PUBLISHER: Global Industry Analysts, Inc. | PRODUCT CODE: 1794495
PUBLISHER: Global Industry Analysts, Inc. | PRODUCT CODE: 1794495
Global Mpox Diagnostics Market to Reach US$2.2 Billion by 2030
The global market for Mpox Diagnostics estimated at US$1.9 Billion in the year 2024, is expected to reach US$2.2 Billion by 2030, growing at a CAGR of 2.7% over the analysis period 2024-2030. Antigen Detection Test, one of the segments analyzed in the report, is expected to record a 2.1% CAGR and reach US$1.5 Billion by the end of the analysis period. Growth in the Molecular Test segment is estimated at 4.0% CAGR over the analysis period.
The U.S. Market is Estimated at US$515.4 Million While China is Forecast to Grow at 5.0% CAGR
The Mpox Diagnostics market in the U.S. is estimated at US$515.4 Million in the year 2024. China, the world's second largest economy, is forecast to reach a projected market size of US$426.1 Million by the year 2030 trailing a CAGR of 5.0% over the analysis period 2024-2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at a CAGR of 1.0% and 2.0% respectively over the analysis period. Within Europe, Germany is forecast to grow at approximately 1.5% CAGR.
Global Mpox Diagnostics Market - Key Trends & Drivers Summarized
Why Is There Renewed Focus on Diagnostic Solutions for Mpox?
Mpox diagnostics have gained renewed urgency due to changing patterns in disease outbreaks, increasing global surveillance efforts, and a shift in case detection priorities. Earlier, mpox was largely endemic to specific regions, but recent cross-border transmission has made timely diagnosis a public health priority. Diagnosis plays a central role in early case isolation, outbreak tracking, and contact tracing. To ensure speed and accuracy, diagnostic tools now focus on lesion-based sampling rather than traditional serological approaches.
Laboratory testing continues to rely primarily on nucleic acid amplification methods. These techniques detect the presence of viral DNA in skin lesions and scabs. Testing accuracy is highest when samples are collected from active lesions, avoiding potential variability in viral load from blood samples. Focus has shifted toward tools that allow rapid, reliable, and decentralized testing, particularly in regions with limited access to advanced laboratory infrastructure. Simplification of sample collection and faster processing times are increasingly important design factors for new diagnostic platforms.
What Makes PCR-Based Testing the Benchmark in Current Practice?
PCR-based testing remains the foundation for accurate mpox diagnosis. This method is highly sensitive and specific, detecting even low quantities of viral DNA. Real-time PCR assays are currently the most trusted platform used in clinical settings and public health laboratories. These tests target specific regions of the mpox virus genome, allowing differentiation between clades and confirmation of infection status. Several types of PCR systems exist, ranging from lab-based analyzers to portable, cartridge-based units designed for point-of-care use.
New molecular diagnostic platforms are emerging to improve access and reduce turnaround times. Some allow testing in under one hour, supporting faster decision-making in outbreak settings. These systems are particularly useful where rapid patient triage and isolation are needed. In addition to centralized testing, portable molecular platforms are gaining relevance for use in field hospitals, border entry points, and mobile health units. Emphasis remains on operational simplicity, minimal technical training, and compatibility with existing healthcare workflows.
Why Have Rapid Antigen Tests Failed to Meet Diagnostic Standards?
Antigen-based rapid diagnostic tests have not yet proven reliable for mpox detection. While some show high specificity, their sensitivity is consistently low. Most antigen tests struggle to detect lower viral loads, especially in early or healing stages of infection. Their inability to detect asymptomatic or pre-symptomatic cases limits their use in surveillance or early response. This limitation restricts their role to supplementary screening rather than standalone diagnosis. Due to these constraints, health authorities do not currently endorse these tests for clinical use.
In response to these gaps, development efforts are shifting toward improved molecular tools and novel detection technologies. Some diagnostic tools now combine molecular detection with digital readouts or remote monitoring features. Experimental systems using AI-assisted image recognition to assess lesion photographs are also being evaluated. These tools aim to support diagnosis in remote locations where laboratory facilities are unavailable. However, such systems require further clinical validation before they can be used widely.
What Factors Are Driving Growth in the Mpox Diagnostics Market?
Growth in the mpox diagnostics market is driven by several factors. Rising frequency of outbreaks and their geographic spread has increased the demand for faster detection tools. Expanded use of point-of-care PCR devices is helping reduce testing delays in rural and low-resource settings. Integration of molecular diagnostics into outbreak response kits is enabling early containment. Increased investment in portable platforms that operate without extensive laboratory infrastructure is encouraging market participation from new manufacturers.
Greater emphasis on decentralized testing and mobile diagnostics is aligning with public health goals in developing countries. Uptake of digital health tools that link test results with surveillance databases is also contributing to efficient outbreak management. Growing need for differential diagnosis due to overlapping symptoms with other skin or febrile illnesses is raising the importance of high-specificity assays. Ongoing product approvals and regulatory guidance for emergency use of new diagnostic platforms continue to support product innovation and regional accessibility.
SCOPE OF STUDY:
The report analyzes the Mpox Diagnostics market in terms of units by the following Segments, and Geographic Regions/Countries:
Segments:
Diagnostic Test (Antigen Detection Test, Molecular Test); Sample (Urine Sample, Whole Blood Sample, Skin Lesion Specimen Sample)
Geographic Regions/Countries:
World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; Spain; Russia; and Rest of Europe); Asia-Pacific (Australia; India; South Korea; and Rest of Asia-Pacific); Latin America (Argentina; Brazil; Mexico; and Rest of Latin America); Middle East (Iran; Israel; Saudi Arabia; United Arab Emirates; and Rest of Middle East); and Africa.
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