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市场调查报告书
商品编码
1887196
凝血因子市场规模、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)Coagulation Factors Market Size, Share, Growth and Global Industry Analysis By Type & Application, Regional Insights and Forecast to 2024-2032 |
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全球凝血因子市场正经历显着成长,主要受血友病A、血友病B和血管性血友病等出血性疾病先进疗法需求不断增长的推动。根据最新的产业分析,2024年全球市场规模为64亿美元,2025年将增至68.9亿美元,预计到2032年将达到121.9亿美元,这主要得益于技术创新、血浆采集能力的提升以及人们对遗传性出血性疾病认识的不断提高。 2024年,北美以58.44%的市占率领跑,这得益于其强大的医疗保健基础设施和血浆衍生疗法的日益普及。
凝血因子在维持正常血液凝固过程中扮演至关重要的角色。随着全球出血性疾病和创伤病例的不断增加,对血浆衍生和重组凝血产品的需求持续增长。包括CSL、Octapharma AG、Kedrion S.p.A.和武田药品工业株式会社在内的主要行业领导者正在加强研发管线并扩大生产能力,以满足全球治疗需求。
市场驱动因素
推动市场成长的关键因素是全球遗传性出血性疾病发生率的上升。根据美国疾病管制与预防中心(CDC)统计,美国约有33,000名男性患有血友病,而血管性血友病影响约1%的美国人口。诊断率的提高、患者意识的增强以及医疗服务提供者对早期治疗的日益重视,持续推动凝血疗法的需求成长。
全球伤害和事故发生率的上升也显着促进了市场扩张。光是在印度,预计2022年道路交通事故将达到461,312起,比前一年增长11.9%。急诊和重症监护机构对凝血因子的大量使用进一步支撑了市场成长趋势。
市场限制因子
儘管成长潜力巨大,但严格的监管框架对製造商构成了挑战。血浆的采集和处理必须符合FDA等机构制定的严格安全和品质标准,这些机构根据 "公共卫生服务法" 和 "联邦食品、药品和化妆品法" 监管血浆疗法。漫长的审批週期和严格的营运要求可能会延迟产品上市,并限制市场扩张,尤其是在新兴经济体。
高昂的生产成本也限制了新进入者,因为血浆分离和生产基础设施需要大量的资本投资。发展中地区有限的保险覆盖范围进一步限制了患者获得治疗的机会。
市场机会
对先进疗法的研发投入不断增加,为市场参与者提供了巨大的机会。新的血浆分离设施、不断扩大的治疗适应症、标靶给药系统和长效因子製剂正在塑造下一波创新浪潮。例如,CSL Behring 将于 2022 年在澳洲开设一家新的血浆分离工厂,以支持血友病和其他严重疾病的治疗,这体现了该行业致力于扩大全球产能的决心。
人工智慧和物联网的进步正在提高生产效率、供应链透明度和患者支援水平,从而加速下一代疗法的应用。
细分市场分析
依类型
预计到 2024 年,VIII 因子细分市场将占最大的市场占有率,这主要得益于血友病 A 的高发病率,据估计,全球有超过 110 万人患有此病。纤维蛋白原浓缩物市场位居第二,这主要得益于监管部门的批准,例如 Octapharma 的 Fibryga 于 2024 年获得美国 FDA 批准。
依应用领域划分
血液学领域在 2024 年引领市场。这主要归功于止血技术的进步以及先天性出血性疾病在全球范围内的高发生率。血友病的盛行率估计为每 6,000 至 10,000 名男性中就有 1 例,这表明存在巨大的临床需求。
依最终使用者划分
2024 年,由于患者对专科护理的偏好、住院率的增加以及行业与医疗机构的合作,医院和诊所占了大部分市场占有率。由于对血浆衍生研发应用的需求不断增长,临床实验室预计将保持稳定成长。
北美
北美在2024年以37.4亿美元的市场规模领先全球市场,这得益于其强大的血浆采集网络、不断增长的产品审批以及先进疗法的广泛应用。美国的血浆库容量持续扩大,武田製药旗下的BioLife Plasma Services于2023年开设了其第200家捐血中心。
欧洲
欧洲占第二大市场占有率,这得益于不断扩大的血浆分离设施和强有力的监管支持。 CSL于2023年扩建其位于德国的血浆工厂,增强了该地区的供应能力。
亚太地区
由于併购活动增加、设施扩建以及血浆衍生产品价格的日益亲民,预计该地区将实现强劲增长。 PlasmaGen Biosciences 等公司正在扩大生产规模,以满足区域需求。
The global coagulation factors market is experiencing strong growth as demand rises for advanced therapies that treat bleeding disorders such as hemophilia A, hemophilia B, and von Willebrand disease. According to the latest industry analysis, the global market was valued at USD 6.40 billion in 2024, is projected to increase to USD 6.89 billion in 2025, and is expected to reach USD 12.19 billion by 2032, driven by technological innovations, expanding plasma collection capacity, and increased awareness of hereditary bleeding disorders. In 2024, North America dominated the market with a 58.44% share, supported by strong healthcare infrastructure and rising adoption of plasma-derived therapies.
