Monkeypox Therapeutics Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Treatment (Smallpox Vaccine, Antivirals, Vaccinia Immune Globulin (VIG)), By End User (Hospitals, Specialty Clinics, Ambulatory Surgical Centers, Others), By Region and Competition, 2020-2030F

Market Overview

The Global Monkeypox Therapeutics Market, valued at USD 87.00 Million in 2024, is projected to experience a CAGR of 9.01% to reach USD 145.99 Million by 2030. Monkeypox therapeutics encompass pharmaceutical interventions, including antiviral drugs and vaccines, primarily utilized for the prevention and treatment of monkeypox virus infections. These interventions address the zoonotic disease characterized by smallpox-like symptoms. The global market for these therapeutics is driven by the increasing incidence of monkeypox outbreaks in various regions. Further impetus stems from governmental initiatives prioritizing public health preparedness, which includes the strategic stockpiling of antiviral treatments and vaccines. Concurrently, heightened public awareness regarding zoonotic diseases and sustained investment in research and development for novel agents contribute to market expansion. According to the World Health Organization (WHO), from January 1, 2022, through November 30, 2024, a cumulative total of 117,663 confirmed cases of mpox were reported globally, underscoring the ongoing demand for therapeutic solutions.

Despite these growth drivers, a significant challenge impeding market expansion is the limited availability of specifically approved therapeutic agents for monkeypox. Current treatment protocols often rely on drugs initially developed for smallpox, which may not always be optimal or widely accessible. This reliance creates a hurdle for rapid and widespread deployment of tailored interventions, especially given evolving viral clades and geographical spread.

Key Market Drivers

The increasing global incidence of monkeypox outbreaks profoundly influences the therapeutics market by creating an urgent and sustained demand for effective treatments and preventative measures. Each new surge in cases directly translates into a heightened need for antiviral drugs and vaccines to manage symptoms, prevent severe disease, and curb transmission. According to the Pan American Health Organization/WHO, in October 2024, an Epidemiological Update reported 109,699 confirmed cases of mpox globally between January 2022 and September 30, 2024, further indicating a monthly increase of 8% in new cases in September 2024 compared to August, underscoring the ongoing spread of the virus and the persistent threat it poses to public health. This rising incidence drives pharmaceutical companies to allocate resources towards research and development, aiming to innovate and expand their portfolio of monkeypox therapeutics.

Concurrently, rising government initiatives and funding for public health preparedness represent a critical accelerator for the global monkeypox therapeutics market. Governments worldwide recognize the imperative of strategic stockpiling and rapid response capabilities to mitigate future outbreaks. These initiatives often include direct procurement agreements with pharmaceutical manufacturers and significant investments in vaccine and antiviral production capacities. According to SIGA Technologies, Inc. , in August 2024, the company announced a procurement order for approximately $113 million of oral TPOXX from the U. S. Government in July 2024, under the 19C BARDA contract, destined for the U. S. Strategic National Stockpile, demonstrating substantial governmental commitment to securing therapeutics. Such proactive measures not only ensure a ready supply of interventions during emergencies but also provide a stable revenue stream and incentive for therapeutic development. Overall, the market for global monkeypox therapeutics saw significant activity, with product sales for SIGA Technologies, Inc. reaching $44.6 million for the first six months of 2024, as reported by the company in August 2024.

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Key Market Challenges

The limited availability of specifically approved therapeutic agents for monkeypox presents a substantial challenge to the growth of the Global Monkeypox Therapeutics Market. Current treatment protocols frequently depend on drugs originally developed for smallpox, which may not consistently prove optimal or widely accessible for monkeypox virus infections. This reliance creates a significant barrier to the rapid and widespread deployment of tailored interventions, particularly when considering evolving viral clades and diverse geographical spread.

The absence of bespoke treatments impedes market expansion by limiting the scope for product innovation and specialized market segments. This situation is further exacerbated by broader trends in pharmaceutical research and development. According to the European Federation of Pharmaceutical Industries and Associations (EFPIA), in 2023, the European Economic Area's share of global commercial clinical trial starts across all therapy areas declined to 9%. This general reduction in clinical trial activity within a key pharmaceutical region underscores the existing hurdles in developing and bringing novel medicines to market, which directly affects emerging therapeutic areas such as monkeypox. This reliance on repurposed drugs, coupled with the slow pace of new drug development, restricts the market's potential for growth and its ability to respond effectively to public health needs.

Key Market Trends

The global monkeypox therapeutics market is experiencing significant evolution, driven by shifts in drug development and preventative strategies. One prominent trend is the **Evolution Towards Oral Antiviral Therapeutic Options**. This movement is crucial for improving patient access, adherence, and facilitating outpatient care, thereby easing the burden on healthcare infrastructure. Oral formulations offer a more convenient alternative to intravenous treatments, which can be critical during outbreaks. For example, NanoViricides, Inc. announced in July 2025 the near-finalization of its adaptive Phase II clinical trial protocol for NV-387, a novel oral antiviral designed to treat monkeypox virus infections, highlighting the ongoing efforts to develop user-friendly treatment options. This aligns with a broader pharmaceutical industry trend where oral drug development remains a priority due to its patient-centric benefits.

