Acute Lymphocytic Leukemia Market Size (7MM) is going to be ~USD 1,878 Million in 2025, and expected to grow with a CAGR of 4.6% during the forecast period (2025-2034) | DelveInsight

(Albany, USA) DelveInsight's "Acute Lymphocytic Leukemia Market Insights, Epidemiology, and Market Forecast-2034" report delivers an in-depth understanding of 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 the United Kingdom), and Japan.

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Key Takeaways from the Acute Lymphocytic Leukemia Market Report
• On 03 November 2025, Amgen conducted a Phase I part of the study aims to evaluate the safety, efficacy, and tolerability of subcutaneous (SC) blinatumomab for treatment of Relapsed or Refractory B cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL), to determine the maximum tolerated dose (MTD), and recommended phase 2 dose(s) (RP2D) of SC administered blinatumomab.
• Among the 7MM, the US accounted for the highest number of incident cases of acute lymphocytic leukemia. The total incident cases of acute lymphocytic leukemia in the US comprised approximately 6,800 cases in 2023 and are projected to increase during the forecast period.
• Amongst EU4 and the UK, Germany accounted for the highest number of incident cases of acute lymphocytic leukemia, while Spain accounted for the lowest number of cases.
• As per the estimates, it was observed that acute lymphocytic leukemia is slightly more common in males than females. In the US, males accounted for nearly 3,800 cases, while females accounted for 3,000 in 2023.
• Among the type-specific cases of acute lymphocytic leukemia, B-acute lymphocytic leukemia accounted for nearly 85% of the cases, while that of T-acute lymphocytic leukemia accounted for nearly 15%, in the US.
• The leading Acute Lymphocytic Leukemia Companies such as AbbVie, Roche (Genentech), Janssen Research & Development, Pharmacyclics (an AbbVie Company), Incyte Corporation, Novartis, Jazz Pharmaceuticals, Autolus Therapeutics, Syndax Pharmaceuticals, Cellectis, ADC Therapeutics, Wugen, Servier, Allogene, Amgen, Astellas Pharma, Gilead Sciences, Syndax, Incyte, Orca Biosystems and others.
• Promising Acute Lymphocytic Leukemia Therapies such as Omitted Doxorubicin, Recombinant Asparaginase, Blinatumomab, Dexamethasone, Vincrisitne, Inotuzumab Ozogamicin, Everolimus (RAD001), Cyclophosphamide, Methotrexate and others.

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Acute Lymphocytic Leukemia Epidemiology Segmentation in the 7MM
• Total Acute Lymphocytic Leukemia incident cases
• Acute Lymphocytic Leukemia Gender-specific cases
• Acute Lymphocytic Leukemia Age-specific cases
• Acute Lymphocytic Leukemia Subtype-specific cases
• Acute Lymphocytic Leukemia Genetic-mutation specific cases
• Total Acute Lymphocytic Leukemia treated cases

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Acute Lymphocytic Leukemia Marketed Drugs

• MN-166: Medicinova
MN-166 is a first in class, orally bioavailable, small molecule glial attenuator that suppresses pro-inflammatory cytokines IL-1ß, TNF-a, and IL-6 and may upregulate the anti-inflammatory cytokine IL-10. It has additionally been shown to be a toll-like receptor 4 (TLR4) functional antagonist that may contribute to its attenuation of neuroinflammation. While considered a New Molecular Entity, or NME, in the United States and Europe, it involves redirection of an approved drug, ibudilast, which was first approved in Japan more than 20 years ago.

• BLINCYTO (blinatumomab): Amgen/Astellas Pharma
BLINCYTO is a BiTE (bispecific T-cell engager) immuno-oncology therapy that targets CD19 surface antigens on B cells. In December 2014, BLINCYTO received accelerated approval for Philadelphia chromosome-negative (Ph-) precursor R/R B-Cell acute lymphoblastic leukemia, which later in 2017 converted to full approval. The sBLA approval also included data from the Phase II ALCANTARA study supporting the treatment of patients with Philadelphia chromosome-positive (Ph+) R/R B-Cell acute Lymphoblastic Leukemia. The approval expands the indication of Blincyto for the treatment of relapsed or refractory B-cell precursor ALL in adults and children. Most recently, in June 2024, the US FDA approved the drug for CD19-positive Ph- B-cell precursor acute lymphoblastic leukemia in the consolidation phase, regardless of measurable residual disease (MRD) status.

• TECARTUS (brexucabtagene autoleucel): Gilead Sciences
TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy, which binds to CD19-expressing cancer cells and normal B cells.

• KYMRIAH (tisagenlecleucel): Novartis
KYMRIAH is a CD19-directed genetically modified autologous T cell immunotherapy that involves reprogramming a patient's T cells with a transgene encoding a chimeric antigen receptor (CAR) to identify and eliminate CD19-expressing malignant and normal cells.

• RYLAZE (asparaginase Erwinia chrysanthemi recombinant/JZP458): Jazz Pharmaceuticals
RYLAZE is an asparagine-specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen. In June 2021, Jazz Pharmaceuticals announced the US FDA approval of RYLAZE for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphocytic leukemia.

