Market Size
The Global Septic Shock Diagnostics Market size is valued at US$ 1,004 million in 2025 and is projected to reach US$ 2,650 million by 2035, assuming a CAGR of around 10.2% over the forecast period 2026-2035.
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
| Metrics | Details |
| CAGR | 10.2% |
| Market Size | 2025-2035 |
| Market Estimation Forecast Period | 2026-2035 |
| Revenue Units | Value (US$ Mn) |
| Segments Covered | Test Type and End-User |
| Regions Covered | North America, Europe, Asia-Pacific, South America and Middle East & Africa |
| Largest Region | North America |
| Fastest Growing Region | Asia-Pacific |
| Report Insights Covered | Competitive Landscape Analysis, Company Profile Analysis, Market Size, Share, Growth, Demand, Recent Developments, Mergers and Acquisitions, New Product Launches, Growth Strategies, Revenue Analysis, Porter’s Analysis, Pricing Analysis, Regulatory Analysis, Supply-Chain Analysis and Other key Insights. |
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.
Recent Developments in the Septic Shock Diagnostics Market
- Immunexpress expands clinical evidence for SeptiCyte RAPID - September 2026: Immunexpress announced a publication examining the test's potential role in distinguishing infection from non-infectious inflammation in post-surgery and trauma patients. This highlights continued interest in host-response testing for complex critical-care cases.
- Cytovale reports multicenter IntelliSep results - March 2026: The company reported real-world findings from implementation across four additional hospitals, covering more than 34,000 emergency-department patients with suspected infection. The results support further evaluation of rapid host-response testing in emergency workflows; the reported outcomes are company-announced findings.
- bioMérieux highlights the economic impact of rapid sepsis diagnostics - April 2026: A health-economic analysis assessed early rapid pathogen identification and antimicrobial susceptibility testing across G7 countries. The work underscores the potential clinical and operational value of faster results for patients at risk of sepsis.
- Updated international sepsis guidance emphasizes clinical judgment - 2026: The Surviving Sepsis Campaign guidelines state that sepsis should not be ruled in or out using a single biomarker or diagnostic test. This reinforces the role of diagnostic tools as part of a broader clinical assessment rather than standalone decision-makers.
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.
Target Audience 2025
- Manufacturers/ Buyers
- Industry Investors/Investment Bankers
- Research Professionals
- Emerging Companies
