Global Sepsis Diagnostics Market By Product Type (Blood Culture Media, Instruments, Assay Kits and Reagents, and Other Product Types), By Pathogen (Bacterial Sepsis, Fungal Sepsis, Viral Sepsis), By Diagnostic Method, Technology, By End-user, By Region and Companies - Market Assessment, Competition Scenario, Trends, and Forecast 2023-2032

Report Overview

The Global Sepsis Diagnostics Market Size is expected to be worth around USD 1392.8 Million by 2032, from USD 628.7 Million in 2022, growing at a CAGR of 8.5% during the forecast period from 2023 to 2032.

Sepsis diagnostics refers to the process of identifying and diagnosing sepsis, a potentially life-threatening condition that arises when the body’s response to infection becomes dysregulated.

Sepsis can progress rapidly and lead to organ dysfunction and death if not promptly diagnosed and treated. The diagnostic approach to sepsis involves a combination of clinical assessment, laboratory tests, and imaging studies. Different methods are used to perform sepsis diagnosis. Imaging techniques such as X-rays, computed tomography (CT), or ultrasound may be used to identify the source of infection, such as pneumonia, urinary tract infection, or intra-abdominal infection.

Samples from suspected infection sites, such as wound swabs, urine, sputum, or cerebrospinal fluid, may be collected and analyzed in the laboratory to identify the causative pathogen and determine its antibiotic susceptibility. The growth of the sepsis diagnostics market is driven by key factors like the rising prevalence of sepsis, the rising geriatric population, growing hospital-acquired infections, and the increasing number of pneumonia cases.

Furthermore, the introduction of technologically advanced diagnostic solutions is promoting market growth.  Also, rising awareness regarding sepsis, along with an increase in funding for sepsis-related research activities, is anticipated to contribute to the growth of the market during the forecast period.

Key Takeaways

• Market Growth: The global sepsis diagnostics market is expected to reach USD 1,392.8 million by 2032, growing at a CAGR of 8.5%.
• Sepsis Diagnosis: Sepsis diagnostics involve identifying and diagnosing sepsis, a life-threatening condition caused by a dysregulated response to infection.
• Diagnostic Approach: Sepsis diagnosis combines clinical assessment, laboratory tests, and imaging techniques, including X-rays and CT scans.
• Market Drivers: Factors driving market growth include the rising prevalence of sepsis, a growing geriatric population, hospital-acquired infections, increasing pneumonia cases, and the introduction of advanced diagnostic solutions.
• Prevalence of Sepsis: In the United States, over 1.7 million cases of adult sepsis occur annually, contributing to one-third of hospitalizations resulting in fatalities.
• Government Investment: Governments globally are investing heavily in infectious disease research, with significant funding allocated to combat sepsis.
• Challenges: Challenges include inaccurate diagnostic results, the high cost of diagnostics, and time-consuming procedures.
• COVID-19 Impact: COVID-19 has led to increased sepsis rates, creating a demand for rapid diagnostic tests to save lives.
• Product Types: Blood culture media dominates the market, with a 39% share, while instruments are expected to grow rapidly.
• Pathogen Analysis: Bacterial sepsis accounts for 75% of the market, with fungal sepsis also witnessing high demand.
• Diagnostic Methods: Conventional diagnostics lead with a 54% share, while automated diagnostics are expected to grow quickly.
• Technology: Microbiology techniques hold a 45% share, and molecular diagnostics are growing rapidly.
• End Users: Hospitals and clinics account for 71% of end users, with pathology and reference laboratories seeing high growth.
• Growth Opportunity: Rapid diagnostic kits are being launched to facilitate quicker sepsis detection.
• Latest Trends: Research into biomarkers and the development of point-of-care testing (POCT) devices are emerging trends.
• Regional Analysis: North America holds the largest market share (41%), with the Asia Pacific region expected to witness high growth.
• Market Share & Key Players: The market is fragmented, with key players including Becton, Dickinson, Abbott Laboratories, F. Hoffmann-La Roche, BioMérieux, Thermo Fisher Scientific, Danaher, T2 Biosystems, Luminex, Immunexpress, Bruker, Axis-Shield Diagnostics, and others.

