表紙
市場調查報告書

急性淋巴白血病(ALL):市場分析,流行病學,到2030年的市場預測

Acute lymphocytic leukemia (ALL) - Market Insight, Epidemiology and Market Forecast -2030

出版商 DelveInsight Business Research LLP 商品編碼 955850
出版日期 內容資訊 英文 257 Pages
商品交期: 最快1-2個工作天內
價格
急性淋巴白血病(ALL):市場分析,流行病學,到2030年的市場預測 Acute lymphocytic leukemia (ALL) - Market Insight, Epidemiology and Market Forecast -2030
出版日期: 2020年06月01日內容資訊: 英文 257 Pages
簡介

白血病是一種在血液和骨髓中發展的癌症,癌細胞以不受控制的方式增殖,從而導致未形成的無功能的血細胞。在急性白血病中,患骨髓會產生異常的原始細胞,稱為白血病細胞,該細胞在骨髓中積累並干擾正常血細胞的產生。急性白血病發展迅速,需要立即治療。

急性白血病的典型形式包括急性髓細胞性白血病(AML),急性淋巴細胞性白血病(ALL)和急性早幼粒細胞性白血病(APML)。其中,急性淋巴細胞白血病(ALL),也稱為急性淋巴細胞白血病,是一種影響血液和骨髓的癌症。

在ALL中,骨髓中稱為淋巴細胞的年輕白細胞會癌變並過度生產未成熟的白細胞,主要是淋巴母細胞或白血病母細胞。這阻止了骨髓產生足夠數量的紅細胞,正常白細胞和血小板,使其易於出現貧血,反覆感染,瘀傷和出血。然後胚細胞從骨髓排入血液,並在各種器官中積累,例如淋巴結或腺體,脾臟,肝臟和中樞神經系統(大腦和脊髓)。

本報告研究了美國,德國,法國,意大利,西班牙,英國和日本等七個主要國家到2030年ALL的流行情況,SWOT分析,疾病背景和概況,診斷方法,流行病學和患者人數,按國家/地區劃分的流行病,當前的治療方法,指南,未滿足的需求,患者的出差情況,臨床試驗的關鍵終點,市場上的藥物,新療法,每個國家/地區的市場規模等有關信息。

目錄

第1章主要調查結果

第2章執行摘要

第3章SWOT分析

第4章市場概述

第5章疾病背景和概述

  • 簡介
    • 子類型
    • 體徵和症狀
    • 風險因素和原因
    • 病因

第6章診斷

  • 驗血
    • 全血細胞計數(CBC)和外周血塗片
    • 血液化學測試
    • 凝血試驗
  • 骨測試
    • 骨穿刺和活檢
  • 用於診斷和分類的測試
    • 用顯微鏡定期檢查
    • 細胞學檢查
    • 流式細胞儀和免疫組化檢查
  • 染色體測試
    • 螢光原位雜交(FISH)
    • 聚合□鏈反應(PCR)
  • 圖像檢查
    • 計算機斷層掃瞄(CT)掃瞄
    • 磁共振圖像(MRI)掃瞄
  • 所有階段
    • B細胞ALL分期
    • T細胞ALL分期

第7章流行病學和患者人群

  • 主要發現
  • 假設和理由:7個主要國家
  • 流行病學情景:7個主要國家
    • 白血病新病例數
    • ALL新病例數
    • 所有特定年齡的診斷病例
    • ALL子類型的病例數
    • 基因突變特例
    • 治療病例

第8章美國流行病學

  • 新病例數
  • 性別案件數
  • 按年齡劃分的案件數
  • 按子類型分類的案件數
  • 基因突變特例
  • 治療病例

第5章歐洲國家的流行病學

  • 德國
  • 法國
  • 意大利
  • 西班牙
  • 英國

第10章日本流行病學

第11章當前處理方法

  • 化學療法
  • 目標療法
  • 免疫療法
  • 放射治療
  • 幹細胞移植

第12章處理算法

第13章準則

  • NCCN指南:2020年
  • ESMO指南:2016年
  • 日本血液學會(JSH)指南:2017年

第14章不受支持的需求

第15章患者旅程

第16章臨床試驗的關鍵終點

第17章已啟動的治療方法

  • Asparlas (calaspargase pegol-mknl):Servier Pharmaceuticals
  • Blincyto(blinatumomab/MT 103):Amgen
  • Kymriah (tisagenlecleucel):NovartisPharmaceuticals
  • Besponsa(inotuzumabozogamicin):Pfizer
  • Erwinaze(asparaginase Erwinia chrysanthemi):Jazz Pharmaceuticals/Porton Biopharma Limited
  • Iclusig(ponatinib):Takeda(Ariad Pharmaceuticals)

第18章新療法

  • Imbruvica (Ibrutinib):Pharmacyclics (AbbVie Company)
  • Jakafi(ruxolitinib):Incyte Corporation/Novartis
  • Motixafortide (BL-8040):BioLine Rx
  • TC-110:TCR2治療藥物
  • Lisocabtagene Maraleucel(JCAR017):Bristol-Myers Squibb
  • TBI-1501:Takara Bio/Otsuka Pharmaceuticals
  • UCART19:Servier/Allogene
  • Venetoclax: AbbVie and Roche
  • NiCord(omidubicel):Gamida Cell Ltd.
  • Eliquis(apixaban):Bristol-Myers Squibb-Pfizer
  • Isatuximab: Sanofi
  • JZP-458(重組Erwinia asparaginase):Jazz Pharmaceuticals
  • Vyxeos(注射用Daunorubicin與Cytarabine ):Jazz Pharmaceuticals Daratumumab: Janssen Research & Development
  • ProTmune:Fate Therapeutics
  • MB-CART19.1:MiltenyiBiotec BV&Co. KG
  • BPX-501 T細胞(rivogenlecleucel; iC9-CAR19細胞):Bellicum Pharmaceuticals
  • PBCAR0191:Precision BioSciences/Servier
  • AUTO1:Autolus Limited
  • KTE-X19:Gilead Sciences

第19章聯合分析

第7章主要國家的市場分析

  • 主要發現
  • 市場前景

第21章7個主要國家/地區的市場規模

  • 市場規模
  • 按治療方法劃分的市場規模

第22章美國市場規模

第23章5個歐洲國家的市場規模

  • 德國
  • 法國
  • 意大利
  • 西班牙
  • 英國
  • 日本

第24章市場准入和贖回

  • 在5個歐洲國家/地區獲取和兌換先進治療藥物(ATMP)
  • 其他治療的獲取和報銷

第25章市場增長因素

第26章市場壁壘

第27章附錄

第28章Delve Insight服務內容

第29章免責聲明

第30章:關於Delve Insight

目錄
Product Code: DIMI0797

DelveInsight's 'Acute Lymphocytic Leukemia (ALL) - Market Insights, Epidemiology and Market Forecast-2030' report delivers an in-depth understanding of the ALL, historical and forecasted epidemiology as well as the ALL market trends in the United States, EU5 (Germany, France, Italy, Spain, and United Kingdom), and Japan.

The ALL market report provides current treatment practices, emerging drugs, ALL market share of the individual therapies, current and forecasted ALL market size from 2017 to 2030 segmented by seven major markets. The Report also covers current ALL treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate best of the opportunities and assesses underlying potential of the market.

Geography Covered

  • The United States
  • EU5 (Germany, France, Italy, Spain and the United Kingdom)
  • Japan
Study Period: 2017-2030.

Acute Lymphocytic Leukemia (ALL): Disease Understanding and Treatment Algorithm

Acute Lymphocytic Leukemia Overview

Leukemia is a term given to a group of cancers that develop in the blood and bone marrow. It originates in developing blood cells that have undergone a malignant change, which means they multiply in an uncontrolled manner, leaving them unformed and inoperative.

Leukemia can be either acute or chronic. In chronic leukemia, there is an accumulation of mature but abnormal white blood cells that have undergone a malignant change when developing from a blast cell. It progresses more slowly than acute leukemia and may not require treatment for a long time after it is diagnosed.

On the other hand, with acute leukemia, the diseased bone marrow produces an excessive number of abnormal blast cells, called leukemic cells. These cells accumulate in the bone marrow interfering with the production of normal blood cells. Acute leukemia develops and progresses quickly, and therefore, needs to be treated as soon as it is detected.

