SEPSIS DIAGNOSTICS MARKET ANALYSIS

The global sepsis diagnostics market is estimated to be valued at US$ 841.4 million in 2023 and is expected to exhibit a CAGR of 9.9% during the forecast period (2023-2030).

Analysts’ Views on Global Sepsis Diagnostics Market:

The immune system releases certain inflammatory chemicals to fight against microbial infections like dysentery, hepatitis, and others. However, when these chemicals start acting against the body’s own tissues and organs, it leads to a condition known as sepsis. The three stages of sepsis include sepsis, severe sepsis, and the final stage of septic shock. Sepsis has a high mortality and morbidity rate. Thus, the market players are focused on developing diagnostic devices that can help diagnose sepsis infection. For Instance, On December 12, 2022, Masimo, a medical device company, announced the limited market release of the Sepsis Index, an early warning indicator designed to help clinicians identify possible sepsis in patients remotely monitored with Masimo Patient SafetyNet. Clinical staff can keep an eye on patient conditions from a distance thanks to Patient SafetyNet, a robust remote patient monitoring and surveillance system that is used all over the world. Patient SafetyNet collects real-time physiological data from Masimo and other bedside monitoring devices for display at central stations.

Figure 1. Global Sepsis Diagnostics Market Share (%), By Product Type, 2023

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Global Sepsis Diagnostics Market– Drivers

Growing prevalence of infectious diseases

The increasing prevalence of infectious diseases is expected to propel the growth of the global sepsis diagnostics market over the forecast period. For instance, on July 19, 2023, according to the World Health Organization (WHO), regional disparities in sepsis incidence and mortality existed; approximately 85% of sepsis cases and sepsis-related deaths worldwide occurred in low- and middle-income countries. Health care-associated infections are one of the most frequent types of adverse events to occur during care delivery and affect hundreds of millions of patients worldwide every year.

Increasing product approvals by regulatory authorities

Increasing product approvals by regulatory authorities is expected to drive the growth of the global sepsis diagnostics market in the near future. For instance, on January 18, 2023, Cytovale, a medical diagnostics company, announced that its IntelliSep test has received U.S. Food and Drug Administration (FDA) 510(k) clearance to aid in the early detection of sepsis for the approximately 30 million adult patients with signs and symptoms of infection who present to US emergency departments (ED) each year.

Figure 2. Global Sepsis Diagnostics Market Share(%), By Region, 2023

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Global Sepsis Diagnostics Market- Regional Analysis

Among regions, North America is estimated to hold a dominant position in the global sepsis diagnostics market over the forecast period. North America is estimated to hold 33.5% of the market share in 2023. The global sepsis diagnostics market is expected to witness significant growth in the coming years, driven by the increasing funding opportunities for research and development activities by market players in the North America region. For instance, on June 8, 2021, CARB-X, a U.S based biotechnology company, raised funds up to US$ 578,000 to develop new fiber optic technology to diagnose sepsis or the risk of sepsis. Accelerate would be eligible for up to US$ 2.1 million in additional funds from CARB-X if the project meets certain milestones, subject to available funds. A rapid test is especially important for sepsis treatment, where every hour of delay in appropriate treatment reduces the chance of survival.

Global Sepsis Diagnostics Market– Impact of Coronavirus (COVID-19) Pandemic

The COVID-19 pandemic and lockdown in various countries across the globe have negatively impacted the financial status of businesses across all sectors. The biotechnology sector is one such sector that has been heavily impacted by the pandemic.

However, the demand for sepsis diagnostics is increasing in this COVID-19 pandemic owing to the rising number of COVID-19 cases reported. For instance, according to a study published by the Global Sepsis Alliance in April 2020, more than 30% of COVID-19 patients reported sepsis-related liver injury, and 75% of patients were observed to have a depressed immune system in the U.S. The study also revealed that sepsis is one of the most critical causes of death among COVID-19 patients, as all the patients who succumbed to COVID-19 infection had sepsis, and around 70% of non-survivors had septic shock.

Moreover, in November 2020, the Hellenic Institute, a Greek health organization, and Sanmina Corporation, a U.S. based electronics manufacturers, funded a study to develop a novel optical biosensor (OB) point-of-care (POC) device for the detection of severe COVID-19 infection and sepsis. Furthermore, according to an investigational study published by the BMC (Biomedcentral) Infectious Diseases Journal in November 2020, at the first phase, the specificity and positive predictive value of this OB diagnostic device were 100% for sepsis diagnosis. In the second phase, the specificity was 87.5% and the positive predictive value was 91.7%. The sensitivity of the OB point-of-care device was estimated to be 83.3% for the diagnosis of a severe COVID-19 infection. Such developments are expected to have a positive impact on the growth of the market. Thus, the COVID-19 pandemic is expected to drive the growth of the global sepsis diagnostics market over the forecast period.

Global Sepsis Diagnostics Market Segmentation:

The global sepsis diagnostics market report is segmented into by product type, by method, by pathogen, by technology, by end user and by region.

