Antimicrobial Susceptibility Testing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product (Manual Tests {MIC Strips, Susceptibility Testing Disks, Susceptibility Plates}, Automated Instruments, Consumables & Media), By Technique (Automated AST, Etest Method, Dilution, Disk Diffusion, Others), By Application (Drug Development, Susceptibility Testing, Others), By End User (Hospitals, Diagnostic Laboratories, Biotechnology & Pharmaceutical Companies, Others), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 4.52 Billion
CAGR (2026-2031)	5.21%
Fastest Growing Segment	Drug Development
Largest Market	North America
Market Size (2031)	USD 6.13 Billion

Market Overview

The Global Antimicrobial Susceptibility Testing Market will grow from USD 4.52 Billion in 2025 to USD 6.13 Billion by 2031 at a 5.21% CAGR. The Global Antimicrobial Susceptibility Testing Market is defined by the sector dedicated to the development and distribution of diagnostic procedures and devices used to determine the efficacy of specific antimicrobial agents against pathogenic microorganisms. The primary driver supporting this market's growth is the escalating global burden of infectious diseases coupled with the critical necessity for antimicrobial stewardship programs to preserve the efficacy of existing therapeutics. This demand is further amplified by the urgent need for rapid diagnostic capabilities in clinical settings to optimize patient outcomes and reduce hospital stays.

However, a significant challenge impeding market expansion is the high cost associated with automated susceptibility testing systems and the complex regulatory landscape governing their approval. These economic and procedural barriers often limit adoption rates, particularly in resource-constrained healthcare environments. According to the International Federation of Pharmaceutical Manufacturers and Associations, in 2025, the fragility of the therapeutic landscape was highlighted by the fact that only 10 new antibiotics or combinations were approved by stringent regulatory authorities between 2017 and 2023, underscoring the indispensable reliance on precise testing to manage resistance trends effectively.

Key Market Drivers

The rising global prevalence of antimicrobial resistance (AMR) acts as the primary catalyst propelling the Global Antimicrobial Susceptibility Testing Market, necessitating precise diagnostic tools to guide effective treatment. As bacterial pathogens increasingly evolve mechanisms to withstand standard drug regimens, empirical prescribing has become hazardous, creating an urgent clinical requirement for susceptibility profiling to prevent treatment failure in life-threatening conditions. This escalation in resistance rates forces healthcare systems to rely heavily on advanced testing infrastructure to optimize stewardship and patient outcomes. According to the World Health Organization, October 2025, in the 'Global Antibiotic Resistance Surveillance Report 2025', antibiotic resistance rose in over 40% of the pathogen-antibiotic combinations monitored between 2018 and 2023, underscoring the critical dependence on accurate susceptibility data.

Simultaneously, the market is being significantly driven by advancements in automated and high-throughput testing systems that address the laboratory need for operational efficiency and speed. Modern microbiology laboratories are rapidly transitioning from manual, labor-intensive methods to fully automated platforms that utilize artificial intelligence to deliver faster, standardized results, thereby managing increasing sample volumes without expanding headcount. This shift towards automation is evidenced by robust commercial performance in the sector; according to bioMérieux, March 2025, in the '2024 Financial Results', the company’s microbiology sales grew by 8.3% in 2024, driven largely by increased reagent volumes and the adoption of automated solutions. The broader ecosystem supporting these diagnostic innovations continues to mature, as according to CARB-X, in 2025, three of its supported products, including two novel diagnostics, successfully reached the market, highlighting the effective translation of R&D into clinical solutions.

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Key Market Challenges

The formidable economic and regulatory barriers inherent in the diagnostic sector are directly restricting the expansion of the Global Antimicrobial Susceptibility Testing Market. As manufacturers face increasingly complex approval pathways, particularly for automated testing systems, the financial resources required for compliance have risen sharply. This regulatory pressure diverts capital away from research and development, effectively stalling the introduction of innovative diagnostic tools. Consequently, many companies are forced to delay product launches or withdraw from specific regional markets entirely, limiting the availability of essential susceptibility testing solutions in healthcare settings where they are most needed to combat resistance.

This constriction of market activity is substantiated by recent industrial data highlighting the severity of these compliance costs. According to MedTech Europe, in 2025, certification and maintenance costs for in vitro diagnostics under the new regulatory standards escalated by up to 100% compared to previous directives. Furthermore, the association reported that the choice of the European Union as a first-launch geography dropped by 40% for large manufacturers due to these hurdles. Such elevated barriers to entry directly reduce the commercial viability of new antimicrobial susceptibility tests, thereby hampering overall market growth.

Key Market Trends

The incorporation of culture-independent molecular testing methods is fundamentally reshaping the market by bypassing time-consuming culture steps to detect resistance genes directly from clinical samples. This shift towards genotypic profiling allows clinicians to identify specific resistance markers, such as mecA or vanA, within hours rather than days, significantly accelerating targeted therapeutic interventions for sepsis and complex bloodstream infections. The commercial traction of these advanced diagnostics is evident in recent industrial performance, as healthcare providers increasingly adopt syndromic panels; according to bioMérieux, March 2025, in the '2024 Financial Results', sales of the company's BIOFIRE non-respiratory panels, which include rapid blood culture identification assays, increased by 17% in 2024, highlighting the growing clinical reliance on rapid molecular testing to manage severe infections.

