Cytokine Release Syndrome Market Summary

• The Cytokine Release Syndrome Market Size is anticipated to grow with a significant CAGR suign the study period (2020-2034).
• The United States accounts for the largest market share (85%) of the cytokine release syndrome market, in comparison to EU4 (Germany, Spain, Italy, France), the United Kingdom, and Japan.
• Among the emerging drugs, itacitinib is expected to garner the highest Cytokine Release Syndrome market share (51%) by 2034 in the 7MM
• According to Delveinsight’s estimates, Germany holds the second-largest Cytokine Release Syndrome market size among the 7MM, in the forecast period (2024–2034).

Cytokine Release Syndrome Market Insight and Trends

• Cytokine Release Syndrome is an acute systemic inflammatory response characterized by fever and multiple organ dysfunction associated with CAR T-cell therapy, therapeutic antibodies, haploidentical allogeneic transplantation, etc.
• Till now, only one therapy has been approved for Cytokine Release Syndrome treatment, i.e., ACTEMRA (tocilizumab). Apart from this therapy, the treatment also depends on the use of off-labeled drugs.
• Currently, some Cytokine Release Syndrome companies have initiated clinical trials investigating new treatment options. Key Cytokine Release Syndrome companies such as Incyte Corporation (Itacitinib), Sobi Pharma (KINERET), and others are investigating their candidates for the management of Cytokine Release Syndrome in the 7MM.
• Among the emerging Cytokine Release Syndrome drugs, itacitinib is expected to garner the highest Cytokine Release Syndrome market share by 2034 in the 7MM.
• As per DelveInsight’s analysts, the maximum number of CRS cases belong to those that developed from allogeneic transplants. In 2023, approximately 80% of CRS cases developed after allogenic transplants, in the 7MM.

Factors Affecting Cytokine Release Syndrome Market Growth

• Rising use of CAR-T and other T-cell redirecting therapies: Growth and broader approvals of CAR-T and bispecific T-cell engagers increase Cytokine Release Syndrome incidence and demand for Cytokine Release Syndrome management products and services.
• Expanding clinical trial activity in cell & gene therapies: More trials → more patients at risk for CRS → larger market for prophylaxis, diagnostics and therapeutics.
• Established effective treatments (IL-6 pathway drugs) and guidelines: Tocilizumab (anti-IL-6R) is standard for moderate–severe CRS; availability of effective therapies drives adoption of formal CRS management pathways.
• Increased awareness, hospital infrastructure & trained treatment centers: More certified CAR-T centers and trained staff leads to higher treatment capacity (and higher diagnosis/treatment rates for CRS).

DelveInsight's “Cytokine Release Syndrome Market Insights, Epidemiology and Market Forecast – 2034” report delivers an in-depth understanding of cytokine release syndrome, historical and forecasted epidemiology as well as the cytokine release syndrome therapeutics market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

Cytokine release syndrome market report provides real-world prescription pattern analysis, emerging drugs, market share of individual therapies, and historical and forecasted 7MM cytokine release syndrome market size from 2020 to 2034. The report also covers current cytokine release syndrome treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s underlying potential.

Cytokine Release Syndrome Disease Understanding

Cytokine Release Syndrome Overview, Country-Specific Treatment Guidelines and Diagnosis

CRS is a systemic inflammatory response triggered by various factors such as infections and certain drugs causing pathologic over-activation of T cells, leading to hypersecretion of cytokines by T cells and other immune cell types. CRS can also occur after certain types of immunotherapy, such as CAR T-cell therapy, and is sometimes called cytokine storm or cytokine-associated toxicity. CRS is clinically characterized by fever and malaise, which can progress rapidly to capillary leak, hypotension, vasodilatory shock, hypoxia, and death. CRS can range in severity from low-grade constitutional symptoms to a high-grade syndrome associated with severe multi-organ dysfunction. Currently, CRS is more prevalent in patients on immune therapies.