Acute Lymphocytic Leukemia Emerging Drugs
• Obecabtagene autoleucel (obe-cel): Autolus Therapeutics
Obe-cel is an autologous CD19 CAR-T cell therapy with a unique CD19 CAR. The CAR is designed to have a fast-off kinetic, which mimics physiological T-cell receptor interactions. Obe-cel has demonstrated that this enhanced kinetic profile results in increased T-cell persistence and reduced T-cell exhaustion, leading to high levels of durable remissions and remarkably low levels of cytokine release syndrome. In March 2022, obe-cel was granted Orphan Medical Product Designation by the EMA for the treatment of acute lymphocytic leukemia, having previously received ODD by the US FDA for B-acute lymphocytic leukemia. In April 2022, the US FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to obe-cel for the treatment of adult B-acute lymphocytic leukemia. Obe-cel also received PRIME designation from the EMA and Innovative Licensing and Access Pathway (ILAP) by the Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom. Recently, in January 2024, the US FDA has accepted its BLA for obe-cel for patients with R/R acute lymphocytic leukemia. Under the PDUFA, the FDA has set a target action date of November 16, 2024.

• WU-CART-007: Wugen
WU-CART-007 is an allogeneic, off-the-shelf, fratricide-resistant CD7-targeted CAR-T cell therapy engineered to overcome the technological challenges of harnessing CAR-T cells to treat CD7+ hematological malignancies. In July 2022, the US FDA granted FTD and Rare Pediatric Disease Designation (RPDD) for WU-CART-007 for the treatment of R/R T-cell acute lymphocytic leukemia (ALL). In March 2022, US FDA granted Orphan Drug Designation (ODD) to WU-CART-007, and in July 2022, FTD and Rare Pediatric Disease Designation (RPDD) for the treatment of acute lymphocytic leukemia. Most recently, in May 2024, WU-CART-007 received RMAT designation in the US and PRIME designation in the European Union for the treatment of R/R T-ALL and T-cell lymphoblastic lymphoma (LBL).

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Acute Lymphocytic Leukemia Companies
AbbVie, Roche (Genentech), Janssen Research & Development, Pharmacyclics (an AbbVie Company), Incyte Corporation, Novartis, Jazz Pharmaceuticals, Autolus Therapeutics, Syndax Pharmaceuticals, Cellectis, ADC Therapeutics, Wugen, Servier, Allogene, Amgen, Astellas Pharma, Gilead Sciences, Syndax, Incyte, Orca Biosystems and others.

Acute Lymphocytic Leukemia Treatment Market Landscape
The Acute Lymphocytic Leukemia treatment include chemotherapy, post-remission therapy (consolidation and maintenance therapy), targeted therapy, immunotherapy, and CAR-T cell therapy. In addition to this, stem cell transplant is also used early in therapy for patients with high-risk subtypes of acute Lymphocytic Leukemia. In December 2018, the US FDA approved ASPARLAS by Servier Pharmaceuticals which is an asparagine-specific enzyme, as a component of a multi-agent chemotherapeutic regimen for acute Lymphocytic Leukemia in pediatric and young adult patients aged 1 month to 21 years. In June 2021, the US FDA approved RYLAZE by Jazz Pharmaceuticals as a component of a multi-agent chemotherapeutic regimen for the treatment of acute Lymphocytic Leukemia and LBL in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli-derived asparaginase.

Acute Lymphocytic Leukemia Drugs Uptake
This section focuses on the rate of uptake of the potential drugs expected to be launched in the market during the study period 2020-2034. The analysis covers acute Lymphocytic Leukemia market uptake by drugs; patient uptake by therapies; and sales of each drug. A significant amount of competition is expected from CAR T-cell therapies. However, BLINCYTO's sales growth rate in the past, the anticipated label expansion, and the publication of new data demonstrates that it is better than traditional chemotherapies for treating acute lymphoblastic leukemia. The US FDA has approved BLINCYTO as a front-line consolidation therapy for individuals with B-cell ALL that lacks the Philadelphia chromosome. Key academic, regional, and community customers are being engaged by Amgen's commercial and medical teams to establish BLINCYTO as the standard of treatment in this setting. Amgen continues to attempt to increase the beneficial effects of BLINCYTO in patients with newly diagnosed B-ALL by doing more research on subcutaneous delivery.

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Scope of the Acute Lymphocytic Leukemia Market Report
• Coverage- 7MM
• Study Period- 2020-2034
• Acute Lymphocytic Leukemia Companies- AbbVie, Roche (Genentech), Janssen Research & Development, Pharmacyclics (an AbbVie Company), Incyte Corporation, Novartis, Jazz Pharmaceuticals, Autolus Therapeutics, Syndax Pharmaceuticals, Cellectis, ADC Therapeutics, Wugen, Servier, Allogene, Amgen, Astellas Pharma, Gilead Sciences, Syndax, Incyte, Orca Biosystems and others.
• Acute Lymphocytic Leukemia Therapies- Omitted Doxorubicin, Recombinant Asparaginase, Blinatumomab, Dexamethasone, Vincrisitne, Inotuzumab Ozogamicin, Everolimus (RAD001), Cyclophosphamide, Methotrexate 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
• Acute Lymphocytic Leukemia 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

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Table of Contents
1. Key Insights
2. Acute Lymphocytic Leukemia Market Report Introduction
3. Acute Lymphocytic Leukemia Market Overview at a Glance
4. Acute Lymphocytic Leukemia Epidemiology and Market Methodology
5. Executive Summary of Acute Lymphocytic Leukemia
6. Key Events
7. Acute Lymphocytic Leukemia Disease Background and Overview
8. Acute Lymphocytic Leukemia Epidemiology and Patient Population
9. Acute Lymphocytic Leukemia Patient Journey
10. Acute Lymphocytic Leukemia Marketed Therapies
11. Emerging Acute Lymphocytic Leukemia Therapies
12. Acute Lymphocytic Leukemia: Market Analysis
13. Key Opinion Leaders' Views
14. SWOT Analysis
15. Acute Lymphocytic Leukemia Unmet Needs
16. Market Access and Reimbursement
17. Appendix
18. DelveInsight Capabilities
19. Disclaimer

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