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
Valeo Pharma Inc	Phase 3
Western University, Canada	Phase 3
Zunyi Medical College	Phase 4

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. General 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 Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Novo Nordisk Inc.	REBINYN	coagulation factor ix (recombinant), glycopegylated	For Injection	125611	7,138,371	2021-10-10	Company disclosures
Novo Nordisk Inc.	REBINYN	coagulation factor ix (recombinant), glycopegylated	For Injection	125611	7,416,858	2040-03-31	Company disclosures
Novo Nordisk Inc.	REBINYN	coagulation factor ix (recombinant), glycopegylated	For Injection	125611	7,473,680	2021-11-28	Company disclosures
Novo Nordisk Inc.	REBINYN	coagulation factor ix (recombinant), glycopegylated	For Injection	125611	8,404,809	2029-10-23	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	2026-07-13	Patent claims search
Medexus Pharma, Inc.	IXINITY	coagulation factor ix (recombinant)	For Injection	125426	8,129,145	2026-07-13	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	RIXUBIS	coagulation factor ix (recombinant)	For Injection	125446	8,129,145	2026-07-13	Patent claims search
Csl Behring Lengnau Ag	IDELVION	coagulation factor ix (recombinant), albumin fusion protein	For Injection	125582	8,129,145	2026-07-13	Patent claims search

Market Dynamics and Financial Trajectory for Recombinant Coagulation Factor IX

Introduction

Recombinant Coagulation Factor IX is a biologic drug used to treat hemophilia B, a hereditary bleeding disorder characterized by a deficiency of clotting factor IX in the blood. This article delves into the market dynamics, financial trajectory, and key factors influencing the growth of this market.

Market Size and Growth

The global recombinant coagulation factors market, which includes recombinant Factor IX, is projected to experience significant growth. As of 2022, the global market size was valued at USD 12.66 billion and is expected to grow to USD 21.94 billion by 2031, at a CAGR of 6.3% during the forecast period (2024-2031)[1].

Another forecast suggests that the market could reach $26.29 billion by 2031, growing at a CAGR of 8.6% from 2024 to 2031[4].

Segmentation and Market Share

The recombinant coagulation factors market is segmented based on type, application, and end user. The recombinant Factor IX segment, while significant, is overshadowed by the recombinant Factor VIII segment, which is expected to account for the largest share of the market due to the high demand for treating hemophilia A[4].

Applications and End Users

Recombinant Coagulation Factor IX is primarily used to treat hemophilia B, also known as Christmas disease. It is used to control and prevent bleeding episodes, and to prevent bleeding during surgery in patients with congenital Factor IX deficiency[2][5].

The hospital segment holds the largest share of the global recombinant coagulation factors market, driven by the increased adoption of these factors for treating coagulation disorders, rising healthcare expenditure, and growing awareness among healthcare professionals[4].

Geographical Distribution

North America is expected to dominate the global market, accounting for approximately 43.4% of the recombinant coagulation factors market in 2024. This dominance is attributed to the increasing prevalence of hemophilia, rising accessibility and affordability of treatment, and supportive government initiatives[4].

However, the Asia-Pacific region is projected to register the highest CAGR of 10.3% during the forecast period, driven by increasing healthcare investments in developing countries like China and India, and a rising preference for recombinant technology[4].

Drivers of Growth

Several factors are driving the growth of the recombinant Coagulation Factor IX market:

• Increasing Incidence of Hemophilia: The rising incidence of hemophilia and other bleeding diseases is a significant driver[1][4].
• Consumer Demand: Increasing consumer demand for plasma-derived and recombinant coagulation factors is another key factor[1].
• R&D and Product Approvals: The consistent increase in R&D expenditure and the approval of new recombinant coagulation factors are driving market expansion[1][4].
• Prophylactic Treatment: The increasing use of prophylactic treatment for hemophilia worldwide is also contributing to market growth[1].

