Febrile Neutropenia - Market Insight, Epidemiology, and Market Forecast - 2034

Key Highlights:

• Febrile neutropenia, also known as neutropenic fever, is the most frequent and serious complication associated with cancer treatment.
• Neutropenic fever is characterized by either a one-time oral temperature of 101°F (38.3°C) or higher, or a sustained temperature of at least 100.4°F (38°C) for one hour or more, accompanied by an absolute neutrophil count (ANC) below 1500 cells per microliter.
• The Febrile Neutropenia market is projected to grow steadily from 2025 to 2034, driven by the rising global cancer burden, increased use of myelosuppressive chemotherapy, and growing awareness of infection risks in immunocompromised patients. Advancements in prophylactic antimicrobials, granulocyte-colony stimulating factor (G-CSF) therapies, and improved risk stratification approaches-alongside a robust clinical research pipeline-are expected to support continued market expansion and enhance patient outcomes.
• The approvals of ROLVEDON and RYZNEUTA represent important progress in granulocyte colony-stimulating factor (G-CSF) therapies for febrile neutropenia, providing long-acting, patient-centered options that improve infection prevention and help maintain continuity of cancer treatment.
• The febrile neutropenia pipeline remains relatively limited, reflecting ongoing reliance on supportive care over innovative therapies. Most progress centers on optimizing existing granulocyte colony-stimulating factors, with few novel or targeted agents emerging. This highlights a significant unmet need for differentiated treatments, especially for high-risk or treatment-refractory patients.
• Market growth in febrile neutropenia is primarily fueled by rising cancer incidence and widespread chemotherapy use. Advancements in supportive care-including novel antimicrobials, growth factors-and improved diagnostics and personalized strategies are enhancing treatment. However, the growing challenge of antimicrobial resistance continues to complicate effective management.

DelveInsight's comprehensive report titled "Febrile Neutropenia- Market Insights, Epidemiology, and Market Forecast - 2034" offers a detailed analysis of febrile neutropenia. The report presents historical and projected epidemiological data covering total incident cases of Febrile Neutropenia, etiology-specific cases of Febrile Neutropenia, severity-specific cases of Febrile Neutropenia, and treated cases of Febrile Neutropenia. In addition to epidemiology, the market report encompasses various aspects related to the patient population. These aspects include the diagnosis process, prescription patterns, physician perspectives, market accessibility, treatment options, and prospective developments in the market across seven major markets: the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan, spanning from 2020 to 2034.

The report analyzes the existing treatment practices and unmet medical requirements in Febrile Neutropenia. It evaluates the market potential and identifies potential business prospects for enhancing therapies or interventions. This valuable information enables stakeholders to make well-informed decisions regarding product development and strategic planning for the market.

Febrile Neutropenia Overview

Neutropenic fever is defined as a single oral temperature >=101°F (38.3°C) or a sustained temperature >=100.4°F (38°C) for over an hour, accompanied by an absolute neutrophil count (ANC) below 1500 cells/µL. It is considered severe when ANC falls below 500/µL and profound when below 100/µL. In many cases, the exact cause of infection remains unidentified, and the fever is classified as fever of unknown origin (FUO).

Neutropenic fever is the most frequent and serious complication in patients with hematologic cancers or those undergoing chemotherapy. It arises when an immunocompromised patient encounters an infection, often due to weakened immune defenses and damaged barriers like the gastrointestinal or sinus mucosa, allowing pathogens to invade.

Febrile Neutropenia Diagnosis and Treatment Algorithm

Initial evaluation of febrile neutropenia includes a complete blood count to assess neutrophil levels and blood, urine, and throat cultures to identify the infection source. Two sets of blood cultures should be drawn-one from a peripheral vein and one from any central line-before starting empirical broad-spectrum antibiotics. Additional cultures should be taken from any suspected infection site. Chest X-rays are recommended for patients with respiratory symptoms, and stool testing may be needed if diarrhea is present.