Typical forms of acute leukemia include acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), and acute promyelocytic leukemia (APML) .

Acute lymphocytic leukemia (ALL) , also known as acute lymphoblastic leukemia, is a type of cancer that affects the blood and bone marrow. It starts from young white blood cells called lymphocytes in the bone marrow; mainly characterized by an overproduction of immature white blood cells, called lymphoblasts or leukemic blasts. Because the bone marrow is unable to make adequate numbers of red cells, normal white cells, and platelets, people with ALL become more susceptible to anemia, recurrent infections, and to bruising and bleeding easily. The blast cells can then spill out of the bone marrow into the bloodstream and accumulate in various organs including the lymph nodes or glands, spleen, liver, and central nervous system (brain and spinal cord).

ALL is mainly classified into B-cell and T-cell ALL. ALL can occur at any age but is more common in young children (0-14 years) and it develops quickly, around 54% of ALL cases in US diagnosed among people aged <20 years. Among children, B-cell lineage ALL constitutes approximately 88% of cases. Among adults, B-cell lineage represents around 75% of cases.

Acute Lymphocytic Leukemia Diagnosis

Certain signs and symptoms can suggest that a person might have ALL, but tests are needed to confirm the diagnosis. During the physical exam, the doctor usually focus on any enlarged lymph nodes, areas of bleeding or bruising, or possible signs of infection. The eyes, mouth, and skin will be looked at carefully, and a thorough nervous system exam may be done. The patient's abdomen will be checked for spleen or liver enlargement.

If there is reason to think low levels of blood cells might be causing symptoms (anemia, infections, bleeding or bruising, etc.), the doctor will most likely order blood tests to check blood cell counts. The patient might also be referred to a hematologist doctor who specializes in diseases of the blood, including leukemia.

The diagnosis of ALL is mainly done by Blood test (complete blood count (CBC) and peripheral blood smear, blood chemistry tests, blood coagulation tests), Bone marrow test (bone marrow aspiration and biopsy), Lab tests (routine exams with a microscope, cytochemistry tests, flow cytometry and immunohistochemistry), Chromosome tests (fluorescent in situ hybridization (FISH), polymerase chain reaction (PCR)), Imaging tests (computerized Tomography (CT) scan, magnetic resonance imaging (MRI) Scan, and staging).

Acute Lymphocytic Leukemia Treatment

ALL is a malignant clonal disease that usually develops when a lymphoid progenitor cell turns into genetically altered through somatic changes and goes through uncontrolled proliferation. This progression of clonal expansion further leads to ALL. However, common treatment of ALL divided into distinct phases such as Induction therapy, Consolidation therapy, Maintenance therapy, and Preventive treatment to the spinal cord, among others.

  • Induction Therapy - The main purpose of the first phase of treatment is to kill most of the leukemia cells in the bone marrow and blood also to restore normal blood cell production.
  • Consolidation Therapy - Consolidation therapy is also known as post-remission therapy. The main purpose of this therapy is to completely wipe out remaining leukemia in the body, such as in the brain or spinal cord. Consolidation therapy is also known as post-remission therapy.
  • Maintenance Therapy - This is known as the third phase of treatment, which prevents leukemia cells from regrowth. However, the treatment used in this stage is often given at much lesser doses for a long period, often years.
  • Preventive treatment to the spinal cord - In this phase of therapy, a patient suffering from ALL may receive additional treatment from killing leukemia cells which are located in the central nervous system. Also, in this type of treatment phase chemotherapy drugs are often injected directly into the fluid that covers the spinal cord.

The therapies that are approved for the treatment of ALL are Blincyto (blinatumomab/MT 103), Kymriah {CTL019 (tisagenlecleucel)}, Besponsa (inotuzumab ozogamicin), Iclusig (Ponatinib), among others.

ALL Epidemiology

The ALL epidemiology division provides the insights about historical and current ALL patient pool and forecasted trend for each 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 part of the DelveInsight report also provides the diagnosed patient pool and their trends along with assumptions undertaken.

Key Findings

In the year 2017, the 7MM total incident case of ALL was 10,341 cases which are expected to grow during the study period, i.e., 2017-2030.

The disease epidemiology covered in the report provides historical as well as forecasted ALL epidemiology [segmented as Total Incident Cases of Leukemia, Total Incident Cases of ALL, Gender-specific cases of ALL, Diagnosed cases of ALL by Age Distribution, Subtype-specific cases of ALL, Genetic mutation-specific cases of ALL, and Total Treated Cases of ALL] scenario of ALL in the 7MM covering United States, EU5 countries (Germany, France, Italy, Spain, and United Kingdom), and Japan from 2017 to 2030.

Country Wise- ALL Epidemiology

Estimates show that the highest cases of ALL in the 7MM were in the United States, followed by Germany, Japan, France, the United Kingdom, Italy, and Spain in 2017.

  • In the United States, the total number of incident cases of ALL was 5,816 cases in the year 2017 which are expected to grow during the study period, i.e., 2017-2030.
  • In the year 2017, the total incident cases of ALL were 3,652 cases in EU-5 which are expected to grow during the study period, i.e., 2017-2030.
  • In Japan, the total number of incident cases of ALL was 872 cases in the year 2017 which are expected to grow during the study period, i.e., 2017-2030.

ALL Drug Chapters

Drug chapter segment of the ALL report encloses the detailed analysis of ALL marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the ALL 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.

ALL Approved Drugs

Blincyto/blinatumomab/MT 103 (Amgen)

Blincyto is a bispecific CD19-directed CD3 T-cell engager (BiTE) immunotherapy that binds to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of T-cells. Blinatumomab possesses two antigen-recognition sites, one for the CD3 complex, a group of T-cell surface glycoproteins that complex with the T-cell receptor (TCR), and one for CD19, a tumor-associated antigen (TAA) overexpressed on the surface of B-cells. This bispecific monoclonal antibody brings CD19-expressing tumor B-cells and cytotoxic T lymphocytes (CTLs) and helper T lymphocytes (HTLs) together, which may result in the CTL- and HTL-mediated cell death of CD19-expressing B-lymphocytes.

In July 2014, the US FDA granted Breakthrough Therapy Designation to Blincyto for adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor ALL. Before this, in May 2008, the US FDA granted orphan drug designation to blinatumomab for the treatment of ALL.

Furthermore, in July 2009, the European Commission granted orphan drug designation to Micromet AG, Germany, for blinatumomab for the treatment of acute lymphoblastic leukemia.

Asparlas/calaspargase pegol-mknl (Servier Pharmaceuticals)

Asparlas (calaspargase pegol-mknl) is an intravenous formulation containing E.coli-derived L-asparaginase II conjugated with succinimidyl carbonate monomethoxypolyethylene glycol (SC-PEG), with potential antineoplastic activity. L-asparaginase hydrolyzes L-asparagine to L-aspartic acid and ammonia, thus depleting cells of asparagine. Asparagine depletion blocks protein synthesis and tumor cell proliferation, especially in the G1 phase of the cell cycle and ultimately induces tumor cell death. Asparagine is critical to protein synthesis in acute lymphoblastic leukemia (ALL) cells which, unlike normal cells, cannot synthesize this amino acid due to the absence of the enzyme asparagine synthase.

In April 2018, Servier entered into a definitive agreement with the Shire, a leading global biotechnology company focused on rare diseases, to acquire its Oncology business for USD 2.4 Billion. The acquisition allows Servier to establish an immediate and direct commercial presence in the United States, the world's leading biopharmaceuticals market.

Kymriah/tisagenlecleucel (Novartis Pharmaceuticals)

Kymriah (tisagenlecleucel, formerly CTL019) suspension for intravenous infusion is a CD19-directed genetically modified autologous chimeric antigen receptor T-cell (CAR-T) therapy. It is approved in the US, the EU, Japan, and other countries for the treatment of:

  • Patients up to 25 years with B-cell acute lymphoblastic leukemia that is refractory or in second or later relapse
  • Adults with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy

In January 2014, the US FDA granted Orphan drug designation to Kymriah for the treatment of ALL. Likewise in April 2014, Orphan drug designation was granted by the European Commission to Novartis for the treatment of B-lymphoblastic leukemia/lymphoma.

