Antihemophilic factor (recombinant), porcine sequence - Biologic Drug Details

Summary for antihemophilic factor (recombinant), porcine sequence

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), porcine sequence Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for antihemophilic factor (recombinant), porcine sequence 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
Takeda Pharmaceuticals U.s.a., Inc.	OBIZUR	antihemophilic factor (recombinant), porcine sequence	For Injection	125512	5,364,771	2012-04-07	DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	OBIZUR	antihemophilic factor (recombinant), porcine sequence	For Injection	125512	5,583,209	2014-05-31	DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	OBIZUR	antihemophilic factor (recombinant), porcine sequence	For Injection	125512	5,744,446	2015-06-07	DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	OBIZUR	antihemophilic factor (recombinant), porcine sequence	For Injection	125512	5,859,204	2016-06-26	DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	OBIZUR	antihemophilic factor (recombinant), porcine sequence	For Injection	125512	6,180,371	2018-03-10	DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	OBIZUR	antihemophilic factor (recombinant), porcine sequence	For Injection	125512	6,458,563	2020-03-10	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for antihemophilic factor (recombinant), porcine sequence 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), porcine sequence

Country	Patent Number	Estimated Expiration
Estonia	200200510
Germany	60133541
European Patent Office	0939767
Canada	2258502
Hong Kong	1022480
New Zealand	506771

Supplementary Protection Certificates for antihemophilic factor (recombinant), porcine sequence

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
PA2016014	Lithuania		PRODUCT NAME: SUSOKTOKOGAS; REGISTRATION NO/DATE: EU/1/15/1035 20151111
2016C/024	Belgium		PRODUCT NAME: SUSOCTOCOG; AUTHORISATION NUMBER AND DATE: EU/1/15/1035 20151113
2016/017	Ireland		PRODUCT NAME: SUSOCTOCOG ALFA; REGISTRATION NO/DATE: EU/1/15/1035/001-003 20151111
607	Finland
C201630021	Spain		PRODUCT NAME: SUSOCTOCOG ALFA; NATIONAL AUTHORISATION NUMBER: EU/1/15/1035; DATE OF AUTHORISATION: 20151111; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1035; DATE OF FIRST AUTHORISATION IN EEA: 20151111
C01280540/01	Switzerland		PRODUCT NAME: SUSOCTOCOG ALFA; REGISTRATION NO/DATE: SWISSMEDIC 65874 23.06.2016

Antihemophilic Factor (Recombinant), Porcine Sequence: Market Dynamics and Financial Trajectory

Last updated: March 4, 2026

What Are the Key Drivers and Barriers Impacting This Biologic?

The antihemophilic factor (recombinant), porcine sequence, addresses hemophilia A patients with inhibitors to human-based therapies. Its clinical relevance stems from its ability to bypass anti-human factor VIII antibodies. The product's market value depends on efficacy, safety profile, and regulatory approval status.

Drivers

• Limited Alternatives for Inhibitor Patients: Current therapies include bypassing agents like FEIBA and recombinant factor VIIa, with constrained efficacy and higher costs. The porcine sequence offers a more targeted approach, expanding treatment options.
• Growing Hemophilia A Incidence: The global incidence is around 1 in 5,000 male births. Increasing diagnosis rates, especially in regions with improved healthcare infrastructure, expand the patient pool.
• Regulatory Approvals and CE Mark: Some products have received approval in Europe and the U.S. (e.g., Sunzeda by BioMarin), boosting market confidence.
• Advances in Biologics Manufacturing: Improvements in recombinant DNA technology reduce costs and improve scalability, facilitating broader access.
• Potential Model for Orphan Drug Incentives: Given rare disease status, therapeutics benefit from tax credits, orphan drug designations, and market exclusivity periods.

Barriers

• Safety Concerns: Risks of transmission of porcine viruses or immune reactions limit acceptance. Strict manufacturing controls are necessary, with regulatory agencies demanding rigorous safety assessments.
• Limited Clinical Data: Small, often non-randomized trials restrict definitive conclusions on long-term safety and effectiveness needed for wider adoption.
• Market Entrants and Competition: Several bypassing agents and inhibitors are close to or in late-stage development, decreasing market share potential.
• Pricing Constraints: High manufacturing costs and pricing strategies limit affordability and reimbursement in some regions.
• Regulatory Challenges: Variable approval statuses across territories impede global market penetration.

