United States Infectious Disease Diagnostics Market to Register 5.65% Growth Due to Rising Prevalence of Infectious Diseases in the Country

United States infectious disease diagnostics market is experiencing substantial growth, due to several factors, including the rising prevalence of infectious diseases, the availability of a wide range of diagnostic tests, and the growing preference for point-of-care diagnostic testing techniques. Additionally, increased investments and ongoing efforts by the key players to develop innovative technologies are contributing to this growth.

According to the Markets and Data Research report, “United States Infectious Disease Diagnostics Market Assessment, Opportunities and Forecast, 2018-2032F”, the market for United States infectious disease diagnostics is expected to grow at a CAGR of 5.65% from 2025 to 2032. The market size shall increase from USD 10.14 billion in 2024 to USD 15.48 billion by 2032. The infectious disease diagnostics market in the USA is expanding due to several factors. The rise in diseases such as tuberculosis, HIV/AIDS, and respiratory infections is driving the demand for accurate and timely diagnostic tools, which are essential for effective treatment and management. The preference for home care and point-of-care testing also contributes to market growth. Additionally, the U.S. government supports this market through funding initiatives to enhance public health infrastructure. Favorable regulatory frameworks, such as expedited FDA approvals during health emergencies, further facilitate the development and availability of new diagnostic tests. Public health initiatives focusing on disease prevention, early diagnosis, and educational campaigns are also boosting demand for these services.

A broad range of infectious disease diagnostic tests involve laboratory, rapid, serology, and PCR tests. These detect antibodies, antigens, and pathogenic microorganisms, which assist in diagnosis. Laboratory tests utilize blood, urine, sputum, or other specimens for identification by staining, culturing, or molecular techniques. In various formats, rapid tests provide results quickly, facilitating clinical decision-making and point-of-care treatment. Serology tests detect antibodies to prove past exposure. PCR tests identify the genetic material of microorganisms. These diverse techniques are responsible for correct and timely diagnosis, driving market growth. Market participants provide various rapid diagnostic kits for various diseases, further increasing growth.

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The "United States Infectious Disease Diagnostics Market" report is 147 pages long and includes an in-depth TOC, over 07 market data figures. Moreover, the report offers market share analysis in detail.

Key Takeaways:

• The demand for diagnostic tools increases with the increasing prevalence of infectious diseases in the country.
• Innovations in diagnostic technologies, such as molecular diagnostics and point-of-care (POC) testing, have enhanced detection capabilities. These technologies enable faster and more precise results, which improve the attractiveness of diagnostic tests.
• Market leaders like F. Hoffmann-La Roche AG are strengthening their diagnostic offerings by proactively receiving FDA approvals for cutting-edge tests and partnering with others to drive diagnostic solutions. This approach will enhance patient results and increase market share.
• Extensive investments by government and private sectors in diagnostics and technologies are driving growth in the market. Investments are directed towards strengthening disease surveillance and enhancing public health results.

United States infectious disease diagnostics market is segmented in the following categories:

By Product: Reagents, Kits, and Consumables, Instruments, Software

By Sample Type: Blood and Components, Urine, Other

By Setting: Laboratory Testing, Point-of-Care Testing

By Type of Testing: Molecular Tests, Serological Tests, Antigen Tests, Culture Tests, Blood Tests, Imaging Tests

By Indication: Bacterial Infections, Viral Infections, CNS Infections, Cardiovascular Infections, Fungal Infections, GI Infections, Sexually Transmitted Diseases, Other

By End-user: Diagnostic Laboratories, Academic and Medical Institutes, Hospitals, Ambulatory Clinics, Home Healthcare

Based on product, the reagents, kits, and consumables segment is dominating in the United States infectious disease diagnostics market due to a number of specific reasons. These include the high-volume usage of reagents in molecular diagnostic tests, including PCR and nucleic acid amplification, generating stable demand, as these tests are critical for reliable pathogen identification. Furthermore, technological advancements in reagent formulations improve test efficiency and reliability, especially for point-of-care (PoC) testing, which is increasingly sought after in clinical environments. Thirdly, the COVID-19 pandemic has triggered an unprecedented boom in testing, significantly boosting the production and commercialization of diagnostic reagents, thus fueling the market's growth.

