Antihemophilic factor (recombinant), single chain - Biologic Drug Details

Summary for antihemophilic factor (recombinant), single chain

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1

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. DrugPatentWatch analysis and 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), single chain Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for antihemophilic factor (recombinant), single chain Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Csl Behring Lengnau Ag	AFSTYLA	antihemophilic factor (recombinant), single chain	For Injection	125591	10,174,116	2034-05-14	DrugPatentWatch analysis and company disclosures
Csl Behring Lengnau Ag	AFSTYLA	antihemophilic factor (recombinant), single chain	For Injection	125591	10,323,080		DrugPatentWatch analysis and company disclosures
Csl Behring Lengnau Ag	AFSTYLA	antihemophilic factor (recombinant), single chain	For Injection	125591	10,472,403	2035-12-23	DrugPatentWatch analysis and company disclosures
Csl Behring Lengnau Ag	AFSTYLA	antihemophilic factor (recombinant), single chain	For Injection	125591	10,537,616	2038-02-20	DrugPatentWatch analysis and company disclosures
Csl Behring Lengnau Ag	AFSTYLA	antihemophilic factor (recombinant), single chain	For Injection	125591	10,562,946	2035-06-19	DrugPatentWatch analysis and company disclosures
Csl Behring Lengnau Ag	AFSTYLA	antihemophilic factor (recombinant), single chain	For Injection	125591	10,836,814	2037-12-19	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for antihemophilic factor (recombinant), single chain 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

International Patents for antihemophilic factor (recombinant), single chain

Country	Patent Number	Estimated Expiration
Brazil	PI0815975
Russian Federation	2015146664
Germany	202008017456
World Intellectual Property Organization (WIPO)	2009129226
Mexico	368228
European Patent Office	3157945

Supplementary Protection Certificates for antihemophilic factor (recombinant), single chain

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
646	Finland
PA2018504	Lithuania		PRODUCT NAME: REKOMBINANTINIS, VIENGUBOS GRANDINES KOAGULIACIJOS FAKTORIUS VIII, KONKRECIAI LONOKTOKOGAS ALFA; REGISTRATION NO/DATE: EU/1/16/1158/001-007 20170104
PA2018504,C2126106	Lithuania		PRODUCT NAME: LONOKTOKOGAS ALFA; REGISTRATION NO/DATE: EU/1/16/1158/001-007 20170104
C20180005 00260	Estonia		PRODUCT NAME: ALFALONOKTOKOG;REG NO/DATE: EU/1/16/1158 06.01.2017

Market Dynamics and Financial Trajectory for Antihemophilic Factor (Recombinant), Single Chain

Last updated: September 19, 2025

---

Introduction

The antihemophilic factor (recombinant), single chain, designated for the treatment of Hemophilia A, is a crucial biopharmaceutical advancing through global markets driven by scientific innovation, regulatory support, and unmet clinical needs. As a recombinant protein therapy, it addresses the limitations of plasma-derived products, including safety concerns and supply variability, fostering significant market growth prospects.

---

Technological and Clinical Features

Antihemophilic factor (recombinant), single chain represents a structurally optimized form of clotting factor VIII, engineered for enhanced stability and activity. Its single-chain design permits rapid and sustained clotting activity, reducing infusion frequency and improving patient compliance. It is produced via recombinant DNA technology in mammalian cell lines, ensuring high purity and reduced immunogenicity compared to plasma-derived counterparts.

Clinical trials have demonstrated comparable or superior efficacy and safety profiles relative to traditional factor VIII concentrates. This innovation addresses vital unmet needs for prophylactic therapy, especially among pediatric and pediatric-onset patients, and reduces bleeding episodes, thereby improving quality of life.

---

Market Drivers

1. Growing Global Hemophilia Population

The prevalence of Hemophilia A is approximately 1 in 5,000 male births globally, translating into an estimated 400,000 affected individuals. Increasing awareness and improved diagnostic techniques contribute to rising diagnoses. Developing regions, such as Asia-Pacific, exhibit significant growth potential due to expanding healthcare infrastructure and increased access.

2. Advancements in Recombinant Technology

The single-chain form offers improved pharmacokinetics with longer half-life and reduced immunogenicity. Such technological advances stimulate adoption, especially for prophylactic regimens. The FDA and EMA approval of similar products validate regulatory pathways, encouraging further development.

3. Rising Adoption of Prophylactic Therapy

Prophylaxis prevents spontaneous bleeding and joint damage, making recombinant single-chain products a preferred choice among clinicians. The shift from episodic to prophylactic treatment expands the market.

4. Competitive Pipeline and Product Approvals

Several pharmaceutical companies, including Bioverativ (a Sanofi subsidiary), Pfizer, and Novocure, are developing or have launched innovative recombinant factor VIII products, intensifying the competitive landscape while simultaneously expanding market adoption.

5. Supportive Regulatory Environment and Reimbursement

Clearance from regulatory agencies for recombinant therapies, combined with reimbursement policies in high-income economies, facilitates market penetration. Government initiatives and orphan drug designations further incentivize innovation.

---

Market Challenges

1. High Cost of Therapy

Recombinant biologics are expensive, often priced at several hundred thousand dollars annually per patient, which constrains access in lower-income settings. Cost-effectiveness debates and reimbursement limitations impact market expansion.

