DelveInsight’s “Hypofibrinogenemia Market Insights, Epidemiology and Market Forecast – 2034” report delivers an in-depth understanding of Hypofibrinogenemia, historical and forecasted epidemiology as well as the Hypofibrinogenemia market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

 

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Key Takeaways from the Hypofibrinogenemia Market Report

• In November 2024:- Weill Medical College of Cornell University- The goal of this quality improvement study is to compare pathogen-reduced cryoprecipitate with traditional cryoprecipitate in liver transplant and cardiovascular patients. The investigators hypothesize that by having immediate access to a readily available thawed blood product that replaces fibrinogen (the main substrate of a blood clot), early bleeding can be treated before it escalates into uncontrolled hemorrhage, and therefore additional blood products, like platelets, plasma and red blood cells can be avoided.
• DelveInsight estimates show that United States accounted for the highest market size of Hypofibrinogenemia in 7MM of ~ USD 150 million.
• Among EU4 and the UK, Germany has the highest market size ~USD 10 million in 2023.
• In the US, cryoprecipitate generated the highest revenue of ~USD 70 million for congenital hypofibrinogenemia and ~10 million for acquired hypofibrinogenemia, in 2023.
• BT-524 (Biotest) is the only emerging therapy in the developmental phase for the treatment of Congenital and Acquired Hypofibrinogenemia.
• The leading Hypofibrinogenemia Companies such as CSL Behring, Grifols, S.A., Kedrion Biopharma Inc., Octapharma AG, LFB S.A., Shanghai RAAS Blood Products Co., Ltd, Hualan Biological Engineering Inc, China Biologic Products Holdings, Inc, Baxter International Inc, Sanquin among others.
• Promising Hypofibrinogenemia Therapies such as Cryoprecipitate, Pathogen-Reduced Cryoprecipitate, and others

 

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Hypofibrinogenemia Epidemiology Segmentation in the 7MM

• Total Diagnosed Prevalence
• Type-specific Diagnosed Prevalence
• Cause-specific Diagnosed Prevalence of Acquired
• Treatable Cases

 

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Hypofibrinogenemia Marketed Drugs

 

• RiaSTAP: CSL Behring

RiaSTAP is a heat-treated, lyophilized fibrinogen (coagulation factor I) powder made from pooled human plasma. It is manufactured from cryoprecipitate into a glycine precipitate, which is then further purified by multiple precipitation/adsorption steps. RiaSTAP is indicated for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia in the US and Europe. Approval was based on a pivotal phase II prospective, open-label pharmacokinetic (PK) and safety study using maximum clot firmness (MCF) as a surrogate endpoint for hemostatic efficacy. Outside the United States, RiaSTAP is marketed under the trade name of Haemocomplettan.

 

• Fibryna: Octapharma

FIBRYNA (Octafibrin) is a human plasma-derived, sterile, purified, virus-inactivated, and nano filtered (20 nm) fibrinogen concentrate. It has a fixed, labeled content of fibrinogen and is double pathogen-inactivated. It supplied as a lyophilized powder that can be stored at room temperature and reconstituted within minutes. The reconstituted product is stable at room temperature for 24 h. Conversely, cryoprecipitate must be thawed before use and must be used within 4 h of thawing. The amount of fibrinogen in cryoprecipitate can vary considerably from preparation to preparation. Also, the pooling of plasma during the preparation of cryoprecipitate carries a potential risk of infectious transmission.

 

Hypofibrinogenemia Emerging Drugs

AdFIrst (BT-524): Biotest AG

BT-524 is a human fibrinogen concentrate purified from human plasma. Fibrinogen is a plasma protein produced by the liver, which is an important component of blood clotting. A deficiency of autologous fibrinogen means that the blood’s ability to clot is impaired, which leads to a greatly increased risk of bleeding and additionally to a delay in bleeding cessation. In the case of congenital fibrinogen deficiency patients can produce no or only insufficient fibrinogen. In acquired fibrinogen deficiency, on the other hand, patients lose fibrinogen because of heavy bleeding, for example due to severe injuries and surgery. In both cases, fibrinogen must be supplied again to stop bleeding.

 

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Scope of the Hypofibrinogenemia Market Report

• Coverage- 7MM
• Study Period- 2020-2034
• Hypofibrinogenemia Companies- CSL Behring, Grifols, S.A., Kedrion Biopharma Inc., Octapharma AG, LFB S.A., Shanghai RAAS Blood Products Co., Ltd, Hualan Biological Engineering Inc, China Biologic Products Holdings, Inc, Baxter International Inc, Sanquin among others.
• Hypofibrinogenemia Therapies- Cryoprecipitate, Pathogen-Reduced Cryoprecipitate, and others.
• Hypofibrinogenemia Therapeutic Assessment: Hypofibrinogenemia Current marketed and Hypofibrinogenemia Emerging Therapies
• Hypofibrinogenemia Market Dynamics: Hypofibrinogenemia Market drivers and Hypofibrinogenemia Market Barriers

 

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Table of Content

1. Key Insights

2. Hypofibrinogenemia: Market Overview at a Glance

3. Executive summary

4. Disease Overview: Hypofibrinogenemia

5. Epidemiology and Patient Population

6. Marketed therapies

7. Emerging Therapies

8. Market Size of Hypofibrinogenemia in 7MM

9. KOL Views

10. SWOT Analysis

11. Unmet Needs

12. Market Access and Reimbursement

13. Appendix

14. DelveInsight Capabilities

15. Disclaimer

16. About DelveInsight

 

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