Sepsis Market Insight, Epidemiology And Market Forecast - 2034

Key Highlights:

• Sepsis is a severe and potentially fatal condition caused by the body's immune system overreacting to an infection. This excessive immune response leads to organ dysfunction and can harm the body's own tissues and organs. If not promptly recognized and treated, sepsis can escalate to shock, multiple organ failure, and death.
• Someone with sepsis may show symptoms such as a rapid heartbeat or a weak pulse, confusion or disorientation, intense pain or discomfort, fever, chills or feeling very cold, difficulty breathing, and cold, sweaty, or clammy skin.
• According to DelveInsight estimates, sepsis affected approximately 2.4 million people in the US in 2024, highlighting its significant clinical and healthcare burden and the need for improved prevention and management.
• In 2024, among the origin-specific cases, lung infections were the leading cause of sepsis in the US, followed by urinary tract infections, while bloodstream infections accounted for the smallest share.
• Sepsis can result from almost any untreated infection, most commonly bacterial, though viral, fungal, and parasitic infections can also cause it. Common sources include the lungs, urinary tract, abdomen, skin, and brain. While sepsis isn't contagious, some underlying infections may be.
• In 2024, the US sepsis market reached approximately USD 1.7 billion, highlighting the significant clinical and economic burden of the condition.
• In July 2025, Hikma Pharmaceuticals announced that the US FDA had approved TYZAVAN (Vancomycin Injection), a first-of-its-kind, ready-to-infuse vancomycin formulation. This novel product is indicated for the treatment of septicemia in adults and pediatric patients aged one month and older, provided appropriate dosing can be achieved.
• In May 2025, The Journal of Critical Care published favorable findings from a prespecified, biomarker-guided subgroup analysis of AdrenoMed's Phase II AdrenOSS-2 trial in patients with septic shock.
• Sepsis pipeline therapies such as VBI-S (Vivacelle Bio), Enibarcimab (AdrenoMed), ZEVTERA (Ceftobiprole Medocaril, Basilea Pharmaceutica), and others highlight cutting-edge approaches, from new antibiotics to immune-focused treatments, designed to enhance outcomes in sepsis care.

Report Summary

• The report offers extensive knowledge regarding the epidemiology segments and predictions, presenting a deep understanding of the potential future growth in diagnosis rates, disease progression, and treatment guidelines. It provides comprehensive insights into these aspects, enabling a thorough assessment of the subject matter.
• Additionally, an all-inclusive account of the current management techniques and emerging therapies and the elaborative profiles of late-stage (Phase III and Phase II) and prominent therapies that would impact the current treatment landscape and result in an overall market shift has been provided in the report.
• The report also encompasses a comprehensive analysis of the sepsis market, providing an in-depth examination of its historical and projected market size (2020-2034). It also includes the market share of therapies, detailed assumptions, and the underlying rationale for our methodology. The report also includes drug outreach coverage in the US region.
• The report includes qualitative insights that provide an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, including experts from various hospitals and prominent universities, patient journey, and treatment preferences that help shape and drive the US Sepsis market.

Sepsis Drug Chapters

The section dedicated to drugs in the sepsis report provides an in-depth evaluation of late-stage pipeline drugs (Phase III and Phase II) related to sepsis. The drug chapters section provides valuable information on various aspects related to clinical trials of sepsis, such as the pharmacological mechanisms of the drugs involved, designations, approval status, patent information, and a comprehensive analysis of the pros and cons associated with each drug. Furthermore, it presents the most recent news updates and press releases on drugs targeting sepsis.

Marketed Therapies

TYZAVAN (vancomycin): Hikma Pharmaceuticals

TYZAVAN is a glycopeptide antibiotic indicated for treating septicemia, as well as infective endocarditis, skin and soft tissue infections, bone infections, and lower respiratory tract infections in adults and pediatric patients aged one month and older, when appropriate dosing with this formulation is possible.

The name TYZAVAN, short for "time-saving vancomycin," highlights its goal of providing fast and straightforward treatment when time is critical. It is the only FDA-approved vancomycin product on the market that can be stored at room temperature and requires no compounding, thawing, activation, or dilution-streamlining preparation and enabling quicker administration.

In July 2025, Hikma Pharmaceuticals announced the approval of a novel formulation of the first-of-its-kind, ready-to-infuse formulation of vancomycin, under the brand name TYZAVAN.

