Market Research Report
Global Sepsis Diagnostics Market Size, Share & Industry Trends Analysis Report By Method, By Test Type, By Pathogen, By Product, By End-User, By Technology, By Regional Outlook and Forecast, 2022 - 2028
|Global Sepsis Diagnostics Market Size, Share & Industry Trends Analysis Report By Method, By Test Type, By Pathogen, By Product, By End-User, By Technology, By Regional Outlook and Forecast, 2022 - 2028|
Published: April 29, 2022
Content info: 378 Pages
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The Global Sepsis Diagnostics Market size is expected to reach $879.5 million by 2028, rising at a market growth of 8.3% CAGR during the forecast period.
Sepsis is a medical disorder that emerges as a result of the body's response to infections caused by bacteria, viruses, or fungus. The immune system produces various substances into the bloodstream in this situation, causing hyper inflammation and the production of blood clots. Multiple organ failures, rapid breathing, neurological dysfunction, low blood pressure, and a higher heart rate are all possible complications of sepsis. Molecular diagnosis, biomarkers, flow cytometry, immunoassays, microfluidics, and other processes are used to diagnose sepsis. Hospitals, pathology and reference laboratories, university academic researchers, and other institutions are all using these diagnostic tools.
In 2016, the Third International Sepsis Consensus Task Force determined the current criteria for clinical sepsis diagnosis, known as Sequential Organ Failure Assessment (SOFA). This scoring system detects cumulative organ dysfunction as a result of an infection-induced dysregulation of the host's immune system. Cardiovascular function, respiration, liver function, coagulation, central nervous system function, and renal function are all regarded in the SOFA score.
A point is given for each malfunctioning organ system, with a score of 2 points or higher indicating a definite sepsis diagnosis. A high SOFA score is linked to a higher than 10% hospital mortality risk. Quick SOFA (qSOFA) is a rapid alternative to SOFA that uses only a subset of the SOFA scoring criteria, such as abnormal mentation, systolic blood pressure under 100 mm Hg, and a breathing rate of 22 or more per minute. qSOFA does not necessitate laboratory testing and can be performed as many times as needed.
SOFA replaces the Systemic Inflammatory Response Syndrome (SIRS) criteria, which was created in 2001. SIRS scoring requires two or more of the following: a temperature of greater than 38°C or less than 36°C, a heart rate of greater than 90 beats per minute, a respiratory rate of greater than 20 beats per minute, or a white blood cell count of greater than 12,000/L or less than 4,000/L. When compared to SIRS and qSOFA, SOFA has higher predictive accuracy.
The COVID-19 pandemic had a marginally beneficial impact on sepsis diagnostics sales. The widespread of COVID-19 and the emergence of sepsis cases among COVID-19 patients are projected to boost the demand for quick diagnosis, speeding up the use of tools, reagents, and test kits for sepsis detection. COVID-19 infection is more likely to affect surgeons and patients undergoing a variety of procedures in hospitals. The bulk of sepsis diagnostics was halted, leading to a decrease in device-based treatments. People postponed health exams as a result of the pandemic's lockdowns, lowering the number of tests conducted and laboratory sales.
Market Growth Factors
A rise in the number of hospital-acquired illnesses
HAIs also characterized as nosocomial infections, a prominent cause of morbidity and mortality in hospitals across the world. The most common hospital-acquired illnesses include urinary tract infections, pneumonia, and sepsis (HAIs). HAIs can induce sepsis in immunocompromised people, the elderly, and people with medical conditions. According to the Centres for Disease Control and Prevention (CDC), sepsis affects at least 1.7 million adults in the United States each year, with about 270,000 deaths. An illness obtained at a medical facility, such as an inpatient setting or a skilled nursing care facility, is characterized as a healthcare-acquired infection (HAI). An HAI might come from anywhere, even a doctor's office or clinic. HAIs are known as nosocomial infections in the medical world. Infections acquired outside of a healthcare centre are known as community-acquired infections.
The rapidly growing Molecular Diagnostics market
Due to their ease of use and effectiveness in diagnostic procedures, molecular diagnostics has attracted a number of multinational companies and institutes. The gold standard for molecular diagnostic methods has been blood culture analysis for quick and precise infection profiling. Several firms are investing in point-of-care molecular diagnostics to improve patient management and early detection of bacterial and viral infections. For example, Immunexpress debuted a quick SeptiCyte, a one-hour molecular diagnostic test for sepsis, on Biocartis' Idylla platform in October 2020. This is one of the first completely integrated, immune response-based diagnostics to help clinicians diagnose sepsis.
Market Restraints Factors
High expense of automated diagnostic instruments
Companies are focusing on creating automated diagnostic instruments for identifying sepsis based on modern technologies such as molecular diagnostics. However, government hospitals and scientific research laboratories cannot acquire such systems due to budget constraints. Furthermore, it is becoming a key impediment to the expansion of the sepsis diagnostics market. In addition, the lowest intensity sepsis cohort population had the major burden of recurrence and total expenses. Sepsis cases that were not discovered until hospitalization, along with those with increasing severity, had a greater economic cost and death rate on a case-by-case basis.
