Monkeypox (mpox) Diagnosis Market Size, Share and Growth Forecast for 2024 -2031

The monkeypox (mpox) diagnosis market is estimated to increase from US$1.95 Bn in 2024 to US$2.4 Bn by 2031. The market is projected to record a CAGR of 4.4% during the forecast period from 2024 to 2031.

Key Highlights of the Market

• Expansion of point-of-care testing (poct) facilities is catering to the overall growth of the monkeypox (mpox) diagnosis market.
• Increasing awareness and surveillance boosts the market’s demand across the world.
• High-end technological advancements in diagnostic tools aids the market’s revenue generation over the forecast period.
• Based on sample, skin lesion specimen segment to account for 60% of the total market share in 2024.
• Integration of monkeypox testing into broad infectious disease panels is one of the crucial market driving elements.
• North America dominates the market accumulating around 41% of the market share.
• Based on diagnostic test, molecular test segment accounts for 55% of the total market share.

There is substantial investment in medical research and development in North America. This includes funding for developing new diagnostic methods and improving existing ones, which contributes to the region's leadership in the market.

The market in North America is characterized by high demand for medical diagnostics supported by well-established healthcare systems and significant healthcare expenditure. This creates a favorable environment for the development and distribution of diagnostic tests.

North America dominates market with a revenue share of around 41% in 2024 owing to the presence of many leading players and their various strategic initiatives. Increase in the prevalence of monkeypox and rising awareness among people regarding vaccination are expected to spur regional market expansion.

Based on diagnostic test, the monkeypox (mpox) diagnosis market is segmented into antigen detection test and molecular test. Among these, the molecular test segment dominates the market.

Molecular diagnostic test dominates the market in terms of revenue and clinical use due to their accuracy and reliability. These tests detect the genetic material of a pathogen using techniques like polymerase chain reaction. Typically, they require more time, ranging from several hours to a few days. Molecular tests are extensively used in clinical settings, especially for detecting diseases like influenza where precision is critical.

Based on sample, the monkeypox diagnosis market is categorized into urine, whole blood and skin lesion specimen. Among these, the skin lesion specimen segment dominates the monkeypox (mpox) diagnosis market.

Monkeypox typically presents with characteristic skin lesions such as rashes, pustules, or scabs. These lesions contain high concentrations of the virus making skin lesion specimens the most reliable and preferred sample for diagnosis. Diagnostic methods like PCR are highly effective when applied to samples from skin lesions.

For many viral infections, including monkeypox, skin lesion specimens are commonly used in diagnostic protocols. The presence of lesions allows for straightforward collection of samples, which can then be tested in a laboratory setting to confirm the diagnosis.

Monkeypox testing involves the diagnostic procedures employed to identify the existence of the monkeypox virus in a person. Monkeypox is a viral illness that can be transmitted from animals to humans and is comparable to smallpox, although typically less severe in its symptoms.

The resurgence of monkeypox outbreaks, particularly the global increase in cases observed in 2022 and 2023, has heightened the demand for diagnostic tools. For instance, in 2022, the World Health Organization (WHO) reported a significant surge in monkeypox cases worldwide, leading to heightened awareness and the need for robust diagnostic solutions

Specimens are obtained from cutaneous lesions, which may involve swabbing the lesion's surface or collecting fluids from the vesicles and pustules. Throat swabs, blood, urine, or other body fluids may sometimes be utilized.

The rapid progress in diagnostic research is a major catalyst for the monkeypox testing industry. The diagnostic method is widely regarded as the most reliable and accurate for detecting monkeypox, as it provides both high sensitivity and specificity.

Multiple real-time PCR assays have been created to target various segments of the monkeypox viral genome, offering a dependable detection method. The implementation of many government programs aimed at enhancing the provision, dissemination, and accessibility of vaccinations to prevent infections is expected to drive monkeypox (mpox) diagnosis market expansion in the future.

The Health Resources and Services Administration was granted a certain amount of JYNNEOS for immediate dissemination to the Ryan White HIV/AIDS Program (RWHAP) to augment the immunization rate among the population at high risk.

The monkeypox (mpox) diagnosis market saw significant growth pre-2023, driven by the global response to the 2022 outbreak. With rising cases across multiple countries, there was an urgent need for accurate and rapid diagnostic tools.

Governments, healthcare organizations, and private companies invested heavily in developing PCR-based tests, point-of-care diagnostics, and serological assays. This led to a robust market expansion, supported by increased awareness, regulatory approvals, and the scaling up of production capacities.

Post-2024, the monkeypox (mpox) diagnosis market is expected to stabilize and mature with growth driven by ongoing surveillance efforts and the integration of monkeypox testing into broader infectious disease panels.

The market is likely to benefit from technological advancements, such as next-generation sequencing and multiplex assays, which allow for the simultaneous detection of multiple pathogens. Expanding diagnostic infrastructure in emerging markets and incorporating monkeypox testing in routine healthcare settings will further support market growth.

