Monkeypox Testing Market By Test Type (Polymerase Chain Reaction Tests, Rapid Antigen Tests, Serological Tests, Viral Culture Tests, Next-Generation Sequencing Tests, Other), By Sample Type (Blood Sample, Swab Sample, Urine Sample, Other), By Technology (Molecular Diagnostics, Immunoassays {ELISA, Lateral Flow Assays}, Genetic Sequencing, Point-of-Care Testing Technologies), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies, Others), By End-User (Hospitals & Clinics, Diagnostic Laboratories, Research & Academic Institutes, Others), Global Market Size, Segmental analysis, Regional Overview, Company share analysis, Leading Company Profiles And Market Forecast, 2025 – 2035

Industry Outlook

The Monkeypox Testing Market accounted for USD 2.13 Billion in 2024 and is expected to reach USD 3.51 Billion by 2035, growing at a CAGR of around 4.65% between 2025 and 2035. The growing Monkeypox Testing Market shows rapid expansion because of escalating Monkeypox outbreak numbers and critical requirements for prompt diagnostic testing methods.

Healthcare organizations together with government institutions are investing in improving surveillance networks which has generated an increased need for monkeypox testing equipment. The monkeypox testing market uses molecular diagnostic advances such as PCR-based and rapid antigen tests for accurate results while enhancing the time needed for testing. The market expands because both public health awareness and regulatory body actions are actively accelerating growth. Companies leading the market continue to invest funds into research and development to establish better cost-effective testing methods.

Diagnostic companies and healthcare institutions collaborate to build new testing capabilities thus providing positive effects on the Monkeypox Testing Market. A shift occurs in market dynamics because healthcare facilities increasingly adopt point-of-care diagnostic solutions while implementing home-based diagnostic systems. The decline in market expansion occurs from two setbacks including inadequate testing equipment in poor regions and slow regulatory approval processes for new tests.

Report Scope:

Market Dynamics

Rising Monkeypox Outbreaks are Fueling Demand for Rapid and Accurate Diagnostics

The rising occurrence of monkeypox outbreaks serves as a major growth factor for the Monkeypox Testing Market. The rise in worldwide monkeypox reports creates an immediate need to detect the disease early so transmission can be blocked effectively. Across different levels of public service such as governments along with healthcare organizations and research institutions large-scale tracking programs are currently being established for disease surveillance. The market demand for rapid testing solutions increases because early detection serves as the fundamental element in managing diseases together with public health responses effectively. The high accuracy levels combined with short results time have made polymerase chain reaction (PCR) tests and rapid antigen tests widely accepted. The World Health Organization together with health agencies stresses the need for broad-based testing availability to stop disease spread.

Diagnostic companies boost their production volume while conducting research for developing cost-effective innovative testing solutions. The Monkeypox Testing Market receives financial support and international implementation efforts which help improve healthcare facilities worldwide. Numerous people are now seeking at-home and point-of-care testing options for monkeypox because improved awareness about disease transmission has resulted in increased detection and isolation of infected patients. The testing accessibility in specific areas remains a challenge because there needs to be more diagnostic facility expansions in those regions. Healthcare systems will remain prepared to manage emerging health crises because of ongoing advancements in testing technologies which develop supported by the rising focus on outbreak preparation.

Advancements in Molecular Diagnostics Enhance Detection Efficiency and Reliability

The Monkeypox Testing Market is expanding quickly because of continual improvements in molecular diagnostic technologies. PCR-based tests represent the current best method for monkeypox detection because they provide high sensitivity and specificity in viral genome detection. Testing produces rapid results which allows medical service providers to deploy instant treatment and containment strategies thus helping affected patients. The accuracy of next-generation sequencing diagnostics increases through genetic examination of the monkeypox virus to track viral changes and detect the progress of outbreaks. The development of enzyme-linked immunosorbent assay (ELISA) and related immunoassays presents new choices for serological diagnosis and evaluation of immunity after infection.

