Antihemophilic factor (recombinant), pegylated - Biologic Drug Details

Summary for antihemophilic factor (recombinant), pegylated

Tradenames:	1
High Confidence Patents:	0
Applicants:	2
BLAs:	2
Suppliers: see list	2

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 antihemophilic factor (recombinant), pegylated Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for antihemophilic factor (recombinant), pegylated 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
Takeda Pharmaceuticals U.s.a., Inc.	ADYNOVATE	antihemophilic factor (recombinant), pegylated	For Injection	125566	7,199,223	2024-02-26	DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	ADYNOVATE	antihemophilic factor (recombinant), pegylated	For Injection	125566	8,247,536	2029-12-11	DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	ADYNOVATE	antihemophilic factor (recombinant), pegylated	For Injection	125566	8,545,476	2031-08-25	DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	ADYNOVATE	antihemophilic factor (recombinant), pegylated	For Injection	125566	9,364,520	2029-08-13	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for antihemophilic factor (recombinant), pegylated 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 antihemophilic factor (recombinant), pegylated

Country	Patent Number	Estimated Expiration
Japan	2017101028
Canada	2517369
China	101124331
Brazil	PI0407882

Supplementary Protection Certificates for antihemophilic factor (recombinant), pegylated

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C202230033	Spain		PRODUCT NAME: RURIOCTOCOG ALFA PEGOL; NATIONAL AUTHORISATION NUMBER: EU/1/17/1247; DATE OF AUTHORISATION: 20180108; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1247; DATE OF FIRST AUTHORISATION IN EEA: 20180108
22C1043	France		PRODUCT NAME: RURIOCTOCOG ALFA PEGOL; REGISTRATION NO/DATE: EU/1/17/1247 20180110
2290031-0	Sweden		PRODUCT NAME: RURIOCTOCOG ALFA PEGOL; REG. NO/DATE: EU/1/17/1247 20180110
SPC/GB22/027	United Kingdom		PRODUCT NAME: RURIOCTOCOG ALFA PEGOL; REGISTERED: CH 65953 20160906; UK PLGB 34078 20180110; UK EU/1/17/1247 (NI) 20180110

Market Dynamics and Financial Trajectory for the Recombinant Pegylated Antihemophilic Factor

Last updated: September 9, 2025

Introduction

The global hemophilia therapeutics market is experiencing substantial growth driven by advancements in biologics, increased prevalence of hemophilia A and B, and innovations like pegylated antihemophilic factors. The recombinant pegylated antihemophilic factor (rFVIIa-PEG) represents a significant milestone, offering improved pharmacokinetics, reduced infusion frequency, and enhanced patient compliance. This analysis explores the market landscape, competitive forces, patent considerations, and financial projections shaping the trajectory of this biologic.

Market Overview and Drivers

Growing Prevalence of Hemophilia

Hemophilia A, caused by deficiency of clotting factor VIII, affects approximately 1 in 5,000 male births globally [1]. Hemophilia B, due to factor IX deficiency, impacts about 1 in 25,000 male births. According to the World Federation of Hemophilia (WFH), over 420,000 people worldwide require treatment for bleeding disorders [2]. Rising diagnosis rates, especially in emerging economies, have expanded market demand.

Innovation in Biologic Therapies

Traditional plasma-derived factors faced issues related to pathogen transmission. Recombinant technologies have mitigated these risks, enabling safer and more effective treatments. Pegylation, the attachment of polyethylene glycol (PEG) chains, prolongs half-life, reduces infusion frequency, and improves quality of life. The approval of pegylated factor VIII (e.g., Adynovate, Baxter) underscores the clinical and commercial value of these innovations.

Regulatory and Clinical Advances

Regulatory agencies like FDA and EMA approve biosimilars and innovative biologics based on robust clinical data. The approval pathway for pegylated factors now favors faster commercialization, particularly with accelerated review mechanisms during unmet medical needs, catalyzing market penetration.

Market Expansion in Emerging Economies

Emerging markets, including China, India, and Latin America, exhibit increasing healthcare access and improving diagnostic rates. Investments by global pharma companies aim at expanding local manufacturing, reducing costs, and capturing market share.

Competitive Landscape

Key Players

• Pfizer/BfArM (or similar companies): Pioneered pegylated factor VIII formulations.
• Shire (now Takeda): Developed Rebinyn, a recombinant factor IX, with pegylation features.
• Baxter (at present part of Shire/Takeda): Noted for biosimilar pegylated products.
• Novo Nordisk and Roche: Focusing on adjunct therapies and novel biologics.
• Emerging Biotech Firms: Innovators exploring next-generation pegylation and alternative half-life extension technologies like albumin fusion.