Currently, no established diagnostic criteria for the CRS are available. An accurate approach includes three key findings compatible with clinical symptoms, elevated biomarkers, and recent treatment with any biological agent. Circulating cytokine levels could serve as biomarkers to diagnose and quantify syndrome severity, but this is often costly and may not be readily available in all clinical settings. The liver produces CRP in response to IL-6, so it serves as a reliable surrogate for IL-6 bioactivity. The measurement of CRP is rapid, inexpensive, can be monitored, and is available in most hospitals.

The cytokine release syndrome market report provides an overview of cytokine release syndrome pathophysiology, diagnostic approaches, and detailed treatment algorithm along with a real-world scenario of a patient’s journey beginning from the first symptom, the time taken for diagnosis to the entire treatment process.

Further details related to country-based variations in diagnosis are provided in the report...

Cytokine Release Syndrome Treatment

There is substantial evidence that IL-6, which has both anti-inflammatory and pro-inflammatory properties, is an essential mediator in the signaling cascade of CRS but may also be implicated in the initiation of the antitumor response.

In August 2017, the FDA approved ACTEMRA (tocilizumab) to treat CAR T-cell-induced severe or life-threatening CRS in patients 2 years and older. ACTEMRA is a humanized IL-6 receptor antagonist that functions by inhibiting both classic and trans-IL-6 signaling on immune effector cells.

IL-6 has emerged as a critical cytokine in exacerbating the progression of CRS in T-cell-engaging therapies. Depending on the clinical center, both tocilizumab (IL-6 receptor targeting monoclonal antibody) and siltuximab (chimeric anti-IL-6 monoclonal antibody) have been used to control CRS. The use of corticosteroids following CAR T-cell therapy is reserved for clinical cases where toxicities are refractory to IL-6 targeting therapies. Currently, a standard intervention for CRS consists of dexamethasone 10 mg/kg intravenous (IV) every 6 h or methylprednisolone 1 mg/kg IV every 12 h in moderate to high-grade CRS.

Further details related to country-based variations in treatment are provided in the report...

Cytokine Release Syndrome Epidemiology

The cytokine release syndrome epidemiology chapter in the report provides historical as well as forecasted epidemiology, in the 7MM, covering the United States, EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan from 2024 to 2034. The cytokine release syndrome epidemiology is segmented with detailed insights into Total Incident Cases of CRS, Grade Specific Cases of CRS, CRS Cases by CAR-T Therapies, CRS Cases by Bispecific Antibodies, and CRS Cases by Allogeneic Transplant.

Key Findings from Cytokine Release Syndrome Epidemiological Analyses and Forecast

• In 2023, according to DelveInsight's estimates, Cytokine Release Syndrome cases in the United States accounted for roughly 30% of the total incidence cases (7MM).
• DelveInsight’s consultant estimates that approximately 30% of total Cytokine Release Syndrome cases in the United States, resulted from treatment with CAR-T therapies, in 2023.
• Based on Grade-specific incidence, Grade 3-4 cases constituted approximately 18% of total incident Cytokine Release Syndrome cases, in 2023, in the 7MM.
• Among the EU4 and the UK, Germany had the highest incidence of cases of Cytokine Release Syndrome, followed by France.

Cytokine Release Syndrome Epidemiology Segmentation

• Total Incident Cases of Cytokine Release Syndrome
• Grade Specific Cases of Cytokine Release Syndrome
• Cytokine Release Syndrome Cases by CAR-T Therapies
• Cytokine Release Syndrome Cases by Bispecific Antibodies
• Cytokine Release Syndrome Cases by Allogeneic Transplant.

Recent Developments In The Cytokine Release Syndrome Treatment Landscape 

• In August 2025, the FDA approved an expanded indication for Celltrion’s AVTOZMA® (tocilizumab-anoh) IV to treat cytokine release syndrome in adults and children aged 2 years and older, aligning it with all approved indications of ACTEMRA® IV in the U.S.

