sepsis market insight

DelveInsight’s ‘Sepsis-Market Insights, Epidemiology, and Market Forecast–2030’ report deliver an in-depth understanding of the Sepsis, historical and forecasted epidemiology as well as the Sepsis market trends in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.

The Sepsis market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM Sepsis market size from 2018 to 2030. The Report also covers current Sepsis treatment practice, market drivers, market barriers, SWOT analysis, reimbursement, and market access, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Geography Covered

• The United States
• EU5 (Germany, France, Italy, Spain, and the United Kingdom)
• Japan

Study Period: 2018–2030

Sepsis Disease Understanding and Treatment Algorithm

Sepsis Overview

As per the Sepsis Alliance, Sepsis is the body’s overwhelming and life-threatening response to infection that can lead to tissue damage, organ failure, and death.

In the past, septicemia, blood poisoning, and other vague terminology, meaning different things to different people, were used frequently, hampering attempts to identify septic patients properly. In 1991, a consensus conference developed definitions of Sepsis that linked infection with a systemic inflammatory response—the systemic inflammatory response syndrome (SIRS)—which was defined using simple clinical and laboratory parameters. Although Sepsis detection was challenging, the definition of SIRS was rather unspecific since similar inflammatory responses were seen as part of the physiological response to noninfectious insults, such as surgery and pancreatitis. Besides, the SIRS criteria performed poorly in identifying patients who required critical care and who had significant morbidity and mortality.

These issues led to a recent new consensus definition for Sepsis and septic shock. This international task force defined Sepsis as ‘life-threatening organ dysfunction caused by a dysregulated host response to infection.’ The United States has not adopted these definitions since they have not been tested prospectively. All of the research and improvement in mortality has been based on utilization of the SEP-2 definitions that have been used since 1992 (in all of the clinical research as well as in clinical practice) and its associated screening and early management bundles. One of the greatest concerns is that waiting till the organ dysfunction before intervening makes it harder to treat and more likely to have poor outcomes.

Continued in the report…..

Sepsis Diagnosis

Diagnosis of Sepsis is a differential exercise, where Sepsis suspicion is easily assessed, but confirmation in terms of positive infection and determination of organ dysfunction remains challenging.

Two diagnostic criteria are being used more extensively to identify septic patients in the current scenario, namely SIRS and SOFA, where qSOFA is used as a screening tool to identify patients with increased mortality risk.

As part of the 2016 Society of Critical Care Medicine (SCCM)/European Society of Intensive Care Medicine (ESICM) evaluation of criteria for identifying septic patients, the task force compared traditional SIRS criteria to other methods, including the Logistic Organ Dysfunction System (LODS) and Sequential Organ Failure Assessment (SOFA) scoring. Based on this analysis, the authors recommended SOFA scoring to assess the severity of organ dysfunction in a potentially septic patient.

Continued in the report…..

Sepsis Treatment

Sepsis is a medical emergency; in other words, Sepsis should be treated as quickly and efficiently as possible. Treatment for Sepsis varies, depending on the site and cause of the initial infection, the organs affected, and the extent of any damage. If the patient is diagnosed with Sepsis, the patient is then immediately taken to the hospital. If Sepsis is left untreated, it can lead to septic shock or death in some cases. Sepsis treatment is generally examined under two main headings: appropriate antimicrobial treatment and all-purpose supporting treatment. The treatment for Sepsis includes several antibiotics to fight infection, vasoactive medications to increase blood pressure, insulin to stabilize blood sugar, and painkillers. In severe cases of Sepsis, extracorporeal therapies are also used.

Continued in the report…..

Sepsis Epidemiology  

The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Total Incident Cases of Sepsis, Gender-specific Incident Cases of Sepsis, Severity-specific Incident Cases of Sepsis, and Origin-specific Incident Cases of Sepsis scenario in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom) and Japan from 2018 to 2030.

Key Findings

• In 2020, the total estimated Incident Cases of Sepsis were 3,400,940 cases in the 7MM, which is expected to increase in the forecast period (2021-2030).
• US is the major contributor (55.01%, in 2020) to the incident population of Sepsis in the 7MM, with 1,870,897 cases.
• Out of EU5 countries, Germany had the highest incident cases in 2020 followed by the UK and Spain. France accounted for the least number of cases in 2020.

“From several epidemiology studies, it was observed that the disease is more common in males as compared to females, but this trend is opposite in the US. In EU, and Japan, 50–65% of sepsis cases are contributed by males, and 35–50% of the cases are contributed by females. But in the US, around 49% of the cases are of males, and 51% are of females. Additionally, there are several infections that lead to sepsis, but it has been seen that lung infection, UTI infection, gut infection, and skin infection were the leading four infection sites in patients with sepsis.”

Country-Wise Sepsis Epidemiology

The epidemiology segment also provides the Sepsis epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.