Emerging Therapies

VBI-S: Vivacelle Bio

VBI-S is Vivacelle Bio's lead Phase III candidate for hypovolemic septic shock. Using patented phospholipid nanoparticle technology, it redistributes nitric oxide to raise blood pressure, improve organ perfusion, and support recovery. Its room-temperature stability makes it practical for use across diverse healthcare settings.

A Phase II trial of VBI-S demonstrated 100% efficacy, with the treatment resulting in elevated blood pressure in hypovolemic septic shock patients who are refractory to therapy. In addition to venture capital, Vivacelle has garnered backing and financial support from the US Department of Defense and the National Institutes of Health.

In September 2024, Vivacelle Bio announced the enrollment of the first patient in a Phase III trial for its lead therapy, VBI-S, a phospholipid nanoparticle-based treatment targeting both absolute and relative hypovolemia caused by septic shock. The company also launched six trial sites for the study.

Enibarcimab: AdrenoMed

Enibarcimab (formerly Adrecizumab) is a humanized, non-neutralizing monoclonal antibody directed against Adrenomedullin (ADM), a key mediator of vascular integrity. By binding to ADM, it elevates circulating levels of bioactive ADM, thereby strengthening endothelial function and mitigating sepsis-related vascular leakage.

Enibarcimab, a first-in-class therapy, aims to restore vascular stability in septic shock by addressing a key mechanism responsible for organ failure and death. Its development utilizes a precision medicine approach, using biomarker-guided patient selection. AdrenoMed is also preparing a confirmatory Phase IIb/III clinical trial to confirm the reduced septic shock mortality under enibarcimab treatment employing a precision medicine approach

In April 2024, AdrenoMed was granted US FDA Fast Track Designation (FTD) for Enibarcimab as a treatment for septic shock.

Sepsis Market Outlook

During the forecast period (2025-2034), pipeline candidates such as VBI-S (Vivacelle Bio), Enibarcimab (AdrenoMed), ZEVTERA (Ceftobiprole Medocaril, Basilea Pharmaceutica), and others are expected to drive the rise in sepsis market size.

• In 2024, antimicrobials remained central to sepsis therapy, with B-lactams and carbapenems dominant, while stewardship, resistance, and combination use shaped treatment trends.
• In 2024, pressor agents like norepinephrine etc. hold approximately 30% share among patients on sepsis treatment in the US market, reflecting their key role in hemodynamic support.
• TYZAVAN entered the sepsis market in 2025 as a ready-to-infuse vancomycin, projected to gain steady growth by meeting hospital demand for safer and more efficient antimicrobial solutions.

The sepsis market is limited by few approved treatments and high unmet need. However, pipeline innovation and rising awareness are expected to drive modest growth and improve future therapeutic options. Even though it is too soon to comment on the above-mentioned promising candidate to enter the market during the forecast period (2025-2034), it is safe to assume that the future of this market is bright. Eventually, these drugs will create a significant difference in the landscape of sepsis in the coming years. The treatment space is expected to experience a significant positive shift in the coming years owing to the improvement in healthcare spending worldwide.

Sepsis Understanding and Treatment

Sepsis Overview

Sepsis is a critical, life-threatening condition that occurs when the body's response to an infection becomes harmful, leading to damage of vital organs and potentially resulting in death. It represents an excessive and toxic immune reaction to infection. Similar to a heart attack or stroke, sepsis is a medical emergency that demands immediate diagnosis and treatment. If not managed promptly, it can progress to severe sepsis or septic shock.

While sepsis can affect anyone, some groups are at greater risk. These include adults over 65, individuals with chronic health conditions like kidney disease, diabetes, lung disease, or cancer, and those with weakened immune systems due to medications or HIV/AIDS. Others at higher risk include people recently hospitalized or seriously ill, those with a history of sepsis, infants under one year old, and pregnant women experiencing complications during pregnancy or childbirth.

Sepsis Diagnosis

Sepsis is primarily diagnosed through clinical evaluation, supported by lab and microbiological findings. It reflects a dysregulated immune response to infection, leading to systemic inflammation and organ dysfunction. Because there's no single definitive test, diagnosis relies on vital signs, lab markers (e.g., lactate, creatinine, bilirubin), and cultures, particularly blood cultures, though these can be negative or contaminated in many cases. Early detection tools like SIRS and qSOFA are used, though each has limitations, and no gold standard currently exists.

A thorough sepsis workup includes evaluating systemic signs (fever, tachycardia, abnormal WBC), organ dysfunction (e.g., low platelets, elevated INR, lactate), and identifying infection sources via imaging and cultures. Key tests include CBC, CMP, lactate, coagulation panels, and imaging (e.g., chest X-ray, CT, MRI). Additional tests like procalcitonin and CRP may support diagnosis. The Sepsis-2 criteria and SEP-1 core measures guide clinicians in assessing organ dysfunction and severity.

