North America And Europe Sepsis Diagnostics Market Size, Share & Trends Analysis Report By Product, By Technology, By Pathogen, By Testing, By Method, By End Use, By Country, And Segment Forecasts, 2025 - 2030

Market Size & Trends

The North America and Europe sepsis diagnostics market size was estimated at USD 816.1 million in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 7.3% from 2025 to 2030. Market growth is driven by a rising incidence of sepsis and hospital-acquired infections (HAIs). In the U.S. alone, approximately 1.7 million people were are affected by sepsis annually, positioning it as the third leading cause of death in hospitals as of 2023. The European Centre for Disease Prevention and Control (ECDC) reported in 2024 that HAIs impacted about 4.5 million patients each year, with sepsis emerging as a critical consequence of these infections. This growing prevalence highlights the urgent need for effective diagnostic solutions to manage and treat sepsis efficiently.

Technological advancements have also played a pivotal role in propelling the sepsis diagnostics market forward. By 2024, over 35% of hospitals in Canada had adopted point-of-care testing, enhancing early diagnosis capabilities. In Spain, approximately 70,000 cases of sepsis were reported annually, underscoring the critical need for improved diagnostic methods. The use of molecular diagnostics surged, with hospitals increasingly employing techniques such as PCR and mass spectrometry for rapid pathogen identification. Research indicates that these advanced methods can enhance treatment outcomes by facilitating timely and appropriate antimicrobial therapy, thereby improving overall patient management and clinical results.

Government initiatives and funding have further underscored the importance of addressing sepsis as a critical health issue. The UK government allocated approximately USD 12 million in 2023 for antimicrobial resistance (AMR) research, directly supporting sepsis management initiatives essential to market growth. Moreover, in 2024, federal funding for sepsis-related programs in the U.S. was projected to exceed USD 50 million, aimed at improving diagnostic technologies and reducing to improve diagnostic technologies and reduce mortality rates associated with sepsis. Such financial commitments reflect a concerted effort to enhance healthcare systems and patient care.

The shift towards value-based care in both regions emphasizes the importance of effective diagnostics to improve patient outcomes while managing healthcare costs. This transformation encourages healthcare providers to adopt innovative diagnostic solutions conducive to better sepsis management. Concurrently, awareness and education initiatives aimed at healthcare professionals about recognizing the signs and risks of sepsis are gaining traction, ultimately promoting. These initiatives ultimately promote earlier diagnosis and treatment, thereby significantly impacting patient survival rates.

Product Insights

Blood culture media led the market and accounted for a share of 38.9% in 2024. Blood culture is recognized as the gold standard for sepsis diagnosis, effectively identifying pathogens responsible for bloodstream infections and guiding appropriate antibiotic treatment. This method allows for comprehensive pathogen identification, which is critical for tailoring specific therapies. Established in clinical practice, blood cultures remain trusted despite longer turnaround times. With the alarming mortality rate of 50.6% due to sepsis in Denmark, the demand for timely diagnostics continues to grow, further propelled by advancements in blood culture technology.

Assay kits & reagents are expected to grow at the fastest CAGR of 7.6% over the forecast period. Assay kits and reagents have played an essential role in the accurate and timely diagnosis of sepsis, facilitating various tests, including critical molecular diagnostics for rapid pathogen identification. With sepsis affecting approximately 1.7 million people annually in the U.S., the demand for these diagnostic tools has surged. Recent advancements, such as multiplex assays for simultaneous pathogen detection, further enhance their efficiency. In addition, their cost-effectiveness compared to automated systems increases accessibility for smaller healthcare facilities.

Technology Insights

Microbiology dominated the market and accounted for a share of 48.7% in 2024. Microbiology accurately identifies pathogens crucial for effective treatment in diagnosing cases, which is crucial for effective treatment and diagnosis of sepsis. The rising incidence of sepsis drives demand for microbiological diagnostics. Recent technological advancements, including automated blood culture systems and multiplex assays, enhance efficiency. Moreover, microbiological testing provides essential data on antibiotic susceptibility, vital for treating multi-drug resistant organisms.

Molecular diagnostics is expected to register the fastest CAGR of 9.3% over the forecast period. Technological advancements such as Polymerase Chain Reaction (PCR) and Nucleic Acid Amplification Tests (NAATs) enable rapid pathogen identification, essential for timely treatment. In Italy, as of 2021, 30 centers within the SIAPEC-PMMP NGS National Network utilized Next Generation Sequencing (NGS) technology, predominantly in the north. Disparities in the diagnostic laboratory/population ratio highlight regional access issues. Moreover, the shift toward value-based care, integration with digital health solutions, and increased research into molecular tools are driving advancements in sepsis diagnostics.