Restraints and Challenges

Despite the growth potential, there are several challenges that hamper the market:

• High Treatment Costs: The high cost of treatment for hemophilia care and the availability of lower-cost plasma-derived alternatives are significant restraints[1].
• Limited Disease Awareness: Limited awareness about hemophilia and its treatment options, especially in developing countries, is another challenge[1].
• Economic and Healthcare System Barriers: High production costs, poor economic conditions, and unfavorable healthcare systems in developing countries further hinder market growth[1].

Key Players and Product Developments

Several key players are investing heavily in the research and development of recombinant coagulation factors. For instance, Medexus Pharmaceuticals recently received FDA approval for its supplemental Biologics License Application (sBLA) for IXINITY®, an intravenous recombinant factor IX therapeutic, for the treatment of pediatric patients under 12 years of age with hemophilia B[3].

Other notable products include Benefix, Ixinity, and Rixubis, which are widely used to treat hemophilia B[2][5].

Mechanism of Action and Clinical Significance

Recombinant Coagulation Factor IX plays a crucial role in the blood coagulation cascade. It is activated by Factor XIa and forms a complex with calcium ions, membrane phospholipids, and Factor VIII to activate Factor X, which is integral to normal blood clotting[2].

Clinical Benefits and Patient Outcomes

The use of recombinant Coagulation Factor IX has significantly improved the management of hemophilia B. It helps in controlling and preventing bleeding episodes, reducing the frequency of these episodes, and preventing bleeding during surgery. This has led to better patient outcomes and improved quality of life for those with hemophilia B[2][5].

Regulatory Environment

The regulatory environment is supportive, with recent approvals such as the FDA approval for IXINITY® highlighting the favorable regulatory landscape for new and expanded indications of recombinant coagulation factors[3].

Market Opportunities

For existing market players and new entrants, there are several opportunities:

• Expanding into Emerging Markets: Investing in developing countries where healthcare infrastructure is improving can provide significant growth opportunities[4].
• R&D and Innovation: Continuing to invest in research and development to improve the efficacy and safety of recombinant coagulation factors can drive market expansion[1][4].
• Partnerships and Collaborations: Forming partnerships with healthcare facilities and research institutions to enhance treatment accessibility and awareness can also be beneficial[4].

Key Takeaways

• The global recombinant coagulation factors market, including Factor IX, is expected to grow significantly by 2031.
• The market is driven by increasing incidence of hemophilia, consumer demand, R&D, and product approvals.
• High treatment costs and limited disease awareness are significant restraints.
• Key players are investing in R&D and product developments.
• The Asia-Pacific region is expected to register the highest CAGR during the forecast period.

FAQs

1. What is the primary use of recombinant Coagulation Factor IX? Recombinant Coagulation Factor IX is primarily used to treat hemophilia B, controlling and preventing bleeding episodes, and preventing bleeding during surgery[2][5].

2. Which region is expected to dominate the global recombinant coagulation factors market? North America is expected to dominate the global market, accounting for approximately 43.4% of the market share in 2024[4].

3. What are the main drivers of the recombinant coagulation factors market? The main drivers include the increasing incidence of hemophilia, consumer demand for recombinant factors, R&D expenditure, and increasing product approvals[1][4].

4. What are the significant restraints to the market growth? High treatment costs, limited disease awareness, and economic and healthcare system barriers in developing countries are significant restraints[1].

5. Which companies are key players in the recombinant Coagulation Factor IX market? Companies like Medexus Pharmaceuticals, with products such as IXINITY®, and other brands like Benefix, Ixinity, and Rixubis, are key players in this market[2][3][5].

Cited Sources

1. SkyQuest Technology Consulting Pvt. Ltd. - Recombinant Coagulation Factors Market Size, Share, Growth... [April, 2024]
2. DrugBank - Coagulation Factor IX (Recombinant)
3. Medexus Pharmaceuticals - FDA Approves Medexus's Supplemental Biologics License... [March 26, 2024]
4. Meticulous Research - Recombinant Coagulation Factors Market Size & Forecast
5. Mayo Clinic - Coagulation factor ix recombinant (intravenous route)

Last updated: 2024-12-17