In addition to this, the US FDA granted Kymriah a breakthrough therapy designation for relapsed or refractory B-cell ALL.

Besponsa/inotuzumabozogamicin (Pfizer)

Besponsa is an antibody-drug conjugate (ADC) composed of a monoclonal antibody (mAb) targeting CD22, a cell surface antigen expressed on cancer cells in almost all B-ALL patients, linked to a cytotoxic agent. It is used for the treatment of adults with relapsed or refractory B-cell precursor ALL. When Besponsa binds to the CD22 antigen on B-cells, it is internalized into the cell, where the cytotoxic agent calicheamicin is released causing cell death. Besponsa originated from a collaboration between Pfizer and Cell tech, now UCB.

In March 2013, the US FDA also granted Inotuzumab ozogamicin with the Orphan Designation Status for the treatment of B-cell ALL. Later, in June 2013, the orphan designation was granted by the European Commission to Pfizer for inotuzumab ozogamicin for the treatment of B-cell ALL.

In October 2015, Inotuzumab ozogamicin was granted with Breakthrough Therapy designation from the US FDA for ALL.

Iclusig/Ponatinib (Takeda/Ariad Pharmaceuticals)

Iclusig is an orally administered kinase inhibitor whose primary target is BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Iclusig was designed using ARIAD's computational and structure-based drug-design platform specifically to inhibit the activity of BCR-ABL. It targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs.

It is used in the treatment of the following:

  • Treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) or Ph+ ALL for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated.
  • Treatment of adult patients with T315I-positive CML (chronic phase, accelerated phase, or blast phase) or T315I-positive Ph+ ALL

Note: Detailed Current therapies assessment will be provided in the full report of ALL

ALL Emerging Drugs

PBCAR0191 (Precision BioSciences/Servier)

Precision BioSciences is investigating their first allogeneic CAR T in Phase I/II clinical trial for relapsed/refractory cases of B-cell ALL and NHL. This product is under investigation in collaboration with Servier. PBCAR0191 is an allogeneic CAR T cell therapy targeting the well-validated tumor target CD19 and is being developed for ALL, and non-hodgkin lymphoma, or NHL. Also, CD19 is a protein that is expressed on the surface of B-cells.

This product is based on the donor-derived T-cells modified using the ARCUS genome editing technology. PBCAR0191 recognizes the well-characterized tumor cell surface protein CD19, an important and validated target in several B-cell cancers. It is designed to avoid graft-versus-host disease, or GvHD, a significant complication associated with donor-derived, cell-based therapies.

AUTO1 (Autolus Limited)

Autolus Limited is also investigating its lead CAR T-cell therapy candidate in pediatric and young adult patients with ALL. It is a CD19 CAR T-cell investigational therapy designed to overcome the limitations in safety-while maintaining similar levels of efficacy-compared to current CD19 CAR T cell therapies. Designed to have a fast target binding off-rate to minimize excessive activation of the programmed T cells, AUTO1 may reduce toxicity and be less prone to T-cell exhaustion, which could enhance persistence and improve the T-cells' abilities to engage in serial killing of target cancer cells. AUTO1 is Autolus' most advanced program and recently entered a pivotal study in adult ALL and is also being evaluated in a Phase I study in pediatric ALL.

In April 2020, the US FDA has accepted the IND application for AUTO1, its lead CAR T product candidate for the treatment of adults with ALL. The active IND allows initiation of the US sites in the company's first pivotal study, AUTO1-AL1. In November 2019, the US FDA granted AUTO1 orphan drug designation for the treatment of ALL patients.

KTE-X19 (Gilead Sciences)

KTE-X19 is an investigational, autologous, anti-CD19 CAR T cell therapy. KTE-X19 uses the XLP manufacturing process that includes T-cell selection and lymphocyte enrichment. Lymphocyte enrichment is a necessary step in certain B-cell malignancies in which circulating lymphoblasts are a common feature. It is a preparation of autologous peripheral blood T lymphocytes (PBTL) that have been transduced with a retroviral vector expressing a chimeric antigen receptor (CAR) consisting of an anti-CD19 single chain variable fragment (scFv) coupled to the costimulatory signaling domain CD28 and the zeta chain of the T-cell receptor (TCR)/CD3 complex (CD3 zeta), with potential immune stimulating and antineoplastic activities. Upon intravenous infusion and re-introduction of autologous anti-CD19 CAR-CD28 T cells KTE-X19 into the patient, these cells bind to and induce selective toxicity in CD19-expressing tumor cells.

UCART19 (Servier/Allogene)

UCART19 is a first-in-class allogeneic CAR T cell product candidate for the treatment of pediatric and adult patients with R/R CD19 positive B-cell ALL. Servier is the sponsor of the UCART19 clinical trials and is also responsible for manufacturing UCART19. This therapy is being jointly developed under a clinical development collaboration between Servier and Allogene based on an exclusive license granted by Cellectis to Servier. UCART19 utilizes TALEN gene-editing technology pioneered and owned by Cellectis.

UCART19 is manufactured to express a CAR that is designed to target CD19 and gene-edited to lack TCRα and CD52 to minimize the risk of GvHD and enable a window of persistence in the patient. In addition, UCART19 cells are engineered to express a small protein on the cell surface called RQR8, which consists of two rituximab recognition domains. This allows for recognition and elimination of cells if silencing of CAR activity is desired.

In February 2020, Cellectis granted additional rights to Servier to develop and commercialize all next-generation gene-edited allogeneic CAR T-cell products targeting CD19, including ALLO-501A.

Lisocabtagene Maraleucel/JCAR017 (Bristol-Myers Squibb)

Lisocabtagene Maraleucel (JCAR017), also known as Liso-cel, is under development by Bristol-Myers Squibb. It is an investigational CAR T-cell therapy designed to target CD19, which is a surface glycoprotein expressed during normal B-cell development and maintained following malignant transformation of B cells. Liso-cel CAR T cells aim to target CD19 expressing cells through a CAR construct that includes an anti-CD19 single-chain variable fragment (scFv) targeting domain for antigen specificity, a transmembrane domain, a 4-1BB co-stimulatory domain hypothesized to increase T-cell proliferation and persistence, and a CD3-zeta T-cell activation domain. The defined composition of CD4+ and CD8+ CAR T cells in liso-cel may limit product variability; however, the clinical significance of defined composition is unknown.

In September 2016, the US FDA granted orphan drug designation to JCAR017 for the treatment of ALL.

Venetoclax/Venclexta/ABT199/RG7601 (AbbVie and Roche)

Venetoclax (Venclexta, Venclyxto) is an oral B-cell lymphoma-2 (BCL-2) inhibitor developed by AbbVie and Genentech. It is used for the treatment of adult patients with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL) and in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are aged 75 or older, or who have comorbidities that preclude the use of intensive induction chemotherapy.

Venetoclax helps restore the process of apoptosis by binding directly to the BCL-2 protein, displacing proapoptotic proteins like BIM, triggering mitochondrial outer membrane permeabilization, and the activation of caspases. In nonclinical studies, venetoclax has demonstrated cytotoxic activity in tumor cells that overexpress BCL-2.

JZP-458/PF743/recombinant Erwinia asparaginase (Jazz Pharmaceuticals)

Jazz Pharmaceuticals is investigating JZP-458 for the treatment for pediatric and adult patients with ALL who are hypersensitive to E. coli-derived asparaginases. JZP-458 is a recombinant of Erwinia asparaginase which uses a novel Pseudomonas fluorescens manifestation platform. This product is in development by using the Pfenex's Expression technology under their agreement with Jazz Pharmaceuticals. Pfenex granted worldwide rights to develop and commercialize multiple early-stage hematology product candidates, including a recombinant Erwinia asparaginase JZP-458 to Jazz pharmaceuticals.

In October 2019, the US Food and Drug Administration granted Fast Track Designation for JZP-458/PF743 for the treatment of ALL.

Daratumumab (Janssen Research & Development)

Daratumumab is a human IgG1k monoclonal antibody that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab is being developed by Janssen Biotech under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. This drug has been already approved by the US FDA to treat multiple myeloma with the brand name Darzalex. Janssen Research & Development had initiated an open-label, multicenter, phase II study evaluating the efficacy and safety of Daratumumab in pediatric and young adult subjects ≥1 and ≤30 years with relapsed/refractory precursor B-cell or T-cell ALL or lymphoblastic lymphoma.