Pathogen Insights

Bacterial sepsis held the largest market share of 86.2% in 2024, driven by significant mortality rates, rising HAIs, and technological advancements. Recent innovations in blood culture technology and molecular diagnostics enable rapid and accurate detection of bacterial pathogens, essential for effective sepsis management. Increased awareness and research initiatives contribute to growing demand. Two notable sub-segments, Gram-positive and Gram-negative bacterial sepsis, exhibit distinct characteristics, common pathogens, and clinical implications. Both sub-segments pose unique challenges and treatment complexities, emphasizing the need for advanced diagnostics and effective treatment strategies.

Fungal sepsis is expected to register significant growth over the forecast period. The rising prevalence of invasive fungal infections among immunocompromised populations drives the demand for effective diagnostics. High mortality rates associated with fungal sepsis necessitate early detection to improve outcomes. Advances in molecular diagnostics and rapid blood culture systems enhance pathogen identification. Increased awareness, and research,, along with regulatory support, and regulatory support further stimulate market growth, addressing pathogens such as Candida, Aspergillus, and Cryptococcus neoformans.

Testing Insights

Laboratory testing led the market and accounted for a share of 82.2% in 2024. Laboratory testing methods have provided comprehensive analyses of sepsis, enabling accurate pathogen identification and infection severity assessment. Advancements such as automated blood cultures and PCR enhance diagnostic speed and reliability. Regulatory support and favorable reimbursement policies also encourage healthcare facilities to adopt advanced testing, complemented by increasing awareness and education among professionals.

Point-of-CarePoint-of-care testing (POCT) is expected to register the fastest CAGR of 9.6% over the forecast period, as it has significantly enhanced sepsis management by providing immediate results, crucial for timely interventions. A 2024 PubMed study shows that delays in antimicrobial therapy reduce survival rates by 7.7% per hour. Its accessibility, particularly in resource-limited settings, facilitates rapid diagnostics using small sample volumes, lowering healthcare costs. Recent technological advancements improved accuracy and integration with electronic health records, aiding clinical decision-making. This demand has prompted companies to accelerate the development of cost-effective, user-friendly POCT products, improving patient management and accessibility.

Method Insights

Conventional diagnostics dominated the market and accounted for a share of 57.0% in 2024. Established reliability and accuracy, cost-effectiveness, and deep integration into clinical protocols have made methods such as blood cultures the gold standard. The rising incidence of hospital-acquired infections, regulatory support, and healthcare providers’ familiarity with these techniques have reinforced their continued preference in for sepsis management.

Automated diagnostics are expected to register the fastest CAGR of 8.5% over the forecast period, owing to their efficiency in processing multiple samples quickly, enhancing speed and turnaround times. These systems increased accuracy through advanced technologies, integrating seamlessly with electronic health records. Rising sepsis incidence and regulatory support for innovative tools, along with a focus on value-based care and enhanced patient management,, regulatory support for innovative tools, a focus on value-based care, and enhanced patient management further facilitated demand for these solutions.

End Use Insights

Hospitals & clinics held the largest revenue share of 79.4% in 2024. The urgent need for timely diagnosis in sepsis management has driven demand for rapid diagnostic solutions in hospitals and clinics, where sepsis contributes to nearly 270,000 deaths annually in the U.S. Healthcare providers have focused on quality improvement initiatives and complied complying with regulatory requirements to enhance diagnostic capabilities. Integration with advanced technologies and ongoing research within clinical settings contributes to effective patient management, while investments in diagnostics help reduce hospital stays and overall healthcare costs.

Pathology & reference laboratories are projected to grow at the fastest CAGR of 7.8% over the forecast period. Pathology and reference laboratories have been essential for specialized testing in sepsis, providing advanced diagnostics such as molecular tests and biomarker analyses that standard hospitals often lack. Their capability to manage high volumes of tests ensures timely results amid rising sepsis cases. Adhering to strict quality control standards and regulatory requirements fosters trust among healthcare providers. With access to advanced technologies and consultative services, they contribute significantly to the growing awareness and early diagnosis of sepsis.

