Smallpox and monkeypox vaccine, live, non-replicating - Biologic Drug Details

Summary for smallpox and monkeypox vaccine, live, non-replicating

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 smallpox and monkeypox vaccine, live, non-replicating Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for smallpox and monkeypox vaccine, live, non-replicating 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
Bavarian Nordic A/s	JYNNEOS	smallpox and monkeypox vaccine, live, non-replicating	For Injection	125678	11,338,030	2040-02-27	DrugPatentWatch analysis and company disclosures
Bavarian Nordic A/s	JYNNEOS	smallpox and monkeypox vaccine, live, non-replicating	For Injection	125678	7,964,395	2028-08-28	DrugPatentWatch analysis and company disclosures
Bavarian Nordic A/s	JYNNEOS	smallpox and monkeypox vaccine, live, non-replicating	For Injection	125678	8,268,329	2031-03-22	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for smallpox and monkeypox vaccine, live, non-replicating 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 smallpox and monkeypox vaccine, live, non-replicating

Country	Patent Number	Estimated Expiration
Japan	2004514436
New Zealand	538575
China	112972668
China	106999565
Eurasian Patent Organization	039715

Supplementary Protection Certificates for smallpox and monkeypox vaccine, live, non-replicating

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
67/2013	Austria		PRODUCT NAME: MODIFIZIERTES VACCINIAVIRUS ANKARA - BAVARIAN-NORDIC-LEBENDVIRUS; REGISTRATION NO/DATE: EU/1/13/855 20130731
CR 2013 00057	Denmark		PRODUCT NAME: LEVENDE MODIFICERET VACCINIA VIRUS ANKARA; REG. NO/DATE: EU/1/13/855 20130805
2013/053	Ireland		PRODUCT NAME: LIVE MODIFIED VACCINA VIRUS ANKARA; REGISTRATION NO/DATE: EU/1/13/855 20130731
1390053-5	Sweden		PRODUCT NAME: LEVANDE MODIFIERAT VACCINIA ANKARA - BAVARIAN NORDIC VIRUS; REG. NO/DATE: EU/1/13/855 20130731
2013C/065	Belgium		PRODUCT NAME: VIRUS VIVANT MODIFIE DE LA VACCINE ANKARA; AUTHORISATION NUMBER AND DATE: EU/1/13/855 20130805

Market Dynamics and Financial Trajectory for the Biologic Drug: Smallpox and Monkeypox Vaccine, Live, Non-Replicating

Last updated: November 6, 2025

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Introduction

The demand for smallpox and monkeypox vaccines, particularly live, non-replicating biologics, is resurging amid evolving infectious disease threats and global health security concerns. The recent outbreaks of monkeypox across multiple regions, coupled with the persistent threat of bioweapons and bioterrorism, have necessitated a reassessment of market opportunities. This article analyzes the current market dynamics and forecasts the financial trajectory of these biologic vaccines, emphasizing key drivers, challenges, competitive landscape, and investment outlook.

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Market Overview

The global vaccine market estimated at approximately USD 65 billion in 2022 is experiencing dynamic growth, with infectious disease vaccines securing significant investment. Among these, biodefense and emerging infectious diseases, such as monkeypox, are gaining prominence. The live, non-replicating smallpox and monkeypox vaccines, notably vaccinia virus-based platforms, are pivotal for biodefense and outbreak containment.

Historically, smallpox vaccination eradicated the disease globally by 1980, but renewed interest in related orthopoxviruses has emerged due to biothreat concerns and zoonotic spillover events. The live, non-replicating vaccines, such as Modified Vaccinia Ankara (MVA)-based vaccines (e.g., Jynneos/Imvamune), offer favorable safety profiles, especially in immunocompromised populations, thus broadening their applicability and market reach.

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Market Drivers

1. Rising Incidence of Monkeypox:
Recent outbreaks, especially in non-endemic regions, have heightened awareness and demand. The WHO declared the 2022 monkeypox outbreak a Public Health Emergency of International Concern (PHEIC). This surge underscores the urgent need for effective vaccines, driving commercial and governmental procurement.

2. Biodefense and Preparedness Policies:
Governments, particularly in North America and Europe, prioritize biodefense preparedness, stockpiling smallpox vaccines as a contingency for bioterrorism. The U.S. Strategic National Stockpile (SNS) anticipates increased procurement of approved vaccines like Jynneos, incentivizing manufacturers.

3. Advancements in Vaccine Technology:
Next-generation live, non-replicating vaccines leverage safety advantages over replicating formulations. The development of thermostable, single-dose vaccines further enhances their commercial viability and logistical appeal.

4. Regulatory Approvals and Emergency Use Authorizations:
Recent approvals by bodies such as the FDA (e.g., for Jynneos) and EMA have accelerated vaccine deployment, expanding market access and confidence among health authorities.

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Market Challenges

1. Supply Chain Constraints:
Manufacturing complexities of live, non-replicating vaccines impose supply limitations. High biosafety and manufacturing requirements restrict scaling, potentially leading to shortages during peak demand periods.