In July 2012, Genmab entered into a collaboration with Janssen Biotech and its affiliates (Janssen) to create and develop bispecific antibodies using its DuoBody technology platform. Genmab created panels of bispecific antibodies to multiple disease target combinations identified by Janssen, who will in turn fully fund research at Genmab.

Imbruvica/Ibrutinib {Pharmacyclics (an AbbVie Company)}

Ibrutinib is an oral small-molecule inhibitor of type of enzyme, called a protein kinase that controls the rate at which certain cells multiply. In particular, ibrutinib has been shown to bind to covalently, and ultimately inhibit, the Bruton's tyrosine kinase (BTK). BTK plays a primary role in signaling healthy B cells to survive, mature, proliferate and release antibodies.

Since its launch in 2013, Imbruvica had received 11 FDA approvals across six disease areas: chronic lymphocytic leukemia (CLL) with or without 17p deletion (del17p); small lymphocytic lymphoma (SLL) with or without del17p; Waldenström's macroglobulinemia (WM); previously-treated patients with mantle cell lymphoma (MCL); previously-treated patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy and previously-treated patients with chronic graft-versus-host disease (cGVHD) after the failure of one or more lines of systemic therapy.

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

ALL Market Outlook

Chemotherapy is often complex and intense, particularly in the initial months of treatment for ALL. The most common treatment regimens use a combination of more than one anticancer drug. It is broken down into three phases: induction phase, consolidation (or intensification) phase, and maintenance phase. Induction is the first phase of chemotherapy, and the goal of this phase is to induce a remission. In this phase, numerous drugs are usually being used depending on the patient's age, the specific features of leukemia, and the overall health of the patient. Induction regimens for ALL generally use a combination of drugs that include vincristine; anthracyclines (daunorubicin, doxorubicin); and corticosteroids (prednisone, dexamethasone) administered either with or without asparaginase and/or cyclophosphamide. Even after the complete remission, some leukemia cells still remain in the body. The presence of these cells is referred to as "minimal residual disease (MRD)." Patients who have MRD, are at increased risk of disease relapse. After a patient achieves a complete remission, postremission therapy is given to kill every remaining leukemia cell in the body.

Oftentimes when residual leukemia cells remain after remission, so the optimal treatment for ALL patients requires additional intensive postremission therapy. The second phase of chemotherapy is called consolidation therapy. The combination of drugs and the duration of therapy for consolidation regimens vary but can consist of combinations of drugs similar to those drugs used during the induction phase. Some drugs which are used in this phase are High-dose methotrexate, Cytarabine, Vincristine, 6-mercaptopurine, Blincyto, Besponsa, Cyclophosphamide, Asparaginase, and Corticosteroids (prednisone, and dexamethasone). The third phase of ALL treatment is called "maintenance phase." The goal of maintenance therapy is to prevent disease relapse after induction and consolidation therapy. Most maintenance regimens include 6-mercaptopurine, Methotrexate, Vincristine, Corticosteroids, and Intrathecal chemotherapy.

At present several pharmaceutical companies are working for the development of novel approach to treat this condition. Key players like KTE-X19 (Gilead Sciences), UCART19 (Servier/Allogene), Lisocabtagene Maraleucel/JCAR017 (Bristol-Myers Squibb), Venetoclax/Venclexta/ABT199/RG7601 (AbbVie and Roche), JZP-458/PF743/recombinant Erwinia asparaginase (Jazz Pharmaceuticals), Daratumumab (Janssen Research & Development), Imbruvica/Ibrutinib {Pharmacyclics (an AbbVie Company)}, AUTO1 (Autolus Limited), PBCAR0191 (Precision BioSciences/Servier), and others.

Key Findings

The ALL market size in the 7MM is expected to change during the study period 2017-2030. The therapeutic market of ALL in the seven major markets was USD 1,246 million in 2017 which is expected to increase during study period (2017-2030). According to the estimates, the highest market size of ALL is found in the United States followed by Germany and France.

The United States Market Outlook

In 2017, the total market size of ALL therapies was USD 907 million in the United States which is expected to increase in the study period (2017-2030).

EU-5 Countries: Market Outlook

In 2017, the total market size of ALL therapies was USD 282 million in the EU-5 countries which is expected to increase in the study period (2017-2030).

Japan Market Outlook

The total market size of ALL therapies in Japan was USD 57 million in 2017 which is expected to increase in the study period (2017-2030).

ALL Pipeline Development Activities

The drugs which are in pipeline include:

  • 1. KTE-X19 (Gilead Sciences)
  • 2. UCART19 (Servier/Allogene)
  • 3. Lisocabtagene Maraleucel/JCAR017 (Bristol-Myers Squibb)
  • 4. Venetoclax/Venclexta/ABT199/RG7601 (AbbVie and Roche)
  • 5. JZP-458/PF743/recombinant Erwinia asparaginase (Jazz Pharmaceuticals)
  • 6. Daratumumab (Janssen Research & Development)
  • 7. Imbruvica/Ibrutinib {Pharmacyclics (an AbbVie Company)}
  • 8. AUTO1 (Autolus Limited)
  • 9. PBCAR0191 (Precision BioSciences/Servier)

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

ALL Drugs Uptake

CAR T cell therapies as a class expected to take major patient share by 2030 in third line and above setting. Around 5 CAR T cell therapies are expected to enter market by 2023 and set to impact the market of current treatment options mainly stem cell transplantation and Kymriah in third line and above setting. Also, intense competition is anticipated among them which might impact the uptake of these therapies.

Access and Reimbursement Scenario in ALL Therapies

ALL is a type of cancer that develops in white blood cells. Over the last few years, the treatment paradigm of ALL is changed due to the launch of a number of therapies that have improved treatment outcomes for patients with ALL such as Blincyto and Besponsa; and the first chimeric antigen receptor (CAR) T-cells for relapsed/refractory pediatric and young adult ALL patients, namely Kymriah. However, chemotherapies are highly effective and remain the backbone of frontline ALL treatment.

The market access and reimbursement of advanced therapy medicinal products (ATMPs) (e.g., Kymriah) is difficult due to its high cost, but these therapies offer ground-breaking new opportunities for the treatment of disease. Two thousand nineteen (2019) was a milestone year for CAR-T cell therapy as the product' manufacturer Novartis (Kymriah) managed to successfully obtain reimbursement in many key countries. The launch of kymriah was highly anticipated by patients, medical professionals, healthcare system stakeholders such as Health Technology Assessment (HTA) bodies and payers, as well as by the wider pharmaceutical industry.

In France, Kymriah was made available to French patients prior to their European MA through the early access program 'Temporary Authorisation for Use' (Autorisation Temporaire d'Utilisation, [ATU]). The ATU route provides reimbursed access before MA approval to therapies that hold particular therapeutic promise and are not currently available through clinical trials in France. After MA, the drug is reimbursed as 'post-ATU' until reimbursement and pricing decisions are finalized. During the ATU/post-ATU period, the manufacturers set the drug price freely, however, the pricing committee sets a maximum price per unit. In addition, drugs with annual pre-tax revenue exceeding Euro 30 million under the ATU/post-ATU period are subject to spending caps, above which manufacturers are liable to pay rebates.

KOL-Views

To keep up with current market trends, we take KOLs and SME's opinion working in ALL 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 ALL market trend. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.

Competitive Intelligence Analysis

We perform Competitive and Market Intelligence analysis of the ALL Market by using various Competitive Intelligence tools that includes - 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 ALL, explaining its causes, signs and symptoms, pathophysiology and currently available therapies.
  • Comprehensive insight has been provided into the ALL epidemiology and treatment in the 7MM.
  • Additionally, an all-inclusive account of both the current and emerging therapies for ALL is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
  • A detailed review of ALL 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 ALL market.

Report Highlights

  • In the coming years, ALL 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 ALL 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 ALL. Launch of emerging therapies, will significantly impact the ALL market.
  • A better understanding of disease pathogenesis will also contribute to the development of novel therapeutics for ALL.
  • 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.

