RIASTAP Drug Profile

Summary for Tradename: RIASTAP

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for RIASTAP
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RIASTAP

Recent Clinical Trials for RIASTAP

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
IRCCS Policlinico S. Donato	Phase 2
Australasian College for Emergency Medicine	Phase 3
Australian and New Zealand Intensive Care Research Centre	Phase 3

See all RIASTAP clinical trials

Recent Litigation for RIASTAP

Identify key patents and potential future biosimilar entrants

PTAB Litigation

Petitioner	Date
	2014-11-04

See all RIASTAP litigation

Pharmacology for RIASTAP

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 RIASTAP Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Csl Behring Gmbh	RIASTAP	fibrinogen concentrate (human)	For Injection	125317	10,046,081	2028-04-11	Patent claims search
Csl Behring Gmbh	RIASTAP	fibrinogen concentrate (human)	For Injection	125317	10,208,101	2033-12-27	Patent claims search
Csl Behring Gmbh	RIASTAP	fibrinogen concentrate (human)	For Injection	125317	10,323,078	2035-03-20	Patent claims search
Csl Behring Gmbh	RIASTAP	fibrinogen concentrate (human)	For Injection	125317	11,071,786	2039-11-05	Patent claims search
Csl Behring Gmbh	RIASTAP	fibrinogen concentrate (human)	For Injection	125317	3,933,996	1993-01-20	Patent claims search
Csl Behring Gmbh	RIASTAP	fibrinogen concentrate (human)	For Injection	125317	4,057,617	1995-05-15	Patent claims search

RIASTAP Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Biologic Drug: RIASTAP

Introduction

RIASTAP, a human fibrinogen concentrate, is a critical biologic drug used in the management of acute bleeding episodes and fibrinogen deficiency disorders. Understanding its market dynamics and financial trajectory is essential for stakeholders, including investors, healthcare providers, and patients.

Market Size and Growth

The global human fibrinogen concentrate market, which includes RIASTAP, was valued at $0.8 billion in 2023 and is projected to reach $2.9 billion by 2035, growing at a Compound Annual Growth Rate (CAGR) of 11% from 2024 to 2035[3].

Key Drivers of Growth

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

• Increasing Incidence of Chronic Diseases: The rise in elderly populations and the increasing incidence of diseases such as heart attacks, strokes, and tumors lead to more surgeries, which in turn increase the demand for fibrinogen concentrates[3].
• Sports Injuries and Accidents: The high number of sports injuries and road accidents also contributes to the growing demand for human fibrinogen products[3].
• Novel Product Introductions: The introduction of novel human fibrinogen products with advanced features, such as rapid reconstitution and swift restoration of fibrinogen levels, further propels market growth. For instance, RIASTAP and Octapharma's Fibryga are notable examples[3].

Regional Market Dynamics

North America

North America dominated the human fibrinogen concentrate market in 2023, driven by the rise in chronic heart disease cases, robust healthcare infrastructure, and increased healthcare expenditure. This region is expected to continue its significant growth due to factors such as increased organ cancer surgeries and a strong presence of key industry players[3].

Asia-Pacific

The Asia-Pacific region is anticipated to grow with a faster CAGR during the forecast period. This growth is attributed to the rapid expansion of the pharmaceutical and biologics industry, increased medical tourism, and a rising geriatric population. These factors lead to an increase in surgeries, thereby driving the demand for human fibrinogen concentrates[3].

Competitive Landscape

The market for human fibrinogen concentrates is competitive, with several key players:

• Grifols, S.A.
• CSL Limited
• The LFB group
• Intas Pharmaceuticals Limited
• Octapharma AG
• Biotest

These companies are actively involved in product development and launch strategies. For example, Biotest’s positive results from its phase 3 clinical trial of BT524, a fibrinogen concentrate, highlight the ongoing innovation in this market[3].

Economic Evaluation and Cost-Effectiveness

Economic evaluations have shown that human fibrinogen concentrates like RIASTAP can be cost-effective in certain clinical settings. A study by the Canadian Agency for Drugs and Technologies in Health (CADTH) found that RIASTAP had a high probability of being cost-effective in cardiac surgery, with a willingness to pay threshold of $100,000 per Quality-Adjusted Life Year (QALY)[1].

Approved Products and Market Share

RIASTAP is one of the key approved products in the congenital fibrinogen deficiency (CFD) market, along with Fibryga, FibCLOT, and Fibrinogen HT. In the 2021 base year, RIASTAP owned the largest market share in the CFD market[5].

Financial Performance and Projections

The financial performance of RIASTAP is closely tied to the overall growth of the human fibrinogen concentrate market. With a projected market size of $2.9 billion by 2035, companies like CSL Limited, which are involved in the development and distribution of such products, are expected to see significant financial growth. CSL Limited, for instance, emphasizes its commitment to sustainable financial growth, which fuels further innovation and research in biologic therapies[4].

Recent Developments

Recent developments in the human fibrinogen concentrate industry include the approval of new products and advancements in clinical trials. For example, Octapharma’s Fibryga received Health Canada approval in 2020 for treating acquired fibrinogen deficiency in surgical settings. Such approvals and the positive outcomes of clinical trials, like Biotest’s AdFIrst trial, are crucial for the market's continued growth[3].

Market Access and Distribution

Human fibrinogen concentrates like RIASTAP reach the market through multiple channels, including retail, mail, commercial hospitals, and Medicare. The distribution landscape is complex, with different payment characteristics across various channels. In the US, for instance, Medicare accounts for 35% of the biotech market, while commercial payers account for 42%[2].

Conclusion

The market dynamics and financial trajectory of RIASTAP are driven by a combination of increasing demand for fibrinogen concentrates, innovative product developments, and a strong competitive landscape. As the global human fibrinogen concentrate market continues to grow, RIASTAP is poised to remain a significant player, contributing to the financial growth of its manufacturers and distributors.

Key Takeaways

• The global human fibrinogen concentrate market is projected to reach $2.9 billion by 2035.
• RIASTAP is a key approved product in the CFD market with a significant market share.
• North America and Asia-Pacific are key regions driving market growth.
• The market is driven by increasing chronic diseases, sports injuries, and novel product introductions.
• Economic evaluations show RIASTAP can be cost-effective in certain clinical settings.

FAQs

1. What is the projected market size of the human fibrinogen concentrate market by 2035? The global human fibrinogen concentrate market is projected to reach $2.9 billion by 2035[3].

2. What are the key drivers of growth for the human fibrinogen concentrate market? The key drivers include the rise in elderly populations, increasing incidence of chronic diseases, sports injuries, road accidents, and the introduction of novel products[3].

3. Which regions are expected to drive the growth of the human fibrinogen concentrate market? North America and Asia-Pacific are expected to drive the growth, with North America currently dominating the market and Asia-Pacific expected to grow at a faster CAGR[3].

4. Who are the leading players in the human fibrinogen concentrate market? Leading players include Grifols, S.A., CSL Limited, The LFB group, Intas Pharmaceuticals Limited, Octapharma AG, and Biotest[3].

5. What is the cost-effectiveness of RIASTAP in clinical settings? RIASTAP has been shown to be cost-effective in certain clinical settings, such as cardiac surgery, with a high probability of being more cost-effective than other treatments at a willingness to pay threshold of $100,000 per QALY[1].