Regional Insights

The U.S. sepsis diagnostics market led the North American market with a revenue share of 86.1% in 2024. Technological advancements in molecular diagnostics, POCT, and biomarker methods have facilitated faster pathogen detection. The shift toward value-based care encourages early detection, while supportive reimbursement policies ease financial burdens for implementing diagnostic technologies. Increased awareness and education about sepsis have heightened demand, and collaborations between healthcare institutions and diagnostic companies foster and collaborations between healthcare institutions and diagnostic companies have fostered innovation. Government initiatives have boosted funding for research and development in sepsis management.

The sepsis diagnostics market in Germany held the dominant share of the European sepsis diagnostics market in 2024. Germany’s sepsis diagnostics market grew due to 60,000 annual deaths, hospital-acquired infections, advanced infrastructure, government initiatives, research investments, and high healthcare expenditure. The German Sepsis Society promoted awareness, while technological advancements, including molecular diagnostics such as SepsiTest, enhanced diagnosis speed and accuracy, driving market growth and precision medicine adoption.

The UK sepsis diagnostics market is expected to grow at the fastest rate of 8.1% over the forecast period in the Europe European market. The UK Sepsis Trust’s initiatives, such as the Sepsis 6 care bundle, led to a 10% increase in survival rates, from 70% to 80%, between 2012 and 2019. The bundle is now implemented in 96% of UK hospitals, and NICE has endorsed itendorsed by NICE. According to the BBC, the USD 10.7 million Longitude Prize incentivized teams to create rapid tests for bacterial infections. However, workforce shortages and public awareness issues persist, necessitating continued education and support for improved patient outcomes.

Key North America and Europe Sepsis Diagnostics Company Insights

Some key companies operating in the market include BD; bioMérieux SA; Thermo Fisher Scientific Inc.; and Beckman Coulter, Inc. (Danaher Corporation). Key players pursued strategic partnerships and technological innovations; North America focused on high incidence rates and advanced diagnostics, while Europe prioritized regulatory advances and collaborative research.

• bioMérieux SA offers comprehensive solutions for rapid pathogen identification and antimicrobial susceptibility testing, thereby enabling informed treatment decisions and cost-efficient care.

• Cepheid specializes in molecular diagnostics, providing accurate and rapid tests for sepsis-causing pathogens through its GeneXpert platform, facilitating POCT and timely antibiotic therapy initiation, ultimately enhancing patient outcomes

Recent Developments

• In April 2024, Bruker showcased advancements in clinical microbiology and infection diagnostics at the ESCMID Global Conference in Barcelona, enhancing solutions for microbial identification and early sepsis diagnostics, amidst regulatory clearances for ELITech acquisition.

• In March 2024, BD collaborated with GOCC in Poland to enhance access to advanced bloodstream infection testing, deploying state-of-the-art microbiology equipment across over 150 hospitals and clinics for improved sepsis management.

• In January 2024, Immunexpress presented data on SeptiCyte RAPID’s effectiveness in differentiating sepsis from systemic inflammatory response syndrome at the Society of Critical Care Medicine Congress in Phoenix, Arizona.

• In January 2024, bioMérieux acquired LUMED, boosting its software portfolio to enhance antimicrobial stewardship and infection prevention in healthcare systems in France and Canada, increasing its stake to 100%.

North America and Europe Sepsis Diagnostics Market Report Scope

North America And Europe Sepsis Diagnostics Market Report Segmentation

This report forecasts revenue growth at regional and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the North America and Europe sepsis diagnostics market report based on product, technology, pathogen, testing, method, end use, and region:

• Product Outlook (Revenue, USD Million, 2018 - 2030)

  • Instruments

  • Blood Culture Media

  • Assay Kits and Reagents

  • Software

• Technology Outlook (Revenue, USD Million, 2018 -2030)

  • Microbiology

  • Molecular Diagnostics

    • Polymerase Chain Reaction (PCR)

    • DNA Microarrays

    • Syndromic Panel Testing

    • Others

  • Immunoassays

  • Flow Cytometry

  • Others

• Pathogen Outlook (Revenue, USD Million, 2018 - 2030)

  • Bacterial Sepsis

    • Gram-positive Bacteria

    • Gram-negative Bacteria

  • Fungal Sepsis

  • Viral Sepsis

  • Others

• Testing Outlook (Revenue, USD Million, 2018 - 2030)

  • Laboratory Testing

  • PoC Testing

• Method Outlook (Revenue, USD Million, 2018 - 2030)

  • Automated Diagnostics

  • Conventional Diagnostics

• End Use Outlook (Revenue, USD Million, 2018 - 2030)

  • Hospitals & Clinics

  • Pathology & Reference Laboratories

  • Research Institutes and Others

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Russia

    • Denmark

    • Sweden

    • Norway