ALL Report Insights

  • Patient Population
  • Therapeutic Approaches
  • ALL Pipeline Analysis
  • ALL Market Size and Trends
  • Market Opportunities
  • Impact of upcoming Therapies

ALL Report Key Strengths

  • 11 Years Forecast
  • 7MM Coverage
  • ALL Epidemiology Segmentation
  • Key Cross Competition
  • Highly Analyzed Market
  • Drugs Uptake

ALL Report Assessment

  • SWOT Analysis
  • Current Treatment Practices
  • Unmet Needs
  • Pipeline Product Profiles
  • Conjoint Analysis
  • Market Attractiveness
  • Market Drivers and Barriers

Key Questions

Market Insights:

  • What was the ALL Market share (%) distribution in 2017 and how it would look like in 2030?
  • What would be the ALL total market size as well as market size by therapies across the 7MM during the study period (2017-2030)?
  • What are the key findings pertaining to the market across the 7MM and which country will have the largest ALL market size during the study period (2017-2030)?
  • At what CAGR, the ALL market is expected to grow in the 7MM during the study period (2017-2030)?
  • What would be the ALL market outlook across the 7MM during the study period (2017-2030)?
  • What would be the ALL 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 a subsequent analysis of the associated trends?
  • ALL patient types/pool where unmet need is more and whether emerging therapies will be able to address the residual unmet need?
  • How emerging therapies are performing on the parameters like efficacy, safety, route of administration (RoA), treatment duration and frequencies on the basis of their clinical trial results?
  • Among the emerging therapies, what are the potential therapies which are expected to disrupt the ALL market?

Epidemiology Insights:

  • What is the disease risk, burden and unmet needs of the ALL?
  • What is the historical ALL patient pool in the seven major markets covering the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan?
  • What would be the forecasted patient pool of ALL in the 7 major markets covering the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan?
  • What will be the growth opportunities in the 7MM with respect to the patient population pertaining to ALL?
  • Out of all the 7MM countries, which country would have the highest incident population of ALL during the study period (2017-2030)?
  • At what CAGR the population is expected to grow in the 7MM during the study period (2017-2030)?
  • What are the various recent and upcoming events which are expected to improve the diagnosis of ALL?

Current Treatment Scenario and Emerging Therapies:

  • What are the current options for the treatment of ALL?
  • What are the current treatment guidelines for the treatment of ALL in the US, Europe and Japan?
  • How many companies are developing therapies for the treatment of ALL?
  • How many therapies are developed by each company for the treatment of ALL?
  • How many emerging therapies are in mid stage, and late stage of development for the treatment of ALL?
  • What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the ALL 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 ALL and their status?
  • What are the key designations that have been granted for the emerging therapies for ALL?
  • What is the global historical and forecasted market of ALL?

Reasons to buy

  • The report will help in developing business strategies by understanding trends shaping and driving the ALL market.
  • To understand the future market competition in the ALL market and Insightful review of the key market drivers and barriers.
  • Organize sales and marketing efforts by identifying the best opportunities for ALL in the US, Europe (Germany, France, Italy, Spain, and the United Kingdom) and Japan.
  • Identification of strong upcoming players in 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 ALL market.
  • To understand the future market competition in the ALL market.

Table of Contents

1. Key Insights

2. Executive Summary of Acute Lymphocytic Leukemia

3. SWOT Analysis of Acute Lymphocytic Leukemia

4. Acute Lymphocytic Leukemia: Market Overview at a Glance

5. Acute Lymphocytic Leukemia (ALL): Disease Background and Overview

  • 5.1. Introduction
    • 5.1.1. Subtypes of ALL
    • 5.1.2. Signs and Symptoms of ALL
    • 5.1.3. Risk Factors and Causes of ALL
    • 5.1.4. Pathogenesis of ALL

6. Diagnosis of ALL

  • 6.1. Blood Test
    • 6.1.1. Complete Blood Count (CBC) and Peripheral Blood Smear
    • 6.1.2. Blood Chemistry Tests
    • 6.1.3. Coagulation Tests
  • 6.2. Bone Marrow Tests
    • 6.2.1. Bone Marrow Aspiration and Biopsy
  • 6.3. Lab Tests used to Diagnose and Classify ALL
    • 6.3.1. Routine Exams with a Microscope
    • 6.3.2. Cytochemistry
    • 6.3.3. Flow Cytometry and Immunohistochemistry
  • 6.4. Chromosome Tests
    • 6.4.1. Fluorescent in situ Hybridization (FISH)
    • 6.4.2. Polymerase Chain Reaction (PCR)
  • 6.5. Imaging Tests
    • 6.5.1. Computerized Tomography (CT) Scan
    • 6.5.2. Magnetic Resonance Imaging (MRI) Scan
  • 6.6. Stages of ALL
    • 6.6.1. B-cell ALL Staging
    • 6.6.2. T-cell ALL Staging

7. Epidemiology and Patient Population

  • 7.1. Key Findings
  • 7.2. Assumptions and Rationale: 7MM
  • 7.3. Epidemiology Scenario: 7MM
    • 7.3.1. Total Incident Cases of Leukemia in the 7MM
    • 7.3.2. Total Incident Cases of ALL in the 7MM
    • 7.3.3. Diagnosed cases of ALL by Age Distribution in the 7MM
    • 7.3.4. Subtype-specific cases of ALL in the 7MM
    • 7.3.5. Genetic mutation-specific cases of ALL in the 7MM
    • 7.3.6. Treated cases of ALL in the 7MM

8. The United States Epidemiology

  • 8.1. Total Incident Cases of ALL in the United States
  • 8.2. Gender-specific cases of ALL in the United States
  • 8.3. Diagnosed cases of ALL by Age Distribution in the United States
  • 8.4. Subtype-specific cases of ALL in the United States
  • 8.5. Genetic mutation-specific cases of ALL in the United States
  • 8.6. Treated cases of ALL in the United States

9. EU-5 Country-wise Epidemiology

  • 9.1. Germany
    • 9.1.1. Total Incident Cases of ALL in Germany
    • 9.1.2. Gender-specific Cases of ALL in Germany
    • 9.1.3. Diagnosed Cases of ALL by Age Distribution in Germany
    • 9.1.4. Subtype-specific Cases of ALL in Germany
    • 9.1.5. Genetic Mutation-specific Cases of ALL in Germany
    • 9.1.6. Total Treated Cases of ALL in Germany
  • 9.2. France
    • 9.2.1. Total Incident Cases of ALL in France
    • 9.2.2. Gender-specific Cases of ALL in France
    • 9.2.3. Diagnosed Cases of ALL by Age Distribution in France
    • 9.2.4. Subtype-specific Cases of ALL in France
    • 9.2.5. Genetic Mutation-specific Cases of ALL in France
    • 9.2.6. Total Treated Cases of ALL in France
  • 9.3. Italy
    • 9.3.1. Total Incident Cases of ALL in Italy
    • 9.3.2. Gender-specific Cases of ALL in Italy
    • 9.3.3. Diagnosed Cases of ALL by Age Distribution in Italy
    • 9.3.4. Subtype-specific Cases of ALL in Italy
    • 9.3.5. Genetic Mutation-specific Cases of ALL in Italy
    • 9.3.6. Total Treated Cases of ALL in Italy
  • 9.4. Spain
    • 9.4.1. Total Incident Cases of ALL in Spain
    • 9.4.2. Gender-specific Cases of ALL in Spain
    • 9.4.3. Diagnosed Cases of ALL by Age Distribution in Spain
    • 9.4.4. Subtype-specific Cases of ALL in Spain
    • 9.4.5. Genetic Mutation-specific Cases of ALL in Spain
    • 9.4.6. Total Treated Cases of ALL in Spain
  • 9.5. The United Kingdom
    • 9.5.1. Total Incident Cases of ALL in the UK
    • 9.5.2. Gender-specific Cases of ALL in the UK
    • 9.5.3. Diagnosed Cases of ALL by Age Distribution in the UK
    • 9.5.4. Subtype-specific Cases of ALL in the UK
    • 9.5.5. Genetic Mutation-specific Cases of ALL in the UK
    • 9.5.6. Total Treated Cases of ALL in the UK

10. Japan Epidemiology

  • 10.1. Total Incident Cases of ALL in Japan
  • 10.2. Gender-specific cases of ALL in Japan
  • 10.3. Diagnosed cases of ALL by Age Distribution in Japan
  • 10.4. Subtype-specific cases of ALL in Japan
  • 10.5. Genetic mutation-specific cases of ALL in Japan
  • 10.6. Treated cases of ALL in Japan