Further diagnostic tests may be required for high-risk or unclear cases. Biomarkers like galactomannan or 1, 3-beta-D-glucan (BDG) can aid in diagnosing fungal infections, while procalcitonin may help detect bacterial sepsis. Bronchoalveolar lavage (BAL) fluid may be cultured in patients with unexplained chest infiltrates. Risk stratification tools like MASCC (score >21 = low risk) and CISNE help classify patients based on the likelihood of complications and guide treatment settings.

Management of febrile neutropenia depends on patient risk level. High-risk patients, such as those with prolonged severe neutropenia, organ dysfunction, uncontrolled cancer, or recent immunosuppressive therapy, require immediate intravenous antibiotics within one hour of presentation. Recommended options include cefepime, piperacillin-tazobactam, or carbapenems. Vancomycin is added only if resistant infections are suspected. If fever persists after 4 to 7 days of antibiotics, empiric antifungal therapy is started. Treatment continues until the ANC reaches 500 cells per microliter or the infection is fully resolved.

Low-risk patients can be managed with oral antibiotics like ciprofloxacin plus amoxicillin-clavulanate in the outpatient setting, with close follow-up. Infection prevention includes fluoroquinolone and antifungal prophylaxis in high-risk patients, TMP-SMX for those at risk of Pneumocystis jirovecii pneumonia, and antiviral prophylaxis for herpes simplex and hepatitis B. Annual influenza vaccination is recommended for all patients on chemotherapy. Colony-stimulating factors are advised for those with a 20 percent or higher risk of developing febrile neutropenia.

Febrile Neutropenia Epidemiology

The epidemiology section of the febrile neutropenia market report offers information on the patient populations, including historical and projected trends for each of the seven major markets. Examining key opinion leader views from physicians or clinical experts can assist in identifying the reasons behind historical and projected trends. The diagnosed patient pool, their trends, and the underlying assumptions are all included in this section of the report.

This section also presents the data with relevant tables and graphs, offering a clear and concise view of the incidence of Febrile Neutropenia. Additionally, the report discloses the assumptions made during the analysis, ensuring data interpretation and presentation transparency. This epidemiological data is valuable for understanding the disease burden and its impact on the patient population across various regions.

Key Findings

As per secondary source, Neutropenic fever develops in up to 30% of cancer patients undergoing chemotherapy and affects over 60,000 individuals each year in the United States.

According to the secondary source, Neutropenia is commonly associated with conditions such as HIV infection, acute leukemia, and myelodysplastic syndromes. Drug-induced neutropenia is relatively rare, with an estimated incidence of approximately one case per million individuals annually. Among patients with febrile neutropenia, around 50% will develop an identifiable infection, and approximately 20% of those with profound neutropenia will experience bacteremia.

The epidemiology of Febrile Neutropenia is expected to change during the forecast period (2025-2034).

Febrile Neutropenia Market Outlook

The febrile neutropenia therapeutics market is further expected to increase by the major drivers, such as the rising incidence population, technological advancements, and upcoming therapies in the forecast period (2025-2034).

With ongoing research and continued dedication, the future holds hope for even more effective treatments and, ultimately, a cure for this challenging condition. According to DelveInsight, the Febrile Neutropenia market in the 7MM is expected to change significantly during the forecast period 2025-2034.

Febrile Neutropenia Drug Chapters

Marketed Febrile Neutropenia Drugs

ROLVEDON (eflapegrastim-xnst): Assertio Holdings/Spectrum Pharmaceuticals

ROLVEDON (eflapegrastim-xnst) is a long-acting granulocyte colony-stimulating factor (G-CSF) with a novel formulation. Spectrum has received an indication to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia.

In September 2022, Spectrum Pharmaceuticals, announced that the US FDA has approved ROLVEDON (eflapegrastim-xnst) injection to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia.

In July 2023, Assertio Holdings has announced the completion of its planned acquisition of Spectrum Pharmaceuticals.

RYZNEUTA (efbemalenograstim alfa-vuxw): Evive Biotechnology/Acrotech Biopharma

RYZNEUTA is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. RYZNEUTA is the first non-pegylated granulocyte colony-stimulating factor approved by both the US FDA.

