패혈증 진단 시장 평가 : 제품, 기술, 방법, 검사 유형, 병원체, 최종사용자, 지역별 기회 및 예측(2017-2031년)

Global sepsis diagnostics market is projected to witness a CAGR of 8.7% during the forecast period 2024-2031, growing from USD 0.8 billion in 2023 to USD 1.56 billion in 2031F. The market expansion is supported by increasing investments towards sepsis related research activities, rising cases of sepsis, growing prevalence of infectious diseases, development of advanced diagnostic solutions, and increasing initiatives by various governments to spread awareness about sepsis.

The increasing emphasis towards the development of advanced diagnostic solutions can be attributed to rising number of cases related to sepsis. As per the Center for Disease Control and Prevention (CDC), approximately 1.7 million adults in the United States develop sepsis and roughly 2,70,000 dies from it every year. Various major medical diagnostic companies and startups are actively working towards developing advanced diagnostic solutions that can provide the healthcare providers with rapid and accurate results, reducing their burden.

Various research and development activities are also underway by leading research institutions, supporting the sepsis diagnostics market growth. For instance, Assiut University, Asyut, Egypt, is currently conducting an interventional study to validate the performance of PCT and CRP for early differentiation of IFI from bloodstream infections. They also aim to detect systemic infections at an earlier stage with the help of blood culture and biomarkers. The study is expected to reach conclusion in March 2025.

The rising efforts of various governments to promote awareness about the condition due to increased prevalence, coupled with growing investments towards the enhancement of the healthcare ecosystem, is boosting the market demand. Strategic collaborations and rising investments by major market players to foster the development and commercialization of advanced diagnostic tools is further expected to propel market growth.

Increasing Investments Support Sepsis Diagnostics Market Expansion

Rising investments by the leading market players in the development of advanced diagnostic solutions, due to increasing prevalence of sepsis in different regions across the globe, are bolstering the market expansion. In 2023, Proxim Diagnostics Corporation, an innovative company involved with the development of handheld, point-of care diagnostic devices received investment from BioMerieux SA, one of the global leaders in the field of in vitro diagnostics. With the received funds, Proxim aims to complete the development of their profile system, a fully automated and portable immunodiagnostic device that can run a wide range of multiplexed assays. Proxim is also developing several immunoassays for infectious diseases, sepsis, and cardiology that can provide the same level of precision and sensitivity as tests run on centralized equipment. Such efforts are expected to propel the development of advanced diagnostic solutions that offer rapid generation of test results.

Rising Prevalence of Sepsis Boost Market Demand

The increasing prevalence of sepsis in different regions is expected to offer lucrative growth opportunities to the market. According to the UK Sepsis Trust, 2,45,000 individuals are affected by sepsis in the United Kingdom alone, with approximately 48,000 individuals losing their lives to various sepsis-related illnesses every year. The rise in incidences related to sepsis can be attributed to the expansion of the aging population with high predisposing comorbidities, increased requirement for invasive procedures and medical devices, spread of multi-drug resistant pathogens, and frequent utilization of immunosuppression. The condition usually occurs when the immune system overreacts to the infection caused by parasites, bacteria, viruses, or fungi. The immune system starts attacking the patient's organs, resulting in organ failure.

North America Accounts for a Significant Market Share

North America accounts for a significant share of the market owing to the growing adoption of advanced diagnostic solutions, the increasing prevalence of sepsis, and presence of a well-established healthcare system, along with prominent diagnostic companies in the region. According to recent estimates, Canadian Sepsis Foundation projects that one in eighteen deaths in Canada occur due to complications involving sepsis, making it the twelfth leading cause of death in the country.

In 2023, Cytovale, a United States based medical diagnostics company raised USD 84 million in venture capital funding to roll out their emergency room-focused diagnostics for detecting early cases of sepsis. In August 2023, the company announced the first placement of their IntelliSep testing platform. With it, they aim to offer diagnosis to adults displaying the signs of the infection in less than ten minutes. The investment round was joined by backers, including Global Health Investment Corporation and Sands Capital.

