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市場調查報告書

細胞因子釋放綜合症(CRS):市場洞察,流行病學和對2030年的預測

Cytokine Release Syndrome (CRS)-Market Insights, Epidemiology, and Market Forecast-2030

出版商 DelveInsight Business Research LLP 商品編碼 948129
出版日期 內容資訊 英文 200 Pages
商品交期: 最快1-2個工作天內
價格
細胞因子釋放綜合症(CRS):市場洞察,流行病學和對2030年的預測 Cytokine Release Syndrome (CRS)-Market Insights, Epidemiology, and Market Forecast-2030
出版日期: 2020年06月01日內容資訊: 英文 200 Pages
簡介

2017年,七個主要國家(美國,德國,法國,意大利,西班牙,英國和日本)的細胞因子釋放綜合症(CRS)市場達到160,000美元。美國市場是七個主要國家中最大的市場,約佔市場總量的85.46%(2019年)。由於市場對疾病的意識增強以及全球醫療成本的上升,預計市場規模將不斷擴大,預計未來幾年會有更多的製藥公司進入該市場。而且,正在開發的療法集中於治療/改善疾病狀態的新方法。預計新興療法的推出將對市場產生重大影響。

該報告調查了七個主要國家的細胞因子釋放綜合徵(CRS)市場,包括主要七個國家的市場份額和預測,增長因素和挑戰,流行病學和市場前景以及主要治療藥物概況。我們提供諸如此類的信息。

內容

第1章主要見解

第2章概述

第3章市場概述

  • 市場佔有率:2019
  • 市場佔有率預測:2030

第4章疾病的背景和概述

  • 簡介
  • 症狀
  • 原因
  • 風險因素
  • 病理生理學
  • 生物標誌物
  • 感染COVID-19的患者的簡歷
  • 診斷

第5章案例報告

第6章流行病學和患者人數

  • 主要發現
  • 範圍
  • KOL的觀點
  • 多發性骨髓瘤治療範例
  • DLBCL治療範例
  • 所有治療範例
  • CAR-T細胞療法的預測流程
  • CRS流行病學調查方法
  • 在7個主要國家/地區接受CAR-T細胞治療的血液系統惡性腫瘤總數
  • 在7個主要國家/地區接受CAR-T細胞治療後罹患CRS的患者總數

第7章美國流行病學

  • 先決條件和理由
  • 接受CAR-T細胞治療的B細胞NHL患者總數
  • 接受CAR-T細胞治療的急性淋巴細胞白血病(ALL)患者總數
  • 接受CAR-T細胞治療的多發性骨髓瘤(MM)患者總數
  • CAR-T細胞治療後CRS患者總數
  • 按嚴重程度/等級劃分的CRS患者數

第8章五種歐洲流行病學

  • 先決條件和理由
  • 德國
  • 法國
  • 意大利
  • 西班牙
  • 英國

第9章日本流行病學

第10章當前的治療和醫療服務

  • CRS處理
  • 處理算法
  • 治療準則

第11章潛在需求

第12章非處方藥

  • Actemra/RoActemra(tocilizumab):Genentech
  • 產品說明
  • 監管里程碑
  • 安全性和有效性
  • 產品簡介

第13章新興藥物

  • 主要競爭
  • Canakinumab (Ilaris): Novartis Pharmaceuticals
  • Itacitinib: Incyte Corporation
  • Cytosorb: CytoSorbents
  • Defitelio (Defibrotide): Jazz pharmaceuticals
  • Anakinra: Swedish Orphan Biovitrum (Sobi)

第14章七個主要國家/地區的市場分析

  • 主要發現
  • 市場調查方法
  • 7個主要國家/地區的市場規模
  • 七個主要國家/地區的治療方法市場規模

第15章聯合分析

第16章美國

  • 美國市場前景
  • 美國市場規模
  • 美國市場總規模
  • 按治療方法劃分的美國市場規模

第17章歐洲五個國家:市場前景

  • 德國
  • 法國
  • 意大利
  • 西班牙
  • 英國

第18章日本市場展望

第19章市場增長因素

第20章市場壁壘

第21章SWOT分析

第22章贖回和市場准入

第23章附錄

第24章DelveInsight的服務內容

第25章免責聲明

第26章關於Delve Insight

目錄
Product Code: DIMI1000

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

The Cytokine Release Syndrome (CRS) market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM Cytokine Release Syndrome (CRS) market size from 2017 to 2030. The Report also covers current Cytokine Release Syndrome (CRS) treatment practice/algorithm, market drivers, market barriers 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: 2017-2030

Cytokine Release Syndrome (CRS) Disease Understanding and Treatment Algorithm

Cytokine Release Syndrome (CRS) Overview

Cytokine release syndrome (CRS) is a systemic inflammatory response that can be triggered by a variety of 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.

The symptoms of CRS typically occur within 30-120 min after the infusion has been initiated, and typically the risk is greater during the first infusion. After CAR T-cell therapy, the onset of CRS symptoms seems to be dependent on the administered dose of the active agent of the proliferation kinetics of adoptively transferred cells and ranges from a few minutes up to 14 days but usually occurs within the first week.

Cytokine Release Syndrome (CRS) Diagnosis

Currently, no established diagnostic criteria for the CRS is 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.

Cytokine Release Syndrome (CRS) 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 the 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).

