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U.S. Monkeypox Testing Market - Industry Outlook & Forecast 2023-2025

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  • 165 Pages
  • March 2023
  • Region: United States
  • Arizton
  • ID: 5743991
UP TO OFF until Jun 30th 2024
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The U.S. monkeypox testing market was valued at USD 5,336.29 thousand in 2022 and is expected to reach USD 91.00 thousand by 2025. The market is projected to register a CAGR of (74.26%) during the forecast period. Monkeypox is an orthopoxviral related to the smallpox virus and initially affected the U.S. population in 2003. Cases of monkeypox increased at the beginning of 2022, and by the end of September, the U.S. became the country with a high number of monkeypox cases. Men accounted for the larger patient group in the country; however, the number of monkeypox cases among women and children was limited.

The major reason for the spread of the disease in the country was sex among men. The LGBT community was one of the majorly affected communities. The country has undergone a huge healthcare crisis due to COVID-19 cases and has taken significant steps to control the spread of infections in the market. The region increased the number of tests conducted and accessibility to the tests through various healthcare settings, thereby contributing to the U.S. monkeypox testing market. Such initiatives have helped the country manage the spread of the disease.

The COVID-19 pandemic made the U.S. healthcare system increase its testing capacity and handle outbreaks and pandemics better. The monkeypox virus was diagnosed through the PCR-based method, like the COVID-19 infection testing, and has helped the government immediately increase the testing and provide treatment to the infected people and contribute to the U.S. monkeypox testing market. From day one of this outbreak, providers had access to a high-quality, FDA-cleared test to detect monkeypox. The CDC has scaled the testing capacity to 78 sites in 48 states, primarily at state public health laboratories, with the capacity to conduct around 10,000 tests per week. In addition, CDC began shipping the tests to some of the largest commercial laboratory companies (including some of the nation’s largest reference laboratories) to increase monkeypox testing capacity. This action improved convenience for patients and healthcare providers across the nation, and the government eased the testing procedures by approving the rapid testing kits for monkeypox. The regulatory bodies approved the products faster and increased access to monkeypox testing, which further accelerated the U.S. monkeypox testing market. In addition, the government took better steps to create awareness, communicate among the LGBTQI+ community, mobilize them, and provide better treatments. It was estimated that the U.S. would require USD 7 billion to handle the monkeypox outbreak.

This expansion increased the testing accessibility, building on the capacities already available within the Laboratory Response Network (LRN). In addition, the CDC has worked with the LRN to increase public health testing capacity by more than 50% since the outbreak's start, increasing testing capacity from 6,000 tests per week to approximately 10,000 tests per week. This network continued to provide spare testing capacity to jurisdictions across the country. CDC worked with the state, territorial, and local health departments to make the monkeypox testing process more accessible to health care providers.

Monkeypox testing has become very significant in the high-risk community. Monkeypox lesions are extremely painful and curable, but the effect of monkeypox among undiagnosed HIV patients is extreme. This is increasing the number of tests conducted in the country. People with simpler symptoms also undergo monkeypox testing to protect them from other disease conditions. In addition, some factors have limited the Mpox testing. Factors like false positive results and the rollout of vaccines in the market reduced the spread of the infections. Such factors helped the government quickly monitor and reduce the country's monkeypox cases. However, this reduced the number of tests conducted in the market, which became a limitation for the U.S. monkeypox testing market.

Monkeypox Cases Are Down but Not Gone

Experts in infectious disease have made statements like monkeypox cases will never leave the country. The number of cases recorded in the U.S. was high but still considered an undercount. It is expected that more cases are not considered as the physicians have not seen this before. The virus will remain infectious for around three weeks. It is challenging for people to stay isolated for three weeks. There is a high chance that this infection will spread to the animal carriers like rodents and again jump back, reinfecting the human population. There are high chances of increasing the infection spread unless the vaccination process is complete. Developed Countries like the U.S. will largely invest in the testing infrastructure to reduce the spread of the disease in the country. Investment measures further support the growth of the U.S. monkeypox testing market. The “Panic buying” concept will hugely impact the industry, increasing the demand for Mpox testing.

Strong Future Diagnostic Pipeline

The U.S. has a strong pipeline in the monkeypox diagnostic segment. National Institutes of Health (NIH), National Institute of Biomedical Imaging and Bioengineering (NIBIB), Department of Defense (DOD), and more institutions have invested in advanced monkeypox diagnostics. The research results are to be released in the first half of 2023. The country is investing in the future-ready diagnostics segment, which will help the region defend against future cases.


