Antihemophilic factor (recombinant) - Biologic Drug Details

Summary for antihemophilic factor (recombinant)

Tradenames:	5
High Confidence Patents:	0
Applicants:	7
BLAs:	15
Suppliers: see list	8
Recent Clinical Trials:	See clinical trials for antihemophilic factor (recombinant)
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for antihemophilic factor (recombinant)

Recent Clinical Trials for antihemophilic factor (recombinant)

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Baxalta Innovations GmbH, now part of Shire	Phase 4
Baxalta US Inc.	Phase 4
Baxalta now part of Shire	Phase 4

See all antihemophilic factor (recombinant) clinical trials

Recent Litigation for antihemophilic factor (recombinant)

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC	2021-11-10
Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC	2021-05-12
Par Pharmaceutical, Inc. v. Eagle Pharmaceuticals, Inc.	2018-05-31

See all antihemophilic factor (recombinant) litigation

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 antihemophilic factor (recombinant) Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for antihemophilic factor (recombinant) Derived from Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Novo Nordisk Inc.	NOVOEIGHT	antihemophilic factor (recombinant)	For Injection	125466		2017-06-20	Company disclosures
Novo Nordisk Inc.	NOVOEIGHT	antihemophilic factor (recombinant)	For Injection	125466			Company disclosures
Novo Nordisk Inc.	NOVOEIGHT	antihemophilic factor (recombinant)	For Injection	125466			Company disclosures

3) Low Certainty: US Patents for antihemophilic factor (recombinant) 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
Bayer Healthcare Llc	HELIXATE FS, KOGENATE, KOGENATE FS	antihemophilic factor (recombinant)	For Injection	103332		2039-02-26	Patent claims search
Bayer Healthcare Llc	HELIXATE FS, KOGENATE, KOGENATE FS	antihemophilic factor (recombinant)	For Injection	103332		2039-02-26	Patent claims search
Bayer Healthcare Llc	HELIXATE FS, KOGENATE, KOGENATE FS	antihemophilic factor (recombinant)	For Injection	103332		2039-02-26	Patent claims search

Antihemophilic factor (recombinant) Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Recombinant Antihemophilic Factor

Introduction

Recombinant antihemophilic factors are biologic drugs used to treat hemophilia, a rare genetic disorder characterized by the inability of blood to clot properly. The market for these drugs is complex and influenced by various factors, including technological advancements, regulatory environments, and economic considerations.

Market Size and Growth

The global antihemophilic factor market is poised for significant growth. By 2036, the market is expected to surpass USD 6 billion, growing at a CAGR of 7% from 2024 to 2036. In 2023, the market size was approximately USD 3 billion[4].

Product Types

The market is dominated by recombinant antihemophilic factors due to their superior efficacy compared to plasma-derived alternatives. Recombinant factor VIII, in particular, holds the largest share of the global market, driven by the increasing number of hemophilia A patients and the rising adoption of prophylactic treatments[3][4].

Distribution Channels

Retail pharmacies are expected to secure the largest revenue share, approximately 57% by 2036, due to high patient footfall and engagement. Hospital pharmacies and online pharmacies also play significant roles, but retail pharmacies remain the dominant channel[4].

Regional Analysis

North America

North America is anticipated to hold the largest share of the antihemophilic factor market, around 53% by 2036. This dominance is attributed to a robust healthcare system, substantial investments in R&D, and the presence of leading pharmaceutical companies. The region's strong regulatory frameworks and supportive policies for biologics and advanced drug therapies also contribute to its leading position[4].

Europe

Europe is expected to be the second most lucrative region, with a market share of about 24% by 2036. High treatment-seeking rates, heightened awareness of hemophilia, and well-established treatment protocols drive the market growth in this region. The sophisticated biotechnology sector and strategic partnerships between pharmaceutical firms further bolster the market[4].

Asia-Pacific

The Asia-Pacific region is emerging as a significant market due to rapidly evolving healthcare infrastructure, increasing medical tourism, and growing awareness about hemophilia treatment. Countries like China and India are expected to witness significant growth driven by improving product availability and per capita health expenditure[1][3].

Latin America and Middle East & Africa

Latin America is expected to witness steady growth due to increasing diagnosis rates, while the Middle East & Africa region remains the least lucrative due to low product penetration[1].

Financial Impact and Costs

Treatment Costs

The treatment costs for hemophilia are exceptionally high. For example, the lifetime treatment costs for severe hemophilia B can reach up to USD 21 million for on-demand treatment and USD 23 million for preventive treatment. Annual treatment costs range between USD 150,000 and USD 300,000, excluding indirect costs like lost productivity[4][5].

