Coagulation Factor Deficiency Therapeutics Market Size in 7MM is expected to grow at a decent CAGR by 2034, estimates DelveInsight | Novo Nordisk, Pfizer, Spark Therapeutics, Roche, Sanofi (Genzyme), Alnylam Pharmaceuticals

DelveInsight's "Coagulation Factor Deficiency Market Insight, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of Coagulation Factor Deficiency, historical and forecasted epidemiology as well as the Coagulation Factor Deficiency market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

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Key Takeaways from the Coagulation Factor Deficiency Market Report
• In March 2025, Hoffmann-La Roche announced a study designed to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of emicizumab in participants with mild or moderate hemophilia A without inhibitors against factor VIII (Coagulation Factor Deficiency FVIII).
• In March 2025, Swedish Orphan Biovitrum conducted a phase 4 study is to assess whether once-weekly prophylaxis with efanesoctocog alfa (50 IU/kg) improves the disease course of existing synovial hypertrophy and prevents the risk of joint bleeds in patients with moderate or severe haemophilia A. The use of imaging assessments will allow for objective detection and monitoring of synovial hypertrophy, and thus expand on the previous findings demonstrating positive effects of once-weekly prophylaxis with efanesoctocog alfa (50 IU/kg) on joint health.
• The total 7MM prevalent cases of coagulation factor deficiency in 2023 were 105,000 out of which the highest prevalent cases estimated in the United States.
• In the 7MM, the US accounted for the highest number of cases of Coagulation Factor Deficiency, with nearly 34,000 in 2023.
• Among EU4 and the UK, UK accounted for the highest number of cases of Coagulation Factor Deficiency, followed by France, whereas Spain occupied the bottom of the ladder.
• Among the factor-specific cases, Hemophilia A accounted for highest number of cases among other types.
• The leading Coagulation Factor Deficiency Companies such as Novo Nordisk, Pfizer, Spark Therapeutics, Roche, Sanofi (Genzyme), Alnylam Pharmaceuticals, Sangamo Therapeutics, Biotest AG, Centessa Pharmaceuticals (Apicntex), Staidson Biopharma Inc., GC Biopharma, Aronora, Inc., Bayer, Ultragenyx Pharmaceutical, OPKO Health, Inc. and others.
• Promising Coagulation Factor Deficiency Therapies such as Prothrombin Complex Concentrate, Eptacog alfa, biosimilar, Efanesoctocog alfa (BIVV001), Emicizumab, Catridecacog, and others.

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Coagulation Factor Deficiency Epidemiology Segmentation in the 7MM
• Total Coagulation Factor Deficiency Diagnosed prevalent cases
• Coagulation Factor Deficiency Factor-specific Prevalent Cases

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Marketed Coagulation Factor Deficiency Drugs
• ESPEROCT (N8-GP; Turoctocog alfa pegol): Novo Nordisk
ESPEROCT (Turoctocog alfa pegol, also known as N8-GP), is an extended half-life glycopegylated factor VIII molecule indicated for routine prophylaxis to reduce the frequency of bleeding episodes, on-demand treatment, and control of bleeding episodes and perioperative management of bleeding. This product has been evaluated across five prospective, multi-center clinical trials in previously-treated patients with severe hemophilia A and no history of inhibitors. The results of these trials have shown that the overall safety profile of ESPEROCT is similar to what has been reported for other long-action Coagulation Factor Deficiency FVIII products. No safety concerns were identified after more than 5-year of clinical exposure.

• JIVI (formerly BAY94-9027): Bayer
JIVI (antihemophilic factor [recombinant] PEGylated-aucl) is a product of Bayer which is specifically used in previously treated adults and adolescents (12 years of age and older) with hemophilia A (Coagulation Factor Deficiency VIII ) for On-demand treatment and control of bleeding episodes, Perioperative management of bleeding, and Routine prophylaxis to reduce the frequency of bleeding episodes.

Emerging Coagulation Factor Deficiency Drugs
• Concizumab (NN7415): Novo Nordisk
Concizumab, under development by Novo Nordisk, is a high-affinity monoclonal antibody against tissue factor pathway inhibitor (TFPI) intended for bleeding prevention after subcutaneous administration. It allows the body to generate adequate amounts of Factor Xa to ensure effective hemostasis. In 2018, Novo Nordisk completed the main phase of the Phase II trials explorer4, in people with hemophilia A and B with inhibitors, and explorer5, in people with severe hemophilia A without inhibitors, with concizumab to evaluate the efficacy and safety of prophylactic treatment in people with hemophilia. Currently, it is in Phase III clinical trial for hemophilia A and B with and without Inhibitors.