Ongoing U.S. Monkeypox Research Activities

Government departments and agencies, with international allies and partners, are accelerating efforts to undertake critical monkeypox research questions to inform the outbreak response and strategically planning to launch further research. Insights from this research will guide swift action during a public health emergency. These studies are poised to yield insights that will accelerate efforts to combat monkeypox, but more research is needed to fill the priority gaps. The Monkeypox Research Priority Team, led by the White House Office of Science and Technology Policy (OSTP) and including experts across the US government, is developing science and research programs to accelerate the monkeypox outbreak response in the country. Such factors are anticipated to support the U.S. monkeypox testing market growth.

Rapidly Growing Commercial Laboratory-Developed Monkeypox Testing

On 22 June 2022, the U.S. Department of Health and Human Services (HHS) announced the authorization of commercial laboratories to conduct monkeypox tests to expand testing as the U.S. confronts a monkeypox outbreak dramatically, thereby propelling the U.S. monkeypox testing market. The Centers for Disease Control and Prevention (CDC) shipped test kits to commercial laboratory companies, allowing health providers to order tests from the labs directly. These commercial laboratories dramatically expanded testing capacity nationwide and made testing more convenient and accessible for patients and healthcare providers. In addition to the FDA-approved or EUA-approved monkeypox tests (MPOX), certain laboratory-developed tests (LDTs) are also being used to detect monkeypox that has not been reviewed or approved by the FDA. LDT is a type of in vitro diagnostic test designed, manufactured, and used in a CLIA-accredited laboratory at a single site that meets the requirements of a highly complex test.

Segmentation By Type

  • PCR
  • Lateral Flow Assay
  • Others

Segmentation By End-User

  • Laboratories
  • Hospitals & Clinics
  • Others


The Southern region accounted for the largest U.S. monkeypox testing market share at 33.58%. The perception that the response to the monkeypox virus in the South has lacked coordination has rekindled familiar concerns about recent state policies. States like California have followed the CDC's recommendation to prioritize gay and bisexual men in outreach, vaccination, and treatment for monkeypox. Such states have declared a public health emergency and initiated aggressive, targeted vaccination campaigns. Although California has the highest number of cases, Florida, Georgia, and Texas are home to robust gay communities and have just over a quarter of the country’s confirmed monkeypox cases.

Segmentation By Region

  • U.S.
  • Southern
  • Western
  • Northeast
  • Central


Amid the CDC’s orthopoxvirus test expansion, several diagnostics companies are developing and launching their monkeypox-specific assays. BD, Cepheid, and Roche have joined the race to roll out accurate, PCR-quality tests for the disease. BD has joined forces with CerTest to adapt one of the Spanish company’s existing tests to run on the BD Max automated PCR system. At the same time, Cepheid partnered with reagent maker BioGX to design a molecular assay of its own. Abbott is developing a polymerase chain reaction (PCR) test to detect the presence of monkeypox. The company is focused on developing a monkeypox test, which could help the world in the early detection of the disease. It will provide test kits to partners in the pandemic defense coalition. In addition, F. Hoffman La Roche launches LightMix Modular Virus test kits to analyze samples using quantitative PCR technology. Various companies across the globe are developing monkeypox test kits to increase the testing and to decrease the spread of infection globally.

Key Company Profiles

  • Abbott
  • F. Hoffmann-La Roche
  • Qiagen
  • Thermo Fisher Scientific

Other Prominent Vendors

  • Alpha Diagnostic
  • AtliaBiosystems
  • Applied DNA Sciences
  • BioGX
  • Co-Diagnostics
  • CorDx
  • Creative Biogene
  • Elabscience Biotechnology
  • Seegene

Laboratory-Developed Monkeypox Tests

  • Aegis Sciences
  • ARUP Laboratories
  • Apostle Diagnostics
  • California Department of Public Health
  • CDR Companies
  • CirrusDx
  • Clinical Reference Laboratory
  • Devlab Bio
  • Discover Labs
  • Integrity Laboratories
  • Laboratory Corporation of America Holdings
  • Madison Core Laboratories
  • Mako Medical Laboratories
  • Mayo Clinic
  • Quest Diagnostics
  • RapidBio
  • Shepard Health
  • Sonic Healthcare
  • US BioTek Laboratories
  • UW Virology Laboratory


  • How big is the U.S. monkeypox testing market?
  • What is the projected CAGR of the U.S. monkeypox testing market during the forecast period?
  • Which are the key players in the U.S. monkeypox testing market?
  • Which region holds the largest U.S. monkeypox testing market share?
  • What are the growing trends in the U.S. monkeypox testing market?

