The coronavirus disease 2019 has proved to be havoc to health system leaders throughout the world. The healthcare systems across the world are witnessing an advanced health system stretched beyond its capacity. For instance, according to The Society of. Critical Care Medicine, in late 2020 the outbreak of COVID-19 has generated a concern that critically ill patients may overwhelm existing ICU bed availability. If the infection curve is not flattened and the pandemic is concentrated in a 6-month period, that would leave a capacity gap of 1,373,248 inpatient beds and 295,350 ICU beds. This surge in hospital admission for the past year has increased the risk of hospital-acquired infection and the health providers are adopting all the protocols and tests to restrain the infection which is expected to boost the market growth.

The major factors for the growth of the sepsis diagnostics market include the increasing burden of sepsis, the growing burden of hospital-acquired infections, the increasing number of pneumonia cases, the rise in the number of sepsis procedures, and an increase in funding for sepsis-related research activities. Hospital-acquired infections (HAIs) are the most common complications among hospitalized patients. As per the data published by World Health Organization (WHO) in April 2018, sepsis affects more than 30 million people globally and over 6 million deaths every year is caused by sepsis. As per the same data around 3 million new-borns, and 1.2 million children suffer from this condition every year.

In present scenario most of the existing sepsis diagnostic tests can take up to 72 hours or more to process and provide results. Thus, there is a high unmet need of more efficient and rapid diagnostic tests in the market for early diagnosis of this life-threatening condition that could save thousands of lives. Also, there has been increasing regulatory approval and the introduction of technologically advanced diagnostic solutions to leverage unmet opportunities.

For instance, in April 2019, Beckman Coulter Inc., a subsidiary of Danaher Corporation received 510(k) clearance from the United States Food and Drug Administration Approval (FDA) for its Early Sepsis Indicator. Earlier in May 2018, T2 Biosystems, Inc., also received the FDA approval for its T2Bacteria Panel, intended for the detection of specific sepsis-causing bacterial pathogens in human whole blood specimens. Thus, the rise in hospital-acquired infections coupled with robust product development by the players is expected to drive the overall growth of the sepsis diagnosis market over the forecast period. 

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Key Market Trends

Molecular Diagnostics Segment by Technology is Expected to be Fastest Growing over the Forecast Period.

As per the Canadian Medical Association in December 2020, the most common complications associated with COVID-19 were pneumonia, respiratory failure, kidney failure, and sepsis or systemic inflammation, consistent with other studies. The absolute risk of someone with COVID-19 having sepsis was estimated to be approximately 10.4%. Researchers are making effort to develop a molecular diagnostic that can detect the COVID-19 as well as sepsis and also discriminate between the two. In November 2020, the Hellenic Institute for the Study of Sepsis and in part by Sanmina Corporation funded a study and developed a novel optical biosensor for the early diagnosis of sepsis and severe Covid-19. These developments are expected to have a positive impact on the growth of the market.

Sepsis affects significant patient populations in hospitals and is the sixth most common reason for hospitalization. Rapid and accurate profiling of infection-causing pathogens remains a significant challenge in modern healthcare. Finally, identification of the causative pathogen is essential in selecting appropriate antibiotic therapy as part of the treatment. These requirements make molecular diagnostics (MDx) an attractive approach to consider for sepsis diagnostics. Molecular diagnostics have attracted several multinational companies and institutions, owing to their easy feasibility and accuracy in detection methods.

The blood culture analysis for rapid and accurate profiling of infections has been the gold standard for the molecular diagnostic method. However, the cost of molecular diagnostics has remained very high, as compared to conventional procedures, which restricts its market growth. Several companies are investing in point of care molecular diagnostics for early diagnosis of bacterial and viral pathogens and better patient management. For instance, in April 2019, GenMark Diagnostics, Inc. received the FDA clearance for its new panel assay, developed to detect gram-negative bacteria causing sepsis. The well-established healthcare infrastructure with high adoption of advanced diagnostic technologies and rising awareness for early disease diagnosis are expected to drive the growth of the market studied.

North America is Expected to Hold Largest Share of the Market

COVID-19 has increased the overall risk of sepsis among the population. The Global Sepsis Alliance stated that COVID-19 can cause sepsis, in which case, the body’s overwhelming and life-threatening response to an infection that can lead to organ damage and death. In the United States, one in three COVID-19 patients who die in a hospital dies of sepsis. Owing to this high susceptibility of the disease in this region, the market is expected to grow in the future to come.

North America is found to hold a major share of the sepsis diagnostics market and is expected to show a similar trend over the forecast period, without significant fluctuations. According to the CDC statistics in 2018, sepsis affects more than a million Americans every year and leads to 15% to 30% deaths in the United States. Furthermore, the number of cases of sepsis is rising on a yearly basis in the country, due to factors, such as the rise in geriatric population, infections that are incurable by antibiotics, and higher risks of the disease among people who have undergone an organ transplant.

The National Institutes of Health supports many studies that are focused on sepsis, which is evaluating various potential treatments for the disease. CDC launched the ‘Get Ahead of Sepsis’, which is an educational initiative to protect Americans from the effect of sepsis. This initiative calls on healthcare professionals to educate patients, prevent infections, identify and diagnose sepsis at an early stage, and start sepsis treatment fast. Emerging technologies linked with an enhanced understanding of the immature and developing neonatal immune system responses to early infection provide an opportunity to develop critically needed biomarkers to improve early identification in this high-risk population. So, the increasing prevalence of sepsis, along with government initiative may augment the growth of the market studied.

Competitive Landscape

The market studied is moderately consolidated owing to the presence of a few key players. Some of the market players are Abbott, Becton, Dickinson, and Company, bioMérieux SA, Bruker Corporation, F. Hoffmann-LA Roche Ltd, Immunexpress Inc., Luminex Corporation, Response Biomedical Corp., T2 Biosystems, Inc., and Thermo Fisher Scientific. Key players are focusing on organic as well as inorganic strategies to leverage market opportunities.

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