Intellectual Property and Patent Dynamics

Patents protect formulations, manufacturing processes, and delivery mechanisms. The expiration of key patents opens opportunities for biosimilar entrants, intensifying market competition. However, proprietary pegylation techniques and formulation data sustain high entry barriers for competitors.

Financial Trajectory

Current Market Valuation

The hemophilia therapeutics market was valued at approximately USD 10.2 billion in 2022, with biologics accounting for over 80% [3]. Pegylated factor products constitute an estimated USD 2.5 billion segment, driven by their superior pharmacokinetics.

Forecast Growth and Revenue Potential

Analysts project a compound annual growth rate (CAGR) of 8-10% for the biologic hemophilia market through 2030 [4]. The adoption of pegylated therapies is expected to outpace conventional factors owing to their convenience.

By 2030, revenues from pegylated antihemophilic factors could reach USD 4-5 billion globally, propelled by increased patient access, biobetters, and pipeline innovations. The Asia-Pacific region is anticipated to contribute disproportionately to growth, driven by pair uptake and expanding healthcare infrastructure.

Pricing and Reimbursement Trends

Premium pricing persists due to clinical benefits, but payers are increasingly emphasizing value-based reimbursement. Health technology assessment (HTA) bodies scrutinize comparative efficacy and cost-effectiveness, affecting pricing strategies. Biosimilar competition may pressure prices downward over time.

Investment and R&D Outlook

Major pharma firms and biotech companies are investing heavily in next-generation long-acting factor analogs, gene therapies, and novel delivery systems. R&D expenditure in this realm has surpassed USD 1 billion annually, signaling robust sector confidence.

Challenges and Risks

• High Development Costs: Biologics development involves extensive R&D, manufacturing complexity, and regulatory approval processes.
• Pricing Pressures: Payers’ emphasis on cost containment and biosimilar proliferation could compress profit margins.
• Patent Expirations and Biosimilar Entry: Timely patent cliffs threaten exclusivity and revenue streams.
• Manufacturing Scalability: Maintaining consistent PEGylation quality at scale presents operational challenges.

Strategic Opportunities

• Pipeline Diversification: Incorporating gene therapy and non-factor therapies could complement or replace existing products, creating new revenue avenues.
• Partnerships and Licensing: Collaborations with biotech firms accelerate innovation and market access.
• Emerging Market Penetration: Tailoring pricing and delivery models for developing economies can expand patient access and revenue.

Key Takeaways

• The biologic hemophilia market is entering an expansionary phase driven by pegylation technology improvements, with a projected USD 4-5 billion revenue potential by 2030.
• Innovation in half-life extension continues to differentiate products, influencing prescribing patterns and payer reimbursement.
• Patent landscapes shape competitive dynamics—biosimilar entry post-expiration could intensify price competition.
• Emerging economies and pipeline developments offer significant growth opportunities but require strategic adaptation.
• Cost control, regulatory navigation, and ongoing R&D investments are crucial for long-term financial sustainability.

FAQs

1. What is the clinical advantage of pegylated antihemophilic factors?
Pegylation extends the half-life of clotting factors, reducing infusion frequency from 2-3 times weekly to weekly or biweekly, improving patient adherence and quality of life.

2. How does patent expiration impact the market for recombinant pegylated factors?
Patent expiration enables biosimilar competitors to enter, increasing market competition and putting downward pressure on prices, while original innovators seek new formulations or indications to maintain market share.

3. Which regions present the highest growth prospects for biologic hemophilia therapies?
While North America and Europe are mature markets, emerging economies in Asia-Pacific and Latin America are rapidly expanding due to improved healthcare infrastructure and increasing diagnosis rates.

4. What are the main risks facing the financial trajectory of pegylated antihemophilic products?
The primary risks include biosimilar competition, regulatory changes, pricing pressures, manufacturing complexities, and potential safety concerns related to PEGylation (e.g., PEG accumulation).

5. How does future pipeline innovation influence market revenues?
Next-generation therapies, including gene editing and non-factor therapies, could disrupt traditional biologics, prompting incumbents to diversify or adapt their portfolios to sustain revenue growth.

References

[1] World Federation of Hemophilia. (2022). Hemophilia Facts and Figures.
[2] WFH Reports, 2022. Global Hemophilia Statistics.
[3] MarketWatch. Hemophilia Therapeutics Market Size & Trends, 2022.
[4] Grand View Research. Hemophilia Market Analysis, 2023.

---

End of Article