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 phase of consistent development as awareness around infectious disease surveillance grows. Following a global health scare caused by a spike in monkeypox cases in recent years, there has been a significant shift in public health priorities. This has created new opportunities and demand for reliable diagnostic solutions across global healthcare systems.

The market is expected to grow from an estimated value of US$2.01 billion in 2025 to approximately US$2.78 billion by 2032, expanding at a CAGR of 4.71% during the forecast period from 2025 to 2032. The growth is being powered by advances in diagnostic technology, an increased focus on point-of-care testing, and enhanced disease surveillance efforts across regions.

Market Insights

The resurgence of monkeypox cases, particularly from 2022 onward, has emphasized the need for timely and precise diagnostic tools. Growing adoption of molecular diagnostic testing and improved healthcare preparedness are contributing to the market’s expansion. The increasing availability of multiplex panels that include monkeypox testing is also helping integrate mpox diagnostics into routine infectious disease testing.

In parallel, many countries have introduced targeted initiatives to increase testing, especially in high-risk populations. Diagnostic firms are responding by developing innovative technologies, ranging from real-time PCR to portable testing kits, thus improving both accessibility and accuracy.

Market Drivers

Global Focus on Early Detection and Surveillance

In the wake of multiple monkeypox outbreaks, healthcare systems worldwide have prioritized surveillance and early detection. This has driven significant investment in diagnostic infrastructure, especially in nations with a history of zoonotic disease outbreaks. Global health agencies have emphasized continued vigilance, encouraging the development and deployment of reliable and easy-to-use diagnostic tests.

Technological Advancement in Molecular Testing

Recent years have seen rapid innovation in molecular testing technologies. High-precision tools like PCR and next-generation sequencing have been increasingly adopted due to their high sensitivity and accuracy. These technologies have become the preferred method for monkeypox diagnosis in clinical settings, allowing for early detection and effective disease containment.

Integration of Mpox Testing into Broader Disease Panels

Healthcare providers are now adopting broader diagnostic approaches that incorporate monkeypox testing into multi-pathogen panels. These panels are highly effective in clinical workflows, particularly where patients present with symptoms that overlap with other infectious diseases. This integration improves diagnosis speed, resource efficiency, and widens the reach of monkeypox testing.

Opportunities for Market Players

Expansion of Point-of-Care Testing (POCT)

The rising demand for faster diagnosis, especially in remote areas and developing countries, has created a strong case for the expansion of point-of-care testing. Portable and user-friendly diagnostic kits that deliver results within minutes are being developed and deployed. This shift toward decentralized testing could lead to improved disease tracking, reduced laboratory workload, and faster response during outbreaks.

Emerging Market Potential

Emerging regions in Asia, Latin America, and Africa represent untapped potential for diagnostic service providers. Efforts by governments and international health organizations to strengthen public healthcare infrastructure in these areas are opening doors for diagnostic manufacturers to enter new and underserved markets.

Regional Analysis

North America

North America is set to maintain its leadership in the monkeypox diagnosis market due to its robust healthcare infrastructure, high healthcare expenditure, and proactive approach to disease control. The region benefits from strong R&D funding and is home to some of the world's most prominent diagnostics companies, helping it dominate the global market.

Europe

Europe remains a significant market, bolstered by public health initiatives and coordinated strategies to control infectious diseases. The region's emphasis on research, along with support from regulatory bodies, is fostering the adoption of advanced diagnostic technologies.

Asia Pacific

Asia Pacific is an emerging hotspot for growth in the monkeypox diagnosis market. With a growing population, increased healthcare investments, and the presence of zoonotic disease risks, countries in this region are adopting more sophisticated diagnostic solutions.

Middle East & Africa

While the Middle East & Africa face infrastructure challenges, rising public health awareness and increasing international collaboration are expected to support market development. Efforts are underway to improve diagnostic capabilities and increase accessibility in rural areas.

Competitive Analysis

The monkeypox diagnosis market features a blend of multinational giants and emerging biotechnology firms. Market leaders such as Abbott Laboratories, Thermo Fisher Scientific, and Quest Diagnostics continue to drive innovation and scale. At the same time, smaller players and regional manufacturers are entering the market with novel technologies aimed at improving cost-effectiveness and accessibility.

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

These players are enhancing their market presence through strategic partnerships, product launches, and regulatory approvals. For instance, in September 2022, Quest Diagnostics secured Emergency Use Authorization (EUA) from the U.S. FDA for its monkeypox molecular test. In June 2022, CerTest Biotec and Becton, Dickinson, and Company collaborated on a new molecular diagnostic solution targeting monkeypox.

Challenges Impacting Market Growth

Infrastructure Gaps in Low-Income Countries

Many developing regions continue to lack essential testing infrastructure. Limited access to advanced diagnostics, trained healthcare personnel, and reliable logistics remain key hurdles. These challenges restrict timely diagnosis and effective disease management, curbing market expansion.

Regulatory Hurdles

Complex and inconsistent regulatory environments across different countries pose barriers to entry and slow down innovation. The high cost and time required for test approvals and certifications can discourage small manufacturers and delay market launches, affecting overall growth potential.

Market Segmentation

By Diagnostic Test Type:
• Antigen Detection Test
• Molecular Test

Molecular tests are expected to remain the leading segment due to their precision, reliability, and widespread application in clinical settings.

By Sample Type:
• Urine
• Whole Blood
• Skin Lesion Specimen

Skin lesion specimens dominate the sample segment, as these typically contain the highest concentration of the virus and are preferred in standard diagnostic protocols.

By Region:
• North America
• Latin America
• Europe
• Asia Pacific
• Middle East & Africa

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