In patients with CRS who respond to tocilizumab, fever and hypotension often resolve within a few hours, and pressors and other supportive care measures can be weaned quickly thereafter. In some cases, however, symptoms may not completely resolve, and continued aggressive support may be necessary for several days. If the patient's condition does not improve or stabilize within 24 h of the tocilizumab dose, administration of a second dose of tocilizumab and/or a second immunosuppressive agent, such as corticosteroids, should be considered. Till now only one therapy is approved for CRS, i.e., Actemra.

Cytokine Release Syndrome (CRS) Epidemiology

The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Total Number of B-cell NHL Patients receiving CART-Therapies, Total Number of Acute lymphoblastic leukemia (ALL) Patients receiving CART-Therapies, Total Number of Multiple Myeloma (MM) Patients receiving CART-Therapies, Total Number of Patients developing Cytokine Release Syndrome (CRS) following CART therapies, and Total Number of Patients Developing Cytokine Release Syndrome (CRS) by Severity/Grade, scenario of CRS in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and United Kingdom) and Japan from 2017 to 2030.

Key Findings

  • Total number of patients who develop Cytokine Release Syndrome following CART therapies in the 7MM were 31 in 2017.
  • Total number of Hematologic malignancies (Includes ALL, B-Cell NHL (DLBCL, FL, PMBCL, etc.), and Multiple Myeloma) patients receiving CART-therapies in the 7MM were observed to be 41 in 2017. These cases will increase in the 7MM throughout the study period, i.e., 2017-2030.
  • Both the therapies Yescarta (Axicabtagene ciloleucel, Kite/Gilead) and Kymriah (Tisagenlecleucel, Novartis) were approved in 2017 in the United States and 2018 in EU-5. Kymriah is the only CAR-T cell therapy, which was approved in Japan in 2019
  • Among the European 5 countries, Germany had the highest population of CRS with 13 cases, followed by France and the United Kingdom with 11 cases respectively. On the other hand, Spain had the lowest population of 6 cases in 2018.
  • Based on the severity criteria, CRS has been classified into Grade 1, 2, 3, and 4. Out of the total population of CRS 31 cases in the US, the highest cases were observed in the grade 1 & 2, and lowest cases accounted in grade 4 in 2017.
  • There is no CAR-T therapy which is approved for Multiple Myeloma (MM) patients. According to DelveInsight, there are around 6-8 emerging CAR-T cell therapies which are expected to launch during forecast period for the treatment of MM and patients will experience cytokine release syndrome. As comparison to Yescarta (Axicabtagene ciloleucel, Kite/Gilead) and Kymriah (Tisagenlecleucel, Novartis), new CAR-T cell therapies that are going to be approved in forecast period, will show lower incidence of Cytokine Release Syndrome based on the preliminary results.

Cytokine Release Syndrome (CRS) Epidemiology

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

Cytokine Release Syndrome (CRS) Drug Chapters

The drug chapter segment of the Cytokine Release Syndrome (CRS) report encloses the detailed analysis of CRS marketed drugs, mid-phase, and late-stage pipeline drugs. It also helps to understand the Cytokine Release Syndrome (CRS) clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details of each included drug and the latest news and press releases.

  • Cytokine Release Syndrome (CRS) Marketed Drugs
  • Actemra/RoActemra (tocilizumab): Genentech

Actemra (tocilizumab) is the first drug approved for the treatment of chimeric antigen receptor (CAR) T-cell-induced severe or life-threatening CRS in patients 2 years and older. Apart from being used in the treatment of chimeric antigen receptor (CAR) T-cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and pediatric patients 2 years and older, the drug is also approved to treat adults with moderately to severely active rheumatoid arthritis (RA), adults with giant cell arteritis (GCA), and children ages two and above with Polyarticular Juvenile Idiopathic Arthritis (PJIA) or Systemic Juvenile Idiopathic Arthritis (SJIA). The drug is approved under the name Actemra in the US and Japan, and as RoActemra in Europe.

Products detail in the report…

  • Cytokine Release Syndrome (CRS) Emerging Drugs
  • Itacitinib: Incyte Corporation

Itacitinib is a potent orally bioavailable and highly selective inhibitor of Janus kinase (JAK)-1, which mediates signaling of several inflammatory cytokines. In preclinical studies of CRS models, JAK1 inhibition with ITA significantly reduced serum levels of cytokines implicated in CRS, including IL-6, IL-12, and IFN-γ, without affecting the antitumor activity of human CD19 CAR T-cells in vivo, suggesting potential utility in the management of CRS.

Products detail in the report…

  • Defitelio (Defibrotide): Jazz pharmaceuticals

Defibrotide, sold under the brand name Defitelio, is a mixture of single-stranded oligonucleotides that is purified from the intestinal mucosa of pigs. Currently, the company is conducting a Phase II clinical trial to evaluate defibrotide intravenous infusion in the prevention of cytokine release syndrome.

