Monkeypox (mpox) Diagnosis Market Outlook Strengthened by Rapid Testing Developments, Says Persistence Market Research

The global monkeypox (mpox) diagnosis market is set for steady growth over the forecast period, with projections indicating an increase from US$1.95 billion in 2024 to US$2.4 billion by 2031. This represents a compound annual growth rate (CAGR) of 4.4% from 2024 to 2031. This growth trajectory is fueled by advancements in diagnostic technologies, increased awareness of the disease, and rising investments in public health infrastructure.

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Key Highlights of the Market

Expansion of point-of-care testing (POCT) solutions is one of the key drivers of the market's growth, making diagnostic tools more accessible.

The global awareness and surveillance of monkeypox (mpox) have significantly increased the demand for diagnostic solutions.

Technological innovations, such as the integration of advanced diagnostic tools, have enabled more accurate and efficient testing, boosting market revenue.

The skin lesion specimen segment is expected to account for 60% of the total market share in 2024, reflecting the virus's characteristic symptoms.

North America dominates the monkeypox diagnosis market, contributing 41% of the market share in 2024, owing to significant investments in research and healthcare systems.

The molecular diagnostic test segment holds a major share, comprising 57% of the market in 2024, due to its accuracy and reliability in detecting the virus.

Market Dynamics

Drivers of Market Growth

Increasing Awareness and Surveillance: The surge in monkeypox cases in 2022 and 2023 raised global awareness, prompting governments and organizations like the World Health Organization (WHO) to enhance surveillance and detection measures. This has led to higher demand for diagnostic solutions, especially in regions with limited healthcare infrastructure.

Technological Advancements: Advancements in molecular diagnostic technologies such as real-time PCR and next-generation sequencing are crucial drivers. These technologies offer higher accuracy, speed, and sensitivity compared to traditional diagnostic methods, expanding their use in clinical settings.

Point-of-Care Testing (POCT): The growing demand for rapid and decentralized testing has spurred the development of point-of-care diagnostic tools, making it easier to detect monkeypox at the onset of symptoms. POCT solutions offer the advantage of rapid results, enabling better containment and management of outbreaks.

Restraints on Market Growth

Limited Awareness and Infrastructure in Developing Regions: While awareness is increasing globally, many developing countries still lack the necessary healthcare infrastructure to implement widespread testing for monkeypox. The scarcity of trained personnel and diagnostic equipment remains a significant barrier to market growth in these regions.

Regulatory Challenges: The regulatory process for diagnostic tools can be slow and costly, especially in regions with strict guidelines for healthcare products. This can delay the introduction of new diagnostic technologies and hinder market expansion.

Opportunities in the Market

Expansion of POCT: The rise in demand for rapid, accessible diagnostics presents an opportunity for market players to develop portable and user-friendly testing kits. These tools could revolutionize the management of monkeypox outbreaks, particularly in remote and underserved areas.

Integration into Broader Infectious Disease Panels: As healthcare providers increasingly adopt multiplex testing platforms that can detect multiple pathogens simultaneously, integrating monkeypox testing into these panels presents a significant opportunity. This would streamline diagnostic workflows and enhance the demand for monkeypox diagnostics as part of broader infectious disease management strategies.

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Category-wise Analysis

Diagnostic Test Segment

The monkeypox (mpox) diagnosis market is primarily divided into two categories based on diagnostic tests: molecular tests and antigen detection tests. Among these, molecular diagnostic tests dominate the market, accounting for 57% of the market share in 2024. These tests, which utilize polymerase chain reaction (PCR) methods, offer a high level of sensitivity and accuracy in detecting the monkeypox virus by identifying its genetic material. The molecular tests, though more time-consuming, remain the preferred choice in clinical settings due to their reliability.

Sample Segment

In terms of sample types, the skin lesion specimen segment is expected to hold the largest market share, approximately 63% in 2024. Monkeypox is commonly identified through skin lesions, which are the hallmark of the disease. These lesions are typically swabbed or sampled to confirm the presence of the virus, making them the most reliable specimen type for accurate diagnosis.

Regional Insights

North America Leads the Market

North America is expected to lead the monkeypox diagnosis market, contributing approximately 41% of the market share in 2024. The region's dominance is driven by substantial investments in medical research and development, the presence of major diagnostic companies, and a well-established healthcare infrastructure. High demand for accurate diagnostic solutions and rising awareness of the importance of early detection further propel market growth in this region.

Europe and Asia Pacific

Europe and the Asia Pacific regions are also expected to see steady growth in the market. In Europe, countries with advanced healthcare systems and strong regulatory frameworks will continue to invest in diagnostic infrastructure. The Asia Pacific region, particularly countries like India and China, presents an opportunity for significant market expansion due to increasing healthcare investments and the need for improved diagnostic capabilities in light of rising disease outbreaks.

Competitive Landscape

The monkeypox (mpox) diagnosis market is highly competitive, with several established players and emerging companies vying for market share. Key players include Roche, Abbott Laboratories, Cepheid, and Thermo Fisher Scientific. These companies dominate the market through the development of advanced diagnostic solutions, strong global distribution networks, and strategic initiatives, including mergers, acquisitions, and partnerships.

Smaller companies and biotech startups are also increasingly entering the market, offering innovative solutions like rapid antigen tests and multiplex assays. Regional players, particularly in high-risk regions, are focusing on providing cost-effective diagnostic solutions, contributing to the growing competition.

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Recent Developments in the Market

Recent industry developments highlight the ongoing efforts to improve diagnostic capabilities for monkeypox. In 2022, Quest Diagnostics received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its laboratory-developed molecular diagnostic test for monkeypox. Similarly, CerTest Biotec and Becton, Dickinson, and Company collaborated in June 2022 to create a molecular diagnostic test designed to detect the virus. These developments reflect the industry's commitment to addressing the growing demand for reliable and accessible diagnostic tools.

Future Outlook for the Monkeypox Diagnosis Market

The future of the monkeypox diagnosis market appears promising, with steady growth driven by ongoing technological advancements, increased awareness, and the expansion of point-of-care testing. Although the immediate threat of large-scale outbreaks may subside, the focus will shift to long-term preparedness, including the integration of monkeypox testing into broader infectious disease panels and enhancing diagnostic infrastructure globally.

The market is expected to benefit from the continued development of innovative diagnostic tools, including next-generation sequencing and multiplex assays, which will enable more efficient and rapid detection of multiple pathogens simultaneously. As the global healthcare landscape continues to evolve, the monkeypox diagnosis market will play a vital role in ensuring rapid identification and containment of future outbreaks.

Conclusion

The monkeypox (mpox) diagnosis market is poised for steady growth, underpinned by technological advancements, an increasing focus on global health surveillance, and the rising demand for rapid, accessible diagnostic solutions. While challenges such as infrastructure limitations in developing regions and regulatory hurdles exist, the market presents ample opportunities for players to capitalize on innovations, particularly in point-of-care testing and the integration of monkeypox diagnostics into broader infectious disease panels. With a robust competitive landscape and ongoing developments, the market is set to continue its upward trajectory, contributing to improved public health preparedness worldwide.

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