Based on sample type, the blood and components segment is the leading segment of the United States infectious disease diagnostics market, primarily because of the frequent use of blood samples for diagnosis. The COVID-19 pandemic has fueled an upsurge in nasal sample usage, the fastest-growing method. Improvements in blood culture methods, enhanced detection of pathogens, and the focus on rapid diagnostic testing support the blood and components' leading position. These improvements increase patient outcomes and simplify treatment protocols.

Based on the setting, laboratory testing is very accurate and reliable, and it presently dominates the infectious disease diagnostics market in the United States. While point-of-care (PoC) testing is the fastest-growing sector, driven by increased patient compliance, laboratory testing continues to have a major market share due to its broad application and capacity to process huge volumes of samples. Several reasons contribute to the dominance of blood, including advances in diagnostic technology, a rise in infectious illness prevalence, and improved laboratory skills for accurate pathogen identification.

Based on the type of testing, blood tests have dominant market shares mainly because of their proven role in the diagnosis of a broad spectrum of infections, such as HIV, hepatitis, and sepsis. Blood tests give complete information about a patient's health status, which helps make effective treatment decisions. Moreover, integrating innovations in blood testing, including automated analyzers and molecular diagnostics, maximizes accuracy and efficiency, cementing their position in the market. However, antigen tests are the fastest-growing segment due to their rapid results and ease of use. They enable quick screening with minimal training, which makes them ideal for point-of-care. This feature became especially critical during the COVID-19 pandemic, where rapid results were critical for outbreak control and timely management of patients.

Based on indications, the bacterial infections segment holds significant shares in the market. This is primarily fueled by the emergence of antimicrobial-resistant infections, which the Centers for Disease Control and Prevention (CDC) estimates to be more than 2.8 million cases per year. These infections are a serious public health threat. The COVID-19 pandemic further accelerated this problem, with a significant spike in hospital-onset infections reaching its peak in 2021. This case indicates an immediate need for better diagnostic techniques and effective interventions to address antimicrobial resistance. The increasing threat of antimicrobial resistance poses great opportunities for innovation in diagnostic tools, focusing on timely and accurate detection to enhance patient outcomes and optimize treatment protocols.

Hospitals have become the dominant segment of the United States infectious disease diagnostics market based on end-users. This was evident during the COVID-19 pandemic when hospitals were flooded with patients. Increased infectious diseases, an aging population, and point-of-care testing innovations have increased the use of ambulatory clinics by enhancing the availability and efficiency of diagnostic tests. Home healthcare is also increasing substantially due to the demand for convenient and timely diagnostics. The industry has immense opportunities for innovation, decentralization of care, and enhanced patient outcomes with faster response times in the management of infections.

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Major Companies Operating in United States Infectious Disease Diagnostics Market Include:

• Becton, Dickinson and Company
• Cepheid Inc.
• Abbott Laboratories
• BioMérieux SA
• Hologic Inc.
• Bio-Rad Laboratories Inc.
• Danaher Corporation
• Thermo Fisher Scientific Inc.
• DiaSorin SpA
• Hoffmann-La Roche AG

Key players in the market have a strong presence with a wide line of diagnostic and research products. They are redirecting investment to advanced diagnostic technology. These players have strengthened their portfolios by strategic partnerships, merging, acquiring, and adopting other strategic market moves.

In January 2025, F. Hoffmann-La Roche AG received FDA clearance and a CLIA waiver for cobas liat molecular tests for point-of-care diagnosis of STIs. These chlamydia, gonorrhea, and Mycoplasma genitalium panels to be tested on a single sample will soon become available only in the U.S., with CE mark commercialization to follow. This FDA clearance reinforces the company's market position by increasing diagnostic performance with state-of-the-art STI test solutions.

“United States Infectious Disease Diagnostics Market Assessment, 2018-2032F”, evaluates the future growth potential of the United States infectious disease diagnostics market and provides statistics and information on market size, structure, and future market growth. The report intends to provide innovative market intelligence and help decision-makers make strategic investment decisions for their organizations. Moreover, the report identifies and examines the emerging trends along with key drivers, challenges, and opportunities in the United States infectious disease diagnostics market.

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