Sepsis Diagnostics Market Size was valued at USD 1.34 billion in 2023. The Sepsis Diagnostics market industry is projected to grow from USD 1.47 Billion in 2024 to USD 3 billion by 2032, exhibiting a compound annual growth rate (CAGR) of 9.36% during the forecast period (2024 - 2032). Factors including the high prevalence of sepsis, growing public awareness, and the development of cutting-edge diagnostic techniques are the key market drivers enhancing the market growth.
Oxford Nanopore and Day Zero Diagnostics (DZD) announced in 2023 that they would be working together to create a comprehensive diagnostic system for bloodstream infections, which are a major source of sepsis. The businesses will work together to integrate and improve a diagnostic technology that will enable same-day detection and genomic-based antibiotic susceptibility profile without blood culture in clinical environments like hospitals. In the future, the firms intend to pursue regulatory clearances, including those from the FDA.
Leading molecular diagnostics business Inflammatix, Inc. (2023) announced today that it has finished developing the TriVerityTM Acute Infection and Sepsis Test System (which comprises the MyrnaTM Instrument) and TriVerityTM Cartridge. TriVerity is designed to evaluate the possibility of a bacterial infection, a viral infection, and the risk of acute decompensation in patients with suspected acute infection and sepsis in emergency department settings.
The IntelliSep sepsis test was commercially released in the United States in 2023 by Cytovale, a medical diagnostic business. The test was started after receiving US Food and Drug Administration 510(k) clearance in December of last year. Adults with infection-related signs and symptoms can receive a prompt diagnosis of sepsis thanks to the test's ten-minute turnaround time.
The market expansion is being enhanced by many factors, like the rising prevalence of sepsis, increasing public awareness, and advancements in diagnostic procedures. The expansion of the sepsis diagnostics market is primarily driven by factors such as the incidence of sepsis, hospital-acquired infections, pneumonia cases, the increasing number of sepsis procedures, and augmented funding for sepsis-related research activities. One of the most prevalent outcomes experienced by persons receiving medical care in hospitals is the acquisition of nosocomial infections.
Therefore, the increasing incidence of sepsis and the growing allocation of funds towards research endeavors for sepsis diagnosis throughout the projected timeframe will contribute to the overall expansion of the sepsis diagnostic market. Hence, the prevalence of this medical condition has contributed to the worldwide compound annual growth rate (CAGR) of the Sepsis Diagnostics market in recent times.
June 2023, The ImmunoScore, developed by Prenosis Inc. in the United States, is a digital diagnostic tool that use Artificial Intelligence/Machine Learning (AI/ML) to predict sepsis. It is a host-based diagnosis that considers both clinical characteristics and protein biomarkers, making it independent of specific pathogens. Prenosis has established an extensive and rapidly expanding dataset and biobank comprising individuals who have been diagnosed with sepsis and several other infectious conditions. Prenosis has successfully built a substantial dataset and biobank for cases of acute care infections through collaboration with more than 10 institutions in the United States.
In May 2023, BD announced FDA 510(k) clearance of the BD KiestraTM MRSA imaging application, which incorporates AI to decipher bacteria growth and release negative samples with minimal human intervention. The AI-based imaging application called BD SynapsysTM Informatics Solution enables reduced laboratory personnel to work more effectively while also enabling lab technicians to use their skills on increased complexity specimens. Sepsis risk is minimized.
Proxim Diagnostics Corp., for example, developed a handheld POC diagnostic device in March 2023 that received $3 million in investment from bioMérieux. The potential for running multiple multiplexed assays with disposable cartridges exists within this handheld automatic instrument. Proxim has several immunoassays in development, including SEPSIS, cardiology and infectious diseases, that can give the same quality as those run on large centralized laboratory equipment.
To further illustrate, Cytovale announced that the FDA had authorized its IntelliSep Sepsis Test for early sepsis detection in January 2023.
Asep Medical Holdings, Inc., meanwhile, entered into a joint venture with Sansure Biotech Inc., a medical diagnostics company based in China, to commercialize Sepset(ER) Sepsis Diagnostic Test into Chinese markets during January 2023.
