The immune system releases certain inflammatory chemicals to fight against microbial infections like dysentery, hepatitis and others however, when these chemicals start acting against body’s own tissues and organs it leads to a condition known as sepsis. The three stages of sepsis include sepsis, severe sepsis, and the final stage of septic shock. Sepsis has a high mortality and morbidity rate. For instance, according to an article published by the National Center for Biotechnology Information in February 2019, it is estimated that the mortality rate of sepsis is 25–30%. Sepsis caused by bacteria involves cascade of reactions such as lack of oxygen supply to cells, inactivation of immune complexes involved in the clearance of bacteria and bacterial particles which further progresses to multiple organ failure.
Global Sepsis Diagnostics Market - Impact of the Coronavirus (COVID-19) Pandemic
Coronavirus (COVID-19) outbreak was first reported on December 31, 2019, in Wuhan, China. The World Health Organization declared COVID-19, as pandemic on March 11, 2020.
For instance, according to the Coronavirus (COVID-19) Weekly Epidemiological Update by the World Health Organization, over 180,492,131 cases and 3,916,771 deaths due to coronavirus disease (COVID-19) were reported till June 27, 2021, across the globe.
Impact of COVID-19 on Demand and Supply of Sepsis Diagnostics
The COVID-19 pandemic and lockdown in various countries across the globe have negatively impacted the financial status of businesses across all sectors. The biotechnology sector is one such sector which has been majorly impacted by the pandemic.
However, the demand for sepsis diagnostics is increasing in this COVID-19 pandemic owing to rising number of COVID-19 cases reported. For instance, according to a study published by the Global Sepsis Alliance in April 2020, more than 30% of COVID-19 patients reported sepsis related liver injury and 75% patients were observed to have a depressed immune system in the U.S. The study also revealed that sepsis is one of the most critical cause of death amongst COVID-19 patients as all the patients who succumbed to COVID-19 infection had sepsis and around 70% of non-survivors had septic shock.
Moreover, in November 2020, the Hellenic Institute, a Greek health organization and Sanmina Corporation, a U.S. based electronics manufacturer funded a study to develop a novel optical biosensor (OB) point-of-care (POC) device for detection of severe COVID-19 infection and sepsis. Furthermore, according to an investigational study published by BMC (Biomedcentral) Infectious Diseases Journal in November 2020, at the first phase, the specificity and positive predictive value of this OB diagnostic device was 100% for sepsis diagnosis. At the second phase, the specificity was 87.5% and positive predictive value was 91.7%. The sensitivity of OB point-of-care device was estimated to be 83.3% for diagnosis of severe COVID-19 infection. Such developments are expected to have a positive impact on the growth of the market. Thus, COVID-19 pandemic is expected to drive the growth of the global sepsis diagnostics market over the forecast period.
The global sepsis diagnostics market is estimated to be valued at US$ 702.2 Mn in 2021, and is expected to exhibit a CAGR of 9.6% over the forecast period (2021-2028).
|Base Year:||2020||Market Size in 2021:||US$ 702.2 Mn|
|Historical Data for:||2017 to 2020||Forecast Period:||2021 to 2028|
|Forecast Period 2021 to 2028 CAGR:||9.6%||2028 Value Projection:||US$ 1,334.0 Mn|
BioMérieux SA, Thermo Fisher Scientific, Abbott Laboratories, Roche Diagnostics AG, Luminex Corporation, CytoSorbents Corporation, Becton Dickinson Company, Danaher Corporation, Axis-Shield Diagnostics, T2 Biosystems, EKF Diagnostics, Immunexpress Inc., Response Biomedical Corporation, and Bruker Corporation
|Restraints & Challenges:||
Figure 1: Global Sepsis Diagnostics Market Share (%) Analysis, By Product Type, 2021
The increasing number of product launches and approvals is the major factor which is expected to drive the market growth over th e forecast period.
The rising product launches and approvals is expected to drive the growth of the global sepsis diagnostics market over the forecast period. For instance, in April 2019, Beckman Coulter Inc., a U.S. based biomedical testing solutions provider received the U.S Food and Drug Administration 510k clearance for its product Early Sepsis Indicator for diagnosis of sepsis at earlier stages of the infection.
The rising number of cases of infectious diseases such as pneumonia, cholera, toxic shock syndrome, salmonellosis, COVID-19, and others is expected to drive the growth of the global sepsis diagnostics market over the forecast period. For instance, according to the World Health Organization fact sheet published in February 2021, around 1.3-4.0 million cases of cholera are reported every year worldwide. Moreover, according to a research study published by NCBI (National Center for Biotechnology Information) in November 2020, the prevalence of toxic shock syndrome is estimated to be approximately 0.8 to 3.4 per 100,000 in the U.S.
