Coagulation factor ix (recombinant) - Biologic Drug Details

Summary for coagulation factor ix (recombinant)

Tradenames:	3
High Confidence Patents:	0
Applicants:	6
BLAs:	6
Suppliers: see list	6
Recent Clinical Trials:	See clinical trials for coagulation factor ix (recombinant)

Recent Clinical Trials for coagulation factor ix (recombinant)

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
University Hospital, Strasbourg, France	PHASE2
SONIRE Therapeutics Inc.	EARLY_PHASE1
B. Braun Medical International Trading Company Ltd.	PHASE4

See all coagulation factor ix (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 ix (recombinant) Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for coagulation factor ix (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
Takeda Pharmaceuticals U.s.a., Inc.	RIXUBIS	coagulation factor ix (recombinant)	For Injection	125446	10,265,405	2035-11-17	DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	RIXUBIS	coagulation factor ix (recombinant)	For Injection	125446	10,568,943	2039-02-08	DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	RIXUBIS	coagulation factor ix (recombinant)	For Injection	125446	10,603,275	2038-11-07	DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	RIXUBIS	coagulation factor ix (recombinant)	For Injection	125446	7,033,590	2020-09-14	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for coagulation factor ix (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
Wyeth Pharmaceuticals Llc	BENEFIX	coagulation factor ix (recombinant)	For Injection	103677	8,129,145	2027-07-11	Patent claims search
Medexus Pharma, Inc.	IXINITY	coagulation factor ix (recombinant)	For Injection	125426	8,129,145	2027-07-11	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	RIXUBIS	coagulation factor ix (recombinant)	For Injection	125446	8,129,145	2027-07-11	Patent claims search
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)

Country	Patent Number	Estimated Expiration
Japan	6941137
Canada	3082043
Australia	2023251546
Japan	2012529297

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

Last updated: August 3, 2025

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Introduction

The global coagulation factor IX (rFIX) market is a critical segment within the broader hemophilia treatment landscape. As a recombinant biologic, rFIX serves as a cornerstone therapy for hemophilia B, a genetic disorder characterized by deficiency of coagulation factor IX, resulting in spontaneous bleeding episodes. Over recent years, advancements in biotechnology, burgeoning patient demand, and evolving healthcare policies have significantly influenced the market dynamics. This analysis explores the key drivers, challenges, competitive landscape, and financial trends shaping the rFIX market trajectory, offering actionable insights for stakeholders.

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Market Overview and Growth Drivers

1. Rising Prevalence of Hemophilia B

Hemophilia B affects approximately 1 in 25,000 male births globally, translating to an estimated population of over 60,000 individuals affected worldwide [1]. Increasing diagnosis rates, coupled with improved awareness, have expanded the patient pool. As new treatments emerge and diagnostic tools advance, the identification of mild to moderate cases is anticipated to surge, amplifying demand for factor IX therapies.

2. Innovations in Recombinant Factor IX Products

Innovation plays a pivotal role in market expansion. The advent of next-generation recombinant products—such asExtended Half-Life (EHL) rFIX formulations like eftrenonacog alfa (Alprolix) and non-factor therapies—has enhanced treatment efficacy and patient adherence [2]. These innovations decrease infusion frequency, improving quality of life and fostering market growth.

3. Growth in Hemophilia Treatment Infrastructure

Global efforts to enhance hemophilia care infrastructure—especially in emerging economies—are facilitating wider access to recombinant therapies. International organizations and government health programs are increasingly subsidizing or including rFIX in public health initiatives, further fueling demand.

4. Therapeutic Progress and Gene Therapy

Gene therapy trials targeting hemophilia B aim to achieve sustained endogenous FIX production, potentially revolutionizing treatment modalities. While long-term commercial availability remains forthcoming, these advancements contextualize the evolving market, influencing current and future revenue streams for recombinant therapeutics.

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Market Challenges and Limitations

1. High Cost and Reimbursement Barriers

rFIX therapy's high manufacturing costs, driven by complex bioprocessing and stringent regulatory standards, translate into elevated prices. Reimbursement limitations, especially in developing countries, restrict access, constraining market growth.

2. Emergence of Non-Factor Therapies

Innovative non-factor options, such as emicizumab analogs and gene therapies, offer alternative treatment paradigms. While primarily for hemophilia A, similar advances could impact the hemophilia B market indirectly by shifting treatment preferences or through combined therapies, posing competitive threats.

3. Immunogenicity and Safety Concerns

Despite advancements, recombinant products carry risks of inhibitor development and immunogenic responses, potentially affecting long-term utilization and brand reputation.

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Competitive Landscape

Major pharmaceutical companies dominate the rFIX market, with key players including:

• Pfizer: Owner of BeneFix, a leading recombinant FIX product.

• CSL Behring: Manufacturer of Idelvion, an EHL rFIX product with extended dosing intervals.

