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Last Updated: January 20, 2025

Coagulation factor ix (human) - Biologic Drug Details


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Summary for coagulation factor ix (human)
Tradenames:2
High Confidence Patents:0
Applicants:2
BLAs:2
Suppliers: see list1
Recent Clinical Trials: See clinical trials for coagulation factor ix (human)
Recent Clinical Trials for coagulation factor ix (human)

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Western University, CanadaPhase 3
Valeo Pharma IncPhase 3
Tanta UniversityPhase 2/Phase 3

See all coagulation factor ix (human) 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
  2. 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.

  3. General brand-side disclosures
  4. 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.

  5. Patents from broad patent text search
  6. 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 (human) Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for coagulation factor ix (human) Derived from Company Disclosures

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Coagulation Factor IX (Human)

Introduction

Coagulation Factor IX is a crucial biologic drug used primarily to treat hemophilia B, a genetic disorder characterized by the body's inability to produce enough of this clotting factor. Here, we delve into the market dynamics and financial trajectory of this vital medication.

Market Size and Growth

The global market for Coagulation Factor IX is experiencing significant growth. As of 2023, the market was valued at approximately $362 million and is projected to reach $526 million by 2030, with a Compound Annual Growth Rate (CAGR) of 5.8% during the forecast period of 2024-2030[1].

Another report indicates that the global Human Coagulation Factor IX market is expected to grow even more robustly, from $1.2 billion in 2023 to $2.5 billion by 2032, registering a CAGR of 8.2%[4].

Key Players

The market for Coagulation Factor IX is dominated by several major pharmaceutical companies, including Pfizer, CSL Behring, Grifols, Novo Nordisk, Bioverativ, Sanquin, Takeda, Baxter, and Aptevo. These companies are driving innovation and competition in the market[1].

Types and Applications

The Coagulation Factor IX market is segmented into two main types: plasma-derived and recombinant Coagulation Factor IX. These types cater to different patient needs and preferences. The applications of Coagulation Factor IX include treatments for adults and children suffering from hemophilia B, as well as certain cases of hemophilia A where traditional treatments are ineffective[1][5].

Evolutionary Insights and Gene Therapy

Recent research has highlighted the potential of high-specific-activity variants of Coagulation Factor IX, such as the Padua variant (R338L), which has shown significant promise in gene therapy for hemophilia B. This variant increases the specific activity of Factor IX, making it a valuable tool in addressing the limitations of current treatments[2].

Market Drivers

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

  • Increasing Prevalence of Hemophilia B: The rising number of patients diagnosed with hemophilia B is a primary driver.
  • Advancements in Gene Therapy: Innovations like the Padua variant are enhancing treatment efficacy and safety.
  • Growing Demand for Recombinant Products: Recombinant Coagulation Factor IX offers a safer alternative to plasma-derived products, driving its adoption.
  • Expanding Healthcare Infrastructure: Improvements in healthcare systems, especially in emerging markets, are increasing access to these treatments[1][4].

Financial Trajectory

The financial trajectory of the Coagulation Factor IX market is influenced by several key factors:

  • Revenue Growth: The market is expected to see steady revenue growth, driven by increasing demand and advancements in treatment options.
  • CAGR: A CAGR of 5.8% to 8.2% indicates a robust growth rate over the forecast period[1][4].
  • Competitive Landscape: The presence of multiple major players ensures continuous innovation and competitive pricing, which can impact revenue and market share.
  • Regulatory and Pricing Dynamics: Global medicine spending trends, including the impact of generics, biosimilars, and pricing controls, will influence the financial performance of Coagulation Factor IX products[3].

Global Medicine Spending Trends

The overall global medicine spending landscape is also relevant. By 2021, global medicine spending reached nearly $1.5 trillion, with a growth rate of 4-7% CAGR. This trend is expected to continue, driven by the adoption of new breakthrough medicines, including those for rare genetic disorders like hemophilia B[3].

Regional Dynamics

The market for Coagulation Factor IX varies by region, with developed markets offsetting increased costs through the use of generics and greater focus on pricing and access measures. Pharmerging markets, however, face challenges in expanding access to these treatments due to economic constraints[3].

Future Outlook

The future outlook for the Coagulation Factor IX market is promising, driven by:

  • Innovative Therapies: Continued advancements in gene therapy and the development of high-specific-activity variants.
  • Expanding Patient Base: Increasing awareness and diagnosis of hemophilia B.
  • Regulatory Support: Favorable regulatory environments that support the development and approval of new treatments.
"Global Human Coagulation Factor IX market size is projected to grow from USD 1.2 billion in 2023 to USD 2.5 billion by 2032, registering a CAGR of 8.2%."[4]

Key Takeaways

  • The global Coagulation Factor IX market is projected to grow significantly, reaching $526 million by 2030 and $2.5 billion by 2032.
  • Key players include Pfizer, CSL Behring, Grifols, and others.
  • The market is driven by increasing prevalence of hemophilia B, advancements in gene therapy, and growing demand for recombinant products.
  • Financial growth is influenced by revenue growth, competitive landscape, and regulatory dynamics.
  • Global medicine spending trends and regional dynamics also play crucial roles.

FAQs

Q: What is the projected market size for Coagulation Factor IX by 2030? A: The global market for Coagulation Factor IX is forecast to reach $526 million by 2030[1].

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

Q: What types of Coagulation Factor IX are available? A: The types include plasma-derived and recombinant Coagulation Factor IX[1].

Q: What is the significance of the Padua variant in Coagulation Factor IX? A: The Padua variant (R338L) is a high-specific-activity variant that has shown significant promise in gene therapy for hemophilia B, increasing the specific activity of Factor IX[2].

Q: How does the global medicine spending trend impact the Coagulation Factor IX market? A: The trend influences the market through the adoption of new medicines, use of generics, and regulatory controls on pricing and access[3].

Sources

  1. Valuates Reports - Coagulation Factor IX - Market Size
  2. Blood Advances - Evolutionary insights into coagulation factor IX Padua and other high-specific-activity factor IX variants
  3. IQVIA - Outlook for Global Medicines through 2021
  4. DataIntelo - Global Human Coagulation Factor IX Market Research Report 2032
  5. Mayo Clinic - Factor IX (Intravenous Route, Injection Route)

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