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市場調查報告書
商品編碼
1954675
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:依應用、最終用戶和地區劃分的洞察與預測(2026-2034年)Human Fibrinogen Concentrates Market Size, Share, Growth and Global Industry Analysis By Type & Application, Regional Insights and Forecast to 2026-2034 |
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到2025年,全球人類纖維蛋白原濃縮物市場規模達到 8.534億美元,預計從2026年的9.4968億美元成長至2034年的21.956億美元,在預測期(2026-2034年)內成長 1.04%。歐洲在2025年將以 23.96%的市場佔有率領先,這主要得益於主要血漿製品生產商的強大影響力以及外科手術量的增加。
人類纖維蛋白原濃縮物是一種血漿衍生療法,用於恢復因創傷、重大手術或先天性/後天性纖維蛋白原缺乏症導致嚴重出血患者的纖維蛋白原水準。纖維蛋白原在血塊形成中發揮關鍵作用,其缺乏會延長凝血時間並增加出血風險,因此需要外源性補充。人們對先進止血療法的認識不斷提高以及血漿分離技術的進步是市場擴張的關鍵驅動因素。
例如,印度醫學科學院(AIIMS)在2022年9月報告指出,印度全膝關節置換手術總數將超過25萬例,證實了手術需求的成長和全球產品應用範圍的擴大。此外,Grifols公司纖維蛋白原濃縮物BT524的III期臨床試驗(2024年2月)的正面結果進一步鞏固了該產業的發展動能。
市場動態
市場驅動因素
外科手術和創傷病例的增加
全球範圍內,心血管、骨科、神經外科和婦科等專科的外科手術數量不斷增加,顯著推動了對纖維蛋白原濃縮物的需求。根據美國國立衛生研究院(2024年6月)的資料,高收入國家平均每年每10萬人進行123.2例心臟手術。此外,世界衛生組織估計,截至2023年9月,全球每年將進行超過3億例外科手術。
為了減少術中和術後出血併發症,人們加速採用纖維蛋白原濃縮物取代傳統的冷沉澱和新鮮冰凍血漿(FFP),這推動了全球市場的成長。
市場限制因子
產品成本高且健保償付有限
儘管臨床療效顯著,但高昂的成本仍然是一個重大障礙。例如,1克FIBRINOREL幹纖維蛋白原(10毫升)的價格約為185.4美元,這限制了低收入地區的可及性。複雜的血漿分離製程、嚴格的安全標準和監管審批都推高了生產成本。新興經濟體嚴格的健保償付政策進一步限制了產品的普及。
市場機會
策略聯盟與市場拓展
血漿製品生產商與區域性公司之間的合作創造獲利成長路徑。2024年6月,Plasmagen Biosciences與CSL Behring合作,在印度生產和銷售Hemocomplettan P,擴大了先天性纖維蛋白原缺乏症和後天性低纖維蛋白原血症的治療範圍。
此類合作關係能夠加強分銷網路,提高產品在未開發市場的供應,並擴大全球影響力。發展中國家慢性病盛行率的不斷上升也為長期擴張提供了機會。
市場挑戰
供應鍊與生產的複雜性
纖維蛋白原濃縮物的生產需要龐大的血漿捐贈者網路、先進的分離設備、冷鏈物流和熟練的人員。嚴格的監管合規性和批次放行規程構成了很高的進入門檻,限制了新進入者,並可能影響供應穩定性。
市場趨勢
新型在研產品取代冷沉澱
傳統上,冷沉澱用於治療纖維蛋白原缺乏症,但它需要解凍且缺乏標準化的劑量。新一代纖維蛋白原濃縮物具有給藥速度更快、安全性更高、劑量更精確等優點。
2025年6月,Grifols宣布BT524 III期臨床試驗取得積極結果,證明其在治療大型手術期間獲得性纖維蛋白原缺乏症方面不劣於冷沉澱和新鮮冰凍血漿(FFP)。本產品無需解凍即可快速、可預測地給藥,進而改善急診環境的患者預後。這些研發管線的進展塑造未來的市場趨勢。
依應用領域
市場細分為先天性纖維蛋白原缺乏症、後天性纖維蛋白原缺乏症/手術和其他。
在創傷和外科手術日益增多的推動下,獲得性纖維蛋白原缺乏症/手術細分市場在2025年佔據92.61%的市場佔有率。例如,2020年至2021年,澳洲共進行了12,700例冠狀動脈繞道手術,推動了止血劑的需求。
先天性纖維蛋白原缺乏症佔據第二大市場佔有率,預計將保持溫和成長。根據Orphanet統計,無纖維蛋白原血症的盛行率為每百萬人1-30例,這支撐了替代療法的穩定需求。
依最終使用者劃分
最終使用者包括醫院、專科診所及其他機構。
預計到2026年,醫院將佔據83.34%的市場佔有率,這主要得益於其高手術量和先進的基礎設施。醫院將成為纖維蛋白原濃縮物的主要用戶,用於控制術中出血。
專科診所佔據第二大市場佔有率,尤其是在專科醫療網路不斷擴展的發展中國家。研究機構和醫療機構正集中精力進行產品研發,因此市場佔有率較小。
歐洲
2025年,歐洲人纖維蛋白原濃縮物市場規模達到4.0991億美元,成為全球最大的市場。這一主導地位歸功於Octapharma AG和LFB等成熟的血漿製品生產商、高手術量以及監管部門的批准。2019年11月,Octapharma將Fibryga的核准範圍擴大到15個歐洲國家。
北美
由於北美擁有完善的醫療保健基礎設施以及出血性疾病發病率的不斷上升,到2025年,北美佔據較大的市場佔有率。根據美國疾病管制與預防中心(CDC)的資料(2024年5月),美國約有33,000名男性患有血友病,這推動了對先進止血劑的需求。
亞太地區
亞太地區佔據第二大市場佔有率,預計到2034年將維持顯著的年複合成長率。人口老化、慢性病增多、醫療保健投資是推動成長的主要因素。2024年12月宣布的在印度建設100家醫院的 "100-4-100計畫" 預計將進一步刺激對外科產品的需求。
拉丁美洲、中東和非洲
儘管這些地區的市場佔有率相對較小,但由於公眾意識的提高和醫療保健支出的增加,預計這些地區將實現穩步成長。
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