Sepsis Diagnostics Market Size & Share, by Product (Assay Kits & Reagents, Blood Culture Media), Technology (Microbiology, Immunoassays, Flow Cytometry), Pathogen (Bacterial Sepsis, Fungal Sepsis), Testing Type (Laboratory Tests, POC Testing) - Global Supply & Demand Analysis, Growth Forecasts, Statistics Report 2025-2037

  • Report ID: 4869
  • Published Date: Oct 14, 2024
  • Report Format: PDF, PPT

Global Market Size, Forecast, and Trend Highlights Over 2025-2037

Sepsis Diagnostics Market size was valued at USD 2.5 billion in 2024 and is likely to exceed USD 10.79 billion by the end of 2037, expanding at over 11.8% CAGR during the forecast period i.e., between 2025-2037. In the year 2025, the industry size of sepsis diagnostics is evaluated at USD 2.74 billion.

The growth of the market can be attributed to the increasing number of elderly people who are prone to sepsis. Further, the growing technological advancements in the field of sepsis diagnostics are expected to add to the market growth. The United States Food and Drug Administration, FDA, granted marketing authorization to Immunoexpress Inc.'s SeptiCyte RAPID in December 2021. In October 2021, Prenosis Inc. extended an existing agreement with Roche Diagnostics to accelerate the clinical diagnosis of sepsis. Prenosis, Inc. is a precision diagnostic company that uses AI in order to help diagnose patients more accurately.

In addition to these, factors that are believed to fuel the growth of sepsis diagnostics market include the increase in sepsis cases, the increased burden of hospital-acquired infections, the rising number of pneumonia cases, a higher level of sepsis treatment, and an increase in funding for research related to sepsis. Increased use of sepsis diagnostic products is expected to contribute to market growth. In addition, a new intervention to actively prevent, treat and evaluate sepsis in pregnant women was funded by more than GBP 3 million in June 2021.


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Sepsis Diagnostics Sector: Growth Drivers and Challenges

Growth Drivers

  • Growing Prevalence of Hospital-Acquired Infections – Hospital-acquired infections (HAIs), also known as nosocomial infections, are a major cause of morbidity and mortality worldwide. Urinary tract infections, pneumonia, and sepsis are the most frequent Hospital Acquired Infections. HAIs can lead to sepsis in immunocompromised patients, geriatric patients, and patients suffering from chronic illnesses. For instance, in the United States, there is an increase in sepsis by 8.7% annually among patients admitted to a hospital. It is estimated that more than 1,000,000 cases of sepsis among hospitalized patients occur each year in the United States.
  • Development of Rapid Diagnostic Techniques for Sepsis Diagnosis – Sepsis is a very difficult condition to diagnose and the risk of mortality increases by 7.6%. Therefore, there is an increasing need to develop diagnostic tools for sepsis. Hence, the BACTEC Plus and BACTEC FX blood culturing instruments manufactured by BD Company (US) an automated microbial detection system offering a rapid diagnosis of sepsis in a turnaround time of three hours. Increase in Funding for Sepsis-Related Research Activities – According to the most recent reports, sepsis funding and directives have been included in the USD 1.7 trillion Omnibus spending bill passed and signed by President Joe Biden in January 2023.  It is predicted that this boom would continue over the forecast period.
  • Increasing Burden of Sepsis – the global sepsis mortality rate is reported as 11 million in the year 2019.  Reports from WHO cite that 85% of sepsis cases occur in low and middle-income countries. This increasing burden of sepsis is hence expected to contribute to the growth of the market in the forecast period.