The current surge in AI-assisted diagnostic technology delivery leads to optimized laboratory operations which results in more accurate interpretations while optimizing workflow processes. The development of cost-effective portable molecular testing solutions by diagnostic companies increases diagnosis accessibility in resource-limited areas while building up investments in research and development. Scientists have introduced multiplex testing methods within the Monkeypox Testing Market which enables the same test to detect various pathogens efficiently thus speeding up outbreak response. vailability of molecular diagnostic solutions remains restricted primarily due to their high prices across lower-income areas. Technology evolution and declining production costs will make molecular diagnostics the key component for enhancing monkeypox detection and control measures.

High Costs of Advanced Testing Technologies Limit Accessibility in Low-Income Regions

Advanced diagnostic technologies establish a major financial restriction for the Monkeypox test market because of their exorbitant price tags. PCR tests along with NGS equipment and immunoassays cannot be used in low-income areas due to their exorbitant costs and specialized maintenance requirements that include trained personnel and high-priced reagents and equipment. Many healthcare facilities within developing countries operate with limited money which keeps them from obtaining and sustaining difficult testing equipment. The high price of diagnostic equipment and laboratory tools operates as an issue for areas with monkeypox outbreaks because it reduces their diagnostic abilities. Basic resource settings find cold-chain storage requirements and complex laboratory infrastructure for molecular diagnosis tests to be impractical because they increase operational costs.

The late or insufficient testing methods prevent fast detection of the virus therefore allowing it to spread unnoticed. The insufficient funding support from authorities together with international health organizations prevents full diagnostic testing infrastructure deployment even though they endorse accessibility. A solution to equality in Monkeypox testing requires the market to create inexpensive testing options that maintain high accuracy levels through usable laboratory requirements including rapid antigen and point-of-care assays. Underprivileged areas need technological developments that enable both production cost reduction and more affordable products to achieve market penetration. The scarcity of testing options creates problems in disease surveillance and containment that signify the necessity for significant international investments and partnerships to bridge affordability gaps in the Monkeypox Testing Market.

Growing Adoption of Point-Of-Care Testing Enhances Accessibility and Early Detection

The Monkeypox Testing Market establishes significant expansion through increased point-of-care testing implementation because it provides better access together with swifter detection capabilities. Patients benefit from POC testing devices because these devices supply instant results to testing sites through physician-operated technology near patients under treatment. These handheld diagnostic tools become crucial tools for health professionals to identify and separate patients during outbreaks thus enabling fast medical interventions. Quick outcomes from rapid antigen tests used with lateral flow assays create a growing demand within the Monkeypox Testing Market because these tests can function without extensive laboratory infrastructure.

Mobile diagnostic units and self-testing kits grant enhanced testing accessibility for people who live in underserved locations. Point-of-care testing devices receive public health programs and governmental funding to enhance disease surveillance functions at airports as well as community clinics and primary healthcare facilities. Improvements in production technology will lead to point-of-care solutions to play a fundamental part in strengthening worldwide Monkeypox response programs together with expanding the effectiveness and reach of the Monkeypox Testing Market.

Increasing Collaborations Between Diagnostic Companies and Healthcare Institutions Expand Market Reach

The Monkeypox Testing Market grows through strategic partnerships established between diagnostic firms and healthcare facilities that create wider access and speed up development programs. Diagnostic leader organizations unite with hospitals research centers and public health agencies to develop superior testing systems and deliver testing products more efficiently through networks. Strong relationships between diagnostic companies and healthcare organizations enable quick advancement of monkeypox testing options and accelerate their regulatory authorizations and market entry processes. Multiple entities collaborate on research programs that help develop precise diagnostic equipment among which are molecular assays and immunoassays and point-of-care technologies. The incorporation of monkeypox testing into routine healthcare screening by multiple institutions drives both increased test numbers along greater awareness of the disease.

