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Yersinia Diagnostics Market

Yersinia Diagnostics Market Size, Share and Growth Forecast by Product (Instruments, Kits and Reagents), by Diagnostic Test (Stool Culture, Imaging Tests, Serological Tests, Colonoscopy, Others), by Technology (Immunoassay, DNA Probes, Polymerase Chain Reaction (PCR), Flow Cytometry, Chromatography, Others), by End User (Hospitals, Public Health Laboratories, Commercial Laboratories, Others), and by Region for 2024-2031

Yersinia Diagnostics Market Size and Share Analysis

The global market for yersinia diagnostics is estimated to value at US$467.0 Mn by the end of 2031 from US$287.0 Mn recorded in 2023. The market is expected to secure a CAGR of 6.3% in the forthcoming years from 2024 to 2031.

Market Attributes

Key Insights

 Market Size (2024E)

US$304.7 Mn

Projected Market Value (2031F)

US$467.0 Mn

Global Market Growth Rate (CAGR 2024 to 2031)

6.3%

Historical Market Growth Rate (CAGR 2018 to 2023)

5.6%

Key Highlights of the Market

  • Rapid advancements in diagnostic techniques
  • Introduction of point-of-care testing (POCT) solutions, targeting faster on-site detection of Yersinia pathogens
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Market Introduction and Trend Analysis

Yersiniosis or Yersinia infection is a zoonotic disease caused by a gram-negative bacillus shaped bacterium, Yersinia enterocolitica, predominantly through the faecal-oral route.

In humans, yersinia infection is caused by consumption of contaminated food or with transfusion of contaminated blood.

The infection is more common in children as compared to adults and can cause fever and gastrointestinal (GI) problems such as diarrhoea.

Yersinia treatment includes pharmacological therapy with trimethoprim-sulfamethoxazole or aminoglycosides, tetracycline, cephalosporins and quinolones, supportive care with hydration and nutritional support and surgical intervention in some cases.

Growing incidence of Yersinia infection poses significant health concerns owed to their potential for outbreaks and severe health consequences if left undiagnosed or untreated.

Over the past decade, several companies have entered the yersinia diagnostics industry, channelizing their efforts to maximize productivity, flexibility, and throughput capabilities significantly influencing market’s growth and development.

These trends are indicative of technological advancements, alterations in healthcare methodologies, and transformations in the epidemiological terrain of Yersinia-associated illnesses.

Rapid advancement of diagnostic techniques is one of the key trends observed within this industry. Traditional methods, such as culture-based techniques, have been supplemented and often replaced by molecular diagnostics.

The molecular diagnostic techniques typically include next-generation sequencing (NGS), and polymerase chain reaction (PCR) assays technologies.

It thus offers higher specificity, sensitivity, and faster turnaround time compared to conventional approaches, driving their widespread adoption in clinical laboratories.

The emergence of POCT solutions in Yersinia diagnostics has also facilitated a swift on-site detection of Yersinia pathogens. These POCT devices negate the requirement for sample transportation, thereby minimizing diagnosis time.

This trend resonates with the increasing focus on decentralized testing and the demand for prompt diagnostic outcomes across diverse healthcare settings, encompassing field hospitals, emergency departments, and primary care clinics.

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Yersinia Diagnostics Market Historical Growth and Course Ahead

The market for yersinia diagnostics has witnessed substantial historic growth and is poised for continued expansion in the forecast period.

Globally, increasing incidence of Yersinia-related diseases, growing awareness regarding importance of early disease detection among the healthcare providers, and advancements in diagnostic technologies have been facilitating rapid and accurate identification of Yersinia strains.

Companies in the yersinia diagnostic market have been investing in research and development to develop and offer efficient and precise detection of Yersinia species, especially Yersinia pestis and Yersinia enterocolitica.

Innovative cutting-edge diagnostic solutions such as serological assays, molecular diagnostics and rapid antigen detection tests have been developed to accurately identify Yersinia pathogens within clinical specimens like stool, tissues or blood samples.

Such advancements have been empowering healthcare professionals around the world to provide reliable and timely information, enable prompt treatment strategies and effective management of Yersinia infections.