In order to address the rising burden of sepsis, PERSOWN Inc. launched SMASH-H, a real-time monitoring system for sepsis (January 2023).
T2 BIOSYSTEMS recently revealed intentions to develop a rapid molecular diagnostic test for the monkeypox virus in August 2022.
As a result, in July 2022, Biomerieux was FDA-approved for the NEPHROCHECK test on VIDAS.
In April 2022, BioMérieux SA, the world leader in in vitro diagnostics, announced that it has entered into an agreement to acquire Specific Diagnostics, a privately-held US-based company that developed a rapid antimicrobial susceptibility test (AST) system providing phenotypic AST directly from positive blood cultures. The SPECIFIC REVEAL Rapid AST expansion broadens the all-encompassing BioMérieux SA Sepsis Solution that allows same-day AST results for Gram-negative bacteria thus enabling more targeted treatment and better patient outcomes.
The prevalence of sepsis, the prevalence of hospital-acquired infections, the number of pneumonia cases, the rise in the number of sepsis procedures, and an increase in financing for sepsis-related research activities are the main drivers of the growth of the sepsis diagnostics market. The most typical consequence for individuals being treated in hospitals is an infection picked up there. For instance, the Centers for Disease Control and Prevention (CDC) reported in 2021 that between 2019 and 2020 in the United States, there was an increase of about 24%, 35%, and 15% in central line-associated bloodstream infections, ventilator-associated events, and Methicillin-resistant Staphylococcus aureus (MRSA) bacteremia. The use of sepsis diagnostic devices will expand as bloodstream infections rise.
In Seattle, Washington, in April 2020, almost 75% of COVID-19 patients showed a suppressed immune response, and about 30% of patients had indications of liver impairment, according to the Sepsis Alliance. According to the Sepsis Alliance, COVID-19, influenza, pneumonia, meningitis, and other viruses are the main causes of sepsis. According to a retrospective study, COVID-19 patients who are hospitalized are more likely to get coinfections. According to the study, almost 50% of patients who did not survive had a secondary infection, almost 100% had sepsis, and about 70% had septic shock.
The use of sepsis diagnostic devices will expand as bloodstream infections rise. Additionally, in June 2021, funding of more than GBP 3 million was awarded to the University of Liverpool-led collaboration for a fresh initiative that will actively prevent, treat, and assess maternal sepsis. Thus, the rising prevalence of sepsis and the rising funding for research activities for sepsis diagnosis over the forecast period would drive the overall growth of the sepsis diagnosis market. Therefore, such medical condition has enhanced the Sepsis Diagnostics market CAGR globally in recent years.
However, the rising prevalence of sepsis is another factor driving the growth of the Sepsis Diagnostics market revenue.
Based on Technology, the Sepsis Diagnostics market segmentation includes molecular diagnostics, biomarkers, and immunoassays. The molecular diagnostics segment held the majority share in 2021, contributing to around ~65-67% of the Sepsis Diagnostics market revenue. The segment is expected to be driven by the adoption of molecular diagnostic technology because of its many benefits, including high sensitivity, accuracy, and quick turnaround times compared to other technologies. This technique's drawback is that it cannot detect impossible organisms to cultivate. However, following blood culture, the molecular diagnostics technique is a standard method for identifying pathogens.
Based on type, the Sepsis Diagnostics market segmentation includes kits, instruments, and blood culture media. The blood culture media segment dominated the market in 2021 and is projected to be the faster-growing segment during the forecast period, 2022-2030. This is because clinicians view blood cultures as the most practical and economical testing method. The market has been divided into three product categories based on products: equipment, blood culture media, and test kits & reagents. A study on sepsis patients in Thailand found that the Septifast assay, a PCR-based technique, provided superior diagnostic performance than blood cultures. Hence, rising applications for Sepsis Diagnostics positively impact the market growth.