Sepsis Drug Chapters

Sepsis Emerging Drugs

VBI-S: Vivacelle Bio

Vivacelle Bio’s lead candidate, VBI-S is made of small particles of specific lipid called micelles and liposomes to treat hypotension. VBI-S is an intravenously injectable fluid comprised of phospholipid nanoparticles that were specifically designed to shift the biophysical properties of the ’body’s fluid volume in hypovolemic shock, due to Sepsis, from non-survival to survival. In July 2019, the company announced US FDA clearance to enroll patients into a Phase IIa clinical trial of VBI-S to elevate blood pressure in subjects who have shock due to Sepsis. The therapy is currently under Phase II clinical evaluation to treat hypovolemia due to Sepsis/septic shock (Vivacelle Bio Inc., n.d.).

Allocetra: Enlivex Therapeutics

Allocetra is being developed by Enlivex Therapeutics as adjunctive therapy for preventing organ failure and mortality in Sepsis, in combination with existing antibiotics agents. It is designed to offer a true paradigm shift in the quest to solve a complex healthcare challenge. The drug is a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. The diseases such as solid cancers, Sepsis, COVID-19, and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, Allocetra has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening clinical indications that are defined as unmet medical needs, as a stand-alone therapy, or in combination with leading therapeutic agents (Enlivex, n.d.).

In light of the encouraging results of Phase Ib in patients with severe Sepsis, the company planned to initiate a Phase IIb or Phase II/III clinical trial with Allocetra for the treatment of organ dysfunction and failure associated with Sepsis. The company currently intends to enroll up to 100 patients in such a clinical trial. The company also intends, subject to the clinical trial results, to request a conditional marketing authorization from the EMA for this indication.

Further, the company anticipates interim data from the macrophage reprogramming Sepsis phase IIb in Q3 2021.

Products detail in the report…

List to be continued in the report…

Sepsis Market Outlook

According to the World Health Organization (WHO), Sepsis is a syndromic response to infection and is frequently a final common pathway to death from many infectious diseases worldwide. The most important concern in Sepsis is a quick diagnosis and prompt treatment. Patients diagnosed with severe Sepsis are usually placed in the intensive care unit (ICU) of the hospital for special treatment.

The treatment encompasses antibiotics, maintaining blood flow to organs (this may involve getting oxygen and intravenous (IV) fluids), treating the source of the infection, vasopressors. And finally, if organ failures occur, the patient will receive the appropriate supportive care (for example, dialysis for kidney failure, mechanical ventilation for respiratory failure, etc.). Sometimes surgery is required to remove tissue damaged by the infection. In November 2001, the US FDA approved a drug by Eli Lilly and Company, Xigris/drotrecogin alfa (drotrecogin alfa [activated] [DrotAA]) for adults who had severe Sepsis and a high risk of death; however, in 2011, the company withdrew the drug from the market as there were no new safety findings, the study failed to demonstrate that Xigris improved patient survival and which called into question the benefit-risk profile of Xigris and its continued use. Giapreza (angiotensin II), a drug by La Jolla Pharmaceutical Company, got FDA approval in 2017 as a vasoconstrictor indicated to increase blood pressure in adults with septic or other distributive shocks.

Physicians prescribe antibiotics (usually more than one type) based on the type of infection. Broad-spectrum antibiotics are the first-line medications. These antibiotics work against several of the more common bacteria. These are intravenous antibiotics so they can get into the blood system quickly and efficiently. Antibiotics alone would not treat Sepsis, there is also the requirement of fluids. The body needs extra fluids to help keep the blood pressure from dropping dangerously low, causing shock. Ensuring the body has enough fluids allows the organs to function and may reduce damage from Sepsis. While there are several types of IV fluids, some are standard in treating Sepsis. Normal saline is one commonly given fluid. It is a crystalloid fluid. These fluids contain minerals, such as sodium, and are water soluble. Colloids, another type of fluid, are thicker fluids. Colloids given by IV include albumin and dextran. Colloids do not dissolve as quickly as crystalloids. More crystalloid fluid is needed than colloid fluid to achieve the same goal of boosting body-fluid volume, but crystalloids are less expensive.

In addition to this, Extracorporeal therapies are also given, which is done using machines and techniques such as continuous renal replacement therapy (a type of dialysis) or extracorporeal membrane oxygenation, or ECMO (life support). Furthermore, few devices are also used to support the patients' survival in the severe condition, which majorly includes endotracheal tube, intracranial pressure (ICP) monitor, kidney dialysis (renal replacement therapy), ventilators, nasogastric (NG) tube, PreSep(tm) catheter, pulmonary artery catheter, and urinary catheter, respectively.

Continued in the report…..

Key Findings

• The market size of Sepsis in the 7MM was estimated to be USD 2,548 million in 2020.
• According to the estimates, the highest market size of Sepsis was found in the US, followed by the Japan.
• The market size of Antimicrobials, Pressor Agents and Other Immunomodulatory Agents in seven major markets was USD 593.3 million, USD 879.2 million and USD 229.7 million in 2020, respectively.