The pace of growth may moderate as the immediate outbreak subsides, with the market shifting focus towards long-term preparedness and outbreak prevention strategies. The market is expected to grow steadily, reflecting a balanced demand driven by public health needs and advancements in diagnostic technologies.

Increasing Global Awareness and Surveillance

The 2022 monkeypox outbreak significantly raised global awareness about the disease leading to enhanced surveillance and reporting systems. Governments and health organizations worldwide recognized the importance of early detection to control the spread of the virus, prompting investments in diagnostic infrastructure. This heightened awareness has driven the demand for accurate and accessible monkeypox testing, particularly in regions with limited diagnostic capabilities.

As global health bodies like the World Health Organization (WHO) emphasize ongoing surveillance, the need for reliable diagnostic tools is expected to continue growing. This driver is crucial as it ensures that countries remain vigilant and prepared for future outbreaks, sustaining the demand for diagnostic solutions.

Technological Advancements in Diagnostic Tools

Technological innovations are a significant growth driver in the monkeypox (mpox) diagnosis market. Advances in molecular diagnostics, such as real-time PCR and next-generation sequencing, have improved the accuracy, speed, and accessibility of monkeypox testing.

The development of point-of-care testing solutions allows for rapid diagnosis in decentralized settings, making it easier to identify and contain outbreaks. These advancements not only enhance the effectiveness of diagnosis but also expand the market by making testing more accessible in resource-limited regions.

As technology continues to evolve, the market is likely to see the introduction of even more sophisticated and user-friendly diagnostic tools driving market growth further.

Integration of Monkeypox Testing into Broader Infectious Disease Panels

The integration of monkeypox testing into broader infectious disease panels is a key growth driver. Healthcare providers are increasingly adopting multiplex testing platforms that can simultaneously detect multiple pathogens, including monkeypox, using a single sample. This approach is particularly valuable in managing outbreaks and in settings where differential diagnosis is critical.

By incorporating monkeypox into routine infectious disease panels, the market for diagnostics is set to expand as these tests become a standard part of healthcare protocols. The integration not only enhances the efficiency of diagnostic workflows but also increases the overall demand for monkeypox testing as part of comprehensive infectious disease management strategies.

Limited Awareness and Testing Infrastructure in Developing Regions

Despite increased global awareness, many developing regions still need to improve in terms of healthcare infrastructure and access to diagnostic tools. The need for sufficient testing facilities, trained personnel, and resources to support widespread diagnostic efforts can hinder the growth of the monkeypox (mpox) diagnosis market in these areas.

Limited public health funding and competing healthcare priorities may result in lower monkeypox diagnostics investments. This disparity in access can slow the market’s overall expansion, particularly in regions where outbreaks are more likely to occur due to factors like high population density and proximity to wildlife reservoirs.

Regulatory and Compliance Challenges

The regulatory landscape for diagnostic tools can be complex and varies significantly across different countries. Obtaining the necessary approvals for new diagnostic tests can be time-consuming and costly, particularly in regions with stringent regulatory requirements.

The need for compliance with various international standards and guidelines can create barriers to market entry, especially for smaller companies or those needing more resources to navigate these challenges. The regulatory hurdles can delay the introduction of new diagnostic tools, limit market expansion, and slow the adoption of innovative technologies, ultimately restraining the growth of the monkeypox (mpox) diagnosis market.

Expansion of Point-of-Care Testing (POCT)

One of the most transformative opportunities in the monkeypox diagnosis market is the expansion of point-of-care testing (POCT). As the demand for rapid and accessible diagnostic solutions grows, POCT offers a way to provide immediate results, particularly in remote or resource-limited settings.

The development of portable, easy-to-use diagnostic kits that can deliver accurate results within minutes has the potential to revolutionize how monkeypox and other infectious diseases are managed. The shift toward decentralization of testing could lead to faster identification of cases, better containment of outbreaks, and more efficient allocation of healthcare resources.

POCT can significantly reduce the burden on centralized laboratories making it easier for healthcare systems to respond swiftly to emerging health threats.

The monkeypox (mpox) diagnosis market is competitive with key players including Roche, Abbott Laboratories, Cepheid, and Thermo Fisher Scientific dominating through advanced molecular diagnostic technologies and extensive global distribution networks.

Several small biotech firms and startups are emerging, focusing on innovative diagnostic tools like rapid antigen tests and multiplex assays. Competition is also driven by regional manufacturers in areas with high disease prevalence, aiming to provide cost-effective solutions. The market's competitiveness is further intensified by ongoing research and development, strategic partnerships, and acquisitions as companies strive to enhance their diagnostic portfolios and expand their global reach.

Recent Industry Developments in the Monkeypox (mpox) Diagnosis Market

• September 2022, Quest Diagnostics announced that it has obtained emergency use permission (EUA) from the U.S. Food and Drug Administration (FDA) for its laboratory-developed molecular diagnostic test.
• June 2022, CerTest Biotec and Becton, Dickinson, and Company joined together to create a molecular diagnostic test designed to detect the Monkeypox virus.