By Product Type, the market is segmented into Blood Culture Media, Assays & Reagents, Instruments, and Software. Out of which, the instruments is expected to hold a dominant position in the global sepsis diagnostics market during the forecast period, and this is attributed to increasing approvals by regulatory authorities.

By Method, the market is segmented into automated Diagnostics and Conventional Diagnostics. Out of which, the automated diagnostics is expected to dominate the market over the forecast period, and this is attributed to increasing adoption of rapid test.

By Pathogen, the market is segmented into bacterial sepsis (gram-negative bacterial sepsis, gram-positive bacterial sepsis), fungal sepsis, and others. Out of which, the bacterial sepsis is expected to hold a dominant position in the global sepsis diagnostics market during the forecast period, owing to the increasing prevalence of infectious diseases such as bacterial sepsis.

By Technology, the market is segmented into microbiology, molecular diagnostics, immunoassays, and flow cytometry. Out of which, Immunoassays is expected to dominate the market over the forecast period, and this is attributed to increasing adoption of rapid test for diagnosis of sepsis.

By End User, the market is segmented into hospitals, pathology & reference laboratories, and research laboratories & academic institutes. Out of which, hospitals is expected to dominate the market over the forecast period, and this is attributed to the prompt treatment that can lead to proper recovery.

Among all the segmentation, the product type segment is expected to dominate the market over the forecast period and this is attributed to increasing product approvals by regulatory authorities

Global Sepsis Diagnostics Market- Cross Sectional Analysis:

Research institutes in the region are focused on the research and development activities which are expected to drive market growth in the North America region. For instance, on July 13, 2022, researchers at the University of Florida created and are using a diagnostic tool that leverages artificial intelligence to identify a patient’s likelihood of developing sepsis and how severe it will be as soon as 12 hours after the patient’s hospital admission.

Global Sepsis Diagnostics Market: Key Developments

On April 13, 2023, AlgoDx, a company that provides artificial intelligence and machine learning evidence-based algorithms, announced that the US Food and Drug Administration has accepted for review the company’s De Novo application for NAVOY Sepsis, a clinical decision support software intended to assist healthcare providers at intensive care units (ICU) with predicting sepsis in adult ICU patients.

On June 13, 2023, DiaSorin, a biotechnology company, secured CE marking for an immunodiagnostic assay to aid diagnosis of severe conditions including sepsis, septic shock, kidney diseases, and lower respiratory and urinary tract infections, and the firm is launching the assay in Europe.

Global Sepsis Diagnostics Market: Key Trends

Introduction of research and development with advanced technology

The introduction of research and development with advanced technology in the market is expected to drive growth of the global sepsis diagnostics market over the forecast period. For instance, on October 28, 2022, DeepUll, a Spanish molecular diagnostics company, focused on developing molecular test to guide therapy selection for patients with sepsis. The DeepUll Company announced that it raised US$ 14.2 million in Series B financing to fund its efforts to offer a multiplex PCR-based alternative to blood culture, still the go-to technology for diagnosing and treating sepsis patients.

Global Sepsis Diagnostics Market: Restraint

Low adherence to guidelines in sepsis care puts patients at risk

Low adherence to guidelines in sepsis care puts patients at risk and is expected to hinder market growth over the forecast period. For instance, on September 22, 2022, according to bioMérieux, a company in vitro diagnostics with a long-standing commitment to the fight against sepsis, and the UK Sepsis Trust, an internationally renowned charity, released new survey data that was commissioned among 368 doctors across six European countries stated that sepsis is a life-threatening condition in which the body’s response to infection causes organ damage. Every year in Europe, more than 3.4 million people develop sepsis, and 700,000 of them do not survive.

Early recognition and rapid diagnosis are essential for early patient management. Any delay in starting appropriate treatment is associated with increased mortality. A set of evidence-based clinical practices, known as sepsis bundles, have been defined internationally. The routine implementation of these bundles by clinicians can greatly improve outcomes for patients with sepsis.

Key players focusing on developing awareness programs and advanced products with safety and cost-effective treatment would help to drive market growth over the forecast period.

Global Sepsis Diagnostics Market - Key Players

Major players operating in the global sepsis diagnostics market include BioMérieux SA, Thermo Fisher Scientific, Abbott Laboratories, Roche Diagnostics AG, Luminex Corporation, CytoSorbents Corporation, Becton Dickinson Company, Danaher Corporation, Axis-Shield Diagnostics, T2 Biosystems, EKF Diagnostics, Immunexpress Inc., Response Biomedical Corporation, and Bruker Corporation

*Definition: Sepsis is a life-threatening medical emergency caused by the body’s overwhelming response to an infection. Without urgent treatment, it can lead to tissue damage, organ failure, and death. Sepsis is the body’s extreme reaction to an infection. When patients have an infection,  immune systems work to try to fight it. But sometimes  the immune system stops fighting the infection and starts damaging  normal tissues and organs, leading to widespread inflammation throughout  the body.