Bacterial Sepsis Anticipated to Account for Significant Market Share

The increasing frequency of various surgical procedures is a key factor supporting the growth of the segment. According to the Global Alliance for Infections in Surgery, after the retrospective review of surgical patients at a medical center in the United States, it was reported that sepsis developed in approximately 3.4% of the nearly 25,500 patients that underwent a surgical procedure over a 3.5-year interval. The growth of the segment is also supported by increasing launch of advanced diagnostic devices for the detection of diseases that are caused by this pathogen.

Meanwhile, fungal sepsis accounts for the second largest share of the market. Usually patients with weak/ compromised immune systems are more susceptible to encounter the disease through various fungal infections.

Hospitals and Clinics Expected to Witness Significant Growth

The growth of the segment can be attributed to growing hospitalization of patients with sepsis and increasing requirement for blood culture tests by in-house hospital and clinic laboratories to identify the type of infection. According to the Center for Disease Control and Prevention, 1 in 3 patients who die in a hospital had sepsis over the course of their hospitalization. The growing awareness about the condition is further bolstering the number of patients that are admitted with sepsis, propelling the requirement for sepsis diagnostic devices and software. The rising investments in the healthcare infrastructure and increasing awareness about the convenience offered by sepsis diagnostic tools to healthcare professionals are further aiding the expansion of the segment.

Future Market Scenario (2024 - 2031F)

Various diagnostic start-ups, key market players, and research organizations are actively working on the development of rapid tests to bypass the requirement of culturing patient samples, provide enhanced determination of the nature of the infection, and improve accuracy. For instance, Inflammatix, a California based biotechnology company involved in the development of rapid point-of-care diagnostic tests, is preparing to launch a thirty-minute blood-based test that could help physicians in detecting sepsis and other acute infections in 2024. The test is expected to aid the healthcare providers in differentiating between viral and bacterial infections, while generating risk scores to determine the likelihood of the patient developing severe diseases in the coming days. The Stanford University Spinout intends to launch the TriVerity Acute Infection and Sepsis Test System in the fourth quarter of 2024.

Key Players Landscape and Outlook

Key participants in the sepsis diagnostic market include Becton, Dickinson & Company, BioMerieux SA, F. Hoffmann-La Roche AG, Luminex Corp., and Thermo Fisher Scientific, Inc. The market expansion is supported by increasing FDA approval for novel diagnostic solutions and rising strategic collaborations for development of end-to-end solutions for diagnosing bloodstream infections.

In 2023, Day Zero Diagnostics, a Boston-based infectious disease diagnostics firm, announced partnership with U.K.-based Oxford Nanopore Technologies. The companies aim to develop an integrated diagnostic system by combining their technologies to combat different infections that may lead to sepsis. According to them, the diagnostic system would offer genomic-based antibiotic susceptibility profiling and same day identification without requiring blood culture. The company will combine the sequencing reads from Nanopore's high-throughput, small-format PromethION 2 Solo and Day Zero Diagnostic's artificial intelligence driven antibiotic susceptibility pipeline and Keynome microbial identification.

