Antihemophilic factor (human) - Biologic Drug Details

Summary for antihemophilic factor (human)

Tradenames:	3
High Confidence Patents:	0
Applicants:	3
BLAs:	3
Suppliers: see list	2
Recent Clinical Trials:	See clinical trials for antihemophilic factor (human)
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for antihemophilic factor (human)

Recent Clinical Trials for antihemophilic factor (human)

Identify potential brand extensions & biosimilar entrants

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

See all antihemophilic factor (human) clinical trials

Recent Litigation for antihemophilic factor (human)

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 (human) 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 (human) Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Antihemophilic factor (human) Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Antihemophilic Factor (Human)

Introduction

Antihemophilic factor, also known as Factor VIII, is a crucial biologic drug used to treat hemophilia A, a rare genetic disorder characterized by the inability of blood to clot properly. The market for antihemophilic factor is complex and influenced by various factors, including technological advancements, regulatory environments, and economic considerations.

Market Size and Growth

The antihemophilic factor market is poised for significant growth. By 2036, the market is expected to surpass USD 6 billion, growing at a Compound Annual Growth Rate (CAGR) of 7% during the forecast period from 2024 to 2036. In 2023, the market size was approximately USD 3 billion[1].

Growth Drivers

Several factors are driving the growth of the antihemophilic factor market:

Increasing Treatment Costs

The high costs associated with treating hemophilia are a major driver. 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[1].

Technological Advancements

The development of recombinant antihemophilic factors has significantly impacted the market. These products, such as those containing recombinant von Willebrand factor (rVWF) co-expressed with human recombinant FVIII (rFVIII), offer superior efficacy and safety. By 2036, recombinant antihemophilic factors are expected to hold 63% of the global market share[1].

Market Evolution and Consumer Demands

The ability to quickly adapt to market trends and consumer demands is crucial. Manufacturers are focusing on value chain optimization and pricing strategies to enhance productivity and competitiveness, which are key to sustained market growth[1].

Distribution Channels

Retail pharmacies are expected to dominate the distribution channel segment, securing the largest revenue share of about 57% by 2036. This is due to substantial patient engagement and the historical success of products like NovoSeven and FEIBA[1].

Regional Market Analysis

North America

The North American market is anticipated to hold the largest share, approximately 53% by 2036. This dominance is attributed to a robust healthcare system, significant investments in research and development, and the presence of leading pharmaceutical companies. The region's strong regulatory frameworks and supportive policies for biologics also contribute to its leading position[1].

Europe

Europe is expected to be the second largest market, with a share of about 24% by 2036. High treatment-seeking rates, heightened awareness of hemophilia, and well-established treatment protocols drive this growth. The region's sophisticated biotechnology sector and strategic partnerships between domestic and global pharmaceutical firms also play a significant role[1].

Asia-Pacific and Other Regions

The Asia-Pacific region is emerging as a significant market due to rapidly evolving healthcare infrastructure. Countries like China and India are expected to witness significant growth due to improving product availability and increasing per capita health expenditure. Latin America is also expected to see steady growth due to an increasing diagnosis rate, while the Middle East and Africa remain the least lucrative regions due to low product penetration[4].

Financial Implications

Direct and Indirect Costs

The financial burden of hemophilia is substantial. Direct medical costs include factor replacement, inpatient and ER procedures, outpatient care, laboratory tests, and the use of medical devices. Indirect costs, such as lost productivity of patients and their families, further exacerbate the financial impact. For instance, severe hemophilia A patients incur average annual costs of about USD 160,000, significantly higher than the average annual cost of USD 4,200 for a person in a commercial population[2].

Impact on Insurance and Healthcare Systems

The costs associated with hemophilia can be unpredictable and pose significant financial risks to insurance entities and healthcare providers. A single case of severe hemophilia can absorb a substantial portion of a provider organization's annual budgeted surplus, especially for smaller entities. Larger organizations can spread the risk across a larger population but may still experience significant financial variability due to familial clustering of patients[2].

Product Segmentation

Recombinant Antihemophilic Factor

Recombinant antihemophilic factors are expected to dominate the market due to their superior efficacy compared to plasma-derived products. These products come in single-dose vials with stabilizers like human albumin, calcium, and polyethylene glycol, enhancing their safety and efficacy[1].

Plasma-Derived and VWF Complex

While recombinant factors lead the market, plasma-derived and VWF complex products still have a presence. However, their share is expected to be lower due to the advancements and preferences for recombinant technologies[1].

Regulatory and Research Environment

FDA Benefits and R&D Activities

Manufacturers benefit from FDA incentives for designing and manufacturing treatments for rare diseases. These benefits include increased research funding and collaborative efforts, which drive innovation and product development in the antihemophilic factor market[4].

Recent Approvals and Pipeline

Recent approvals, such as Sanofi's ALTUVIIIO for hemophilia A, highlight the ongoing innovation in the field. This approval has driven significant sales growth and improved Sanofi's market share in the hemophilia A market. Ongoing pipeline activities, including phase 2 and phase 3 studies, are expected to further benefit patients and drive market growth[3].

Challenges

High Treatment Costs

The high costs of antihemophilic factor treatments remain a significant challenge. These costs can be prohibitive, especially in middle and low-income countries, limiting access to effective treatments[1][4].

Unpredictable Costs and Risk Management

The unpredictability of treatment costs due to factors like familial clustering, phenotypic variability, and the development of inhibitors poses a challenge for insurers and healthcare providers. Managing these risks is crucial for maintaining financial stability in the healthcare system[2].

Key Takeaways

• The antihemophilic factor market is projected to grow significantly, reaching USD 6 billion by 2036.
• Recombinant antihemophilic factors are expected to dominate the market due to their superior efficacy.
• North America and Europe are the leading regions, driven by robust healthcare systems and high treatment-seeking rates.
• High treatment costs and unpredictable financial risks are major challenges.
• Regulatory incentives and ongoing R&D activities are driving innovation and market growth.

FAQs

What is the projected market size of the antihemophilic factor market by 2036?

The antihemophilic factor market is expected to surpass USD 6 billion by 2036, growing at a CAGR of 7% during the forecast period[1].

Which region is expected to dominate the antihemophilic factor market?

North America is anticipated to hold the largest share, approximately 53% by 2036, due to its robust healthcare system and significant investments in R&D[1].

What are the main drivers of the antihemophilic factor market growth?

Key drivers include high treatment costs, technological advancements in recombinant factors, and the ability to adapt to market trends and consumer demands[1].

How do indirect costs impact the financial burden of hemophilia?

Indirect costs, such as lost productivity of patients and their families, significantly add to the financial burden, making the overall cost of treating hemophilia even more substantial[2].

What role do regulatory incentives play in the antihemophilic factor market?

Regulatory incentives from the FDA for rare disease treatments increase research funding and collaborative efforts, driving innovation and product development in the market[4].

Sources

1. Research Nester: Antihemophilic Factor Market Size & Share, Growth Trends 2036
2. Milliman: An Actuarial Study of Hemophilia
3. Sanofi: Q2: strong performance with 10% sales growth; 2024
4. Persistence Market Research: Antihemophilic Factor Market Size, Share, Forecast 2019-2029