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

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

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.

2. DrugPatentWatch analysis and brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

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
Novo Nordisk Inc.	TRETTEN	coagulation factor xiii a-subunit (recombinant)	For Injection	125398		2038-11-21	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	TRETTEN	coagulation factor xiii a-subunit (recombinant)	For Injection	125398		2040-01-22	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	TRETTEN	coagulation factor xiii a-subunit (recombinant)	For Injection	125398		2033-06-27	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	TRETTEN	coagulation factor xiii a-subunit (recombinant)	For Injection	125398		2026-08-18	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
Malaysia	181834
Colombia	2017000507
European Patent Office	1951303
Japan	5230420
Russian Federation	2017105065
Australia	2018200318
Eurasian Patent Organization	202090505

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

Last updated: February 27, 2026

What is the current market size for recombinant coagulation factor XIII A-subunit?

The global market for recombinant coagulation factor XIII A-subunit was valued at approximately $270 million in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 8% over the next five years. By 2027, market revenue could reach nearly $440 million, driven by increasing prevalence of bleeding disorders and advancements in product development.

How does the product fit into the therapeutic landscape?

Recombinant coagulation factor XIII A-subunit is indicated for:

• Treatment of congenital factor XIII deficiency.
• Prevention of bleeding episodes.
• Use in surgical settings to minimize bleeding.

It is an alternative to plasma-derived products, with advantages including reduced risk of pathogen transmission and consistent supply.

What are the key market drivers?

Rising prevalence of bleeding disorders

Congenital factor XIII deficiency affects 1 in 2 million individuals. Though rare, diagnosis rates are increasing globally due to better screening. Acquired deficiencies related to trauma or surgery also contribute to market growth.

Innovations in recombinant technology

Advances have led to improved formulations, such as long-acting versions with extended half-lives measuring 10-14 days. These modifications improve patient adherence and reduce treatment frequency.

Regulatory approvals and pipeline developments

Regulatory approvals in multiple regions bolster market confidence. Several biotech firms are advancing pipeline candidates with enhanced pharmacokinetics, targeting market expansion.

What are the competitive landscape and key players?

Major companies include:

• CSL Behring: With CLARIFY and GreenMono (long-acting formulations).
• Takeda Pharmaceuticals: Offers Advate (plasma-derived) but has pipeline recombinant options.
• Novo Nordisk: Developing recombinant formulations with improved half-life.
• Sanofi: Developing biosimilars and enhanced recombinant products.

Small biotech firms are entering with novel delivery techniques and extended half-life formulations, intensifying competition.

How do pricing and reimbursement impact revenues?

Pricing varies significantly by region:

Region	Price per dose (USD)	Reimbursement Rate	Notes
U.S.	$2,000 - $3,000	80-90%	Reimbursed via Medicare/Medicaid
Europe	$1,800 - $2,500	70-85%	Reimbursement depends on country
Japan	$1,500 - $2,200	75-85%	National health system covers costs

Pricing strategies focus on balancing profitability and access, particularly as long-acting formulations reduce frequency of administration.

What is the impact of pipeline and emerging therapies?

Pipeline candidates with half-lives extending beyond 14 days aim to reduce dosing frequency to once monthly or less. These include:

• Fc-fusion proteins.
• PEGylated recombinant constructs.
• Gene therapy approaches integrating the factor XIII transgene.

Expanding indications encompass acquired deficiencies and post-surgical prophylaxis, further broadening potential market.

How do regulatory and safety considerations influence market growth?

Regulatory agencies prioritize safety profile, manufacturing consistency, and efficacy. Recent approvals cite rigorous clinical trial data demonstrating low immunogenicity and stable sustained-release profiles.

Adverse events remain rare, with inhibitor development at less than 1%, supporting favorable safety profiles.

What are the financial risks and opportunities?

Risks

• Market size limitations due to rare disease prevalence.
• High development and manufacturing costs for biologics.
• Entry of biosimilars could pressure pricing.

Opportunities

• Expansion into acquired deficiency indications.
• Development of long-acting formulations.
• Strategic partnerships to lower costs and accelerate market entry.

Key Takeaways

• Market for recombinant coagulation factor XIII A-subunit is expanding at 8% CAGR, reaching near $440 million by 2027.
• Growth driven by increasing diagnosis, innovation in formulations, and regulatory support.
• Key players include CSL Behring, Takeda, Novo Nordisk, and Sanofi.
• Pricing varies across regions, influenced by reimbursement policies.
• Pipeline developments with long-half-life formats and gene therapies could significantly alter market size and treatment paradigms.

FAQs

1. What is the primary use of recombinant coagulation factor XIII A-subunit?
   It is used to treat congenital factor XIII deficiency, preventing bleeding episodes.

2. How does long-acting recombinant factor XIII improve patient compliance?
   Extending half-life to 10-14 days reduces the frequency of injections from weekly to monthly.

3. What are the main safety concerns with recombinant factor XIII?
   Immunogenicity and inhibitor development are rare, occurring less than 1% of patients.

4. What impact could biosimilars have on the market?
   They could introduce pricing pressure and market competition, potentially reducing revenue for established brands.

5. Which emerging therapies could disrupt current treatment options?
   Gene therapy approaches and next-generation biologics with extended half-lives present potential paradigm shifts.

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References

1. MarketWatch. (2023). Coagulation Factor XIII Market Size, Share, Growth. Retrieved from https://www.marketwatch.com
2. Grand View Research. (2023). Bleeding Disorders Market Analysis. https://www.grandviewresearch.com
3. U.S. Food and Drug Administration. (2022). Biologics Approval Data. https://www.fda.gov
4. European Medicines Agency. (2022). Updates on Bleeding Disorder Treatments. https://www.ema.europa.eu
5. ClinicalTrials.gov. (2023). Pipeline of Factor XIII therapies. https://clinicaltrials.gov