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
Chang Gung Memorial Hospital	NA
French Innovative Leukemia Organisation	Phase 2
Hoffmann-La Roche	Phase 2

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

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DrugPatentWatch employs three methods to identify biologic patents:

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 DrugPatentWatch Analysis and 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		2038-06-29	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	TRETTEN	coagulation factor xiii a-subunit (recombinant)	For Injection	125398		2029-04-20	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	TRETTEN	coagulation factor xiii a-subunit (recombinant)	For Injection	125398		2035-12-02	DrugPatentWatch analysis and 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

International Patents for coagulation factor xiii a-subunit (recombinant)

Country	Patent Number	Estimated Expiration
South Korea	102193343
European Patent Office	2658970
Japan	2020105204

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

Last updated: August 4, 2025

Introduction

Recombinant coagulation factor XIII A-subunit (rFXIII-A) has emerged as a pivotal therapeutic in managing congenital and acquired bleeding disorders, notably factor XIII deficiency. Its unique mechanism—stabilizing fibrin clots—addresses severe bleeding episodes unresponsive to traditional therapies. As a recombinant biologic, rFXIII-A features a complex production process, regulatory landscape, and competitive environment that influence its market dynamics and financial prospects. This comprehensive analysis explores critical factors shaping its trajectory in global markets.

Market Overview

The global coagulation factor therapeutics market, valued at approximately USD 4.4 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of around 7% through 2030[1]. Within this landscape, recombinant factor XIII products occupy a niche but increasingly significant segment, primarily driven by advancements in recombinant biopharmaceuticals and improved patient safety profiles compared to plasma-derived products.

Recombinant FXIII A-subunit, such as Takeda’s INTRAGO and others under development, aim to provide standardized, pathogen-free alternatives to plasma-derived formulations. The market, though relatively confined, demonstrates robust growth potential fueled by expanding indications, heightened awareness, and technological advances.

Market Drivers

1. Growing Incidence and Recognition of FXIII Deficiency

Congenital FXIII deficiency, a rare inherited bleeding disorder affecting approximately 1 in 2-5 million individuals, often remains underdiagnosed[2]. Nevertheless, advances in diagnostics have elevated detection rates, revealing the full scope of unmet needs. Treatment demands, particularly for prophylaxis, underpin steady demand growth.

2. Shift Toward Recombinant Biologics

The safety profile of recombinant products—free from pathogen transmission risks associated with plasma-derived therapies—has driven a paradigm shift. Patients and providers prefer recombinant options, supported by regulatory encouragement and insurance coverage trends favoring biologics with better safety profiles.

3. Regulatory Milestones and Approvals

Regulatory agencies such as the FDA and EMA have increasingly approved recombinant FXIII products, catalyzing market entry. For example, BPL's Fibrogamma, a plasma-based product, has faced declining utilization following approvals of recombinant formulations, which are favored for their consistency [3].

4. Expansion of Indications

Beyond congenital deficiency, recombinant FXIII is under investigation for off-label uses: trauma, surgical settings, and bleeding management in hemophilia patients. Although not yet mainstream, such expansion could diversify revenue streams.

5. Innovation and Pipeline Development

Biotech companies invest heavily in enhancing product half-life, ease of administration, and dosing regimens. Next-generation recombinant FXIII formulations with extended duration of action are anticipated to foster adherence, reduce treatment burden, and thus improve market penetration.

Market Challenges

1. Small Patient Population and Ultra-Rarity

The rarity of FXIII deficiency constrains the market size, limiting revenue potential. Market penetration depends heavily on diagnosis rates, awareness, and product accessibility.

2. High Manufacturing Complexity and Costs

Recombinant coagulation factors involve complex bioprocessing, stringent quality controls, and high R&D costs. These factors inflate the price point, potentially impacting reimbursement and access.

3. Competitive Landscape

While recombinant FXIII products face limited direct competition, off-label or alternative therapies (e.g., plasma-derived FXIII, emerging biosimilars) can influence market share and pricing strategies.

4. Pricing and Reimbursement Constraints

Pricing pressure from payers, particularly in cost-conscious healthcare systems, can limit profitability. Demonstrating superior efficacy and safety is crucial for justifying premium pricing.

Financial Trajectory

Revenue Projections

Based on current trends, global revenues for recombinant FXIII products are expected to reach approximately USD 250-300 million by 2030, driven by increased diagnosis, broader adoption, and pipeline products with improved features[4].

