Anthrax vaccine adsorbed - Biologic Drug Details

Summary for anthrax vaccine adsorbed

Tradenames:	1
High Confidence Patents:	0
Applicants:	2
BLAs:	2
Suppliers: see list	2
Recent Clinical Trials:	See clinical trials for anthrax vaccine adsorbed

Recent Clinical Trials for anthrax vaccine adsorbed

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Rho, Inc.	Phase 2
Biomedical Advanced Research and Development Authority	Phase 2
Emergent BioSolutions	Phase 4

See all anthrax vaccine adsorbed clinical trials

Pharmacology for anthrax vaccine adsorbed

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 Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for anthrax vaccine adsorbed 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		2034-12-23	DrugPatentWatch analysis and company disclosures
Emergent Product Development Gaithersburg, Inc.	CYFENDUS	anthrax vaccine adsorbed, adjuvanted	Injection	125761		2031-05-27	DrugPatentWatch analysis and company disclosures
Emergent Product Development Gaithersburg, Inc.	CYFENDUS	anthrax vaccine adsorbed, adjuvanted	Injection	125761		2016-10-30	DrugPatentWatch analysis and company disclosures
Emergent Product Development Gaithersburg, Inc.	CYFENDUS	anthrax vaccine adsorbed, adjuvanted	Injection	125761		2019-06-03	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for anthrax vaccine adsorbed 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
Emergent Biodefense Operations Lansing Llc	BIOTHRAX	anthrax vaccine adsorbed	Injection	103821		2037-06-09	Patent claims search
Emergent Biodefense Operations Lansing Llc	BIOTHRAX	anthrax vaccine adsorbed	Injection	103821		2025-05-12	Patent claims search
Emergent Biodefense Operations Lansing Llc	BIOTHRAX	anthrax vaccine adsorbed	Injection	103821		2037-01-31	Patent claims search
Emergent Biodefense Operations Lansing Llc	BIOTHRAX	anthrax vaccine adsorbed	Injection	103821		2037-02-14	Patent claims search

Market Dynamics and Financial Trajectory for the Biologic Drug: Anthrax Vaccine Adsorbed

Last updated: July 30, 2025

Introduction

Anthrax Vaccine Adsorbed (AVA), developed primarily for military and biodefense purposes, occupies a strategic niche within the biologics market. As a recombinant protein-based vaccine, AVA holds significance for biodefense, public health preparedness, and potential civilian applications. Understanding the evolving market dynamics and financial trajectory involves assessing regulatory landscapes, geopolitical influences, product lifecycle, competitive environment, and emerging opportunities. This analysis provides a comprehensive overview of the current state, future prospects, and market drivers shaping AVA’s commercial trajectory.

Market Overview and Historical Context

Initially licensed in 1970 by the U.S. Food and Drug Administration (FDA), AVA, marketed under the brand name BioThrax, remains the only FDA-approved anthrax vaccine for human use in the United States. It is primarily employed for pre-exposure prophylaxis among military personnel and high-risk populations. The vaccine’s market has been historically limited due to its niche application, regulatory constraints, and vaccine hesitancy rooted in its administration regimen.

Despite its specialized usage, AVA’s strategic importance surged post-2001 anthrax attacks, prompting increased federal investment in biodefense vaccines. The U.S. government became the primary purchaser, with contracts awarded to Biothrax’s manufacturer, Emergent BioSolutions. This dependency on government procurement influences the vaccine’s market size and financial outlook significantly.

Regulatory Landscape and Market Drivers

Key regulations impacting AVA’s market include FDA approvals, CDC guidelines, and compliance with international health standards. The FDA’s approval process emphasizes safety, efficacy, and manufacturing quality, with recent updates enabling simplified approval pathways for biodefense vaccines.

Market drivers encompass:

• Biodefense Funding: Heightened government focus on biothreat preparedness, particularly in the U.S., sustains demand. Congressional appropriations for biodefense reach billions annually, with a significant portion allocated for anthrax vaccines and stockpiling.

• Strategic Stockpiling: The Department of Health and Human Services (HHS) maintains stockpiles of BioThrax for public health emergencies, ensuring sustained, albeit limited, demand.

• Public-Private Collaborations: Partnerships facilitate research and potential civilian applications, boosting future market prospects.

• Biological Threat Evolution: Emerging biothreats could influence demand for AVA enhancements or novel vaccines, reshaping market dynamics.

Market Challenges and Constraints

Despite its strategic importance, AVA faces notable challenges:

• Limited Commercial Appeal: The vaccine’s niche application constrains market growth; civilian adoption remains limited, primarily due to vaccine hesitancy and regulatory hurdles related to non-military uses.

• Manufacturing Complexity and Cost: The production process is biologically complex and expensive, impacting scalability and pricing strategies.

• Regulatory Barriers for Broader Use: Transitioning AVA from biodefense to civilian healthcare involves extensive regulatory hurdles and clinical trials, which can be time-consuming and costly.