“The approved drugs for Sepsis are not very much, and in the emerging pipeline it was seen that majority of the drugs in the pipeline failed to show any improvement in the clinical trial. The main reason for the failure of the trials was selection for primary endpoint, but in new trials the primary endpoint was to determine the change observed at the 28-day all-cause mortality rate compared to the placebo control group. The potential therapies that can be launched in the forecasted period, are Fetroja/Fetcroja (Cefiderocol), Recombinant human alkaline phosphatase, Nangibotide (LR12), Adrecizumab, and CYT107. Apart from these few approved therapies are also there, i.e., GIAPREZA (angiotensin II), Vasostrict (vasopressin), Empressin (Argipressin), and Recomodulin (ART-123). The peak share of all these therapies is based on their targeted patient pool (severe Sepsis, septic shock and overall Sepsis).”

The United States Market Outlook

This section provides the total Sepsis market size and; market size by therapies in the United States.

EU-5 Market Outlook

The total Sepsis market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.

Japan Market Outlook

The total Sepsis market size and market size by therapies in Japan are provided.

Sepsis Drugs Uptake

This section focuses on the rate of uptake of the potential drugs recently launched in the Sepsis market or expected to get launched in the market during the study period 2018–2030. The analysis covers the Sepsis market uptake by drugs; patient uptake by therapies; and sales of each drug.  

This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs, and allows the comparison of the drugs based on market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

Sepsis Development Activities

The report provides insights into different therapeutic candidates in Phase II, and Phase III stage. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition, and merger, licensing, and patent details for Sepsis emerging therapies.

Reimbursement Scenario in Sepsis

Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In the report, we consider reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.

Competitive Intelligence Analysis

We perform competitive and market Intelligence analysis of the Sepsis market by using various competitive intelligence tools that include–SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability. 

Scope of the Report

• The report covers the descriptive overview of Sepsis, explaining its causes, symptoms, pathophysiology, genetic basis, and currently available therapies.
• Comprehensive insight has been provided into the Sepsis epidemiology and treatment.
• Additionally, an all-inclusive account of both the current and emerging therapies for Sepsis is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of the Sepsis market; historical and forecasted is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM Sepsis market.

Report Highlights

• The robust pipeline with novel MOA and oral ROA, increasing incidence, effectiveness of drugs as both mono and combination therapy will positively drive the Sepsis market.
• The companies and academics are working to assess challenges and seek opportunities that could influence Sepsis R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
• Major players are involved in developing therapies for Sepsis. The launch of emerging therapies will significantly impact the Sepsis market.
• Our in-depth analysis of the pipeline assets across different stages of development (Phase III and Phase II), different emerging trends and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.

Sepsis Report Insights

• Patient Population
• Therapeutic Approaches
• Sepsis Pipeline Analysis
• Sepsis Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies

Sepsis Report Key Strengths

• 10 Years Forecast
• 7MM Coverage
• Sepsis Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake

Sepsis Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Market Drivers and Barriers
• SWOT analysis

Key Questions

Market Insights:

• What was the Sepsis market share (%) distribution in 2018 and how it would look like in 2030?
• What would be the Sepsis total market size as well as market size by therapies across the 7MM during the forecast period (2021–2030)?
• What are the key findings pertaining to the market across the 7MM and which country will have the largest Sepsis market size during the forecast period (2021–2030)?
• At what CAGR, the Sepsis market is expected to grow at the 7MM level during the forecast period (2021–2030)?
• What would be the Sepsis market outlook across the 7MM during the forecast period (2021–2030)?
• What would be the Sepsis market growth till 2030 and what will be the resultant market size in the year 2030?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights:

• What are the disease risk, burdens, and unmet needs of Sepsis?
• What is the historical Sepsis patient pool in the United States, EU5 (Germany, France, Italy, Spain, and the UK), and Japan?
• What would be the forecasted patient pool of Sepsis at the 7MM level?
• What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Sepsis?
• Out of the above-mentioned countries, which country would have the highest incident population of Sepsis during the forecast period (2021–2030)?
• At what CAGR the population is expected to grow across the 7MM during the forecast period (2021–2030)?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:

• What are the current options for the treatment of Sepsis along with the approved therapy?
• What are the current treatment guidelines for the treatment of Sepsis in the US and Europe?
• What are the Sepsis marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, and efficacy, etc.?
• How many companies are developing therapies for the treatment of Sepsis?
• How many emerging therapies are in the mid-stage and late stages of development for the treatment of Sepsis?
• What are the key collaborations (Industry–Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Sepsis therapies?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Sepsis and their status?
• What are the key designations that have been granted for the emerging therapies for Sepsis?
• What are the 7MM historical and forecasted market of Sepsis?

Reasons to buy

• The report will help in developing business strategies by understanding trends shaping and driving Sepsis.
• To understand the future market competition in the Sepsis market and Insightful review of the key market drivers and barriers.
• Organize sales and marketing efforts by identifying the best opportunities for Sepsis in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom), and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Organize sales and marketing efforts by identifying the best opportunities for the Sepsis market.
• To understand the future market competition in the Sepsis market.