Driving Factors

Increasing Prevalence of Sepsis

Sepsis is an overpowering response to infection and can cause organ failure, tissue damage, and even death. Sepsis is one of the main causes of death in the United States, according to the Centers for Disease Control and Prevention (CDC).

In the US, there are over 1.7 million cases of adult sepsis each year, and sepsis is a factor in one-third of hospitalizations that result in fatalities. According to Sepsis Alliance, sepsis accounts for 35% of all hospital deaths and about 6% of all hospital admissions. As many as 19% of sepsis patients who were first admitted to the hospital experience a readmission within 30 days, and 40% experience a readmission within 90 days, making sepsis the main cause of hospital readmissions.

Up to 87% of sepsis cases begin outside of the hospital, in the community. Every hour that treatment is put off increases the chance of death from sepsis by 4-9%. Rapid diagnosis and treatment can save up to 80% of septic shock patients. This rising prevalence of sepsis is a major factor driving the growth of the sepsis diagnostics market during the forecast period.

Increasing Government Investment in R&D for Infectious Diseases

Several governments all over the globe are focusing on heavily investing in infectious disease diagnosis and research. For instance, a division of the National Institutes of Health I.e. National Institute of Allergy and Infectious Diseases (NIAID), to establish the CREID i.e. Centers for Research in Emerging Infectious Diseases, announced in August 2020 that it had given out 11 grants totaling roughly $17 million in first-year funding.

Investigating how and where viruses and other infections develop from wildlife and spread to infect humans will be a multidisciplinary task for the global network. The network will be supported by about $82 million from NIAID over a five-year period. Therefore, such key government investments in the R&D of infectious diseases are likely to fuel the demand for sepsis diagnostics during the projected time period.

Restraining Factors

Inaccurate Diagnostic Results

Sepsis diagnostics can sometimes produce false-negative results, meaning that a patient with sepsis may be incorrectly identified as not having the condition. This can delay treatment and potentially lead to a worsening of the patient’s condition. Conversely, sepsis diagnostics can also yield false-positive results, indicating that a patient has sepsis when they do not.

This can result in unnecessary treatment, including the use of antibiotics, which can contribute to the development of antibiotic resistance and expose patients to potential side effects. Thus, inaccuracy associated with diagnostic results may limit the growth of the sepsis diagnostics market during the forecast period.

High Cost of Sepsis Diagnostics

Advanced sepsis diagnostics can be expensive, especially if multiple tests are required to confirm the diagnosis or monitor the progression of the condition. This can pose financial challenges for healthcare systems and patients, particularly in resource-limited settings. Hence, the high cost involved in sepsis diagnostics may restrict the growth of the sepsis diagnostics market in the upcoming years.

Time-Consuming Procedures

Certain diagnostic methods for sepsis can be time-consuming, requiring several hours or even days to obtain results. This delay in diagnosis can impact timely intervention and treatment initiation, potentially affecting patient outcomes. Thus, more time required diagnostic process may hamper the sepsis diagnostics market growth during the projection period.

Product Type Analysis

Blood Culture Media Holds Major Share

The blood culture media segment is likely to dominate the market with a share of 39 %. The demand for blood culture media in sepsis diagnosis is significant and continues to grow due to the prevalence and severity of sepsis as a healthcare concern. Sepsis is a life-threatening condition that requires prompt diagnosis and treatment to improve patient outcomes. Blood cultures play a crucial role in identifying the causative pathogens responsible for bloodstream infection, guiding appropriate antibiotic therapy, and helping to monitor treatment efficacy.

On the other hand, the instruments segment is anticipated to expand at a high rate during the projection period. Instruments play a crucial role in sepsis diagnosis by facilitating the collection, processing, and analysis of clinical samples. The demand for instruments in sepsis diagnosis is significant and continues to grow due to the increasing emphasis on early and accurate detection of sepsis.

Pathogen Analysis

Bacterial Sepsis Is Expected to Account for the Largest Sepsis Diagnostics Market Share

Bacterial sepsis is witnessing the highest growth in the market, with a revenue share of 75% in 2022. Bacterial sepsis is associated with high mortality rates and is a leading cause of hospitalization. The condition places a substantial burden on healthcare resources, including hospital beds, intensive care units, and personnel. Effective diagnosis of bacterial sepsis can help optimize resource allocation by identifying patients who require prompt intervention and intensive care management. Thus, the rise in cases of bacterial sepsis is a major factor stimulating the growth of the segment.

