The global sepsis diagnostics market size was estimated at USD 1.14 billion in 2024 and is projected to reach USD 1.81 billion by 2030, growing at a CAGR of 8.09% from 2025 to 2030. The market’s growth is primarily driven by the introduction of technologically advanced diagnostic solutions, the high global prevalence of sepsis, and increasing awareness among healthcare professionals and patients about early diagnosis and treatment. These factors collectively contribute to the rising demand for efficient and rapid diagnostic tools that can improve patient outcomes and reduce mortality rates.

Sepsis remains one of the leading causes of death, particularly in high-income countries such as the U.S., where approximately 270,000 people die from the condition every year, according to data from the Centers for Disease Control and Prevention (CDC). Despite advanced healthcare systems, the early identification and management of sepsis continue to pose significant challenges, emphasizing the need for better diagnostic solutions and timely interventions.

In low- and middle-income countries, sepsis remains highly prevalent but is frequently underdiagnosed and undertreated due to inadequate healthcare infrastructure and limited access to diagnostic facilities. According to a 2020 report by the Global Sepsis Alliance, sepsis accounts for nearly 11 million deaths globally each year—exceeding the combined mortality rates of breast cancer, prostate cancer, and HIV/AIDS. The burden is particularly severe in low-income regions, where disease-related mortality is highest. This highlights the urgent global need for improved awareness, prevention programs, and accessible diagnostic and treatment strategies, especially in resource-limited settings.

Pneumonia is recognized as the leading cause of sepsis and septic shock, affecting individuals across all age groups. Both community-acquired and hospital-acquired pneumonia can progress to severe infection, significantly increasing the risk of developing sepsis. Recent research indicates that more than half of sepsis patients have a history of pneumonia, underscoring the close connection between the two conditions. Furthermore, the global incidence of pneumonia and sepsis surged during the COVID-19 pandemic. A study published in The Lancet Respiratory Medicine in August 2021 revealed that both the prevalence of sepsis and sepsis-related mortality rates rose substantially during this period. This trend underscores the critical need for continuous improvements in sepsis diagnosis, management, and prevention to mitigate future healthcare crises.

Key Market Trends & Insights:

• In 2024, North America dominated the global sepsis diagnostics market, accounting for the largest revenue share of more than 43.9%. This dominance can be attributed to the region’s advanced healthcare infrastructure, high awareness regarding early sepsis detection, and strong presence of key market players developing innovative diagnostic solutions. Additionally, favorable government initiatives and increasing healthcare expenditure have further supported the adoption of advanced sepsis diagnostic technologies in hospitals and laboratories across the region.

• The Asia Pacific sepsis diagnostics market is projected to be the fastest-growing regional market from 2024 to 2030. The rapid growth in this region is driven by the rising prevalence of infectious diseases, growing healthcare investments, and improving diagnostic capabilities in emerging economies such as China, India, and Japan. Moreover, increasing awareness about sepsis, coupled with expanding access to modern healthcare facilities and government efforts to enhance disease surveillance, is expected to further accelerate market growth in the coming years.

• By product, the blood culture media segment dominated the global sepsis diagnostics market in 2024, accounting for a revenue share of more than 38.90%. Blood culture remains the gold standard for diagnosing sepsis, as it allows for the identification of the causative pathogen and guides appropriate antimicrobial therapy. The segment’s growth is supported by technological advancements that have improved the accuracy, sensitivity, and turnaround time of blood culture testing.

• In terms of technology, the microbiology segment led the global market in 2024, capturing the largest share of more than 48.77%. Microbiological methods remain critical for detecting pathogens responsible for sepsis, offering reliable results that help clinicians make informed treatment decisions. The increasing adoption of automated microbiology systems and molecular techniques within this segment has further enhanced the efficiency and precision of sepsis diagnosis.

• By pathogen, the bacterial segment accounted for the largest revenue share of 86.22% in 2024. Bacteria are the primary cause of sepsis cases worldwide, often resulting from infections such as pneumonia, urinary tract infections, or bloodstream infections. The high prevalence of bacterial sepsis, combined with the growing need for rapid identification of bacterial strains and resistance patterns, continues to drive the dominance of this segment in the global market.

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Market Size & Forecast:

• 2024 Market Size: USD 1.14 Billion

• 2030 Projected Market Size: USD 1.81 Billion

• CAGR (2025-2030): 8.09%

• North America: Largest market in 2024

Key Companies & Market Share Insights:

The key players operating in the sepsis diagnostics market are increasingly focusing on inorganic growth strategies such as mergers, acquisitions, and strategic partnerships to enhance their product portfolios and accelerate the development of advanced diagnostic solutions. These collaborations enable companies to leverage complementary technologies, expand their geographic presence, and strengthen their position in the global market.

• In October 2024, Trinity Biotech announced the acquisition of a 12.5% equity stake in Novus Diagnostics, valued at USD 2.5 million. This strategic investment aims to support the acceleration of Novus Diagnostics’ commercialization efforts and the development of innovative point-of-care diagnostic solutions, enhancing accessibility and efficiency in sepsis detection.

• In April 2024, F. Hoffmann-La Roche entered into a distribution collaboration with Prenosis, Inc. to distribute ImmunoScore, an AI-powered software as a medical device (AI SaMD). This solution is designed to assist healthcare professionals in the rapid diagnosis of sepsis and prediction of adverse patient outcomes, demonstrating Roche’s commitment to integrating artificial intelligence into clinical diagnostics.

• In November 2023, Danaher Corporation partnered with the University of Oxford to develop a test utilizing rapid molecular diagnostic technologies from its subsidiary, Cepheid. This collaboration focuses on identifying various subtypes of sepsis, enabling the advancement of personalized care pathways and improving patient management strategies.

• In February 2023, Immunexpress commercialized its SeptiCyte Rapid test in the U.S., a point-of-care diagnostic tool capable of identifying sepsis in patients within an hour. This innovation allows for earlier detection, timely intervention, and improved patient outcomes, addressing one of the most critical challenges in sepsis management.

• In January 2023, Cytovale launched its IntelliSep sepsis diagnostic test, specifically designed for emergency department use. This new test aims to facilitate the rapid identification of sepsis among patients presenting with symptoms, supporting prompt decision-making and treatment initiation.

• In the same month, PERSOWN Inc. introduced SMASH-H, a real-time sepsis monitoring system. This innovative solution was developed to help healthcare providers address the rising burden of sepsis by enabling continuous monitoring and early detection, ultimately improving clinical outcomes and reducing mortality rates.

Key Players

• BD

• bioMérieux SA

• Thermo Fisher Scientific, Inc.

• Danaher Corporation (Beckman Coulter, Inc.)

• F. Hoffmann-La Roche AG

• Cepheid

• Luminex Corp.

• Koninklijke Philips N.V.

• Bruker

• Immunexpress, Inc.

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Conclusion:

The global sepsis diagnostics market is expected to witness steady growth over the coming years, primarily driven by the rising prevalence of sepsis worldwide and growing awareness about the importance of early and accurate diagnosis. Technological advancements in diagnostic methods, including molecular diagnostics and AI-driven tools, are further propelling market expansion.