Cytokine Release Syndrome - Market Insight, Epidemiology And Market Forecast - 2032

Cytokine Release Syndrome - Market Insight, Epidemiology And Market Forecast - 2032

DelveInsight's ""Cytokine Release Syndrome (CRS)- Market Insights, Epidemiology, and Market Forecast-2032"" report delivers an in-depth understanding of the cytokine release syndrome, historical and forecasted epidemiology as well as the cytokine release syndrome market trends in the United States, the EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.

The cytokine release syndrome market report provides current treatment practices, emerging drugs, cytokine release syndrome market share of the individual therapies, and current and forecasted cytokine release syndrome market size from 2019 to 2032 segmented by seven major markets. The report also covers current cytokine release syndrome treatment practice/algorithm, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Geography Covered

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

Study Period: 2019–2032

Cytokine Release Syndrome (CRS) Understanding and Treatment Algorithm

The DelveInsight’s cytokine release syndrome epidemiology report gives a thorough understanding of cytokine release syndrome. Cytokine release syndrome 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.

Symptoms of CRS are caused by a widespread immune response affecting different organ systems in the body. The symptoms range from mild, flu-like symptoms to severe life-threatening manifestations of the overshooting inflammatory response. Mild symptoms include fever, fatigue, headache, rash, arthralgia, and myalgia. Severe symptoms include hypotension as well as high fever and can progress to an uncontrolled systemic inflammatory response with vasopressor-requiring circulatory shock, vascular leakage, disseminated intravascular coagulation, and multi-organ system failure.

The pathophysiology of CRS is incompletely understood. CRS usually occurs due to on-target effects induced by binding of the bispecific antibody or CAR T-cell receptor to its antigen and subsequent activation of bystander immune cells and non-immune cells, such as endothelial cells. Activation of the bystander cells results in the massive release of a range of cytokines. The initial activation of CAR T cells results in the distortion of the cytokine network driving the inflammatory process in CRS is unknown (Shimabukuro-Vornhagen et al., 2018).

Currently, no established diagnostic criteria for the CRS are available. An accurate approach included three key findings: compatible clinical symptoms, elevated biomarkers, and recent treatment with any biological agent. Clinically, CRS patients present with unspecific syndromes making the diagnosis challenging. It is important to distinguish CRS from other inflammatory disorders that present with similar clinical signs and symptoms but require different treatment.

Treatment

There is very little evidence-based data regarding the management of CRS. Currently, no guidelines are available for the standard treatment and it is solely based on the experience of a small group of individuals.

Tocilizumab, a humanized monoclonal immunoglobulin G1k antibody that binds to soluble and membrane-bound IL-6 receptors thereby inhibiting IL-6 signaling, is the only FDA-approved drug for the treatment of severe or life-threatening CRS (Varadarajan et al., 2020).

Depending on the clinical center both tocilizumab (IL-6R targeting monoclonal antibody) and siltuximab (chimeric anti-IL-6 monoclonal antibody) have been used to control CRS. Considering approval of tocilizumab for CRS management by both the US FDA and EMA, there have been concerns about the possible elevation of IL-6 due to blockade of the receptor that subsequently leads to accumulation of this effector cytokine in the CNS. Therefore, the prospect of siltuximab being included to intervene in CRS is probable based on the rationale that it can lead to a favorable outcome in cases of passive diffusion of IL-6 into the CNS. Currently, the greater effectiveness of siltuximab over tocilizumab is highly debatable, and these concerns highlight the need for direct comparative studies that elucidate the efficacy of tocilizumab and siltuximab.

Cytokine Release Syndrome (CRS) Epidemiology

The cytokine release syndrome epidemiology division provides insights about the historical and current cytokine release syndrome patient pool and forecasted trends for every seven major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This report also provides the diagnosed patient pool and their trends along with assumptions undertaken.

Key Findings

The disease epidemiology covered in the report provides a historical as well as cytokine release syndrome epidemiology scenario in the 7MM covering the United States, the EU5 countries (Germany, Spain, Italy, France, and the United Kingdom), and Japan from 2019 to 2032.

In the year 2021, the total incident cases of cytokine release syndrome were 48,853 in the 7MM which are expected to grow during the study period, i.e., 2019–2032.

The disease epidemiology covered in the report provides historical as well as forecasted cytokine release syndrome epidemiology (segmented as Total Incident Cases of Cytokine Release Syndrome, Grade-specific cases of Cytokine Release Syndrome (CRS), Cytokine Release Syndrome Cases by CAR-T Therapies, Cytokine Release Syndrome Cases by Bispecific Antibodies, and Cytokine Release Syndrome Cases by Allogenic Transplant in the 7MM covering the United States, the EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2019 to 2032.