In November 2023, Evive Biotech and Acrotech Biopharma announced that the US FDA has approved RYZNEUTA (efbemalenograstim alfa) for the reduction of infection risk, as indicated by febrile neutropenia, in adult patients with non-myeloid cancers undergoing myelosuppressive chemotherapy associated with a clinically significant risk of febrile neutropenia.

In March 2024, Evive Biotech announced European Commission approval of RYZNEUTA (efbemalenograstim alfa injection) for chemotherapy-induced neutropenia (CIN).

Febrile Neutropenia Market Segmentation

DelveInsight's 'Febrile Neutropenia- Market Insights, Epidemiology, and Market Forecast - 2034' report provides a detailed outlook of the current and future febrile neutropenia market, segmented within countries, by therapies, and by classes. Further, the market of each region is then segmented by each therapy to provide a detailed view of the current and future market share of all therapies.

Febrile Neutropenia Market Size by Countries

The febrile neutropenia market size is assessed separately for various countries, including the United States, EU4 (Germany, France, Italy, and Spain), the UK, and Japan. In 2024, the United States held a significant share of the overall 7MM (Seven Major Markets) febrile neutropenia market, primarily attributed to the country's higher incidence of the condition and the elevated cost of the available treatments. This dominance is projected to persist, especially with the potential early introduction of new products.

Febrile Neutropenia Drugs Uptake

This section focuses on the sales uptake of potential febrile neutropenia drugs that have recently been launched or are anticipated to be launched in the febrile neutropenia market between 2020 and 2034. It estimates the market penetration of febrile neutropenia drugs for a given country, examining their impact within and across classes and segments. It also touches upon the financial and regulatory decisions contributing to the probability of success (PoS) of the drugs in the febrile neutropenia market.

The emerging febrile neutropenia therapies are analyzed based on various attributes such as safety and efficacy in randomized clinical trials, order of entry and other market dynamics, and the unmet need they fulfill in the Febrile Neutropenia market.

Febrile Neutropenia Market Access and Reimbursement

DelveInsight's 'Febrile Neutropenia- Market Insights, Epidemiology, and Market Forecast - 2034' report provides a descriptive overview of the market access and reimbursement scenario of febrile neutropenia.

This section includes a detailed analysis of the country-wise healthcare system for each therapy, enlightening the market access, reimbursement policies, and health technology assessments.

KOL Views

To keep up with current febrile neutropenia market trends and fill gaps in secondary findings, we interview KOLs and SMEs' working in the febrile neutropenia domain. Their opinion helps understand and validate current and emerging therapies and treatment patterns or febrile neutropenia market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the febrile neutropenia unmet needs.

Febrile Neutropenia: KOL Insights

DelveInsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. These KOLs were from organizations, institutes, and hospitals, such as University of Washington, US, University Hospital Cologne, Germany, University of Barcelona, Barcelona, Spain, Institut de Cancerologie, France, Duke University, UK, and Kobe University, Japan, among others.

"Gram-positive bacteria are currently the leading cause of infections in febrile neutropenia, with many cases linked to the use of long-term central venous catheters. While there has been a slight increase in gram-negative infections, the overall ratio of gram-positive to gram-negative organisms causing bacteremia in cancer patients remains around 60 to 40."

"Common strategies to reduce the risk and impact of febrile neutropenia include adjusting the intensity of cytotoxic therapy, administering prophylactic antibiotics, and utilizing myeloid growth factors to promote faster bone marrow recovery. However, each of these interventions carries its own limitations and potential challenges."

"Antibiotic therapy may be continued until the absolute neutrophil count (ANC) reaches at least 500 cells/mm3 or the infection has resolved. If neutropenia persists after completing the appropriate treatment, oral fluoroquinolone prophylaxis can be resumed, provided all signs and symptoms of documented infection have resolved, and continued until bone marrow recovery occurs."