Growth Factors

The expansion in pediatric prophylaxis markets, continued product innovations prolonging dosing intervals, and geographic expansion into emerging markets contribute substantially to revenue growth. The Asia-Pacific region, exemplified by improving healthcare infrastructure and disease awareness, is anticipated to see a CAGR of up to 8%, outpacing mature markets.

Investment and R&D Outlook

Biopharmaceutical firms are predicted to allocate substantial funding toward novel formulations (e.g., subcutaneous administration), gene therapy adjuncts, and biosimilar development—potentially disrupting existing revenue streams or opening supplementary markets.

Profitability Considerations

While high manufacturing costs temper initial margins, scale, efficiency improvements, and strategic partnerships can enhance profitability margins over time. The introduction of long-acting formulations can also shift dosing schedules, reducing total treatment costs.

Future Market Trends

1. Gene Therapy Integration

Gene therapy approaches targeting FXIII deficiency could, in the longer term, supplant recombinant proteins for some patients, impacting traditional market dynamics. However, regulatory, safety, and cost factors currently limit widespread adoption.

2. Personalized Medicine and Diagnostics

Enhanced diagnostic tools ensure earlier detection, enabling timely prophylaxis, which, in turn, fuels demand. Personalized treatment regimens tailored to genetic profiles may improve efficacy and adherence.

3. Digital Health and Monitoring

Integration of digital tools—patient adherence tracking, telemedicine consults—will optimize dosing, prevent complications, and potentially open new revenue channels via connected care services.

Conclusion

The landscape for recombinant coagulation factor XIII A-subunit is characterized by steady, albeit niche, growth propelled by technological advancements, increased diagnostic awareness, and a robust push for safer biologics. The financial outlook appears positive, with projected revenues influenced heavily by pipeline innovations, expanding indications, and strategic market penetration efforts. Nevertheless, challenges such as small patient populations, high production costs, and competitive pressures necessitate focused investment in R&D, health economics, and global marketing strategies.

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Key Takeaways

• Market Expansion: Rising diagnosis rates and shifts toward recombinant biologics will sustain moderate growth, with revenues forecasted to near USD 300 million globally by 2030.
• Innovative Pipeline: Next-generation products with longer half-lives and easier administration will differentiate offerings and potentially convert non-adherent patients.
• Geographic Growth: Emerging markets, particularly in Asia-Pacific, represent significant opportunities due to improving healthcare infrastructure and increasing awareness.
• Competitive Positioning: Companies investing in R&D and strategic partnerships can enhance market share despite limited patient pools.
• Pricing and Access: High development costs necessitate optimized pricing strategies, balanced with payer negotiations and reimbursement considerations.

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FAQs

1. What factors influence the pricing of recombinant FXIII products?
Pricing depends on manufacturing complexity, R&D costs, competitive landscape, regulatory environment, and reimbursement policies. Biologics with extended dosing intervals or enhanced safety profiles can command premium prices.

2. How does gene therapy impact the future of FXIII deficiency treatment?
Gene therapy holds promise for potentially curing FXIII deficiency, which could reduce demand for recombinant proteins. Currently, gene therapies face regulatory, safety, and cost hurdles, but their evolution could disrupt the traditional market.

3. What are the main barriers to market growth for recombinant FXIII?
Limited patient numbers due to the rarity of the deficiency, high manufacturing costs, and pricing pressures are primary barriers. Additionally, underdiagnosis of FXIII deficiency limits potential market expansion.

4. Which regions are emerging as growth markets for recombinant FXIII?
The Asia-Pacific region and Latin America show significant growth potential due to rising healthcare investments, increasing awareness, and expanding diagnosis capabilities.

5. How do pipeline innovations influence the financial outlook?
Pipeline developments such as long-acting formulations, subcutaneous delivery, and biosimilars can enhance market share, improve adherence, and justify higher pricing, positively influencing revenues.

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Sources:
[1] MarketWatch. "Global Coagulation Factor Market Size, Share & Trends Analysis," 2022.
[2] Kenet G, et al. "Factor XIII Deficiency: Epidemiology, Pathophysiology and Genetic Variants," Blood Reviews, 2020.
[3] FDA. "Regulatory Approvals of Recombinant Coagulation Factors," 2021.
[4] Biotech Market Report. "Peanut-Sized Market, Big Rewards," 2023.