Based on Method, the market is segmented into Conventional and Automated. The automated segment witnessed a substantial revenue share in the Sepsis Diagnostics Market in 2021. The use of billing codes and the installation of predictable evaluation are based on agreement definitions that have been used in efforts to automate sepsis identification. Although billing codes are simple to extract and have a strong positive predictive value (PPV) for sepsis, they typically do not document the onset of sepsis and have low sensitivity when compared to clinician assessment. Changing medical practicing habits and reimbursement policies also have an impact on them. Consensus-based definitions have improved over time and across institutions, but they still rely on doctors to validate if organ dysfunction is attributable to sepsis, resulting in low PPV when automated.
Test Type Outlook
Based on Test Type, the market is segmented into Laboratory Tests and Point-of-Care Tests. The laboratory tests procured the highest revenue share in the Sepsis Diagnostics Market in 2021. This is mostly attributable to the fact that laboratory testing is more accurate than POC testing when it comes to identifying sepsis. Laboratory testing allows for a comprehensive examination of the pathogen and its medication resistance profile. In addition, routine lactate testing, which is a vague but valuable indication of sepsis, is done efficiently in laboratory settings. The public's and physicians' dependence on these labs has grown dramatically with the introduction of technologically advanced products.
Based on Pathogen, the market is segmented into Bacterial Sepsis, Fungal Sepsis, Viral Sepsis, and Others. The fungal sepsis recorded a substantial revenue share in the Sepsis Diagnostics Market in 2021. Fungi are responsible for about 15% of all infections, and invasive fungal infections are becoming a more common cause of sepsis, especially in critically ill patients. This disease are life-threatening illness that can occur anywhere in the body as a result of an infection. Severe instances of sepsis are frequently caused by infections that spread throughout the body and through the bloodstream.
Based on Product, the market is segmented into Blood Culture Media, Assays & Reagents, Instruments, and Software. The software segment registered a substantial revenue share in the Sepsis Diagnostics Market in 2021. This rapid expansion of this segment can be ascribed to a rise in healthcare professionals' implementation of modern software platforms for better sepsis detection and management. For example, Guthrie, anintegrated health care system, used Wolters Kluwer's POC Advisor to diagnose and treat sepsis at four local hospitals in September 2019.
Based on End-User, the market is segmented into Hospitals & specialty clinics, Pathology & Reference Laboratories, and Research Laboratories & Academic Institutes. The hospitals and specialty clinics segment procured the highest revenue share in the Sepsis Diagnostics Market in 2021. The rising number of patients diagnosed with sepsis, and in-house hospital and clinics are undertaking a large number of blood culture tests to identify blood stream infections (BSIs caused by bacteria, fungi/yeast, or viruses) contribute to the increased growth of this segment.
Based on Technology, the market is segmented into Blood Culture, Immunoassays, Molecular Diagnostics, Flow Cytometry, Microfluidics, and Biomarkers. The blood culture segment garnered the largest revenue share in the Sepsis Diagnostics Market in 2021. One of the most significant investigations in the treatment of sepsis is blood culture. It enables the identification of the sepsis-causing bacterium, the selection of a relevant empirical and specific antibiotic, and the identification of the infection's focal location. All sepsis patients should have a blood culture taken. Sepsis is traditionally described as the presence of infection-induced systemic inflammatory response syndrome (SIRS). Moreover, the affordable pricing of microbiological techniques and the widespread usage of blood culture procedures for sepsis diagnosis also account for this proportion.
Based on Regions, the market is segmented into North America, Europe, Asia Pacific, and Latin America, Middle East & Africa. The North America segment acquired the highest revenue share in the Sepsis Diagnostics Market in 2021. The medical device market in North America is well-established. The presence of a well-developed healthcare system, widespread implementation of innovative sepsis diagnosing technologies between health personnel, a reducing number of surgical procedures, growing prevalence of healthcare-associated infections (HAIs), and adoption of advanced technologies of sepsis diagnostics are all key factors that drive the sepsis diagnostics market in North America.
The major strategies followed by the market participants are Acquisitions. Based on the Analysis presented in the Cardinal matrix; F. Hoffmann-La Roche Ltd. is the major forerunner in the Sepsis Diagnostics Market. Companies such as Thermo Fisher Scientific, Inc., Bruker Corporation and BioMerieux S.A. are some of the key innovators in the Market.
The market research report covers the analysis of key stake holders of the market. Key companies profiled in the report include BioMerieux S.A., F. Hoffmann-La Roche Ltd., Becton, Dickinson and Company, Abbott Laboratories, Thermo Fisher Scientific, Inc., DiaSorin S.p.A., Bruker Corporation, Siemens Healthineers AG, Danaher Corporation, and Quidel Corporation.