Also, fungal sepsis is likely to witness high demand in the sepsis diagnostics market throughout the forecast period. The recognition of fungal sepsis as a distinct and clinically significant entity has improved in recent years. Healthcare professionals are increasingly aware of the potential for fungal infections, leading to a greater emphasis on early detection and management. This increased awareness contributes to the demand for diagnostic tools specific to fungal sepsis.

Diagnostic Method Analysis

Conventional Diagnostics are Highly Preferred

Conventional diagnostics leads the sepsis diagnostics market with a revenue share of 54% in 2022. Conventional sepsis diagnostic methods are widely available in healthcare settings and are often more accessible and affordable compared to newer, advanced diagnostic technologies. They can be implemented in a wide range of healthcare facilities, including those with limited resources. Therefore, the high affordability offered by the conventional method is a major factor driving the segment growth during the projection period.

Moreover, automated diagnostics are expected to grow at the fastest rate during the estimated time period. There is a high demand for automated sepsis diagnostics due to several factors, including the need for rapid and accurate diagnosis, the increasing prevalence of sepsis, and the benefits of automation in laboratory workflows.

Technology Analysis

Microbiology Shows Highest Growth

Microbiology segment dominated the sepsis diagnostics market with a share of 45% in 2022. Microbiology techniques, such as blood cultures and molecular assays, are essential for identifying the specific bacteria or fungi causing sepsis. Accurate identification of the pathogens is crucial for guiding targeted antimicrobial therapy, as different microorganisms may have varying susceptibilities to antibiotics. There is a high demand for microbiology in sepsis diagnosis due to its crucial role in identifying the causative pathogens responsible for bloodstream infections.

Also, the molecular diagnostics segment is anticipated to grow at a high rate during the projection period. Molecular diagnostics offer rapid and sensitive detection of microbial DNA or RNA in clinical samples. Techniques such as polymerase chain reaction (PCR) and nucleic acid amplification tests (NAATs) can detect even low levels of pathogen nucleic acids, enabling early identification of the causative organisms in sepsis. This rapid detection allows for the timely initiation of appropriate antimicrobial therapy. Thus, rapid and sensitive pathogen detection is a key advantage that is likely to fuel the segment growth over the forecast period.

End User Analysis

Hospitals & Clinics are Major End-Users

Hospitals & clinics are expected to lead the end-user segment by accounting for a share of 71% during the forecast period. The high demand for sepsis diagnostics in hospitals and clinics is driven by the urgent need for timely and accurate diagnosis, the impact on patient outcomes, quality improvement initiatives, regulatory requirements, and ongoing research and development efforts. Healthcare providers and institutions continually strive to enhance their diagnostic capabilities to effectively diagnose and manage sepsis, reducing mortality rates and improving patient care.

Also, pathology & reference laboratories are predicted to witness high growth during the estimated time period. The high demand for sepsis diagnostics in pathology and reference laboratories is stimulated by the need for specialized testing, access to advanced technologies, high-volume capacity, quality control and accreditation, consultative services, and research and development activities. These laboratories play a critical role in supporting accurate and timely sepsis diagnosis, enabling effective management of the condition and improved patient outcomes.

Key Market Segments

By Product Type

• Blood Culture Media
• Instruments
• Assay Kits and Reagents
• Other Product Types

By Pathogen

• Bacterial Sepsis
• Fungal Sepsis
• Viral Sepsis
• Other Pathogens

By Diagnostic Method

• Automated Diagnostics
• Conventional Diagnostics

By Technology

• Microbiology
• Molecular Diagnostics
• Immunoassays
• Other Technologies

By End-User

• Hospitals & Clinics
• Pathology & Reference Laboratories
• Other End-users

Opportunity

Launch of Rapid Diagnostic Kits

Several companies around the world are launching rapid diagnostic kits to facilitate quicker and easier detection of sepsis. For instance, in November 2022, Immunexpress unveiled a quick molecular diagnostic test that would allow sepsis to be confirmed or ruled out in an hour. By operating directly from a blood draw, the SeptiCyte Rapid test differs from virtually all other sepsis diagnostics in the sepsis diagnostics market. The company received FDA 510(k) clearance for its SeptiCyte Rapid test last year.

