Coagulation factor ix (recombinant), albumin fusion protein - Biologic Drug Details

Summary for coagulation factor ix (recombinant), albumin fusion protein

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 ix (recombinant), albumin fusion protein Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for coagulation factor ix (recombinant), albumin fusion protein 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
Csl Behring Lengnau Ag	IDELVION	coagulation factor ix (recombinant), albumin fusion protein	For Injection	125582	7,939,632	2027-12-17	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for coagulation factor ix (recombinant), albumin fusion protein 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
Csl Behring Lengnau Ag	IDELVION	coagulation factor ix (recombinant), albumin fusion protein	For Injection	125582	8,129,145	2027-07-11	Patent claims search

International Patents for coagulation factor ix (recombinant), albumin fusion protein

Country	Patent Number	Estimated Expiration
Denmark	2032607
Canada	2655248
World Intellectual Property Organization (WIPO)	2007144173
Denmark	2256135
Spain	2910207
South Korea	20140101877

Supplementary Protection Certificates for coagulation factor ix (recombinant), albumin fusion protein

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C02032607/01	Switzerland		PRODUCT NAME: ALBUTREPENONACOGUM ALPHA; REGISTRATION NO/DATE: SWISSMEDIC AUTHORISATION 65743 30.08.2016
39/2016	Austria		PRODUCT NAME: ALBUTREPENONACOG; REGISTRATION NO/DATE: EU/1/16/1095 (MITTEILUNG) 20160513
16C1005	France		PRODUCT NAME: ALBUTREPENONACOG ALFA; REGISTRATION NO/DATE: EU/1/16/1095 20160513
1690038-3	Sweden		PRODUCT NAME: ALBUTREPENONAKOG ALFA; REG. NO/DATE: EU/1/16/1095 20160513
132016000097045	Italy		PRODUCT NAME: ALBUTREPENONACOG ALFA(IDELVION); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1095/001-004, 20160513
C201630051	Spain		PRODUCT NAME: ALBUTREPENONACOG ALFA; NATIONAL AUTHORISATION NUMBER: EU/1/16/1095; DATE OF AUTHORISATION: 20160511; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/16/1095; DATE OF FIRST AUTHORISATION IN EEA: 20160511

Market Dynamics and Financial Trajectory for the Biologic Drug: Coagulation Factor IX (Recombinant), Albumin Fusion Protein

Last updated: July 29, 2025

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Introduction

The biologic landscape is rapidly evolving, propelled by innovative protein engineering techniques that enhance therapeutic efficacy and safety. Among these advancements, fusion proteins combining coagulation Factor IX (rFIX) with albumin represent a significant leap forward in hemophilia B treatment. This article examines the market dynamics and financial trajectory of this novel biologic, focusing on its clinical innovation, competitive positioning, regulatory environment, and commercial potential.

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Clinical and Technological Context

Hemophilia B, characterized by deficiency in coagulation Factor IX, affects approximately 1 in 25,000 male births globally. Existing therapies primarily involve infusions of plasma-derived or recombinant Factor IX. Despite advances, these treatments face challenges such as limited half-life, frequent infusions, and development of inhibitors.

Emerging recombinant Factor IX products with extended half-lives aim to reduce infusion frequency, improving patient quality of life (QoL). Fusion proteins involving albumin or Fc regions leverage the neonatal Fc receptor (FcRn) pathway to prolong circulation time. The albumin-Factor IX fusion protein combines the stability and prolonged half-life of albumin with targeted coagulation activity, promising less frequent dosing and improved adherence.

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Market Dynamics

1. Drivers of Market Growth

• Increasing Prevalence of Hemophilia B:
  The global hemophilia B market is projected to grow at a compound annual growth rate (CAGR) of over 5% through the next decade, driven by better diagnostics and awareness. The unmet need for therapies that offer longer dosing intervals fuels innovation in albumin-fusion biologics.

• Enhanced Patient Compliance:
  The high frequency of infusions for conventional recombinant FIX therapies hampers adherence. Extended half-life fusion proteins can significantly reduce dosing frequency, improving QoL and adherence, thus directly influencing market uptake.

• Technological Advancements:
  Recombinant DNA technology enabling the fusion of Factor IX with albumin appears promising. The ability to engineer stable, high-purity proteins with prolonged circulation times positions albumin fusion proteins as competitive alternatives.

• Regulatory Incentives:
  The Orphan Drug designation and accelerated approval pathways in major markets like the U.S. and EU incentivize pharmaceutical development, decreasing time-to-market and associated costs.

2. Competitive Landscape

While traditional recombinant Factor IX products dominate, a new wave of extended half-life biologics, including albumin-fusion proteins, is emerging. Notable competitors include:

• Idelvion (CSL Behring): A recombinant Factor IX with a transfusion interval of 7-14 days.
• Rebinyn (Pfizer): Extended half-life FIX product with weekly dosing.
• Future contenders: Biosimilar and biosimilar-like products entering the market.

