Sepsis Diagnostics Market Size, Share & Trends Analysis Report By Product (Instruments, Blood Culture Media, Assay Kits and Reagents, Software), By Technology (Microbiology, Molecular Diagnostics, Immunoassays, Flow Cytometry), By Pathogen (Bacterial Sepsis, Gram Positive, Gram Negative, Fungal Sepsis, Others), By Testing Type (Laboratory Testing, Point-of-Care Testing) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2024-2032

Market Overview

The global sepsis diagnostics market size was valued at USD 685 million in 2022. It is expected to reach USD 1,427.44 million by 2031 at a CAGR of 8.5% during the projected period (2023–2031). Factors such as increasing prevalence of sepsis and rising number of pneumonia cases, significantly drives the sepsis diagnostics market demand by 2031.

Sepsis is a potentially fatal condition in which the body's response to an infection causes tissue damage within the body itself. When the body's defenses against infection backfire, they disrupt normal organ function. Septic shock is a possible outcome of sepsis. This dangerously low blood pressure can cause organ failure and even death. Changes in mental status, systolic blood pressure, and respiratory rate are all diagnostic of sepsis because they indicate the presence of an infection.

Sepsis affects hospitalized patients and those recently released from the hospital most frequently. Infections, which can progress to sepsis, are more common in ICU patients. In addition to a blood test, additional laboratory testing is required to diagnose sepsis. A blood sample can diagnose infection, clotting disorders, abnormal liver or kidney function, decreased oxygen availability, and electrolyte imbalances. Patients with sepsis must be closely monitored and treated in an ICU setting. Breathing and heart rates may need to be stabilized with emergency care.

Market Dynamics

Sepsis Diagnostics Market Drivers

Increasing Prevalence of Sepsis

Sepsis is a bloodstream disease that occurs due to a response to pathogenic microorganisms present in the blood—patients suffering from sepsis experience severe inflammation, which leads to prolonged hospitalization. According to WHO, around 30 million people are estimated to be affected with sepsis every year. The NCBI stated that the largest sepsis cases had been observed in the youngest and oldest age groups. Therefore, there is a rising need for early diagnosis of sepsis. The WHO also reported that sepsis worldwide affects 1.2 million children and 3 million newborns yearly. This has further boosted the demand for sepsis diagnostic tools for quick results and improved patient outcomes.

Additionally, sepsis is common in both low- and middle-income countries. Sepsis Alliance reported that nearly 258,000 people in the U.S. die yearly from sepsis. In order to lower the death rate, early diagnosis is necessary to initiate treatment. Moreover, Sepsis Alliance stated that nearly 7,000 children die due to sepsis each year. The death rate of sepsis in children is higher in developing regions worldwide. This is due to factors such as maternal infections passed onto the newborns, unhygienic birth conditions, and infections caused due to limited vaccinations. Hence, early sepsis identification helps reduce the mortality rate, raising the demand for diagnostic tools for sepsis. The increasing prevalence of sepsis has led to the growing need for early diagnosis to reduce the high mortality rate in people and facilitate timely treatment.

Rising Incidence of Hospital-Acquired Infections

The prevalence of hospital-acquired infections is increasing due to the high incidence of chronic diseases, such as diabetes. A rise in admissions in acute care hospitals often leads to infections, which cause sepsis. Sepsis in such a group of patients sometimes leads to re-hospitalization within 30 days of treatment, which propels the demand for sepsis diagnostic products in hospitals. Hospital-acquired infections include Urinary Tract Infections (UTIs) and Surgical-Site Infections (SSIs), which can result in sepsis. According to WHO, seven out of every 100 hospitalized patients will develop hospital-acquired infections in developed countries. On the other hand, in developing countries, 10 out of every 100 hospitalized patients are estimated to develop hospital-acquired infections due to poor healthcare infrastructure. The WHO also estimated that the rate of ICU-acquired infections is at least 2 to 3 times higher in developing nations than in developed nations.

Additionally, UTIs are generally caused due to catheter insertion in a patient's body for a long period during hospital stays. This is called catheter-associated UTI, which is the most common hospital-acquired infection. Sepsis Alliance states that 75% of UTIs are catheter-associated, leading to high demand for sepsis diagnostics. SSI is another vital hospital-acquired infection causing sepsis. Infections arising during or after surgery often result in sepsis. According to CDC, one out of every 24 patients undergoing surgery in the U.S. develops postoperative infection each year. Such SSIs increasingly lead to sepsis or septic shock. In addition, causes of postsurgical infections include failure of surgical site sterilization and lack of use of sterile surgical instruments. Septic shock is associated with a high risk of mortality, which increases the need for early diagnosis of sepsis among patients affected with SSIs. As a result, the demand for diagnostic instruments and assays is increasing for early detection in hospitals.

Sepsis Diagnostics Market Restraint

Lack of Awareness about Sepsis

Based on several journals, the mortality rate of sepsis was 40% to 50% due to a lack of public awareness. Although some laboratories and hospitals in low- and middle-income countries have adequate resources for properly diagnosing sepsis, they lack significant education and awareness. Efforts to raise public awareness through various awareness campaigns are expected to reduce the death rate among patients suffering from sepsis. The TOI also reported that some healthcare professionals lack awareness about sepsis along with patients. Sepsis treatment delays of one hour are predicted to increase mortality risk by 8%. According to a recent Indian study on intensive care case mix and practice patterns, one in two sepsis patients will die. Hence, poor awareness among patients and medical professionals in developing countries will likely impede the sepsis diagnostics market growth.

