Shigella Test Kit Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Test Type (Lateral flow assays, Enzyme-linked immunosorbent assay (ELISA), Polymerase chain reaction (PCR) assay, and Others), By Technology (Conventional diagnostic tests, Nucleic acid-based tests, and Others), By End User (Hospitals, Diagnostic laboratories, Research institutes, and Others), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 178.86 Million
CAGR (2026-2031)	7.11%
Fastest Growing Segment	Polymerase Chain Reaction Assay
Largest Market	North America
Market Size (2031)	USD 270.08 Million

Market Overview

The Global Shigella Test Kit Market will grow from USD 178.86 Million in 2025 to USD 270.08 Million by 2031 at a 7.11% CAGR. Shigella test kits are diagnostic tools utilized to detect Shigella antigens or genetic material in clinical stool samples, employing technologies such as lateral flow immunoassays and molecular polymerase chain reaction to confirm shigellosis infection. The market is primarily driven by the rising global incidence of foodborne diseases and the critical necessity to identify antimicrobial-resistant strains, which requires precise sensitivity profiling to guide effective treatment. According to the UK Health Security Agency, in 2023, the number of extensively antibiotic-resistant Shigella cases increased by 53 percent, underscoring the urgent demand for accurate and rapid diagnostic capabilities to manage this escalating public health threat.

Despite these strong growth drivers, the market faces a significant challenge regarding the high implementation costs of advanced molecular diagnostic platforms. This financial barrier restricts the adoption of modern testing solutions in resource-limited settings where shigellosis is most endemic. Furthermore, inadequate laboratory infrastructure in these developing regions complicates the deployment of comprehensive testing protocols, thereby impeding the global reach and expansion of the market.

Key Market Drivers

The growing burden of multidrug-resistant Shigella strains is a primary force accelerating the Global Shigella Test Kit Market. As resistance to first-line antibiotics such as azithromycin and ciprofloxacin intensifies, clinical laboratories are compelled to adopt advanced diagnostic solutions capable of not only detecting the pathogen but also identifying specific resistance markers to guide effective therapy. This urgency is highlighted by recent surveillance data regarding the rapid spread of dangerous variants; according to the California Department of Public Health, August 2024, in the 'Health Advisory: Rise in Extensively Drug-Resistant Shigella Strains', the proportion of Shigella isolates identified as extensively drug-resistant (XDR) in California rose to 12% between January and May 2024, a significant increase from 6.8% the previous year. Consequently, healthcare providers are prioritizing test kits that support precise clinical decision-making to manage these complex, hard-to-treat infections.

Technological advancements in molecular diagnostics further propel market expansion by enabling rapid, high-throughput detection through syndromic testing panels. The shift from traditional culture methods to multiplex polymerase chain reaction (PCR) platforms allows for the simultaneous identification of Shigella and other enteric pathogens, drastically reducing turnaround times and improving outbreak response. This demand for rapid diagnostics is reflected in recent industry performance; according to BioMérieux, March 2024, in the '2023 Financial Results', sales for BIOFIRE non-respiratory panels, which encompass gastrointestinal testing, achieved a growth of 20% in the fourth quarter of 2023. These advanced tools are critical for managing the vast disease burden, as according to the Centers for Disease Control and Prevention, in 2024, an estimated 450,000 Shigella infections occur annually in the United States alone.

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Key Market Challenges

The high implementation costs associated with advanced molecular diagnostic platforms constitute a substantial impediment to the growth of the Global Shigella Test Kit Market. This financial barrier severely restricts the adoption of modern testing solutions in resource-limited economies, which represent the regions with the highest endemic burden of the disease. Since healthcare budgets in these developing areas are often constrained, facilities cannot procure or maintain the expensive instrumentation required for precise sensitivity profiling. Consequently, the market faces a structural ceiling on its expansion as it remains unable to monetize the demand in geographies where the clinical need is most acute.

The lack of adequate laboratory infrastructure in these regions further complicates the deployment of necessary testing protocols. This inability to establish robust diagnostic frameworks prevents the identification of complex resistant strains, limiting the market's reach. The urgency of this issue is evidenced by recent resistance trends that require such advanced detection. According to the California Department of Public Health, in 2024, the prevalence of extensively drug-resistant Shigella isolates rose to 12 percent between January and May, reflecting a 78 percent increase compared to the previous year. This escalation in resistance underscores the critical need for advanced diagnostics, yet the prohibitive costs associated with these tools continue to hamper their market penetration and overall industry growth.

Key Market Trends

The proliferation of multiplex syndromic gastrointestinal panels is reshaping the market by addressing the clinical challenge of distinguishing shigellosis from infections caused by other enteric pathogens with identical symptom profiles. Unlike traditional single-target tests, these comprehensive panels enable the simultaneous detection of a wide array of bacteria, viruses, and parasites, thereby reducing diagnostic uncertainty and optimizing patient management in complex clinical scenarios. This trend towards broader diagnostic granularity is exemplified by recent product launches; according to Qiagen, June 2024, in the press release 'QIAGEN expands QIAstat-Dx syndromic testing menu in the U.S.', the company launched the QIAstat-Dx Gastrointestinal Panel 2, which allows for the rapid identification of up to 16 common gastrointestinal pathogens in approximately one hour.

