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市場調查報告書
商品編碼
1887196
凝血因子市場規模、佔有率、成長及全球產業分析:依類型、應用和地區劃分的洞察與預測(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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全球凝血因子市場正經歷顯著成長,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進療法需求不斷增長的推動。根據最新的產業分析,2024年全球市場規模為64億美元,2025年將增至68.9億美元,預計到2032年將達到121.9億美元,這主要得益於技術創新、血漿採集能力的提升以及人們對遺傳性出血性疾病認識的不斷提高。 2024年,北美以58.44%的市佔率領跑,這得益於其強大的醫療保健基礎設施和血漿衍生療法的日益普及。
凝血因子在維持正常血液凝固過程中扮演至關重要的角色。隨著全球出血性疾病和創傷病例的不斷增加,對血漿衍生和重組凝血產品的需求持續增長。包括CSL、Octapharma AG、Kedrion S.p.A.和武田藥品工業株式會社在內的主要行業領導者正在加強研發管線並擴大生產能力,以滿足全球治療需求。
市場驅動因素
推動市場成長的關鍵因素是全球遺傳性出血性疾病發生率的上升。根據美國疾病管制與預防中心(CDC)統計,美國約有33,000名男性患有血友病,而血管性血友病影響約1%的美國人口。診斷率的提高、患者意識的增強以及醫療服務提供者對早期治療的日益重視,持續推動凝血療法的需求成長。
全球傷害和事故發生率的上升也顯著促進了市場擴張。光是在印度,預計2022年道路交通事故將達到461,312起,比前一年增長11.9%。急診和重症監護機構對凝血因子的大量使用進一步支撐了市場成長趨勢。
市場限制因子
儘管成長潛力巨大,但嚴格的監管框架對製造商構成了挑戰。血漿的採集和處理必須符合FDA等機構制定的嚴格安全和品質標準,這些機構根據 "公共衛生服務法" 和 "聯邦食品、藥品和化妝品法" 監管血漿療法。漫長的審批週期和嚴格的營運要求可能會延遲產品上市,並限制市場擴張,尤其是在新興經濟體。
高昂的生產成本也限制了新進入者,因為血漿分離和生產基礎設施需要大量的資本投資。發展中地區有限的保險覆蓋範圍進一步限制了患者獲得治療的機會。
市場機會
對先進療法的研發投入不斷增加,為市場參與者提供了巨大的機會。新的血漿分離設施、不斷擴大的治療適應症、標靶給藥系統和長效因子製劑正在塑造下一波創新浪潮。例如,CSL Behring 將於 2022 年在澳洲開設一家新的血漿分離工廠,以支持血友病和其他嚴重疾病的治療,這體現了該行業致力於擴大全球產能的決心。
人工智慧和物聯網的進步正在提高生產效率、供應鏈透明度和患者支援水平,從而加速下一代療法的應用。
細分市場分析
依類型
預計到 2024 年,VIII 因子細分市場將佔最大的市場佔有率,這主要得益於血友病 A 的高發病率,據估計,全球有超過 110 萬人患有此病。纖維蛋白原濃縮物市場位居第二,這主要得益於監管部門的批准,例如 Octapharma 的 Fibryga 於 2024 年獲得美國 FDA 批准。
依應用領域劃分
血液學領域在 2024 年引領市場。這主要歸功於止血技術的進步以及先天性出血性疾病在全球範圍內的高發生率。血友病的盛行率估計為每 6,000 至 10,000 名男性中就有 1 例,這表明存在巨大的臨床需求。
依最終使用者劃分
2024 年,由於患者對專科護理的偏好、住院率的增加以及行業與醫療機構的合作,醫院和診所佔了大部分市場佔有率。由於對血漿衍生研發應用的需求不斷增長,臨床實驗室預計將保持穩定成長。
北美
北美在2024年以37.4億美元的市場規模領先全球市場,這得益於其強大的血漿採集網絡、不斷增長的產品審批以及先進療法的廣泛應用。美國的血漿庫容量持續擴大,武田製藥旗下的BioLife Plasma Services於2023年開設了其第200家捐血中心。
歐洲
歐洲佔第二大市場佔有率,這得益於不斷擴大的血漿分離設施和強有力的監管支持。 CSL於2023年擴建其位於德國的血漿工廠,增強了該地區的供應能力。
亞太地區
由於併購活動增加、設施擴建以及血漿衍生產品價格的日益親民,預計該地區將實現強勁增長。 PlasmaGen Biosciences 等公司正在擴大生產規模,以滿足區域需求。
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