IMVAMUNE Sales Forecast, and Market Size Analysis - 2034

Key Factors Driving IMVAMUNE Growth

1. Global Leadership in the Mpox Vaccine Market

IMVAMUNE is one of the few approved vaccines specifically available for both mpox and smallpox prevention and has become the preferred vaccine for many governments and public-health agencies. Following recurrent mpox outbreaks, demand from the US, Europe, Canada, and international organizations increased substantially. Bavarian Nordic reported DKK 3.105 billion (~US$450 million) in 2025 revenue from JYNNEOS/IMVAMUNE/IMVANEX alone, representing approximately 50% of total company revenue.

2. Strong Government Stockpiling and Preparedness Contracts

A major growth driver is continued procurement by governments for biodefense stockpiles. In 2025, Bavarian Nordic received approximately US$340 million in vaccine orders for 2025 deliveries, while additional contracts were secured from the U.S., Canada, the European Union, and other governments. The company disclosed that approximately DKK 1.4 billion of Public Preparedness revenue for 2026 was already secured through contracts early in the year.

3. Expansion of European and International Procurement Programs

In 2025, the European Commission signed a new framework agreement allowing participating countries to purchase up to 8 million doses of the vaccine over four years. Initial commitments included approximately 1.1 million doses, with 750,000 doses scheduled for delivery in 2026. This agreement extends IMVAMUNE's role in long-term public-health preparedness across Europe and neighboring regions.

4. WHO Prequalification Expands Access to Developing Countries

The vaccine became the first WHO-prequalified mpox vaccine, enabling procurement by United Nations agencies and facilitating access in low- and middle-income countries. WHO prequalification is particularly important because it allows organizations such as UNICEF and Gavi-supported programs to purchase the vaccine more easily during outbreaks. This significantly broadens the addressable market beyond traditional government stockpiles.

5. Freeze-Dried Formulation Improves Stockpiling Economics

The US FDA approved a freeze-dried formulation of JYNNEOS in 2025. Compared with the original frozen formulation, the freeze-dried version offers substantially improved storage, transportation, and shelf-life characteristics, making it more attractive for national stockpile programs. Following approval, the US government exercised additional contract options, including a USD 97 million contract announced in 2026 for freeze-dried vaccine supply.

IMVAMUNE Recent Developments

In March 2026, Bavarian Nordic submitted clinical data to the European Medicines Agency (EMA) seeking to extend the vaccine's approval to include children aged 2 to 11 years. This follows positive topline trial data showing that the immune response in young children was non-inferior (and in some age groups, significantly higher) than in adults.

"IMVAMUNE Sales Forecast, and Market Size Analysis - 2034" report provides comprehensive insights of IMVAMUNE for approved indication like Monkeypox, Smallpox, and Vaccinia virus infections; as well as potential indication like Orthopoxvirus infections in the 7MM. A detailed picture of IMVAMUNE's existing usage in approved and anticipated entry and performance in potential indications in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan for the study period 2020 -2034 is provided in this report along with a detailed description of the IMVAMUNE for approved and potential indications. The IMVAMUNE market report provides insights about IMVAMUNE's sales forecast, mechanism of action (MoA), dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of historical and current IMVAMUNE performance, future market assessments inclusive of the IMVAMUNE market forecast analysis for approved and potential indications in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in respective indications. It also provides analysis of IMVAMUNE sales forecasts, along with factors driving its market.

IMVAMUNE Drug Summary

IMVAMUNE (marketed as JYNNEOS in the United States and as Imvanex in Europe) is a non-replicating, live attenuated vaccine based on the Modified Vaccinia Ankara (MVA) strain of vaccinia virus, developed by Bavarian Nordic for the prevention of smallpox and mpox (monkeypox). Unlike traditional replicating smallpox vaccines, IMVAMUNE cannot reproduce in human cells, resulting in an improved safety profile, particularly for individuals with weakened immune systems, atopic dermatitis, or other conditions that increase the risk of vaccine-related complications. Administered as a two-dose regimen by subcutaneous injection, the vaccine induces robust humoral and cellular immune responses that provide cross-protection against orthopoxviruses, including variola virus and mpox virus. IMVAMUNE has received regulatory approvals in multiple regions for smallpox and mpox prevention and played a central role in global public health responses during recent mpox outbreaks. Its favorable safety, immunogenicity, and established manufacturing platform have made it a key component of strategic national stockpiles and outbreak preparedness programs worldwide. The report provides IMVAMUNE's sales, growth barriers and drivers, post usage and approvals in multiple indications.

