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Report Overview

Monkeypox (Mpox) is a viral zoonotic infection caused by the orthopoxvirus, presenting with fever, rash, and lymphadenopathy. According to Abisola M. Oladimeji et al., 2024, during the 2022–2023 outbreak, the United States reported 31,277 confirmed cases, while Texas accounted for 3,085 cases. Treatment includes antivirals such as tecovirimat, brincidofovir, and cidofovir, alongside JYNNEOS vaccination. As per monkeypox pipeline analysis by Expert Market Research, growing focus on monkeypox drug pipeline, antiviral therapies, vaccine innovation, and emergency preparedness is driving market expansion, with increased R&D investments and improved global preparedness expected to support growth in the coming years.

  • Major companies involved in the monkeypox pipeline analysis include BioNTech SE, Shanghai JunTop Biosciences Co., Ltd., and others.

  • Leading drugs currently in the pipeline include BNT166a, JT118, and others.

  • Advancing antiviral therapies, expanding vaccine candidates, and increased clinical trials are strengthening therapeutic development, supported by rising emerging infectious disease preparedness and accelerated regulatory approvals across global healthcare systems.

Report Coverage

The Monkeypox Pipeline Analysis Report by Expert Market Research gives comprehensive insights into monkeypox therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for monkeypox. The monkeypox report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The monkeypox pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials, including their adverse effects on patients suffering from the condition, and alignment with monkeypox treatment guidelines to ensure optimal care practices.

The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to monkeypox.

Monkeypox Pipeline Analysis by Drug Class

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Monkeypox Pipeline Outlook

Mpox is a viral zoonotic disease caused by an orthopoxvirus that spreads from infected animals and through close human-to-human contact. Transmission occurs via direct contact with lesions, bodily fluids, or contaminated materials, leading to symptoms such as fever, lymph node swelling, fatigue, and a painful vesicular-pustular rash.

Mpox is treated with supportive care including hydration, antipyretics, and pain management, while severe cases may require antiviral therapy such as tecovirimat. Vaccination with Mpox vaccine helps reduce infection risk and transmission in high-risk populations. Mpox drug pipeline includes development of vaccines and antiviral agents targeting orthopoxvirus infection. Candidates such as JYNNEOS continue to support prevention strategies, with ongoing evaluation of immunogenicity and safety in at-risk populations under clinical development programs.

Monkeypox Epidemiology

Recent developments in the pipeline, epidemiology, and incidence trends highlight rising global disease burden. According to Abisola M. Oladimeji et al., 2024, during the 2022–2023 outbreak, the United States reported 31,277 confirmed cases, while Texas accounted for 3,085 cases. As per Chirantan Maity et al., 2026, India recorded its first case in 2022, with 56 total confirmed cases till October 2025, including one death. A shift in circulating clades from IIb to Ib has been observed, indicating evolving transmission dynamics and increasing relevance for antiviral development and Mpox therapeutics pipeline planning.

Monkeypox – Pipeline Therapeutic Assessment

This section of the report covers the analysis of monkeypox drug candidates based on several segmentations, including:

By Phase

The pipeline assessment report covers 50+ drug analyses based on phase:

  • Late-Stage Products (Phase 3 and Phase 4)
  • Mid-Stage Products (Phase 2)
  • Early-Stage Products (Phase 1)
  • Preclinical and Discovery Stage Products

By Drug Class

The monkeypox pipeline analysis report covers 50+ drug analyses based on drug classes:

  • Small Molecules
  • Monoclonal Antibodies
  • Vaccines

By Route of Administration

The pipeline assessment report covers 50+ drug analyses based on the route of administration:

  • Oral
  • Parenteral
  • Others

Monkeypox Pipeline Assessment Segmentation, By Phases

The report covers phase I, phase II, phase III, phase IV, and early-phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to EMR analysis, phase II, at 33%, covers a major share of the total monkeypox clinical trials, drives strong late-stage efficacy validation. Phase III is at 27% with accelerated clinical progression supports near-term approvals, phase I at 20% with early safety assessment strengthens innovation, and phase IV at 20% with post approval monitoring enhances real-world therapeutic expansion.

