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

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.

MARKET TRENDS & OPPORTUNITIES

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

REGIONAL ANALYSIS

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

COMPETITIVE LANDSCAPE

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
• BIONEER
• CERTEST BIOTEC
• Co-Diagnostics
• CorDx
• Creative Biogene
• Elabscience Biotechnology
• LABNOVATION TECHNOLOGIES
• 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

KEY QUESTIONS ANSWERED:

• 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?