Smallpox Treatment Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Treatment Type (Antiviral Drugs, Vaccination, Supportive Care), By Product Type (Vaccines, Antiviral Drugs), By End user (Hospitals & Clinics, Ambulatory Care Centers, Others), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 75.12 Million
CAGR (2026-2031)	3.92%
Fastest Growing Segment	Hospitals & Clinics
Largest Market	North America
Market Size (2031)	USD 94.61 Million

Market Overview

The Global Smallpox Treatment Market will grow from USD 75.12 Million in 2025 to USD 94.61 Million by 2031 at a 3.92% CAGR. The Global Smallpox Treatment Market comprises medical countermeasures, specifically antiviral therapeutics and vaccines, designed to prevent and manage orthopoxvirus infections such as variola and mpox. Growth in this sector is primarily supported by government mandates for biodefense stockpiling to counter potential bioterrorism threats and the necessity to manage re-emerging zoonotic outbreaks. These procurement programs ensure a sustained demand for approved products despite the eradication of smallpox. According to Gavi, the Vaccine Alliance, in 2024, the organization entered an advance purchase agreement to secure 500,000 doses of vaccine to address escalating regional outbreaks.

One significant challenge that could impede market expansion is the reliance on sporadic government contracts rather than a consistent commercial consumer base. The high cost of maintaining manufacturing readiness for products with limited routine use creates financial uncertainty for private developers. This dependence on public funding cycles means that shifts in political priorities or budget reallocations can abruptly reduce revenue streams, discouraging new entrants from investing in this specialized pharmaceutical niche.

Key Market Drivers

The surge in demand driven by recurring mpox and orthopoxvirus outbreaks effectively propels the market as nations prioritize immediate procurement of medical countermeasures. This driver is characterized by rapid response mechanisms where governments and international bodies secure vaccines and therapeutics to contain transboundary viral threats, moving beyond theoretical preparedness to active disease management. The 2024 declaration of mpox as a public health emergency accelerated these acquisition channels, compelling authorities to bolster inventories for immediate deployment. According to Bavarian Nordic, August 2024, in a corporate announcement, the European Health Emergency Preparedness and Response Authority (HERA) procured 175,420 doses of the MVA-BN vaccine to support the response to the escalating health crisis in Africa. Such acute needs ensure that manufacturing lines remain active, bridging the gap between sporadic biodefense orders and providing manufacturers with crucial operational revenue during active health crises.

Simultaneously, the expansion of national strategic stockpiles for biodefense acts as the foundational stabilizer for the industry, ensuring long-term sustainability for drug developers. Governments view smallpox as a high-consequence biological weapon, necessitating maintained reserves of antivirals and second-generation vaccines regardless of current infection rates. This security-driven logic fosters multi-year contracts that insulate companies from commercial market volatility. According to SIGA Technologies, July 2024, in a company announcement, the U.S. Department of Health and Human Services exercised a procurement option worth approximately $113 million for oral TPOXX to enhance national orthopoxvirus preparedness. Highlighting the scale of these federal investments, according to Emergent BioSolutions, July 2024, in a press release, the company secured a contract modification valued at $99.9 million for the continued supply of the ACAM2000 vaccine to the U.S. Strategic National Stockpile, reinforcing the sector's reliance on government defense spending.

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Key Market Challenges

The reliance on sporadic government contracts constitutes a primary restraint on the global smallpox treatment market, creating a volatile revenue environment that deters consistent private sector investment. Unlike commercial pharmaceutical sectors driven by steady patient demand, this market depends heavily on irregular procurement cycles and biodefense stockpiling mandates. Manufacturers are compelled to maintain expensive, specialized production facilities and regulatory readiness without the assurance of recurring sales. This financial uncertainty creates a boom-and-bust dynamic where revenue streams can evaporate abruptly if public health priorities shift or perceived threats diminish, making long-term strategic planning difficult for developers.

The impact of this instability is compounded by the conditional nature of procurement, which often arises only in response to active emergencies rather than through sustained preventative funding. This reactive approach forces companies to shoulder the risk of inventory management and capacity maintenance. According to UNICEF, in 2024, the organization launched an emergency tender to potentially secure up to 12 million doses of mpox vaccine through 2025, but the acquisition was explicitly contingent upon available financing and confirmed demand. This specific instance highlights how the lack of a guaranteed commercial consumer base and the dependence on unsecured public funding hamper the market's ability to maintain a stable growth trajectory.

Key Market Trends

Regulatory bodies and manufacturers are placing a renewed emphasis on expanding drug labels to include pediatric populations and special risk groups, addressing a critical gap in historical biodefense strategies that largely excluded these demographics. This trend is characterized by an increase in clinical trials and regulatory actions specifically targeting children to ensure comprehensive population protection against orthopoxviruses. A pivotal development in this area is the deployment of safer, third-generation vaccines capable of inducing immunity in younger subjects without the severe side effects associated with earlier replicating formulations. According to the World Health Organization, November 2024, in the 'WHO adds LC16m8 mpox vaccine to Emergency Use Listing' report, the agency granted emergency approval to the LC16m8 vaccine for children over one year of age and facilitated the donation of 3.05 million doses from Japan to the Democratic Republic of the Congo to protect this vulnerable group.

