Sepsis Diagnostics Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented by Technology (Molecular Diagnostics, Microbiology, Immunoassay, and Other Technologies), By Product (Instruments, Assays and Reagents, and Other Products), By Diagnostic Method (Conventional Diagnostics and Automated Diagnostics), By Pathogen (Bacterial Sepsis, Fungal Sepsis, and Other Pathogens)

Published Date: November - 2024 | Publisher: MIR | No of Pages: 320 | Industry: Healthcare | Format: Report available in PDF / Excel Format

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Sepsis Diagnostics Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented by Technology (Molecular Diagnostics, Microbiology, Immunoassay, and Other Technologies), By Product (Instruments, Assays and Reagents, and Other Products), By Diagnostic Method (Conventional Diagnostics and Automated Diagnostics), By Pathogen (Bacterial Sepsis, Fungal Sepsis, and Other Pathogens)

Forecast Period2024-2028
Market Size (2022)571.03 million
CAGR (2023-2028)7.22%
Fastest Growing SegmentMolecular Diagnostics
Largest MarketNorth America

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Market Overview

Global Sepsis Diagnostics Market has valued at USD 571.03 million in 2022 and is anticipated to witness an impressive growth in the forecast period with a CAGR of 7.22% through 2028.

In sepsis, the immune response becomes dysregulated or overactive. Instead of effectively targeting the infection, the immune system goes into overdrive, releasing excessive amounts of inflammatory chemicals into the bloodstream. The increasing prevalence of sepsis cases worldwide has been a significant driver for the sepsis diagnostics market. Sepsis is a critical condition that requires early and accurate diagnosis for effective treatment. There has been a growing awareness among healthcare professionals and the general public about sepsis and its potential severity. This awareness has led to increased testing and diagnosis.

Key Market Drivers

Advancements in Sepsis Diagnostic Technologies

Advancements in sepsis diagnostic technologies have been crucial in improving the accuracy, speed, and efficiency of sepsis diagnosis. These innovations enable healthcare professionals to identify sepsis earlier and initiate timely treatment, which is critical for patient outcomes.

POCT (Point-of-Care Testing) devices with biosensors can detect sepsis-related biomarkers in blood samples, providing rapid results at the bedside. Microfluidic systems enable the efficient processing of small sample volumes and can be integrated into portable diagnostic devices for sepsis detection.

Rising cases of Sepsis

The global incidence of sepsis has been on the rise. This can be attributed to factors such as an aging population, a growing number of people with chronic illnesses, and the emergence of antibiotic-resistant pathogens. As more individuals are at risk of sepsis, the need for early and accurate diagnosis becomes crucial. There has been a growing awareness among the public and healthcare professionals about the signs and symptoms of sepsis. Increased awareness leads to more people seeking medical attention when they suspect sepsis, resulting in higher diagnostic demand. Advances in medical science and technology have improved the understanding of sepsis, its pathophysiology, and the importance of early diagnosis. Healthcare providers are more inclined to use diagnostic tools to confirm or rule out sepsis quickly.

Regulatory bodies and healthcare organizations have placed an increased emphasis on the early detection and management of sepsis. This has led to the development and adoption of guidelines that recommend the use of diagnostic tests to identify sepsis promptly. The demand for point-of-care testing for sepsis has grown due to its ability to provide rapid results at the patient's bedside. This is especially valuable in emergency departments and critical care settings, where timely diagnosis is critical. Advances in sepsis treatment, such as new antibiotics and therapies, have underscored the importance of accurate diagnosis to tailor treatment regimens to the specific pathogens causing the infection. Improvements in healthcare infrastructure and laboratory facilities have made it easier to perform sepsis diagnostic tests, even in resource-limited settings. The healthcare community has been working on infection control and prevention measures to reduce the incidence of sepsis, but early detection remains essential. Effective prevention and early diagnosis complement each other in reducing sepsis cases. Events like the COVID-19 pandemic have highlighted the critical role of diagnostics in managing infectious diseases, including sepsis. Investments in healthcare infrastructure and diagnostics have been made in response to such crises.