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Market Growth Drivers

Changes in Epidemiological Landscape of Yersinia-related Diseases

The market for Yersinia diagnostic is influenced by growing incidence of Yersinia-related diseases. Over the past few decades, yersinia infections have become very common with epidemics reported in many parts of the globe.

  • In the U.S., around 117 thousand people suffer illness from yersiniosis infections caused by Y. enterocolitica every year, with more than 35 deaths and around 650 getting admitted to the hospital yearly. (CDC, 2023)
  • A US study found that approximately 6% of Y. enterocolitica infections were associated with travel. (CDC, 2023)

While plague remains a significant public health concern in certain regions, the incidence of Yersinia enterocolitica infections has been rising in various parts of the world.

The shift in prevalence of yersiniosis infection underscores the importance of adaptable diagnostic strategies capable of addressing evolving epidemiological trends and emerging infectious threats.

Increasing Adoption of Molecular Diagnostic Techniques

Continual evolution of diagnostic technologies has revolutionised the overall Yersinia diagnostics market.

Rapid detection of causative agents using molecular techniques like PCR, and NGS, and availability of multiplex assays for detection of multiple pathogens simultaneously further enhances the efficiency and utility of Yersinia diagnostics.

Companies have been investing in designing and developing tools and assays which can be used clinically for precise and rapid diagnosis of Y. pseudotuberculosis infection.

CIDT (Culture-Independent Diagnostic Tests) utilizing molecular techniques like PCR, for Yersinia pathogens represent a significant advancement in diagnostic capabilities.

CIDTs are cheaper, easier, and faster ways to detect pathogens than culture-based techniques and work by detecting the presence of a gene or antigen associated with a specific pathogen.

Many CIDTs are more sensitive than the culture, while some can detect more than one pathogen from a single patient sample. Increasing adoption of molecular diagnostic techniques is likely to drive the global market for Yersinia diagnostics market.

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Factors Impeding the Market Growth

Variability in Yersinia Strains, and Complexity of Yersinia Infections

Yersinia species encompass a wide array of strains and serotypes, each characterized by unique pathogenicity profiles and virulence factors.

Yersinia enterocolitica, for instance, presents with numerous biotypes and serotypes, each linked to distinct clinical manifestations and varying degrees of disease severity.

This genetic diversity and antigenic variability among Yersinia strains pose significant challenges for the development and validation of diagnostic tests.

The complexity of Yersinia diversity necessitates diagnostic assays capable of robust performance across various strains to ensure accurate detection and differentiation of Yersinia infections.

However, the strain-specific differences in antigenicity and genetic markers may present obstacles to achieving optimal sensitivity and specificity in diagnostic tests.

These challenges underscore the importance of comprehensive validation studies that encompass a diverse range of Yersinia strains to ensure the reliability and effectiveness of diagnostic assays.

Cost and Resource Constraints

Access to healthcare services, particularly in low-resource or rural areas, presents a significant barrier to the availability and utilization of Yersinia diagnostic tests.

Inadequate infrastructure, such as limited laboratory facilities, insufficient diagnostic equipment, and a shortage of trained personnel, exacerbates the challenge of delivering timely and accurate diagnostic services.

Furthermore, the affordability of Yersinia diagnostic tests poses a considerable obstacle to their widespread adoption, particularly in resource-constrained settings.

The high cost of advanced molecular assays, including upfront expenses for purchasing diagnostic equipment and reagents, as well as ongoing maintenance and operational costs, presents financial challenges for healthcare facilities and patients alike.

In low-resource settings where healthcare budgets are limited, prioritizing investments in Yersinia diagnostics may compete with other essential healthcare needs, leading to underinvestment and restricted access to diagnostic services.

The economic burden of Yersinia-related diseases, including healthcare expenditures, lost productivity, and treatment costs, further compounds the affordability challenge for patients and healthcare systems.

Future Opportunities for the Yersinia Diagnostics Market Players

Rising Demand for Point-of-Care Testing

The expanding market for point-of-care testing (POCT) devices presents opportunities for decentralized Yersinia diagnostics, allowing for rapid on-site detection of Yersinia pathogens in various healthcare settings.

Portable and user-friendly POCT platforms enable timely diagnosis and treatment initiation, particularly in resource-limited or remote environments where access to laboratory facilities may be limited.

Advances in miniaturization, biosensor technology, and connectivity options enhance the capabilities and versatility of POCT devices, driving their adoption in diverse clinical and public health settings.

Emergence of Precision Medicine, and Personalised Diagnostics

The emergence of precision medicine methods, customized to the unique characteristics of each patient and their disease presentation, opens doors for personalized Yersinia diagnostics and treatment plans.

By analysing genomic and host response biomarkers, valuable information is gained about disease development, susceptibility factors, and response to treatment, aiding in the creation of focused diagnostic tests and therapeutic approaches.

Precision diagnostics facilitate precise risk assessment, early identification of Yersinia infections, and the tailoring of antimicrobial treatment schedules, ultimately improving patient outcomes while minimizing negative side effects.

Category-wise Analysis

Category

Projected CAGR through 2031

Diagnostic Test Category – Stool Culture

6.2%

Technology – Polymerase Chain Reaction

6.4%

Stool Culture Segment to Account for the Significant Share

The stool culture segment accounted for one-third of the global market revenue in 2023 and is likely to maintain its dominance during in the forthcoming years recording a CAGR of 6.2%.

Yersinia being an acute diarrheal illness is caused by Yersinia species- Y.enterocolitis, Y.pestic and Y.pseudotuberculosis. The diagnostic test predominantly is based on the positive stool culture which provides the evidence of the bacterium in faeces, and in a viable state.

It thus helps with detection of the presence of Yersinia organisms in the gastrointestinal system. Additionally, stool cultures can also help determine the antibiotic susceptibility of the Yersinia strain, which is essential for guiding appropriate treatment.

PCR to be the Preferred Technology for Yersinia Diagnostics

Amongst various technologies used for Yersinia diagnosis, PCR is the most preferred method as it enables highly sensitive and specific detection of the pathogen by amplifying specific DNA sequences characteristic of Yersinia species, even at low concentrations in clinical samples like stool or blood.

PCR technology is a valuable tool for timely diagnosis and management of Yersinia infections as it offers rapid turnaround times.

Furthermore, PCR assays for Yersinia can be designed to target genes specific to the genus or species level, enhancing the accuracy of disease diagnosis.

Region-wise Analysis

Region

CAGR through 2034

North America

5.8%

East Asia

6.4%

North America to Account for the Significant Share in the Yersinia Diagnostics Market

North America is the most significant shareholder in the global market and is expected to grow at a CAGR of 5.8% during the forecast period.

North America market accounts for the notable share owing to the factors such as presence of key players in the region offering yersinia diagnostic solutions, presence of leading academic and research laboratories, and increasing prevalence of Yersinia infection.

North America has well-established healthcare infrastructure and resources such as advanced laboratories and diagnostic facilities equipped with cutting-edge technology, and a strong network of research institutions and healthcare organizations.

This allows for active collaborations in conducting clinical trials, fostering innovation in diagnostic techniques and enhancing Yersinia epidemiology understanding in the region.

Moreover, North America's regulatory agencies, such as the CDC play a pivotal role in setting standards for Yersinia diagnostics. Thereby, providing guidance on best practices, quality assurance, and surveillance protocols, ensuring accuracy and consistency in diagnostic procedures across the region.

East Asia to Exhibit a Notable CAGR by 2033

East Asia’s market for Yersinia diagnostics is projected to secure a CAGR of 6.4% in the forecast period from 2024 to 2031.

Rapid economic development and urbanization in this region contribute significantly to the Yersinia diagnostics industry development, as it allows for improved healthcare infrastructure and increased access to medical services.

Furthermore, characterized by densely populated demographic, the risk of infectious disease transmission, including Yersinia infections is quite high.

This underscores the importance of effective diagnostic tools for early detection and management of outbreaks.

  • A systematic review and meta-analysis of 5000 plus published articles between Jan. 1, 2000, and Dec. 31, 2019, was done to understand the “Global Prevalence of Yersinia enterocolitica in Cases of Gastroenteritis”. The study revealed the pooled prevalence rate of Y. enterocolitica by culture method in China was around 2.41% (International Journal of Microbiology, 2021)

Significant investments in healthcare research and development, supported by both public and private sectors is fostering innovation in diagnostic technologies with rapid, cost-effective, and accurate Yersinia diagnostic assays tailored to the needs of the local population.

Several local players offering Yersinia diagnostic services and products have been catering to the demands domestically, as well as competing with leading players at a global level.

Competitive Landscape Analysis

Continual investments in research and development activities to develop novel products with high specificity for pathogen detection and accelerating the regulatory approval process to launch products across nations are the key growth strategies followed by the key players in the market.

Recent Industry Developments

January 2024

ELITech Group launched GI Bacterial PLUS ELITe MGB® Kit, their kit of the Gastrointestinal assay panel targeting bacterial pathogens including Clostridium difficile, Campylobacter spp., Salmonella spp., Yersinia enterocolitica, and Shigella spp.

September 2023

The T2Biothreat Panel developed by BARDA’s partner T2 Biosystems, Inc., received US FDA 510(k) clearance, becoming the latest BARDA-supported medical countermeasure. The T2Biothreat Panel is a direct-from-blood molecular diagnostic test which can detect and differentiate between six biothreat pathogens in a single sample and runs on the T2Dx instrument. The biothreat pathogens categorized as high-priority threat to US health security includes organisms that cause melioidosis (Burkholderia pseudomallei), anthrax (Bacillus anthracis), plague (Yersinia pestis), glanders (Burkholderia mallei), tularemia (Francisella tularensis), and epidemic typhus (Rickettsia prowazekii).

Report Scope

Attributes

Details

Forecast Period

2024 to 2031

Historical Data Available for

2018 to 2023

Market Analysis

US$ Million for Value

Key Regions Covered

  • North America
  • Europe
  • East Asia
  • South Asia & Oceania
  • Latin America
  • Middle East and Africa

Key Market Segments Covered

  • Product
  • Diagnostic Test
  • Technology
  • End User
  • Region

Key Companies Profiled in the Report

  • TestLine Clinical Diagnostics s.r.o
  • CERTEST BIOTEC
  • T2 Biosystems
  • Demeditec Diagnostics GmbH
  • Launch Diagnostics Limited
  • ELITech Group
  • Advanced Molecular Diagnostics
  • SeraCare (LGC Clinical Diagnostics)
  • Hygiena LLC
  • Diagnostiki Athinon
  • QED Bioscience Inc.
  • BioFire Defense
  • VIROTECH Diagnostics GmbH
  • Thermo Fisher Scientific Inc.
  • Seegene Inc.
  • Diasorin S.p.A.

Report Coverage

  • Market Forecast and Trends
  • Company Share Analysis
  • Competitive Intelligence
  • DROT Analysis
  • Market Dynamics and Challenges
  • Strategic Growth Initiatives  

Customization & Pricing

Available upon request

Market Segmentation

By Product

  • Instruments
  • Kits and Reagents

By Diagnostic Test

  • Stool Culture
  • Imaging Tests
  • Serological Tests
  • Colonoscopy
  • Others

By Technology

  • Immunoassay
  • DNA Probes
  • Polymerase Chain Reaction (PCR)
  • Flow Cytometry
  • Chromatography
  • Others

By End User

  • Hospitals
  • Public Health Laboratories
  • Commercial Laboratories
  • Others

By Region

  • North America
  • Europe
  • East Asia
  • South Asia and Oceania
  • Latin America
  • Middle East and Africa

- Companies Covered in This Report -

- Frequently Asked Questions -

Increasing incidence of Yersinia infection, increasing adoption of advanced technologies for disease diagnosis, and growing demand for healthcare services in the emerging nations is surging the demand for Yersinia diagnostics.

Some of the key players operating in the market are Thermo Fisher Scientific Inc., Seegene Inc., Diasorin S.p.A., VIROTECH Diagnostics GmbH, SeraCare (LGC Clinical Diagnostics), Advanced Molecular Diagnostics, ELITech Group and CERTEST BIOTEC.

The stool culture segment recorded the significant market share in 2023.

Need for rapid and accurate diagnostic solutions and growing investments in research and development activities to develop novel diagnostic assay kits are estimated to present opportunities for the market players.

North America is set to account for the significant share in the market.

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