Table of Contents

1 Research Methodology

2 Research Objectives

3 Research Process

4 Scope & Coverage
4.1 Market Definition
4.1.1 Inclusions
4.1.2 Exclusions
4.1.3 Market Estimation Caveats
4.2 Base Year
4.3 Scope of the Study
4.3.1 Market Segmentation by Type
4.3.2 Market Segmentation by End-User
4.3.3 Market Segmentation by Region

5 Report Assumptions & Caveats
5.1 Key Caveats
5.2 Currency Conversion
5.3 Market Derivation

6 Premium Insights
6.1 Overview

7 Market at a Glance

8 Introduction
8.1 Overview

9 Market Opportunities & Trends
9.1 Ongoing Us Monkeypox Research Activities
9.2 Growing Development of Rapid Testing Methods
9.3 Rapidly Growing Commercial Laboratory-Developed Monkeypox Testing

10 Market Growth Enablers
10.1 Increasing Product Launches
10.2 Advances in Pcr Technology
10.3 Monkeypox Eradication Unlikely to Continue in US

11 Market Restraints
11.1 Growing Access to Vaccination Against Monkeypox
11.2 Monkeypox Cases Are in a Sharp Decline
11.3 Potential Risk of False Monkeypox Test Results

12 Market Landscape
12.1 Market Overview
12.1.1 Insights by Type
12.1.2 Insights by End-User
12.1.3 Insights by Region
12.2 Five Forces Analysis
12.2.1 Threat of New Entrants
12.2.2 Bargaining Power of Suppliers
12.2.3 Bargaining Power of Buyers
12.2.4 Threat of Substitutes
12.2.5 Competitive Rivalry

13 Testing Type
13.1 Market Snapshot & Growth Engine
13.2 Market Overview
13.3 Polymerase Chain Reaction (Pcr)
13.3.1 Market Overview
13.3.2 Market Size & Forecast
13.4 Lateral Flow Assay
13.4.1 Market Overview
13.4.2 Market Size & Forecast
13.5 Other
13.5.1 Market Overview
13.5.2 Market Size & Forecast

14 End-User
14.1 Market Snapshot & Growth Engine
14.2 Market Overview
14.3 Laboratories
14.3.1 Market Overview
14.3.2 Market Size & Forecast
14.4 Hospitals & Clinics
14.4.1 Market Overview
14.4.2 Market Size & Forecast
14.5 Others
14.5.1 Market Overview
14.5.2 Market Size & Forecast

15 Region
15.1 Market Snapshot & Growth Engine
15.2 Market Overview
15.3 Southern
15.3.1 Market Overview
15.3.2 Market Size & Forecast
15.4 Western
15.4.1 Market Overview
15.4.2 Market Size & Forecast
15.5 Northeast
15.5.1 Market Overview
15.5.2 Market Size & Forecast
15.6 Central
15.6.1 Market Overview
15.6.2 Market Size & Forecast

16 Competitive Landscape
16.1 Competition Overview
16.2 Market Share Analysis
16.2.1 Abbott
16.2.2 F. Hoffmann-La Roche
16.2.3 Qiagen
16.2.4 Thermo Fisher Scientific

17 Key Company Profiles
17.1 Abbott
17.1.1 Business Overview
17.1.2 Product Offerings
17.1.3 Key Strategies
17.1.4 Key Strengths
17.1.5 Key Opportunities
17.2 F. Hoffmann-La Roche
17.2.1 Business Overview
17.2.2 Product Offerings
17.2.3 Key Strategies
17.2.4 Key Strengths
17.2.5 Key Opportunities
17.3 Qiagen
17.3.1 Business Overview
17.3.2 Product Offerings
17.3.3 Key Strategies
17.3.4 Key Strengths
17.3.5 Key Opportunities
17.4 Thermo Fisher Scientific
17.4.1 Business Overview
17.4.2 Product Offerings
17.4.3 Key Strategies
17.4.4 Key Strengths
17.4.5 Key Opportunities