Simultaneously, the expansion of point-of-care (POC) diagnostic solutions is decentralizing antimicrobial susceptibility testing, moving critical analysis from the central laboratory to the patient bedside. This trend is driven by the urgent need for immediate results in emergency and outpatient settings to curb unnecessary antibiotic prescriptions and improve stewardship before hospital admission. The scale of this decentralized infrastructure is rapidly widening, as established molecular platforms leverage their extensive installed bases to deploy resistance assays; according to Danaher, January 2025, in the 'Supplemental Earnings Information for the Fourth Quarter 2024', the company’s Cepheid division generated approximately $550 million in respiratory revenue in the fourth quarter alone, underscoring the massive operational footprint available for the broader adoption of rapid diagnostic tests.

Segmental Insights

The Drug Development segment represents the fastest-growing category in the Global Antimicrobial Susceptibility Testing Market. This surge is fueled by the intensifying global focus on combating antimicrobial resistance, which has necessitated increased investment in pharmaceutical research for novel antibiotics. Susceptibility testing plays a critical role in clinical trials by validating the efficacy of new drug candidates against specific pathogens. Furthermore, regulatory bodies like the US Food and Drug Administration have implemented guidelines to synchronize the approval of antimicrobial drugs and susceptibility testing devices, creating a favorable environment for sustained segment expansion.

Regional Insights

North America maintains a dominant position in the global antimicrobial susceptibility testing market, driven by established healthcare infrastructure and a strong focus on combatting drug-resistant infections. The region benefits from substantial government initiatives, such as the antibiotic resistance monitoring programs led by the U.S. Centers for Disease Control and Prevention. Additionally, the presence of major diagnostic manufacturers facilitates the high adoption of automated testing solutions. This market strength is further supported by clear regulatory guidelines from the U.S. Food and Drug Administration, which streamline product approvals and commercialization.

Recent Developments

• In June 2024, bioMérieux announced that the U.S. Food and Drug Administration (FDA) had granted 510(k) clearance for its VITEK REVEAL system. This rapid antimicrobial susceptibility testing instrument is designed to deliver phenotypic results for gram-negative bacteria directly from positive blood cultures in an average of 5.5 hours. By utilizing a unique metabolomic signature technology, the system monitors bacterial growth and response to antibiotics in real-time. This addition to the company’s comprehensive sepsis portfolio allows clinicians to optimize antibiotic therapy much sooner than with traditional methods, thereby supporting antimicrobial stewardship programs and improving patient care.
• In April 2024, Q-linea AB received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its ASTar System, a fully automated platform for rapid antimicrobial susceptibility testing. The system is capable of analyzing gram-negative bacteria directly from positive blood cultures and delivering results in approximately six hours. This regulatory approval enables the company to launch the product commercially in the United States, offering clinical laboratories a solution to drastically reduce the time required to identify effective antibiotic treatments. The clearance represents a significant achievement in the company’s efforts to improve patient outcomes in cases of severe bloodstream infections.
• In March 2024, Becton, Dickinson and Company (BD) announced a strategic collaboration with the Great Orchestra of Christmas Charity to upgrade microbiology diagnostics in Poland. As part of this initiative, the company agreed to install its automated bacterial identification and antimicrobial susceptibility testing systems at over 150 hospitals and clinics across the country. The deployment of these advanced instruments aims to enhance the management of sepsis and bloodstream infections by providing clinicians with rapid and accurate diagnostic data. This partnership underscores the company’s commitment to expanding access to critical testing technologies that help determine appropriate antibiotic treatments and combat resistance.
• In February 2024, Selux Diagnostics announced that it had received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its proprietary Positive Blood Culture (PBC) Separator. This technology is a critical component of the company’s Next Generation Phenotyping (NGP) System, which is designed to provide rapid antimicrobial susceptibility testing results. The cleared device enables the platform to process samples directly from positive blood cultures, eliminating the need for time-consuming subcultures. This regulatory milestone positions the company to offer a unified solution that significantly accelerates the selection of targeted antibiotic therapies, thereby addressing the urgent global challenge of antimicrobial resistance.

Key Market Players

• Bio-Rad Laboratories Inc.
• Merck & Co., Inc.
• Thermo Fisher Scientific Inc.
• Danaher Corporation
• bioMérieux SA
• Becton, Dickinson and Company
• ELITech Group SAS
• F. Hoffmann-La Roche Ltd.
• Accelerate Diagnostics, Inc.
• HiMedia Laboratories Private Limited

By Product	By Technique	By Application	By End User	By Region
Manual Tests {MIC Strips Susceptibility Testing Disks Susceptibility Plates} Automated Instruments Consumables & Media	Automated AST Etest Method Dilution Disk Diffusion Others	Drug Development Susceptibility Testing Others	Hospitals Diagnostic Laboratories Biotechnology & Pharmaceutical Companies Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Antimicrobial Susceptibility Testing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Antimicrobial Susceptibility Testing Market, By Product:

• Manual Tests {MIC Strips
• Susceptibility Testing Disks
• Susceptibility Plates}
• Automated Instruments
• Consumables & Media

• Antimicrobial Susceptibility Testing Market, By Technique:

• Automated AST
• Etest Method
• Dilution
• Disk Diffusion
• Others

• Antimicrobial Susceptibility Testing Market, By Application:

• Drug Development
• Susceptibility Testing
• Others

• Antimicrobial Susceptibility Testing Market, By End User:

• Hospitals
• Diagnostic Laboratories
• Biotechnology & Pharmaceutical Companies
• Others

• Antimicrobial Susceptibility Testing Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE