Coagulation factor viia (recombinant) - Biologic Drug Details

Summary for coagulation factor viia (recombinant)

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

Recent Clinical Trials for coagulation factor viia (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 viia (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 viia (recombinant) Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Recombinant Coagulation Factor VIIa

Last updated: August 2, 2025

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Introduction

Recombinant coagulation factor VIIa (rFVIIa), marketed primarily under brands like NovoSeven, represents a critical therapeutic agent for bleeding disorders, notably hemophilia A and B with inhibitors, acquired hemophilia, and other bleeding conditions. As a recombinant biologic, its market dynamics are influenced significantly by therapeutic advancements, regulatory environments, competitive landscape, and healthcare economics. Analyzing these factors reveals insights into its current market position and future financial trajectory.

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Market Overview

The global demand for rFVIIa is driven predominantly by its application in hemophilia management, which affects approximately 1 in 5,000 male births worldwide. The growth of the hemophilia population, combined with increased awareness, improved diagnostics, and expanding indications—including trauma, surgery, and rare bleeding disorders—propels volume growth. According to Grand View Research, the global coagulation factor market was valued at USD 6.4 billion in 2020, with recombinant factors, including rFVIIa, forming a substantial segment (1).

Despite this, growth is moderated by factors such as high treatment costs, development of biosimilars, and emerging non-factor therapies, which are reshaping the competitive landscape and reimbursement frameworks.

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Market Dynamics

1. Therapeutic Innovations and Competition

Recombinant FVIIa was revolutionary upon approval, offering a reliable, pathogen-free product. However, the landscape has evolved with the introduction of extended half-life factors and non-factor therapies like emicizumab (Hemlibra), a bispecific antibody that reduces the need for factor concentrates in hemophilia A patients with inhibitors (2). These emerging therapies often offer improved dosing convenience and lower treatment costs, creating competitive pressure and challenging the growth trajectory of rFVIIa.

2. Regulatory Environment and Approvals

Regulatory agencies like the FDA and EMA continuously evaluate the safety and efficacy of coagulation products. The approval of biosimilar versions of recombinant factors is expected to increase, potentially eroding market share for originator brands. Moreover, ongoing post-marketing surveillance and safety data influence prescribing practices and reimbursement policies.

3. Pricing and Reimbursement Trends

Reimbursement landscapes are complicated by the high cost of biologics. Payers increasingly favor cost-effective, long-acting products or non-factor therapies. This trend influences market access and revenues for rFVIIa, particularly in cost-sensitive regions like parts of Asia and Latin America.

4. Geographic Market Expansion

Developing markets present significant growth opportunities due to increasing healthcare infrastructure and rising awareness. However, hurdles such as pricing, supply chain infrastructure, and regulatory barriers persist.

5. Manufacturing and Supply Chain Considerations

The manufacturing of recombinant biologics involves complex, costly processes. Supply chain stability, capacity expansion, and facility approvals impact the availability and pricing of rFVIIa.

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Financial Trajectory and Forecasting

1. Revenue Trends and Market Share

Based on industry reports, the global coagulation factor segment, including rFVIIa, is expected to grow at a compound annual growth rate (CAGR) of approximately 4-6% over the next five years (3). However, this growth rate is susceptible to fluctuations driven by non-factor therapies gaining market share.

2. Impact of Biosimilars

The emergence of biosimilars in key markets, such as Europe, is anticipated to temper revenue growth of originator brands like NovoSeven. Biosimilar products have already entered markets with significant price reductions, offering cost savings to payers and patients.

3. Adoption of Non-Factor Therapies

While non-factor therapies like emicizumab have disrupted the traditional prophylaxis paradigm, rFVIIa continues to find niche roles, especially in patients with inhibitors or contraindications to non-factor therapies. The integration of these new approaches is expected to redistribute market share rather than eliminate the demand for recombinant FVIIa.

4. R&D and Pipeline Prospects

Investments in next-generation recombinant factors or combination therapies could influence future profitability. Currently, the pipeline for coagulation factors remains modest, with focus shifting toward gene therapy and other modalities.

5. Key Financial Indicators

Projected revenue for top brands like NovoSeven suggests a plateauing trend amid increasing competition. Nevertheless, legacy contracts, expansion into emerging markets, and potential indications expansion offer avenues for sustaining revenues.

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Strategic Considerations for Stakeholders

• Biotech and Pharma Companies: Focus on manufacturing efficiencies, patient access programs, and innovation to defend market share.
• Payers: Emphasize value-based care models to balance high-cost biologic therapies with emerging, more cost-effective treatments.
• Healthcare Providers: Optimize patient management by integrating new therapies and ensuring timely diagnosis and treatment.

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Future Outlook

The future of recombinant FVIIa's market and financial trajectory hinges on several key factors:

• The pace of biosimilar entry and adoption.
• The evolution of non-factor therapies, especially their real-world efficacy, safety, and cost-effectiveness.
• Regulatory approvals for new indications or dosing regimens.
• Expansion strategies into developing regions.

Overall, despite intense competition and evolving therapeutic standards, recombinant FVIIa maintains a vital role, especially in complex bleeding scenarios, supporting a moderate but stable revenue outlook in the coming years.

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Key Takeaways

• The recombinant FVIIa market is characterized by steady growth, driven by hemophilia patient demographics and expanding indications.
• Competition from biosimilars and non-factor agents is a primary factor tempering future revenue growth.
• Pricing pressures and reimbursement challenges necessitate strategic adaptations from manufacturers.
• Market expansion into emerging regions offers promising growth avenues.
• Innovations in therapy and regulation will crucially influence the financial trajectory over the next decade.

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FAQs

1. How is increased competition from biosimilars affecting the revenue of recombinant FVIIa?
Biosimilars entering key markets like Europe and Asia typically lead to significant price reductions, eroding revenue for originator products such as NovoSeven. As biosimilars gain market adoption, manufacturers must adapt through pricing strategies, patient access programs, and innovation.

2. What role do non-factor therapies play in the future of bleeding disorder management?
Non-factor therapies, notably emicizumab, offer less invasive dosing and improved prophylaxis, especially for patients with inhibitors. They are gradually replacing traditional factor concentrates in many settings, which could limit the growth of recombinant FVIIa’s market share but still preserve niche indications.

3. Which regions are most promising for expanding recombinant FVIIa usage?
Emerging markets in Asia, Latin America, and parts of Africa are promising due to improving healthcare infrastructure and increasing awareness. However, pricing and regulatory hurdles must be effectively managed to realize growth potential.

4. Are there any significant R&D initiatives promising to change the landscape?
Current R&D focuses on long-acting factors, gene therapies, and novel delivery platforms. While these innovations could alter treatment paradigms, their commercial impact on recombinant FVIIa remains uncertain in the near term.

5. How will regulatory approaches influence the financial outlook of recombinant FVIIa?
Regulatory authorities' approval of biosimilars and new indications, alongside stringent safety monitoring, will shape market access. Favorable policies can expand usage, while restrictive regulations may limit growth and profitability.

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References

1. Grand View Research. Coagulation Factors Market Size & Trends. 2021.
2. Oldenburg J, et al. Emicizumab prophylaxis in hemophilia A. N Engl J Med. 2017;377(9):809-818.
3. MarketsandMarkets. Coagulation Factor Market Forecast. 2022.