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), B

Market Overview

Global Shigella Test Kit Market was valued at USD 106.83 Million in 2023 and is anticipated to project steady growth in the forecast period with a CAGR of 6.34% through 2029.

These kits employ advanced molecular techniques such as PCR or antigen-antibody assays to detect specific elements and genetic sequences unique to Shigella bacteria. The market growth is driven by the increasing prevalence of Shigella infections worldwide and the rising demand for precise and prompt diagnostic tests for this pathogen. Challenges include cost constraints, especially in resource-limited settings, and the requirement for reliable cold chain logistics for certain types of test kits. Technological advancements and growing global awareness of foodborne illnesses are also contributing to the growth and development of this market segment.

Key Market Drivers

Rising Incidence of Shigella Infections

The global rise in Shigella infections has spurred demand for diagnostic tools that can accurately detect the bacteria in clinical samples such as stool specimens. This capability is essential for timely diagnosis and treatment, significantly impacting patient outcomes. According to The Centers for Disease Control and Prevention's Yellow Book 2024, Shigella is estimated to cause between 80 to 165 million cases of disease and 600,000 deaths annually worldwide, with children being the most affected. Of these cases, approximately 20 to 119 million illnesses and 6,900 to 30,000 deaths are attributed to foodborne transmission.

Shigella outbreaks can occur in diverse settings including healthcare facilities, schools, childcare centers, and community gatherings. The rapid identification of Shigella through test kits enables swift public health responses, such as implementing infection control measures and administering targeted antibiotic therapy. According to the European Centre for Disease Prevention and Control's annual epidemiological report for 2022, the highest rate of shigellosis was reported in children under five years at 3.0 cases per 100,000 population.

Effective surveillance of Shigella infections relies on diagnostic data obtained from these test kits. Increasing incidence rates underscore the importance of robust surveillance systems supported by accurate and reliable diagnostic tools to monitor trends and detect outbreaks early. Governments and healthcare organizations prioritize addressing infectious diseases like Shigella to reduce morbidity and mortality rates. Regulatory frameworks increasingly emphasize the importance of accurate diagnostics in healthcare settings, driving the adoption of validated Shigella test kits to ensure quality and reliability in diagnostic procedures. The rising incidence of Shigella infections intensifies the market demand for dependable and efficient diagnostic solutions. Shigella test kits play a critical role in healthcare settings and public health strategies by enabling early detection, effective treatment, and proactive disease management. Manufacturers and healthcare providers respond to this demand by advancing diagnostic capabilities and expanding the availability of test kits to support global health initiatives.

Increasing Focus on Point-of-Care Testing

Point-of-Care (POC) testing enables rapid identification of Shigella bacteria, facilitating immediate initiation of treatment and infection control measures, which are essential for managing outbreaks and preventing further transmission. Quick test results empower healthcare providers to make informed decisions at the point of care, including prescribing appropriate antibiotics or implementing isolation protocols to contain the spread of infection. This capability of POC testing contributes significantly to more effective public health interventions and containment strategies in response to Shigella outbreaks.

Dr. Subhra Chakraborty and her team from Johns Hopkins Bloomberg School of Public Health developed a new rapid diagnostic test for ETEC and Shigella diarrhea using a DNA amplification method called Rapid Loop-mediated Isothermal Amplification (LAMP). The RLDT provides results as positive or negative within 40 minutes, offering simplicity, rapidity, and the advantage of operating without a cold chain, extensive training, or significant electricity requirements. The study detailing the development of this test kit was published in PLOS Neglected Tropical Diseases in 2023.

The increasing recognition of POC testing's benefits, coupled with advancements enhancing the accuracy and reliability of these tests, is driving demand for Shigella test kits specifically designed for POC settings. This shift toward POC testing represents a pivotal market driver in the Shigella test kit segment, leveraging its capability to deliver rapid and dependable diagnostic outcomes directly in bedside or community healthcare settings.

Key Market Challenges

Cold Chain Logistics Hurdles

Cold chain logistics pose a significant challenge for the Shigella test kit market, especially for kits that rely on delicate reagents or advanced molecular techniques like PCR or antigen detection. These kits require precise temperature control to preserve the stability and accuracy of their reagents. Temperature fluctuations during transportation or storage can degrade these reagents, compromising the reliability of test results. Maintaining the cold chain from manufacturing facilities to distribution points and finally to end-users, such as healthcare facilities or field settings, presents logistical complexities. It involves specialized packaging, temperature monitoring devices, and expedited shipping methods to ensure that the required temperature conditions are maintained throughout the supply chain.

The additional costs associated with cold chain logistics contribute to the overall expense of Shigella test kits. Expenses include investments in packaging, monitoring equipment, and logistics to uphold cold chain integrity. These added costs can restrict affordability and accessibility, particularly in resource-constrained settings where the prevalence of Shigella infections is high. Healthcare facilities must have adequate refrigeration infrastructure and protocols in place to store Shigella test kits according to stringent manufacturer guidelines. In regions with unreliable electricity supply, ensuring consistent storage conditions becomes even more challenging. To overcome these challenges in the Shigella test kit market, innovative solutions are essential. These may include developing reagents that are more resilient to temperature fluctuations, enhancing packaging designs for better insulation, and forging partnerships with logistics expert's adept in managing cold chain logistics effectively. Such measures are crucial for ensuring reliable access to accurate Shigella diagnostics across diverse healthcare settings.

