Coagulation factor xiii a-subunit (recombinant) - Biologic Drug Details

Summary for coagulation factor xiii a-subunit (recombinant)

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for coagulation factor xiii a-subunit (recombinant)

Recent Clinical Trials for coagulation factor xiii a-subunit (recombinant)

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Hoffmann-La Roche	Phase 2
French Innovative Leukemia Organisation	Phase 2
University of Florida	Phase 4

See all coagulation factor xiii a-subunit (recombinant) clinical trials

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1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

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1) High Certainty: US Patents for coagulation factor xiii a-subunit (recombinant) Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for coagulation factor xiii a-subunit (recombinant) Derived from Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Novo Nordisk Inc.	TRETTEN	coagulation factor xiii a-subunit (recombinant)	For Injection	125398	10,391,062	2029-04-20	Company disclosures

3) Low Certainty: US Patents for coagulation factor xiii a-subunit (recombinant) Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source

Market Dynamics and Financial Trajectory for Coagulation Factor XIII A-Subunit (Recombinant)

Introduction

Coagulation Factor XIII A-subunit, also known as fibrin-stabilizing factor, is a crucial component in the blood coagulation cascade. The recombinant form of this factor has emerged as a significant biologic drug, particularly for treating congenital and acquired Factor XIII deficiencies. Here, we delve into the market dynamics and financial trajectory of this biologic drug.

Market Overview

The market for coagulation Factor XIII A-subunit is driven by the increasing prevalence of bleeding disorders and the need for effective treatments. Factor XIII deficiency is a rare genetic disorder, but its impact on patients' quality of life and the complexity of managing the condition make it a significant market segment[5].

Regulatory Approval and Commercialization

The recombinant form of Factor XIII A-subunit, such as Catridecacog, has gained regulatory approval in several countries. For instance, Corifact, a commercially available product, is approved by the FDA for routine prophylactic treatment and peri-operative management of surgical bleeding in patients with congenital Factor XIII deficiency[4].

Demand and Patient Population

The demand for recombinant Factor XIII A-subunit is primarily driven by patients with congenital Factor XIII deficiency, a condition characterized by unstable blood clots and prolonged bleeding episodes. Additionally, acquired deficiencies due to various medical conditions such as major surgery, pulmonary embolism, and certain types of leukemia also contribute to the demand[2].

Competitive Landscape

The market for Factor XIII A-subunit is relatively niche but competitive. Key players include pharmaceutical companies that produce recombinant forms of the factor, such as Novo Nordisk (producer of Tretten, another recombinant FXIII) and CSL Behring (producer of Corifact). These companies compete based on the efficacy, safety, and convenience of their products[4].

Pricing and Reimbursement

The pricing of recombinant Factor XIII A-subunit is influenced by several factors, including production costs, regulatory approvals, and reimbursement policies. Given the rare nature of the condition it treats, the drug is often classified as an orphan drug, which can lead to higher pricing. Reimbursement policies vary by country but generally include coverage under specialized programs for rare diseases[5].

Financial Performance

The financial performance of recombinant Factor XIII A-subunit is robust due to its high demand and limited competition. The long half-life of the factor (5-11 days) allows for less frequent dosing, which can reduce overall treatment costs but maintains a steady revenue stream through regular replacements[4].

Revenue Growth

The revenue from recombinant Factor XIII A-subunit has seen steady growth over the years. This growth is attributed to increased awareness and diagnosis of Factor XIII deficiency, as well as the expansion of treatment options into new markets.

Cost Structure

The cost structure includes research and development expenses, manufacturing costs, and marketing expenditures. The use of recombinant DNA technology to produce the factor in yeast or other cell lines can be cost-effective compared to traditional plasma-derived products[4].

Market Trends and Future Outlook

Increasing Awareness and Diagnosis

There is a growing awareness among healthcare professionals about the importance of diagnosing and treating Factor XIII deficiency. This increased awareness is expected to drive up demand for recombinant Factor XIII A-subunit.

Advances in Technology

Advancements in recombinant DNA technology and manufacturing processes are likely to improve the efficiency and reduce the costs associated with producing the factor. This could lead to more competitive pricing and broader market penetration.

Expanding Indications

Research into the role of Factor XIII in other medical conditions, such as wound healing and pregnancy maintenance, may expand the indications for its use, further increasing market demand[3].

Challenges and Opportunities

Regulatory Hurdles

Navigating regulatory approvals in different countries can be challenging. However, the orphan drug designation often facilitates the approval process for rare disease treatments.

Competition from Alternative Treatments

While the market is currently dominated by recombinant products, traditional plasma-derived Factor XIII and other emerging treatments could pose competition. However, the safety and efficacy of recombinant products generally make them the preferred choice.

Patient Access and Affordability

Ensuring patient access and affordability remains a significant challenge. Efforts to improve reimbursement policies and reduce costs through efficient manufacturing can help address this issue.

Key Players and Partnerships

Novo Nordisk and CSL Behring

These companies are among the leading players in the market, with products like Tretten and Corifact. Partnerships with healthcare providers and patient advocacy groups are crucial for these companies to maintain market share.

Research Collaborations

Collaborations between pharmaceutical companies and research institutions are vital for advancing the understanding and treatment of Factor XIII deficiency. These collaborations can lead to new products and improved treatment outcomes.

Conclusion

The market for recombinant coagulation Factor XIII A-subunit is characterized by strong demand driven by the need for effective treatments for rare bleeding disorders. With regulatory approvals, competitive pricing, and advancements in technology, this market is poised for continued growth. However, challenges such as regulatory hurdles, competition, and patient access must be addressed to ensure sustained success.

Key Takeaways

• Growing Demand: Increasing awareness and diagnosis of Factor XIII deficiency drive market demand.
• Regulatory Approvals: Products like Corifact have gained FDA approval, facilitating market entry.
• Competitive Landscape: The market is relatively niche but competitive, with key players like Novo Nordisk and CSL Behring.
• Financial Performance: Robust revenue growth due to high demand and limited competition.
• Market Trends: Advances in technology and expanding indications are expected to drive future growth.

FAQs

What is the primary use of recombinant Factor XIII A-subunit?

The primary use of recombinant Factor XIII A-subunit is for the treatment of congenital and acquired Factor XIII deficiencies, helping to stabilize blood clots and prevent prolonged bleeding episodes.

How is recombinant Factor XIII A-subunit produced?

Recombinant Factor XIII A-subunit is produced using recombinant DNA technology, where the target protein is grown in yeast or other cell lines and then isolated.

What are the key challenges in the market for recombinant Factor XIII A-subunit?

Key challenges include regulatory hurdles, competition from alternative treatments, and ensuring patient access and affordability.

Which companies are leading players in the market for recombinant Factor XIII A-subunit?

Leading players include Novo Nordisk and CSL Behring, with products like Tretten and Corifact.

What is the expected future outlook for the market?

The market is expected to grow due to increasing awareness and diagnosis of Factor XIII deficiency, advances in technology, and potential expansion of treatment indications.

Sources

1. Ash Publications: Role of factor XIII in fibrin clot formation and effects of genetic ...
2. Allen Press: Congenital Deficiency Factor XIII, Acquired Deficiency ...
3. MDPI: Factor XIII-A: An Indispensable “Factor” in Haemostasis and Wound ...
4. DrugBank: Factor XIII (human): Uses, Interactions, Mechanism of Action
5. NORD: Factor XIII Deficiency - Symptoms, Causes, Treatment | NORD

Last updated: 2024-12-18