MIR Segment1

Increasing Incidence of Hospital-Acquired Infections

Hospital-acquired infections are infections that patients acquire during their stay in a healthcare facility, including hospitals and nursing homes. These infections can often progress to sepsis if not promptly detected and treated.

Healthcare facilities are subject to regulatory requirements and guidelines that mandate the monitoring and reporting of HAIs. Compliance with these regulations often involves using sepsis diagnostics to track infection rates and outcomes. Hospitals and healthcare providers prioritize patient safety and strive to improve clinical outcomes. Timely diagnosis and management of sepsis cases resulting from HAIs are key components of these efforts. Sepsis resulting from HAIs can significantly increase healthcare costs due to prolonged hospital stays, intensive care treatment, and additional medical interventions. Timely diagnosis and intervention can help reduce the economic burden on healthcare systems. Patient advocacy groups and organizations have raised awareness about the risks of HAIs and the importance of infection control. This has led to increased scrutiny and emphasis on the need for effective sepsis diagnostics in healthcare settings.

Key Market Challenges

Generic Competition

When generic alternatives become found at for diagnostic tests, they often come at a lower price than branded products. This can lead to price erosion in the market, putting pressure on the revenues and profit margins of companies manufacturing branded sepsis diagnostic tests. Generic manufacturers can capture a significant share of the market by offering cost-effective alternatives to branded sepsis diagnostic tests. This competition can affect the market share of existing diagnostic companies and potentially limit their growth prospects. Diagnostic companies typically invest substantial resources in research and development to create innovative sepsis diagnostic technologies. Once patents and exclusivity rights expire, generic manufacturers can legally produce and market similar diagnostic tests, reducing the competitive advantage of the original innovator. To compete with generics, branded sepsis diagnostic companies may need to adjust their pricing strategies, which can impact their profitability. Lowering prices to remain competitive may be necessary, but it can affect the overall market dynamics. The presence of generic competition can deter companies from investing in research and development for new and improved sepsis diagnostic technologies. This can slow down innovation in the field and limit the introduction of advanced diagnostic tools. While generic diagnostic tests aim to provide cost-effective alternatives, there may be concerns about the quality, reliability, and accuracy of these products. Regulatory bodies play a crucial role in ensuring that generic tests meet the necessary quality and safety standards.

Adverse Effects

Some diagnostic procedures used in sepsis diagnostics, such as blood culture collection, may be invasive and carry a risk of discomfort, infection, or other complications. While these procedures are necessary for accurate diagnosis, healthcare providers should take appropriate precautions to minimize risks. Frequent blood drawers for diagnostic tests can lead to potential discomfort and complications, especially in critically ill patients. The risks associated with blood collection, such as hematoma formation or infection at the puncture site, should be managed effectively. Diagnostic testing, especially in an intensive care or emergency setting, can cause anxiety and stress for patients. It is essential for healthcare providers to communicate effectively and provide emotional support to patients undergoing sepsis diagnostics. In some cases, there may be a risk of overusing diagnostic tests for sepsis, which can lead to unnecessary discomfort and costs for patients. Effective clinical guidelines and decision support tools are essential to ensure appropriate test utilization. Following diagnosis, patients with sepsis require continuous monitoring and management. While this is not an adverse effect per se, it is a critical aspect of sepsis care to prevent complications and optimize patient outcomes.


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Key Market Trends

Biomarker Discovery

Biomarkers provide a more precise and specific way to identify sepsis compared to traditional clinical signs and symptoms. This can lead to earlier and more accurate diagnosis, allowing for timely intervention. Sepsis can present with symptoms that overlap with other medical conditions. Biomarkers that are specific to sepsis help differentiate it from non-septic conditions, reducing the risk of misdiagnosis. Certain biomarkers can indicate the severity of sepsis, helping healthcare providers assess the level of organ dysfunction and tailor treatment accordingly. Biomarkers can be used to monitor the progression of sepsis, allowing for adjustments in treatment plans as needed. Biomarker discovery contributes to the trend of personalized medicine in sepsis care. Tailoring treatment based on a patient's specific biomarker profile can lead to more effective and targeted interventions. The identification of novel biomarkers for sepsis has been a focus of research and development efforts. This has led to the introduction of new diagnostic tests and products onto the market. Multiplex assays that measure multiple biomarkers simultaneously have gained popularity. These panels can provide a more comprehensive diagnostic profile and improve the accuracy of sepsis diagnosis. Research has shown promise in using microRNA profiles as diagnostic markers for sepsis. MicroRNA biomarkers can provide valuable information about the host response to infection.