  • Products detail in the report…
  • Anakinra: Kite Pharma/Swedish Orphan Biovitrum (Sobi)

Anakinra is a recombinant human interleukin-1 (IL-1) receptor antagonist protein. It is administered through the subcutaneous route and approved for the treatment of rheumatoid arthritis and cryopyrin-associated periodic syndromes (CAPS). Company is developing anakinra in axicabtagene ciloleucel therapy to reduce the occurrence of the side effects-cytokine release syndrome (CRS)-and neurologic toxicities with relapsed or refractory Non-Hodgkin lymphoma (NHL). The company is investigating this combination in phase II clinical trial. Another Phase II clinical trial is conducted by Swedish Orphan Biovitrum (Sobi) in collaboration with Fred Hutchinson Cancer Research Center and National Cancer Institute (NCI) to investigate the potential of anakinra in axicabtagene ciloleucel therapy in reducing CRS and neurotoxicity in patients with B-cell lymphoma who are receiving CD19-targeted CAR T-cell therapy.

  • Products detail in the report…

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 as approaches to control CRS. In light of the approval of Actemra (tocilizumab) for management of CRS by both 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.

Subsequent studies confirmed that the administration of monoclonal antibodies against IL-6 (siltuximab) and its receptor (tocilizumab) led to the rapid resolution of CRS symptoms. In an early-stage clinical trial, tocilizumab demonstrated a 69% response rate in patients with severe or life-threatening CRS. As a consequence, tocilizumab has quickly become the gold standard for the initial treatment of severe CRS in patients receiving CAR T-cells.

Currently, there are several other IL-6-targeting monoclonal antibodies in late-stage clinical development, which could also potentially be used to treat CRS. Siltuximab is a chimeric, IGK monoclonal antibody that binds human IL-6 and prevents it from interacting with both the membrane-bound and soluble form of the IL-6 receptor. Clazakizumab is another monoclonal antibody targeting IL-6. Corticosteroids should generally be avoided as first-line treatment of CRS in patients receiving CAR T-cells and should be reserved for cases refractory to IL-6 blockade or patients with severe neurotoxicity. The current recommendations, therefore, prefer the use of corticosteroids for the treatment of the neurologic adverse effects of T-cell engaging therapies.

Monoclonal antibodies target IL-6 directly, thereby eliminating it from the circulation, which might be advantageous in patients with severe CRS and concurrent neurotoxicity since tocilizumab does not cross the blood-brain barrier, and therefore, fails to inhibit IL-6 signaling in the CNS. Corticosteroids should also be considered in patients who develop HLHI/MAS as part of their CRS.

According to DelveInsight, Cytokine Release Syndrome (CRS) 7MM is expected to change in the study period 2017-2030.

Key Findings

  • The market size of Cytokine Release Syndrome (CRS) in the 7MM was found to be USD 0.16 million in 2017.
  • Among the 7MM countries, the United States had the highest market size of Cytokine Release Syndrome (CRS) in 2019, which accounts for approximately 85.46% of the total market.

The United States Market Outlook

This section provides the total Cytokine Release Syndrome (CRS) market size and; market size by therapies in the United States.

EU-5 Market Outlook

The total Cytokine Release Syndrome (CRS) 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 Cytokine Release Syndrome (CRS) market size and market size by therapies in Japan are provided.

Cytokine Release Syndrome (CRS) Drugs Uptake

This section focusses on the rate of uptake of the potential drugs recently launched in the Cytokine Release Syndrome (CRS) market or expected to get launched in the market during the study period 2017-2030. The analysis covers Cytokine Release Syndrome (CRS) 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.

Cytokine Release Syndrome (CRS) 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 Cytokine Release Syndrome (CRS) emerging therapies.

Reimbursement Scenario in Cytokine Release Syndrome (CRS)

Reimbursement is a crucial factor that affects the drug's access to the market. Often, the decision to reimburse comes down to the price of the drug relative to the benefit it produces in treated patients.

Tocilizumab is a recombinant humanized anti-human IgG1 monoclonal antibody directed against the interleukin-6 receptor (IL-6R) that binds specifically to both soluble and membrane-bound IL-I receptor (L-6R), thereby inhibiting IL-6-mediated signaling. IL-6 is a cytokine produced by a wide variety of cells in the human body. Its normal role is primarily to regulate hematopoiesis, to stimulate immune responses, and to mediate acute phase reactions (CHMP, 2018b).

Medicare does not have a National Coverage Determination (NCD) that addresses Actemra (tocilizumab) explicitly. NCD is an evidence-based determination of whether Medicare will pay for an item or service. Also, Local Coverage Determinations (LCDs) do not exist for Actemra (UnitedHealthcare, 2020).

Genentech is running an Actemra Co-pay Card Program that helps eligible commercially insured patients to 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 (Genentech, 2020). 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.

Competitive Intelligence Analysis

We perform competitive and market Intelligence analysis of the Cytokine Release Syndrome (CRS) 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 (CRS), explaining its causes, signs and symptoms, pathogenesis and currently available therapies.
  • Comprehensive insight has been provided into the Cytokine Release Syndrome (CRS) epidemiology and treatment.
  • Additionally, an all-inclusive account of both the current and emerging therapies for Cytokine Release Syndrome (CRS) are provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
  • A detailed review of Cytokine Release Syndrome (CRS) 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 Cytokine Release Syndrome (CRS) market.

Report Highlights:

  • In the coming years, Cytokine Release Syndrome (CRS) market is set to change due to the rising awareness of the disease, and incremental healthcare spending across the world; 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 (CRS) 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 (CRS). Launch of emerging therapies will significantly impact the Cytokine Release Syndrome (CRS) 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.

