Acute Lymphocytic Leukemia Market: Analysis of Epidemiology, Pipeline Products, and Key Companies Working, DelveInsight | Amgen, Astellas Pharma, Gilead Sciences, Novartis, Jazz Pharmaceuticals, Wugen, Autolus Therapeutics, Syndax, Incyte, Orca Biosystems

Acute Lymphocytic Leukemia emerging therapies such as BLINCYTO, GLEEVEC, ICLUSIG, RITUXAN, BESPONSA, KYMRIAH, TECARTUS, WU-CART-007, Obecabtagene autoleucel, SNDX-561, and others are expected to boost the Acute Lymphocytic Leukemia Market in the upcoming years.

DelveInsight has launched a new report on "Acute Lymphocytic Leukemia - Market Insights, Epidemiology, and Market Forecast-2034" that delivers an in-depth understanding of the Acute Lymphocytic Leukemia, historical and forecasted epidemiology as well as the Acute Lymphocytic Leukemia market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.

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Some of the key facts of the Acute Lymphocytic Leukemia Market Report:

In 2023, the Acute Lymphocytic Leukemia (ALL) market across the 7MM was valued at approximately $1.6 billion and is projected to grow further by 2034. The United States led the market, accounting for around $1.2 billion in 2023.
The treatment landscape for ALL has evolved significantly with the introduction of targeted therapies, including BCR-ABL1 tyrosine kinase inhibitors (Gleevec, Sprycel, Iclusig), CD20 monoclonal antibodies (Rituxan), CD22-targeting antibody-drug conjugates (Besponsa), bispecific antibodies (Blincyto), and CD19 CAR-T therapies (Kymriah, Tecartus).
Blincyto currently dominates the market, and Amgen continues to expand its BiTE technology, securing FDA clearance in June 2024 for further innovation, including a subcutaneous version of blinatumomab.
Key regulatory milestones in 2024 include:
March: FDA approved Pfizer's Besponsa for pediatric patients (1 year and older) with relapsed/refractory (R/R) CD22-positive B-cell ALL, following its 2017 adult approval.
March: Takeda's Iclusig became the first targeted frontline treatment for Philadelphia chromosome-positive (Ph+) ALL, in combination with chemotherapy.
The future treatment landscape is expected to be dominated by CAR-T therapies, with several candidates in the pipeline, including obe-cel, UCART22, and WU-CART-007. Among them, Autolus's obe-cel is poised to be the first to market, gaining a competitive edge.
In January 2024, the FDA accepted obe-cel's Biologics License Application (BLA) for R/R ALL, with a target action date of November 16, 2024.
In February 2024, BioNTech and Autolus announced a co-development and commercialization agreement, including a $50 million upfront payment and a $200 million equity investment.
Meanwhile, Wugen is distinguishing itself by targeting T-cell leukemia/lymphoma, an area with high unmet demand. While B-cell leukemias have shown strong responses to CAR-T therapy, T-cell ALL/LBL remains a challenging disease with high mortality rates in both children and adults.
Key Acute Lymphocytic Leukemia companies such as Amgen, Astellas Pharma, Gilead Sciences, Novartis, Jazz Pharmaceuticals, Wugen, Autolus Therapeutics, Syndax, Incyte, Orca Biosystems, and others are evaluating new drugs for Acute Lymphocytic Leukemia to improve the treatment landscape.
Promising Acute Lymphocytic Leukemia pipeline therapies in various stages of development include BLINCYTO, GLEEVEC, ICLUSIG, RITUXAN, BESPONSA, KYMRIAH, TECARTUS, WU-CART-007, Obecabtagene autoleucel, SNDX-561, and others.
According to estimates, acute lymphocytic leukemia is slightly more prevalent in males than females. In the United States, approximately 3,800 cases were reported in males, while around 3,000 cases were observed in females in 2023. Regarding type-specific cases, B-cell acute lymphocytic leukemia accounted for approximately 85% of all cases, whereas T-cell acute lymphocytic leukemia made up about 15% of cases in the US.
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Key benefits of the Acute Lymphocytic Leukemia market report:
Acute Lymphocytic Leukemia market report covers a descriptive overview and comprehensive insight of the Acute Lymphocytic Leukemia Epidemiology and Acute Lymphocytic Leukemia market in the 7MM (the United States, EU5 (Germany, Spain, France, Italy, UK) & Japan.)
The Acute Lymphocytic Leukemia market report provides insights on the current and emerging therapies.
Acute Lymphocytic Leukemia market report provides a global historical and forecasted market covering drug outreach in 7MM.
The Acute Lymphocytic Leukemia market report offers an edge that will help in developing business strategies by understanding trends shaping and driving the Acute Lymphocytic Leukemia market.

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Acute Lymphocytic Leukemia Overview

Acute lymphocytic leukemia (ALL), also referred to as acute lymphoblastic leukemia, is a type of cancer that originates in the blood and bone marrow. It develops from immature white blood cells, known as lymphocytes, in the bone marrow and is primarily characterized by an excessive production of abnormal white blood cells called lymphoblasts or leukemic blasts. This overproduction disrupts the bone marrow's ability to generate sufficient red blood cells, normal white blood cells, and platelets, leading to anemia, frequent infections, and an increased tendency for bruising and bleeding. The blast cells can escape from the bone marrow into the bloodstream and accumulate in various organs such as the lymph nodes, spleen, liver, and central nervous system (brain and spinal cord).

