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市場調查報告書
商品編碼
1880600
人類纖維蛋白原濃縮物市場規模、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 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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由於外科手術的增加、人們對先進止血療法的認識不斷提高以及血漿衍生技術的持續進步,全球人類纖維蛋白原濃縮物市場正在快速擴張。根據最新估計,2024 年全球市場規模約為 7.687 億美元,預計到 2025 年將達到 8.534 億美元。預計到 2032 年,市場規模將加速成長至 19.011 億美元,預測期內複合年增長率 (CAGR) 為 12.1%。歐洲在全球市場佔主導地位,2024 年市佔率達到 48.39%,這得益於其強大的生產能力、監管審批以及外科手術和出血性疾病的高發生率。
人類纖維蛋白原濃縮物是一種重要的血漿衍生止血產品,用於快速恢復因創傷、手術或先天性纖維蛋白原缺乏症(例如無纖維蛋白原血症)而導致嚴重出血患者的纖維蛋白原水平。全球手術負擔的不斷加重仍然是推動市場需求的主要因素。例如,全印度醫學科學研究所 (AIIMS) 報告稱,2022 年 9 月印度進行了超過 25 萬例全膝關節置換手術,顯示市場對可靠的止血解決方案的需求日益增長。 LFB、CSL、Octapharma AG 和 Grifols S.A. 等領先企業持續投資於研發、產品線拓展和臨床試驗,以鞏固其全球影響力。 2024 年 2 月,Grifols 公佈了 Biotest 的纖維蛋白原濃縮物 BT524 的 III 期臨床試驗的積極結果,證明其在治療獲得性纖維蛋白原缺乏症 (AFD) 方面的療效。
市場推動因素
主要推動因素之一是全球外科手術數量的快速增長,這歸因於人口老化、慢性病增多、不健康的生活方式以及創傷病例的增加。隨著外科手術變得越來越複雜,對快速有效的術中止血液的需求也相應增長。根據美國國立衛生研究院 (NIH) 發布的 "2024 年全球心臟外科手術量報告" ,高收入國家平均每年每 10 萬人進行 123.2 例心臟手術。減少術中和術後併發症的需求日益增長,顯著加速了纖維蛋白原濃縮物相對於新鮮冷凍血漿 (FFP) 和冰凍血漿等傳統選擇的應用。
市場限制因子
然而,人類纖維蛋白原濃縮物的高成本仍然是一個主要阻礙因素,尤其是在新興經濟體。複雜的生產流程、對捐獻血漿的需求以及嚴格的監管規程都顯著增加了生產成本。例如,1克FIBRINOREL的商業價格約為185.4美元,限制了其在低收入地區的普及。有限的保險覆蓋範圍進一步阻礙了其在發展中國家的應用,並減緩了其市場滲透速度。
市場機會
全球和區域製造商之間不斷擴大的策略聯盟正在創造強勁的成長機會。製藥公司、生技公司和血漿分離專家之間的合作能夠加快產品開發速度並深化市場滲透。 2024年6月,Plasmagen Biosciences與CSL Behring合作,開始在印度生產和銷售Hemocomplettan P,這標誌著在改善發展中國家市場可及性方面邁出了重要一步。除了不斷擴大的研發管線外,政府為改善外科基礎設施所做的努力預計也將支持長期成長。
市場挑戰
供應鏈的複雜性仍然是一項重大挑戰。人類纖維蛋白原濃縮物需要強大的供體網絡、嚴格的冷鏈物流、高技能人員以及嚴格的批次放行監管。這些因素為新生產商設置了很高的進入門檻,減緩了競爭擴張速度,並限制了全球供應。
產業趨勢
一個關鍵的新興趨勢是轉向研發管線創新,以縮短給藥時間、實現劑量標準化並改善臨床療效。傳統的冷凍纖維蛋白原補充劑受限於劑量差異和耗時的解凍過程。像 Grifols 的 BT524 這樣的新產品,預計將於 2025 年在 III 期臨床試驗中達到其主要目標,在治療獲得性纖維蛋白原缺乏症 (AFD) 方面具有更可預測的療效和更快速的給藥方式。這些進步有望重新定義全球臨床實踐。
市場區隔概覽
依應用領域
預計到2024年,獲得性纖維蛋白原缺乏症和外科手術領域將成為市場主導,這主要得益於創傷病例的增加以及全球外科手術數量的增長。作為參考,2020-2021年澳洲共進行了12,700例冠狀動脈繞道手術(CABG)。先天性纖維蛋白原缺乏症仍是第二大區隔市場,這主要歸功於其較高的盛行率(每百萬人口1-30例)以及人們對該疾病的認識和診斷率的不斷提高。
依最終使用者
預計到2024年,醫院領域將佔最大市場佔有率,這得益於其先進的基礎設施和龐大的手術量。根據世界衛生組織統計,全球每年進行的外科手術數量超過3億例,增加了醫院對纖維蛋白原濃縮物的依賴。
歐洲
歐洲將佔最大的區域市場佔有率,到2024年市場規模將達到3.72億美元,這得益於該地區強大的行業地位以及對諸如Octapharma的Fibriga等產品的早期應用。
北美
成長的推動因素是出血性疾病發生率的上升(據估計,美國約有33,000人患有血友病)以及健全的醫療保健生態系統。
亞太地區
亞太地區未來成長潛力巨大,這得益於人口老化、慢性病增多以及基礎設施建設,例如旨在升級100家醫院的 "2024 100-4-100" 計畫。
拉丁美洲、中東和非洲
儘管這些地區的市場佔有率較小,但它們正受益於人們意識的提高和醫療保健投資的增加。
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