Table of Contents

1.Research Methodology

2.Project Scope & Definitions

3.Executive Summary

4.Global Sepsis Diagnostics Market Outlook, 2017-2031F

• 4.1.Market Size & Forecast
  • 4.1.1.By Value
  • 4.1.2.By Volume
• 4.2.By Product
  • 4.2.1.Blood Culture Media
  • 4.2.2.Assay Kits and Reagents
  • 4.2.3.Instruments
  • 4.2.4.Software
• 4.3.By Technology
  • 4.3.1.Microbiology
  • 4.3.2.Molecular Diagnostics
  • 4.3.3.Immunoassays
  • 4.3.4.Flow Cytometry
  • 4.3.5.Others
• 4.4.By Method
  • 4.4.1.Conventional
  • 4.4.2.Automated
• 4.5.By Test Type
  • 4.5.1.Laboratory Tests
  • 4.5.2.Point-of-Care Tests
• 4.6.By Pathogen
  • 4.6.1.Fungal Sepsis
  • 4.6.2.Bacterial Sepsis
    • 4.6.2.1.Gram-positive bacteria
    • 4.6.2.2.Gram-negative bacteria
  • 4.6.3.Viral Sepsis
  • 4.6.4.Others
• 4.7.By End-user
  • 4.7.1.Diagnostic Centers
  • 4.7.2.Hospitals & Clinics
  • 4.7.3.Pathology & Reference Laboratories
  • 4.7.4.Research Laboratories & Academic Institutes
  • 4.7.5.Others
• 4.8.By Region
  • 4.8.1.North America
  • 4.8.2.South America
  • 4.8.3.Europe
  • 4.8.4.Asia-Pacific
  • 4.8.5.Middle East & Africa
• 4.9.By Company Market Share (%), 2023

5.Global Sepsis Diagnostics Market Outlook, By Region, 2017-2031F

• 5.1.North America*
  • 5.1.1.Market Size & Forecast
    • 5.1.1.1.By Value
    • 5.1.1.2.By Volume
  • 5.1.2.By Product
    • 5.1.2.1.Blood Culture Media
    • 5.1.2.2.Assay Kits and Reagents
    • 5.1.2.3.Instruments
    • 5.1.2.4.Software
  • 5.1.3.By Technology
    • 5.1.3.1.Microbiology
    • 5.1.3.2.Molecular Diagnostics
    • 5.1.3.3.Immunoassays
    • 5.1.3.4.Flow Cytometry
    • 5.1.3.5.Others
  • 5.1.4.By Method
    • 5.1.4.1.Conventional
    • 5.1.4.2.Automated
  • 5.1.5.By Test Type
    • 5.1.5.1.Laboratory Tests
    • 5.1.5.2.Point-of-Care Tests
  • 5.1.6.By Pathogen
    • 5.1.6.1.Fungal Sepsis
    • 5.1.6.2.Bacterial Sepsis
    • 5.1.6.2.1.Gram-positive bacteria
    • 5.1.6.2.2.Gram-negative bacteria
    • 5.1.6.3.Viral Sepsis
    • 5.1.6.4.Others
  • 5.1.7.By End-user
    • 5.1.7.1.Diagnostic Centers
    • 5.1.7.2.Hospitals & Clinics
    • 5.1.7.3.Pathology & Reference Laboratories
    • 5.1.7.4.Research Laboratories & Academic Institutes
    • 5.1.7.5.Others
  • 5.1.8.United States*
    • 5.1.8.1.Market Size & Forecast
    • 5.1.8.1.1.By Value
    • 5.1.8.1.2.By Volume
    • 5.1.8.2.By Product
    • 5.1.8.2.1.Blood Culture Media
    • 5.1.8.2.2.Assay Kits and Reagents
    • 5.1.8.2.3.Instruments
    • 5.1.8.2.4.Software
    • 5.1.8.3.By Technology
    • 5.1.8.3.1.Microbiology
    • 5.1.8.3.2.Molecular Diagnostics
    • 5.1.8.3.3.Immunoassays
    • 5.1.8.3.4.Flow Cytometry
    • 5.1.8.3.5.Others
    • 5.1.8.4.By Method
    • 5.1.8.4.1.Conventional
    • 5.1.8.4.2.Automated
    • 5.1.8.5.By Test Type
    • 5.1.8.5.1.Laboratory Tests
    • 5.1.8.5.2.Point-of-Care Tests
    • 5.1.8.6.By Pathogen
    • 5.1.8.6.1.Fungal Sepsis
    • 5.1.8.6.2.Bacterial Sepsis
    • 5.1.8.6.2.1.Gram-positive bacteria
    • 5.1.8.6.2.2.Gram-negative bacteria
    • 5.1.8.6.3.Viral Sepsis
    • 5.1.8.6.4.Others
    • 5.1.8.7.By End-user
    • 5.1.8.7.1.Diagnostic Centers
    • 5.1.8.7.2.Hospitals & Clinics
    • 5.1.8.7.3.Pathology & Reference Laboratories
    • 5.1.8.7.4.Research Laboratories & Academic Institutes
    • 5.1.8.7.5.Others
  • 5.1.9.Canada
  • 5.1.10.Mexico

