Anthrax vaccine adsorbed, adjuvanted - Biologic Drug Details

Summary for anthrax vaccine adsorbed, adjuvanted

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

Pharmacology for anthrax vaccine adsorbed, adjuvanted

Ingredient-type	Anthrax Vaccines Vaccines, Attenuated
Physiological Effect	Actively Acquired Immunity
Established Pharmacologic Class	Live Attenuated Bacillus Anthracis Vaccine

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 anthrax vaccine adsorbed, adjuvanted Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for anthrax vaccine adsorbed, adjuvanted 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
Emergent Product Development Gaithersburg, Inc.	CYFENDUS	anthrax vaccine adsorbed, adjuvanted	Injection	125761	10,357,559	2034-12-23	DrugPatentWatch analysis and company disclosures
Emergent Product Development Gaithersburg, Inc.	CYFENDUS	anthrax vaccine adsorbed, adjuvanted	Injection	125761	10,456,463	2031-05-27	DrugPatentWatch analysis and company disclosures
Emergent Product Development Gaithersburg, Inc.	CYFENDUS	anthrax vaccine adsorbed, adjuvanted	Injection	125761	6,207,646	2016-10-30	DrugPatentWatch analysis and company disclosures
Emergent Product Development Gaithersburg, Inc.	CYFENDUS	anthrax vaccine adsorbed, adjuvanted	Injection	125761	6,406,705	2019-06-03	DrugPatentWatch analysis and company disclosures
Emergent Product Development Gaithersburg, Inc.	CYFENDUS	anthrax vaccine adsorbed, adjuvanted	Injection	125761	8,552,165	2029-12-08	DrugPatentWatch analysis and company disclosures
Emergent Product Development Gaithersburg, Inc.	CYFENDUS	anthrax vaccine adsorbed, adjuvanted	Injection	125761	8,778,359	2029-07-30	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for anthrax vaccine adsorbed, adjuvanted 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 anthrax vaccine adsorbed, adjuvanted

Country	Patent Number	Estimated Expiration
Brazil	112012030337
European Patent Office	2759306
Australia	2016203611
Argentina	074501
Canada	2800158
Mexico	2011006088
European Patent Office	2320945

Market Dynamics and Financial Trajectory for Anthrax Vaccine Adsorbed, Adjuvanted

Last updated: August 20, 2025

Introduction

The anthrax vaccine adsorbed, adjuvanted (AV-A) represents a critical component in biodefense strategies and military healthcare. Its unique formulation enhances immunogenicity, resulting in increased protection against Bacillus anthracis. This article evaluates the evolving market landscape, regulatory and societal influences, R&D advancements, and financial prospects shaping the trajectory of AV-A globally.

Market Overview

Biodefense Sector Dominance
The market for anthrax vaccines predominantly revolves around government and military procurement, with the U.S. Department of Health and Human Services (HHS) and Department of Defense (DoD) serving as primary clients. Despite a niche commercial profile, the global biodefense market—projected at approximately $10 billion by 2027—drives steady demand for anthrax prophylactics [1].

Product Differentiation: Adjuvanted Formulation
AV-A's adjuvant component boosts immune response, enabling shorter dosage regimens and improved field efficacy. This enhancement bolsters its appeal amidst concerns over vaccine efficacy and safety, further strengthening market positioning.

Current Market Leaders and Pipeline
Pharmaceutical companies like Emergent BioSolutions (BioThrax), and additional contenders investing in novel formulations, dominate the landscape. Notably, novel adjuvants and delivery technologies are in advanced preclinical and clinical stages, promising future competition and innovation.

Regulatory and Policy Influences

FDA Approval and Regulatory Pathways
AV-A's approval relies on rigorous safety and efficacy assessments by authorities such as the FDA. The FDA’s Emergency Use Authorization (EUA) framework can expedite deployment during biothreat crises, influencing market demand cycles [2].

Strategic National Stockpiles
Government policies prioritize stockpiling anthrax vaccines as part of national biodefense initiatives, offering a stable revenue base. The U.S. Strategic National Stockpile (SNS) allocates billions toward maintaining and replenishing vaccine supplies, which continues to support market stability despite low commercial sales.

International Regulations and Procurement
Global health security strategies, including WHO recommendations and collaborations with defense programs in Europe, Asia, and the Middle East, diversify supply chains and expand market reach. Challenges include regulatory harmonization and procurement policies transitioning towards commercialization in some regions.

Market Drivers

• Biodefense Funding & Preparedness: Rising government investments in biodefense preparedness sustain demand. The U.S. government committed over $1.5 billion to biodefense research in 2022 alone [3].
• Emerging Biothreats: Advances in synthetic biology raise concerns about biological weapon proliferation, heightening the need for potent vaccines like AV-A.
• Adjuvant Innovation: Novel adjuvants extending vaccine shelf-life, reducing doses, and improving immune responses increase the attractiveness of AV-A formulations.
• Pandemic Lessons: The COVID-19 pandemic demonstrated the importance of rapid vaccine deployment, influencing biodefense preparedness policies and increasing strategic stockpile investments.

