Coagulation factor ix (recombinant), glycopegylated - Biologic Drug Details

Summary for coagulation factor ix (recombinant), glycopegylated

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. 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), glycopegylated Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for coagulation factor ix (recombinant), glycopegylated 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), glycopegylated 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 coagulation factor ix (recombinant), glycopegylated

Country	Patent Number	Estimated Expiration
Japan	5743368
Brazil	0213207
European Patent Office	1720892
Japan	5739632

Supplementary Protection Certificates for coagulation factor ix (recombinant), glycopegylated

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
122017000105	Germany		PRODUCT NAME: NONACOG BETA PEGOL; REGISTRATION NO/DATE: EU/1/17/1193 20170602
300912	Netherlands		PRODUCT NAME: NONACOG BETA PEGOL; REGISTRATION NO/DATE: EU/1/17/1193/001-003 20170607
608	Finland
132017000138764	Italy		PRODUCT NAME: NONACOG BETA PEGOL(REFIXIA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1193, 20170607

Coagulation factor ix (recombinant), glycopegylated Market Analysis and Financial Projection

Coagulation Factor IX (Recombinant), GlycoPEGylated: Market Dynamics and Financial Trajectory

Market Overview

The market for coagulation factor IX (recombinant), glycoPEGylated, is a niche but critical segment within the biopharmaceutical industry, specifically targeting the treatment of hemophilia B. Hemophilia B is a rare genetic disorder characterized by the deficiency or absence of blood clotting factor IX, leading to spontaneous or prolonged bleeding episodes. This market is driven by the need for effective and safe treatments to manage and prevent these bleeding episodes[1].

Increasing Prevalence of Hemophilia B

The primary driver of the coagulation factor IX market is the increasing prevalence of hemophilia B worldwide. With approximately 1 in 30,000 male births affected globally, improved diagnostic capabilities and awareness are leading to more identified cases, thereby increasing the demand for factor IX concentrates[1].

Prophylactic Treatment Approaches

There is a growing emphasis on comprehensive care and prophylactic treatment approaches for hemophilia patients. Prophylactic treatment, involving regular infusions of factor IX concentrates, has been shown to significantly improve patient outcomes and reduce long-term complications associated with hemophilia B. This shift towards proactive management has further boosted the demand for factor IX products[1].

Advanced Formulations: Extended Half-Life and Long-Acting Products

A significant opportunity for growth lies in the development of extended half-life and long-acting factor IX products. These advanced formulations aim to extend the duration of action and reduce the frequency of infusions, potentially improving patient compliance and quality of life while reducing the overall treatment burden. For instance, Novo Nordisk's REBINYN®, a glycoPEGylated factor IX concentrate, has been approved for routine prophylaxis to reduce the frequency of bleeding episodes and has shown promising results in clinical studies[2].

Gene Therapy: A Potential Game-Changer

The integration of gene therapy approaches holds immense potential for transforming the treatment landscape for hemophilia B. Gene therapies aim to introduce a functional copy of the factor IX gene into the patient's cells, potentially providing a long-term or even curative solution for the disease. Although still in the early stages of development, progress in this area could revolutionize the management of hemophilia B and drive significant market growth[1].

Regional Analysis

The coagulation factor IX market exhibits regional variations influenced by healthcare infrastructure, access to treatment, and reimbursement policies.

• North America and Europe: These regions have traditionally been the leaders in the factor IX market, driven by well-established healthcare systems, high awareness of hemophilia B, and favorable reimbursement policies. The United States and countries like Germany, France, and the United Kingdom are major contributors to the market's growth in these regions[1].
• Asia-Pacific: This region is expected to witness significant growth, driven by increasing awareness, improving healthcare infrastructure, and the rising adoption of prophylactic treatment approaches. Countries like Japan, China, and India represent significant potential markets for factor IX concentrates as access to these treatments improves[1].

Competitive Landscape

The coagulation factor IX market is highly specialized and dominated by a few key players, primarily large biopharmaceutical companies with expertise in the production and development of coagulation factor products.

• Leading Companies: Shire (now part of Takeda Pharmaceutical Company), CSL Behring, Pfizer, Sanofi, and Novo Nordisk are among the major players. These companies have established a strong presence through their extensive product portfolios, robust manufacturing capabilities, and global distribution networks[1].
• Strategic Partnerships and Acquisitions: Strategic partnerships, collaborations, and acquisitions have played a significant role in shaping the competitive landscape. For example, Takeda's acquisition of Shire in 2019 solidified its position in the coagulation factor market[1].

