Septic Shock Diagnostics Market Size, Share, Industry, Forecast and outlook (2024-2031)

Septic Shock Diagnostics Market is segmented By Test Type(Electrochemiluminescence Immunoassay (ECLIA), Chemiluminescent Immunoassay, Immunofluorescent Assay, Blood Tests and Others), By End-User(Hospitals, Diagnostics centers, Academic Research Laboratories and Others), and By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2023-2030

Market Overview

Global septic shock diagnostics market reached US$ XX million in 2022 and is expected to reach US$ XX million by 2030, growing at a CAGR of XX% during the forecast period 2023-2030.

Septic shock is the last and most severe stage of the sepsis. Sepsis occurs when the immune system has an extreme reaction to an infection. The inflammation throughout the body can cause dangerously low blood pressure. Septic shock is life-threatening and requires immediate medical treatment.

Moreover, in case of sudden fever or hypothermia, rapid heart rate or breathing rate, or low blood pressure, blood tests are performed to diagnose the presence of bacteria and/or infection. This blood test may include a complete blood count and blood chemistries, including lactate, blood oxygen levels and organ malfunction. In some diagnosis tests collection of samples of urine, saliva, tissues and/or cerebrospinal fluid for further tests. In addition, electrochemiluminescence immunoassay (ECLIA), chemiluminescent immunoassay, immunofluorescent assay, and other tests are performed to test the septic shock to reduce further complications.

Market Scope

Market Dynamics: Drivers

Increasing adoption of rapid diagnostic tests for early detection

The increasing adoption of rapid diagnostic tests for the early detection of septic shock is expected to drive the market over the forecast period. The rapid diagnostic tests enables healthcare providers to identify septic shock in early stages, allowing for timely intervention and treatment. This can significantly improve patient outcomes and reduce the risk of complications.

For instance, on August 23, 2023, a nonprofit health system in North Carolina adopted a molecular test that analyzes a patient's immune system to detect sepsis. The test mitigates the severity of a sepsis episode or progression to septic shock.

Moreover, many technological advancements like AI and machine learning are going on, leads to increasing adoption of rapid diagnostic tests. For instance, on June 05, 2023, Asep Medical unveiled new artificial intelligence (AI) technology for the rapid detection of infections associated with severe sepsis and septic shock. The method studies the dysfunctional immune responses in sepsis to detect gene sets that can predict the likelihood of a patient developing septic shock.

In addition, many rapid diagnostic tests like PCR-based tests are mostly adopted for advanced results and better patient outcomes. These rapid tests provide results quickly, often within hours or even minutes. This efficiency is crucial in emergency settings where time is of the essence, helping clinicians make faster and more informed decisions.

For instance, on March 28, 2023, Todos Medical, Ltd., a comprehensive medical diagnostics and related solutions company, with Acumen Diagnostics Pte Ltd licensed the laboratory-developed test rights to commercialize the sepsis PCR-based diagnostic test AcuSept in the United States. AcuSept is a host immune response test that identifies 19 mRNA biomarkers of infection, sepsis and septic shock.

Further, the increasing prevalence of septic shock, rising FDA approvals, increasing clinical trials, increasing awareness and technological advancements in diagnostic tests such as AI and machine learning and therapies are the factors expected to drive the market over the forecast period.

Restraints

Factors such as the high cost of diagnostic tests, producing, procuring, and maintaining diagnostic tools can be expensive and are expected to hamper the market growth. Particularly in places with low resources, the high cost of these test devices might influence healthcare budgets and accessibility. The high price of the tests is expected to hamper the market. 

Segment Analysis

The global septic shock diagnostics market is segmented based on test type, end-user and region.

The blood tests segment accounted for approximately 45.6% of the septic shock diagnostics market share

The blood tests segment is expected to hold the largest market share over the forecast period. Blood tests can assess various aspects of health, including blood cell counts, chemistry, enzymes, hormones, and markers of inflammation and infection. This versatility allows for the diagnosis and monitoring of septic shock. Blood tests are relatively non-invasive diagnostic procedures. They typically involve drawing a small sample of blood from a vein, which is less uncomfortable and risky for patients.