• Fidanacogene elaparvovec: Pfizer/Spark Therapeutics
Fidanacogene elaparvovec, previously SPK-9001 or PF-06838435, is a novel, investigational bio-engineered AAV vector utilizing a high-activity F9 transgene for hemophilia B or factor IX deficiency. The Fidanacogene Elaparvovec's BLA has been accepedted by the FDA. SPK-9001 Phase III (NCT03861273) clinical trial study wherein the study will evaluate the efficacy and safety of SPK-9001 (a gene therapy drug) in adult male participants with moderately severe to severe hemophilia B (participants that have a Factor IX circulating activity of 2% or less). The study's main objectives are to compare the annualized bleeding rate [ABR] of the gene therapy to routine prophylaxis from the lead-in study and to evaluate its impact on the participant's Factor IX circulating activity [FIX:C]. This study includes 55 participants, with an estimated completion date of May 2027.

• RG6357 (SPK-8011): Roche (Spark Therapeutics)
RG6357 (SPK-8011), which is under development by Roche's subsidiary Spark Therapeutics, is an intravenously administered novel bio-engineered AAV vector utilizing the AAV-LK03 capsid, also referred to as Spark200, contains a codon-optimized human Coagulation Factor Deficiency VIII gene under the control of a liver-specific promoter for hemophilia A, or Coagulation Factor Deficiency VIII.

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Coagulation Factor Deficiency Companies
Novo Nordisk, Pfizer, Spark Therapeutics, Roche, Sanofi (Genzyme), Alnylam Pharmaceuticals, Sangamo Therapeutics, Biotest AG, Centessa Pharmaceuticals (Apicntex), Staidson Biopharma Inc., GC Biopharma, Aronora, Inc., Bayer, Ultragenyx Pharmaceutical, OPKO Health, Inc. and others.

Coagulation Factor Deficiency Market Outlook
Due to the technological improvements in the manufacture of coagulation proteins, new age recombinants concentrate has been developed in past years. These Recombinants Concentrate products are mainly derived from Chinese hamster (CHO) or baby hamster kidney (BHK) cells that have been transfected with the human factor FVIII. Although the cell lines used in fermentation are considered to be free of viruses, these concentrates are still subjected to a combination of viral clearance and inactivation steps to ensure safety and purity.

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Scope of the Coagulation Factor Deficiency Market Report
• Coverage- 7MM
• Study Period- 2020-2034
• Coagulation Factor Deficiency Companies- Novo Nordisk, Pfizer, Spark Therapeutics, Roche, Sanofi (Genzyme), Alnylam Pharmaceuticals, Sangamo Therapeutics, Biotest AG, Centessa Pharmaceuticals (Apicntex), Staidson Biopharma Inc., GC Biopharma, Aronora, Inc., Bayer, Ultragenyx Pharmaceutical, OPKO Health, Inc. and others.
• Coagulation Factor Deficiency Drugs- Prothrombin Complex Concentrate, Eptacog alfa, biosimilar, Efanesoctocog alfa (BIVV001), Emicizumab, Catridecacog, and others.
• Coagulation Factor Deficiency Market Dynamics: Coagulation Factor Deficiency Market Drivers and Barriers
• Coagulation Factor Deficiency Market Access and Reimbursement, Unmet Needs and Future Perspectives

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Table of Content
1. KEY INSIGHTS
2. REPORT INTRODUCTION
3. COAGULATION FACTOR DEFICIENCY MARKET OVERVIEW AT A GLANCE
4. EXECUTIVE SUMMARY OF COAGULATION FACTOR DEFICIENCY
5. KEY EVENTS
6. EPIDEMIOLOGY AND MARKET METHODOLOGY
7. COAGULATION FACTOR DEFICIENCY DISEASE - OVERVIEW
8. EPIDEMIOLOGY AND PATIENT POPULATION
9. PATIENT JOURNEY
10. MARKETED THERAPIES
11. EMERGING DRUGS
12. COAGULATION FACTOR DEFICIENCY: SEVEN MAJOR MARKET ANALYSIS
13. Coagulation Factor Deficiency MARKET ACCESS AND REIMBURSEMENT
14. UNMET NEEDS
15. SWOT ANALYSIS
16. KOL VIEWS
17. APPENDIX
18. DELVEINSIGHT CAPABILITIES
19. DISCLAIMER
20. ABOUT DELVEINSIGHT

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