The FDA approved the test as a tool for assisting hospitalized patients with sepsis suspicion in distinguishing sepsis from infection-negative systemic inflammation. SeptiCyte Rapid can now be used in the EU and other nations that recognize the CE Mark thanks to Immunexpress, which also acquired the certification. Thus, the launch of such rapid diagnostic kits is likely to drive market growth during the projection period and provide lucrative growth opportunities for key players operating in the market.

Trends

New Research Regarding Biomarkers and Development Of POCT Devices

Researchers have been exploring the use of novel biomarkers to aid in the early and accurate diagnosis of sepsis. These biomarkers can include cytokines, procalcitonin (PCT), C-reactive protein (CRP), lactate, and presepsin. The combination of multiple biomarkers or the development of new biomarkers can improve the sensitivity and specificity of sepsis diagnosis. The development of rapid, bedside sepsis diagnostic tests has gained traction.

Point-of-care testing (POCT) devices enable healthcare providers to quickly assess sepsis biomarkers, blood cell counts, or pathogen identification at the patient’s bedside, facilitating early intervention and improving patient outcomes. Thus, the use of biomarkers and the development of POCT devices are emerging trends that are expected to stimulate the sepsis diagnostics market’s growth in the upcoming years.

Regional Analysis

North America is projected to hold the largest share at 41% and a revenue of 257.7 million in 2022. The growth of the sepsis diagnostics market in the region is fuelled by key factors such as the increasing prevalence of sepsis and infectious diseases, along with rising investments in the fields of research and development for the diagnosis of sepsis.

According to the CDC, sepsis will affect over 1.7 million adults in the United States in August 2021, and it will be responsible for nearly 270,000 deaths. It was also shown that sepsis affects 1 in 3 hospital deaths. Thus, the rising prevalence of sepsis is a major factor stimulating the growth of the sepsis diagnostics market in the region. Additionally, the presence of advanced healthcare infrastructure, supportive reimbursement scenarios, and the presence of key players are likely to boost the regional market.

The Asia Pacific region is expected to witness high growth during the projected time period.  The increasing demand for sepsis diagnostics due to the rising number of hospital-acquired infections (HAIs) is a major factor stimulating the market growth in the region. Moreover, the rising prevalence of a variety of infectious disorders, rising investments in the healthcare sector, and increased awareness of sepsis monitoring and diagnosis are likely to contribute to the sepsis diagnostics market growth in the region over the forecast period.

Key Regions

• North America
  • US
  • Canada
  • Mexico
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Russia
  • Spain
  • Rest of Europe
• APAC
  • China
  • Japan
  • South Korea
  • India
  • Rest of Asia-Pacific
• South America
  • Brazil
  • Argentina
  • Rest of South America
• MEA
  • GCC
  • South Africa
  • Israel
  • Rest of MEA

Key Players Analysis

The global Sepsis Diagnostics market is highly fragmented. High demand for quality diagnostic options due to the high prevalence of infectious diseases is one of the main factors boosting competition among key industry players. Additionally, the adoption of key strategies such as mergers and acquisitions, collaborations and partnerships, etc., and the launch of efficient diagnostics are fuelling the market growth during the projection period.

Market Key Players

• Becton, Dickinson, and Company
• Abbott Laboratories Inc.
• F. Hoffmann-La Roche AG
• BioMérieux SA
• Thermo Fisher Scientific, Inc.
• Danaher Corporation
• T2 Biosystems Inc.
• Luminex Corp.
• Immunexpress, Inc.
• Bruker Corporation
• Axis-Shield Diagnostics Ltd
• Other Key Players

Recent Developments

Mentioned below are some of the latest developments by key players in the Sepsis Diagnostics Market:

• In February 2023, the SeptiCyte Rapid test from Immunexpress, which may identify sepsis in patients within an hour, was commercialized in the United States. In order to improve outcomes and facilitate timely intervention, practitioners can identify patients with sepsis earlier thanks to the point-of-care test.
• In August 2022, BD and Accelerate Diagnostics joined forces in order to develop a comprehensive sepsis management program. The collaborative program is expected to give medical professionals advanced, efficient, quicker, and more precise diagnostic tools, enabling effective sepsis management and enhancing patient outcomes.

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