Monkeypox (mpox) Diagnosis Market Driven by Increased Surveillance, Notes Persistence Market Research

The global monkeypox (mpox) diagnosis market has witnessed significant growth in recent years, reflecting the increasing global emphasis on infectious disease surveillance and preparedness. Valued at approximately US$1.95 billion in 2024, the market is projected to reach US$2.4 billion by 2031, advancing at a steady CAGR of 4.4% during the forecast period (2024-2031). This sustained growth is largely driven by heightened awareness following the 2022-2023 global outbreaks, technological advancements in diagnostic testing, and increasing integration of monkeypox testing into broader infectious disease diagnostic panels.

Among the key segments, molecular diagnostic tests lead the market, accounting for nearly 57% of the total market share in 2024. Molecular testing's superior accuracy and sensitivity make it the preferred choice for confirming mpox infections in clinical settings. In terms of samples, skin lesion specimens represent about 63% of total market usage, owing to the high viral concentration present in skin lesions, which ensures accurate detection. Geographically, North America dominates the global market with a 41% share, driven by strong R&D investment, established healthcare infrastructure, and robust regulatory support for diagnostic innovations. The region's leadership reflects both its capacity to respond rapidly to emerging health threats and its ongoing commitment to research and diagnostic advancement.

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Key Highlights from the Report

• Expansion of point-of-care testing (POCT) facilities supports overall market growth.
• Increasing global awareness and surveillance are boosting diagnostic demand.
• Technological advancements in molecular tools are propelling revenue generation.
• Skin lesion specimen segment accounts for 63% of total market share in 2024.
• Integration of monkeypox testing into infectious disease panels drives adoption.
• North America leads the market with approximately 41% revenue share.

Market Segmentation Analysis

The monkeypox (mpox) diagnosis market segmentation provides insights into the product landscape, test types, samples, and end-users shaping global demand.

By Diagnostic Test Type: The market is primarily segmented into molecular tests and antigen detection tests. Among these, molecular diagnostics hold a commanding 57% share in 2024. These tests, particularly polymerase chain reaction (PCR) assays, remain the gold standard for detecting the monkeypox virus due to their high sensitivity and specificity. Molecular tests can detect minute quantities of viral genetic material, ensuring accurate identification even during early infection stages. While antigen detection tests offer quicker turnaround times, they are generally considered less reliable for confirmatory diagnosis, limiting their adoption to point-of-care and screening applications.

By Sample Type: Based on sample collection, the market is categorized into skin lesion specimens, blood, and urine samples. Skin lesion specimens dominate the segment with 63% market share in 2024. The high viral load present in vesicular or pustular lesions enables precise detection, making them the preferred sample for PCR-based testing. These specimens offer a straightforward collection process, enhancing diagnostic efficiency. Blood and urine samples, while used in specific cases, typically serve as supplementary sources, especially in patients without visible lesions.

By End-User: The end-user landscape of the monkeypox diagnosis market includes hospitals and clinics, diagnostic laboratories, and research institutions. Diagnostic laboratories lead in revenue generation, attributed to their established infrastructure, advanced equipment, and expertise in molecular testing. However, the point-of-care testing (POCT) trend is expanding the market presence of hospitals and community clinics, particularly in resource-limited regions where rapid detection is critical for outbreak containment.

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Regional Insights

Regionally, the North American market dominates with approximately 41% market share in 2024, supported by extensive diagnostic infrastructure, government-backed research funding, and the presence of leading diagnostic companies such as Abbott Laboratories, Thermo Fisher Scientific, and Quest Diagnostics. Substantial investment in R&D and high healthcare expenditure continue to reinforce the region's leadership position.

Europe represents another significant market, characterized by strong public health surveillance systems and favorable government initiatives. The European Centre for Disease Prevention and Control (ECDC) has actively promoted mpox testing and reporting, encouraging widespread use of molecular assays.

In the Asia-Pacific region, the market is poised for accelerated growth driven by expanding healthcare infrastructure and increasing awareness of emerging infectious diseases. Countries like India, Japan, and South Korea are investing in diagnostic research and public health preparedness, while regional manufacturers focus on affordable, scalable diagnostic solutions.

The Latin American and Middle Eastern markets are emerging segments, driven by rising cases in tropical regions and efforts to improve diagnostic access. However, these markets face infrastructural and regulatory challenges that could restrain immediate growth. Over time, expanding POCT capabilities and increased collaboration with global health organizations are expected to improve market penetration in these regions.

Market Drivers

The monkeypox (mpox) diagnosis market's steady growth is fueled by several key drivers.

Increasing Global Awareness and Surveillance
The 2022 outbreak served as a critical turning point, raising international awareness about the threat of monkeypox transmission. Governments and global health organizations, including the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC), emphasized early detection and surveillance as vital to outbreak containment. This global response led to the expansion of diagnostic networks, greater funding for public health laboratories, and increased demand for accurate testing kits.

Technological Advancements in Diagnostic Tools
Technological innovation has revolutionized monkeypox diagnosis. Real-time PCR, next-generation sequencing (NGS), and multiplex assays have improved testing speed, precision, and scalability. These advancements have not only enhanced outbreak response but also facilitated integration of monkeypox testing into broader infectious disease platforms. Portable PCR analyzers and digital diagnostic systems have enabled more accessible testing in remote or resource-constrained settings, driving global adoption.