Acute Lymphocytic Leukemia Market Outlook

Treatment options for acute lymphocytic leukemia include chemotherapy, post-remission therapy (such as consolidation and maintenance therapy), targeted therapy, immunotherapy, and CAR-T cell therapy. Additionally, stem cell transplantation is often utilized early in treatment for patients with high-risk subtypes.

In December 2018, the US FDA approved ASPARLAS, an asparagine-specific enzyme developed by Servier Pharmaceuticals, as part of a multi-agent chemotherapy regimen for pediatric and young adult patients (ages 1 month to 21 years) with acute lymphocytic leukemia. Similarly, in June 2021, the FDA approved RYLAZE by Jazz Pharmaceuticals for use in patients aged 1 month and older who developed hypersensitivity to E. coli-derived asparaginase.

Amgen's BLINCYTO, a bispecific CD19-directed CD3 T cell engager (BiTE) immunotherapy, achieved one of the fastest FDA approvals on record in 2014. CAR-T cell therapies are also emerging as a promising treatment approach. The Phase III Golden Gate study, which evaluates BLINCYTO alternating with low-intensity chemotherapy in older adults with newly diagnosed Philadelphia chromosome-negative (Ph-) B-ALL, is actively enrolling patients.

In mid-June 2024, Amgen announced that BLINCYTO had received FDA approval for the treatment of CD19-positive Philadelphia chromosome-negative B-ALL during the consolidation phase, regardless of minimal residual disease (MRD) status. This approval helps address unmet medical needs by providing a more effective alternative to conventional chemotherapy. Amgen is also developing a subcutaneous formulation of blinatumomab, with a registration-enabling trial expected to commence in the second half of 2025. Additionally, a Phase I/II study investigating subcutaneous blinatumomab in adults with relapsed or refractory Ph- B-ALL is currently enrolling patients.

Several companies are actively developing and testing therapies for acute lymphocytic leukemia, including AbbVie and Roche with venetoclax, Orca Biosystems with Orca-T, J&J Innovative Medicine with daratumumab, Jazz Pharmaceuticals with CPX-351, Syndax Pharmaceuticals with SNDX-5613, Autolus Therapeutics with obe-cel, Wugen with WU-CART-007, and Cellectis with UCART22, among others.
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Acute Lymphocytic Leukemia Marketed Drugs:

TECARTUS (brexucabtagene autoleucel): Gilead Sciences
KYMRIAH (tisagenlecleucel): Novartis
RYLAZE (asparaginase Erwinia chrysanthemi recombinant/JZP458): Jazz Pharmaceuticals
BLINCYTO (blinatumomab): Amgen/Astellas Pharma

Acute Lymphocytic Leukemia Emerging Drugs:

WU-CART-007: Wugen
Obecabtagene autoleucel (obe-cel): Autolus Therapeutics
To know more about which acute lymphocytic leukemia drugs will capture the market, click here: https://www.delveinsight.com/report-store/acute-lymphocytic-leukemia-all-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=kpr

Scope of the Acute Lymphocytic Leukemia Market Report

Study Period: 2020-2034
Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
Key Acute Lymphocytic Leukemia Companies: Amgen, Astellas Pharma, Gilead Sciences, Novartis, Jazz Pharmaceuticals, Wugen, Autolus Therapeutics, Syndax, Incyte, Orca Biosystems, and others
Key Acute Lymphocytic Leukemia Therapies: BLINCYTO, GLEEVEC, ICLUSIG, RITUXAN, BESPONSA, KYMRIAH, TECARTUS, WU-CART-007, Obecabtagene autoleucel, SNDX-5613, and others
Acute Lymphocytic Leukemia Therapeutic Assessment: Acute Lymphocytic Leukemia current marketed and Acute Lymphocytic Leukemia emerging therapies
Acute Lymphocytic Leukemia Market Dynamics: Acute Lymphocytic Leukemia market drivers and Acute Lymphocytic Leukemia market barriers
Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
Acute Lymphocytic Leukemia Unmet Needs, KOL's views, Analyst's views, Acute Lymphocytic Leukemia Market Access and Reimbursement

Table of Contents

1. Report Introduction
2. Executive Summary
3. SWOT analysis
4. Acute Lymphocytic Leukemia Patient Share (%) Overview at a Glance
5. Acute Lymphocytic Leukemia Market Overview at a Glance
6. Acute Lymphocytic Leukemia Disease Background and Overview
7. Acute Lymphocytic Leukemia Epidemiology and Patient Population
8. Country-Specific Patient Population of Acute Lymphocytic Leukemia
9. Acute Lymphocytic Leukemia Current Treatment and Medical Practices
10. Unmet Needs
11. Acute Lymphocytic Leukemia Emerging Therapies
12. Acute Lymphocytic Leukemia Market Outlook
13. Country-Wise Acute Lymphocytic Leukemia Market Analysis (2020-2034)
14. Market Access and Reimbursement of Therapies
15. Market drivers
16. Market barriers
17. Appendix
18. Acute Lymphocytic Leukemia Report Methodology
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight

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Related Reports:

Acute Lymphocytic Leukemia Pipeline Insights, DelveInsight

"Acute Lymphocytic Leukemia Pipeline Insight, 2024" report by DelveInsight outlines comprehensive insights of present clinical development scenarios and growth prospects across the Acute Lymphocytic Leukemia market. A detailed picture of the Acute Lymphocytic Leukemia pipeline landscape is provided, which includes the disease overview and Acute Lymphocytic Leukemia treatment guidelines.

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About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.

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