Competitive Intelligence Analysis

We conduct a Competitive and Market Intelligence analysis of the febrile neutropenia market, utilizing various Competitive Intelligence tools such as SWOT analysis and Market entry strategies. The inclusion of these analyses is contingent upon data availability, ensuring a comprehensive and well-informed assessment of the market landscape and competitive dynamics.

Febrile Neutropenia Pipeline Development Activities

The report offers an analysis of therapeutic candidates in Phase II and III stages and examines companies involved in developing targeted therapeutics for febrile neutropenia. It provides valuable insights into the advancements and progress of potential treatments in clinical development for this condition.

Pipeline Development Activities

The report covers information on collaborations, acquisition and merger, licensing, patent details, and other information for emerging febrile neutropenia therapies.

Febrile Neutropenia Report Insights

• Febrile Neutropenia Patient Population
• Therapeutic Approaches
• Febrile Neutropenia Pipeline Analysis
• Febrile Neutropenia Market Size and Trends
• Febrile Neutropenia Market Opportunities
• Impact of Upcoming Therapies

Febrile Neutropenia Report Key Strengths

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

Febrile Neutropenia Report Assessment

• Febrile Neutropenia Current Treatment Practices
• Unmet Needs
• Febrile Neutropenia Pipeline Product Profiles
• Febrile Neutropenia Market Attractiveness

Key Questions:

• How common is febrile neutropenia?
• What are the key findings of febrile neutropenia epidemiology across the 7MM, and which country will have the highest number of patients during the study period (2020-2034)?
• What are the currently available treatments for febrile neutropenia?
• What are the disease risk, burden, and unmet needs of febrile neutropenia?
• At what CAGR is the febrile neutropenia market and its epidemiology is expected to grow in the 7MM during the forecast period (2025-2034)?
• How would the unmet needs impact the febrile neutropenia market dynamics and subsequently influence the analysis of the related trends?
• What would be the forecasted patient pool of febrile neutropenia in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), the UK, and Japan?
• Among EU4 and the UK, which country will have the highest number of patients during the forecast period (2025-2034)?
• How many companies are currently developing therapies for the treatment of febrile neutropenia?

Reasons to buy:

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the febrile neutropenia Market.
• Insights on patient burden/disease incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• To understand the existing market opportunity in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of current treatment in the US, EU4 (Germany, France, Italy, and Spain), 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.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of off-label expensive therapies, and patient assistance programs.
• To understand the perspective of Key Opinion Leaders around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.

Frequently Asked Questions:

1. What are the treatment goals for febrile neutropenia?

The primary goals in treating febrile neutropenia are to promptly control infection, restore neutrophil counts, and prevent complications like sepsis. Management involves early broad-spectrum antibiotics, fever resolution, and immune stabilization to reduce morbidity and hospital stay. Long-term strategies include prophylactic antimicrobials, G-CSF support, and chemotherapy optimization, with a focus on improving quality of life and reducing recurrence.

2. What are the challenges in managing febrile neutropenia?

Managing febrile neutropenia is challenging due to its rapid onset, varied infectious etiologies, and the immunocompromised state of patients. Diagnosis is complicated by nonspecific symptoms and difficulty in identifying the infection source. Long-term management is hindered by chemotherapy-induced bone marrow suppression, rising antimicrobial resistance, and limited access to supportive treatments like G-CSF. Financial burden, poor adherence, and comorbidities further complicate sustained infection control.

3. What are the key factors driving the growth of the febrile neutropenia market?

Key factors driving the growth of the febrile neutropenia market include rising cancer rates, broader use of myelosuppressive chemotherapy, and heightened awareness of infection risks. Advances in long-acting G-CSF, rapid diagnostics, and the availability of biosimilars have improved prevention and access. Increased healthcare investment and favorable reimbursement are also fueling market growth.

4. How will the Febrile Neutropenia Market and Epidemiology Forecast Report benefit the clients?

The report will provide comprehensive insights into the current febrile neutropenia market landscape, emerging therapies, competitive dynamics, regulatory requirements, and market access considerations, enabling informed decision-making, strategic planning, and optimization of business strategies to capitalize on market opportunities and drive growth.