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Last Updated: December 26, 2024

Fibrinogen concentrate (human) - Biologic Drug Details


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Summary for fibrinogen concentrate (human)
Tradenames:1
High Confidence Patents:0
Applicants:1
BLAs:1
Suppliers: see list1
Pharmacology for fibrinogen concentrate (human)
Physiological EffectIncreased Coagulation Activity
Established Pharmacologic ClassHuman Blood Coagulation Factor
Chemical StructureBlood Coagulation Factors
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 fibrinogen concentrate (human) Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for fibrinogen concentrate (human) Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for fibrinogen concentrate (human) Derived from Patent Text Search

No patents found based on company disclosures

Fibrinogen concentrate (human) Market Analysis and Financial Projection Experimental

Human Fibrinogen Concentrate Market: Dynamics and Financial Trajectory

Market Introduction and Definition

Human fibrinogen concentrate is a crucial biologic drug used in the management of bleeding disorders and surgical procedures. It is a soluble plasma glycoprotein essential for the formation of blood clots, making it a vital component in treating conditions such as congenital fibrinogen deficiency, afibrinogenemia, and hypofibrinogenemia[2][4].

Market Size and Growth Projections

The global human fibrinogen concentrate market is experiencing significant growth, driven by several key factors. As of 2023, the market size was valued at $0.8 billion and is projected to reach $2.9 billion by 2035, growing at a Compound Annual Growth Rate (CAGR) of 11% from 2024 to 2035[1][2].

Key Drivers of Market Growth

Increasing Incidence of Bleeding Disorders

The rising incidence of bleeding disorders such as afibrinogenemia, hypofibrinogenemia, and dysfibrinogenemia is a major driver of the market. These conditions necessitate the use of fibrinogen concentrate to manage acute bleeding episodes, thereby increasing demand for the product[2][4].

Growing Geriatric Population

The global population is aging, with the elderly population (aged 60 and above) projected to rise significantly by 2050. This demographic shift increases the prevalence of age-related bleeding disorders and the need for surgical interventions, which in turn boosts the demand for fibrinogen concentrate[4].

Rise in Surgical Procedures

The increasing number of surgical procedures, including those for chronic heart diseases, dental conditions, and post-operative complications, contributes to the growing demand for human fibrinogen concentrate. Sports injuries and road accidents also add to the volume of surgeries, further propelling market growth[2][4].

Advances in Biotechnology

Developments in biotechnology have led to more sophisticated formulations of human fibrinogen concentrate with improved safety and efficacy profiles. This has enhanced the acceptance of fibrinogen concentrate therapy among patients and medical professionals[1].

Market Segmentation

By Indication

The market is segmented into congenital fibrinogen deficiency and surgical procedures. The congenital fibrinogen deficiency segment dominated the global market in 2023 and is expected to continue its dominance during the forecast period[1][2].

By Form

The market is segmented into lyophilized, powder, and liquid forms. The liquid form segment acquired a major share in the global market in 2023 due to its ease of administration and stability[1][2].

By End User

The market is segmented into hospitals, ambulatory surgical centers (ASCs), and others. Hospitals acquired a major share in the global market in 2023, driven by the high frequency of surgical procedures and the need for efficient hemostatic agents[2].

By Region

Geographically, the market is analyzed across North America, Europe, Asia-Pacific, and Latin America, Middle East & Africa (LAMEA). North America led the market in terms of revenue in 2023, driven by a high prevalence of bleeding disorders, advanced healthcare infrastructure, and the presence of key industry players. The Asia-Pacific region is anticipated to experience significant growth due to increasing healthcare investments and rising surgical procedures[1][2].

Market Dynamics

Drivers

  • Increasing Preference Over Fresh-Frozen Plasma: The preference for fibrinogen concentrate over fresh-frozen plasma due to its better safety profile and ease of use is a significant driver[3].
  • Rising R&D Investments: Increased research and development activities aimed at developing advanced fibrinogen products are driving market growth[3].
  • Growing Geriatric Population: The aging population increases the need for surgical services and the management of age-related bleeding disorders[4].

Restraints

  • Stringent Regulatory Requirements: The high regulatory barriers for product approval can restrict market growth[2].
  • High Cost: The cost associated with fibrinogen concentrate therapy is a significant restraint, especially in underdeveloped and developing economies[2].
  • Limited Availability of Skilled Healthcare Professionals: The lack of skilled healthcare professionals in some regions hampers the administration of fibrinogen concentrate[2].