Concurrently, the integration of automated real-time PCR assays in clinical laboratories is accelerating as facilities seek to streamline high-volume diagnostic workflows and mitigate chronic staff shortages. Healthcare providers are increasingly adopting fully automated molecular platforms that minimize manual handling and enhance throughput, allowing for the efficient processing of routine gastrointestinal samples beyond the capacity of manual methods. This operational shift towards automation is driving significant commercial uptake; according to Seegene Inc., May 2024, in the 'Q1 2024 Results' presentation, sales for the company’s gastrointestinal diagnostic products grew by 36 percent year-over-year, a performance attributed to the successful securing of new customers transitioning to advanced automated solutions.

Segmental Insights

The Polymerase Chain Reaction Assay segment represents the fastest-growing category in the Global Shigella Test Kit Market due to the rising adoption of culture-independent diagnostic tests. Clinical laboratories increasingly utilize these molecular methods because they provide results much faster than traditional bacterial culture techniques, allowing for quicker patient treatment and isolation decisions. This expansion is further supported by regulatory clearances from agencies such as the U.S. Food and Drug Administration for multi-pathogen panels, which encourage healthcare facilities to integrate these efficient testing solutions into standard diagnostic workflows.

Regional Insights

North America maintains a leading position in the Global Shigella Test Kit Market, primarily due to its well-established healthcare infrastructure and the extensive adoption of advanced diagnostic technologies. The region's market dominance is reinforced by strict food safety protocols and active surveillance programs overseen by authoritative bodies such as the U.S. Food and Drug Administration (FDA). These regulatory frameworks mandate rigorous pathogen detection standards to effectively manage and control foodborne illness outbreaks. Additionally, the strong presence of major diagnostic manufacturers within the region ensures the widespread availability of reliable testing solutions, further sustaining North America's superior market standing.

Recent Developments

• In October 2025, Hologic, Inc. announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new Panther Fusion Gastrointestinal Bacterial and Expanded Bacterial Assays. These molecular diagnostic tests were designed to detect common bacterial pathogens that cause infectious gastroenteritis, including Shigella, Salmonella, Campylobacter, and E. coli O157. The company highlighted that these assays could be run individually or in combination as a customizable mini-panel on the Panther Fusion system. This clearance marked Hologic’s expansion into the gastrointestinal testing market, offering laboratories a streamlined, fully automated workflow to replace labor-intensive traditional culture methods.
• In February 2025, bioMérieux received FDA clearance for its BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid, a new mid-plex syndromic testing solution. This panel was developed to identify eleven of the most common causes of infectious gastroenteritis, including bacteria such as Shigella and Enteroinvasive E. coli (EIEC), as well as key viruses and parasites. The company positioned this product as a complementary option to its comprehensive 22-target GI panel, enabling clinicians to choose a testing solution that best fits the patient's clinical needs. The panel provided results in approximately one hour, facilitating rapid decision-making for appropriate patient management and antimicrobial stewardship.
• In January 2025, Qiagen N.V. announced that it had obtained FDA clearance for the QIAstat-Dx Gastrointestinal Panel 2 Mini B&V, the first in a series of targeted mini-panels for its syndromic testing system. This diagnostic test was designed to detect five specific pathogens recommended by the Infectious Diseases Society of America (IDSA) for gastrointestinal testing, including Shigella, Campylobacter, Salmonella, Shiga toxin-producing E. coli (STEC), and Norovirus. The launch aimed to provide outpatient settings with a cost-effective and clinically relevant testing option that delivered rapid results, thereby supporting timely diagnosis and treatment in cases of acute gastroenteritis.
• In June 2024, Qiagen N.V. launched the QIAstat-Dx Gastrointestinal Panel 2 in the United States following its regulatory clearance. This comprehensive syndromic panel was engineered to simultaneously detect and differentiate sixteen varied gastrointestinal pathogens, including bacteria like Shigella and Salmonella, as well as viruses and parasites, from a single stool sample. The company emphasized that the panel utilized real-time PCR technology to deliver results in about one hour, which significantly reduced the time to diagnosis compared to traditional methods. This launch was intended to address the challenges of diagnosing overlapping gastrointestinal symptoms and to improve operational efficiency in clinical laboratories.

Key Market Players

• Thermo Fisher Scientific Inc.
• Meridian Bioscience, Inc.
• QIAGEN N.V.
• Diasorin S.p.A.
• Bio-Rad Laboratories Inc.
• BioMérieux SA
• Hygiena LLC
• Molbio Diagnostics Pvt. Ltd.
• Fujirebio Diagnostics, Inc.
• CTK Biotech, Inc.

By Test Type	By Technology	By End User	By Region
Lateral flow assays Enzyme-linked immunosorbent assay (ELISA) Polymerase chain reaction (PCR) assay and Others	Conventional diagnostic tests Nucleic acid-based tests and Others	Hospitals Diagnostic laboratories Research institutes and Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

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

• Shigella Test Kit Market, By Test Type:

• Lateral flow assays
• Enzyme-linked immunosorbent assay (ELISA)
• Polymerase chain reaction (PCR) assay
• and Others

• Shigella Test Kit Market, By Technology:

• Conventional diagnostic tests
• Nucleic acid-based tests
• and Others

• Shigella Test Kit Market, By End User:

• Hospitals
• Diagnostic laboratories
• Research institutes
• and Others

• Shigella Test Kit 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