Sepsis Diagnostics Market: Growth, Size, Share, and Trends

Market Growth Outlook Summary

The global sepsis Diagnostics market growth forecasted to transform from USD 634 million in 2024 to USD 890 million by 2029, driven by a CAGR of 7.0%. The market growth is driven ongoing transformation of the US & European health systems towards value-based care, recent advances in biomarker-based diagnostic methods, and technological innovations in molecular diagnostics. For example, at hospitals and emergency care centers, point-of-care sepsis diagnostic methods are being increasingly used for the early detection of multiple organ failures, HAIs, and chronic infections in critically ill patients.

The continued market growth is expected to be driven by the continued digitalization and automation of diagnostic lab workflows, the integration of rapid test kits with routine hospital workflows, the enabling of real-time data management capabilities with EHRs, and the government's worldwide emphasis on reducing mortality rates and improving patient care. Some of the notable startups in this regard include Genemark Diagnostics, QuantuMDx, Seegene, iPath Diagnostics, and Tasso.

Sepsis Diagnostics Market Size, Dynamics & Ecosystem

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Sepsis Diagnostics Market Dynamics

Driver: Increasing hospital-acquired infection incidences

The main driving force for the growth of the sepsis diagnostics market is the rising incidence of Hospital-acquired infections (HAIs). Hospital-acquired infections (healthcare-associated infections) are nosocomially acquired infections that are not present or incubating at the time of admission to a hospital. Globally there is a rapid increase in HAIs, due to which in the coming years the demand for sepsis diagnostic products is also expected to rise. In the US, sepsis is the third most common cause of death in U.S. hospitals affecting 1.7 million people nationwide each year (Source: Centers for Disease Control and Prevention (CDC)).

Restraint: High costs of automated diagnostic devices

The material used in the development of diagnostic devices significantly contribute to the cost of the automated diagnostic devices. For instance, the price of the molecular diagnostic tests is USD 300–3,000 (and above), thus diagnostic devices are too expensive (with advanced materials) to be used on a regular basis (mainly in the developing markets). The price is very high compared to the cost of blood culture tests, priced as low as ~USD 28–35. Further, though in developed countries sepsis diagnosis is relatively common, automated diagnostic devices are still unaffordable in countries with a per capita government healthcare expenditure below USD 50. Government hospitals (especially in emerging nations) and academic research laboratories due to limited budgets, cannot afford such systems.

Opportunity: Rapid diagnostic/POC techniques development for early sepsis diagnosis

The product offering are being expanded by many sepsis diagnostic manufacturers in point of care (POC) technology for rapidly detecting the sepsis, reducing the overall turnaround time of diagnosis. Within three hours in septic shock, the risk of mortality increases by 35% with every one hour delay in antibiotic administration. Thus, increasing the need for the rapid diagnosis of sepsis to reduce the delay of antibiotic therapy among patients with sepsis. Becton Dickinson and Company (US) manufacture blood culturing instruments like BACTEC FX, BACTEC Plus and BacT/Alert which are automated microbial detection systems offering a rapid diagnosis of sepsis in the minimum turnaround time.

Challenge: Dearth of skilled healthcare professionals

The shortage of skilled professionals is a major concern worldwide. Sepsis is a life-threatening condition that needs to be diagnosed and treated at the earliest with the help of skilled healthcare professionals. The lack of trained paramedics affects each phase of patient care— screening patients for the presence of sepsis and sepsis awareness. Only 50% of patients with severe sepsis transported by the EMS system have a paramedic.

Sepsis Diagnostics Market Segmentation & Geographical Spread

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By technology, the blood culture segment accounted for the largest share of sepsis diagnostics industry during the forecast period.

Based on the technology, the sepsis diagnostics is segmented into blood culture, immunoassays, molecular diagnostics, flow cytometry, microfluidics, and biomarkers. Molecular diagnostics is further sub-segmented into PCR, microarray, peptide nucleic acid fluorescent in situ hybridization and DNA sequencing. The blood culture segment accounts for the largest share of the sepsis diagnostics market. The extensive use of blood culture methods for the diagnosis of sepsis and the low cost of microbiology techniques contribute to the large share.