Market Size and Growth

The global coagulation factor concentrates market, which includes factor IX, is valued at US$ 7.8 billion in 2022 and is predicted to climb to US$ 11.4 billion by the end of 2027, growing at a CAGR of 7.8% over the next five years[3].

Recombinant Coagulation Factors Market

The recombinant coagulation factors market, which includes factor IX produced using recombinant DNA technology, is projected to reach $26.29 billion by 2031, at a CAGR of 8.6% from 2024 to 2031. This growth is driven by the low risk of blood-borne transmission of infectious diseases associated with recombinant factors, making them a preferred choice for treating bleeding disorders like hemophilia[4].

Financial Trajectory

The financial trajectory of the coagulation factor IX market is promising due to several factors:

• Increasing Demand: The rising prevalence of hemophilia B and the growing emphasis on prophylactic treatment approaches are driving up the demand for factor IX concentrates.
• Advanced Products: The development and approval of extended half-life and long-acting products, such as REBINYN®, are expected to improve patient outcomes and reduce treatment burdens, further increasing market value.
• Regional Growth: The Asia-Pacific region, particularly countries like China and India, is expected to contribute significantly to the market's growth due to improving healthcare infrastructure and increasing awareness of hemophilia B[1][3].

Cost and Coverage

Despite the high cost of treatment, financial programs and support mechanisms are in place to help patients access these essential therapies. For instance, Novo Nordisk's NovoCare® program provides assistance through co-pay savings and other support to help patients access REBINYN®[5].

Key Trends Shaping the Market

• Extended Half-Life Products: Continued development of extended half-life and long-acting factor IX products will offer improved patient convenience, reduced treatment burden, and better adherence to prophylactic regimens.
• Gene Therapy: Progress in gene therapy could revolutionize the treatment of hemophilia B, offering a potential long-term or curative solution.
• Regional Expansion: The Asia-Pacific region is expected to see significant growth due to improving healthcare infrastructure and increasing awareness of hemophilia B[1][2].

Challenges

• High Cost of Treatment: The high cost of blood disorder treatments, including coagulation factor IX concentrates, can be a barrier to access, particularly in regions with limited healthcare resources[3].

"In clinical studies, when adults and adolescent people living with Hemophilia B were given prophylactic treatment with REBINYN®, patients experienced factor IX activity in the same range as people without hemophilia (above 40%) for nearly 80% of the week" - Allison P. Wheeler, MD, MSCI, Vanderbilt University Medical Center[2].

Key Takeaways

• The coagulation factor IX market is driven by the increasing prevalence of hemophilia B and the growing emphasis on prophylactic treatment.
• Advanced formulations like extended half-life and long-acting products are improving patient outcomes and reducing treatment burdens.
• The Asia-Pacific region is expected to see significant growth due to improving healthcare infrastructure and increasing awareness.
• Gene therapy holds immense potential for transforming the treatment landscape for hemophilia B.
• The market is dominated by a few key biopharmaceutical companies, with strategic partnerships and acquisitions shaping the competitive landscape.

FAQs

What is the primary driver of the coagulation factor IX market?

The primary driver is the increasing prevalence of hemophilia B worldwide and the growing emphasis on comprehensive care and prophylactic treatment approaches.

Which regions are expected to see significant growth in the coagulation factor IX market?

North America and Europe are currently leading, but the Asia-Pacific region, particularly countries like Japan, China, and India, is expected to witness significant growth in the coming years.

What are the benefits of extended half-life and long-acting factor IX products?

These products extend the duration of action and reduce the frequency of infusions, potentially improving patient compliance and quality of life while reducing the overall treatment burden.

How does gene therapy impact the coagulation factor IX market?

Gene therapy holds immense potential for transforming the treatment landscape for hemophilia B by offering a long-term or even curative solution through the introduction of a functional copy of the factor IX gene into the patient's cells.

What financial support mechanisms are available for patients accessing coagulation factor IX treatments?

Financial programs such as Novo Nordisk's NovoCare® provide assistance through co-pay savings and other support to help patients access these essential therapies.

Sources

1. Data Horizon Research: Coagulation Factor IX Market Size, Share & Forecast 2033.
2. Novo Nordisk: Novo Nordisk receives FDA approval for REBINYN® for routine prophylaxis.
3. Fact.MR: Coagulation Factor Concentrates Market Growth Trends 2027.
4. Meticulous Research: Recombinant Coagulation Factors Market Size & Forecast.
5. NovoMEDLINK: Rebinyn® Cost & Coverage.