Factor xiii concentrate (human) - Biologic Drug Details

Summary for factor xiii concentrate (human)

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for factor xiii concentrate (human)

Recent Clinical Trials for factor xiii concentrate (human)

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
University of Virginia	Phase 1
University of Colorado, Boulder	Phase 2
National Institute on Drug Abuse (NIDA)	Phase 2

See all factor xiii concentrate (human) clinical trials

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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

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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 factor xiii concentrate (human) Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Factor XIII Concentrate (Human)

Introduction to Factor XIII Deficiency

Factor XIII deficiency is a rare, genetic bleeding disorder characterized by the deficiency of clotting factor XIII, a protein essential for stabilizing blood clots. This condition leads to the formation of unstable blood clots, resulting in prolonged and uncontrolled bleeding episodes[2].

Market Size and Growth

The global Factor XIII deficiency treatment market is projected to experience significant growth. As of 2023, the market is valued at US$ 210.3 million and is expected to expand at a Compound Annual Growth Rate (CAGR) of 5.8% to reach US$ 400.7 million by 2034[1].

Key Drivers of Market Growth

Increased Awareness and Diagnosis

The lack of awareness about factor XIII deficiency among both the general public and healthcare providers has historically led to many cases going undiagnosed. However, educational initiatives by patient advocacy groups and healthcare providers have significantly raised awareness, encouraging more accurate diagnoses. Advanced diagnostic techniques, including genetic testing and sensitive coagulation assays, have also played a crucial role in early and accurate diagnosis, thereby increasing the demand for effective treatments[1].

Advancements in Treatment Options

Continuous improvements in treatment techniques are another essential factor driving the market growth. Recent research and development have focused on enhancing treatment options, moving beyond traditional transgenic products and fibrinogen concentrates. The approval of specific treatments, such as Corifact™ (Factor XIII Concentrate), has been a significant milestone, providing a routine prophylactic treatment option for congenital factor XIII deficiency[5].

Regional Outlook

The factor XIII deficiency treatment market varies significantly across different regions. The Middle East and Africa region has the highest incidence of factor XIII deficiency due to the prevalence of consanguineous marriages, although many cases in these regions remain undiagnosed. North America, particularly the United States, holds a substantial market share, with a projected growth rate of 5.9% from 2024 to 2034. Other lucrative regions include Canada, Brazil, Mexico, and China[1].

Distribution Channels and Patient Types

Distribution Channels

The market is segmented by distribution channels, including hospital pharmacies, retail pharmacies, and blood banks. Hospital pharmacies are a significant channel due to the need for immediate and specialized care for patients with factor XIII deficiency[1].

Patient Types

The market is also segmented by patient type, including congenital and acquired factor XIII deficiency. Congenital factor XIII deficiency is the more common form, accounting for the majority of cases, while acquired deficiency can result from various medical conditions or treatments[1].

Financial Trajectory

Historic Analysis

From 2019 to 2023, the factor XIII deficiency treatment market grew at a CAGR of 4.9%, reaching a value of US$ 210.3 million by the end of 2023. This growth was driven by increasing awareness and advancements in diagnostic and treatment options[1].

Future Projections

The market is anticipated to continue its upward trend, with a projected CAGR of 5.8% from 2024 to 2034. This growth will be fueled by ongoing research and development, increased diagnosis rates, and better patient engagement and adherence to treatment protocols[1].

Key Companies and Market Players

Several pharmaceutical companies are actively involved in the research and development of factor XIII deficiency treatments. Key players include Grifols, CSL Behring, Octapharma, LFB Group, and Novo Nordisk. The FDA approval of Corifact™ by CSL Behring has been a significant development in this market[1][5].

Challenges and Limitations

Despite the growth, the market faces challenges such as the rarity of the disorder, which can lead to under-diagnosis and misdiagnosis. Additionally, the risk of adverse reactions associated with some treatments can limit market growth. For instance, plasma-derived factor XIII concentrates have been associated with adverse drug reactions, although they are generally considered safe over long-term use[4].

Illustrative Statistics

• Market Value (2023): US$ 210.3 million
• Projected Market Value (2034): US$ 400.7 million
• CAGR (2024-2034): 5.8%
• North America Market Share (2024): 35.7%
• Incidence of Factor XIII Deficiency: 1 in 2,000,000 to 5,000,000 people[1][2]

Expert Insights

"FDA approval of Corifact™ marks a significant milestone in the treatment of congenital factor XIII deficiency, providing a routine prophylactic treatment option that can significantly improve the quality of life for patients with this rare and potentially life-threatening bleeding disorder," said a spokesperson from CSL Behring[5].

Key Takeaways

• The factor XIII deficiency treatment market is expected to grow significantly, driven by increased awareness and advancements in diagnostic and treatment options.
• The market is valued at US$ 210.3 million in 2023 and is projected to reach US$ 400.7 million by 2034.
• North America holds a substantial market share, with other key regions including the Middle East, Africa, and parts of Latin America and Asia.
• Key companies such as CSL Behring and Grifols are driving innovation in this market.
• Despite growth, the market faces challenges related to under-diagnosis and adverse reactions.

Frequently Asked Questions (FAQs)

Q: What is factor XIII deficiency? A: Factor XIII deficiency is a rare genetic bleeding disorder characterized by the deficiency of clotting factor XIII, leading to unstable blood clots and prolonged bleeding episodes[2].

Q: What are the symptoms of factor XIII deficiency? A: Symptoms include bleeding from the umbilical stump after birth, spontaneous bleeding into the brain, poor or delayed wound healing, and enhanced bleeding after trauma or surgery[2].

Q: How is factor XIII deficiency diagnosed? A: Diagnosis involves genetic testing and sensitive coagulation assays to detect the deficiency of factor XIII[1].

Q: What are the treatment options for factor XIII deficiency? A: Treatment options include plasma-derived factor XIII concentrates, such as Corifact™, which is approved for routine prophylactic treatment of congenital factor XIII deficiency[5].

Q: What is the projected growth rate of the factor XIII deficiency treatment market? A: The market is expected to grow at a CAGR of 5.8% from 2024 to 2034[1].

Cited Sources

1. Fact.MR: Factor XIII Deficiency Treatment Market Size, Forecast 2034.
2. NORD: Factor XIII Deficiency - Symptoms, Causes, Treatment.
3. Maximize Market Research: Fibrinogen Concentrates Market - Industry Analysis Forecast 2030.
4. Karger: Safety of Factor XIII Concentrate: Analysis of More than 20 Years of Clinical Experience.
5. CSL Behring: CSL Behring Receives FDA Approval of Corifact™ for Treatment of Congenital Factor XIII Deficiency.

Last updated: 2024-12-20