Coagulation factors play a crucial role in supporting normal blood clotting. With the rising prevalence of bleeding disorders and trauma cases globally, demand for plasma-derived and recombinant coagulation products continues to accelerate. Key industry leaders-such as CSL, Octapharma AG, Kedrion S.p.A., and Takeda Pharmaceuticals-are strengthening their research pipelines while expanding manufacturing capacity to meet global therapeutic needs.
Market Drivers
A primary driver of market expansion is the growing incidence of hereditary bleeding disorders worldwide. According to the CDC, approximately 33,000 males in the U.S. live with hemophilia, and von Willebrand disease affects nearly 1% of the U.S. population. Rising diagnostic rates, improved patient awareness, and increased clinician focus on early-stage treatment continue to boost demand for coagulation therapies.
Rising trauma and accident rates globally also contribute significantly to market expansion. In India alone, 461,312 road accidents occurred in 2022, representing an 11.9% increase over the previous year. Emergency and critical care facilities rely heavily on coagulation factors for immediate treatment, further supporting the market's upward momentum.
Market Restraints
Despite strong growth potential, stringent regulatory frameworks pose challenges for manufacturers. Plasma collection and processing must comply with rigorous safety and quality standards enforced by agencies such as the FDA, which monitors plasma therapies under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act. Lengthy approval cycles and strict operational requirements can slow product launches and limit market expansion, especially in emerging economies.
High production costs also restrict new market entrants, as plasma fractionation and manufacturing infrastructure require significant capital investment. Limited reimbursement coverage in developing regions further restricts treatment accessibility.
Market Opportunities
Increasing investments in R&D for advanced therapies offer significant opportunities for market players. New plasma fractionation facilities, expanded treatment indications, targeted delivery systems, and long-acting factor products are shaping the next wave of innovation. For example, CSL Behring opened a new plasma fractionation facility in Australia in 2022 to support treatments for hemophilia and other critical disorders, illustrating the industry's commitment to expanding global capacity.
Advancements in AI and IoT are improving manufacturing efficiency, supply chain visibility, and patient support, accelerating the adoption of next-generation therapies.
Segment Analysis
By Type
The Factor VIII segment held the largest market share in 2024, supported by high hemophilia A prevalence-estimated at over 1.1 million cases globally. The fibrinogen concentrates segment ranked second, fueled by regulatory approvals such as Octapharma's 2024 U.S. FDA approval for Fibryga.
By Application
The hematology segment dominated in 2024, driven by advancements in hemostasis technologies and a high global burden of congenital bleeding disorders. Prevalence of hemophilia is estimated at 1 in 6,000 to 10,000 males, highlighting the large clinical need.
By End User
Hospitals & clinics held the majority share in 2024 due to high patient preference for specialized treatment, increasing hospital admissions, and industry collaboration with healthcare institutions. Clinical research laboratories are expected to grow steadily with rising demand for plasma-derived R&D applications.
North America
North America led the global market in 2024 with USD 3.74 billion, driven by strong plasma collection networks, growing product approvals, and high adoption of advanced therapies. The U.S. continues to expand plasma banking capacity, with Takeda's BioLife Plasma Services opening its 200th donation center in 2023.
Europe
Europe holds the second-largest share, supported by expanded plasma fractionation facilities and strong regulatory backing. CSL's 2023 plasma plant expansion in Germany strengthens regional supply capabilities.
Asia Pacific
The region is projected to witness strong growth due to rising mergers, facility expansions, and increasing affordability of plasma-based products. Companies such as PlasmaGen Biosciences are expanding manufacturing operations to meet regional demand.
Conclusion
With a strong rise from USD 6.40 billion in 2024 to USD 6.89 billion in 2025, and a projected USD 12.19 billion market size by 2032, the coagulation factors industry is poised for sustained long-term growth. Strategic investments, technological innovation, and expanding treatment needs will continue to shape the global market landscape.
Segmentation By Type
By Application
By End User
By Geography