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

  • Eleven 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
  • Market Drivers and Barriers

Key Questions

Market Insights:

  • What was the Cytokine Release Syndrome (CRS) market share (%) distribution in 2017 and how it would look like in 2030?
  • What would be the Cytokine Release Syndrome (CRS) total market size as well as market size by therapies across the 7MM during the forecast period (2020-2030)?
  • What are the key findings pertaining to the market across the 7MM and which country will have the largest Cytokine Release Syndrome (CRS) market size during the forecast period (2020-2030)?
  • What would be the Cytokine Release Syndrome (CRS) market outlook across the 7MM during the forecast period (2020-2030)?
  • What would be the Cytokine Release Syndrome (CRS) 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 is the disease risk, burden and unmet needs of Cytokine Release Syndrome (CRS)?
  • What is the historical Cytokine Release Syndrome (CRS) patient pool in the United States, EU5 (Germany, France, Italy, Spain, and the UK) and Japan?
  • What would be the forecasted patient pool of Cytokine Release Syndrome (CRS) at the 7MM level?
  • What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Cytokine Release Syndrome (CRS)?
  • Out of the above-mentioned countries, which country would have the highest population of Cytokine Release Syndrome (CRS) during the forecast period (2020-2030)?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:

  • What are the current options for the treatment of Cytokine Release Syndrome (CRS) along with the approved therapy?
  • What are the current treatment guidelines for the treatment of Cytokine Release Syndrome (CRS) in the US and Europe?
  • What are the Cytokine Release Syndrome (CRS) 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 Cytokine Release Syndrome (CRS)?
  • How many therapies are developed by each company for the treatment of Cytokine Release Syndrome (CRS)?
  • How many emerging therapies are in the mid-stage and late stages of development for the treatment of Cytokine Release Syndrome (CRS)?
  • What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Cytokine Release Syndrome (CRS) 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 Cytokine Release Syndrome (CRS) and their status?
  • What are the key designations that have been granted for the emerging therapies for Cytokine Release Syndrome (CRS)?
  • What are the 7MM historical and forecasted market of Cytokine Release Syndrome (CRS)?

Reasons to buy:

  • The report will help in developing business strategies by understanding trends shaping and driving the Cytokine Release Syndrome (CRS).
  • To understand the future market competition in Cytokine Release Syndrome (CRS) 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 (CRS) 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 Cytokine Release Syndrome (CRS) market.
  • To understand the future market competition in the Cytokine Release Syndrome (CRS) market.

Table of Contents

1. Key Insights

2. Executive Summary of Cytokine Release Syndrome (CRS)

3. Cytokine Release Syndrome (CRS) Market Overview at a Glance

  • 3.1. Market Share (%) Distribution of CRS in 2019
  • 3.2. Market Share (%) Distribution of CRS in 2030

4. Disease Background and Overview: Cytokine Release Syndrome (CRS)

  • 4.1. Introduction
  • 4.2. Symptoms
  • 4.3. Causes
  • 4.4. Risk Factors
  • 4.5. Pathophysiology
  • 4.6. Biomarkers
  • 4.7. CRS in patients with COVID-19 infection
  • 4.8. Diagnosis
    • 4.8.1. Grading

5. Case Reports

  • 5.1. Severe cytokine release syndrome resulting in purpura fulminans despite successful response to nivolumab therapy in a patient with pleomorphic carcinoma of the lung: A case report
  • 5.2. The first case of cytokine release syndrome after nivolumab for gastric cancer
  • 5.3. Multimodal therapeutic approach of Cytokine Release Syndrome developing in a child given chimeric antigen receptor-modified T-cell Infusion

6. Epidemiology and Patient Population

  • 6.1. Key Findings
  • 6.2. Scope
  • 6.3. KOL Views
  • 6.4. Multiple Myeloma Treatment Paradigm
  • 6.5. DLBCL Treatment Paradigm
  • 6.6. ALL Treatment Paradigm
  • 6.7. CAR-T Cell Therapies Forecast Flow
  • 6.8. CRS Epidemiology Methodology
  • 6.9. Total Number of Hematologic Malignancies Patients receiving CAR-T Cell Therapies in the 7MM
  • 6.10. Total Number of Patients develop CRS following CAR-T Cell Therapies in the 7MM

7. United States Epidemiology

  • 7.1. Assumptions and Rationale
  • 7.2. Total Number of B-cell NHL Patients receiving CAR-T Cell Therapies in the United States
  • 7.3. Total Number of Acute lymphoblastic leukemia (ALL) Patients receiving CAR-T Cell Therapies in the United States
  • 7.4. Total Number of Multiple Myeloma (MM) Patients receiving CAR-T Cell Therapies in the United States
  • 7.5. Total Number of Patients developing Cytokine Release Syndrome (CRS) following CAR-T Cell Therapies in the United States
  • 7.6. Number of Patients Developing Cytokine Release Syndrome (CRS) by Severity/Grade in the United States