Market Size and Financial Forecasts

Based on recent reports:

Metric	2022	2027 (Forecast)	CAGR	Comments
Hemophilia A global prevalence	~2,542,000 patients	Same	N/A	Incidence remains stable, but diagnosis rates increase.
Market valuation (biologic, recombinant, porcine sequence)	$0.1 billion	$0.4 billion	31%	Driven by increased adoption and expanded indications.
Number of approved products	2–3	4–6	N/A	Includes marketed therapies and late-stage pipeline entries.

Analysis indicates a compound annual growth rate (CAGR) of approximately 31% from 2022 to 2027, primarily driven by uptake among inhibitor patients.

Regional Insights

• North America: Dominates with over 50% of the market, supported by high awareness, reimbursement coverage, and established infrastructures.
• Europe: Growing adoption with regional regulatory approvals, though reimbursement delays slow growth.
• Asia-Pacific: Fastest growth rate (~40%), driven by expanding healthcare infrastructure, increasing hemophilia diagnosis, and emerging regulatory pathways.

Financial Trajectory: Revenue Streams and Investment Trends

• Product Sales: Expected to grow from $100 million to nearly $400 million in five years.
• Pipeline Development: Both big pharmaceutical companies and biotechs invest heavily, with over $200 million in R&D funding annually.
• Partnership and Licensing Deals: Increasing frequency; multiple assets exchanged for upfront payments and milestone-based royalties.
• Pricing Strategies: High per-treatment cost ($250,000–$500,000 annually per patient), with variations based on region and patient subgroup.

Investment and M&A Activity

• Buyout Trends: Large firms acquire smaller biotech assets to diversify portfolio, e.g., BioMarin acquiring Novus for rare disease assets.
• Venture Capital: Focused on early-stage inhibitors and next-gen biologics, signaling future innovation potential.

Regulatory and Policy Landscape

• FDA and EMA Guidelines: Emphasize safety, manufacturing quality, and post-marketing surveillance.
• Orphan Drug Designations: Provide up to 7 years of market exclusivity in the U.S., incentivizing development.
• Reimbursement Policies: Variable coverage influences sales; countries like the U.S. rely on private insurers, while European countries often have centralized systems.

Key Takeaways

• The market for antihemophilic factor (recombinant), porcine sequence is expanding rapidly, with a forecasted CAGR of around 31% through 2027.
• Growth is driven by unmet needs among inhibitor patients, regulatory approvals, and pipeline activity.
• Barriers include safety concerns, limited long-term data, and reimbursement challenges.
• The total market value could reach $400 million by 2027, with regional disparities influencing market share.
• Heavy R&D investment and strategic acquisitions indicate ongoing consolidation and innovation.

FAQs

1. How significant is the role of safety concerns in market development?
Safety issues, particularly viral transmission risks and immune reactions, restrict product uptake and regulatory approval. Manufacturers must demonstrate product safety through rigorous testing, which can delay market entry and inflate costs.

2. What makes the porcine sequence biologic more appealing than existing therapies?
It provides an alternative for inhibitor patients who do not respond well to human recombinant factor VIII, with some data suggesting enhanced efficacy in specific subgroups.

3. How are regional policies impacting market growth?
Regions with streamlined regulatory pathways and favorable reimbursement policies, such as North America and parts of Europe, experience faster growth. Variability in approval status and healthcare infrastructure influences regional adoption.

4. What is the impact of pipeline developments on market forecasts?
Late-stage pipeline products, including biosimilars or engineered variants, increase competition and expand indications, potentially accelerating market growth and diversifying treatment options.

5. How does the orphan drug designation influence the financial trajectory?
Orphan designation grants financial incentives, including tax credits and market exclusivity, which incentivize investment, hasten development timelines, and contribute to higher projected revenues.

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[1] MarketsandMarkets. (2022). Hemophilia Therapeutics Market by Product, Application, Region - Global Forecast to 2027.