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Last Updated: February 12, 2025

FIBRYGA Drug Profile


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Recent Clinical Trials for FIBRYGA

Identify potential brand extensions & biosimilar entrants

SponsorPhase
IRCCS Policlinico S. DonatoPhase 2
University of VirginiaPhase 4
OctapharmaPhase 4

See all FIBRYGA clinical trials

Recent Litigation for FIBRYGA

Identify key patents and potential future biosimilar entrants

PTAB Litigation
PetitionerDate
2014-11-04

See all FIBRYGA litigation

Pharmacology for FIBRYGA
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 FIBRYGA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for FIBRYGA Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for FIBRYGA Derived from Patent Text Search

These patents were obtained by searching patent claims

Market Dynamics and Financial Trajectory for FIBRYGA: A Comprehensive Overview

Introduction to FIBRYGA

FIBRYGA, a fibrinogen concentrate developed by Octapharma, is a crucial biologic drug used in the treatment of congenital and acquired fibrinogen deficiencies. This drug has been gaining significant traction in the medical field due to its efficacy and the growing demand for advanced therapies in bleeding disorders.

Market Size and Growth Projections

The global fibrinogen concentrate market, which includes products like FIBRYGA, is anticipated to experience robust growth over the coming years. According to recent reports, the market size is projected to reach USD 4.19 billion by 2028, growing at a Compound Annual Growth Rate (CAGR) of 6.1% from 2020[1].

Another forecast indicates that the fibrinogen concentrates market will grow to USD 4.63 billion by 2031, with a CAGR of 5.64% during the forecast period of 2024-2031[3].

Key Drivers of Market Growth

Several factors are driving the growth of the fibrinogen concentrate market, including:

Increasing Preference Over Fresh-Frozen Plasma

There is a growing preference for fibrinogen concentrates over fresh-frozen plasma due to their convenience, stability, and reduced risk of transfusion-related complications. This shift is a significant driver for the market[1].

Rising Incidence of Bleeding Disorders

The increasing incidence of bleeding disorders such as hemophilia and congenital fibrinogen deficiency is another key factor. These conditions require effective and safe treatments, which fibrinogen concentrates like FIBRYGA provide[1][4].

Regulatory Approvals and R&D Investments

Recent regulatory approvals, such as the European approval for FIBRYGA to treat acquired fibrinogen deficiencies, have substantially benefited the market. Additionally, significant investments in research and development (R&D) to advance fibrinogen products are expected to drive market growth[2][4].

Regional Market Dynamics

North America

North America is expected to dominate the fibrinogen concentrate market due to a high incidence of bleeding disorders, an aging population, and advancements in diagnostics and therapeutics. Government initiatives, such as healthcare funding to address surgery backlogs in Canada, further support market expansion in this region[1][4].

Competitive Landscape

The fibrinogen concentrate market is characterized by the presence of several key players, including Octapharma, CSL Behring, LFB Group, and Baxter. These companies are actively working to enhance their market presence through innovative products and strategic investments.

Octapharma, in particular, has been delivering strong financial performance. In 2019, the company reported revenues of €2.2 billion, an increase of 23.2% from 2018, and an operating income of €424 million, up by 22.7% from the previous year. This growth is attributed to significant investments in R&D and the expansion of plasma collection and production capacities[2].

Financial Performance of Octapharma

Octapharma's financial trajectory has been impressive, reflecting the company's commitment to innovation and patient care. Here are some key financial highlights:

  • Revenue Growth: Octapharma reported sales of €2.854 billion in 2022, representing a 13.7% growth over 2021[5].
  • Operating Income: The operating income increased to €522 million in 2022, a 13.7% increase from the previous year[5].
  • Investments in R&D: The company continues to invest significantly in R&D to fund the discovery and development of new life-changing treatments. This includes expanding plasma collection capacities to ensure future supplies of life-saving products[2].

Regulatory Milestones

FIBRYGA has received several regulatory approvals that have been pivotal in its market success. For instance, the European Medicines Agency (EMA) approved FIBRYGA for the treatment of acquired fibrinogen deficiencies, extending its earlier approval for congenital fibrinogen deficiency[2].

Impact on Patient Care

FIBRYGA has made a substantial impact on patient care by providing a safe and effective treatment for bleeding disorders. Here is a highlight from Octapharma's annual report:

"Last year our products touched hundreds of thousands of patients globally," said Roger Mächler, Chief Financial Officer of the Octapharma Group. "Our significant investments in research and infrastructure strongly position Octapharma to fulfil the unmet needs of more healthcare professionals and patients around the world in the coming years"[2].

Challenges and Opportunities

Despite the promising outlook, the market faces challenges such as stringent regulatory frameworks and the impact of global events like the COVID-19 pandemic, which disrupted blood donation activities and affected demand. However, as facilities reopen and surgical procedures resume, the market is expected to recover and expand[4].

Key Takeaways

  • The fibrinogen concentrate market, including FIBRYGA, is expected to grow significantly, driven by increasing demand for treatments of bleeding disorders and advancements in R&D.
  • North America is anticipated to dominate the market due to high incidence rates and government initiatives.
  • Octapharma's strong financial performance and continuous investments in R&D position the company for continued growth.
  • Regulatory approvals and the safety and efficacy of fibrinogen concentrates are key drivers of market expansion.

FAQs

What is FIBRYGA used for?

FIBRYGA is used for the treatment of congenital and acquired fibrinogen deficiencies, providing a safe and effective alternative to fresh-frozen plasma.

Who are the key players in the fibrinogen concentrate market?

Key players include Octapharma, CSL Behring, LFB Group, and Baxter, among others.

What are the main drivers of the fibrinogen concentrate market growth?

The main drivers include the increasing preference for fibrinogen concentrates over fresh-frozen plasma, rising incidence of bleeding disorders, and significant investments in R&D.

How has the COVID-19 pandemic affected the fibrinogen concentrate market?

The pandemic disrupted blood donation activities and affected demand, but the market is expected to recover as facilities reopen and surgical procedures resume.

What is the projected market size for fibrinogen concentrates by 2028?

The global fibrinogen concentrate market is expected to reach USD 4.19 billion by 2028, growing at a CAGR of 6.1% from 2020[1].

Sources

  1. Reports and Data: Fibrinogen Concentrate Market Size to Reach USD 4.19 Billion in 2028[1].
  2. Business Wire: Octapharma Group Delivered Strong Growth in Both Sales and Operating Income In 2019[2].
  3. Verified Market Research: Fibrinogen Concentrates Market Size & Forecast[3].
  4. Mordor Intelligence: Global Fibrinogen Concentrate Market Size[4].
  5. Octapharma: Annual Report 2022[5].

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