8. EU5 Epidemiology

  • 8.1. Assumptions and Rationale
  • 8.2. Germany Epidemiology
    • 8.2.1. Total Number of B-cell NHL Patients receiving CAR-T Cell Therapies in Germany
    • 8.2.2. Total Number of Acute lymphoblastic leukemia (ALL) Patients receiving CAR-T Cell Therapies in Germany
    • 8.2.3. Total Number of Multiple Myeloma (MM) Patients receiving CAR-T Cell Therapies in Germany
    • 8.2.4. Total Number of Patients developing Cytokine Release Syndrome (CRS) following CAR-T Cell Therapies in Germany
    • 8.2.5. Number of Patients Developing Cytokine Release Syndrome (CRS) by Severity/Grade in Germany
  • 8.3. France Epidemiology
    • 8.3.1. Total Number of B-cell NHL Patients receiving CAR-T Cell Therapies in France
    • 8.3.2. Total Number of Acute lymphoblastic leukemia (ALL) Patients receiving CAR-T Cell Therapies in France
    • 8.3.3. Total Number of Multiple Myeloma (MM) Patients receiving CAR-T Cell Therapies in France
    • 8.3.4. Total Number of Patients developing Cytokine Release Syndrome (CRS) following CAR-T Cell Therapies in France
    • 8.3.5. Number of Patients Developing Cytokine Release Syndrome (CRS) by Severity/Grade in France
  • 8.4. Italy Epidemiology
    • 8.4.1. Total Number of B-cell NHL Patients receiving CAR-T Cell Therapies in Italy
    • 8.4.2. Total Number of Acute lymphoblastic leukemia (ALL) Patients receiving CAR-T Cell Therapies in Italy
    • 8.4.3. Total Number of Multiple Myeloma (MM) Patients receiving CAR-T Cell Therapies in Italy
    • 8.4.4. Total Number of Patients developing Cytokine Release Syndrome (CRS) following CAR-T Cell Therapies in Italy
    • 8.4.5. Number of Patients Developing Cytokine Release Syndrome (CRS) by Severity/Grade in Italy
  • 8.5. Spain Epidemiology
    • 8.5.1. Total Number of B-cell NHL Patients receiving CAR-T Cell Therapies in Spain
    • 8.5.2. Total Number of Acute lymphoblastic leukemia (ALL) Patients receiving CAR-T Cell Therapies in Spain
    • 8.5.3. Total Number of Multiple Myeloma (MM) Patients receiving CAR-T Cell Therapies in Spain
    • 8.5.4. Total Number of Patients developing Cytokine Release Syndrome (CRS) following CAR-T Cell Therapies in Spain
    • 8.5.5. Number of Patients Developing Cytokine Release Syndrome (CRS) by Severity/Grade in Spain
  • 8.6. United Kingdom Epidemiology
    • 8.6.1. Total Number of B-cell NHL Patients receiving CAR-T Cell Therapies in the UK
    • 8.6.2. Total Number of Acute lymphoblastic leukemia (ALL) Patients receiving CAR-T Cell Therapies in the UK
    • 8.6.3. Total Number of Multiple Myeloma (MM) Patients receiving CAR-T Cell Therapies in the UK
    • 8.6.4. Total Number of Patients developing Cytokine Release Syndrome (CRS) following CAR-T Cell Therapies in the UK
    • 8.6.5. Number of Patients Developing Cytokine Release Syndrome (CRS) by Severity/Grade in the United Kingdom

9. Japan Epidemiology

  • 9.1. Assumptions and Rationale
  • 9.2. Total Number of B-cell NHL Patients receiving CAR-T Cell Therapies in Japan
  • 9.3. Total Number of Acute lymphoblastic leukemia (ALL) Patients receiving CAR-T Cell Therapies in Japan
  • 9.4. Total Number of Multiple Myeloma (MM) Patients receiving CAR-T Cell Therapies in Japan
  • 9.5. Total Number of Patients developing Cytokine Release Syndrome (CRS) following CAR-T Cell Therapies in Japan
  • 9.6. Number of Patients Developing Cytokine Release Syndrome (CRS) by Severity/Grade in Japan

10. Current Treatment and Medical Practices

  • 10.1. Treatment of CRS
  • 10.2. Treatment algorithm
  • 10.3. Treatment Guideline

11. Unmet needs

12. Marketed Drugs

  • 12.1. Actemra/RoActemra (tocilizumab): Genentech
  • 12.2. Product Description
  • 12.3. Regulatory Milestones
  • 12.4. Safety and Efficacy
  • 12.5. Product Profile

13. Emerging Drugs

  • 13.1. Key Cross Competition
  • 13.2. Canakinumab (Ilaris): Novartis Pharmaceuticals
    • 13.2.1. Product Description
    • 13.2.2. Regulatory Milestones
    • 13.2.3. Clinical Development
    • 13.2.4. Product Profile
  • 13.3. Itacitinib: Incyte Corporation
    • 13.3.1. Product Description
    • 13.3.2. Regulatory Milestones
    • 13.3.3. Clinical Development
    • 13.3.4. Product Profile
  • 13.4. Cytosorb: CytoSorbents
    • 13.4.1. Product Description
    • 13.4.2. Regulatory Milestones
    • 13.4.3. Clinical Development
    • 13.4.4. Safety and Efficacy
    • 13.4.5. Product Profile
  • 13.5. Defitelio (Defibrotide): Jazz pharmaceuticals
    • 13.5.1. Product Description
    • 13.5.2. Regulatory Milestones
    • 13.5.3. Clinical Development
    • 13.5.4. Product Profile
  • 13.6. Anakinra: Swedish Orphan Biovitrum (Sobi)
    • 13.6.1. Product Description
    • 13.6.2. Other Developmental Activities
    • 13.6.3. Clinical Development
    • 13.6.4. Clinical Trials Information
    • 13.6.5. Product Profile

