Sepsis Diagnostics Market: Opportunities & Challenges
The sepsis diagnostics market is primarily driven by the rising prevalence of sepsis across the globe. Factors such as the rising geriatric population, growing number of surgical procedures, high incidence of hospital-acquired infections, and the commercialization and availability of a wide variety of approved sepsis diagnostic devices are also supporting the growth of this market. However, lack of established reimbursement policies for sepsis and the high cost of automated diagnostic devices are the major factors restraining the growth of this market.
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Development of rapid diagnostic/POC techniques for early sepsis diagnosis;
Sepsis is a very difficult condition to diagnose as the clinical presentation of sepsis is highly variable depending on etiology. Once the infection sets in, the condition of a patient deteriorates rapidly owing to which early diagnosis is a major area of focus in this market. Mortality rates from sepsis range between 40% to 70% for septic shock and 25% to 30% for severe sepsis (Source: Am Fam Physician. 2013 Jul 1; 88(1):44-53.). Early goal-directed therapy completed within the first six hours of sepsis diagnosis significantly reduces in-hospital mortality. Moreover, early antibiotic therapy helps in improving the clinical outcomes, which leads to improvement in sepsis outcomes, as the risk of mortality increases by 7.6% with a delay of even 1 minute in antibiotic administration in septic shock patients having hypertension. As a result, slower turnaround times of conventional/manual blood culture methods have created a demand for rapid diagnostic techniques providing faster results. The turnaround time of a conventional/manual blood culture method is more than 24 hours. On the other hand, fully automated blood culture systems offer faster turnaround times (4-6 hours) and also reduce labor costs. In addition, these automated systems can be used for large-scale sample handling and easier processing of challenging specimens.
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Lack of standard protocols and awareness for sepsis diagnosis and treatment;
Lack of consensus on the clinical definition of sepsis and low awareness about sepsis among doctors and nurses is a major challenge in this market. Most physicians do not have an adequate understanding of sepsis as its symptoms are similar to other disease conditions; this often leads to incorrect or delayed examination and diagnosis of sepsis. According to a survey conducted among EMS professionals, awareness among these professionals is less than 10% in pre-hospital providers, who require sufficient knowledge to handle sepsis-focused scenarios. This is due to lack of pre-hospital sepsis dispatch and clinical care protocols across various regions (Source: Prehosp Disaster Med. 2013;28:104–6. doi: 10.1017/S1049023X12001744). Moreover, the protocols set for sepsis diagnosis are often impractical to implement; in some cases, the protocols are too detailed to understand the eventualities, whereas, in other cases, they suggest resources, which are unavailable locally. In 2015, according to a survey conducted by the UK Sepsis Trust, only 16% of the community was aware that sepsis was a time-critical medical condition. These findings mirror similar surveys conducted in Germany and the US. Similarly, according to a survey conducted for the Sepsis Alliance only 44% of the Americans had heard of sepsis.
Sepsis diagnosis is a difficult process due to a lack of appropriate standard protocols for the identification of this clinical condition. Moreover, hospital staff does not give much priority to patients with sepsis due to a lack of knowledge about sepsis being a medical emergency. Furthermore, in the US, the sepsis guidelines are considered as performance measures to evaluate the quality of the hospital accreditation or physician care, which is another reason for no compliance with these guidelines. Additionally, with the lack of standard protocols, there is a failure to communicate the risk and symptoms of sepsis between in-house hospital departments during clinical data exchange.
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