Based on End User, the Sepsis Diagnostics industry has been segmented into pathology laboratories, Specialty clinics, hospitals, and diagnostic centers. Pathology laboratories held the largest segment share in 2021, mostly because lab testing is more accurate than POC testing for diagnosing sepsis. An extensive examination of the microorganism and its medication resistance profile is provided by clinical laboratory testing. Furthermore, routine assessment of lactate levels, a vague but helpful indication of sepsis, is successfully carried out in lab settings. The dependence of the general public and medical professionals on these labs has dramatically expanded with the introduction of technologically enhanced products. Due to the quick diagnosis and improved accuracy, the laboratory testing type sector is anticipated to increase at the quickest rate over the projection period. Additionally, it is anticipated that the rising number of diagnostic labs will help this segment grow throughout the projection period.
The fastest growing segment in the Sepsis Diagnostics industry is hospitals. The higher occurrence of hospital-transmitted infections and the rising number of surgical procedures conducted.
Figure 2: Sepsis Diagnostics Market, by End User, 2023 & 2030 (USD Billion)
Source: Secondary Research, Primary Research, MRFR Database and Analyst Review
August 2023, FirstHealth of the Carolinas, a nonprofit health institution operating four hospitals in North Carolina, United States, will employ Immunexpress' SeptiCyte Rapid test to aid in distinguishing cases of sepsis-positive individuals from those exhibiting infection-negative systemic inflammation. According to Immunexpress, the cartridge-based test assesses the relative expression levels of genes associated with a patient's immunological response to infection. This test produces a score that reflects the probability of sepsis. The methodology employed involves the utilization of reverse transcription polymerase chain reaction (RT-PCR) technology for the purpose of quantifying the relative expression levels of host-response genes that have been extracted from whole blood.
August 2023, Cytovale, a medical diagnostic business, commenced the commercial launch of their latest diagnostic tool, known as the IntelliSep sepsis test, within the United States. The test was initiated subsequent to receiving 510(k) approval from the US Food and Drug Administration in December of the previous year. The test possesses the capacity to provide findings within a span of 10 minutes, hence facilitating prompt identification of sepsis in adult individuals exhibiting indications and symptoms of infection. The patients are categorized into three groups depending on their sepsis likelihood by utilizing a conventional blood sample. The findings have the potential to provide healthcare practitioners with a valuable instrument for improving clinical outcomes and optimizing resource use in hospitals, hence resulting in operational enhancements.
By Region, the study provides market insights into North America, Europe, Asia-Pacific, and the Rest of the World. The North America Sepsis Diagnostics market accounted for USD 0.457 billion in 2021 and is expected to exhibit a significant CAGR growth during the study period. This development can be linked to the region's increased use of advanced diagnostic tools due to strong healthcare infrastructure. Additionally, this area's market growth is 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.
Further, the major countries studied in the market report are The U.S., Canada, Germany, France, the UK, Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil.
Figure 3: Sepsis Diagnostics MARKET SHARE BY REGION 2023 (%)
Source: Secondary Research, Primary Research, MRFR Database and Analyst Review
Europe Sepsis Diagnostics market accounts for the second-largest market share. Rising research and development expenditures for sepsis diagnostics are anticipated to benefit the sector. Because of the area's advanced healthcare system, sepsis diagnostic tools are frequently used in diagnostic labs and centers. Further, the Germany Sepsis Diagnostics market held the largest market share, and the UK Sepsis Diagnostics market was the fastest growing market in the European region.
The Asia-Pacific Sepsis Diagnostics Market is expected to grow at the fastest CAGR from 2024 -2032. The a growing need for sepsis diagnostic tools in nations like Algeria and Morocco, where infectious illness frequency is significant. Moreover, the China Sepsis Diagnostics market held the largest market share, and the India Sepsis Diagnostics market was the fastest-growing market in the Asia-Pacific region.
Sepsis Diagnostics Key Market Players & Competitive Insights
Major market companies are investing a lot of money in R&D to expand their product portfolios, which will spur further market growth for sepsis diagnostics. With significant key developments like new product releases, contractual agreements, mergers and acquisitions, increased investments, and collaboration with other organizations, market participants are also undertaking various strategic activities to expand their presence. To grow and thrive in a market that is becoming more and more competitive and volatile, competitors in the Sepsis Diagnostics industry must provide affordable products.