14. Cytokine Release Syndrome (CRS): 7MM Market Analysis

  • 14.1. Key Findings
  • 14.2. Market Methodology
  • 14.3. Market Size of Cytokine Release Syndrome (CRS) in the 7MM
  • 14.4. Market Size of Cytokine Release Syndrome (CRS) by Therapies in the 7MM

15. Conjoint Analysis

16. United States

  • 16.1. United States Market Outlook
  • 16.2. United States Market Size
  • 16.3. Total Market size of Cytokine Release Syndrome (CRS) in the United States
  • 16.4. Market Size of Cytokine Release Syndrome (CRS) by Therapies in the US

17. EU-5 Countries: Market Outlook

  • 17.1. Germany Market Size
    • 17.1.1. Total Market size of Cytokine Release Syndrome (CRS) in Germany
    • 17.1.2. Market Size of Cytokine Release Syndrome (CRS) by therapies in Germany
  • 17.2. France Market Size
    • 17.2.1. Total Market size of Cytokine Release Syndrome (CRS) in France
    • 17.2.2. Market Size of Cytokine Release Syndrome (CRS) by therapies in France
  • 17.3. Italy Market Size
    • 17.3.1. Total Market size of Cytokine Release Syndrome (CRS) in Italy
    • 17.3.2. Market Size of Cytokine Release Syndrome (CRS) by therapies in Italy
  • 17.4. Spain Market Size
    • 17.4.1. Total Market size of Cytokine Release Syndrome (CRS) in Spain
    • 17.4.2. Market Size of Cytokine Release Syndrome (CRS) by therapies in Spain
  • 17.5. United Kingdom Market Size
    • 17.5.1. Total Market size of Cytokine Release Syndrome (CRS) in the United Kingdom
    • 17.5.2. Market Size of Cytokine Release Syndrome (CRS) by therapies in the UK

18. Japan Market Outlook

  • 18.1. Japan Market Size
    • 18.1.1. Total Market size of Cytokine Release Syndrome (CRS) in Japan
    • 18.1.2. Market Size of Cytokine Release Syndrome (CRS) by therapies in Japan