Monkeypox Pipeline Assessment Segmentation, By Drug Classes

The drug molecule categories covered under the monkeypox pipeline analysis include small molecules, monoclonal antibodies, and vaccines. The monkeypox report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for monkeypox. Antiviral therapies remain the leading drug class in the monkeypox (mpox) treatment pipeline, driven by agents such as tecovirimat, which targets orthopoxvirus replication and supports rapid lesion resolution. Additionally, immune-based therapies and monoclonal antibodies are under evaluation to enhance viral clearance. Moreover, vaccine-based prophylaxis continues to strengthen prevention and outbreak control strategies for mpox management.

Monkeypox Clinical Trials – Key Players

The EMR report for the monkeypox pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed monkeypox therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in monkeypox clinical trials:

  • BioNTech SE
  • Shanghai JunTop Biosciences Co., Ltd.
  • Bavarian Nordic
  • ICON plc
  • SIGA Technologies
  • Emergent BioSolutions
  • Labcorp
  • Sonic Healthcare
  • QIAGEN

Monkeypox – Emerging Drugs Profile

This section covers the detailed analysis of each drug under multiple phases, including phase I, phase II, phase III, phase IV, and emerging drugs for monkeypox. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of monkeypox drug candidates.

Biological: BNT166a

BNT166a is an mRNA-based mpox vaccine candidate being developed by BioNTech SE, with a randomized, double-blind, placebo-controlled Phase II trial currently assessing its safety, reactogenicity, and immunogenicity. The study is examining how two doses of the vaccine, administered at least 28 days apart, stimulate immune responses against Orthopoxvirus in both naïve and experienced healthy adults. The vaccine is being designed to encode target antigens that trigger protective antibody and cellular responses. The trial enrolls approximately 310 participants, with an estimated study completion by June 2027 and a planned participant follow-up duration of around 14 months.

Biological: JT118

JT118 is a recombinant protein vaccine being developed for monkeypox virus (MPXV) prevention, and it is sponsored by Shanghai JunTop Biosciences Co., Ltd. It is a subunit vaccine containing MPXV antigens designed to induce protective immune responses by stimulating antibody-mediated immunity against viral infection. The ongoing Phase I randomized, double-blind, placebo-controlled study is examining its safety, tolerability, and immunogenicity in healthy adults, while exploring single-, two-, and three-dose regimens. The vaccine is being administered to approximately 180 participants, and the study is expected to be completed by November 07, 2027. The trial is evaluating dose-dependent immune response development and preliminary vaccination scheduling strategies.

*Please note that this is only a partial list; the complete list of drugs will be available in the full report.*

Key Questions Answered in the Monkeypox Pipeline Insight Report

  • Which companies/institutions are leading the monkeypox drug development?
  • Which company is leading the monkeypox pipeline development activities?
  • What is the current monkeypox commercial assessment?
  • What are the opportunities and challenges present in the monkeypox pipeline landscape?
  • What is the efficacy and safety profile of monkeypox pipeline drugs?
  • Which company is conducting major trials for monkeypox drugs?
  • Which companies/institutions are involved in monkeypox collaborations aimed at providing enhanced therapeutic alternatives for patients?
  • What are the geographies covered for clinical trials in monkeypox?

Reasons To Buy This Report

The monkeypox pipeline analysis report provides a strategic overview of the latest and future landscape of treatments for monkeypox. It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into monkeypox collaborations, regulatory environments, and potential growth opportunities.

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*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*

Report Summary

Explore our key highlights of the report and gain a concise overview of key findings, trends, and actionable insights that will empower your strategic decisions.

Key Highlights of the Report

Please note that the figures mentioned in the description serve as estimates and may vary from the actual figures presented in the final report.

Scope of the Report

Details

Drug Pipeline by Clinical Trial Phase

  • Late-Stage Products (Phase III and Phase IV)
  • Mid-Stage Products (Phase II)
  • Early-Stage Products (Phase I)
  • Preclinical and Discovery Stage Products

Route of Administration

  • Oral
  • Parenteral
  • Others

Drug Classes

  • Small Molecules
  • Monoclonal Antibodies
  • Vaccines

Leading Sponsors Covered

  • BioNTech SE
  • Shanghai JunTop Biosciences Co., Ltd.
  • Bavarian Nordic
  • ICON plc
  • SIGA Technologies
  • Emergent BioSolutions
  • Labcorp
  • Sonic Healthcare
  • QIAGEN

Geographies Covered

  • North America
  • Europe
  • Asia Pacific
  • Others

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