Regulatory Approvals and Launch of Technologically Innovative Diagnostic Tools to Fuel the Sepsis Diagnostics Market

Introduction

It is projected that increased regulatory approvals and the launch of technologically innovative diagnostic tools will be the prominent factors that promote demand growth over the forecast era. For example, Beckman Coulter Inc., a wholly-owned Danaher Corporation subsidiary, received 510(k) clearance from the U.S. in April 2019. This measure is a cellular biomarker developed to help healthcare professionals classify patients with sepsis or at high risk for disease progression.

Besides, Sysmex Corporation, headquartered in Japan, unveiled its latest HISCL Presepsin Assay Kit in August 2018 to evaluate levels of presepsin, the principal test parameter for bacterial sepsis. This kit is designed to achieve early diagnosis of bacterial sepsis with high precision compared to conventional biomarkers.

Sepsis Alliance, a non-profit group, sponsored "It's About TIME" in June 2018, a national campaign to increase awareness about rapid diagnosis and illness care. It is expected that such initiatives by different organizations will raise awareness of the disease and increase the demand for its diagnostic solutions. Therefore, a favorable climate for Sepsis Diagnostics market growth is supposed to be developed.

Key Highlights

• The global sepsis diagnostics market was valued at USD 426 million in 2019 and is expected to grow at 8.4% CAGR during the forecast study period.
• In terms of product, in 2019, the blood culture media segment accounted for the maximum revenue share due to the surged use of blood culture media. It is the standard method for the diagnosis of sepsis across the globe.
• The microbiology segment accounted for the largest revenue share in terms of technology and is expected to hold its dominance over the forecast period. This is due to the fact that microbiology allows the quantitative detection and identification of microorganisms through the application of blood culture media tests.
• In terms of the pathogen, the bacterial sepsis segment held the largest revenue share and is likely to hold its dominance over the estimated period owing to its high prevalence.
• In terms of testing type, the laboratory testing segment is estimated to grow rapidly over the forecast period due to the escalating number of blood culture tests being conducted in laboratories.
• North America held a dominant position in revenue and is anticipated to hold its dominance over the forecast period. This can be attributed to the rising, rising prevalence of sepsis, growing incidence of hospital-acquired infections, rapid adoption of high-end sepsis diagnostics devices, and mounting government support for sepsis-related research.
• Some of the major key players operating in this market 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, Nanosphere, Inc., and Abbott.
• In September 2019, T2 Biosystems launched T2 Resistance Panel.
• In December 2018, BioMérieux (France) received FDA approval for BPA and BPN used with BACT/ALERT VIRTUO for quality control testing of platelets.

Competitive Players

1. Becton
2. Dickinson and Company
3. biomérieux SA
4. F. Hoffmann-La Roche
5. Beckman Coulter Inc.
6. Koninklijke Philips N.V.
7. Wolters Kluwer N.V.
8. Thermo Fisher Scientific Inc.
9. Cepheid
10. Amara Health Analytics
11. Bruker Corporation
12. Luminex Corporation
13. Cerner Corporation
14. Epic Systems Corporation
15. McKesson Corporation
16. GE Healthcare

Recent Developments

• June 2023- Prenosis Inc. received a BARDA contract to study the utility of its sepsis diagnostic tool.
• January 2023- Cytovale®, a medical diagnostics company focused on advancing early detection technologies to diagnose fast-moving and immune-mediated diseases, announced that its IntelliSep® test has received U.S. Food and Drug Administration (FDA) 510(k) clearance to aid in the early detection of sepsis for the approximately 30 million adult patients with signs and symptoms of infection who present to US emergency departments (ED) each year.

Segmentation

1. By Product
   1. Instruments
   2. Blood Culture Media
   3. Assay Kits and Reagents
   4. Software
2. By Technology
   1. Microbiology
   2. Molecular Diagnostics
   3. Immunoassays
   4. Flow Cytometry
3. By Pathogen
   1. Bacterial Sepsis
   2. Gram Positive
   3. Gram Negative
   4. Fungal Sepsis
   5. Others
4. By Testing Type
   1. Laboratory Testing
   2. Point-of-Care Testing