International organizations together with governments have established partnerships with diagnostic companies to find funding resources that lower testing prices in low-income areas to improve accessibility of diagnostic services. Public-private partnerships within the Monkeypox Testing Market enable substantial manufacturing operations and distribution channels for addressing supply chain problems during disease outbreak periods. Technology partnerships between international diagnostic firms and biotechnology companies enable them to build next-generation diagnostic solutions that combine AI-based testing analysis with home test kits. The Monkeypox Testing Market will sustain its expansion through these strategic partnerships which will ensure broad availability of economic testing solutions for future outbreak control.

Industry Experts Opinion

“We launched a viral surveillance panel that can do the sequencing of 66 of the most critical viruses that are of public health concern, including monkeypox. We want to track how it’s spreading and how it’s evolving, and this will allow our customers to do that. And so, we’re making that viral surveillance panel available for early access, and then commercializing it as quickly as possible after that.”

• Francis deSouza, CEO, Illumina

Segment Analysis

Based on Test Type, the Monkeypox Testing Market is primarily driven by the demand for Polymerase Chain Reaction (PCR) tests and Rapid Antigen Tests. PCR tests stand as the reference standard due to their superior accuracy together with high sensitivity in detecting low viral loads. The wide patient care network inclusive of hospitals diagnostic laboratories and research institutions utilizes these tests for specific diagnostic confirmation. Rapid Antigen Tests build momentum across different healthcare facilities because they deliver fast test results suitable for both large-scale screenings and point-of-care situations. The increasing focus on early detection through containment efforts has driven external actors to choose these test types. The market is experiencing expansion because Next-Generation Sequencing (NGS) allows researchers to perform deep genetic analysis of the monkeypox virus. The Monkeypox Testing Market will experience increased technological innovation and market expansion due to ongoing outbreaks.

Based on Technology, the Monkeypox Testing Market is significantly influenced by Molecular Diagnostics and Immunoassays. The most dependable test method available today for identifying monkeypox is the PCR-based testing system because it detects viral DNA efficiently with absolute precision. Both ELISA and Lateral Flow Assays under the Immunoassay category enable healthcare professionals to identify immune reactions along with detecting viral antigens. The market continues to grow because providers choose Point-of-Care Testing Technologies to deliver rapid disease diagnosis at various locations where healthcare resources are limited. The importance of genetic sequencing increases because it helps monitor viral mutations along with improving outbreak readiness capabilities. The future of the Monkeypox Testing Market will be shaped by technological progress alongside increasing diagnostic research funding which will promote market expansion and increased accessibility. 

Regional Analysis

North America is the largest market in the Monkeypox Testing Market, due to its strong healthcare infrastructure and technological advancement alongside governmental support efforts. The United States leads North American monkeypox surveillance because it has the highest case numbers and advanced monitoring systems alongside the quick acceptance of PCR machine diagnostic tools. Market expansion receives additional support because of key diagnostic manufacturers together with research institutions and biotechnology firms operating in the market.

The CDC and FDA use increased funding allocations to speed up the creation and distribution of optimized testing systems. Effective monkeypox testing kits remain accessible through hospital and retail pharmacy networks across the market. The need for rapid point-of-care testing solutions has risen significantly because of public education initiatives and massive screening programs. The Monkeypox Testing Market in North America will sustain its market dominance because of ongoing technological developments and increases in regulatory support during the upcoming years.

Asia-Pacific is the fastest-growing region in the Monkeypox Testing Market because governmental health initiatives support both diagnostics capabilities enhancement and increasing awareness and funding for healthcare services. The monkeypox testing market is expanding quickly in China India and Japan because these nations have received government funding to develop disease monitoring and pandemic readiness capabilities. The increasing demand for economical testing systems which include rapid antigen and point-of-care tests grows because infection risks continue to grow. Market expansion occurs through developments in molecular diagnostics and healthcare institutions working together with diagnostic companies in the industry. Offline pharmacies and online platforms deliver testing kits with better accessibility to rural residents through their expansion. The market penetration gets a boost from both supportive regulatory policies and foreign investments that fund diagnostic research. Asia-Pacific stands ready to become a primary market player for Monkeypox Testing while delivering promising business prospects to all stakeholders.  