Product Pricing

The prices of antihemophilic factors are steep. For instance, the average retail price per prescription of Advate, a third-generation recombinant antihemophilic factor, is $20,630. Extended half-life products, although requiring fewer doses, often have higher unit prices, which can double or triple the costs compared to standard half-life products[5].

Hospital Finances

An analysis on the financial impact of using recombinant porcine FVIII (rpFVIII) versus recombinant FVIIa (rFVIIa) in hospitals found that while rpFVIII has a higher per-unit cost, it may have no significant impact on hospital finances due to similar reimbursement margins for both treatments[2].

Drivers of Market Growth

Increasing Incidence of Hemophilia

The rising incidence of hemophilia and other bleeding diseases drives the demand for antihemophilic factors. This increase is coupled with a growing awareness and adoption of prophylactic treatments worldwide[3][4].

R&D and Product Approvals

Significant investments in R&D and the increasing number of product approvals for new recombinant coagulation factors are key drivers. Manufacturers are focusing on breakthrough therapies and targeted genetic mutation treatments, which enhance the market's growth prospects[1][3].

Regulatory Benefits

Benefits provided by regulatory bodies, such as the FDA, for designing and manufacturing treatments for rare diseases further boost R&D activities and research funding, driving market growth[1].

Challenges

High Treatment Costs

The high cost of hemophilia care is a significant restraint. Despite the efficacy of recombinant antihemophilic factors, the cost can be prohibitive, especially in developing countries with poor economic conditions and unfavorable healthcare systems[3][4].

Alternative Factors

The availability of plasma-derived coagulation factors and other alternative treatments at lower costs hampers the growth of the recombinant coagulation factors market[3].

Limited Disease Awareness

Limited awareness about hemophilia and its treatments, particularly in developing countries, is another challenge. This lack of awareness reduces the demand for recombinant coagulation factors in these regions[3].

Technological Advancements

Extended Half-Life Products

The development of extended half-life antihemophilic factors has significantly impacted the market. These products, although more expensive, reduce the frequency of infusions, which can offset some long-term costs associated with the disease[5].

Gene Therapies

Emerging gene therapies for hemophilia A and B are poised to enter the market, offering potential curative solutions. However, these therapies are expected to be highly expensive, which may not immediately reduce the overall treatment costs[5].

Market Forces and Trends

Prophylactic Treatment

The shift towards prophylactic treatment has increased short-term costs but is likely to offset long-term costs such as treating bleeds, replacing joints, or addressing lost income due to work absenteeism. This trend is driven by studies showing reduced joint damage and improved outcomes with regular infusions of recombinant FVIII[5].

Regulatory and Economic Considerations

Regulatory frameworks and economic policies play a crucial role in the market. For instance, the cost of severe hemophilia in European countries is significant, influencing drug development and healthcare policy decisions. In the U.S., the rapid growth of the Medicare population and improved profitability of managed Medicaid also impact market dynamics[4][5].

Key Takeaways

• The global antihemophilic factor market is expected to grow significantly, driven by increasing product penetration and R&D investments.
• Recombinant antihemophilic factors dominate the market due to their superior efficacy.
• North America and Europe are the leading regions, with Asia-Pacific emerging as a significant market.
• High treatment costs and limited disease awareness are major challenges.
• Technological advancements, including extended half-life products and gene therapies, are shaping the market.

FAQs

Q: What is the projected market size of the antihemophilic factor market by 2036? A: The antihemophilic factor market is expected to surpass USD 6 billion by 2036[4].

Q: Which region dominates the antihemophilic factor market? A: North America is anticipated to hold the largest share of the antihemophilic factor market by 2036[4].

Q: What are the main drivers of the antihemophilic factor market growth? A: The main drivers include the increasing incidence of hemophilia, R&D investments, and regulatory benefits for rare disease treatments[1][3][4].

Q: What are the challenges facing the recombinant coagulation factors market? A: High treatment costs, availability of alternative factors, and limited disease awareness are significant challenges[3][4].

Q: How do extended half-life products impact the market? A: Extended half-life products reduce the frequency of infusions but often come with higher unit prices, which can maintain or even increase overall treatment costs[5].

Sources

1. Persistence Market Research - Antihemophilic Factor Market Size, Share, Forecast 2019-2029
2. PubMed - Evaluating the financial impact of utilizing recombinant porcine FVIII or rFVIIa during a hospital admission for acquired hemophilia A
3. SkyQuestT - Recombinant Coagulation Factors Market Size, Share, Growth
4. Research Nester - Antihemophilic Factor Market Size & Share, Growth Trends 2036
5. ASH Clinical News - The High Price of Hemophilia