11. Current Treatment Practices: ALL

  • 11.1. Chemotherapy
  • 11.2. Targeted Therapy
  • 11.3. Immunotherapy
  • 11.4. Radiation Therapy
  • 11.5. Stem Cell Transplant

12. Treatment Algorithms

13. Guideline of ALL

  • 13.1. The National Comprehensive Cancer Network (NCCN) Guidelines for Diagnosis and Management of ALL: 2020
  • 13.2. The European Society for Medical Oncology (ESMO)Clinical Practice Guidelines for Diagnosis, Treatment, and Follow-up of ALL in Adult Patients: 2016
  • 13.3. The Japanese Society of Hematology (JSH) Guidelines for ALL: 2017

14. Unmet Needs of Acute Lymphocytic Leukemia (ALL)

15. Patient Journey of Acute Lymphocytic Leukemia (ALL)

16. Key Endpoints in ALL Clinical Trials

17. Marketed Therapies

  • 17.1. Key Cross
  • 17.2. Asparlas (calaspargase pegol-mknl):Servier Pharmaceuticals
    • 17.2.1. Product Description
    • 17.2.2. Regulatory Milestones
    • 17.2.3. Other Developmental Activities
    • 17.2.4. Pivotal Clinical Trials
  • 17.3. Blincyto (blinatumomab/MT 103):Amgen
    • 17.3.1. Product Description
    • 17.3.2. Regulatory Milestones
    • 17.3.3. Other Developmental Activities
    • 17.3.4. Pivotal Clinical Trials
    • 17.3.5. Ongoing Current Pipeline Activity
  • 17.4. Kymriah (tisagenlecleucel): NovartisPharmaceuticals
    • 17.4.1. Product Description
    • 17.4.2. Regulatory Milestones
    • 17.4.3. Other Developmental Activities
    • 17.4.4. Pivotal Clinical Trial
    • 17.4.5. Ongoing Current Pipeline Activity
  • 17.5. Besponsa (inotuzumabozogamicin): Pfizer
    • 17.5.1. Product Description
    • 17.5.2. Regulatory Milestones
    • 17.5.3. Other Developmental Activities
    • 17.5.4. Pivotal Clinical Trial
    • 17.5.5. Ongoing Current Pipeline Activity
  • 17.6. Erwinaze (asparaginase Erwinia chrysanthemi): Jazz Pharmaceuticals/Porton Biopharma Limited
    • 17.6.1. Product Description
    • 17.6.2. Regulatory Milestones
    • 17.6.3. Other Developmental Activities
    • 17.6.4. Pivotal Clinical Trial
  • 17.7. Iclusig (ponatinib): Takeda (Ariad Pharmaceuticals)
    • 17.7.1. Product Description
    • 17.7.2. Regulatory Milestones
    • 17.7.3. Other Developmental Activities.
    • 17.7.4. Pivotal Clinical Trial
    • 17.7.5. Ongoing Current Pipeline Activity

18. Emerging Therapies

  • 18.1. Key Cross
  • 18.2. Imbruvica (Ibrutinib): Pharmacyclics (an AbbVie Company)
    • 18.2.1. Product Description
    • 18.2.2. Other Developmental Activities
    • 18.2.3. Clinical Development
  • 18.3. Jakafi (ruxolitinib): Incyte Corporation/Novartis
    • 18.3.1. Product Description
    • 18.3.2. Other Developmental Activities
    • 18.3.3. Clinical Development
  • 18.4. Motixafortide (BL-8040): BioLine Rx
    • 18.4.1. Product Description
    • 18.4.2. Other Developmental Activities
    • 18.4.3. Clinical Development
    • 18.4.4. Safety and Efficacy
  • 18.5. TC-110: TCR2 Therapeutics
    • 18.5.1. Product Description
    • 18.5.2. Other Developmental Activities
    • 18.5.3. Clinical Development
    • 18.5.4. Safety and Efficacy
  • 18.6. Lisocabtagene Maraleucel (JCAR017): Bristol-Myers Squibb
    • 18.6.1. Product Description
    • 18.6.2. Other Developmental Activities
    • 18.6.3. Clinical Development
    • 18.6.4. Safety and Efficacy
  • 18.7. TBI-1501: Takara Bio/Otsuka Pharmaceuticals
    • 18.7.1. Product Description
    • 18.7.2. Other Developmental Activities
    • 18.7.3. Clinical Development
  • 18.8. UCART19: Servier/Allogene
    • 18.8.1. Product Description
    • 18.8.2. Other Developmental activities
    • 18.8.3. Clinical Development
    • 18.8.4. Safety and Efficacy
  • 18.9. Venetoclax: AbbVie and Roche
    • 18.9.1. Product Description
    • 18.9.2. Other Developmental Activities
    • 18.9.3. Clinical Development
    • 18.9.4. Safety and Efficacy
  • 18.10. NiCord (omidubicel): Gamida Cell Ltd.
    • 18.10.1. Product Description
    • 18.10.2. Other Developmental Activities
    • 18.10.3. Clinical Development
    • 18.10.4. Safety and Efficacy
  • 18.11. Eliquis (apixaban): Bristol-Myers Squibb-Pfizer
    • 18.11.1. Product Description
    • 18.11.2. Other Developmental Activities
    • 18.11.3. Clinical Development
  • 18.12. Isatuximab: Sanofi
    • 18.12.1. Product Description
    • 18.12.2. Other Developmental Activities
    • 18.12.3. Clinical Development
  • 18.13. JZP-458 (recombinant Erwinia asparaginase): Jazz Pharmaceuticals
    • 18.13.1. Product Description
    • 18.13.2. Other Developmental Activities
    • 18.13.3. Clinical Development
  • 18.14. Vyxeos (Daunorubicin and Cytarabine for Injection): Jazz Pharmaceuticals
    • 18.14.1. Product Description
    • 18.14.2. Clinical Development
    • 18.14.3. Safety and Efficacy
  • 18.15. Daratumumab: Janssen Research & Development
    • 18.15.1. Product Description
    • 18.15.2. Other Developmental Activities
    • 18.15.3. Clinical Development
  • 18.16. ProTmune: Fate Therapeutics
    • 18.16.1. Product Description
    • 18.16.2. Other Developmental Activities
    • 18.16.3. Clinical Development
    • 18.16.4. Safety and Efficacy
  • 18.17. MB-CART19.1: MiltenyiBiotec B.V. & Co. KG
    • 18.17.1. Product Description
    • 18.17.2. Clinical Development
  • 18.18. BPX-501 T Cells (rivogenlecleucel; iC9-CAR19 cells): Bellicum Pharmaceuticals
    • 18.18.1. Product Description
    • 18.18.2. Clinical Development
    • 18.18.3. Safety and Efficacy
  • 18.19. PBCAR0191: Precision BioSciences/Servier
    • 18.19.1. Product Description
    • 18.19.2. Other Developmental Activities
    • 18.19.3. Clinical Development
    • 18.19.4. Safety and Efficacy
  • 18.20. AUTO1: Autolus Limited
    • 18.20.1. Product Description
    • 18.20.2. Other Developmental Activities
    • 18.20.3. Clinical Development
    • 18.20.4. Safety and Efficacy
  • 18.21. KTE-X19: Gilead Sciences
    • 18.21.1. Product Description
    • 18.21.2. Clinical Development
    • 18.21.3. Safety and Efficacy

19. Conjoint Analysis of Acute Lymphocytic Leukemia (ALL)

20. Acute Lymphocytic Leukemia (ALL): Seven Major Market Analysis

  • 20.1. Key Findings
  • 20.2. Market Outlook: 7MM

21. 7MM Market Size

  • 21.1. Total Market Size of Acute Lymphoblastic Leukemia in the 7MM
  • 21.2. Total Market size of Acute Lymphoblastic Leukemia by Therapies in the 7MM