Challenges

  • High cost of diagnostic devices - The increasing concern amongst people about the high cost of diagnostic devices is one of the major factors predicted to slow down the market growth. The cost of molecular diagnostic tests is between USD 300 and USD 3,000, which is very high compared to the cost of blood culture tests priced as low as ~USD 28–35.
  • Shortage of skilled healthcare professionals
  • Lack of appropriate testing for sepsis

Sepsis Diagnostics Market: Key Insights

Base Year

2024

Forecast Year

2025-2037

CAGR

11.8%

Base Year Market Size (2024)

USD 2.5 billion

Forecast Year Market Size (2037)

USD 10.79 billion

Regional Scope

  • North America (U.S., and Canada)
  • Latin America (Mexico, Argentina, Rest of Latin America)
  • Asia-Pacific (Japan, China, India, Indonesia, Malaysia, Australia, Rest of Asia-Pacific)
  • Europe (U.K., Germany, France, Italy, Spain, Russia, NORDIC, Rest of Europe)
  • Middle East and Africa (Israel, GCC North Africa, South Africa, Rest of the Middle East and Africa)

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Sepsis Diagnostics Segmentation

Product (Assay Kits & Reagents, Blood Culture Media)

The global market is segmented and analyzed for demand and supply by product into IBS with assay kits & reagents and blood culture media. Out of the two types of sepsis diagnostics, the blood culture media segment is estimated to gain the largest sepsis diagnostics market share of about 42% in the year 2037. The growth of the segment can be attributed to the increasing convenience and cost-effectiveness of this mode of testing. Further, the growing use of blood culture media by hospitals and pathology laboratories is also expected to contribute to the growth of the segment. For instance, it was found that the Sepifast system, which uses PCR techniques, had a better diagnostic performance when compared to blood cultures during an experimental study on patients from Thailand suffering from sepsis. As a result of increasing awareness about health care and the growing number of surgical procedures, it is also noted that instrument segments will continue to grow over the forecast period. For example, in September 2019 Guthrie, a U.S.-based Integrated Health System, started to use Wolters Kluwer Point of Care advisors for detecting and treating Sepsis at four hospitals within the area. All these factors are anticipated to contribute to the growth of the segment.

Technology (Microbiology, Immunoassays, Flow Cytometry)

The global sepsis diagnostics market is also segmented and analyzed for demand and supply by technology into microbiology, immunoassays, and flow cytometry. Amongst these three segments, the microbiology segment is expected to garner a significant share of around 45% in the year 2037. It is based on the fact that microbiological technology makes use of culture media tests to detect and identify sepsis organisms in a precise manner. Moreover, the growing segment is being driven by New Strategic Initiatives undertaken by major players. For instance, in April 2019, BD introduced the new BACTEC plasma quality monitoring media to help identify and reduce sepsis incidence among patients who receive blood transfusions. This, as a result, is anticipated to create numerous opportunities for the growth of the segment in the coming years.

Our in-depth analysis of the global market includes the following segments:

       By Product

  • Assay Kits & Reagents
  • Blood Culture Media

      By Technology

 

  • Microbiology
  • Immunoassays
  • Flow Cytometry

     By Pathogen

  • Bacterial Sepsis
  • Fungal Sepsis
  • Others

     By Testing Type

  • Laboratory Testing
  • POC Testing

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Sepsis Diagnostics Industry - Regional Synopsis

North American Market Forecast

The share of sepsis diagnostics market in North America, amongst the market in all the other regions, is projected to be the largest with a share of about 39% by the end of 2037. The growth of the market can be attributed majorly to the increasing and developed healthcare infrastructure in the region. This has led to an increase in the number of advanced diagnostic equipment and programs being used across the region. Furthermore, the sepsis diagnostics market's growth is supported by a high presence of key players and an adequate reimbursement framework across that region. Moreover, demand for new diagnostics solutions is expected to rise due to a high incidence of sepsis and infectious diseases. For instance, according to the Centers for Disease Control and Prevention, in August 2021, approximately 1.7 million adults in America develop sepsis, and nearly 270,000 Americans die due to sepsis. It was also found that 1 in 3 patients who die in a hospital have sepsis. Hence, its diagnosis will increase and the market will grow as a result of the high number of cases in the country. The market will also be supported by increasing investments in research and development to diagnose sepsis. For example, Cytovale Inc., in April 2020, expanded its partnership with the Biomedical Advanced Research and Development Authority, BARDA, to diagnose sepsis in patients with potential respiratory infections, including COVID-19. Research costs are estimated to be US$1.2 billion. 5.9 million.