19. Market Drivers

20. Market Barriers

21. SWOT Analysis

22. Reimbursement and market access

23. Appendix

  • 23.1. Bibliography
  • 23.2. Report Methodology

24. DelveInsight Capabilities

25. Disclaimer

26. About DelveInsight

List of Tables

  • Table 1 Summary of Cytokine Release Syndrome (CRS), Market, Epidemiology and Key Events (2017-2030)
  • Table 2 Clinical risk factors for severe CRS
  • Table 3 Cytokines and Chemokines involved in CRS
  • Table 4 Diagnostic criteria for severe CRS
  • Table 5 Differential diagnoses of CRS-related HLH/MAS
  • Table 6 Published CRS grading systems
  • Table 7 ASTCT CRS Consensus grading
  • Table 8 Total Number of Hematologic malignancies Patients receiving CAR-T Cell Therapies in the 7MM (2017-2030)
  • Table 9 Total Number of Patients develop CRS following CAR-T Cell Therapies in the 7MM (2017-2030)
  • Table 10 Total Number of B-cell NHL Patients receiving CAR-T Cell Therapies in the US (2017-2030)
  • Table 11 Total Number of ALL Patients receiving CAR-T Cell Therapies in the US (2017-2030)
  • Table 12 Total Number of MM Patients receiving CAR-T Cell Therapies in the US (2017-2030)
  • Table 13 Total Number of Patients developing CRS following CAR-T Cell Therapies in the US (2017-2030)
  • Table 14 Number of Patients Developing CRS by Severity/Grade in the US (2017-2030)
  • Table 15 Total Number of B-cell NHL Patients receiving CAR-T Cell Therapies in Germany (2017-2030)
  • Table 16 Total Number of ALL Patients receiving CAR-T Cell Therapies in Germany (2017-2030)
  • Table 17 Total Number of MM Patients receiving CAR-T Cell Therapies in Germany (2017-2030)
  • Table 18 Total Number of Patients developing CRS following CAR-T Cell Therapies in Germany (2017-2030)
  • Table 19 Number of Patients Developing CRS by Severity/Grade in Germany (2017-2030)
  • Table 20 Total Number of B-cell NHL Patients receiving CAR-T Cell Therapies in France (2017-2030)
  • Table 21 Total Number of ALL Patients receiving CAR-T Cell Therapies in France (2017-2030)
  • Table 22 Total Number of MM Patients receiving CAR-T Cell Therapies in France (2017-2030)
  • Table 23 Total Number of Patients developing CRS following CAR-T Cell Therapies in France (2017-2030)
  • Table 24 Number of Patients Developing CRS by Severity/Grade in France (2017-2030)
  • Table 25 Total Number of B-cell NHL Patients receiving CAR-T Cell Therapies in Italy (2017-2030)
  • Table 26 Total Number of ALL Patients receiving CAR-T Cell Therapies in Italy (2017-2030)
  • Table 27 Total Number of MM Patients receiving CAR-T Cell Therapies in Italy (2017-2030)
  • Table 28 Total Number of Patients developing CRS following CAR-T Cell Therapies in Italy (2017-2030)
  • Table 29 Number of Patients Developing CRS by Severity/Grade in Italy (2017-2030)
  • Table 30 Total Number of B-cell NHL Patients receiving CAR-T Cell Therapies in Spain (2017-2030)
  • Table 31 Total Number of ALL Patients receiving CAR-T Cell Therapies in Spain (2017-2030)
  • Table 32 Total Number of MM Patients receiving CAR-T Cell Therapies in Spain (2017-2030)
  • Table 33 Total Number of Patients developing CRS following CAR-T Cell Therapies in Spain (2017-2030)
  • Table 34 Number of Patients Developing CRS by Severity/Grade in Spain (2017-2030)
  • Table 35 Total Number of B-cell NHL Patients receiving CAR-T Cell Therapies in the UK (2017-2030)
  • Table 36 Total Number of ALL Patients receiving CAR-T Cell Therapies in the UK (2017-2030)
  • Table 37 Total Number of MM Patients receiving CAR-T Cell Therapies in the UK (2017-2030)
  • Table 38 Total Number of Patients developing CRS following CAR-T Cell Therapies in the UK (2017-2030)
  • Table 39 Number of Patients Developing CRS by Severity/Grade in the UK (2017-2030)
  • Table 40 Total Number of B-cell NHL Patients receiving CAR-T Cell Therapies in Japan (2017-2030)
  • Table 41 Total Number of ALL Patients receiving CAR-T Cell Therapies in Japan (2017-2030)
  • Table 42 Total Number of MM Patients receiving CAR-T Cell Therapies in Japan (2017-2030)
  • Table 43 Total Number of Patients developing CRS following CAR-T Cell Therapies in Japan (2017-2030)
  • Table 44 Number of Patients Developing CRS by Severity/Grade in Japan (2017-2030)
  • Table 45 Recommended anti-cytokine agents and dosing (where reasonable data are available)
  • Table 46 Recommended timing of initial intervention with tocilizumab and corticosteroids based on the grade of CRS
  • Table 47 CRS revised grading system
  • Table 48 High-dose vasopressors (all doses are required for ≥3 hours)
  • Table 49 Emerging Drugs Analysis
  • Table 50 Emerging Drugs Analysis
  • Table 51 Canakinumab, Clinical Trial Description, 2020
  • Table 52 Itacitinib, Clinical Trial Description, 2020
  • Table 53 Cytosorb, Clinical Trial Description, 2020
  • Table 54 Defibrotide, Clinical Trial Description, 2020
  • Table 55 Anakinra, Clinical Trial Description, 2020
  • Table 56 Market Size of Cytokine Release Syndrome (CRS) in the 7MM in USD Million (2017-2030)
  • Table 57 Market Size of CRS by therapies in the 7MM, in USD Million (2017-2030)
  • Table 58 Conjoint Analysis for Anakinra
  • Table 59 Conjoint Analysis for Defibrotide
  • Table 60 Conjoint Analysis for Itacitinib
  • Table 61 Market Size of CRS in the United States, in USD Million (2017-2030)
  • Table 62 Market Size of CRS by therapies in the US, in USD Million (2017-2030)
  • Table 63 Market Size of CRS in Germany, USD Million (2017-2030)
  • Table 64 Market Size of CRS by therapies in Germany, in USD Million (2017-2030)
  • Table 65 Market Size of CRS in France, USD Million (2017-2030)
  • Table 66 Market Size of CRS by therapies in France, in USD Million (2017-2030)
  • Table 67 Market Size of CRS in Italy, USD Million (2017-2030)
  • Table 68 Market Size of CRS by therapies in Italy, in USD Million (2017-2030)
  • Table 69 Market Size of CRS in USD Million (2017-2030)
  • Table 70 Market Size of CRS by therapies in Spain, in USD Million (2017-2030)
  • Table 71 Market Size of CRS in the United Kingdom, in USD Million (2017-2030)
  • Table 72 Market Size of CRS by therapies in the UK, in USD Million (2017-2030)
  • Table 73 Market Size of CRS in Japan, in USD Million (2017-2030)
  • Table 74 Market Size of CRS by therapies in Japan, in USD Million (2017-2030)