In addition, the blood tests for septic shock patients are performed mainly to check the presence of bacteria and/or infection, complete blood count., blood chemistries, including lactate, blood oxygen levels and organ malfunction. Even blood cultures are also performed for rapid testing in patients. Many kits have been launched for the rapid testing of septic shock in many patients.

For instance, on January 04, 2021, Bruker Corporation cleared the US FDA clearance and the US launch of the MBT Sepsityper Kit US IVD for rapid microbial identification of more than 425 microorganisms from positive blood cultures on the MALDI BiotyperCASystem. Rapid testing from positive blood cultures is gaining increasing interest in the clinical microbiology community due to high mortality and morbidity rates in sepsis and septic shock.

Geographical Analysis

North America accounted for approximately 39.6% of the market share 

North America region is expected to hold the largest market share over the forecast period owing to the strong presence of major players and increasing adoption of diagnostic tests. North America especially the United States is well-known for its strong presence of major players such as pharmaceutical companies and diagnostic companies. The presence of major players actively performing in research activities, leads to the launch of novel and advanced diagnostic tests.

Furthermore, the increasing prevalence of septic shock in the region led to the increasing adoption of diagnostic tests to reduce further complications. This increasing adoption of these diagnostic tests paved the way for more technologically advanced tests including artificial intelligence, machine learning and rapid tests.

For instance, on May 27, 2020, according to a study published in Nature Communications, using machine learning algorithms, an extremely sensitive method that can analyze biomarkers to predict sepsis outcomes with nearly 100 percent accuracy and diagnosis and prognostication of sepsis and septic shock. More than 1.7 million Americans develop sepsis each year, which further leads to septic shock, and more than 270,000 die from it, researchers noted. 

Competitive Landscape

The major global players in the septic shock diagnostics market include Thermo Fisher Scientific Inc., F. Hoffmann-La Roche Ltd, BRUKER CORPORATION, DiaSorin S.p.A., T2 Biosystems, Inc., BIOMÉRIEUX S.A, TCS Biosciences Ltd, Immunexpress Inc., Siemens Healthcare Private Limited and EKF Diagnostics Holdings plc among others. 

Key Developments

• On August 01, 2023, Cytovale, a pioneering medical diagnostics company focused on advancing early detection technologies to diagnose fast-moving and immune-mediated diseases, cleared the U.S. commercial launch of the IntelliSep sepsis test following FDA 510(k) clearance. The test aids in the rapid diagnosis of sepsis and septic shock for adult patients with signs and symptoms of infection, providing results in under 10 minutes.
• On March 10, 2020, Instrumentation Laboratory (IL) released the commercial launch of the GEM Premier ChemSTAT in vitro diagnostic (IVD) analyzer with Intelligent Quality Management (iQM) in the US. The GEM Premier ChemSTAT system is a whole-blood analyzer designed for rapid basic metabolic panel (BMP) testing at the point of care. BMP is one of the most widely ordered tests for diagnosing acute conditions, such as acute kidney injury, sepsis and septic shock.

COVID-19 Impact Analysis

The COVID-19 pandemic significantly impacted the global septic shock diagnostics market. The pandemic created unprecedented challenges for pharmaceutical and diagnostic industries worldwide, including the global septic shock diagnostics market by temporarily disrupting many clinical trials, research activities and regulatory approvals of many diagnostic tests, assays and kits due to the redirected focus on the COVID-19 pandemic and its related restrictions. 

Moreover, according to the National Institute of Health (NIH), 2022, coronavirus disease 2019 (COVID-19) can be associated with life-threatening organ dysfunction due to septic shock. Therefore, clear clinical criteria are pivotal for early recognition of patients more likely to need prompt organ support. Although most patients with severe COVID-19 meet the Sepsis-3.0 criteria for septic shock, it has been increasingly recognized that hyperlactatemia is frequently absent, possibly leading to an underestimation of illness severity and mortality risk.

Why Purchase the Report?

• To visualize the global septic shock diagnostics market segmentation based on test type, end-user and region as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development
• Excel data sheet with numerous data points of septic shock diagnostics market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as excel consisting of key products of all the major players.

The global septic shock diagnostics market report would provide approximately 53 tables, 50 figures, and 187 Pages.

Target Audience 2023

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies

Suggestions for Related Report

For more clinical diagnostics-related reports, please click here