Coagulation factor ix (human) - Biologic Drug Details

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Summary for coagulation factor ix (human)

Tradenames:	2
High Confidence Patents:	0
Applicants:	2
BLAs:	2
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for coagulation factor ix (human)

Recent Clinical Trials for coagulation factor ix (human)

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
University Hospital, Strasbourg, France	PHASE2
SONIRE Therapeutics Inc.	EARLY_PHASE1
Shanghai Zhongshan Hospital	PHASE4

See all coagulation factor ix (human) 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:

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.

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.

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 ix (human) Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for coagulation factor ix (human) Derived from DrugPatentWatch Analysis and Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for coagulation factor ix (human) Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for the Biologic Drug: Coagulation Factor IX (Human)

Last updated: August 2, 2025

Introduction

Coagulation Factor IX (Human), a vital protein in the blood clotting cascade, plays an essential role in managing hemophilia B, a hereditary bleeding disorder. Over recent years, the market for this biologic has experienced significant shifts driven by advancements in biotherapeutics, regulatory approvals, and evolving treatment paradigms. This comprehensive analysis explores current market dynamics and forecasts the financial trajectory of Coagulation Factor IX (Human), considering technological innovations, competitive landscape, regulatory environment, and patient population trends.

Market Overview

The global hemophilia market, valued at approximately USD 10 billion in 2022, includes several key therapeutic classes: plasma-derived and recombinant coagulation factors, non-factor therapies, and supportive treatments. Coagulation Factor IX (Human) constitutes a significant segment within this framework, especially given its longstanding clinical use and evolving manufacturing techniques.

Historical Context

Historically, plasma-derived Factor IX (pd-FIX) dominated the treatment landscape but has been gradually supplanted by recombinant forms due to concerns over pathogen transmission (e.g., HIV, hepatitis C) and supply consistency. Recombinant Factor IX (rFIX) now accounts for a majority of prescriptions, with continued innovation aimed at improving half-life, immunogenicity, and patient convenience.

Market Drivers

Advancements in Biologics and Manufacturing Technologies

The development of recombinant manufacturing processes has markedly increased product efficacy and safety profiles. Significant innovations, notably extended half-life (EHL) products, such as albutrepenonacog alfa and nonacog alfa, have improved patient adherence and reduced infusion frequency, positively impacting market growth [1].

Growing Global Patient Population

The prevalence of hemophilia B is approximately 1:25,000 male births. With an estimated 15,000–20,000 patients receiving treatment globally, the unmet need persists, particularly in low- and middle-income countries (LMICs). Increasing diagnosis rates and expanded healthcare access are further fueling demand.

Regulatory Approvals and Product Pipeline

Recent approvals of EHL Factor IX products in key markets, including the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), have spurred market expansion. Additionally, innovative gene therapies in clinical development promise potential paradigm shifts, though their commercial impact remains a future prospect [2].

Therapeutic Shift Toward Prophylaxis and Improved Quality of Life

Enhanced efficacy and safety profiles facilitate prophylactic regimens, reducing bleeding episodes and joint damage. This shift from on-demand to prophylactic therapy underpins sustained revenue generation and market expansion.

Market Challenges

Price Pressures and Reimbursement Constraints

High manufacturing costs for biologics and extended half-life products lead to premium pricing strategies. Payer resistance, particularly in cost-containment environments, constrains access, necessitating health economics evaluations demonstrating long-term cost savings.

Emergence of Non-Factor Technologies

Gene therapies, such as BioMarin's Roctavian and others in development, threaten to disrupt traditional coagulation factor markets by offering potentially curative options. While still under regulatory review, their eventual commercialization could reshape market dynamics.

Supply Chain and Manufacturing Complexity

Producing biologic products like coagulation factors involves complex, costly processes with stringent quality controls. Any disruptions can impact supply and costs, influencing market stability.

Financial Trajectory Forecasts (2023–2032)

Market Growth Projections

The Coagulation Factor IX (Human) market is projected to grow at a compounded annual growth rate (CAGR) of approximately 6.5% through 2032, reaching an estimated USD 18 billion globally. Key growth drivers include:

Adoption of EHL products
Expanded use in pediatric and elderly populations
Increasing intervention in emerging markets

Regional Market Trends

North America: Continues to dominate, driven by high diagnosis and treatment rates, along with robust reimbursement frameworks.
Europe: Stable growth due to mature healthcare systems but faces pricing pressures.
Asia-Pacific: Fastest growth segment, with a CAGR of approx. 9%, fostered by improving healthcare infrastructure, rising awareness, and increasing procurement in China and India.
Emerging markets: Expansion opportunities exist but are tempered by affordability and infrastructure challenges.

Impact of Biotech Alliances and Partnerships

Strategic licensing, collaborations, and acquisitions (e.g., Bioverativ's acquisition of Sanofi's Hemophilia assets) will influence market consolidation. These collaborations will accelerate innovation, diversify portfolios, and optimize manufacturing capacities.

Technological and Clinical Innovation Impact

The future financial trajectory heavily depends on technological advancements, notably:

Longer-lasting products: EHL FIX variants reduce infusion frequency, enhancing compliance and reducing treatment costs over time.
Gene Therapy: With companies like Pfizer and uniQure developing potentially curative approaches, a decline in demand for traditional factor concentrates may occur within the next decade, impacting revenues.

Market Entry of Biosimilars

Once patent protections expire, biosimilars could introduce price competition, potentially reducing costs and expanding access, notably in price-sensitive markets.

Regulatory Environment and Market Access

Regulatory agencies are increasingly demanding robust demonstration of quality, efficacy, and cost-effectiveness. Differential pricing strategies and health technology assessments (HTAs) influence reimbursement and commercialization strategies, impacting revenue trajectories.

Key Takeaways

The Coagulation Factor IX (Human) market is poised for steady growth, driven by technological innovation, increased global diagnosis, and evolving treatment paradigms favoring prophylaxis.
Extended half-life products and gene therapies are expected to reshape the competitive landscape, potentially reducing dependence on traditional plasma-derived and recombinant products.
Despite promising innovations, pricing pressures, manufacturing complexities, and regulatory hurdles will influence revenue stability and growth potential.
Emerging markets represent significant growth opportunities, driven by improving healthcare infrastructure and rising disease awareness.
Strategic collaborations, licensing agreements, and investments in pipeline innovations are crucial for manufacturers to maintain market share and capitalize on future growth.

Conclusion

The market for Coagulation Factor IX (Human) remains a dynamic domain, underpinned by continuous technological progress and demographic shifts. While traditional products will retain relevance in the near term, the ascendancy of gene therapies and extended half-life biologics portends an evolving, complex landscape. Firms that adapt through innovation, strategic partnerships, and tailored market access strategies will position themselves advantageously for the financial opportunities ahead.

References

[1] BioWorld. (2022). Advances in Hemophilia B Treatment.
[2] FDA. (2023). Regulatory Review of Gene Therapies in Hemophilia.

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