List of Figures

  • Figure 1 Pathogenesis and management of CRS
  • Figure 2 Clinical presentation of CRS
  • Figure 3 Causes of CRS
  • Figure 4 Mechanism of CAR T-cell therapy and CRS
  • Figure 5 Pathophysiology of CRS
  • Figure 6 Pathways leading to CRS
  • Figure 7 United States KOL Views
  • Figure 8 Europe KOL Views
  • Figure 9 Total Number of Hematologic malignancies Patients receiving CAR-T Cell Therapies in the 7MM (2017-2030)
  • Figure 10 Total Number of Patients develop CRS following CAR-T Cell Therapies in the 7MM (2017-2030)
  • Figure 11 Total Number of B-cell NHL Patients receiving CAR-T Cell Therapies in the US (2017-2030)
  • Figure 12 Total Number of ALL Patients receiving CAR-T Cell Therapies in the US (2017-2030)
  • Figure 13 Total Number of MM Patients receiving CAR-T Cell Therapies in the US (2017-2030)
  • Figure 14 Total Number of Patients developing CRS following CAR-T Cell Therapies in the US (2017-2030)
  • Figure 15 Number of Patients Developing CRS by Severity/Grade in the US (2017-2030)
  • Figure 16 Total Number of B-cell NHL Patients receiving CAR-T Cell Therapies in Germany (2017-2030)
  • Figure 17 Total Number of ALL Patients receiving CAR-T Cell Therapies in Germany (2017-2030)
  • Figure 18 Total Number of MM Patients receiving CAR-T Cell Therapies in Germany (2017-2030)
  • Figure 19 Total Number of Patients developing CRS following CAR-T Cell Therapies in Germany (2017-2030)
  • Figure 20 Number of Patients Developing CRS by Severity/Grade in Germany (2017-2030)
  • Figure 21 Total Number of B-cell NHL Patients receiving CAR-T Cell Therapies in France (2017-2030)
  • Figure 22 Total Number of ALL Patients receiving CAR-T Cell Therapies in France (2017-2030)
  • Figure 23 Total Number of MM Patients receiving CAR-T Cell Therapies in France (2017-2030)
  • Figure 24 Total Number of Patients developing CRS following CAR-T Cell Therapies in France (2017-2030)
  • Figure 25 Number of Patients Developing CRS by Severity/Grade in France (2017-2030)
  • Figure 26 Total Number of B-cell NHL Patients receiving CAR-T Cell Therapies in Italy (2017-2030)
  • Figure 27 Total Number of ALL Patients receiving CAR-T Cell Therapies in Italy (2017-2030)
  • Figure 28 Total Number of MM Patients receiving CAR-T Cell Therapies in Italy (2017-2030)
  • Figure 29 Total Number of Patients developing CRS following CAR-T Cell Therapies in Italy (2017-2030)
  • Figure 30 Number of Patients Developing CRS by Severity/Grade in Italy (2017-2030)
  • Figure 31 Total Number of B-cell NHL Patients receiving CAR-T Cell Therapies in Spain (2017-2030)
  • Figure 32 Total Number of ALL Patients receiving CAR-T Cell Therapies in Spain (2017-2030)
  • Figure 33 Total Number of MM Patients receiving CAR-T Cell Therapies in Spain (2017-2030)
  • Figure 34 Total Number of Patients developing CRS following CAR-T Cell Therapies in Spain (2017-2030)
  • Figure 35 Number of Patients Developing CRS by Severity/Grade in Spain (2017-2030)
  • Figure 36 Total Number of B-cell NHL Patients receiving CAR-T Cell Therapies in the UK (2017-2030)
  • Figure 37 Total Number of ALL Patients receiving CAR-T Cell Therapies in the UK (2017-2030)
  • Figure 38 Total Number of MM Patients receiving CAR-T Cell Therapies in the UK (2017-2030)
  • Figure 39 Total Number of Patients developing CRS following CAR-T Cell Therapies in the UK (2017-2030)
  • Figure 40 Number of Patients Developing CRS by Severity/Grade in the UK (2017-2030)
  • Figure 41 Total Number of B-cell NHL Patients receiving CAR-T Cell Therapies in Japan (2017-2030)
  • Figure 42 Total Number of ALL Patients receiving CAR-T Cell Therapies in Japan (2017-2030)
  • Figure 43 Total Number of MM Patients receiving CAR-T Cell Therapies in Japan (2017-2030)
  • Figure 44 Total Number of Patients developing CRS following CAR-T Cell Therapies in Japan (2017-2030)
  • Figure 45 Number of Patients Developing CRS by Severity/Grade in Japan (2017-2030)
  • Figure 46 Grading and management of CRS
  • Figure 47 Treatment algorithm for management of CRS based on the revised CRS grading system
  • Figure 48 Unmet needs of CRS
  • Figure 49 Market Size of Cytokine Release Syndrome (CRS) in the 7MM in USD Million (2017-2030)
  • Figure 50 Market Size of CRS by therapies in the 7MM, in USD Million (2017-2030)
  • Figure 51 Market Size of Cytokine Release Syndrome (CRS) in the US, USD Millions (2017-2030)
  • Figure 52 Market Size of CRS by therapies in the US, in USD Million (2017-2030)
  • Figure 53 Market Size of CRS in Germany, USD Millions (2017-2030)
  • Figure 54 Market Size of CRS by therapies in Germany, in USD Million (2017-2030)
  • Figure 55 Market Size of CRS in France, USD Millions (2017-2030)
  • Figure 56 Market Size of CRS by therapies in France, in USD Million (2017-2030)
  • Figure 57 Market Size of CRS in Italy, USD Millions (2017-2030)
  • Figure 58 Market Size of CRS by therapies in Italy in USD Million (2017-2030)
  • Figure 59 Market Size of CRS in Spain, USD Millions (2017-2030)
  • Figure 60 Market Size of CRS by therapies in Spain in USD Million (2017-2030)
  • Figure 61 Market Size of CRS in the UK, USD Millions (2017-2030)
  • Figure 62 Market Size of CRS by therapies in the UK in USD Million (2017-2030)
  • Figure 63 Market Size of CRS in Japan, USD Millions (2017-2030)
  • Figure 64 Market Size of CRS by therapies in Japan in USD Million (2017-2030)
  • Figure 65 Market Drivers
  • Figure 66 Market Barriers
  • Figure 67 SWOT analysis of CRS