Emerging Market Opportunities

While the existing market remains largely dependent on government procurement, emerging factors could influence future financial trajectories:

• Expanded Indications: Research into AVA’s potential for post-exposure prophylaxis or therapeutic use could open new markets.

• International Markets: Growing biodefense initiatives in Asia-Pacific, Europe, and Africa present export opportunities, contingent on regulatory approvals and geopolitical considerations.

• Next-Generation Vaccines: Development of improved formulations—e.g., fewer doses, enhanced stability—could enhance marketability while reducing costs.

• Pandemic Preparedness Synergies: The COVID-19 pandemic spotlighted the importance of biologic preparedness, encouraging investments into vaccine platforms that could be adapted for anthrax or other biothreat pathogens.

Financial Trajectory and Market Projections

The financial trajectory of AVA hinges primarily on military and government procurement contracts. Historical analysis shows:

• Revenue Stability: The U.S. government’s multi-year contracts have provided consistent revenue streams. For instance, a 2017 contract valued at over $499 million secured AVA supply for multiple years [1].

• Pricing Strategies: Due to the small market, prices have remained high, with the vaccine costing approximately $600–$700 per dose, reflecting manufacturing costs, R&D, and procurement negotiations.

• Investment Trends: Emergent companies like Emergent BioSolutions continue to invest in manufacturing capacity and pipeline development, signaling expectations of sustained demand.

Projected growth remains modest, with estimates suggesting that, barring major policy shifts or market expansions, annual revenues could hover around $300–$500 million in the next five years, primarily supported by government procurement.

However, any significant diversification into civilian markets or international sales could substantially alter this outlook.

Competitive Landscape

Currently, BioThrax remains the sole FDA-approved anthrax vaccine, conferring a monopoly position. Nonetheless, competition exists from:

• Other Biodefense Platforms: Investigations into novel anthrax vaccine candidates, such as recombinant subunit vaccines or vector-based platforms, threaten to disrupt the existing market.

• Alternative Prevention Strategies: Monoclonal antibodies and therapeutics focused on biothreats could complement or replace traditional vaccines.

The competitive environment remains limited but dynamic, with technological advancements and biodefense investments driving innovation.

Future Outlook and Strategic Considerations

Market sustainability depends on continued biodefense funding, regulatory support, and potential civilian applications. The anticipated introduction of next-generation vaccines with more favorable dosing regimens could catalyze broader adoption. International collaborations and exports stand to diversify revenue streams but require navigating complex geopolitical and regulatory landscapes.

Manufacturers must also invest in ramping production capacities while maintaining stringent quality standards, ensuring readiness for emergency deployment and potential market expansion.

Key Takeaways

• Dependence on Government Contracts: The financial stability of AVA is highly tied to U.S. government biodefense budgets, with minimal civilian market penetration to date.

• Market Constraints and Opportunities: While current demand is limited, strategic stockpiling and emerging biodefense needs sustain the market. Future growth hinges on technological innovation and international sales.

• Pricing and Manufacturing: High per-dose costs limit profitability but are justified by the complex biological manufacturing process. Enhancing manufacturing efficiency and vaccine formulations could improve financial viability.

• Regulatory Evolution: Streamlined approvals and expanded indications are critical for unlocking broader markets, especially for civilian and international use.

• Competitive Landscape: Monopoly status offers protection but may be challenged by new vaccine candidates or alternative preventive therapies.

Conclusion

Anthrax Vaccine Adsorbed represents a niche but critical component of biodefense infrastructure. Its market dynamics are characterized by robust government support, technological and regulatory hurdles, and emerging opportunities stemming from biodefense investments and threat landscape evolution. While near-term growth prospects remain modest, strategic investments into next-generation formulations and international markets could shape a favorable financial trajectory. Continuous monitoring of regulatory developments, geopolitical factors, and technological innovations will be essential for stakeholders aiming to capitalize on AVA’s strategic position.

FAQs

1. What factors primarily influence the financial stability of AVA?
U.S. government biodefense budgets, procurement contracts, and the vaccine’s monopoly status significantly influence AVA’s financial stability. International adoption and technological innovations also play roles.

2. Can AVA be used outside military and biodefense contexts?
Currently, AVA is approved for pre-exposure prophylaxis in high-risk populations, mainly military personnel. Expanding civilian use requires regulatory approval and clinical validation, which remain logistical challenges.

3. What are the main barriers to expanding AVA’s market?
Regulatory hurdles, high manufacturing costs, vaccine hesitancy, and limited civilian demand restrict broader adoption.

4. How does international procurement impact AVA’s market outlook?
Growing international biodefense initiatives, especially in emerging economies, offer potential markets. However, approval processes and geopolitical considerations can limit access.

5. What innovations could enhance AVA’s market potential?
Developments such as shorter dosing regimens, improved thermostability, and alternative delivery platforms could increase acceptance and open new markets.

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Sources:

1. Emergent BioSolutions Contract Awards and Financial Reports, 2017.