| Study Period | 2019 - 2032 |
| Market Size in 2024 | USD 621.1 Million |
| Market Size in 2025 | USD 672.0 Million |
| Market Size by 2032 | USD 1242.0 Million |
| Projected CAGR | 9.2% |
| Largest Region | North America |
| Fastest Growing Region | APAC |
| Market Structure | Fragmented |
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The global sepsis diagnostics market generated USD 621.1 million in 2024, which will reach to USD 1242.0 million by 2032, progressing at a CAGR of 9.2% during 2025–2032. The growth is attributed to increasing cases of hospital-acquired infections (HAIs) and sepsis and initiatives taken by healthcare as well as government bodies.
Major risk factors for these infections include the use of indwelling catheters, longer hospital stays, antibiotics overuse. Moreover, HAIs is one of the major reasons for mortality globally compared to other death reasons.
Increasing participation of government and non-government organizations to increase awareness regarding sepsis and its diagnosis is also playing pivotal role in the growth of the market. For instance, the WHO organizes World Sepsis Day (WSD) events globally to increase awareness for sepsis. The events include photo exhibitions, sport activities, gala events, pink picnics, dinners, public events such as open houses in hospitals and health care facilities. Moreover, the integration of nanotechnology has shown promising results to overcome the challenges faced during sepsis diagnosis.
The rate of HAIs significantly increased during the pandemic with the rise in nursing hours. During the period, medical device-related infections such as catheter-associated urinary tract infections (CAUTIs) and central line-associated bloodstream infections (CLABSIs) also increased, thereby escalating the demand for sepsis diagnostics in hospitals. Additionally, the lack of HAI control measures has impacted the sepsis diagnostics market growth positively during the pandemic.
The blood culture media category dominates the market with a revenue share, over 65%, in 2024. This is because of the extensive utilization of the blood culture method in sepsis analysis due to its cost-effectiveness and usage convenience.
The importance of the blood culture media is increase by its capability to identify a broad range of microorganisms such as bacteria and fungi which are general causes of sepsis.
This segment has four categories:
The microbiology category holds the largest revenue share, around 60%, in 2024. With the use of culture media testing, like mycobacteriology tests, bacteriology tests, and serology tests, microbiology allows for the quantitative identification of microorganisms causing sepsis. The factors responsible for category growth are the increasing investments in clinical laboratories, rising awareness amongst scientists and researchers regarding microbiological testing, and shoot in the cases of infectious diseases.
Additionally, considering the global burden of this condition, hospitals and MedTech companies are actively conducting trials of products that help in its detection. For instance, in October 2024, the U.S. FDA approved Prenosis' Sepsis ImmunoScore which is the first AI diagnostic test for sepsis. This will help in diagnosing infections as well as predicting severe cases within the next 24 hours.
However, molecular diagnostics is expected to experience the highest CAGR in the sepsis diagnostics market, during 2025–2032. This is associated with the growing interest in diagnostic test development and increasing demand for point-of-care diagnosis. The detection of the pathogen responsible for sepsis is essential for the selection of the antibiotic therapy, which makes molecular diagnostics an attractive strategy. The product launches by key players are contributing to the high-paced growth of the category.
Further, this segment is divided into following categories:
The bacterial sepsis category dominated the market in 2024 with a nearly 75% share, and it is set to record the highest CAGR, in the forecast period. This is ascribed to the increase in bacterial sepsis incidence, shoot in the prevalence of HAIs, and surge in the number of surgical procedures.
As per a government organization, amongst all the pathogens, bacteria are the most-common cause of septicemia. In U.S., in the third quarter of 2021, the standardized infection ratio for hospital onset methicillin-resistant Staphylococcus aureus (MRSA) was 1.17 which is above the baseline of 1.0.
These Pathogen types are included in the report:
Automated diagnostics holds the largest share of 70% in 2024 and growing with highest CAGR. This is due to its better traceability, high efficiency, and elimination of repetitive diagnostic practices. Additionally, the rise in the demand for the timely treatment of the condition and the execution of different strategies by leading players, like widening their product portfolio, mergers and acquisitions, and partnerships are intensifying the category growth.
For example, in November 2023, Oxford Nanopore and Day Zero Diagnostics partnered up to develop a culture free diagnostics system for sepsis. This will help in provide same-day organism detection and antibiotic susceptibility profiling. Moreover, the progressions in medical technology also led to the fast category growth. According to a Europe PMC research study, by enabling the early detection of sepsis, the SERA algorithm provides healthcare professionals with the opportunity to commence treatment, thereby lowering the mortality rate.
Further, these methods have been analysed:
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North America is the largest region with a market share of 40% in 2024. This is due to the high prevalence and mortality rates associated with sepsis in the region. Currently, an American government organization stated that in an average year, 2 million Americans develop sepsis and 1 in 3 patients die in hospitals following onset.
Further, the presence of a highly developed healthcare system is offering beneficial opportunities for the market growth. Additionally, the high frequency of product innovations, connected with the increment in R&D investments, is fueling the market growth in North America.
For example, in October 2024, Ad Astra Diagnostics (AAD) announced that it has got a federal contract at $5 million, with the potential to increase up to $12.6 million. The funding will help in the development of the increased diagnostics system to provide the faster complete blood count (CBC) test results and the prior detection of the serious infections including sepsis.
However, APAC is set to register the highest CAGR in the forecast period, owing to the growth in the number of product approvals and increment in the R&D funding for modern diagnostic solutions. In the APAC region, China, and Japan together account for nearly 50% of the revenue, driven by their rapid economic development. Additionally, the increasing mortality rate due to sepsis is a key factor responsible for the surging demand of sepsis diagnosis in these countries. China dominates the APAC market due to the growing number of hospitals, clinics, and diagnostic centers along with easy convenience of advanced healthcare in the country.
Moreover, the development of POC and rapid diagnostic techniques and evolution of novel biomarkers for the early diagnosis of sepsis are anticipated to offer lucrative opportunities for the market growth in the region.
The regions and countries analyzed for this report include:
The nature of the sepsis diagnostics market is fragmented due to the large number of players who offers diverse diagnostics solutions. The major players in the industry are keeping an eye on growth strategies like R&D investments, collaborations, partnerships, and innovations with products. A robust supply chain is also possessed by the major players which help them to fulfill the demand from customers rapidly and efficiently.
In May 2023, Sysmex Corporation introduced sample preparation system PS-10, antibody reagents, the flow cytometer XF-1600 clinical flow cytometry system, and other related products in Japan. In April 2023, BIOFIRE FIREWORKS was launched by the bioMérieux SA which is an advanced software solution for BIOFIRE systems to support data-driven decisions and optimize laboratory operations. In February 2023, Immunexpress Inc. introduced its SeptiCyte Rapid test in the U.S. which can detect sepsis within an hour. This test is used for identifying sepsis in patients at an earlier stage which help in timely interventions and better outcomes. In January 2023, IntelliSep sepsis diagnostic test was announced by the Cytovale which is especially created to aid in diagnosing sepsis in patients in emergency departments.
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