Monkeypox (mpox) Diagnosis Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2032 - By Product, Technology, Grade, Application, End-user, Region: (North America, Europe, Asia Pacific, Latin America and Middle East and Africa)

The global monkeypox (mpox) diagnosis market is experiencing a notable shift as public health efforts intensify worldwide. The resurgence of monkeypox cases over the past few years has spotlighted the urgent need for rapid, accurate, and accessible diagnostic solutions. With increasing investments in diagnostic infrastructure and innovations in testing technologies, the monkeypox diagnosis market is set to witness steady growth in the coming years.

Market Insights

According to recent analysis, the global monkeypox (mpox) diagnosis market is projected to rise from a valuation of US$2.01 billion in 2025 to reach approximately US$2.78 billion by the end of 2032. The market is anticipated to record a CAGR of 4.71% between 2025 and 2032. This growth is driven by the growing incidence of monkeypox infections, heightened global awareness, integration of diagnostic tools into healthcare systems, and continuous improvements in testing technologies.

Significant progress in diagnostic methods, including molecular and antigen testing, has increased the market's ability to provide early and precise detection. Furthermore, robust initiatives led by global health authorities are contributing to expanded diagnostic coverage, especially in high-risk and resource-limited regions.

Key Market Drivers

Growing Global Awareness and Surveillance Systems

One of the pivotal drivers of the monkeypox diagnosis market is the heightened global awareness stemming from the 2022 and 2023 outbreaks. Governments, NGOs, and healthcare organizations have significantly improved their monitoring and reporting infrastructure. This surge in awareness has led to increased demand for diagnostic tools that ensure timely detection and control of virus spread.

Technological Advancements in Diagnostic Tools

Rapid developments in molecular diagnostic tools, such as real-time polymerase chain reaction (PCR) and next-generation sequencing, have elevated the standard of monkeypox testing. These technologies offer unparalleled accuracy and reliability, making them essential in clinical settings. Additionally, innovations like point-of-care testing (POCT) are revolutionizing how diagnostic services are delivered, particularly in underserved regions.

Integration with Infectious Disease Panels

The ability to integrate monkeypox testing with other infectious disease panels has further fueled market expansion. Multiplex assays that allow the detection of multiple pathogens from a single sample are gaining traction in hospitals and laboratories. This integration not only enhances testing efficiency but also positions monkeypox diagnostics as a crucial component of broader disease management protocols.

Business Opportunities in the Market

Expansion of Point-of-Care Testing (POCT)

One of the most promising opportunities in the monkeypox diagnosis market lies in the continued development of POCT solutions. Portable, easy-to-use diagnostic kits capable of delivering accurate results within minutes are being developed to meet the demand for immediate testing. These tools are particularly valuable in remote and underserved areas where centralized labs are not feasible. Widespread adoption of POCT will not only improve healthcare outcomes but also reduce the burden on centralized diagnostic facilities.

Emerging Markets and Government Initiatives

The expansion of healthcare access and diagnostic infrastructure in emerging markets is expected to significantly contribute to future growth. Governments in Asia, Africa, and Latin America are launching national health programs aimed at improving infectious disease surveillance, including monkeypox. Such programs offer vendors a strategic opportunity to penetrate new regions with high growth potential.

Region-wise Market Outlook

North America

North America leads the monkeypox diagnosis market with a dominant share, primarily due to substantial investment in research and development, presence of advanced healthcare infrastructure, and proactive disease surveillance systems. The region is home to several prominent diagnostic firms actively engaged in launching innovative testing solutions. Moreover, strategic partnerships and a favorable regulatory environment have further enhanced the region's market leadership.

Europe

Europe follows closely, supported by strong government funding, public health initiatives, and high public awareness. Countries like Germany, the UK, and France are at the forefront in terms of diagnostic development and implementation. The presence of globally recognized health research institutions adds to the region’s strategic importance in the market.

Asia Pacific

Asia Pacific is emerging as a key growth region due to rapid urbanization, population density, and an increasing focus on healthcare modernization. While the region still faces infrastructure and regulatory challenges, ongoing initiatives aimed at improving testing accessibility and capacity are expected to create robust growth opportunities over the forecast period.

Middle East & Africa

Despite infrastructure limitations, the Middle East and Africa region holds promise due to the higher likelihood of zoonotic disease transmission. Efforts to strengthen public health systems, coupled with international aid and strategic collaborations, are expected to improve the region’s market performance.

Key Players in the Market

The monkeypox (mpox) diagnosis market is highly competitive, with several global and regional players striving to enhance their product offerings and geographical reach. Prominent companies include:

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

These players are actively engaged in R&D, mergers and acquisitions, and product launches. For instance, in September 2022, Quest Diagnostics received Emergency Use Authorization (EUA) from the U.S. FDA for its monkeypox molecular diagnostic test. Similarly, CerTest Biotec and Becton, Dickinson, and Company collaborated to develop a new molecular diagnostic tool in June 2022.

Challenges Restraining Market Growth

Limited Testing Infrastructure in Developing Regions

Despite growing awareness, many regions, particularly in parts of Africa, South Asia, and Latin America, face challenges due to weak healthcare infrastructure. Limited availability of diagnostic tools and trained professionals may hinder market expansion in these areas.

Regulatory Complexities

Varying regulatory standards across different countries pose a significant barrier for new entrants and smaller firms. The need for approvals from multiple agencies and compliance with international protocols adds complexity to launching new products, slowing down market penetration.

Market Segmentation

By Diagnostic Test:

• Antigen Detection Test
• Molecular Test

The molecular test segment leads the market due to its high accuracy, reliability, and adoption in clinical settings. These tests, particularly PCR, have become a gold standard for monkeypox detection.

By Sample Type:

• Urine
• Whole Blood
• Skin Lesion Specimen

Skin lesion specimens dominate the sample segment owing to the high viral load typically found in these lesions. They remain the preferred sample for most diagnostic procedures.

By Region:

• North America
• Latin America
• Europe
• Asia Pacific
• Middle East & Africa

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