Competitive Landscape

The competitive nature of the Monkeypox Testing Market pushes key players to develop technologies along with building strategic partnerships to achieve market dominance through regulatory approvals. The diagnostic industry leadership rests firmly with Roche together with Labcorp along with Quest Diagnostics because these organizations provide established testing solutions that incorporate molecular and immunoassay methods. The technologies based on advanced PCR diagnostics combined with high-throughput sequencing help these companies provide precise and fast detection of the monkeypox virus. The biotech firms SIGA Technologies and Bavarian Nordic build their business portfolios by developing innovative testing kits for point-of-care applications and serology analysis. Government support along with development research funding enables companies to create affordable testing solutions that enhance market rivalry.

New diagnostic firms together with local competitors have entered the Monkeypox Testing Market by creating budget-friendly portable testing systems. Atomo Diagnostics together with Newfoundland Diagnostics continue developing rapid antigen and lateral flow assays to service underserved African territories. Retail pharmacies have joined online platforms to distribute monkeypox test kits so market competition has grown more severe while expanding test kit accessibility. The competitive landscape transforms through strategic mergers together with acquisitions and licensing agreements due to company objectives of enhancing their production capabilities and expanding market reach. The Monkeypox Testing Market will see market leaders separated by their innovations in AI-driven diagnostics and next-generation sequencing as the demand for early detection and large-scale testing keeps rising.

Monkeypox Testing Market, Company Shares Analysis, 2024

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Recent Developments:

• In December 2024, moldiag established its production base in Morocco to develop pox testing kits which became the first domestically produced diagnostics in Africa for reducing dependency on imported products.
• In October 2024, the World Health Organization (WHO) authorized Abbott Laboratories' mpox diagnostic test Alinity m MPXV assay under emergency use granting nations worldwide new testing capabilities.
• In August 2024, the 'ErbaMDx MonkeyPox RT-PCR Kit' became the first locally created mpox testing solution when Andhra Pradesh MedTech Zone (AMTZ) in India introduced it.

Report Coverage:

By Test Type

• Polymerase Chain Reaction Tests
• Rapid Antigen Tests
• Serological Tests
• Viral Culture Tests
• Next-Generation Sequencing Tests
• Other

By Sample Type

• Blood Sample
• Swab Sample
• Urine Sample
• Other

By Technology

• Molecular Diagnostics
• Immunoassays
  • ELISA
  • Lateral Flow Assays
• Genetic Sequencing
• Point-of-Care Testing Technologies

By Distribution Channel

• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies
• Others

By End-User

• Hospitals & Clinics
• Diagnostic Laboratories
• Research & Academic Institutes
• Others

By Region

North America

• U.S.
• Canada

Europe

• U.K.
• France
• Germany
• Italy
• Spain
• Rest of Europe

Asia Pacific

• China
• Japan
• India
• Australia
• South Korea
• Singapore
• Rest of Asia Pacific

Latin America

• Brazil
• Argentina
• Mexico
• Rest of Latin America

Middle East & Africa

• GCC Countries
• South Africa
• Rest of the Middle East & Africa

List of Companies:

• Labcorp
• F. Hoffmann-La Roche Ltd
• Quest Diagnostics Incorporated
• Molding
• Bavarian Nordic
• Emergent BioSolutions
• Tonix Pharmaceuticals Holding Corp.
• Moderna, Inc.
• BioNTech SE.
• SIGA Technologies
• Atomo Diagnostics
• Newfoundland Diagnostics Ltd
• GSK plc
• Abbott Laboratories
• Thermo Fisher Scientific Inc.

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