By product, the blood culture media segment of sepsis diagnostics industry is expected to grow at the highest rate during the forecast period.

Based on the product, the sepsis diagnostics is segmented into blood culture media, assays & reagent kits, instruments, and software. In 2024, the blood culture media segment is expected accounted for the largest share of market during the forecast period. The increase in the availability of blood culture media and growing utilization of blood culture media by hospitals & pathology laboratories for the diagnosis of sepsis has led to the growth of the segment.

By pathogen type, the bacterial sepsis segment of sepsis diagnostics industry is expected to witness significant growth during the forecast period.

Based on the pathogen type, the sepsis diagnostics is segmented into bacterial sepsis, fungal sepsis, and other pathogen. The other pathogen segment of the sepsis diagnostics market includes viral sepsis and parasitic sepsis. The bacterial sepsis segment is expected to witness significant growth during the forecast period. the rising prevalence of HAIs and the increasing number of surgical procedures have led to the significant growth and dominance of the segment in the industry in the upcoming years.

North America is expected to be the largest market of sepsis diagnostics industry during the forecast period.

On the other hand, the Asia Pacific market is estimated to register the highest growth rate during the forecast period. North America accounted for a share of 43.4% of the market, followed by Europe with a share of 30.7%.

As of 2023, prominent players in the Sepsis diagnostics market are bioMérieux (France), Becton, Dickinson and Company (US), Danaher Corporation (US), T2 Biosystems (US), QuidelOrtho Corporation (US), F. Hoffmann-La Roche AG (Switzerland), Thermo Fisher Scientific (US), Bruker Corporation (US), Abbott Laboratories (US), Immunexpress (Australia), Axis-Shield Diagnostics (UK), among others.

Scope of the Sepsis Diagnostics Industry

This study categorizes the global sepsis diagnostics market to forecast revenue and analyze trends in each of the following submarkets:

By Technology

• Blood Culture
• Immunoassays
• Molecular Diagnostics
  • PCR
  • Peptide Nucleic Acid-Fluorescent In Situ Hybridization
  • Microarrays
  • DNA sequencing
  • Syndromic Panel-Based Testing
• Flow Cytometry
• Microfluidics
• Biomarkers

By Product

• Blood Culture Media
• Assays & Reagents
• Instruments
• Software

By Method

• Automated Diagnostics
• Conventional Diagnostics

By Pathogen Type

• Bacterial Sepsis
  • Gram-Negative Bacterial Sepsis
  • Gram-Positive Bacterial Sepsis
• Fungal Sepsis
• Other Pathogen

By Test Type

• Laboratory Tests
• Point-of-Care Tests

By End User

• Hospitals and specialty clinics
• Pathology & Reference Laboratories
• Research Laboratories, Academic Institutes & CROs

By Region

• North America
  • US
  • Canada
• Europe
  • Germany
  • France
  • UK
  • Spain
  • Italy
  • RoE
• Asia Pacific
  • China
  • Japan
  • Australia
  • South Korea
  • India
  • RoAPAC
• Latin America
  • Brazil
  • Mexico
  • RoLATAM
• Middle East & Africa
  • GCC Countries
  • Rest of the Middle East & Africa

Recent Developments of the Sepsis Diagnostics Industry

• In April 2023, BioMérieux launched BIOFIRE FIREWORKS, an integrated software solution for BIOFIRE Systems optimizing laboratory services and supporting data-driven decisions.
• In May 2023, Sysmex Corporation launched clinical flow cytometry system Flow Cytometer XF-1600, Sample Preparation System PS-10, antibody reagents, and other related products in Japan.
• In June 2023, T2 Biosystems collaborated with Vanderbilt University Medical Center to implement and evaluate the T2Bacteria Panel for clinical use.

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