Biopharmaceutical companies are increasingly merging their research and development pipelines for smallpox and mpox, leveraging active outbreaks to validate dual-indication therapeutics. By utilizing clinical data from mpox cases, developers can accelerate the regulatory approval pathways for broad-spectrum orthopoxvirus countermeasures that would otherwise be difficult to test due to the eradication of smallpox. This strategic integration optimizes R&D spending and ensures that new platforms, such as mRNA technology, can rapidly address emerging threats while satisfying long-term government biodefense contracts. According to Pharmaceutical Technology, September 2024, in the 'Moderna mpox mRNA vaccine shows early promise in monkey study' article, Moderna is advancing this dual-purpose strategy through a Phase 1/2 clinical trial enrolling 351 adults to evaluate the safety and immunogenicity of its mRNA-1769 candidate against both mpox and smallpox.

Segmental Insights

The Hospitals and Clinics segment is currently recognized as the fastest-growing category within the Global Smallpox Treatment Market. This expansion is primarily driven by the central role these facilities play in government-led biodefense strategies and the management of orthopoxvirus cases. Agencies such as the Centers for Disease Control and Prevention designate hospitals as the required sites for administering specific stockpiled antivirals under strict isolation protocols. The necessity for professional medical supervision to ensure patient safety and containment guarantees that these institutions remain the primary channel for dispensing restricted therapeutics.

Regional Insights

North America maintains a dominant position in the Global Smallpox Treatment Market, largely due to extensive government-led biodefense strategies. The United States government actively prioritizes national health security through the Strategic National Stockpile, ensuring a steady supply of medical countermeasures against potential bioterrorism threats. Key federal agencies, including the Biomedical Advanced Research and Development Authority (BARDA), drive market activity by funding the procurement and development of therapeutics. Furthermore, the U.S. Food and Drug Administration (FDA) supports this ecosystem with clear regulatory pathways for approval. These concerted efforts create a stable demand for smallpox antivirals and vaccines, cementing the region's market leadership.

Recent Developments

• In January 2025, SIGA Technologies announced that its antiviral drug, branded as TEPOXX in the local market, received regulatory approval in Japan for the treatment of smallpox, mpox, cowpox, and complications arising from smallpox vaccination. This decision by the Japanese Ministry of Health, Labour and Welfare marks the first antiviral therapy sanctioned in the country specifically for targeting orthopoxviruses. The Chief Executive Officer of the company highlighted that this regulatory success supports the mission to expand global access to critical treatments. Furthermore, the approval underscores the strategic importance of stockpiling effective therapeutics to safeguard public health against the threat of serious infectious disease outbreaks.
• In November 2024, BioFactura, Inc. received $7.8 million in funding through contract option activations from the Biomedical Advanced Research and Development Authority (BARDA). This financial support is directed toward the advanced development of the company’s Smallpox Biodefense Therapeutic, a monoclonal antibody cocktail intended to augment current countermeasures and address potential viral resistance. The funding will support non-clinical efficacy studies and manufacturing process optimization to prepare for future clinical trials. The President of BioFactura emphasized that this continued federal backing validates the necessity of developing complementary therapies to enhance the nation’s biodefense preparedness against smallpox and related threats.
• In September 2024, Emergent BioSolutions Inc. confirmed securing approximately $400 million in orders for 2024 and 2025 associated with its smallpox and mpox product portfolio. This total includes an incremental $185 million for the supply of the ACAM2000 vaccine and the VIGIV therapeutic, facilitated by a contract modification with the U.S. government. The President and CEO of Emergent stated that these orders demonstrate the company’s sustained leadership in supplying medical countermeasures for biodefense. The agreement ensures the continued delivery of these critical products to the Strategic National Stockpile, reinforcing domestic preparedness capabilities against serious viral threats like smallpox.
• In July 2024, SIGA Technologies exercised a procurement option valued at approximately $113 million with the U.S. Department of Health and Human Services for the delivery of its oral antiviral drug, TPOXX. This transaction, executed under an existing contract, aims to replenish and maintain the U.S. Strategic National Stockpile’s reserves of orthopoxvirus treatments. The Chief Executive Officer of SIGA remarked that this order is vital for enhancing national preparedness against natural, accidental, or intentional biological threats. The procurement underscores the government's ongoing commitment to securing effective antiviral countermeasures to treat smallpox and related orthopoxvirus infections.

Key Market Players

• Bavarian Nordic A/S
• Chimerix, Inc.
• Pfizer Inc.
• Sanofi SA
• GlaxoSmithKline plc
• Novartis AG
• Johnson & Johnson
• SIGA Technologies, Inc.
• BioCryst Pharmaceuticals, Inc.
• Bharat Biotech International Ltd

By Treatment Type	By Product Type	By End user	By Region
Antiviral Drugs Vaccination Supportive Care	Vaccines Antiviral Drugs	Hospitals & Clinics Ambulatory Care Centers Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Smallpox Treatment Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Smallpox Treatment Market, By Treatment Type:

• Antiviral Drugs
• Vaccination
• Supportive Care

• Smallpox Treatment Market, By Product Type:

• Vaccines
• Antiviral Drugs

• Smallpox Treatment Market, By End user:

• Hospitals & Clinics
• Ambulatory Care Centers
• Others

• Smallpox Treatment Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE