![]() |
市场调查报告书
商品编码
1954675
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:依应用、最终用户和地区划分的洞察与预测(2026-2034年)Human Fibrinogen Concentrates Market Size, Share, Growth and Global Industry Analysis By Type & Application, Regional Insights and Forecast to 2026-2034 |
||||||
到2025年,全球人类纤维蛋白原浓缩物市场规模达到 8.534亿美元,预计从2026年的9.4968亿美元成长至2034年的21.956亿美元,在预测期(2026-2034年)内成长 1.04%。欧洲在2025年将以 23.96%的市场占有率领先,这主要得益于主要血浆製品生产商的强大影响力以及外科手术量的增加。
人类纤维蛋白原浓缩物是一种血浆衍生疗法,用于恢復因创伤、重大手术或先天性/后天性纤维蛋白原缺乏症导致严重出血患者的纤维蛋白原水准。纤维蛋白原在血块形成中发挥关键作用,其缺乏会延长凝血时间并增加出血风险,因此需要外源性补充。人们对先进止血疗法的认识不断提高以及血浆分离技术的进步是市场扩张的关键驱动因素。
例如,印度医学科学院(AIIMS)在2022年9月报告指出,印度全膝关节置换手术总数将超过25万例,证实了手术需求的成长和全球产品应用范围的扩大。此外,Grifols公司纤维蛋白原浓缩物BT524的III期临床试验(2024年2月)的正面结果进一步巩固了该产业的发展动能。
市场动态
市场驱动因素
外科手术和创伤病例的增加
全球范围内,心血管、骨科、神经外科和妇科等专科的外科手术数量不断增加,显着推动了对纤维蛋白原浓缩物的需求。根据美国国立卫生研究院(2024年6月)的资料,高收入国家平均每年每10万人进行123.2例心臟手术。此外,世界卫生组织估计,截至2023年9月,全球每年将进行超过3亿例外科手术。
为了减少术中和术后出血併发症,人们加速采用纤维蛋白原浓缩物取代传统的冷沉淀和新鲜冰冻血浆(FFP),这推动了全球市场的成长。
市场限制因子
产品成本高且健保偿付有限
儘管临床疗效显着,但高昂的成本仍然是一个重大障碍。例如,1克FIBRINOREL干纤维蛋白原(10毫升)的价格约为185.4美元,这限制了低收入地区的可及性。复杂的血浆分离製程、严格的安全标准和监管审批都推高了生产成本。新兴经济体严格的健保偿付政策进一步限制了产品的普及。
市场机会
策略联盟与市场拓展
血浆製品生产商与区域性公司之间的合作创造获利成长路径。2024年6月,Plasmagen Biosciences与CSL Behring合作,在印度生产和销售Hemocomplettan P,扩大了先天性纤维蛋白原缺乏症和后天性低纤维蛋白原血症的治疗范围。
此类合作关係能够加强分销网路,提高产品在未开发市场的供应,并扩大全球影响力。发展中国家慢性病盛行率的不断上升也为长期扩张提供了机会。
市场挑战
供应炼与生产的复杂性
纤维蛋白原浓缩物的生产需要庞大的血浆捐赠者网路、先进的分离设备、冷链物流和熟练的人员。严格的监管合规性和批次放行规程构成了很高的进入门槛,限制了新进入者,并可能影响供应稳定性。
市场趋势
新型在研产品取代冷沉淀
传统上,冷沉淀用于治疗纤维蛋白原缺乏症,但它需要解冻且缺乏标准化的剂量。新一代纤维蛋白原浓缩物具有给药速度更快、安全性更高、剂量更精确等优点。
2025年6月,Grifols宣布BT524 III期临床试验取得积极结果,证明其在治疗大型手术期间获得性纤维蛋白原缺乏症方面不劣于冷沉淀和新鲜冰冻血浆(FFP)。本产品无需解冻即可快速、可预测地给药,进而改善急诊环境的患者预后。这些研发管线的进展塑造未来的市场趋势。
依应用领域
市场细分为先天性纤维蛋白原缺乏症、后天性纤维蛋白原缺乏症/手术和其他。
在创伤和外科手术日益增多的推动下,获得性纤维蛋白原缺乏症/手术细分市场在2025年占据92.61%的市场占有率。例如,2020年至2021年,澳洲共进行了12,700例冠状动脉绕道手术,推动了止血剂的需求。
先天性纤维蛋白原缺乏症占据第二大市场占有率,预计将保持温和成长。根据Orphanet统计,无纤维蛋白原血症的盛行率为每百万人1-30例,这支撑了替代疗法的稳定需求。
依最终使用者划分
最终使用者包括医院、专科诊所及其他机构。
预计到2026年,医院将占据83.34%的市场占有率,这主要得益于其高手术量和先进的基础设施。医院将成为纤维蛋白原浓缩物的主要用户,用于控制术中出血。
专科诊所占据第二大市场占有率,尤其是在专科医疗网路不断扩展的发展中国家。研究机构和医疗机构正集中精力进行产品研发,因此市场占有率较小。
欧洲
2025年,欧洲人纤维蛋白原浓缩物市场规模达到4.0991亿美元,成为全球最大的市场。这一主导地位归功于Octapharma AG和LFB等成熟的血浆製品生产商、高手术量以及监管部门的批准。2019年11月,Octapharma将Fibryga的核准范围扩大到15个欧洲国家。
北美
由于北美拥有完善的医疗保健基础设施以及出血性疾病发病率的不断上升,到2025年,北美占据较大的市场占有率。根据美国疾病管制与预防中心(CDC)的资料(2024年5月),美国约有33,000名男性患有血友病,这推动了对先进止血剂的需求。
亚太地区
亚太地区占据第二大市场占有率,预计到2034年将维持显着的年复合成长率。人口老化、慢性病增多、医疗保健投资是推动成长的主要因素。2024年12月宣布的在印度建设100家医院的 "100-4-100计画" 预计将进一步刺激对外科产品的需求。
拉丁美洲、中东和非洲
儘管这些地区的市场占有率相对较小,但由于公众意识的提高和医疗保健支出的增加,预计这些地区将实现稳步成长。