APAC Market Statistics

The Asia Pacific sepsis diagnostics market is estimated to be the second largest, registering a significant share by the end of 2037. The growth of the market can be attributed majorly to the increasing research efforts by key players in the last few years that have fueled a growing need to rapidly diagnose sepsis. For instance, Cytovale Inc. announced a partnership with the Biomedical Advanced Research and Development Authority, BARDA, for the diagnosis of sepsis in patients with infectious respiratory disease, including COVID-19, in April 2020. In addition to a contribution of 3.83 million by BARDA, the research was expected to amount to US$ 5.9 million. In addition, the region's launch of effective treatments and clinical trials are also anticipated to boost the sepsis diagnostics market growth during the forecast period.

Europe Market Forecast

Further, the sepsis diagnostics market in Europe, amongst the market in all the other regions, is projected to hold a majority of the share by the end of 2037. The growth of the market can be attributed majorly to the increasing number of fatalities caused by sepsis in the region. There is a series of trials in order to reduce the number of diseases that have been caused, as well as by applying novel diagnostics and therapeutic approaches. The growing incidence of sepsis, coupled with a rising number of diagnostic laboratories across the country, is driving the market. For instance, the Pasteur Institute, a non-profit foundation dedicated to studying vaccines and diseases reports that the sepsis-related death rate in France is nearly 27%. All these factors contribute to the growth of the market.

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Companies Dominating the Sepsis Diagnostics Landscape

    • BioMérieux SA
      • Company Overview
      • Business Strategy
      • Key Product Offerings
      • Financial Performance
      • Key Performance Indicators
      • Risk Analysis
      • Recent Development
      • Regional Presence
      • SWOT Analysis
    • Becton, Dickinson and Company
    • Thermo Fisher Scientific, Inc.
    • F. Hoffmann-La Roche AG
    • Danaher Corporation (Beckman Coulter, Inc.)
    • Cepheid
    • Beckman Coulter, Inc.
    • Amara Health Analytics
    • Wolters Kluwer N.V.
    • Cerner Corp.

In the News

  • Beckman Coulter announced the availability in the United States of its DxH 690T hematology analyzer, which is used as an early sepsis indicator. In addition, this announcement has contributed to the company's increased global presence and growth in revenues.
     
  • Prenosis Inc., a precision diagnostics company that uses artificial intelligence to better diagnose patients, renewed its existing agreement with Roche Diagnostics in order to accelerate the detection of sepsis.

Author Credits:  Radhika Pawar


  • Report ID: 4869
  • Published Date: Oct 14, 2024
  • Report Format: PDF, PPT

Frequently Asked Questions (FAQ)

In the year 2025, the industry size of sepsis diagnostics is evaluated at USD 2.74 billion.

The sepsis diagnostics market size was valued at USD 2.5 billion in 2024 and is likely to exceed USD 10.79 billion by the end of 2037, expanding at over 11.8% CAGR during the forecast period i.e., between 2025-2037. Increasing prevalence of hospital-acquired infections, the rising burden of sepsis in the world, and rising diagnostic developments will boost the market growth.

North America industry is set to hold 39% of the revenue share by 2037, due to increasing and developed healthcare infrastructure in the region.

The major players in the market include BioMérieux SA, Becton, Dickinson and Company, Thermo Fisher Scientific, Inc., F. Hoffmann-La Roche AG, Danaher Corporation (Beckman Coulter, Inc.), Cepheid, Beckman Coulter, Inc., Amara Health Analytics, Wolters Kluwer N.V., Cerner Corp.
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