Fibrinogen (human) - Biologic Drug Details

Summary for fibrinogen (human)

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for fibrinogen (human)
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for fibrinogen (human)

Recent Clinical Trials for fibrinogen (human)

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
French Innovative Leukemia Organisation	Phase 2
Hoffmann-La Roche	Phase 2
University of California, San Francisco	Phase 2

See all fibrinogen (human) clinical trials

Recent Litigation for fibrinogen (human)

Identify key patents and potential future biosimilar entrants

PTAB Litigation

Petitioner	Date
	2014-11-04

See all fibrinogen (human) litigation

Pharmacology for fibrinogen (human)

Physiological Effect	Increased Coagulation Activity
Established Pharmacologic Class	Human Blood Coagulation Factor
Chemical Structure	Blood 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

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 fibrinogen (human) Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Human Fibrinogen Concentrate Market: Dynamics and Financial Trajectory

Introduction to Human Fibrinogen Concentrate

Human fibrinogen concentrate is a hematological agent that plays a crucial role in blood clotting, particularly for patients with congenital fibrinogen deficiency. This protein, synthesized in the liver, is essential for the formation of blood clots, preventing excessive bleeding and facilitating wound healing[2][4].

Market Size and Growth Projections

The global human fibrinogen concentrate market has been experiencing significant growth, driven by various factors. As of 2023, the market was valued at approximately $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].

Alternatively, other forecasts suggest that the market size was around $1.6 billion in 2022 and is estimated to achieve $2.8 billion by 2032, with a CAGR of 5.8% during the analysis period of 2024 to 2032[4].

Key Drivers of Market Growth

Increasing Prevalence of Chronic Diseases

The rise in chronic diseases such as heart attacks, strokes, tumors, and blockages in blood vessels significantly contributes to the demand for human fibrinogen concentrate. These conditions often require surgical interventions, which in turn increase the need for fibrinogen concentrates to manage bleeding episodes[1].

Growing Geriatric Population

An aging population is more prone to chronic diseases and surgical procedures, thereby increasing the demand for human fibrinogen concentrates. This demographic shift is particularly notable in regions like North America and Asia-Pacific[1][4].

Rise in Sports Injuries and Road Accidents

Sports injuries and road accidents are additional factors driving the demand for human fibrinogen concentrates. For instance, the high number of sports-related injuries, especially among children and teens, contributes to the increased use of fibrinogen products in medical treatments[1].

Advances in Healthcare Infrastructure

Regions with robust healthcare infrastructure, such as North America, are witnessing significant growth in the human fibrinogen concentrate market. This is due to better access to healthcare services, increased healthcare spending, and the presence of key industry players[1][4].

Market Segmentation

By Indication

The congenital fibrinogen deficiency segment dominates the global human fibrinogen concentrate market. Conditions such as afibrinogenemia, hypofibrinogenemia, and dysfibrinogenemia are the primary indications for the use of fibrinogen concentrates. These conditions affect both genders equally and can manifest at any age, although afibrinogenemia typically appears early in life[1][4].

By Form

The liquid form of human fibrinogen concentrate has acquired a major share in the global market. This form is preferred due to its ease of administration and stability[1].

By End User

Hospitals are the major end users of human fibrinogen concentrates, given the frequent need for these products in surgical and emergency settings[1].

By Region

North America currently dominates the market in terms of revenue, driven by the presence of key players, robust healthcare infrastructure, and increased healthcare spending. However, the Asia-Pacific region is expected to grow at a faster CAGR due to the rapid growth in the pharmaceutical and biologics industry, increased medical tourism, and a rising geriatric population[1][4].

Competitive Analysis

The human fibrinogen concentrate market is highly competitive, with major players focusing on product development and launches. Companies like Grifols, S.A., CSL Limited, The LFB group, Intas Pharmaceuticals Limited, and Octapharma AG are key players in this market. Recent developments include Biotest’s positive topline results from its phase 3 clinical trial of its fibrinogen concentrate, BT524, which targets acquired fibrinogen deficiency (AFD)[1].

Market Challenges

Despite the growth prospects, the human fibrinogen concentrate market faces challenges such as the high cost of fibrin sealant products. This high cost can limit access to these essential medical products, particularly in developing nations[1][4].

Regional Outlook

North America

North America is the leading region in the human fibrinogen concentrate market, driven by modern healthcare infrastructure, significant healthcare spending, and a sizable patient population with bleeding disorders. Strict regulatory frameworks and favorable reimbursement policies also contribute to the market's growth in this region[4].

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 contribute to the region's growth[1][4].

Financial Trajectory

The financial trajectory of the human fibrinogen concentrate market is promising, with significant growth projected over the next decade. Here are some key financial highlights:

• Market Size by 2035: Expected to reach $2.9 billion[1].
• CAGR: 11% from 2024 to 2035[1].
• Alternative Forecast: Expected to reach $2.8 billion by 2032, with a CAGR of 5.8% from 2024 to 2032[4].

Analyst Review and Industry Insights

Analysts suggest that the utilization of human fibrinogen concentrates yields positive impacts on surgical outcomes, including enhanced time to hemostasis, reduced blood loss, and minimized complications. The market has garnered significant interest within the healthcare industry due to its critical role in managing bleeding disorders and its potential in various surgical procedures[1].

"Fibrinogen, also known as factor I, is a protein produced by the liver that aids in blood clotting by facilitating the thickening of blood. The soluble fibrinogen in blood plasma is converted into fibrins by the enzyme thrombin, resulting in blood clot formation." - Acumen Research and Consulting[4]

Key Takeaways

• The global human fibrinogen concentrate market is projected to grow significantly, driven by the rise in chronic diseases, a growing geriatric population, and increased sports injuries and road accidents.
• North America dominates the market due to robust healthcare infrastructure and significant healthcare spending, while the Asia-Pacific region is expected to grow at a faster CAGR.
• The congenital fibrinogen deficiency segment and liquid form of fibrinogen concentrates are major market segments.
• High costs of fibrin sealant products are a significant challenge, but untapped medical needs in developing nations present lucrative opportunities.

FAQs

What is the primary use of human fibrinogen concentrate?

Human fibrinogen concentrate is primarily used to control acute bleeding episodes in patients with congenital fibrinogen deficiency and to facilitate blood clotting in various surgical procedures.

Which region dominates the human fibrinogen concentrate market?

North America currently dominates the market in terms of revenue, due to its robust healthcare infrastructure, significant healthcare spending, and the presence of key industry players.

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

The key drivers include the rise in chronic diseases, a growing geriatric population, increased sports injuries and road accidents, and advances in healthcare infrastructure.

What are the challenges facing the human fibrinogen concentrate market?

The high cost of fibrin sealant products is a significant challenge, limiting access to these essential medical products, especially in developing nations.

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

Major players include Grifols, S.A., CSL Limited, The LFB group, Intas Pharmaceuticals Limited, and Octapharma AG.

Sources

1. Allied Market Research - Human Fibrinogen Concentrate Market Size | Forecast - 2035
2. Haematologica - Fibrin(ogen) in human disease: both friend and foe
3. DataIntelo - Human Fibrinogen Concentrate Market Research Report 2032
4. Acumen Research and Consulting - Human Fibrinogen Concentrate Market Size Report Forecast 2032
5. GlobeNewswire - Human Fibrinogen Concentrate Market Global Size Worth Around $1.4 Billion By 2025: Acumen Research and Consulting