Sepsis Diagnostic Market Size, Share & Trends Analysis Report By Product (Instruments, Blood Culture Media, Assay Kits & Reagents, Software), By Technology, By Pathogen, By Testing Type, By Region, And Segment Forecasts, 2020 - 2027

Industry Insights

The global sepsis diagnostic market size was valued at USD 550.2 million in 2019 and is expected to witness attractive growth over the forecast period. Factors such as high prevalence of sepsis, increasing awareness, and introduction of technologically advanced diagnostic solutions are expected to significantly fuel market growth over the forecast period.

Sepsis is a severe medical condition caused by the overwhelming immune response to an infection. Recent studies have shown an increasing prevalence of this life-threatening disease across the globe. According to the data published by WHO in April 2018, sepsis affects more than 30 million people globally and leads to around 6 million deaths every year. The same source states that globally, around 3 million newborns and 1.2 million children suffer from this condition every year. Such high prevalence is anticipated to increase the demand for diagnostic solutions and drive market growth over the forecast period.

Currently, most of the existing sepsis diagnostic tests can take up to 72 hours to process and provide final results. Thus, a high demand for rapid diagnostic tests exists in the market for early diagnosis of this life-threatening condition that could save thousands of lives. In February 2019, researchers at the University of Strathclyde discovered a cost-effective test for earlier diagnosis of sepsis. This newly developed test uses a microelectrode to analyze the patients’ blood and can provide final results in around two and a half minutes. Key players in the market have lucrative opportunities to strengthen their market position with the development and launch of such advanced rapid tests.

Increasing regulatory approval and the introduction of technologically advanced diagnostic solutions are expected to be the prominent factors facilitating market growth over the forecast period. For instance, in April 2019, Beckman Coulter Inc., a fully owned subsidiary of Danaher Corporation received 510(k) clearance from the U.S. FDA for its Early Sepsis Indicator. This indicator is a cellular biomarker intended to help healthcare professionals to identify patients with sepsis or at high risk of developing the disease. Additionally, in August 2018, Japan-based Sysmex Corporation launched its new HISCL Presepsin Assay Kit, for determining levels of presepsin, the main test parameter for bacterial sepsis. This kit is designed to achieve early diagnosis of bacterial sepsis with high precision as compared to conventional biomarkers.

In June 2018 Sepsis Alliance, a non-profit organization involved “It's About TIME”, a nationwide initiative to spread huge awareness about rapid diagnosis and treatment of the disease. Such initiatives by various organizations are expected to increase the awareness about the disease and increase the demand for its diagnostic solutions. Thus, it is expected to create a lucrative environment for market growth.

Furthermore, hospital-acquired infections (HAIs) can trigger sepsis, especially in the geriatric population, newborn babies, and people suffering from chronic disease. According to the CDC estimates, every year around 1.7 million patients suffer from HAIs and around 99,000 patients die due to HAIs in U.S. Hence, increase in the prevalence of HAIs is anticipated to raise demand for diagnostic solutions for the disease and drive the market for sepsis diagnostics over the forecast period.

Product Insights

Based on the product, the market is segmented into instruments, blood culture media, assay kits and reagents, and software. In 2019, the blood culture media segment accounted for the largest revenue share and is expected to hold its dominance over the forecast period. This can be attributed to the fact that blood culture media is considered as the cost-effective and gold standard method by most of the clinicians.

Assay kits and reagents segment is expected to show lucrative growth over the forecast period. This can be attributed to increased demand for kits and reagents with the rising prevalence of sepsis in key regions. According to the study published by The Journal of the American Medical Association in February 2019, sepsis is a leading cause of death in hospitals and affects around 1.7 million adults in U.S. Hence, there is an increasing demand for assay kits and reagents for rapid diagnosis of the disease condition.

Technology Insights

On the basis of technology, the sepsis diagnostic market is segmented into microbiology, molecular diagnostics, immunoassays, and flow cytometry. In 2019, the microbiology segment accounted for the largest share in terms of revenue and is anticipated to hold its dominance over the forecast period. This can be attributed to the fact that microbiology allows the quantitative detection and identification of microorganisms through the application of blood culture media tests.

The molecular diagnostics segment is anticipated to witness a lucrative CAGR over the forecast period. Increasing adoption of molecular diagnostic technology due to its several advantages such as high sensitivity, accuracy, and less turnaround time over the other technologies is anticipated to drive segment growth. However, a disadvantage in this technique is that it is unable to identify uncultivable organisms. Nevertheless, molecular diagnostic technique is considered as a standard pathogen identification technique after blood culture.

Pathogen Insights

Based on the pathogen, the market is segmented into bacterial and fungal sepsis, and other pathogens. The bacterial sepsis segment held the largest revenue share in 2019 and is anticipated to hold its dominance over the forecast period owing to its high prevalence. According to the study published by SAGE Journals in January 2019, bacterial sepsis is the most common type, with 62.2% of patients infected with Gram-negative bacteria and 46.8% with Gram-positive bacteria.