Cytokine Release Syndrome Drug Analysis

The drug chapter segment of the cytokine release syndrome market report encloses a detailed analysis of cytokine release syndrome marketed drugs and late-stage (Phase II) pipeline drugs. It also deep dives into the cytokine release syndrome clinical trial details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations.

Cytokine Release Syndrome Marketed Drugs

ACTEMRA/ROACTEMRA (tocilizumab): Genentech

Tocilizumab is a first-in-class anti-IL-6 receptor (aIL-6R) therapy. ACTEMRA/ROACTEMRA is available in both subcutaneous (SC) and intravenous (IV) formulations. In August 2017, the US FDA approved ACTEMRA (tocilizumab) intravenous injection to treat CAR T-cell-induced severe or life-threatening CRS in patients 2 years and older.

Note: Detailed marketed therapies assessment will be provided in the final report...

Cytokine Release Syndrome Emerging Drugs

Itacitinib: Incyte Corporation

Itacitinib is a potent, orally bioavailable, and highly selective inhibitor of Janus kinase (JAK)-1, which mediates the signaling of several inflammatory cytokines. In December 2018, Innovent Biologics (Innovent) and Incyte, through their respective subsidiaries, entered into a strategic collaboration agreement for three clinical-stage product candidates discovered and developed by Incyte - pemigatinib (FGFR1/2/3 inhibitor), itacitinib (JAK1 inhibitor), and parsaclisib (PI3Kδ inhibitor).

KINERET (anakinra): Swedish Orphan Biovitrum (sobi)

Anakinra is a recombinant human interleukin-1 (IL-1) receptor antagonist protein. It is administered through the subcutaneous route and is approved to treat rheumatoid arthritis and cryopyrin-associated periodic syndromes (CAPS). Kite Pharma is developing anakinra in axicabtagene ciloleucel therapy to reduce the occurrence of the side effects - CRS - and neurologic toxicities with relapsed or refractory non-Hodgkin lymphoma (NHL). The company is investigating this combination in a Phase II clinical trial.

Note: Detailed emerging therapies assessment will be provided in the final report...

Cytokine Release Syndrome Market Outlook

Key Cytokine Release Syndrome companies, such as Incyte Corporation, Swedish Orphan Biovitrum (sobi), and others are evaluating their lead candidates in different stages of clinical development, respectively. They aim to investigate their products for the treatment of cytokine release syndrome.

• The United States represents approximately 85% of the Cytokine Release Syndrome market size, surpassing the market size of EU4,  the UK, and Japan.
• Among the emerging drugs, itacitinib is expected to garner the highest market share (51%) by 2034 in the 7MM
• According to Delveinsight’s estimates, Germany holds the second-largest Cytokine Release Syndrome market size among the 7MM, in the forecast period (2024–2034).

Cytokine Release Syndrome Drugs Uptake

This section focuses on the uptake rate of potential Cytokine Release Syndrome drugs expected to be launched in the market during 2024–2034, which depends on the competitive landscape, safety, and efficacy data along with order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.

Further detailed analysis of emerging therapies drug uptake in the report...

Cytokine Release Syndrome Clinical Trial Analysis

The Cytokine Release Syndrome market report provides insights into different therapeutic candidates in the Phase II stages. It also analyzes key Cytokine Release Syndrome companies involved in developing targeted therapeutics.

Cytokine Release Syndrome Pipeline Development Activities

The Cytokine Release Syndrome market report covers information on collaborations, acquisitions and mergers, licensing, and patent details for cytokine release syndrome emerging therapies.

Latest KOL Views on Cytokine Release Syndrome

To keep up with the real-world scenario in current and emerging Cytokine Release Syndrome market trends, we take opinions from Key Industry leaders working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts were contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility.

DelveInsight’s analysts connected with 10+ KOLs to gather insights; however, interviews were conducted with 5+ KOLs in the 7MM. Centers such as Johns Hopkins Hospital, Guy's and St Thomas' NHS Foundation Trust, National Center for Global Health and Medicine, etc., were contacted. Their opinion helps understand and validate current and emerging treatment patterns of cytokine release syndrome. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Cytokine Release Syndrome 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 gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint Analysis analyzes multiple approved and emerging Cytokine Release Syndrome therapies based on relevant attributes such as safety, efficacy, frequency of administration, 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.