Recent strategies deployed in Sepsis Diagnostics Market
Partnerships, Collaborations and Agreements:
Jan-2022: Oncocyte Corporation signed a development and co-marketing agreement with Thermo Fisher Scientific, an American supplier of scientific instrumentation, reagents and consumables, and software services. This agreement aimed to distribute Vitro diagnostic evaluation on Thermo Fisher Scientific's Ion Torrent Genexus System. Additionally, Oncocyte would clinically approve Thermo Fisher's existing Oncomine complete Assay Plus on the Genexus System, paving the way toward IVD authorization for use in tumour mark and future resignation as a companion diagnostic.
Sep-2021: Thermo Fisher Scientific joined hands with AstraZeneca, a multinational pharmaceutical and biotechnology company. Together, the companies aimed to co-build NGS-based companion diagnostics to support AstraZeneca's expanding offering of address therapies. Additionally, Thermo Fisher would provide the expertise, technology, and capabilities to disperse CDx tests to local healthcare suppliers around our global markets, which would help in identifying more patients across the world who may asset from effective patient care and treatments.
Sep-2021: Siemens Healthineers joined hands with A1 Life Sciences, a pioneering biotechnology company. Together, the companies aimed to support global attempts to record variants of SARS-CoV-2, allowing Siemens Healthineers to provide a developing offering of PCR-based appraisal for the recognization of SARS-CoV-2 variants and mutations.
Apr-2021: DiaSorin came into a definitive merger agreement for DiaSorin to acquire Luminex Corporation. Under this acquisition DiaSorin would gain approach to Luminex's molecular diagnostics multiplexing technology and a offering that would reinforce its existing suite while expanding its presence in the U.S.
Mar-2021: Roche signed an agreement to acquire GenMark Diagnostics, a leading provider of multiplex molecular diagnostic solutions. Under the terms of the merger agreement, Roche would directly commence a tender provide to obtain all outstanding shares of GenMark's common stock. Additionally, GenMark would file a endorsement statement containing the united recommendation of the GenMark board that GenMark stockholders delicate shares to Roche.
Product Launches and Product Expansions:
Dec-2021: BD expanded the BD COR System by including a new MX instrument. This expansion aimed to assist proteomic molecular testing for contagious diseases. Additionally, the MX instrument is designed to prove BD MAX System molecular PCR technology platform, a medium-throughput system usually found in hospital labs, and BD aims to use the BD MAX System menu of contagious disease trail to generate assays that can be achieved in high-throughput central reference labs on the BD COR System
Jul-2020: Bruker Corporation introduced FluoroType SARS-CoV-2 along with next-generation 6-plex PCR. The medicine appraisal for the highly specific observation of the SARS-CoV-2 virus, which causes systemic and respiratory disease. Additionally, FluoroType SARS-CoV-2 plus estimation is CE-IVD characterised as per the European IVD Directive. Moreover, two clinical testings require almost ninety CV19 positive patients and over 100 CV19 negative individuals, this enhanced CV19 infection estimation showed 100% specificity and sensitivity.
Acquisitions and Merger:
Dec-2021: Thermo Fisher Scientific completed the acquisition of PPD, a global contract research organization. Under this acquisition, Thermo Fisher planned to deliver an entire offering of services around the clinical development spectrum, handling trial logistics, efficacy and healthcare outcome assessment, safety, comprising scientific discovery, along with the production and advancement of the therapeutics.
Dec-2021: Quidel Corporation completed the acquisition of Ortho Clinical Diagnostics Holdings, an in vitro diagnostics company. Under this acquisition, Ortho would assist concrete Quidel as a leader in the diagnostics companies, bringing together complementary products, innovative, services, and solutions that improve the health and well-being of patients around the world.
Sep-2021: Abbott took over Walk Vascular, a commercial-stage medical device enterprise. Through this acquisition, Walk Vascular would integrate within the vascular device portfolio and further propel Abbott's capabilities to deliver one-of-a-kind endovascular treatment solutions to enhance patient care.
Apr-2021: Siemens Healthineers took over Varian Medical Systems, an American radiation oncology treatments and software developer. With this acquisition, Siemens Healthineers has the most complete suite in the MedTech sector, which provides the enterprise with appreciable potential for value creation. Additionally, Siemens Healthineer's integrated approach would take the broad fight against cancer to a new level.
Jan-2021: Thermo Fisher Scientific completed the acquisition of Mesa Biotech, a molecular diagnostic company. Under this acquisition, Mesa Biotech's convenient quick PCR-based test would highly integral to the existing portfolio and would further assist to fulfil the constant demand for COVID-related checking while the company works to rapidly scale and advance point-of-care tests for other contagious diseases in the future.
Approvals and Trials:
Mar-2021: Thermo Fisher Scientific received FDA approval for the Applied Biosystems QuantStudio 5 Dx Real-Time PCR System. The PCR System would clarify abilities to workflow decrease steps to provide quality results in less than 30 minutes. Moreover, the PCR system has high sensitivity and precision as well as delivers up to six channels for multiplexing.
Sep-2020: Roche received FDA approval for Elecsys HIV Duo immunoassay. The approval enables a strong complete infectious diseases menu on the Cobas e 801 system and is a compelling step towards bringing integrative value to the U.S. market within the area of contagious diseases.
Market Segments covered in the Report:
By Test Type
Unique Offerings from KBV Research
List of Figures