Sepsis Diagnostics Market Opportunities

Rising Number of Pneumonia Cases

Pneumonia is one of the primary reasons for sepsis or septic shock. Pneumonia can be a community-acquired disease or hospital-acquired disease. According to MedicineNet, patients suffering from pneumonia have a compromised immune system, which accounts for around 30% mortality rate. Sepsis Alliance noted that sepsis is a direct outcome of pneumonia because bacteria causing pneumonia leave the lung and enter the bloodstream, which results in sepsis. According to various research papers, sepsis is found in more than 50% of terminal hospitalizations.

Additionally, the Journal of Medical Microbiology found that over half of the patients suffering from sepsis had been a victim of pneumonia. Hence, the need for sepsis diagnosis is growing, creating lucrative opportunities for sepsis diagnostic instruments, culture media, and test kits in emerging markets. Patients confirmed with COVID-19 requiring hospitalization tend to develop pneumonia of varying severity which might pose a risk of developing sepsis. Therefore, early diagnosis and treatment for sepsis are significant in such patients.

Regional Analysis

North America Dominates the Global Market

Based on region, the global sepsis diagnostics market share is segmented into North America, Europe, Asia-Pacific, and LAMEA.

North America is the most significant global sepsis diagnostics market shareholder and is expected to grow at a CAGR of 8.61% over the forecast period. This dominance can be attributed to the favorable reimbursement scenario, local presence of major players, high adoption of novel solutions, and launch of new sepsis diagnostics products. For instance, in May 2020, Beckman Coulter, a subsidiary of Danaher Corporation, launched its new DxH 690T hematology analyzer in the U.S. with early sepsis indicators. Similarly, Cytovale Inc. expanded its collaboration with the Biomedical Advanced Research and Development Authority (BARDA) in April 2020 to enable the detection of sepsis in patients with potential respiratory infections, such as COVID-19. The Biomedical Advanced Research and Development Authority (BARDA) is estimated to have contributed about USD 3.83 toward the research's estimated cost of USD 5.9 million, driving the market.

In addition, major players are also expected to increase their strategic initiatives to increase the availability of sepsis diagnostic products in the United States, which will contribute to expansion. For instance, in December 2017, bioMérieux SA entered a strategic distribution partnership with McKesson Medical-Surgical to expand access to its products, including the Vidas BRAHMS PCT, in U.S. community hospitals.

Europe is estimated to exhibit a CAGR of 9.1% over the forecast period. Developed healthcare infrastructure and increasing demand for sepsis diagnostic solutions due to the rising prevalence of infectious diseases are expected to support market growth. European Center for Disease Prevention and Control 2018 stated that the nearly 80,000 patients hospitalized daily are prone to suffer from at least one HAI. In addition, the growing number of HAI cases in this region is creating the need for early diagnosis of sepsis. Hence, there is an expected growth in sepsis diagnostics services in Europe.

Segmental Analysis

Based on region, the global sepsis diagnostics market is segmented into product, pathogen testing, and type.

Based on product, the global market is broadly divided into instruments, blood culture media, assay kits and reagents, and software. 

The blood culture media segment dominates the global market and is predicted to exhibit a CAGR of 10.12% during the forecast period. The blood culture tests provide qualitative as well as quantitative results. These tests are cheaper and more accurate when compared to automated tests. However, they require a skilled labor force and are time-consuming. Most bacteria grow in blood culture media in 2 to 3 days, but some can take up to 10 days or longer. The fungus may take around 30 days to grow in the cultural media. It is anticipated that the launch of new products will encourage market expansion. For instance, in April 2019, Becton Dickinson launched its new BD BACTEC platelet quality control media that identifies and decreases sepsis incidence in patients receiving platelet transfusion. This product enables blood banks, microbiology laboratories, and transfusion services to detect contaminated platelet units.

By technology, the global market is bifurcated into microbiology, molecular diagnostics, immunoassays, and flow cytometry. 

The microbiology segment owns the largest sepsis diagnostics market share and is predicted to exhibit a CAGR of 9.2% during the forecast period. The microbiological technique involves the detection of microorganisms through blood culture media. For instance, BD BACTEC Media, manufactured by BD, involves discovering microorganisms in a blood sample. BD BACTECPlus Anaerobic/F and Aerobic/F media isolate anaerobic and aerobic microorganisms, namely bacteria and yeast, from a blood sample. This media is specifically designed for use with BACTEC fluorescent series instruments. In addition, new strategic initiatives by key players are further driving the segment growth over the forecast period.

Based on pathogen type, the global market is bifurcated into bacterial sepsis, fungal sepsis, and others. 

The bacterial sepsis segment dominates the global market and is estimated to exhibit a CAGR of 9.4% during the forecast period. Bacterial infection is among the most common causes of life-threatening sepsis, specifically in hospitalized patients. It accounts for around 80% of the total sepsis-causing pathogens. Bacterial sepsis may arise from pneumonia or urinary tract infection. These bacterial infections can affect any organ, further spreading into the bloodstream. The common sites for bacterial sepsis may include surgical incisions, intravenous lines, bed sores, and urinary catheters.

Based on testing type, the global market for sepsis diagnostics is bifurcated into laboratory testing and point-of-care testing. 

The laboratory testing segment owns the largest market share and is estimated to exhibit a CAGR of 9.4% during the forecast period. Clinical laboratory testing provides an in-depth analysis of the pathogen and its drug resistance profile. In addition, routine testing of lactate levels, which is a nonspecific, however useful marker of sepsis, is effectively performed in laboratory settings. With the advent of technologically advanced products, the reliance of the public and physicians on these tests has significantly increased.

Recent Developments

• June 2023- Prenosis Inc. received a BARDA contract to study the utility of its sepsis diagnostic tool.
• January 2023- Cytovale®, a medical diagnostics company focused on advancing early detection technologies to diagnose fast-moving and immune-mediated diseases, 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.