However, fusion proteins inherently carry advantages such as component stability and manufacturing efficiency, which could confer a competitive edge.

3. Regulatory and Reimbursement Considerations

Regulatory agencies have demonstrated readiness to approve novel fusion biologics, provided robust clinical data supports safety and efficacy. Reimbursement prospects favorably hinge on demonstrated improvements in patient adherence and health economics, such as reduced hospital visits and bleeding episodes.

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Financial Trajectory Analysis

1. Revenue Potential and Market Penetration

Given the current hemophilia B market size estimated at approximately $4–5 billion globally, with a CAGR of 5%–6%, the adoption of albumin fusion versions could significantly expand this figure. Industry projections suggest:

• Initial Launch Years (Year 1–3):
  Market penetration remains modest (5–10%) as clinicians evaluate the new therapy, with revenues in the hundreds of millions globally.

• Mid-term (Years 4–7):
  Accelerated uptake driven by clinical endorsement, patient preference, and proven efficacy may lead to 25–40% market share, pushing revenues toward $1 billion annually.

• Long-term (Years 8+):
  With broader implementation, these biologics could capture up to half of the eligible hemophilia B market, supporting revenues surpassing $2 billion annually.

2. Cost Structures and Profitability

High manufacturing complexity and cost of goods (COGS) for biologics, especially fusion proteins, can initially constrain margins. However, process optimization and scalable production techniques, including cell line engineering and purification advancements, are expected to improve gross profit margins over time.

Investment in clinical trials, regulatory filings, and market access shape the financial landscape. Early development phases demand significant capital; however, successful approvals and commercialization will unlock substantial revenues, particularly given the premium pricing associated with extended half-life biologics.

3. Investment and Partnership Strategies

Pharmaceutical incumbents and biotech firms are likely to pursue strategic partnerships to mitigate development risks, share costs, and accelerate market entry. Investment flows into biologic innovations related to hemophilia are projected at approximately $1.5–2 billion over the next five years, supporting R&D pipelines for albumin-fusion products.

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Future Outlook and Market Challenges

Despite promising forecasts, several challenges temper financial optimism:

• Pricing Pressures:
  Payers may push for cost containment, potentially limiting premium pricing strategies.

• Generic and Biosimilar Competition:
  Biosimilar development could erode market share, though fusion proteins' complex structure complicates biosimilar entry.

• Clinical Development Risks:
  Unanticipated safety or efficacy issues can delay or hinder commercialization.

• Market Adoption Lag:
  Physician and patient familiarity with novel biologics influences uptake trajectory.

Addressing these challenges requires strategic planning, robust clinical data, and proactive payor engagement.

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Key Takeaways

• Innovative fusion proteins, such as albumin-Factor IX, target unmet needs for longer-acting hemophilia B treatments, offering potential for improved patient adherence and QoL.
• The market is poised for growth, driven by rising prevalence, technological differentiation, and regulatory support, with revenues potentially exceeding $1 billion annually within a decade.
• Manufacturing efficiencies and strategic partnerships will be critical to optimizing profitability and scaling commercialization.
• Pricing and reimbursement landscape complexities could influence market penetration and revenue realization.
• Continued innovation and clinical validation are essential to sustain competitive advantage amid emerging biosimilar and alternative therapies.

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FAQs

1. What distinguishes albumin-Factor IX fusion proteins from traditional Factor IX therapies?
Albumin fusion extends the biologic’s half-life by leveraging the FcRn pathway, enabling less frequent dosing compared to conventional therapies, thus enhancing adherence and QoL.

2. How does regulatory approval impact the financial trajectory of albumin fusion Factor IX?
Regulatory approval certifies safety and efficacy, enabling market entry and revenue generation. Fast-track pathways further expedite commercialization, accelerating financial gains.

3. What are the main barriers to market penetration for this biologic?
Barriers include high development costs, pricing pressures, clinicians’ acceptance, competition from existing therapies, and uncertainties surrounding long-term safety.

4. How does the competitive landscape influence the financial prospects of albumin-fused Factor IX?
The presence of established extended half-life products creates a competitive environment, but fusion proteins’ manufacturing advantages and clinical benefits may offer differentiation and market share opportunities.

5. What strategies can maximize the commercial success of albumin-Factor IX?
Strategies include demonstrating clear clinical superiority, optimizing manufacturing, engaging stakeholders early, negotiating favorable reimbursement terms, and establishing robust clinical evidence.

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References

[1] World Federation of Hemophilia. (2022). Annual Global Survey.
[2] Lee, C. W., et al. (2021). Advances in Hemophilia B Therapeutics. Journal of Thrombosis and Haemostasis.
[3] MarketWatch. (2022). Hemophilia Market Size & Trends.
[4] U.S. Food and Drug Administration. (2020). Regulatory Pathways for Biologics.
[5] Deloitte. (2022). Biologic Manufacturing Cost Trends.