Sepsis Treatment

Effective management of sepsis and septic shock requires early recognition and rapid intervention, following evidence-based guidelines like those from the Surviving Sepsis Campaign (SSC). Key components include prompt initiation of broad-spectrum intravenous antibiotics-ideally within one hour-after obtaining blood cultures, fluid resuscitation with crystalloids, and hemodynamic support using vasopressors like norepinephrine to maintain a MAP of 65 mmHg. Additional agents, such as vasopressin or epinephrine, may be added in refractory cases or when cardiac dysfunction is present. Antifungals are used when invasive fungal infection is suspected, and combination therapy may be needed for patients at risk of multidrug-resistant organisms.

Adjunctive therapies like corticosteroids are considered in septic shock unresponsive to fluids and vasopressors, with hydrocortisone (200 mg/day) being the standard. Steroids enhance vascular tone and support circulating volume through glucocorticoid and mineralocorticoid effects. Emerging adjuncts, including vitamin C and thiamine, have shown potential in reducing mortality and organ failure when used alongside steroids, as demonstrated in studies. These therapies aim to modulate immune responses and correct metabolic imbalances common in severe sepsis.

Sepsis Epidemiology

The sepsis epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by incident cases, origin-specific cases, gender-specific cases, severity-specific cases, total treated cases and refractory cases of sepsis in the United States from 2020 to 2034.

• In 2024, sepsis without organ dysfunction accounted for the majority of severity-specific cases in the US, representing about 60% of patients, followed by severe sepsis and septic shock.
• In 2024, roughly 2.4 million sepsis cases were treated in the US, highlighting its significant clinical and economic impact.
• In 2024, around 350 thousand refractory sepsis cases in the US highlighted a high-need patient population requiring advanced therapies.

KOL Views

To stay abreast of the latest trends in the market, we conduct primary research by seeking the opinions of Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) who work in the relevant field. This helps us fill any gaps in data and validate our secondary research.

We have reached out to industry experts to gather insights on various aspects of sepsis, including the evolving treatment landscape, patients' reliance on conventional therapies, their acceptance of therapy switching, drug uptake, and challenges related to accessibility. The experts we contacted included medical/scientific writers, professors, and researchers from prestigious universities in the US.

Our team of analysts at Delveinsight connected with more than 10 KOLs across the US. We contacted institutions such as the University of Pittsburgh, the Ohio State University, etc., among others. By obtaining the opinions of these experts, we gained a better understanding of the current and emerging treatment patterns in the sepsis market, which will assist our clients in analyzing the overall epidemiology and market scenario.

Qualitative Analysis

We perform Qualitative and Market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, designation, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

In efficacy, the trial's primary and secondary outcome measures are evaluated; for instance, in trials for sepsis, one of the most important primary endpoints was achieving Sepsis Support Index (SSI), Sequential Organ Failure Assessment (SOFA) score, Mean Arterial Blood Pressure (MAP), etc. Based on these, the overall efficacy is evaluated.

Further, the therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

Because newly authorized drugs are often expensive, some patients escape receiving proper treatment or use off-label, less expensive prescriptions. Reimbursement plays a critical role in how innovative treatments can enter the market. The cost of the medicine, compared to the benefit it provides to patients who are being treated, sometimes determines whether or not it will be reimbursed. Regulatory status, target population size, the setting of treatment, unmet needs, the number of incremental benefit claims, and prices can all affect market access and reimbursement possibilities.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Sepsis Report Insights

• Patient Population
• Therapeutic Approaches
• Sepsis Market Size and Trends
• Existing Market Opportunity

Sepsis Report Key Strengths

• Ten-year Forecast
• The US Coverage
• Sepsis Epidemiology Segmentation
• Key Cross Competition

Sepsis Report Assessment

• Current Treatment Practices
• Reimbursements
• Market Attractiveness
• Qualitative Analysis (SWOT, Conjoint Analysis, Unmet needs)

Key Questions:

• Would there be any changes observed in the current treatment approach?
• Will there be any improvements in sepsis management recommendations?
• Would research and development advances pave the way for future tests and therapies for sepsis?
• Would the diagnostic testing space experience a significant impact and lead to a positive shift in the treatment landscape of sepsis?
• What kind of uptake will the new therapies witness in the coming years in sepsis patients?