Furthermore, governments of various countries are taking initiatives for raising funds and creating awareness about sepsis is expected to aid in the growth of the global sepsis diagnostics market over the forecast period. For instance, in 2018, the government of Scotland collaborated with Sepsis Research FEAT (The Fiona Elizabeth Agnew Trust), a charitable trust to initiate a fund raising campaign across the country to raise awareness about sepsis.
Global Sepsis Diagnostics Market – Restraints
However, growth of the global sepsis diagnostics market may be hampered, owing to lack of skilled professionals in developing countries such as Bangladesh, Niger, Kenya and others, as the collection and analysis of clinical sample for diagnosis of sepsis requires laboratory skills and knowledge. For instance, according to an article published in Young Scientist Journal in April 2018, the sub-Saharan Africa faces a critical shortage of healthcare workers due to lack of medical graduates, emigration of healthcare professionals and lack of proper healthcare infrastructure which acts as a restraint for development of public health system in that region. Sub-Saharan Africa region is considered to have the weakest healthcare system in the world. Such limitations are expected to hamper the growth of the global sepsis diagnostics market over the forecast period.
Global Sepsis Diagnostics Market – Regional Analysis
On the basis of region, the global sepsis diagnostics market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa.
Among regions, North America is expected to hold dominant position in the global sepsis diagnostics market over the forecast period, owing to rising number of product launches and approvals. For instance, in April 2019, GenMark Diagnostics, Inc. received the U.S. FDA approval for its new panel assay which is used for detection of gram-negative bacteria causing sepsis. Moreover, in April 2019, Becton, Dickinson and Company, a U.S. based biomedical technology company launched it new product BD BACTEC anaerobic platelet media used for identification of contaminated platelet units and decrease the incidences of sepsis in patients receiving platelet transfusion.
Figure 2: Global Sepsis Diagnostics Market Value (US$ Mn), by Region, 2021
Global Sepsis Diagnostics Market – Competitive Landscape
Major players operating in the global sepsis diagnostics market include BioMérieux SA, Thermo Fisher Scientific, Abbott Laboratories, Roche Diagnostics AG, Luminex Corporation, CytoSorbents Corporation, Becton Dickinson Company, Danaher Corporation, Axis-Shield Diagnostics, T2 Biosystems, EKF Diagnostics, Immunexpress Inc., Response Biomedical Corporation, and Bruker Corporation.
Sepsis is a condition wherein the body’s response to infection trigger an inflammation reaction throughout the body. Immune system releases inflammatory chemicals into the bloodstream to clear out pathogens from the body but instead these chemicals cause cascade of reactions that result in organ damage and may be fatal. Few of the symptoms of sepsis include low blood pressure, mental confusion, fever, increased heart rate, and difficulty in breathing. Sepsis may be caused by infectious agents such as bacteria, virus, and fungi. Several factors that increase the risk of sepsis include old age, diabetes, liver disease, use of antibiotics, and usage of invasive medical devices such as catheters.
Market players are conducting clinical trials for developing more efficient diagnostic systems for sepsis, which could contribute to the growth of the market over the forecast period. For instance, in February 2020, Inflammatix, Inc., a U.S. based diagnostics company initiated clinical trial study for their product HostDx Sepsis with 1500 participants which is expected to be completed by November 2021. This clinical study investigates the performance of HostDx Sepsis diagnostic test in the diagnosis and prognosis of patients with suspected sepsis.
Market players are focusing on launch of products, which is expected to strengthen their position in the global sepsis diagnostics market. For instance, in July 2018, Thermo Fisher Scientific Inc., a U.S. based diagnostics solutions provider launched its product B·R·A·H·M·S PCT which is a direct POC (Point of Care) assay for early detection of sepsis.
Market players are involved in expanding their presence globally, by entering into collaboration with other companies in order to enhance distribution, this is expected to drive the growth of the global sepsis diagnostics market. For instance, in May 2020, BARDA (Biomedical Advanced Research and Development Authority) and Beckman Coulter Inc., a U.S. based biomedical testing solutions provider entered into a strategic collaboration for development of a diagnostic algorithm for early detection of sepsis in COVID-19 patients.
Key features of the study:
“*” marked represents similar segmentation in other categories in the respective section.