Scope of the IMVAMUNE Market Report

The report provides insights into:

• A comprehensive product overview including the IMVAMUNE MoA, description, dosage and administration, research and development activities in approved indications like Monkeypox, Smallpox, and Vaccinia virus infections; as well as potential indication like Orthopoxvirus infections.
• Elaborated details on IMVAMUNE regulatory milestones and other development activities have been provided in IMVAMUNE market report.
• The report also highlights IMVAMUNE's cost estimates and regional variations, reported and estimated sales performance, research and development activities in approved and potential indications across the United States, Europe, and Japan.
• The IMVAMUNE market report also covers the patents information, generic entry and impact on cost cut.
• The IMVAMUNE market report contains current and forecasted IMVAMUNE sales for approved and potential indications till 2034.
• Comprehensive coverage of the late-stage emerging therapies for respective indications.
• The IMVAMUNE market report also features the SWOT analysis with analyst views for IMVAMUNE in approved and potential indications.

Methodology:

The IMVAMUNE market report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by DelveInsight's team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

IMVAMUNE Analytical Perspective by DelveInsight

• In-depth IMVAMUNE Market Assessment

This IMVAMUNE sales market forecast report provides a detailed market assessment of IMVAMUNE for approved indication like Monkeypox, Smallpox, and Vaccinia virus infections; as well as potential indication like Orthopoxvirus infections in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This segment of the report provides current and forecasted IMVAMUNE sales data uptil 2034.

• IMVAMUNE Clinical Assessment

The IMVAMUNE market report provides the clinical trials information of IMVAMUNE for approved and potential indications covering trial interventions, trial conditions, trial status, start and completion dates.

IMVAMUNE Competitive Landscape

The report provides Insights on competitors and marketed products within the domain, along with a summary of emerging products and their respective launch dates, posing significant competition in the market.

IMVAMUNE Market Potential & Revenue Forecast

• Projected market size for the IMVAMUNE and its key indications
• Estimated IMVAMUNE sales potential (IMVAMUNE peak sales forecasts)
• IMVAMUNE Pricing strategies and reimbursement landscape

IMVAMUNE Competitive Intelligence

• Number of competing drugs in development (pipeline analysis)
• IMVAMUNE Market positioning compared to existing treatments
• IMVAMUNE Strengths & weaknesses relative to competitors

IMVAMUNE Regulatory & Commercial Milestones

• IMVAMUNE Key regulatory approvals & expected launch timelines
• Commercial partnerships, licensing deals, and M&A activity

IMVAMUNE Clinical Differentiation

• IMVAMUNE Efficacy & safety advantages over existing drugs
• IMVAMUNE Unique selling points

IMVAMUNE Market Report Highlights

• In the coming years, the IMVAMUNE market scenario is set to change due to strong adoption, increased prescriptions and broader uptake in multiple immunological indications; which would expand the size of the market.
• The IMVAMUNE companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence IMVAMUNE's dominance.
• Other emerging products for Monkeypox, Smallpox, and Vaccinia virus infections; as well as potential indication like Orthopoxvirus infections are expected to give tough market competition to IMVAMUNE and launch of late-stage emerging therapies in the near future will significantly impact the market.
• A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of IMVAMUNE in approved and potential indications.
• Analyse IMVAMUNE cost, pricing trends and market positioning to support strategic decision-making in the immunology landscape.
• Our in-depth analysis of the forecasted IMVAMUNE sales data uptil 2034 will support the clients in decision-making process regarding their therapeutic portfolio by identifying the overall scenario of IMVAMUNE in approved and potential indications.

Key Questions:

• What is the class of therapy, route of administration and mechanism of action of IMVAMUNE? How strong is IMVAMUNE's clinical and commercial performance?
• What is IMVAMUNE's clinical trial status in each individual indications such as Monkeypox, Smallpox, and Vaccinia virus infections; as well as potential indication like Orthopoxvirus infections and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the IMVAMUNE Manufacturers?
• What are the key designations that have been granted to IMVAMUNE for approved and potential indications? How are they going to impact IMVAMUNE's penetration in various geographies?
• What is the current and forecasted IMVAMUNE market scenario for approved and potential indications? What are the key assumptions behind the forecast?
• What are the current and forecasted sales of IMVAMUNE in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain) and the United Kingdom, and Japan?
• What are the other emerging products available and how are these giving competition to IMVAMUNE for approved and potential indications?
• Which are the late-stage emerging therapies under development for the treatment of approved and potential indications?
• How cost-effective is IMVAMUNE? What is the duration of therapy and what are the geographical variations in cost per patient?