The global human fibrinogen concentrates market size was valued at USD 853.4 million in 2025 and is projected to grow from USD 949.68 million in 2026 to USD 2,195.60 million by 2034, registering a robust CAGR of 11.04% during the forecast period (2026-2034). Europe dominated the market with a 23.96% share in 2025, supported by strong presence of leading plasma product manufacturers and increasing surgical volumes.
Human fibrinogen concentrates are plasma-derived therapies used to restore fibrinogen levels in patients experiencing significant bleeding due to trauma, major surgeries, or congenital and acquired fibrinogen deficiencies. Fibrinogen plays a critical role in blood clot formation; its deficiency prolongs clotting time and increases bleeding risk, necessitating external supplementation. Growing awareness of advanced hemostatic therapies and technological advancements in plasma fractionation are key contributors to market expansion.
For instance, in September 2022, AIIMS reported over 250,000 total knee replacement surgeries in India, reflecting rising surgical demand and supporting product adoption globally. Additionally, positive Phase 3 trial results for BT524 fibrinogen concentrate by Grifols (February 2024) further strengthened industry momentum.
Market Dynamics
Market Drivers
Rising Surgical Volumes and Trauma Cases
Increasing global surgical procedures across cardiovascular, orthopedic, neurological, and gynecological specialties significantly drive demand for fibrinogen concentrates. According to the National Institutes of Health (June 2024), high-income countries perform an average of 123.2 cardiac surgeries per 100,000 population annually. Moreover, the WHO estimated in September 2023 that over 300 million surgical procedures are conducted worldwide each year.
The need to reduce operative and postoperative bleeding complications has accelerated adoption of fibrinogen concentrates over conventional cryoprecipitate and fresh frozen plasma (FFP), thereby fueling global market growth.
Market Restraints
High Product Costs and Limited Reimbursement
Despite strong clinical benefits, high costs remain a significant barrier. For example, FIBRINOREL 1g dried fibrinogen (10 ml) costs around USD 185.4, limiting accessibility in low-income regions. The complex plasma fractionation process, stringent safety standards, and regulatory approvals increase production costs. Limited reimbursement policies in emerging economies further restrict product penetration.