18 Other Prominent Vendors
18.1 Alpha Diagnostic
18.1.1 Business Overview
18.1.2 Product Offerings
18.2 Atilabiosystems
18.2.1 Business Overview
18.2.2 Product Offerings
18.3 Applied Dna Sciences
18.3.1 Business Overview
18.3.2 Product Offerings
18.4 Biogx
18.4.1 Business Overview
18.4.2 Product Offerings
18.5 Bioneer
18.5.1 Business Overview
18.5.2 Product Offerings
18.6 Certest Biotec
18.6.1 Business Overview
18.6.2 Product Offerings
18.7 Co-Diagnostics
18.7.1 Business Overview
18.7.2 Product Offerings
18.8 Cordx
18.8.1 Business Overview
18.8.2 Product Offerings
18.9 Creative Biogene
18.9.1 Business Overview
18.9.2 Product Offerings
18.10 Elabscience Biotechnology
18.10.1 Business Overview
18.10.2 Product Offerings
18.11 Labnovation Technologies
18.11.1 Business Overview
18.11.2 Product Offerings
18.12 Seegene
18.12.1 Business Overview
18.12.2 Product Offerings

19 Laboratory-Developed Monkeypox Tests
19.1 Aegis Sciences
19.1.1 Business Overview
19.1.2 Product Offerings
19.2 Arup Laboratories
19.2.1 Business Overview
19.2.2 Product Offerings
19.3 Apostle Diagnostics
19.3.1 Business Overview
19.3.2 Product Offerings
19.4 California Department of Public Health
19.4.1 Business Overview
19.4.2 Product Offerings
19.5 Cdr Companies
19.5.1 Business Overview
19.5.2 Product Offerings
19.6 Cirrusdx
19.6.1 Business Overview
19.6.2 Product Offerings
19.7 Clinical Reference Laboratory
19.7.1 Business Overview
19.7.2 Product Offerings
19.8 Devlab Bio
19.8.1 Business Overview
19.8.2 Product Offerings
19.9 Discover Labs
19.9.1 Business Overview
19.9.2 Product Offerings
19.10 Integrity Laboratories
19.10.1 Business Overview
19.10.2 Product Offerings
19.11 Laboratory Corporation of America Holdings
19.11.1 Business Overview
19.11.2 Product Offerings
19.12 Madison Core Laboratories
19.12.1 Business Overview
19.12.2 Product Offerings
19.13 Mako Medical Laboratories
19.13.1 Business Overview
19.13.2 Product Offerings
19.14 Mayo Clinic
19.14.1 Business Overview
19.14.2 Product Offerings
19.15 Quest Diagnostics
19.15.1 Business Overview
19.15.2 Product Offerings
19.16 Rapidbio
19.16.1 Business Overview
19.16.2 Product Offerings
19.17 Shepard Health
19.17.1 Business Overview
19.17.2 Product Offerings
19.18 Sonic Healthcare
19.18.1 Business Overview
19.18.2 Product Offerings
19.19 Us Biotek Laboratories
19.19.1 Business Overview
19.19.2 Product Offerings
19.2 Uw Virology Laboratory
19.20.1 Business Overview
19.20.2 Product Offerings

20 Report Summary
20.1 Key Takeaways
20.2 Strategic Recommendations

21 Quantitative Summary
21.1 Market by Type
21.2 Market by End-User
21.3 Market by Region

22 Appendix
22.1 Abbreviations

Companies Mentioned

  • Abbott
  • F. Hoffmann-La Roche
  • Qiagen
  • Thermo Fisher Scientific
  • Alpha Diagnostic
  • AtliaBiosystems
  • Applied DNA Sciences
  • BioGX
  • Co-Diagnostics
  • CorDx
  • Creative Biogene
  • Elabscience Biotechnology
  • Seegene
  • Aegis Sciences
  • ARUP Laboratories
  • Apostle Diagnostics
  • California Department of Public Health
  • CDR Companies
  • CirrusDx
  • Clinical Reference Laboratory
  • Devlab Bio
  • Discover Labs
  • Integrity Laboratories
  • Laboratory Corporation of America Holdings
  • Madison Core Laboratories
  • Mako Medical Laboratories
  • Mayo Clinic
  • Quest Diagnostics
  • RapidBio
  • Shepard Health
  • Sonic Healthcare
  • US BioTek Laboratories
  • UW Virology Laboratory


Our research comprises a mix of primary and secondary research. The secondary research sources that are typically referred to include, but are not limited to, company websites, annual reports, financial reports, company pipeline charts, broker reports, investor presentations and SEC filings, journals and conferences, internal proprietary databases, news articles, press releases, and webcasts specific to the companies operating in any given market.

Primary research involves email interactions with the industry participants across major geographies. The participants who typically take part in such a process include, but are not limited to, CEOs, VPs, business development managers, market intelligence managers, and national sales managers. We primarily rely on internal research work and internal databases that we have populated over the years. We cross-verify our secondary research findings with the primary respondents participating in the study.