Manufacturing locally to cut operational costs is one of the main business tactics used by manufacturers in the worldwide Sepsis Diagnostics industry to benefit customers and increase the market sector. In recent years, Sepsis Diagnostics industry has provided medicine with some of the most significant benefits. The Sepsis Diagnostics market major player such as Cytovale Inc, Immunexpress, and blood culture media are working to expand the market demand by investing in research and development activities.
They are a remarkable team of biologists, data scientists, engineers, previous healthcare professionals, investors, and caring individuals at Cytovale. They have a vision for bringing extremely complicated, life-threatening diseases into sharp and immediate focus. In April 2020, The Biomedical Advanced Research and Development Authority, or BARDA, and Cytovale Inc. have partnered to increase the use of Cytovale's Rapid Sepsis Diagnostic System for sepsis diagnosis in patients with probable respiratory infections, such as COVID-19.
Also, Immunexpress is creating technology to confirm or disprove sepsis in people with a history of infection. The overtreatment of sepsis caused by unreliable diagnoses places a heavy cost on healthcare systems, hospitals, doctors, nurses, payers, and antibiotic stewardship initiatives. In October 2020, On the Idylla platform from Biocartis, Immunexpress introduced the fast SeptiCyte, a one-hour molecular diagnostic test for sepsis. This one is one of the first quick, comprehensively integrated, and immune response-based diagnostics to help clinicians diagnose sepsis.
Key Companies in the Sepsis Diagnostics market includes
Sepsis Diagnostics Industry Developments
July 2023: Cytovale Inc. announced commercial launch of the Intellisep Test in United States. The diagnosis test is designed to be used in emergency departments to quickly diagnose sepsis patients presenting with signs of infection.
January 2023: Cytovale Inc. received U.S. Food and Drug Administration (FDA) 510(k) clearance IntelliSep test. The test helps in the early detection of sepsis in adult patients with signs and symptoms of infection that visit emergency departments (ED).
| Report Attribute/Metric | Details |
| Market Size 2023 | USD 1.34 billion |
| Market Size 2024 | USD 4.47 billion |
| Market Size 2032 | USD 3 billion |
| Compound Annual Growth Rate (CAGR) | 9.36% (2024-2032) |
| Base Year | 2023 |
| Market Forecast Period | 2024-2032 |
| Historical Data | 2018 & 2020 |
| Market Forecast Units | Value (USD Billion) |
| Report Coverage | Revenue Forecast, Market Competitive Landscape, Growth Factors, and Trends |
| Segments Covered | Technology, Type, End User, and Region |
| Geographies Covered | North America, Europe, Asia Pacific, and Rest of the World |
| Countries Covered | The U.S, Canada, Germany, France, UK, Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil |
| Key Companies Profiled | M Sandstone Diagnostics Inc. (US), T2 Biosystems, Immunexpress (US), Axis-Shield Diagnostics Ltd. (Scotland), Becton Dickinson and Company (US), EKF Diagnostics (UK), Cube Dx GmbH (Austria), Wolters Kulwer N.V. (Netherlands),Amara Health (US) |
| Key Market Opportunities | Emergence of hospital-acquired infections |
| Key Market Dynamics | Rising prevalence of sepsis has led to a growing need for its early diagnosis |
Frequently Asked Questions (FAQ) :
The Sepsis Diagnostics market size was valued at USD 1.34 Billion in 2023.
The market is projected to grow at a CAGR of 9.36% during the forecast period, 2024-2032.
North America had the largest share in the market
The key players in the market are M Sandstone Diagnostics Inc. (US), T2 Biosystems, Immunexpress (US), Axis-Shield Diagnostics Ltd. (Scotland), Becton Dickinson and Company (US).
The molecular diagnostics category dominated the market in 2023.
The blood culture mediahad the largest share in the market.
Research Analyst Level I He is an extremely curious individual currently working in healthcare and medical devices domain. kinjoll is comfortably versed in data centric research backed by healthcare educational background. he leverages extensive data mining and analytics tools such as primary and secondary research, statistical analysis, machine learning, data modelling. his key role also involves technical sales support, client interaction and project management within the healthcare team. lastly, he showcases extensive affinity towards learning new skills and remain fascinated in implementing them.
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