fibrinogen concentrates are essential plasma-derived hemostatic products used to rapidly restore fibrinogen levels in patients suffering from significant bleeding due to trauma, surgical procedures, or congenital deficiencies such as afibrinogenemia. Rising surgical burden worldwide continues to be a major demand driver. For example, the All India Institute of Medical Sciences (AIIMS) reported in September 2022 that over 250,000 total knee replacement surgeries were performed in India, highlighting the growing need for reliable hemostatic solutions. Key industry players-including LFB, CSL, Octapharma AG, and Grifols S.A.-continue to invest in R&D, portfolio expansion, and clinical trials to strengthen their global footing. In February 2024, Grifols reported positive Phase 3 results for Biotest's BT524, a fibrinogen concentrate demonstrating effectiveness in treating acquired fibrinogen deficiency (AFD).
Market Drivers
One of the leading drivers is the surging number of surgical procedures worldwide, driven by an aging population, rising prevalence of chronic diseases, unhealthy lifestyles, and increased trauma cases. As surgical complexity rises, demand for rapid, efficient intraoperative bleeding control increases proportionately. According to NIH's 2024 report on global cardiac surgical volume, high-income countries performed an average of 123.2 cardiac surgeries per 100,000 population annually. The growing need for reduced intraoperative and postoperative complications has strongly accelerated adoption of fibrinogen concentrates over traditional options such as fresh frozen plasma (FFP) and cryoprecipitate.
Market Restraints
However, the high cost associated with human fibrinogen concentrates remains a major limiting factor, particularly in emerging economies. Complex manufacturing processes, donor plasma requirements, and stringent regulatory protocols significantly elevate production costs. For example, the commercial price for FIBRINOREL 1g is approximately USD 185.4, restricting affordability in low-income regions. Limited reimbursement coverage further impedes adoption, slowing market penetration across developing countries.
Market Opportunities
Growing strategic collaborations among global and regional manufacturers are creating strong expansion opportunities. Partnerships between pharmaceutical companies, biotech firms, and plasma fractionation specialists enable faster product development and deeper market penetration. In June 2024, Plasmagen Biosciences partnered with CSL Behring to manufacture and commercialize Haemocomplettan P in India, marking a significant milestone for improving access in developing markets. Expanding R&D pipelines, along with government focus on improving surgical infrastructure, are expected to support long-term growth.
Market Challenges
Supply chain complexities remain a major challenge. Human fibrinogen concentrates require robust donor networks, stringent cold chain logistics, highly skilled personnel, and rigorous regulatory compliance for batch release. These factors create a high entry barrier for new manufacturers, slowing competitive expansion and limiting global supply.
Industry Trends
A key emerging trend is the shift toward pipeline innovations that offer faster administration, standardized dosing, and improved clinical outcomes. Cryoprecipitate-traditionally used for fibrinogen replenishment-faces limitations due to variable dosing and time-consuming thawing requirements. New products like Grifols' BT524, which met primary goals in a 2025 Phase 3 trial, offer more predictable efficacy and rapid administration for managing acquired fibrinogen deficiency (AFD). These advancements are expected to redefine global clinical practice.
Segmentation Overview
By Application
The acquired fibrinogen deficiency & surgical procedures segment dominated in 2024 due to rising trauma cases and increasing surgical volumes globally. For reference, Australia reported 12,700 coronary artery bypass graft (CABG) surgeries in 2020-2021. Congenital fibrinogen deficiency remains the second-largest segment, driven by its prevalence (1-30 cases per 1 million population) and increased awareness and diagnosis.
By End-user
The hospital segment accounted for the largest share in 2024, supported by advanced infrastructure and high surgical caseloads. According to WHO, global surgical volumes exceeded 300 million annually, reinforcing hospital dependency on fibrinogen concentrates.
Europe
Europe held the largest regional share in 2024 with a market size of USD 372.0 million, supported by strong industry presence and early adoption of products like Octapharma's Fibryga.
North America
Growth is driven by rising bleeding disorder cases-approximately 33,000 U.S. males are estimated to have hemophilia-and a robust healthcare ecosystem.
Asia Pacific
APAC shows strong future growth potential due to aging populations, rising chronic conditions, and infrastructure initiatives like the 2024 100-4-100 Project, aimed at upgrading 100 hospitals.
Latin America & Middle East/Africa
These regions maintain smaller shares but are benefiting from rising awareness initiatives and healthcare investment.
Conclusion
With the global human fibrinogen concentrates market expected to reach USD 1,901.1 million by 2032, sustained growth will be driven by expanding surgical needs, strategic collaborations, and advancements in plasma-derived product innovation. The industry's future hinges on improved accessibility, cost optimization, and continued R&D progress.
Segmentation By Application
By End-user
By Region