Monkeypox Disease Diagnostics Market Size, Share, By Testing Method (Real-Time/Conventional PCR, Sequencing, Serological Tests, Viral Culture, Immunohistochemistry, and Others), Sample Type (Skin Lesion Swabs, Exudates, Roofs, and Crusts), End-Use (Hospitals & Clinics, Diagnostic Laboratories, and Others), and Region - Trends, Analysis, and Forecast till 2035

• The monkeypox disease diagnostics market share is predicted to be USD 4.7 Billion by 2035.
• The market size was calculated at USD 2.9 Billion by 2024.
• The target market is increasing at a CAGR of 5.0%.

Mpox, previously known as monkeypox, is a viral illness caused by the monkeypox virus, a species of the genus Orthopoxvirus. There are two distinct clades of the virus, which include clade I (with subclades Ia and Ib) and clade II (with subclades IIa and IIb). In order to diagnose monkeypox illness, samples from lesions or scabs are tested for the monkeypox virus (MPXV). Real-time polymerase chain reaction (PCR) is the most widely used assay. The rising prevalence of monkeypox infections, the need for rapid diagnostics, public health concerns and emergency declarations, the development of new diagnostics technologies, government initiatives, and surveillance programs, and limited treatment options for the monkeypox virus are contributing to driving monkeypox disease diagnostics market growth. Early diagnosis and treatment of the monkeypox virus is essential, thereby further contributing to the market expansion. 

Impact of AI on Monkeypox Disease Diagnostics Market:

The primary method of diagnosing monkeypox is by analyzing skin lesions obtained from suspected cases using a PCR test. However, new developments in artificial intelligence (AI) are demonstrating great promise for quickly and precisely identifying monkeypox by examining digital skin images, enabling earlier detection and better disease containment.

Key Drivers of Target Market:

Growing Need for Rapid Diagnostics for Monkeypox Disease is Pitching the Market Growth

The increased emphasis on quick and precise testing to contain outbreaks by the international health community is a major driver of the monkeypox diagnostics industry. In order to control the virus's spread, the World Health Organization (WHO) has underlined the importance of efficient diagnostics, especially in low-income areas. Due to this need, manufacturers are working quickly to create and deploy trustworthy testing solutions.

• For instance, in June 2022, CerTest Biotec and BD (Becton, Dickinson, and Company), a leading global medical technology company, announced a collaboration to develop a molecular diagnostic test for the Monkeypox virus. As part of the collaboration, the assay would leverage the BD MAX open system reagent suite to validate the CerTest VIASURE Monkeypox CE/IVD molecular test on the BD MAX System. The assay would be available for BD MAX users and may help advance understanding of the global spread of the disease.

Restraints:

Restricted Availability of Diagnostic Services in Rural Areas is Hindering the Market Growth

The restricted availability of diagnostic services in rural and low-resource regions poses a significant obstacle in the monkeypox diagnostics sector. Numerous areas do not have the required laboratory facilities and qualified staff for conducting tests. This leads to late detection, heightened transmission, and ineffective outbreak management. Moreover, elevated testing expenses further limit access in underserved areas.

• Counterbalance Statements: Deploying mobile testing devices and making more reasonably priced point-of-care diagnostics kits available are possible solutions for boosting diagnostic services in rural and low-resource regions.

Opportunities:

Developing Advanced Monkeypox Disease Diagnostics Technologies Opens Up Growth Opportunities

Monkeypox disease is diagnosed using nucleic acid amplification testing, such as polymerase chain reaction (PCR), and other methods including antigen or antibody detection. Advanced technologies, such as biosensors, artificial intelligence (AI), and local interpretable model-agnostic explanations (LIME) can help in fueling the monkeypox disease diagnostics market growth.

• For instance, in November 2024, Researchers from the University of California School of Medicine, and Boston University, and their colleagues of those researchers had developed an optical biosensor that could rapidly detect monkeypox, the virus that causes mpox. The technology could allow clinicians to diagnose the disease at the point of care rather than waiting for lab results. Point-of-care (POCT) methods are essential for quickly and reliably identifying monkeypox infections.

The monkeypox disease diagnostics market is classified into testing method, sample type, end-use, and region.

Testing Method

On the basis of testing methods, the market is segmented into real-time or conventional PCR, sequencing, serological tests, viral culture, immunohistochemistry, and others. The real-time polymerase chain reaction or conventional (PCR) is attributed to dominate the market as this method is considered the gold standard for diagnosing monkeypox in a laboratory as it is fast, sensitive, and can process large quantities of samples.

• For instance, in October 2024, the World Health Organization (WHO) listed the first mpox in vitro diagnostic (IVD) under its Emergency Use Listing (EUL) procedure, enhancing global access to mpox testing. The approval for emergency use of the Alinity m MPXV assay, manufactured by Labcorp Molecular Inc., would expand diagnostic capacity in countries facing mpox outbreaks, enabling timely treatment and control of the virus. The Alinity m MPXV assay was a real-time PCR test and was designed for trained clinical laboratory personnel.