Country Wise- Cytokine Release Syndrome (CRS) Epidemiology

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

According to the DelveInsight, in the year 2021, the total incident cases of cytokine release syndrome were 11,559 in the United States which are expected to grow during the study period, i.e., 2019–2032.

The highest number of total incident cases of cytokine release syndrome was observed in Germany among the EU5 countries with 8,222 cases in 2021 which are expected to grow during the study period, i.e., 2019–2032.

In the year 2021, the total incident cases of cytokine release syndrome were 3,792 in Japan which are expected to grow during the study period, i.e., 2019–2032.

Cytokine Release Syndrome (CRS) Drug Chapters

The drug chapter segment of the cytokine release syndrome report encloses the detailed analysis of cytokine release syndrome marketed drugs and late-stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the cytokine release syndrome clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.

Emerging Drugs

The report provides the details of the emerging therapies under the late and mid-stage of development for cytokine release syndrome treatment.

Cytokine Release Syndrome (CRS) Market Outlook

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. In light of the approval of Actemra (tocilizumab) for management of CRS by both the US FDA and European Medicines Agency, there have been concerns raised about the possible elevation of IL-6 due to blockade of the receptor that subsequently leads to accumulation of this effector cytokine in the CNS. Therefore, the prospect of siltuximab being included to intervene in CRS is probable based on the rationale that it can lead to a favorable outcome in cases of passive diffusion of IL-6 into the CNS. Currently, the greater effectiveness of siltuximab over tocilizumab is highly debatable, and these concerns highlight the need for direct comparative studies that elucidate the efficacy of tocilizumab and siltuximab. Nevertheless, strategies to target IL-6 have been particularly effective in alleviating CAR T-cell-mediated CRS and will continue to be used as a component of the first-line treatment.

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. Despite existing reservations about broad immunosuppression as well as impairment of T-cell function, corticosteroids remain valuable when paired with the first-line of treatments to manage moderate-to-severe CRS. Systemic corticosteroids are effective in dampening CRS due to their established anti-inflammatory properties. Due to early concern about steroids inhibiting CAR-T activity and expansion, its use early in CRS onset was relatively restricted to preserve CAR-T antitumor activity. Typically, corticosteroids are reserved for cases of CRS refractory to tocilizumab or being administered concomitantly with tocilizumab for high-grade CRS or CRS that occurs with associated neurotoxicity.

With the growing use of T-cell-engaging therapies, there is an urgent need for clinical trials that improve the evidence base to treat CRS. The current management strategies for CRS are predominantly based on biological reasoning, expert opinion, and retrospective analyses. To further improve the safety and effectiveness of the clinical management of CRS, randomized controlled trials that evaluate different treatment strategies for CRS are necessary.

In short, efficacious pharmacologic options for managing the most incident and disabling phases of CRS are extremely limited. Treatments that work in both phases of the disorder are especially rare; therefore, new treatments are desperately needed.

According to DelveInsight, the cytokine release syndrome (CRS) market in 7MM is expected to witness a major change in the study period 2019–2032.

Key Findings

The cytokine release syndrome market size in the 7MM is expected to change during the study period 2019–2032. The therapeutic market of cytokine release syndrome in the seven major markets is expected to increase during the study period (2019–2032). In 2021, the total market size of cytokine release syndrome was USD 4.3 million which is expected to rise during the study period (2019–2032).

The United States Market Outlook

The total market size of cytokine release syndrome in the United States accounted for USD 3.5 million in 2021 which is expected to rise during the study period (2019–2032).

The EU5 Countries: Market Outlook

In the EU5, the total market size of cytokine release syndrome was USD 0.8 million in 2021, which is expected to rise during the study period (2019–2032).

Japan Market Outlook

In Japan, the total market size of cytokine release syndrome was USD 0.01 million in 2021, which is expected to rise during the study period (2019–2032).

Cytokine Release Syndrome (CRS) Uptake

This section focuses on the rate of uptake of the potential drugs recently launched in the cytokine release syndrome market or expected to get launched in the market during the study period 2019-2032. The analysis covers cytokine release syndrome market uptake by drugs; patient uptake by therapies; and sales of each drug.

This helps in understanding the drugs with the most rapid uptake, and 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.

Cytokine Release Syndrome (CRS) Development Activities

The report provides insights into different therapeutic candidates in Phase II, and Phase III stages. It also analyses cytokine release syndrome key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers detailed information on collaborations, acquisition, and merger, licensing patent details, and other information for cytokine release syndrome emerging therapies.

Reimbursement Scenario in Cytokine Release Syndrome (CRS)

Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In a 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.