Market Opportunities
Strategic Collaborations and Market Expansion
Collaborations among plasma product manufacturers and regional players are creating lucrative growth avenues. In June 2024, Plasmagen Biosciences partnered with CSL Behring to manufacture and commercialize Haemocomplettan P in India, expanding access to therapy for congenital afibrinogenemia and acquired hypofibrinogenemia.
Such partnerships enhance distribution networks, improve product accessibility in untapped markets, and strengthen global footprint. Increasing chronic disease prevalence in developing nations also offers long-term expansion opportunities.
Market Challenges
Supply Chain and Manufacturing Complexities
Production of fibrinogen concentrates requires extensive plasma donor networks, advanced fractionation facilities, cold chain logistics, and skilled personnel. Strict regulatory compliance and batch-release protocols create high entry barriers, limiting new market entrants and potentially impacting supply stability.
Market Trends
Emerging Pipeline Products Replacing Cryoprecipitate
Traditionally, cryoprecipitate has been used to treat fibrinogen deficiency; however, it requires thawing and lacks standardized dosing. New-generation fibrinogen concentrates offer faster administration, improved safety, and precise dosing.
In June 2025, Grifols announced positive Phase 3 results for BT524, demonstrating non-inferiority to cryoprecipitate and FFP in managing acquired fibrinogen deficiency during major surgeries. The product enables rapid, predictable dosing without thawing delays, improving patient outcomes in emergency settings. Such pipeline advancements are shaping future market trends.
By Application
The market is segmented into congenital fibrinogen deficiency, acquired fibrinogen deficiency & surgical procedures, and others.
The acquired fibrinogen deficiency & surgical procedures segment dominated with a 92.61% share in 2025, driven by rising trauma and surgical cases. For example, Australia recorded 12,700 coronary artery bypass graft surgeries during 2020-2021, boosting demand for hemostatic agents.
Congenital fibrinogen deficiency held the second-largest share and is projected to grow moderately. According to Orphanet, afibrinogenemia prevalence ranges from 1 to 30 cases per 1 million individuals, supporting steady demand for replacement therapies.
By End-user
Based on end-user, the market includes hospitals, specialty clinics, and others.
The hospitals segment accounted for 83.34% share in 2026, owing to high surgical volumes and advanced infrastructure. Hospitals are primary users of fibrinogen concentrates for managing intraoperative bleeding.
Specialty clinics represent the second-largest segment, particularly in developing countries with expanding specialty care networks. Research institutes and healthcare organizations contribute a smaller share, focusing on product development initiatives.
Europe
The Europe human fibrinogen concentrates market was valued at USD 409.91 million in 2025, leading globally. Dominance is attributed to established plasma manufacturers such as Octapharma AG and LFB, high surgical volumes, and regulatory approvals. In November 2019, Octapharma expanded Fibryga approval across 15 European countries.
North America
North America held a significant share in 2025 due to well-developed healthcare infrastructure and rising bleeding disorder cases. According to CDC data (May 2024), approximately 33,000 males in the U.S. have hemophilia, increasing demand for advanced hemostatic agents.
Asia Pacific
Asia Pacific accounted for the second-largest share and is projected to grow at a notable CAGR through 2034. Aging populations, increasing chronic diseases, and healthcare investments are driving growth. The December 2024 "100-4-100 Project" initiative to upgrade 100 hospitals in India is expected to further stimulate surgical product demand.
Latin America & Middle East & Africa
These regions hold comparatively smaller shares but are expected to grow steadily due to rising awareness programs and improving healthcare expenditure.
Competitive Landscape
The market is consolidated, led by Octapharma AG, CSL, and LFB, along with key players such as Grifols, Shanghai RAAS, Reliance Life Sciences, and China Resources Boya Biopharmaceutical Group.
Key developments include:
Conclusion
The global human fibrinogen concentrates market is projected to expand significantly from USD 853.4 million in 2025 to USD 949.68 million in 2026, reaching USD 2,195.60 million by 2034 at a CAGR of 11.04%. Growth is driven by increasing surgical volumes, trauma cases, rising bleeding disorder prevalence, and advancements in plasma-derived therapies. While high costs and supply chain complexities pose challenges, strategic collaborations, expanding healthcare infrastructure, and innovative pipeline products are expected to sustain long-term market growth.
Segmentation By Application
By End-user
By Region