Sample Type

Depending on the sample type, the market is divided into skin lesion swabs, exudates, roofs, and crusts. The skin lesion swab is expected to hold the largest monkeypox disease diagnostics market share. This is due to the accuracy of skin lesion swabs in confirming the infection as they contain the most viral DNA.

• For instance, in November 2022, QIAGEN N.V. announced the launch of the monkeypox (MPXV) test for its NeuMoDx automated PCR platform to strengthen surveillance and research into the outbreak of monkeypox disease in the non-endemic regions. The NeuMoDx assay extracted DNA from skin lesion swabs to isolate the target nucleic acids and then conducted a real-time polymerase chain reaction.

End-Use

By end-use, the market is categorized into hospitals & clinics, diagnostic laboratories, and others. The hospitals & clinics segment is leading the monkeypox disease diagnostics market as it is essential to quickly test patients for outbreaks and care, and these healthcare facilities have adopted testing for monkeypox disease or infections widely.

• For instance, in April 2024, investigators from Massachusetts General Hospital, a founding member of the Mass General Brigham healthcare system, developed and validated a computer program that could be incorporated into electronic medical record systems to help clinicians diagnose monkeypox disease as the diagnosis is especially challenging for uncommon and emerging infectious diseases for which there is limited clinical experience.

Region

Geographically, the market is cataloged into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.

North America: North America has the biggest monkeypox disease diagnostics market share, which is 36.7%. This is due to the region’s strong healthcare infrastructure, government support, leading medical technology companies, rising incidences of monkeypox, and presence of key market players, thereby dominating the market.

• For instance, in July 2022, Quest Diagnostics launched a molecular diagnostic test for monkeypox virus infection, a first-of-its-kind commercially available test. The dual-target real-time polymerase chain reaction (PCR) test was believed to aid in the qualitative detection and differentiation of monkeypox virus DNA from other non-variola orthopoxviruses, making it the first of its kind in the country.

Asia Pacific: Asia Pacific is considered to have the fastest-growing market during the forecast period. This is due to this region’s rapid economic development, a rising number of monkeypox infections, growing healthcare spending, dense urbanization and population growth, and increasing research and development for developing therapeutic options.

• For instance, in August 2024, the Prime Minister of India launched India’s first indigenous Monkeypox RT-PCR Kit made at Medtech Zone, called ErbaMDx MonkeyPox RT-PCR Kit. The main aim of this launch was to control the rising cases of monkeypox diseases in the region, which further led to growing concerns about the spread of the virus.

Monkeypox Disease Diagnostics Market Report Scope:

Segmentation:

By Testing Method:

• Real-Time/Conventional PCR
• Sequencing
• Serological Tests
• Viral Culture
• Immunohistochemistry
• Others

By Sample Type:

• Skin Lesion Swabs
• Exudates
• Roofs
• Crusts

By End Use:

• Hospitals & Clinics
• Diagnostic Laboratories
• Others

By Region:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • U.K.
  • France
  • Russia
  • Italy
  • Spain
  • Netherlands
  • Rest of Europe
• Asia Pacific
  • China
  • India
  • Japan
  • Australia
  • Indonesia
  • Malaysia
  • South Korea
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Rest of Latin America
• Middle East & Africa
  • GCC
  • Israel
  • South Africa
  • Rest of the Middle East & Africa

The key players are adopting strategies, such as developing new tests, collaborating with research institutes, and increasing access to rapid testing for monkeypox disease diagnostics market diversification. The companies operating in the market are Labcorp, ARUP Laboratories, Mirimus, Abbott, and others.

Monkeypox Disease Diagnostics Market Companies:

• Labcorp
• ARUP Laboratories
• Mirimus
• Abbott
• F. Hoffmann-La Roche Ltd
• JOYSBIO (Tianjin) Biotechnology Co., Ltd
• BIOMÉRIEUX
• Quest Diagnostics Incorporated
• Sonic Reference Laboratory
• BioGX
• Bio-Rad Laboratories, Inc.
• Cepheid
• Sonic Reference Laboratory

View a Additional List of Companies in Monkeypox Disease Diagnostics Market

• In October 2024, bioMérieux launched a PCR kit called the MONKEYPOX R-GENE to allow qualitative detection of virus. The MONKEYPOX R-GENE test can be carried out by any type of laboratory using nucleic acid extraction and amplification platforms commonly available on the market. A result is obtained in four to five hours. The test design is aimed to enable reliable detection through the detection of two different genes, even in the event of possible monkeypox mutations.
• In August 2024, Bluestain Global, a British Portuguese joint-venture, announced the launch of the Bluestain MPox virus detection kit. The new rapid detection test for the monkeypox virus was engineered with cutting-edge molecular techniques, delivering unmatched speed and accuracy at a critical moment. The test offered unparalleled sensitivity and specificity and delivered results within 15 to 30 minutes.

Analyst View:

The monkeypox disease diagnostics market is expanding due to a number of factors, including the growing frequency of monkeypox infections, the need for quick diagnosis, public health concerns and emergency declarations, the development of new diagnostics technologies, government initiatives and surveillance programs, and the limited number of treatment options for the monkeypox virus.

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