22. United States Market Size

  • 22.1. Total Market size of Acute Lymphoblastic Leukemia in the United States

23. EU-5 Market Size

  • 23.1. Germany Market Size
    • 23.1.1. Total Market size of Acute Lymphoblastic Leukemia in Germany
  • 23.2. France Market Size
    • 23.2.1. Total Market size of Acute Lymphoblastic Leukemia in France
  • 23.3. Italy Market Size
    • 23.3.1. Total Market size of Acute Lymphoblastic Leukemia in Italy
  • 23.4. Spain Market Size
    • 23.4.1. Total Market size of Acute Lymphoblastic Leukemia in Spain
  • 23.5. United Kingdom Market Size
    • 23.5.1. Total Market size of Acute Lymphoblastic Leukemia in the United Kingdom
  • 23.6. Japan Market Size
    • 23.6.1. Total Market size of Acute Lymphoblastic Leukemia in Japan

24. Market Access and Reimbursement of Acute Lymphocytic Leukemia (ALL) Therapies

  • 24.1. Access and Reimbursement of Advanced Therapy Medicinal Products (ATMPs) in EU-5 Countries
  • 24.2. Access and Reimbursement of Other Therapies

25. Market Drivers of Acute Lymphocytic Leukemia (ALL)

26. Market Barriers of Acute Lymphocytic Leukemia (ALL)

27. Appendix

  • 27.1. Bibliography
  • 27.2. Report Methodology

28. DelveInsight Capabilities

29. Disclaimer

30. About DelveInsight

List of Tables

  • Table 1: Summary of ALL Market, Epidemiology, and Key Events (2017-2030)
  • Table 2: WHO Classification of ALL
  • Table 3: Total Incident Cases of Leukemia in the 7MM (2017-2030)
  • Table 4: Total Incident Cases of ALL in the 7MM (2017-2030)
  • Table 5: Diagnosed cases of ALL by Age Distribution in the 7MM (2017-2030)
  • Table 6: Subtype-specific cases of ALL in the 7MM (2017-2030)
  • Table 7: Genetic mutation-specific cases of ALL in the 7MM (2017-2030)
  • Table 8: Treated cases of ALL in EU-5 (2017-2030)
  • Table 9: Total Incident Cases of ALL in the United States (2017-2030)
  • Table 10: Gender-specific cases of ALL in the United States (2017-2030)
  • Table 11: Diagnosed cases of ALL by Age Distribution in the United States (2017-2030)
  • Table 12: Subtype-specific cases of ALL in the United States (2017-2030)
  • Table 13: Genetic mutation-specific cases of ALL in the United States (2017-2030)
  • Table 14: Treated cases of ALL in the United States (2017-2030)
  • Table 15: Total Incident Cases of ALL in Germany (2017-2030)
  • Table 16: Gender-specific Cases of ALL in Germany (2017-2030)
  • Table 17: Diagnosed Cases of ALL by Age Distribution in Germany
  • Table 18: Subtype-specific Cases of ALL in Germany (2017-2030)
  • Table 19: Genetic Mutation-specific Cases of ALL in Germany (2017-2030)
  • Table 20: Total Treated Cases of ALL in Germany (2017-2030)
  • Table 21: Total Incident Cases of ALL in France (2017-2030)
  • Table 22: Gender-specific Cases of ALL in France (2017-2030)
  • Table 23: Diagnosed Cases of ALL by Age Distribution in France
  • Table 24: Subtype-specific Cases of ALL in France (2017-2030)
  • Table 25: Genetic Mutation-specific Cases of ALL in France (2017-2030)
  • Table 26: Total Treated Cases of ALL in France (2017-2030)
  • Table 27: Total Incident Cases of ALL in Italy (2017-2030)
  • Table 28: Gender-specific Cases of ALL in Italy (2017-2030)
  • Table 29: Diagnosed Cases of ALL by Age Distribution in Italy
  • Table 30: Subtype-specific Cases of ALL in Italy (2017-2030)
  • Table 31: Genetic Mutation-specific Cases of ALL in Italy (2017-2030)
  • Table 32: Total Treated Cases of ALL in Italy (2017-2030)
  • Table 33: Total Incident Cases of ALL in Spain (2017-2030)
  • Table 34: Gender-specific Cases of ALL in Spain (2017-2030)
  • Table 35: Diagnosed Cases of ALL by Age Distribution in Spain
  • Table 36: Subtype-specific Cases of ALL in Spain (2017-2030)
  • Table 37: Genetic Mutation-specific Cases of ALL in Spain (2017-2030)
  • Table 38: Total Treated Cases of ALL in Spain (2017-2030)
  • Table 39: Total Incident Cases of ALL in the UK (2017-2030)
  • Table 40: Gender-specific Cases of ALL in the UK (2017-2030)
  • Table 41: Diagnosed Cases of ALL by Age Distribution in the UK
  • Table 42: Subtype-specific Cases of ALL in the UK (2017-2030)
  • Table 43: Genetic Mutation-specific Cases of ALL in the UK (2017-2030)
  • Table 44: Total Treated Cases of ALL in the UK (2017-2030)
  • Table 45: Total Incident Cases of ALL in Japan (2017-2030)
  • Table 46: Gender-specific cases of ALL in Japan (2017-2030)
  • Table 47: Diagnosed cases of ALL by Age Distribution in Japan (2017-2030)
  • Table 48: Subtype-specific cases of ALL in Japan (2017-2030)
  • Table 49: Genetic mutation-specific cases of ALL in Japan (2017-2030)
  • Table 50: Treated cases of ALL in Japan (2017-2030)
  • Table 51: Summary of Recommendations for Adult ALL
  • Table 52: Key cross of Marketed Products
  • Table 53: Blincyto (blinatumomab/MT 103), Clinical Trial Description, 2020
  • Table 54: Kymriah (tisagenlecleucel), Clinical Trial Description, 2020
  • Table 55: Besponsa (inotuzumabozogamicin), Clinical Trial Description, 2020
  • Table 56: Iclusig (ponatinib), Clinical Trial Description, 2020
  • Table 57: Key Cross of Emerging Drugs
  • Table 58: Ibrutinib, Clinical Trial Description, 2020
  • Table 59: Jakafi (ruxolitinib), Clinical Trial Description, 2020
  • Table 60: Motixafortide (BL-8040), Clinical Trial Description, 2020
  • Table 61: TC-110, Clinical Trial Description, 2020
  • Table 62: Lisocabtagene Maraleucel (JCAR017), Clinical Trial Description, 2020
  • Table 63: TBI-1501, Clinical Trial Description, 2020
  • Table 64: UCART19, Clinical Trial Description, 2020
  • Table 65: Venetoclax, Clinical Trial Description, 2020
  • Table 66: NiCord (omidubicel), Clinical Trial Description, 2020
  • Table 67: Eliquis (apixaban), Clinical Trial Description, 2020
  • Table 68: Isatuximab, Clinical Trial Description, 2020
  • Table 69: JZP-458, Clinical Trial Description, 2020
  • Table 70: Vyxeos(CPX-351), Clinical Trial Description, 2020
  • Table 71: Daratumumab, Clinical Trial Description, 2020
  • Table 72: ProTmune, Clinical Trial Description, 2020
  • Table 73: MB-CART19.1, Clinical Trial Description, 2020
  • Table 74: BPX-501, Clinical Trial Description, 2020
  • Table 75: PBCAR0191, Clinical Trial Description, 2020
  • Table 76: AUTO1, Clinical Trial Description, 2020
  • Table 77: KTE-X19, Clinical Trial Description, 2020
  • Table 78: 7MM Market Size of Acute Lymphoblastic Leukemia, in USD Million (2017-2030)
  • Table 79: 7MM Market Size of Acute Lymphoblastic Leukemia by Line of Therapy, in USD Million (2017-2030)
  • Table 80: 7MM Market Size of Acute Lymphoblastic Leukemia by Therapies, in USD Million (2017-2030)
  • Table 81: United States Market Size of Acute Lymphoblastic Leukemia by Line of Therapy, in USD Million (2017-2030)
  • Table 82: United States Market Size of Acute Lymphoblastic Leukemia by Therapies, in USD Million (2017-2030)
  • Table 83: Germany Market Size of Acute Lymphoblastic Leukemia by Line of Therapy, in USD Million (2017-2030)
  • Table 84: Germany Market Size of Acute Lymphoblastic Leukemia by Therapies, in USD Million (2017-2030)
  • Table 85: France Market Size of acute lymphoblastic leukemia by Line of Therapy, in USD Million (2017-2030)
  • Table 86: France Market Size of Acute Lymphoblastic Leukemia by Therapies, in USD Million (2017-2030)
  • Table 87: Italy Market Size of Acute Lymphoblastic Leukemia by Line of Therapy, in USD Million (2017-2030)
  • Table 88: Italy Market Size of Acute Lymphoblastic Leukemia by Therapies, in USD Million (2017-2030)
  • Table 89: Spain Market Size of Acute Lymphoblastic Leukemia by Line of Therapy, in USD Million (2017-2030)
  • Table 90: Spain Market Size of Acute Lymphoblastic Leukemia by Therapies, in USD Million (2017-2030)
  • Table 91: United Kingdom Market Size of Acute Lymphoblastic Leukemia by Line of Therapy, in USD Million (2017-2030)
  • Table 92: United Kingdom Market Size of Acute Lymphoblastic Leukemia by Therapies, in USD Million (2017-2030)
  • Table 93: Japan Market Size of Acute Lymphoblastic Leukemia by Line of Therapy, in USD Million (2017-2030)
  • Table 94: Japan Market Size of Acute Lymphoblastic Leukemia by Therapies, in USD Million (2017-2030)
  • Table 95: National Institute for Health and Care Excellence (NICE) Decisions for ALL Therapies
  • Table 96: Haute Autorité de santé (HAS) Decisions for ALL Therapies