Market Challenges

• Limited Commercial Demand: Apart from biodefense applications, commercial markets for anthrax vaccines are minimal, constraining revenue streams.
• Safety and Public Perception: Adverse reactions, as with earlier anthrax vaccines, can hamper uptake. Enhanced safety profiles from adjuvanted formulations mitigate this but require continuous monitoring.
• Manufacturing Complexities: Ensuring scalability and quality control for adjuvant components increases production costs, impacting margins.

Financial Trajectory and Investment Outlook

Historical Revenue and Investment Trends
The AV-A sector has historically seen modest revenues, primarily from government contracts. However, recent investments in adjuvant technologies and expanded clinical trials signal a positive growth trajectory. For example, Emergent BioSolutions invested over $50 million in R&D for next-generation anthrax vaccines between 2020-2022 [4].

Future Revenue Potential
Based on current contract pipelines, global biodefense budgets, and upcoming regulatory approvals, revenues are projected to grow at a compounded annual growth rate (CAGR) of approximately 8-10% over the next five years [5].

Valuation and Market Capitalization
Companies focusing on AV-A compounds and enhanced adjuvant technologies could see their market capitalizations increase substantially, especially if novel formulations achieve regulatory clearance and broader acceptance.

Risks and Capital Allocation Strategies
Investment risks involve regulatory delays, funding uncertainties, and geopolitical shifts affecting procurement practices. Diversifying portfolios to include pipelines of next-generation adjuvants and delivery platforms can mitigate these risks.

Emerging Trends and Opportunities

• Combination Vaccines: Developing multispecific vaccines that protect against multiple biothreats may open new markets.
• Enhanced Delivery Systems: Innovations such as intranasal formulations could ease administration and improve compliance.
• International Collaborations: Partnerships with global health agencies and defense organizations can accelerate market access and funding.

Regulatory and Scientific Innovations

Advancements in adjuvant science, including saponin-based and Toll-like receptor agonists, promise to improve AV-A’s efficacy and safety. The integration of biomarker-driven clinical trials could streamline approval pathways, reducing time-to-market.

Conclusion

The market for adjuvanted anthrax vaccines, particularly AV-A, demonstrates resilience driven by biodefense priorities, technological innovation, and strategic government investments. While commercial opportunities remain limited, targeted growth is driven by pandemic lessons and biothreat proliferation. Continued R&D, alongside supportive regulatory and policy frameworks, will shape the financial prospects of AV-A over the coming decade.

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Key Takeaways

• Stable Demand Despite Niche Market: The AV-A segment’s core demand hinges on government and military procurement, ensuring a stable but limited revenue base.
• Innovation as a Growth Catalyst: Next-generation adjuvants and delivery technologies could expand usage, improve safety profiles, and enhance market share.
• Regulatory Environment as a Critical Factor: Accelerated approval pathways and EUA provisions can swiftly influence market dynamics.
• Investment Opportunities in R&D: Funding in adjuvant science and combination strategies offers potential high returns amid evolving biothreats.
• Strategic Partnerships Crucial: Collaborations with defense bodies and international agencies can facilitate market expansion and risk mitigation.

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FAQs

1. What factors most influence the financial success of anthrax vaccines like AV-A?
Government biodefense budgets, regulatory approvals, technological innovations in adjuvation, and international procurement policies primarily drive financial success.

2. How does adjuvant technology enhance anthrax vaccine efficacy?
Adjuvants amplify immune responses, potentially reducing dosing frequency, improving long-term immunity, and allowing formulations to be effective against diverse strains or biothreats.

3. What are the main challenges in commercializing AV-A globally?
Limited commercial demand, complex manufacturing processes, regulatory hurdles, and public perception concerns pose significant commercialization challenges.

4. How might emerging biothreats impact AV-A market prospects?
Increased bioweapons proliferation risks encourage continued investment in AV-A, reinforcing its strategic importance and future financial opportunities.

5. Which regions present the most promising growth prospects for AV-A?
Regions with strong biodefense infrastructure, including North America, Europe, and select Asian countries, offer promising growth opportunities through government procurement and international collaborations.

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References

[1] Biodefense Market Outlook, Global Data. (2022).
[2] FDA Guidance on Emergency Use Authorizations. (2021).
[3] U.S. Government Biodefense Investment Data, HHS. (2022).
[4] Emergent BioSolutions Annual Report, 2022.
[5] Market Analytics for Biodefense Vaccines, Frost & Sullivan. (2023).