Integration into Broader Infectious Disease Panels
A major trend shaping the market is the integration of mpox testing into multiplex infectious disease panels. This integration enables simultaneous detection of multiple pathogens, optimizing diagnostic workflows and improving patient management efficiency. Such consolidation aligns with the increasing preference for comprehensive disease surveillance approaches in hospitals and laboratories, significantly contributing to market expansion.

Market Restraints

Despite promising growth prospects, the monkeypox (mpox) diagnosis market faces challenges that could impede its expansion.

Limited Diagnostic Infrastructure in Developing Regions
Many low- and middle-income countries lack adequate diagnostic facilities and trained personnel. Limited access to advanced laboratory infrastructure hampers widespread testing, especially in rural areas. Furthermore, competing healthcare priorities, insufficient funding, and low disease awareness constrain the establishment of sustainable diagnostic programs. This uneven distribution of diagnostic capacity may result in underreporting of cases, undermining global surveillance efforts.

Regulatory and Compliance Complexities
The regulatory environment for diagnostic products is stringent and varies across jurisdictions. Companies face challenges in securing approvals from agencies such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). These hurdles can delay product launches and increase development costs. Smaller diagnostic firms, in particular, may struggle to meet compliance requirements, restricting innovation and market entry. The need to adhere to multiple international standards can slow the commercialization of novel tests, hindering overall market momentum.

Market Opportunities

The evolving landscape of infectious disease management presents abundant opportunities for market players in the mpox diagnostic domain.

Expansion of Point-of-Care Testing (POCT)
The growing demand for rapid and decentralized testing is one of the most significant opportunities in the monkeypox diagnosis market. POCT technologies enable healthcare providers to obtain immediate results, reducing dependence on centralized laboratories. The development of portable diagnostic kits, leveraging isothermal amplification and lateral flow assays, could revolutionize outbreak management, especially in regions with limited laboratory access. These innovations not only enhance testing accessibility but also support faster response times, contributing to effective disease containment.

R&D Collaborations and Public-Private Partnerships
Collaboration between public health agencies and diagnostic manufacturers offers another promising growth avenue. Governments and global organizations are increasingly funding research projects to develop scalable and cost-effective testing solutions. Public-private partnerships (PPPs) are expected to drive technological innovation and expand diagnostic reach, particularly in endemic regions.

Integration with Digital Health Platforms
The convergence of diagnostics and digital health technologies presents new opportunities for data-driven disease surveillance. Cloud-based diagnostic platforms and telehealth integration can streamline reporting, enhance traceability, and facilitate real-time outbreak monitoring. As digital transformation accelerates across healthcare systems, mpox diagnostics are expected to benefit from improved connectivity and data management efficiency.

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Company Insights

Key players operating in the monkeypox (mpox) diagnosis market are actively investing in research and development to strengthen their market position and introduce innovative diagnostic solutions. Prominent companies include:

• Abbott Laboratories
• Aegis Sciences Corporation
• Applied DNA Sciences, Inc.
• Becton, Dickinson and Company
• BioGX
• bioMérieux SA
• Bio-Rad Laboratories, Inc.
• CerTest Biotec
• Creative Biogene
• Danaher Corporation
• Flow Health
• Laboratory Corporation of America Holdings
• Mayo Clinic Laboratories
• Quest Diagnostics, Inc.
• Thermo Fisher Scientific Inc.

Market Segmentation

By Diagnostic Test

Antigen Detection Test
Molecular Test

By Sample

Urine
Whole Blood
Skin lesion Specimen

By Region

North America
Latin America
Europe
South Asia & Oceania
East Asia
The Middle East & Africa

Recent Developments

September 2022: Quest Diagnostics received Emergency Use Authorization (EUA) from the U.S. FDA for its laboratory-developed molecular diagnostic test for mpox detection, expanding access to accurate and timely testing across the United States.

June 2022: CerTest Biotec and Becton, Dickinson, and Company (BD) collaborated to develop a molecular diagnostic assay designed to detect the monkeypox virus, further strengthening the molecular testing landscape.

These strategic initiatives highlight the industry's focus on innovation, partnerships, and rapid commercialization to meet evolving diagnostic needs.

Future Outlook and Emerging Trends

The monkeypox (mpox) diagnosis market is entering a phase of consolidation and technological maturity. While the explosive growth observed during the 2022-2023 outbreaks may taper, ongoing surveillance and preparedness measures will sustain steady demand. The next wave of growth will likely stem from automation in laboratory workflows, integration of AI-driven data analytics, and expansion of multiplex testing systems.

Moreover, governments and healthcare organizations are emphasizing pandemic preparedness through enhanced laboratory networks and rapid response mechanisms. The market's evolution will increasingly align with global health priorities that focus on early detection, efficient containment, and sustainable disease monitoring systems.

Conclusion

In conclusion, the monkeypox (mpox) diagnosis market is poised for sustained growth, underpinned by global awareness, technological progress, and increased investment in healthcare infrastructure. With a projected CAGR of 4.4% from 2024 to 2031, the market reflects the ongoing transformation of infectious disease diagnostics. North America's dominance underscores the importance of innovation and R&D investment, while emerging markets offer significant untapped potential as diagnostic capacity expands.

Future market dynamics will be shaped by the continued adoption of molecular testing, the integration of monkeypox diagnostics into broader disease surveillance frameworks, and the widespread implementation of point-of-care testing technologies. As diagnostic manufacturers, research institutions, and public health agencies collaborate to strengthen global health resilience, the monkeypox (mpox) diagnosis market is expected to remain a vital component of the global diagnostic ecosystem, driving both public health preparedness and innovation in molecular medicine.

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