Financial Implications and Cost-Effectiveness

Economic Evaluation

Studies have shown that the use of human fibrinogen concentrate is cost-effective compared to standard treatments. For instance, a study in Mexico found that using human fibrinogen concentrate plus blood products resulted in significant savings and a reduction in deaths associated with severe bleeding during surgery[5].

Market Revenue and Growth

The market is expected to grow substantially, with North America and Europe leading the way due to their advanced healthcare infrastructure and high prevalence of bleeding disorders. The Asia-Pacific region is also poised for significant growth, driven by increasing healthcare investments and a rising geriatric population[1][2][4].

Key Market Players

The human fibrinogen concentrate market includes several key players such as Grifols, S.A., CSL Limited, The LFB group, Intas Pharmaceuticals Limited, Octapharma AG, and Shanghai RAAS Blood Products Co., Ltd. These companies are focusing on developing advanced fibrinogen concentrates to treat bleeding disorders, which is expected to drive market growth[2].

Regional Outlook

North America

North America dominated the market in 2023 due to a high frequency of bleeding disorders, the presence of key industry players, and an increase in chronic heart diseases. The region's robust healthcare infrastructure and high healthcare spending also contribute to its leading position[1][2].

Asia-Pacific

The Asia-Pacific region is anticipated to experience noteworthy growth due to factors such as a rising geriatric population, unmet medical needs, and increased public-private investments in the healthcare sector. Initiatives by governmental and non-governmental organizations to promote awareness about fibrin sealant usage in surgeries also drive growth in this region[1][2].

Industry Trends

Increasing R&D Investments

There is a significant increase in research and development activities aimed at developing new therapies for bleeding disorders. This includes the development of advanced and innovative fibrinogen products, which is expected to contribute to market growth[3].

New Product Launches and Approvals

New product launches and approvals of fibrinogen concentrates are key factors driving market growth. These new products often have better safety and efficacy profiles, further increasing their adoption in clinical practice[3].

Key Takeaways

  • The global human fibrinogen concentrate market is projected to reach $2.9 billion by 2035, growing at a CAGR of 11% from 2024 to 2035.
  • The congenital fibrinogen deficiency segment dominates the market by indication.
  • The liquid form segment holds a major share in the market by form.
  • Hospitals are the primary end users of human fibrinogen concentrate.
  • North America leads the market in terms of revenue, followed by the Asia-Pacific region.

FAQs

What are the primary drivers of the human fibrinogen concentrate market?

The primary drivers include the increasing incidence of bleeding disorders, the growing geriatric population, and the rise in surgical procedures. Additionally, advances in biotechnology and the increasing preference for fibrinogen concentrate over fresh-frozen plasma contribute to market growth[1][2][4].

Which region is expected to experience the most significant growth in the human fibrinogen concentrate market?

The Asia-Pacific region is anticipated to experience significant growth due to a rising geriatric population, unmet medical needs, and increased public-private investments in the healthcare sector[1][2].

What are the major restraints to the human fibrinogen concentrate market?

The major restraints include stringent regulatory requirements, the high cost associated with fibrinogen concentrate therapy, and the limited availability of skilled healthcare professionals in some regions[2].

How does the use of human fibrinogen concentrate impact healthcare costs?

The use of human fibrinogen concentrate is associated with cost savings and a reduction in deaths compared to standard treatments. It provides a cost-effective alternative by reducing the need for blood products and minimizing complications during surgery[5].

Who are the key players in the human fibrinogen concentrate market?

Key players include Grifols, S.A., CSL Limited, The LFB group, Intas Pharmaceuticals Limited, Octapharma AG, and Shanghai RAAS Blood Products Co., Ltd.[2].

Sources

  1. EIN Presswire: Human Fibrinogen Concentrate Market Trends - EIN Presswire
  2. Allied Market Research: Human Fibrinogen Concentrate Market Size | Forecast - 2035
  3. Biospace: Fibrinogen Concentrate Market Size to Reach USD 4.19 Billion in 2028
  4. Allied Market Research: Fibrinogen Concentrate Market Size, Share, Growth | 2033
  5. ISPOR: Cost-Effectiveness Study of the Use of Fibrinogen Concentrate

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