2. Competition from Replicating Vaccines:
While live, non-replicating vaccines offer safety benefits, traditional replicating vaccines like Dryvax have historically dominated due to established manufacturing infrastructure, posing competitive challenges.

3. Regulatory and Patent Barriers:
Evolving regulatory standards and patent protections influence market entry and pricing strategies. The expiration of some patents may catalyze generic or biosimilar development, impacting pricing.

4. Public Perception and Vaccine Hesitancy:
Vaccine acceptance remains variable, affected by safety perceptions, misinformation, and cultural factors, which may dampen adoption rates.

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Competitive Landscape

Major players include biotech firms and pharmaceutical giants developing or marketing live, non-replicating orthopoxvirus vaccines:

• Bavarian Nordic:
  The producer of Jynneos/Imvamune, leading the market with an FDA and EMA-approved non-replicating vaccine for smallpox and monkeypox. Their robust manufacturing capacity positions them favorably.

• Emergent BioSolutions:
  Focuses on biodefense vaccines, with ongoing development of related candidates, leveraging their existing vaccine platform expertise.

• Potential New Entrants:
  Small biotech firms are pursuing novel vaccine platforms, including mRNA and protein-based vectors, to diversify options, which may alter the competitive dynamics.

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Financial Trajectory and Market Forecast

Short-term Outlook (2023-2025):
The immediate post-outbreak period is characterized by rapid procurement, government stockpiling, and emergency authorizations. This results in an anticipated CAGR of approximately 8-10%, driven by clinician demand, stockpile replenishments, and emergency use authorizations. The projected market share for approved live, non-replicating vaccines is expected to grow steadily, with sales potentially reaching USD 2-3 billion globally.

Medium to Long-term Outlook (2026-2030):
As outbreaks stabilize and vaccination campaigns mature, market growth may taper but remain buoyant due to accumulated stockpiles, increased routine immunization in certain demographics, and preparedness measures. The CAGR is forecasted to moderate to 4-6%, with revenues stabilizing around USD 3-4 billion globally, assuming ongoing threat mitigation and vaccine adoption.

Innovative vaccine delivery methods, including thermostable formulations and single-dose regimens, are expected to facilitate expansion into wider populations, including pediatric and immunocompromised groups. Government investments and policy shifts toward broader biodefense strategies will be decisive in shaping long-term revenue streams.

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Investment and Business Strategies

Companies with existing manufacturing infrastructure, regulatory approvals, and supply chain agility will have a pronounced advantage. Strategic alliances with governments for stockpiling and outbreak response are crucial for sustained growth. Diversification into related orthopoxvirus vaccines and platform technologies further enhances long-term profitability.

Emerging biotech firms focusing on next-generation vaccine platforms may challenge incumbents, especially if they demonstrate superior safety profiles, ease of administration, or cost advantages. Patent expirations and biosimilar development also present opportunities and risks, necessitating vigilant intellectual property management and proactive R&D investments.

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Conclusion

The market for live, non-replicating smallpox and monkeypox vaccines is poised for meaningful growth driven by outbreak responses, biodefense initiatives, and technological advancements. While challenges persist, especially regarding supply constraints and market competition, the overall financial trajectory appears promising, with significant revenue potential over the next decade. Stakeholders that effectively leverage regulatory frameworks, optimize manufacturing capabilities, and anticipate evolving public health needs will position themselves advantageously in this niche yet strategically vital segment.

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Key Takeaways

• The resurgence of monkeypox and ongoing biodefense concerns are primary growth catalysts.
• Approved vaccines like Bavarian Nordic’s Jynneos enjoy a lead, but competition and technological innovation will influence future market shares.
• Supply chain limitations and vaccine hesitancy remain significant hurdles.
• Forecasts suggest a CAGR of 8-10% in the short term, with long-term revenues stabilizing around USD 3-4 billion globally.
• Strategic collaborations with governments and continuous R&D are essential for sustained profitability.

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FAQs

1. What defines live, non-replicating smallpox and monkeypox vaccines?
These vaccines use genetically modified vaccinia virus strains (e.g., MVA) incapable of replication in human cells, offering a safer profile compared to traditional replicating vaccinia vaccines while maintaining immunogenicity.

2. Why has demand for monkeypox vaccines surged recently?
Recent outbreaks outside endemic regions, coupled with WHO and national health agencies’ declaration of emergencies, have driven urgent vaccination campaigns and stockpiling.

3. How does the safety profile of live, non-replicating vaccines compare to traditional versions?
They are generally safer, especially in immunocompromised populations, due to inability to replicate, reducing adverse events like eczema vaccinatum or progressive vaccinia.

4. What factors could hinder the market growth of these vaccines?
Supply chain bottlenecks, vaccine hesitancy, high manufacturing costs, and the emergence of competitive or alternative platforms.

5. What is the role of government procurement in shaping the vaccine market?
Government buying policies, stockpiling strategies, and emergency response plans directly influence demand, pricing, and market stability for these biologics.

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Sources:
[1] Market research reports on infectious disease vaccines and biodefense markets.
[2] WHO, CDC, and FDA releases on monkeypox outbreaks and vaccine approvals.
[3] Industry analysis on vaccine manufacturing and technological innovations.