KOL- Views

To keep up with current market trends, we take KOLs and SMEs ' opinions working in the cytokine release syndrome domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps to understand and validate current and emerging therapies treatment patterns or cytokine release syndrome market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Competitive Intelligence Analysis

We perform Competitively and Market Intelligence analysis of the cytokine release syndrome 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 cytokine release syndrome, explaining its causes, signs and symptoms, pathophysiology, diagnosis, and currently available therapies
• Comprehensive insight has been provided into the cytokine release syndrome epidemiology and treatment in the 7MM
• Additionally, an all-inclusive account of both the current and emerging therapies for cytokine release syndrome are provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape
• A detailed review of the cytokine release syndrome market; historical and forecasted is included in the report, covering drug outreach in the 7MM
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the global cytokine release syndrome market.

Report Highlights

• In the coming years, the cytokine release syndrome market is set to change due to the upcoming therapies with novel route of administrations which are under investigation and ongoing research in the cytokine release syndrome; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
• The companies and academics are working to assess challenges and seek opportunities that could influence cytokine release syndrome 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 cytokine release syndrome. The launch of emerging therapies will significantly impact the cytokine release syndrome market.
• A better understanding of disease pathogenesis will also contribute to the development of novel therapeutics for cytokine release syndrome.
• 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.

Cytokine Release Syndrome (CRS) Report Insights

• Patient Population
• Therapeutic Approaches
• Cytokine release syndrome (CRS) Pipeline Analysis
• Cytokine release syndrome (CRS) Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies
 
Cytokine Release Syndrome (CRS) Report Key Strengths
• 11 Years Forecast
• 7MM Coverage
• Cytokine release syndrome (CRS) Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake
Cytokine Release Syndrome (CRS) Report Assessment
• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
Key Questions

Market Insights:
• What was the cytokine release syndrome drug class share (%) distribution in 2019 and how it would look like in 2032?
• What would be the cytokine release syndrome total market size as well as market size by therapies across the 7MM during the forecast period (2019-2032)?
• What are the key findings of the market across 7MM and which country will have the largest cytokine release syndrome market size during the forecast period (2019-2032)?
• At what CAGR, the cytokine release syndrome market is expected to grow by 7MM during the forecast period (2019-2032)?
• What would be the cytokine release syndrome market outlook across the 7MM during the forecast period (2019-2032)?
• What would be the cytokine release syndrome market growth till 2032, and what will be the resultant market Size in the year 2032?
• How would the unmet needs affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights:
• What are the disease risk, burden, and regional/ethnic differences of cytokine release syndrome?
• What are the key factors driving the epidemiology trend for seven major markets covering the United States, the EU5 (Germany, Spain, France, Italy, UK), and Japan?
• What is the historical cytokine release syndrome patient pool in seven major markets covering the United States, the EU5 (Germany, Spain, France, Italy, UK), and Japan?
• What would be the forecasted patient pool of cytokine release syndrome in seven major markets covering the United States, the EU5 (Germany, Spain, France, Italy, UK), and Japan?
• Where will be the growth opportunities in the 7MM concerning the patient population about cytokine release syndrome?
• Out of all 7MM countries, which country would have the highest prevalent population of cytokine release syndrome during the forecast period (2019-2032)?
• At what CAGR the patient population is expected to grow by 7MM during the forecast period (2019-2032)?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:
• What are the current options for the cytokine release syndrome treatment in addition to the approved therapies?
• What are the current treatment guidelines for the treatment of cytokine release syndrome in the USA, Europe, and Japan?
• What are the cytokine release syndrome marketed drugs and their respective MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, efficacy, etc.?
• How many companies are developing therapies for the treatment of cytokine release syndrome?
• How many therapies are in-development by each company for cytokine release syndrome treatment?
• How many are emerging therapies in mid-stage, and late stage of development for cytokine release syndrome treatment?
• What are the key collaborations (Industry - Industry, Industry-Academia), mergers and acquisitions, licensing activities related to the cytokine release syndrome therapies?
• What are the recent novel therapies, targets, mechanisms of action, and technologies being developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for cytokine release syndrome and their status?
• What are the current challenges faced in drug development?
• What are the key designations that have been granted for the emerging therapies for cytokine release syndrome?
• What are the global historical and forecasted markets of cytokine release syndrome?
Reasons to buy
• The report will help in developing business strategies by understanding trends shaping and driving the cytokine release syndrome market
• To understand the future market competition in the cytokine release syndrome market and Insightful review of the key market drivers and barriers
• Organize sales and marketing efforts by identifying the best opportunities for cytokine release syndrome 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 cytokine release syndrome market
• To understand the future market competition in the cytokine release syndrome market