Amongst the bacterial sepsis segment, the Gram-negative bacteria segment is anticipated to dominate the market over the forecast period. Robust R&D activities and increasing regulatory approval of novel solutions are expected to significantly support segment growth. For instance, in April 2019, GenMark Diagnostics, Inc. received the U.S. FDA approval for its new panel assay, developed to detect gram-negative bacteria causing sepsis.

Testing Type Insights

Based on testing type, the market is segmented into laboratory testing and PoC testing. The laboratory testing segment held significant revenue share in 2019. The laboratory testing segment is anticipated to grow at a rapid pace over the forecast period owing to the rising number of blood culture tests being conducted in laboratories. Growing number of diagnostic laboratories in key regions coupled with the availability of advanced instruments are anticipated to foster the growth of this segment.

Furthermore, introduction of novel point-of-care (PoC) solutions for sepsis diagnosis is expected to support the growth of PoC segment over the forecast period. For instance, in July 2018, Thermo Fisher Scientific Inc., a U.S.-based diagnostics solution provider launched its new B·R·A·H·M·S PCT, a direct point of care assay designed for early diagnosis of bacterial infection and sepsis.

Regional Insights

In 2019, North America held a dominant position in terms of revenue and is anticipated to hold its dominance over the forecast period owing to the increasing healthcare expenditure and favorable reimbursement scenarios for diagnostic tests in U.S. In addition, presence of a well-established healthcare infrastructure as well as rapid adoption of advanced diagnostic products in U.S. are also some of the factors driving the regional growth. Factors such as high prevalence of hospital-acquired infections, frequent product approvals, and presence of key players in North America further fuels market growth.

Asia Pacific is projected to exhibit attractive growth over the forecast period. Key players operating in the market are adopting organic growth strategies such as product development and launch for gaining major market growth. For instance, in August 2018, Japan-based Sysmex Corporation launched its new HISCL Presepsin Assay Kit. This kit is intended to measure the levels of presepsin, a major test parameter for bacterial sepsis. Furthermore, high prevalence of sepsis in the key countries of Asia Pacific is expected to drive the demand for its diagnostics solutions. For instance, according to areport published by PLOS Journal, in 2019, India has very high incidence of clinical sepsis; it affected around 17,000 out of 100,000 live births.

Sepsis Diagnostic Market Share Insights

Some of the key players operating in this space comprise Becton, Dickinson and Company; bioMérieux SA; Sysmex Corporation; F. Hoffmann-La Roche AG; Beckman Coulter, Inc.; Thermo Fisher Scientific, Inc.; Cepheid Inc.; Bruker Corporation; and Nanosphere, Inc.

The key players operating in the market are adopting inorganic growth strategies such as mergers and partnerships in order to penetrate new regions and provide access of its solutions into vast geography. For instance, in December 2019, U.S.-based Ontera, Inc. and England-based QuantuMDx Group Limited entered into a strategic collaboration for the development of advanced sepsis diagnostic solutions.

Report Scope

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2016 to 2027. For the purpose of this study, Grand View Research has segmented the global sepsis diagnostic market report on the basis of product, technology, pathogen, testing type, and region:

• Product Outlook (Revenue, USD Million, 2016 - 2027)

  • Instruments

    • Microbiology

    • Molecular Diagnostics

    • Immunoassays

    • Flow Cytometry

  • Blood Culture Media

    • Microbiology

    • Molecular Diagnostics

    • Immunoassays

    • Flow Cytometry

  • Assay Kits and Reagents

    • Microbiology

    • Molecular Diagnostics

    • Immunoassays

    • Flow Cytometry

  • Software

    • Microbiology

    • Molecular Diagnostics

    • Immunoassays

    • Flow Cytometry

• Technology Outlook (Revenue, USD Million, 2016 - 2027)

  • Microbiology

  • Molecular Diagnostics

  • Immunoassays

  • Flow Cytometry

• Pathogen Outlook (Revenue, USD Million, 2016 - 2027)

  • Bacterial Sepsis

    • Gram-Positive Bacteria

    • Gram-Negative Bacteria

  • Fungal Sepsis

  • Others

• Testing Type Outlook (Revenue, USD Million, 2016 - 2027)

  • Laboratory Testing

  • PoC Testing

• Regional Outlook (Revenue, USD Million, 2016 - 2027)

  • North America

    • U.S.

    • Canada

  • Europe

    • Germany

    • U.K.

    • Spain

    • France

    • Italy

    • Russia

  • Asia Pacific

    • Japan

    • China

    • India

    • South Korea

    • Singapore

    • Australia

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • MEA

    • South Africa

    • Saudi Arabia

    • UAE