Factor ix complex - Biologic Drug Details

Summary for factor ix complex

Tradenames:	2
High Confidence Patents:	0
Applicants:	2
BLAs:	2
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 factor ix complex Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for factor ix complex Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for factor ix complex Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Factor IX Complex

Introduction to Factor IX Complex

Factor IX complex, used primarily in the treatment of hemophilia B, is a crucial biologic drug that replaces the deficient or absent factor IX in patients. This drug is a mixture of vitamin K-dependent clotting factors, including factors IX, II, X, and low levels of VII[5].

Market Size and Growth

The global market for Factor IX complex is experiencing significant growth. Here are some key metrics:

• Current Market Size: The global market for Coagulation Factor IX was estimated to be worth US$ 362 million in 2023[1].
• Forecasted Market Size: By 2030, the market is forecast to reach a readjusted size of US$ 526 million, growing at a CAGR of 5.8% during the forecast period 2024-2030[1].

Additionally, the broader category of Factor IX complex drugs is projected to grow substantially. For instance, the global market size for Factor IX complex drugs was estimated at $1.5 billion in 2023 and is projected to reach $3.1 billion by 2032, growing at a notable CAGR[4].

Market Drivers

Several factors are driving the growth of the Factor IX complex market:

• Increasing Prevalence of Hemophilia B: Hemophilia B is a recessive X-linked bleeding disorder that affects approximately 1 out of 30,000 male births and about 5,000 people in the US. The need for effective treatments is driving market growth[2].
• Technological Advancements: Continuous technological advancements in biologic drug development, including the emergence of recombinant Factor IX products, are enhancing treatment options and efficacy[2].
• Prophylactic Therapy: The use of prophylactic therapy with Factor IX products has been associated with a reduction in bleeds and improved outcomes for patients, increasing demand for these drugs[2].
• Regulatory Approvals: The escalating approvals of biologics by regulatory agencies are also contributing to market expansion[3].

Types of Factor IX Products

The market is segmented into two main types of Factor IX products:

• Plasma-Derived Factor IX: Derived from human plasma, these products have been used historically but come with risks such as the transmission of blood-borne pathogens[1][2].
• Recombinant Factor IX: Produced through genetic engineering, these products offer a safer alternative with reduced risk of pathogen transmission and are increasingly preferred[1][2].

Applications and Patient Segments

Factor IX complex is used in various applications and patient segments:

• Adult and Pediatric Patients: The drug is indicated for both adult and pediatric patients with hemophilia B[1].
• Bleeding Episodes and Surgery: It is used for the prevention and control of bleeding in patients with factor IX deficiency, including minor to moderate hemorrhages, major hemorrhages, and surgical procedures[5].

Key Players

The market for Factor IX complex is dominated by several key players:

• Pfizer: Known for its extensive portfolio of biologic drugs.
• CSL Behring: A major player in the plasma-derived and recombinant biologics market.
• Grifols: Specializes in plasma-derived therapies.
• Novo Nordisk: A leading company in the biopharmaceutical industry.
• Bioverativ, Sanquin, Takeda, Baxter, Aptevo: Other significant players in the Factor IX complex market[1].

Financial Trajectory

The financial trajectory of the Factor IX complex market is promising:

• Revenue Growth: The market is expected to grow from US$ 362 million in 2023 to US$ 526 million by 2030, indicating a steady increase in revenue[1].
• CAGR: A CAGR of 5.8% during the forecast period 2024-2030 suggests a stable and growing market[1].
• Broader Biologics Market: The overall biologics market, which includes Factor IX complex, is expected to reach USD 699.5 billion by 2032, growing at a CAGR of 7.8% during 2024-2032. This broader market growth also supports the financial trajectory of Factor IX complex drugs[3].

Challenges and Risks

Despite the growth, there are challenges and risks associated with Factor IX complex:

• Thromboembolic Complications: Patients are at risk of thromboembolic complications, especially those undergoing surgery or with known liver disease. This requires careful monitoring and management[5].
• Development of Inhibitors: Patients may develop inhibitors to Factor IX, which can reduce the effectiveness of the treatment. This necessitates close monitoring and adjustment of treatment protocols[2][5].

Conclusion

The market for Factor IX complex is driven by the increasing prevalence of hemophilia B, technological advancements, and the need for effective prophylactic therapy. With a projected market size of US$ 526 million by 2030 and a broader biologics market reaching USD 699.5 billion by 2032, the financial trajectory is positive. However, it is crucial to address the challenges associated with thromboembolic complications and the development of inhibitors.

Key Takeaways

• The global Factor IX complex market is expected to reach US$ 526 million by 2030.
• The market is driven by the increasing prevalence of hemophilia B and technological advancements.
• Both plasma-derived and recombinant Factor IX products are available, with recombinant products gaining preference.
• Key players include Pfizer, CSL Behring, Grifols, and Novo Nordisk.
• The broader biologics market is expected to reach USD 699.5 billion by 2032.

FAQs

Q: What is the current market size for Coagulation Factor IX? A: The global market for Coagulation Factor IX was estimated to be worth US$ 362 million in 2023[1].

Q: What is the forecasted market size for Factor IX complex by 2030? A: The market is forecast to reach a readjusted size of US$ 526 million by 2030[1].

Q: What are the main types of Factor IX products available? A: The main types are plasma-derived Factor IX and recombinant Factor IX[1][2].

Q: Who are the key players in the Factor IX complex market? A: Key players include Pfizer, CSL Behring, Grifols, Novo Nordisk, Bioverativ, Sanquin, Takeda, Baxter, and Aptevo[1].

Q: What are the potential risks associated with Factor IX complex treatment? A: Potential risks include thromboembolic complications and the development of inhibitors[2][5].

Sources

1. Valuates Reports: Global Coagulation Factor IX Market Report.
2. Cigna Healthcare: Hemophilia – Factor IX Products Coverage Policy.
3. Biospace: Biologics Market Size to Reach USD 699.5 Billion by 2032.
4. Dataintelo: Factor IX Complex Drug Market Research Report 2032.
5. DailyMed: Profilnine, Factor IX Complex.