• Novo Nordisk: Producer of Rebinyn, notable for its rapid onset and short half-life profile.

• Shire/Takeda: Previously a significant player, now part of Takeda Pharmaceuticals after acquisition.

Emerging players and biosimilar entrants aim to improve affordability and accessibility, intensifying the competitive landscape.

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Financial Trajectory and Market Forecasts

Historical Revenue Trends

The global recombinant FIX market generated approximately USD 1.2 billion in 2022, driven by steady demand in developed markets. The market has exhibited compounded annual growth rates (CAGR) of around 6-8% over the past five years [3].

Projected Market Growth

Projections indicate the market may reach USD 2 billion by 2030, with a CAGR of approximately 7%. Key growth factors include:

• Accelerated adoption of EHL products.
• Expansion into emerging regions due to improved healthcare coverage.
• Increasing lifetime management of hemophilia B, which has shifted from acute care to chronic management.

Revenue Segmentation

North America retains the largest market share (~45%) owing to high prevalence, advanced healthcare infrastructure, and favorable reimbursement policies. Europe accounts for roughly 30%, buoyed by mature healthcare systems, while Asia-Pacific shows promising growth potential (~15%) due to rising diagnosis and new treatment adoption.

Pricing Dynamics

Average treatment costs for rFIX products range from USD 250,000 to USD 500,000 annually per patient, depending on dosing regimens and product type. EHL formulations, despite their premium pricing, offer reduced infusion frequency, potentially lowering total cost over time.

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Regulatory and Policy Impact

Stringent regulatory approvals and evolving policies directly influence the market's financial trajectory. Recent approvals of biosimilars and EHL products by agencies like the FDA and EMA have created new revenue streams, while reimbursement negotiations impact profitability margins.

The inclusion of rFIX therapies in national formularies and health schemes further stimulates market penetration, especially in emerging economies. Policies promoting early diagnosis and prophylactic treatment are expected to sustain demand.

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Future Market Dynamics

Emerging trends likely to shape future market trajectory include:

• Gene Therapy Integration: Although still in clinical phases, gene therapies promise to significantly disrupt traditional rFIX markets by offering potentially curative solutions. Early commercial introductions could reorient revenue streams and investment priorities.

• Personalized Medicine: Pharmacogenomic profiling may optimize treatment regimens, leading to more efficient utilization of rFIX products and potentially reducing costs.

• Biosimilars Market Entry: Cost-effective biosimilars are poised to penetrate markets, increasing competition and pressuring prices.

• Patient-centric Innovations: Development of subcutaneous formulations and longer-acting products will improve adherence, broaden patient populations, and contribute to revenue expansion.

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Conclusion

The coagulation factor IX (recombinant) market is on a steady growth path driven by technological innovation, increasing disease awareness, and expanding healthcare infrastructure. While high costs and emerging therapies pose challenges, strategic positioning—focusing on innovation, affordability, and geographical expansion—will underpin sustained financial growth. Stakeholders should closely monitor regulatory developments and gene therapy advancements, which hold transformative potential for the market's future.

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Key Takeaways

• The rFIX market is projected to grow at a CAGR of ~7% through 2030, reaching approximately USD 2 billion.
• Demand is bolstered by innovations such as extended half-life formulations and global healthcare infrastructure expansion.
• High treatment costs and competition from non-factor therapies remain significant challenges.
• Emerging gene therapies threaten to disrupt traditional revenue streams but also open new investment avenues.
• Market success depends on strategic alignment with regulatory trends, reimbursement landscapes, and technological innovation.

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FAQs

1. What factors most significantly influence the growth of the recombinant FIX market?
Advancements in product innovations (e.g., EHL formulations), rising global hemophilia B prevalence, improved diagnosis rates, and expanding healthcare infrastructure are primary growth drivers.

2. How do biosimilars impact the recombinant FIX market?
Biosimilars introduce cost competitiveness, increase market competition, and can improve access, particularly in price-sensitive markets, potentially reducing revenue for originator brands.

3. What role does gene therapy play in shaping the future of coagulation factor IX treatments?
Gene therapy has the potential to provide a one-time, curative approach, which may significantly reduce dependence on recombinant products and reshape the market landscape.

4. Which regions are projected to experience the fastest growth in recombinant FIX adoption?
Emerging markets in Asia-Pacific and Latin America are expected to see the fastest growth due to increased diagnosis, healthcare investments, and governmental support.

5. How do pricing and reimbursement policies affect the financial trajectory of rFIX products?
Pricing strategies directly impact revenue; reimbursement policies determine patient access and affordability, influencing overall market size and profitability.

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References

[1] World Federation of Hemophilia. (2022). Annual Global Survey Data.

[2] European Medicines Agency. (2023). Market authorization for next-generation recombinant FIX products.

[3] Market Research Future. (2022). Coagulation Factor IX Market Analysis and Forecast.