2. Development of Biosimilars

The entry of biosimilars, designed to offer cost-effective alternatives, poses competitive pressure. Regulatory approval processes for biosimilars have become more streamlined, especially in Europe, reducing barrier to market entry.

3. Immune Response and Inhibitor Development

A significant concern remains the development of neutralizing antibodies (inhibitors), which can render therapy ineffective. Innovations in product design aim to reduce immunogenicity, influencing market dynamics.

4. Market Penetration in Emerging Economies

Limited healthcare infrastructure and affordability issues slow adoption in developing regions, despite increasing disease prevalence.

---

Financial Trajectory Forecast

Market Size and Growth Projections

The global Hemophilia A treatment market was valued at approximately USD 10 billion in 2021, with recombinant factor VIII comprising a significant share. The segment dedicated to recombinant, single-chain formulations is anticipated to grow at a compound annual growth rate (CAGR) of approximately 7-9% over the next five years (2023–2028), driven by technological advancements and expanding diagnostic rates.

Key Revenue Drivers

• Increased usage of prophylactic regimens
• Expanding geographic footprint, especially in Asia-Pacific and Latin America
• Introduction of next-generation long-acting products which reduce infusion frequency, improve adherence, and thus boost sales**
• Biosimilar competition, prompting premium product innovation

Revenue Segmentation

North America and Europe currently represent over 70% of sales, reflecting mature markets with high adoption rates. However, Asia-Pacific is projected to grow fastest, with a CAGR exceeding 10% due to rising awareness, improved healthcare access, and local manufacturing initiatives.

Pricing and Reimbursement Trends

Pricing pressures from biosimilars and healthcare austerity measures may moderate growth, but technological benefits and novel delivery options can sustain premium pricing strategies. Personalized dosing and patient-specific treatment plans contribute to revenue maximization.

Investment in R&D and Pipeline

Major players are investing heavily ($200–$300 million annually) to develop next-gen formulations, including improved half-life products and gene therapies, which could disrupt traditional revenue streams. Such innovations could extend patent protection and create new market segments.

---

Regulatory and Market Entry Outlook

Regulatory pathways for recombinant products are well-established, with several approvals across US, EU, and Japan. The upcoming pipeline includes gene therapy options aiming for potential cure, which may initially serve as adjuncts rather than replacements, but ultimately could redefine the therapeutic landscape.

Market entry strategies emphasize collaborations with local health authorities, educational outreach, and establishing manufacturing facilities in emerging markets for cost control.

---

Conclusion

The antihemophilic factor (recombinant), single chain, stands at a pivotal juncture, with technological advancements fueling robust market growth amidst challenges related to cost and biosimilar competition. Its trajectory is bolstered by ongoing innovations, expanding treatment indications, and evolving healthcare policies favoring prophylactic regimens. Stakeholders in this space should prioritize pipeline development, strategic geographic expansion, and cost management to optimize growth and profitability.

---

Key Takeaways

• The recombinant, single-chain antihemophilic factor addresses critical needs in Hemophilia A management—improved stability, reduced immunogenicity, and enhanced patient adherence.
• Market growth is driven by increasing diagnosis rates, technological advancements, and favorable regulatory environments, with Asia-Pacific projecting the highest CAGR.
• Cost and biosimilar competition remain significant hurdles; innovative pricing models and product differentiation are essential for sustained profitability.
• Investment in next-generation long-acting products and gene therapies will shape long-term financial trajectories, potentially shifting market share.
• Emerging markets represent substantial growth opportunities, provided manufacturers adapt to local healthcare infrastructure and affordability constraints.

---

FAQs

1. What differentiates recombinant, single-chain antihemophilic factor from traditional products?
It features an engineered single-chain structure providing enhanced stability and longer half-life, enabling less frequent dosing and improved efficacy compared to traditional factor VIII products.

2. How does biosimilar competition influence the market for recombinant antihemophilic factors?
Biosimilars offer cost-effective alternatives, pressuring innovator companies to justify premium pricing through product differentiation and technological superiority, while expanding overall market access.

3. What role do regulatory agencies play in shaping the market trajectory?
Regulatory bodies like the FDA and EMA facilitate product approvals, streamline pathways for biosimilars, and support orphan drug designations, thus accelerating market entry and expansion.

4. How might upcoming gene therapies impact the financial outlook of recombinant products?
Gene therapies offer potential cures, which could reduce reliance on recombinant factor VIII, possibly leading to market contraction for current therapies but opening new opportunities for combination treatments and long-term disease management.

5. What strategies can companies adopt to expand in emerging markets?
Local manufacturing, tiered pricing, collaborations with healthcare authorities, patient education programs, and tailored reimbursement schemes are key strategies to penetrate high-growth emerging economies.

---

Sources:

1. National Hemophilia Foundation. Hemophilia Overview. 2022.
2. Market Research Future. Hemophilia Treatment Market Forecast. 2023.
3. FDA. Guidance for Industry: Biosimilar Biological Products. 2018.
4. IQVIA. Hemophilia Market Analysis. 2022.
5. World Federation of Hemophilia. Global Statistics. 2022.