Coagulation factor deficiency Market Analysis

Emerging therapies for coagulation factor deficiency, including ESPEROCT (N8-GP; Turoctocog alfa pegol), JIVI (formerly BAY94-9027), Concizumab (NN7415), Fidanacogene elaparvovec, RG6357 (SPK-8011), and others, are expected to drive growth in the coagulation factor deficiency market in the coming years.

DelveInsight has released a new report titled “Coagulation factor deficiency – Market Insights, Epidemiology, and Market Forecast-2034,” providing a comprehensive analysis of the disease, including historical and projected epidemiology, as well as market trends across the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.

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Some of the key facts of the Coagulation factor deficiency Market Report:

• In 2023, the coagulation factor deficiency market across the seven major markets (7MM) was valued at approximately USD 13.5 billion, with an estimated 105,000 prevalent cases, the highest number occurring in the United States. Among the various factor-specific deficiencies, Hemophilia A had the largest patient population.

• In March 2024, ReciBioPharm partnered with preclinical gene therapy company GeneVentiv Therapeutics to develop an AAV-based universal gene therapy for hemophilia, reportedly the first targeting patients with inhibitors.

• In June 2023, the US FDA accepted the Biologics License Application (BLA) for fidanacogene elaparvovec to treat adults with hemophilia B, while the European Medicines Agency (EMA) simultaneously accepted its European marketing authorization application (MAA), which is currently under review.

• In May 2023, Novo Nordisk received a Complete Response Letter (CRL) from the FDA for their investigational subcutaneous therapy, concizumab, delaying anticipated approval timelines.

• Key companies driving development in this field include Novo Nordisk, Pfizer, Spark Therapeutics, Roche, Sanofi (Genzyme), Alnylam Pharmaceuticals, Sangamo Therapeutics, Biotest AG, Centessa Pharmaceuticals, Staidson Biopharma, GC Biopharma, Aronora, Bayer, Ultragenyx, Opko Health, and others, all advancing novel therapies for coagulation factor deficiencies.

• Promising treatments under development or in the market include ESPEROCT (N8-GP; Turoctocog alfa pegol), JIVI (formerly BAY94-9027), Concizumab (NN7415), Fidanacogene elaparvovec, RG6357 (SPK-8011), and others.

Coagulation factor deficiency Overview

Coagulation factor deficiency disorders, also known as bleeding or clotting disorders, comprise a set of inherited or acquired conditions caused by the absence or dysfunction of specific proteins necessary for blood clotting. These proteins, called coagulation factors, play a critical role in stopping bleeding by forming clots that seal injured blood vessels.

There are thirteen coagulation factors (I–XIII) that act in a tightly coordinated cascade to maintain proper hemostasis. A deficiency in any of these factors can lead to abnormal bleeding, with severity varying from mild to severe depending on the specific factor involved and the degree of deficiency.

Coagulation factor deficiency Market Outlook

Recent technological progress in coagulation protein production has enabled the creation of advanced recombinant concentrates. These products are mainly produced using genetically engineered Chinese hamster ovary (CHO) or baby hamster kidney (BHK) cells that generate human factor VIII. Although the cell lines themselves are considered virus-free, the concentrates undergo additional viral inactivation and clearance processes to ensure their safety and purity.

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Coagulation factor deficiency marketed drugs:

• ESPEROCT (N8-GP; Turoctocog alfa pegol): Novo Nordisk

• JIVI (formerly BAY94-9027): Bayer

Coagulation factor deficiency Emerging Drugs

• Concizumab (NN7415): Novo Nordisk

• Fidanacogene elaparvovec: Pfizer/Spark Therapeutics

• RG6357 (SPK-8011): Roche (Spark Therapeutics)

Scope of the Coagulation factor deficiency Market Report

• Study Period: 2020-2034

• Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]

• Key Coagulation factor deficiency Companies: Novo Nordisk, Pfizer, Spark Therapeutics, Roche, Sanofi (Genzyme), Alnylam Pharmaceuticals, Sangamo Therapeutics, Biotest AG, Centessa Pharmaceuticals (Apcintex), Staidson Biopharma Inc., GC Biopharma, Aronora, Inc., Bayer, Ultragenyx Pharmaceutical, Opko Health, Inc., and others

• Key Coagulation factor deficiency Therapies: ESPEROCT (N8-GP; Turoctocog alfa pegol), JIVI (formerly BAY94-9027), Concizumab (NN7415), Fidanacogene elaparvovec, RG6357 (SPK-8011), and others

• Coagulation factor deficiency Therapeutic Assessment: Coagulation factor deficiency current marketed and Coagulation factor deficiency emerging therapies

• Coagulation factor deficiency Market Dynamics: Coagulation factor deficiency market drivers and Coagulation factor deficiency market barriers

• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies

• Coagulation factor deficiency Unmet Needs, KOL’s views, Analyst’s views, Coagulation factor deficiency Market Access and Reimbursement

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Key benefits of the Coagulation factor deficiency Market Report:

1. Coagulation factor deficiency market report covers a descriptive overview and comprehensive insight of the Coagulation factor deficiency Epidemiology and Coagulation factor deficiency market in the 7MM (the United States, EU5 (Germany, Spain, France, Italy, UK) & Japan).

2. The Coagulation factor deficiency market report provides insights into the current and emerging therapies.

3. The Coagulation factor deficiency market report provides a global historical and forecasted market covering drug outreach in 7MM.

4. The Coagulation factor deficiency market report offers an edge that will help in developing business strategies by understanding trends shaping and driving the Coagulation factor deficiency market.

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Table of Contents

1. Report Introduction

2. Executive Summary

3. SWOT analysis

4. Coagulation factor deficiency Patient Share (%) Overview at a Glance

5. Coagulation factor deficiency Market Overview at a Glance

6. Coagulation factor deficiency Disease Background and Overview

7. Coagulation factor deficiency Epidemiology and Patient Population

8. Country-Specific Patient Population of Coagulation factor deficiency

9. Coagulation factor deficiency Current Treatment and Medical Practices

10. Unmet Needs

11. Coagulation factor deficiency Emerging Therapies

12. Coagulation factor deficiency Market Outlook

13. Country-Wise Coagulation factor deficiency Market Analysis (2020–2034)

14. Market Access and Reimbursement of Therapies

15. Market drivers

16. Market barriers

17. Appendix

18. Coagulation factor deficiency Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

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Related Reports:

Coagulation factor deficiency Pipeline Insights, DelveInsight

“Coagulation factor deficiency Pipeline Insight, 2024” report by DelveInsight outlines comprehensive insights of present clinical development scenarios and growth prospects across the Coagulation factor deficiency market. A detailed picture of the Coagulation factor deficiency pipeline landscape is provided, which includes the disease overview and Coagulation factor deficiency treatment guidelines.

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.

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