Coagulation factor x (human) - Biologic Drug Details

Summary for coagulation factor x (human)

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1

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 x (human) Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for coagulation factor x (human) 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
Bio Products Laboratory	COAGADEX	coagulation factor x (human)	For Injection	125506		2028-05-29	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for coagulation factor x (human) 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
Bio Products Laboratory	COAGADEX	coagulation factor x (human)	For Injection	125506		2031-07-13	Patent claims search

International Patents for coagulation factor x (human)

Country	Patent Number	Estimated Expiration
United Kingdom	0710321
Portugal	2152867
Australia	2008257222
Denmark	2152867
Japan	2010528096

Market Dynamics and Financial Trajectory for Coagulation Factor X (Human)

Last updated: March 1, 2026

What is Coagulation Factor X (Human)?

Coagulation Factor X (Human) is a vitamin K-dependent protein crucial in blood clotting. It converts prothrombin to thrombin, facilitating clot formation. Recombinant and plasma-derived versions serve as treatments for bleeding disorders, primarily hemophilia A and B, and rare deficiency conditions.

Market Overview

The global market for coagulation Factor X (Human) is driven mainly by hemophilia treatment needs. It includes plasma-derived and recombinant formulations. The demand is influenced by diagnosis rates, product approvals, and developments in biosimilar and gene therapy pipelines.

Estimated Market Size (2022): $350 million
Forecast (2023–2028): Compound annual growth rate (CAGR) of 6.5%
Projected Market (2028): $470 million

Key Drivers

• Growing hemophilia prevalence: Estimated worldwide at 1 in 5,000 male births.
• Advances in recombinant technology: Enhanced safety profiles reduce transmission of blood-borne pathogens, increasing adoption.
• Extended product approval: Several countries have approved recombinant Factor X variants and extended indications.
• Emergence of gene therapy: Potential to alter the treatment paradigm for rare and severe bleeding disorders.

Market Segmentation

Segment Type	2022 Revenue	Growth Drivers	Notable Players
Plasma-derived Factor X	$150 million	Older, lower-cost alternative, limited supply	CSL Behring, Grifols
Recombinant Factor X	$200 million	Safer, higher purity, growing preference	Shire (Takeda), Baxalta (SOMALOG), Novo Nordisk
Biosimilar versions	$<20 million	Cost reduction strategies, late-stage pipeline	Biogen, Sandoz

Regional Breakdown

Region	Market Share (2022)	Key Trends	Leading Companies
North America	45%	Largest market, high diagnosis and treatment rates	Shire, Bioverativ, CSL Behring
Europe	30%	High adoption, well-established healthcare systems	Bayer, Grifols, Novo Nordisk
Asia-Pacific	15%	Rapid growth, increasing diagnosis rates	Takeda, Sandoz, Biogen
Rest of World	10%	Emerging markets, import dependencies	Local distributors, regional players

Financial Trajectory and Impact Factors

Revenue Growth

Revenue for Factor X (Human) is expected to grow at a 6.5% CAGR from 2023 to 2028. Factors influencing this include increased diagnosis, product innovation, and market expansion.

Price Dynamics

• Recombinant products: Prices are generally higher than plasma-derived but are trending downward due to biosimilars and competition.
• Biosimilars: Entering late-stage clinical development, expected to reduce overall market prices by up to 20% over five years.

Manufacturing and R&D Investment

Manufacturers are investing in improving recombinant production efficiency, increasing yields, and reducing costs. R&D for gene therapies aims to replace protein replacement therapies, potentially disrupting market revenues by 2030.

Investment Area	Focus	Estimated Spending (2022–2025)	Impact
R&D	Gene therapy, novel formulations	$500 million annually	Long-term market disruption
Manufacturing	Automation, yield enhancement	$150 million annually	Cost reduction, capacity increase

Regulatory & Policy Outlook

• Regulatory agencies like FDA and EMA are increasingly approving recombinant and biosimilar products.
• Orphan drug designation accelerates approval timelines and offers market exclusivity.

Competition and Patent Landscape

Patent expirations for early recombinant formulations are expected between 2025-2030, enabling biosimilar entrants. Patent litigation and licensing agreements influence market stability and entry.

Risks and Challenges

• Pricing pressures: Governments and payers push for cost reductions.
• Market saturation: Limited patient population constrains growth.
• Technological shifts: Gene therapy could replace plasma and recombinant therapies, impacting revenue stability.

Strategic Opportunities

• Focus on biosimilars to capture cost-sensitive segments.
• Invest in novel delivery systems to improve patient compliance.
• Engage early with regulatory pathways for emerging gene therapies.

Key Takeaways

• The coagulation Factor X (Human) market is expanding modestly at a 6.5% CAGR through 2028.
• Growth hinges on increased diagnosis, product innovations, and regional market penetration—especially in Asia-Pacific.
• Recombinant products dominate the market, with biosimilars poised to reduce costs.
• Long-term disruption is possible from gene therapy pipelines, with significant R&D investment underway.
• Pricing and patent landscapes are evolving, influencing competitive dynamics.

FAQs

1. What are the main factors driving growth in coagulation Factor X (Human)?
Increasing diagnosis rates, technological advances in recombinant manufacturing, and approvals of new formulations.

2. How will biosimilars affect market revenues?
Biosimilars are expected to lower prices by up to 20%, increasing access and pressuring original manufacturers' margins.

3. What role will gene therapy play in this market?
Gene therapy may replace protein-based treatments, potentially reducing demand for Factor X products by 2030.

4. Which regions present the most growth opportunities?
Asia-Pacific and emerging markets show rapid growth due to expanding healthcare infrastructure and diagnosis programs.

5. What are the primary risks facing market participants?
Pricing pressures, patent expirations, and technological shifts toward gene therapies.

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References

[1] MarketWatch. (2022). Coagulation factor market size and forecast.
[2] Evaluate Pharma. (2023). Hemophilia market analysis.
[3] ClinicalTrials.gov. (2023). Gene therapy pipeline for coagulation disorders.
[4] GlobalData. (2023). Biosimilar landscape in hemophilia treatment.
[5] World Federation of Hemophilia. (2022). Annual global survey report.