Segmental Insights

Technology Insights

In 2022, the Global Sepsis Diagnostics Market dominated by microbiology technology segment and is predicted to continue expanding over the coming years.

Product Insights

In 2022, the Global Sepsis Diagnostics Market dominated by blood culture media product segment and is predicted to continue expanding over the coming years.

Diagnostic Method Insights

In 2022, the Global Sepsis Diagnostics Market dominated by conventional diagnostics segment and is predicted to continue expanding over the coming years.

Pathogen Insights

In 2022, the Global Sepsis Diagnostics Market largest share was dominated by bacterial sepsis segment in the forecast period and is predicted to continue expanding over the coming years.

Regional Insights

The North America region dominates the Global Sepsis Diagnostics Market in 2022. Throughout the predicted period, it is anticipated that the region would keep up its lead. This development can be linked to the region's increased use of advanced diagnostic tools due to the presence of a strong healthcare infrastructure. Additionally, the market expansion in this area is being fueled by the substantial presence of important competitors and a favorable reimbursement system. Additionally, it is anticipated that the rising prevalence of infectious illnesses and sepsis will increase the need for cutting-edge diagnostic methods.

Recent Developments

  • In May 2020, TheDxH 690T haematology analyzer from Beckman Coulter is now available in the US.The DxH 690T table-top haematology analyzer from DxH delivers all theadvantages of the company's flagship DxH 900 large-volume haematology analyzer.It is designed to optimise workflow and reduce downtime in mid-volumelaboratories. In urgent care settings, haematology analysis is a crucialcomponent of patient triage. Advanced capabilities like the Early SepsisIndicator (ESId), which is accessible on Beckman Coulter's bigger high-volumeanalyzer, the DxH900, are now available to mid-volume facilities thanks to theDxH 690T. ESId is a brand-new, hematology-based cellular biomarker that hasbeen FDA-cleared and is part of a typical CBC with differential. It was createdto assist emergency room doctors in identifying adult patients who have sepsisor are at higher risk of developing sepsis.
  • In August 2022, AccelerateDiagnostics, Inc. a pioneer in rapid in-vitro diagnostics in microbiology, andBD, a leading global medical technology company, announced a worldwidecommercial collaboration agreement. Under the terms of the agreement, BD willoffer Accelerate's rapid testing solution for antibiotic resistance andsusceptibility, which provides results in hours as opposed to one to two dayswith some traditional laboratory methods. Accordingto the agreement, BD will use its global sales network to promote and sell theAccelerate Pheno system, Accelerate ArcTM module, and related test kits inregions where the products have received regulatory approval or registration.These products enhance BD's current Clinical Microbiology offering and furtherthe firm’s joint objective of addressing the global problem posed by antibioticresistance.

Key Market Players

  • Abbott Laboratories Inc.
  • DiaSorin SpA
  • Becton, Dickinson, and Company
  • BioMerieux Inc.
  • F. Hoffmann-La Roche AG
  • Danaher Corporation
  • Thermo Fisher Scientific Inc
  • Siemens Healthineers AG
  • Seegene, Inc.
  • RocheDiagnostics Corporation

By Technology

By Product

By Diagnostic Method

By Pathogen

By Region

  • Molecular Diagnostics
  • Microbiology
  • Immunoassay
  • Other Technologies
  • Instruments
  • Assays and Reagents
  • Other Products
  • Conventional Diagnostics
  • Automated Diagnostics
  • Bacterial Sepsis
  • Fungal Sepsis
  • Other Pathogens
  • North America
  • Asia-Pacific
  • Europe
  • South America
  • Middle East & Africa

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