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 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.

Cytokine Release Syndrome Market Access and Reimbursement

Medicare does not explicitly have a National Coverage Determination (NCD) that addresses ACTEMRA (tocilizumab). NCD is an evidence-based determination of whether Medicare will pay for an item or service. Also, Local Coverage Determination (LCDs) do not exist for ACTEMRA.

Genentech runs an ACTEMRA Co-pay Card Program that helps eligible commercially insured patients pay as low as USD 5 for the drug. The card has validity for up to USD 15,000 of co-pay assistance within 12 months. It also helps patients by referring to the Medicare Low-Income Subsidy (LIS) program for patients with Medicare Part D. It refers to patients without insurance, medical coverage, or high out-of-pocket costs to Genentech Patient Foundation. The foundation may help the patient with free medication.

The Cytokine Release Syndrome market report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of currently used 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.

Scope of the Cytokine Release Syndrome Market Report

• The report covers a segment of key events, an executive summary, descriptive overview of cytokine release syndrome, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, and disease progression along with country specific treatment guidelines.
• Additionally, an all-inclusive account of both the current and emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
• A detailed review of the cytokine release syndrome market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM cytokine release syndrome market.

Cytokine Release Syndrome Market Report Insights

• Cytokine Release Syndrome Patient Population
• Cytokine Release Syndrome Therapeutic Approaches
• Cytokine Release Syndrome Pipeline Analysis
• Cytokine Release Syndrome Market Size and Trends
• Existing and Future Market Opportunity

Cytokine Release Syndrome Market Report Key Strengths

• Eleven-year Forecast
• 7MM Coverage
• Cytokine Release Syndrome Epidemiology Segmentation
• Inclusion of Country Specific Treatment Guidelines
• KOL’s Feedback on Approved and Emerging Therapies
• Key Cross Competition
• Conjoint Analysis
• Cytokine Release Syndrome Drugs Uptake
• Key Cytokine Release Syndrome Market Forecast Assumptions

Cytokine Release Syndrome Market Report Assessment

• Current Cytokine Release Syndrome Treatment Practices
• Cytokine Release Syndrome Unmet Needs
• Cytokine Release Syndrome Pipeline Product Profiles
• Cytokine Release Syndrome Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)
• Cytokine Release Syndrome Market Drivers
• Cytokine Release Syndrome Market Barriers

Frequently Asked Question on Cytokine Release Syndrome Market Report

• What is the growth rate of the 7MM cytokine release syndrome treatment market?
• What was the cytokine release syndrome market size, the market size by therapies, market share (%) distribution in 2020, and what would it look like in 2034? What are the contributing factors/key catalysts for this growth?
• Is there any unexplored patient setting that can open the window for growth in the future?
• What are the pricing variations among different geographies for approved and off-label therapies?
• How would the market drivers, barriers, and future opportunities affect the Cytokine Release Syndrome market dynamics and subsequent analysis of the associated trends?
• What are the current and emerging options for the treatment of cytokine release syndrome?
• How many Cytokine Release Syndrome companies are developing therapies for the treatment of cytokine release syndrome?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing Cytokine Release Syndrome therapies?
• Patient/physician acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently Cytokine Release Syndrome approved therapies?

Reasons to buy the Cytokine Release Syndrome Forecast Market

• The Cytokine Release Syndrome market report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the cytokine release syndrome market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years
• Understand the existing Cytokine Release Syndrome market opportunities 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 approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identifying strong upcoming Cytokine Release Syndrome companies in the Cytokine Release Syndrome market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging Cytokine Release Syndrome 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 expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders’ perspectives 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 Cytokine Release Syndrome companies can strengthen their development and launch strategy.