All segments will be provided for all regions and countries covered

• 5.2.Europe
  • 5.2.1.Germany
  • 5.2.2.France
  • 5.2.3.Italy
  • 5.2.4.United Kingdom
  • 5.2.5.Russia
  • 5.2.6.Netherlands
  • 5.2.7.Spain
  • 5.2.8.Turkey
  • 5.2.9.Poland
• 5.3.Asia-Pacific
  • 5.3.1.India
  • 5.3.2.China
  • 5.3.3.Japan
  • 5.3.4.Australia
  • 5.3.5.Vietnam
  • 5.3.6.South Korea
  • 5.3.7.Indonesia
  • 5.3.8.Philippines
• 5.4.South America
  • 5.4.1.Brazil
  • 5.4.2.Argentina
• 5.5.Middle East & Africa
  • 5.5.1.Saudi Arabia
  • 5.5.2.UAE
  • 5.5.3.South Africa

6.Market Mapping, 2023

• 6.1.By Product
• 6.2.By Technology
• 6.3.By Method
• 6.4.By Test Type
• 6.5.By Pathogen
• 6.6.By End-user
• 6.7.By Region

7.Macro Environment and Industry Structure

• 7.1.Supply Demand Analysis
• 7.2.Import Export Analysis
• 7.3.Value Chain Analysis
• 7.4.PESTEL Analysis
  • 7.4.1.Political Factors
  • 7.4.2.Economic System
  • 7.4.3.Social Implications
  • 7.4.4.Technological Advancements
  • 7.4.5.Environmental Impacts
  • 7.4.6.Legal Compliances and Regulatory Policies (Statutory Bodies Included)
• 7.5.Porter's Five Forces Analysis
  • 7.5.1.Supplier Power
  • 7.5.2.Buyer Power
  • 7.5.3.Substitution Threat
  • 7.5.4.Threat from New Entrant
  • 7.5.5.Competitive Rivalry

8.Market Dynamics

• 8.1.Growth Drivers
• 8.2.Growth Inhibitors (Challenges and Restraints)

9.Regulatory Framework and Innovation

• 9.1.Patent Landscape
• 9.2.Regulatory Approvals
• 9.3.Innovations/Emerging Technologies

10.Key Players Landscape

• 10.1.Competition Matrix of Top Five Market Leaders
• 10.2.Market Revenue Analysis of Top Five Market Leaders (in %, 2023)
• 10.3.Mergers and Acquisitions/Joint Ventures (If Applicable)
• 10.4.SWOT Analysis (For Five Market Players)
• 10.5.Patent Analysis (If Applicable)

11.Pricing Analysis

12.Case Studies

13.Key Players Outlook

• 13.1.Becton, Dickinson & Company
  • 13.1.1.Company Details
  • 13.1.2.Key Management Personnel
  • 13.1.3.Products & Services
  • 13.1.4.Financials (As reported)
  • 13.1.5.Key Market Focus & Geographical Presence
  • 13.1.6.Recent Developments
• 13.2.BioMerieux SA
• 13.3.F. Hoffmann-La Roche AG
• 13.4.Luminex Corp.
• 13.5.Thermo Fisher Scientific, Inc.
• 13.6.Abbott Laboratories
• 13.7.Danaher Corporation
• 13.8.Bruker Corporation
• 13.9.Cerner Corporation
• 13.10.GE Healthcare

Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work

14.Strategic Recommendations

15.About Us & Disclaimer