Complexity of Diagnosis

Shigellosis, caused by Shigella bacteria, presents a variety of symptoms such as diarrhea, fever, abdominal cramps, and sometimes vomiting, which can overlap with other gastrointestinal infections. Differentiating Shigella infections from other causes of acute gastroenteritis based solely on clinical symptoms can be challenging. Accurate diagnosis often necessitates specific laboratory tests to identify Shigella bacteria, as symptoms alone are not conclusive. Conventional methods like culture-based tests are time-consuming and may lack sensitivity compared to more advanced molecular techniques such as PCR or antigen detection.

Molecular diagnostic methods like PCR require specialized equipment, trained personnel, and laboratory infrastructure. Access to these resources can be limited in certain healthcare settings, particularly in low-resource or rural areas where Shigella infections are prevalent. The time required to obtain test results, particularly with traditional culture methods, can delay the initiation of diagnosis and treatment. This delay is critical during outbreaks or in cases requiring immediate intervention to prevent further transmission. Addressing the complexity of diagnosis in the Shigella test kit market requires innovative approaches, including the development of user-friendly and reliable diagnostic tools that are accessible even in resource-limited settings.

Key Market Trends

Growing Focus on Surveillance and Epidemiology

There is an increasing recognition of the importance of robust surveillance systems to monitor the prevalence, incidence, and geographic distribution of Shigella infections. Accurate and timely data from these surveillance efforts inform public health strategies and interventions aimed at controlling the spread of the disease. Rapid detection of Shigella outbreaks is crucial for implementing timely public health interventions to prevent further transmission. Surveillance systems, equipped with effective diagnostic tools such as Shigella test kits, play a pivotal role in detecting and responding to outbreaks. A study on Molecular Characterization of Multidrug-Resistant Shigella flexneri published in 2024 highlights the dynamic nature of Shigella infections, including varying occurrence patterns, evolving resistance landscapes, and genetic adaptability. These insights are essential for addressing the rising challenge of antibiotic resistance in Shigella infections and guiding efforts in disease surveillance, prevention, and treatment.

The Centers for Disease Control and Prevention (CDC) have observed an increase in extensively drug-resistant (XDR) Shigella infections through national surveillance systems. In 2022, approximately 5% of reported Shigella infections to the CDC were caused by XDR strains, compared to none reported in 2015. Surveillance programs are instrumental in monitoring trends in antibiotic resistance among Shigella strains, which is critical for informing treatment strategies and containing the spread of drug-resistant infections. Shigella test kits capable of identifying resistance markers contribute significantly to these surveillance efforts. Advancements in diagnostic technologies, including molecular techniques and data analytics, enhance the sensitivity, specificity, and scalability of surveillance efforts for Shigella. These technologies enable real-time data collection and analysis, thereby improving the responsiveness of public health systems to outbreaks and emerging trends. The growing emphasis on surveillance and epidemiology as a market trend in the Shigella test kit sector underscores the importance of proactive disease monitoring, early outbreak detection, and evidence-based public health interventions. Innovations in surveillance capabilities supported by advanced diagnostic tools are crucial for effectively controlling and managing Shigella infections on a global scale.

Segmental Insights

Test Type Insights

Based on Test Type, the Polymerase chain reaction

Technology Insights

Based on Technology Type, Nucleic acid-based tests emerged as the dominating segment in the global market for Shigella Test Kit in 2023.

Regional Insights

Based on Region, Asia Pacific emerged as the fastest growing region in the Global Shigella Test Kit Market during the forecast period. Countries such as India, China, and Southeast Asian nations are facing significant challenges related to infectious diseases, particularly Shigella infections. The high prevalence of these diseases underscores the urgent need for effective diagnostic tools to improve disease management and public health outcomes.

Recent Development

• In2023, Thermo Fisher Scientific introduced the CE-IVD marked TaqPath EntericBacterial Select Panel. This panel utilizes polymerase chain reaction (PCR)technology to analyze stool samples for several common gastrointestinal (GI)bacteria, such as Salmonella spp., Shigella spp./enteroinvasive E. coli (EIEC),Campylobacter jejuni, Campylobacter coli, and Campylobacter upsaliensis. It hasbeen validated and registered under IVDD, enabling clinicians to promptlyidentify the root cause of GI infections and administer the most appropriatetreatment to their patients.
• In2023, LimmaTech Biologics AG, a clinical-stage biotechnology companyspecializing in vaccines for severe diseases, entered into an in-licenseagreement with GlaxoSmithKline Biologicals SA. This agreement enables LimmaTechBiologics AG to advance and commercialize a quadrivalent bioconjugate vaccinecandidate for shigellosis. The vaccine under development contains antigensderived from the four most prevalent strains of Shigella bacteria. It iscurrently undergoing Phase I/II clinical trials, utilizing a dose-findingapproach and studying various age groups from adults to infants, in adouble-blind study to assess both safety and immune response efficacy ininfants aged 9 months, the target population.

Key Market Players

• ThermoFisher Scientific Inc.
• MeridianBioscience, Inc.
• QIAGENN.V.
• DiasorinS.p.A.
• Bio-RadLaboratories Inc.
• BioMérieuxSA
• HygienaLLC
• MolbioDiagnostics Pvt. Ltd.
• FujirebioDiagnostics, Inc.
• CTKBiotech, Inc.