Fibrin sealant (human) - Biologic Drug Details

Summary for fibrin sealant (human)

Tradenames:	4
High Confidence Patents:	0
Applicants:	4
BLAs:	4
Suppliers: see list	2

Pharmacology for fibrin sealant (human)

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

Note on Biologic Patents

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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 fibrin sealant (human) Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Fibrin sealant (human) Market Analysis and Financial Projection Experimental

Fibrin Sealants Market: Dynamics and Financial Trajectory

Introduction to Fibrin Sealants

Fibrin sealants, also known as fibrin glues, are biologic products used to manage bleeding during surgical procedures. These sealants are composed of fibrinogen and thrombin, two essential components in the blood clotting process. Their primary function is to induce blood clotting at the site of bleeding, thereby preventing unnecessary blood loss and reducing the risk of complications and mortality associated with excessive bleeding.

Market Size and Growth Projections

The global fibrin sealants market is anticipated to experience significant growth over the coming years. By 2032, the market is expected to be worth around USD 2,561.1 million, up from USD 1,306.1 million in 2023, growing at a Compound Annual Growth Rate (CAGR) of 8.0% during the forecast period[1][3][4].

Key Drivers of the Market

Increasing Prevalence of Chronic Diseases

The rising global prevalence of chronic diseases, such as cardiovascular diseases, is a major driver of the fibrin sealants market. Cardiovascular surgeries, in particular, are a significant segment, with cardiovascular surgery accounting for a revenue share of 48% in the fibrin sealants market[1].

Technological Advancements

Recent improvements in hemostasis technology have led to the development of biocompatible sealants that reduce complexities and support the normal movement of tissues without restraining the functioning of organs. This has enhanced the adoption of fibrin sealants in various surgical fields, including general surgery, orthopedics, and neurosurgery[3][4].

Growing Demand for Minimally Invasive Surgeries

The increasing preference for minimally invasive surgeries has driven the demand for effective hemostatic agents like fibrin sealants. These sealants are crucial in achieving effective hemostasis, reducing the need for transfusions, and enhancing patient recovery[4].

Aging Population and Healthcare Spending

The aging population, particularly in North America, is another significant factor driving the market. The rise in healthcare spending, demand for better care, and the increasing prevalence of chronic diseases among the elderly population are expected to fuel the growth of the fibrin sealants market[1][3][4].

End-User Analysis

Dominance of Hospitals

Hospitals are the most dominant segment in terms of end-users, primarily due to the increasing number of coronary bypass grafting (CABG) and other cardiological surgeries performed in these settings. Specialty clinics and ambulatory surgical centers also contribute to the market, although to a lesser extent[1].

Regional Analysis

North America

North America holds a dominant market share, accounting for 47% of the global fibrin sealants market in 2022. This is attributed to the region's well-developed healthcare infrastructure, high prevalence of chronic diseases, and significant investments in medical technologies[1][3][4].

Asia-Pacific

The Asia-Pacific region is expected to experience the fastest growth rate, with a CAGR of 6.9% from 2023 to 2032. This growth is driven by the rapidly expanding healthcare sector, increasing investments in healthcare infrastructure, and a growing patient population in countries like China, Japan, and India[1][4].

Product Segmentation

Liquid Fibrin Sealant Patches

Liquid fibrin sealant patches are the largest contributors to the fibrin sealants market and are predicted to continue growing throughout the forecast period. These patches are applied in a thin layer over the bleeding tissue to generate a cross-linked fibrin clot and achieve hemostasis[1][2].

Recent Developments and Approvals

FDA Approval for Pediatric Use

Grifols' VISTASEAL, a plasma-protein-based fibrin sealant, has recently received FDA approval for use in pediatric patients to control mild to moderate bleeding during surgeries. This approval highlights the expanding applications of fibrin sealants in various patient demographics[2].

Industry Trends

Next-Generation Bioengineered Sealants

The development of next-generation bioengineered sealants with enhanced biocompatibility and efficacy is a significant trend in the market. These advancements are expected to further increase the adoption of fibrin sealants in minimally invasive and robotic-assisted surgeries[4].

Expanding Applications

Fibrin sealants are increasingly being used in diverse surgical fields such as orthopedics, cardiovascular surgery, and neurosurgery. This expansion in applications is driven by the need for effective hemostatic solutions to reduce bleeding complications and improve patient outcomes[4].

Financial Trajectory

The financial trajectory of the fibrin sealants market is robust, with significant growth projected over the next decade. Here are some key financial highlights:

• Market Size: Expected to reach USD 2,561.1 million by 2032 from USD 1,306.1 million in 2023[1].
• CAGR: Growing at a CAGR of 8.0% during the forecast period from 2023 to 2032[1].
• Regional Contribution: North America accounts for a dominant market share, while the Asia-Pacific region is expected to experience the fastest growth rate[1][4].

Key Takeaways

• The global fibrin sealants market is driven by the increasing prevalence of chronic diseases, technological advancements, and the growing demand for minimally invasive surgeries.
• Hospitals are the dominant end-users, with North America holding the largest market share.
• The Asia-Pacific region is expected to experience rapid growth due to expanding healthcare infrastructure and a growing patient population.
• Recent FDA approvals and the development of next-generation bioengineered sealants are key trends in the market.

FAQs

What is the primary use of fibrin sealants in surgery?

Fibrin sealants are used to manage bleeding during surgeries by inducing blood clotting at the site of bleeding, thereby preventing unnecessary blood loss and reducing the risk of complications and mortality.

Which region dominates the fibrin sealants market?

North America dominates the fibrin sealants market, accounting for 47% of the global market share in 2022, due to its well-developed healthcare infrastructure and high prevalence of chronic diseases.

What is the expected CAGR of the fibrin sealants market from 2023 to 2032?

The fibrin sealants market is expected to grow at a CAGR of 8.0% from 2023 to 2032.

Which segment is the largest contributor to the fibrin sealants market?

Liquid fibrin sealant patches are the largest contributors to the fibrin sealants market and are predicted to continue growing throughout the forecast period.

What are the key drivers of the fibrin sealants market?

The key drivers include the increasing prevalence of chronic diseases, technological advancements, growing demand for minimally invasive surgeries, and the aging population.

Sources

1. Market.us: Fibrin Sealants Market Share, Size, Trends | CAGR of 8.0%[1]
2. Biospace: Grifols Receives FDA Approval to Treat Surgical Bleeding in Pediatric Patients with Its Fibrin Sealant Solution[2]
3. Transparency Market Research: Fibrin Sealants Market to reach US$ 2 bn by 2031[3]
4. Allied Market Research: Absorbable Fibrin Sealant Patch Market Size, Forecast - 2033[4]