List of Figures

  • Figure 1: Acute Lymphocytic Leukemia SWOT Analysis
  • Figure 2: Development of ALL
  • Figure 3: Sign and Symptoms of ALL
  • Figure 4: Risks Factors of ALL
  • Figure 5: Philadelphia Chromosome Translocation (translocation between 9 and 22 chromosomes)
  • Figure 6: Cytogenetic and Molecular Genetic Abnormalities in Childhood ALL
  • Figure 7: Genetic Pathogenesis of B Lymphoblastic Leukemia at Diagnosis and Relapse
  • Figure 8: Complete Blood Count
  • Figure 9: Bone Marrow Aspiration and Biopsy
  • Figure 10: Cytogenetic Analysis
  • Figure 11: Global Heat Map of Leukemia
  • Figure 12: Total Incident Cases of Leukemia in the 7MM (2017-2030)
  • Figure 13: Total Incident Cases of ALL in the 7MM (2017-2030)
  • Figure 14: Diagnosed cases of ALL by Age Distribution in the 7MM (2017-2030)
  • Figure 15: Subtype-specific cases of ALL in the 7MM (2017-2030)
  • Figure 16: Genetic mutation-specific cases of ALL in the 7MM (2017-2030)
  • Figure 17: Treated cases of ALL in the 7MM (2017-2030)
  • Figure 18: Total Incident Cases of ALL in the United States (2017-2030)
  • Figure 19: Gender-specific cases of ALL in the United States (2017-2030)
  • Figure 20: Diagnosed cases of ALL by Age Distribution in the United States (2017-2030)
  • Figure 21: Subtype-specific cases of ALL in the United States (2017-2030)
  • Figure 22: Genetic mutation-specific cases of ALL in the United States (2017-2030)
  • Figure 23: Treated cases of ALL in the United States (2017-2030)
  • Figure 24: Total Incident Cases of ALL in Germany (2017-2030)
  • Figure 25: Gender-specific Cases of ALL in Germany (2017-2030)
  • Figure 26: Diagnosed Cases of ALL by Age Distribution in Germany (2017-2030)
  • Figure 27: Subtype-specific Cases of ALL in Germany (2017-2030)
  • Figure 28: Genetic Mutation-specific Cases of ALL in Germany (2017-2030)
  • Figure 29: Total Treated Cases of ALL in Germany (2017-2030)
  • Figure 30: Total Incident Cases of ALL in France (2017-2030)
  • Figure 31: Gender-specific Cases of ALL in France (2017-2030)
  • Figure 32: Diagnosed Cases of ALL by Age Distribution in France (2017-2030)
  • Figure 33: Subtype-specific Cases of ALL in France (2017-2030)
  • Figure 34: Genetic Mutation-specific Cases of ALL in France (2017-2030)
  • Figure 35: Total Treated Cases of ALL in France (2017-2030)
  • Figure 36: Total Incident Cases of ALL in Italy (2017-2030)
  • Figure 37: Gender-specific Cases of ALL in Italy (2017-2030)
  • Figure 38: Diagnosed Cases of ALL by Age Distribution in Italy (2017-2030)
  • Figure 39: Subtype-specific Cases of ALL in Italy (2017-2030)
  • Figure 40: Genetic Mutation-specific Cases of ALL in Italy (2017-2030)
  • Figure 41: Total Treated Cases of ALL in Italy (2017-2030)
  • Figure 42: Total Incident Cases of ALL in Spain (2017-2030)
  • Figure 43: Gender-specific Cases of ALL in Spain (2017-2030)
  • Figure 44: Diagnosed Cases of ALL by Age Distribution in Spain (2017-2030)
  • Figure 45: Subtype-specific Cases of ALL in Spain (2017-2030)
  • Figure 46: Genetic Mutation-specific Cases of ALL in Spain (2017-2030)
  • Figure 47: Total Treated Cases of ALL in Spain (2017-2030)
  • Figure 48: Total Incident Cases of ALL in the UK (2017-2030)
  • Figure 49: Gender-specific Cases of ALL in the UK (2017-2030)
  • Figure 50: Diagnosed Cases of ALL by Age Distribution in the UK (2017-2030)
  • Figure 51: Subtype-specific Cases of ALL in the UK (2017-2030)
  • Figure 52: Genetic Mutation-specific Cases of ALL in the UK (2017-2030)
  • Figure 53: Total Treated Cases of ALL in the UK (2017-2030)
  • Figure 54: Total Incident Cases of ALL in Japan (2017-2030)
  • Figure 55: Gender-specific cases of ALL in Japan (2017-2030)
  • Figure 56: Diagnosed cases of ALL by Age Distribution in Japan (2017-2030)
  • Figure 57: Subtype-specific cases of ALL in Japan (2017-2030)
  • Figure 58: Genetic mutation-specific cases of ALL in Japan (2017-2030)
  • Figure 59: Treated cases of ALL in Japan (2017-2030)
  • Figure 60: Treatment Overview of ALL
  • Figure 61: Intrathecal Chemotherapy
  • Figure 62: CAR T-cell Therapy
  • Figure 63: Stem Cell Transplant
  • Figure 64: Philadelphia Negative Precursor B (Pre-B) Lymphoblastic Leukemia/Lymphoma
  • Figure 65: Philadelphia Chromosome (Ph) Positive Acute Lymphoblastic Leukemia
  • Figure 66: Burkitt or Burkitt-like Leukemia/Lymphoma
  • Figure 67: Precursor T-lymphoblastic Leukemia/Lymphoma
  • Figure 68: Unmet Needs
  • Figure 69: Market Size of Acute Lymphoblastic Leukemia in the 7MM, in USD Million (2017-2030)
  • Figure 70: Market Size of Acute Lymphoblastic Leukemia in the 7MM by Line of Therapy, in USD Million (2017-2030)
  • Figure 71: Market Size of Acute Lymphoblastic Leukemia in the 7MM by Therapies, in USD Million (2017-2030)
  • Figure 72: Market Size of Acute Lymphoblastic Leukemia in the United States by Therapy, in USD Millions (2017-2030)
  • Figure 73: Market Size of Acute Lymphoblastic Leukemia in Germany by Therapies, in USD Million (2017-2030)
  • Figure 74: Market Size of Acute Lymphoblastic Leukemia in France by therapies, in USD Million (2017-2030)
  • Figure 75: Market Size of Acute Lymphoblastic Leukemia in Italy by Therapies, in USD Million (2017-2030)
  • Figure 76: Market Size of Acute Lymphoblastic Leukemia in Spain by therapies, in USD Million (2017-2030)
  • Figure 77: Market Size of Acute Lymphoblastic Leukemia in the United Kingdom by Therapies, in USD Million (2017-2030)
  • Figure 78: Market Size of Acute Lymphoblastic Leukemia in Japan by Therapy, in USD Millions (2017-2030)
  • Figure 79: Market Drivers
  • Figure 80: Market Barriers