Concurrently, the **Advancement of Next-Generation Vaccine Technologies** is profoundly impacting the preventative landscape of monkeypox. These technologies, including mRNA and viral vector platforms, promise enhanced efficacy, durability, and adaptability against evolving viral strains. Such innovations are vital for bolstering global preparedness and response capabilities. BioNTech, in partnership with the Coalition for Epidemic Preparedness Innovations (CEPI), commenced a Phase 1/2 clinical trial in September 2023 for its mRNA-based mpox vaccine program, BNT166, demonstrating the commitment to leveraging advanced platforms for prevention. According to the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), manufacturers affiliated with IFPMA accounted for approximately 83% of the total financial value in the global vaccine market in 2023, reflecting substantial investment and innovation within the vaccine sector.

Segmental Insights

The Smallpox Vaccine segment is the fastest-growing component within the Global Monkeypox Therapeutics Market. This rapid expansion is primarily driven by the established cross-protection these vaccines offer against monkeypox, stemming from the genetic and antigenic similarities between the two Orthopoxviruses. Heightened global monkeypox outbreaks, particularly in non-endemic regions, have underscored the critical need for effective preventive measures. Consequently, regulatory bodies such as the U. S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have facilitated swift deployment through emergency use authorizations and accelerated approval processes. Furthermore, governments and international health organizations are actively implementing vaccination campaigns and strategically stockpiling these vaccines, responding to a significant decline in population-level immunity following the cessation of routine smallpox vaccination decades ago.

Regional Insights

North America leads the Global Monkeypox Therapeutics Market due to its advanced healthcare infrastructure, which facilitates efficient drug delivery and administration. The region benefits from robust research and development capabilities, with substantial investments in vaccine production, antiviral drugs, and clinical trials by key pharmaceutical and biotechnology entities. Furthermore, strong government initiatives and funding from regulatory bodies, such as the Centers for Disease Control and Prevention (CDC) and the U. S. Food and Drug Administration (FDA), drive research, administer vaccines, and support outbreak control measures. High healthcare expenditure also ensures ample resources for procuring advanced treatments and widespread public awareness regarding monkeypox, contributing to its market leadership.

Recent Developments

• In July 2025, Emergent BioSolutions Inc. announced the publication of a comprehensive review article, "Brincidofovir in the Era of Mpox," in the peer-reviewed journal Expert Review of Anti-infective Therapy. The article provides an overview of brincidofovir, an investigational antiviral also known as Tembexa, including in vitro and in vivo data, human case studies, and its current evaluation for treating mpox infections in adults and pediatric patients within the Democratic Republic of Congo. This research highlights the ongoing efforts to assess brincidofovir's potential as an antiviral in response to the sustained global mpox threat, with its evaluation continuing in the MpOx Study in Africa (MOSA) clinical trial.

• In August 2024, Tonix Pharmaceuticals and Bilthoven Biologicals announced a collaboration to advance the development of TNX-801, Tonix's mpox vaccine candidate. Bilthoven Biologicals, a part of the Cyrus Poonawalla Group, is tasked with developing Good Manufacturing Practice (GMP) manufacturing processes for the vaccine. This strategic partnership aims to address the global need for accessible and affordable mpox vaccines, particularly in light of the World Health Organization's declaration of mpox as a public health emergency. TNX-801, a live virus vaccine based on horsepox, has previously demonstrated positive preclinical efficacy, providing protection to non-human primates against lethal monkeypox challenge.

• In August 2024, Sanyou Biopharmaceuticals (Shanghai) Co., Ltd. introduced a comprehensive product line specifically designed to target monkeypox. This extensive launch includes 65 distinct items across three key categories: 26 natural epitope antigens, 28 high-affinity monoclonal antibodies, and 11 overexpression cell lines. The products are engineered to engage multiple critical sites on the monkeypox virus surface, vital for viral infection and assembly. Developed using the company's proprietary "over-trillion innovative antibody discovery" platform, these offerings are intended to bolster the development of vaccines, therapeutics, diagnostic tools, and research initiatives within the global monkeypox therapeutics market.

• In August 2024, SIGA Technologies received topline results from the Phase II PALM007 clinical trial for its antiviral drug TPOXX (tecovirimat). The study indicated that the treatment was ineffective against clade I mpox, the strain responsible for the ongoing outbreak in Africa. This research, which involved approximately 600 patients, demonstrated that TPOXX did not significantly outperform a placebo in accelerating lesion resolution. Furthermore, interim analysis in December 2024 from the STOMP study also revealed that tecovirimat failed to improve the time to lesion resolution for adults with mild to moderate clade II mpox, resulting in the discontinuation of patient enrollment.

Key Market Players

• Chimerix Inc.
• SIGA Technologies, Inc.
• Emergent BioSolutions Inc.
• Bavarian Nordic A/S
• Hetero Drugs Limited
• Mylan N.V.
• Piramal Enterprises Limited
• Olon S.p.A.
• Teva Pharmaceutical Industries Limited
• CIDIC Company Limited

Report Scope:

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

• Monkeypox Therapeutics Market, By Treatment:

o   Smallpox Vaccine

o   Antivirals

o   Vaccinia Immune Globulin (VIG)

• Monkeypox Therapeutics Market, By End User:

o   Hospitals

o   Specialty Clinics

o   Ambulatory Surgical Centers

o   Others

• Monkeypox Therapeutics Market, By Region:

o   North America

§  United States

§  Canada

§  Mexico

o   Europe

§  France

§  United Kingdom

§  Italy

§  Germany

§  Spain

o   Asia Pacific

§  China

§  India

§  Japan

§  Australia

§  South Korea

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies presents in the Global Monkeypox Therapeutics Market.

Available Customizations:

Global Monkeypox Therapeutics Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

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