The United States clinical microbiology market was valued at USD 1.29 Billion in 2025, driven by the increasing prevalence of infectious diseases and the rising adoption of automated systems enhances laboratory efficiency and diagnostic accuracy across the region. The market is anticipated to grow at a CAGR of 6.20% during the forecast period of 2026-2035, with the values likely to reach USD 2.35 Billion by 2035.
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According to the Centers for Disease Control and Prevention (CDC), nearly 16 million United States adults have chronic obstructive pulmonary disease (COPD), a leading cause of death, driving demand for advanced clinical microbiology diagnostics in the United States.
One of the major market trends includes the advancement of metagenomic sequencing-based diagnostics. For instance, in May 2024, Karius received FDA Breakthrough Device Designation for its Karius Test® to diagnose lung infections in immunocompromised patients.
Increasing demand for rapid diagnostic tools, rising incidence of hospital-acquired infections, and growing awareness of early disease detection are key drivers accelerating the United States clinical microbiology market growth, enhancing timely treatment and infection control.
Compound Annual Growth Rate
6.2%
Value in USD Billion
2026-2035
*this image is indicative*
Clinical microbiology is the branch of medical science focused on the study, identification, and management of infectious diseases caused by bacteria, viruses, fungi, and parasites. It plays a vital role in disease diagnosis, antimicrobial susceptibility testing, and infection control, supporting effective patient care and public health strategies. The clinical microbiology market in the United States is poised to reach USD 2.35 Billion by 2035, driven by the rising prevalence of infectious diseases, increased demand for rapid diagnostic techniques, and advancements in molecular diagnostics. Growing healthcare expenditures and a strong presence of key industry players further support market expansion.
Rising Adoption of Advanced Technologies to Augment Market Growth
The increasing adoption of advanced antimicrobial susceptibility testing (AST) technologies is significantly driving growth in the market. For instance, in June 2024, bioMérieux received FDA 510(k) clearance for its Vitek Reveal AST System, which delivers same-day AST results directly from positive blood cultures within 5.5 to 6 hours. This system, based on patented metabolomic signature technology, enhances diagnostic speed and accuracy for sepsis management and antimicrobial stewardship. The FDA clearance underscores the market’s ongoing shift toward rapid, high-impact diagnostic solutions, supporting overall market expansion.
The market is witnessing several trends, including a rising demand for rapid infectious disease diagnostics and an increasing preference for patient-centric diagnostic solutions.
Rising Demand for Rapid Infectious Disease Diagnostics Expected to Boost Clinical Microbiology Market Value in the United States
The increasing demand for rapid, accurate, and efficient diagnostic solutions for infectious diseases is emerging as a key trend driving the growth of the clinical microbiology market in the United States. One significant example is the rising prevalence of urinary tract infections (UTIs), which continue to pose a major public health concern. According to Fatemeh Amiri et al., January 2025, UTIs contribute to nearly 7 million medical visits annually in the United States, with 2 million cases linked to cystitis and over 3 million patients receiving antibiotic treatment. This growing clinical and economic burden is intensifying the need for advanced microbiological diagnostics to support timely intervention and improved patient outcomes, which is expected to substantially accelerate market growth.
Growing Preference for Patient-Centric Diagnostics Driving United States Clinical Microbiology Market Demand
The market is experiencing a strong shift toward patient-centric diagnostic innovations that emphasize convenience, accessibility, and enhanced care quality. This trend is gaining momentum as healthcare providers seek more efficient and less-invasive testing methods to improve patient outcomes. In December 2024, BD (Becton, Dickinson and Company) partnered with Babson Diagnostics to advance fingertip blood collection by integrating BD’s MiniDraw capillary system with Babson’s BetterWay technology. This innovative approach enables accurate testing using only a few drops of blood, eliminating the need for traditional venipuncture and allowing trained personnel without phlebotomy experience to collect samples. By simplifying diagnostic procedures and expanding availability across ambulatory and underserved settings, such technologies are expected to significantly accelerate market growth and transform the delivery of clinical microbiology services.
Respiratory Diseases to Lead the Market Share Based on Application
Driven by evolving disease patterns and the growing need for rapid, precise diagnostics, the market continues to expand across multiple applications. These include respiratory diseases, bloodstream infections, urinary tract infections, gastrointestinal diseases, sexually transmitted diseases, periodontal disease, and others. Among these, respiratory diseases are expected to lead the market, supported by the high and increasing prevalence of conditions such as asthma, which affects nearly 28 million individuals, approximately 1 in every 12 Americans. The rising burden of respiratory infections and the demand for accurate microbial identification are key factors reinforcing this segment’s leading position.
The clinical microbiology market in the United States covers prominent regions including New England, the Mideast, the Great Lakes, the Plains, the Southeast, the Southwest, the Rocky Mountains, and the Far West. Among these, the Mideast and Far West regions are projected to lead the market due to their advanced healthcare infrastructure, concentration of top-tier research institutions, strong funding support, rising demand for infectious disease diagnostics, and widespread adoption of innovative microbiological technologies.
The key features of the market report comprise patent analysis, funding and investment analysis, and strategic initiatives by the leading players. The major companies in the market are as follows:
Headquartered in Franklin Lakes, New Jersey, Becton, Dickinson and Company plays a critical role in shaping clinical microbiology practices across the U.S. Through its development of BD BBL™ plated media and advanced specimen collection systems, BD supports laboratories in achieving high diagnostic accuracy. Its U.S.-based innovations have become integral in improving workflow efficiency and accelerating pathogen identification across healthcare institutions nationwide.
Roche, headquartered in Switzerland, is known for its key role in molecular diagnostic technologies. The company designs advanced PCR-based diagnostic solutions that support a range of applications, including clinical microbiology, oncology, virology, and blood screening. Its portfolio further features next-generation sequencing technologies and automated sample preparation platforms, enabling laboratories to produce precise diagnostic data essential for early disease detection and individualized treatment planning.
Founded in 1952 and headquartered in Hercules, California, Bio-Rad Laboratories, Inc. has become a pivotal contributor to the evolution of clinical diagnostics. The company supports laboratories worldwide by delivering tools that enhance microorganism detection and antibiotic resistance monitoring. Its broad portfolio, spanning culture media to antimicrobial susceptibility platforms, strengthens diagnostic accuracy and plays a key role in combating infectious diseases.
With headquarters in France since 1963, bioMérieux SA has carved a niche in the in vitro diagnostics sector, particularly microbiology. The firm excels at developing advanced systems that streamline pathogen identification and antibiotic profiling. Serving clinical laboratories across diverse regions, including South America, bioMérieux drives initiatives that improve public health through timely infection control and resistance management.
*Please note that this is only a partial list; the complete list of key players is available in the full report. Additionally, the list of key players can be customized to better suit your needs.*
Other key players in the market include Sysmex Corporation, Abbott, Thermo Fisher Scientific Inc., QIAGEN, Agilent Technologies, Inc., and Danaher Corporation.
The market report offers a detailed analysis of the market based on the following segments:
Market Breakup by Product
Market Breakup by Application
Market Breakup by End User
Market Breakup by Region
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| REPORT FEATURES | DETAILS |
| Base Year | 2025 |
| Historical Period | 2019-2025 |
| Forecast Period | 2026-2035 |
| Scope of the Report |
Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:
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| Breakup by Product |
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| Breakup by Application |
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| Breakup by End User |
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| Breakup by Region |
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| Market Dynamics |
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| Supplier Landscape |
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