Acute Lymphocytic Leukemia Market Summary

• In 2023, the Acute Lymphocytic Leukemia market size in the 7MM was approximately ~USD 1,600 million and is anticipated to grow with a significant CAGR during the study period (2020-2034).
• Among the 7MM, the US accounted for the largest market size in 2023, with approximately USD 1,200 million.

Acute Lymphocytic Leukemia Market & Epidemiology Insights

• The treatment paradigms of Acute Lymphocytic Leukemia have been revolutionized with the advent of tyrosine kinase inhibitors targeting BCR-ABL1 (GLEEVEC [imatinib mesylate], SPRYCEL [dasatinib], and ICLUSIG [ponatinib]), monoclonal antibodies targeting CD20 (RITUXAN), antibody-drug conjugates targeting CD22 (BESPONSA), bispecific antibodies (BLINCYTO), CD19 chimeric antigen receptor T cell therapy (KYMRIAH and TECARTUS), and others.
• Acute Lymphocytic Leukemia represents a large market opportunity, where BLINCYTO is the current market leader. Amgen is continuing to advance its BiTE Technology innovation in Acute Lymphocytic Leukemia, having received recent FDA clearance in June of 2024. Using a registration-enabling study, Amgen  also aims to pursue blinatumomab subcutaneous injection.
• Key Acute Lymphocytic Leukemia companies include Novartis, Amgen, Pfizer, Jazz Pharmaceuticals, and Kite Pharma, driving innovative treatment advancements.
• In November 2024, Shorla Oncology, a U.S.-Ireland specialty pharmaceutical company, announced that the FDA approved IMKELDI (imatinib) oral solution, the first oral liquid form of imatinib for treating certain forms of leukemia and other cancers.
• In March 2024, the FDA approved Pfizer’s BESPONSA for pediatric patients 1 year and older with relapsed or refractory CD22-positive B-cell ALL. Prior to this approval, BESPONSA received priority review and orphan drug designation. BESPONSA was also approved in 2017 to treat R/R B-cell precursor ALL in adult patients.
• Takeda’s ICLUSIG became the first and only targeted treatment for frontline Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy on March 19, 2024, after receiving FDA approval.
• The future of the Acute Lymphocytic Leukemia treatment landscape is anticipated to be dominated by CAR-T cell therapies. There are several CAR T-cell therapies in the pipeline such as obecabtagene autoleucel (obe-cel), UCART22, WU-CART-007, and others.
• Among the emerging CAR-Ts, Autolus’s obe-cel is anticipated to be the first to enter the market, giving it a competitive edge over other emerging assets. In January 2024, the US FDA accepted its biologics license application (BLA) for obe-cel for patients with R/R Acute Lymphocytic Leukemia. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of November 16, 2024.
• More good news for Autolus came in February 2024 when it signed a new agreement with BioNTech to co-develop and market CAR-T cell treatments, following the FDA's acceptance of its BLA. The agreement between BioNTech and Autolus is to progress the autologous CAR-T programs into commercialization. These programs include AUTO1/22 and AUTO6NG in any oncology indication, obe-cel in adult acute lymphoblastic leukemia, and BNT211 in CLDN6+ malignancies. This expanded collaboration comprised a USD 50 million upfront payment and a USD 200 million equity investment from BioNTech.
• At the moment, Wugen has set itself apart from its rivals. Rather than focusing on B-cell leukemia/lymphoma, the company is targeting the T-cell leukemia/lymphoma subpopulation. Despite the relatively smaller patient pool, this market has a significant unmet demand.
• Although B-cell leukemias have responded well to CAR-T treatments, T-cell diseases present unique difficulties. T-ALL/LBL are challenging hematologic cancers with high rates of mortality in both children and adults.

Key Factors Driving the Acute Lymphocytic Leukemia Market

• Rising Acute Lymphocytic Leukemia Incidence: 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.
• Dominance of Amgen’s BLINCYTO: Currently, Amgen’s BLINCYTO is the ALL market leader. Amgen is continuing to advance its BiTE Technology innovation in Acute Lymphocytic Leukemia, having received recent FDA clearance in June of 2024. Using a registration-enabling study, Amgen also aims to pursue blinatumomab subcutaneous injection.
• SPRYCEL: A Key Second-Generation Tyrosine Kinase Inhibitor: In the realm of ALL, protein kinase inhibitors present promising advancements. SPRYCEL, the premier second-generation tyrosine kinase inhibitor, holds significance as the sole option approved for pediatric patients with newly diagnosed Philadelphia chromosome-positive ALL, used alongside chemotherapy.
• Expected Launch of Emerging Acute Lymphocytic Leukemia Drugs : Some of the ALL drugs in clinical trials include Orca-T [Orca Biosystems (Orca Bio)], UCART22 (Cellectis), and AZD0486 (AstraZeneca), AUTO1/22 (Autolus Therapeutics), among others.
• Growing Adoption of Targeted & Immunotherapies: New modalities, especially CD19-directed CAR-T therapies for pediatric/young-adult B-ALL and bispecific antibodies/antibody–drug conjugates, have shifted treatment away from chemotherapy in many relapsed/refractory settings, expanding addressable spend and specialist care demand.

DelveInsight’s “Acute Lymphocytic Leukemia Market Insight, 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 therapeutics market trends in the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan.

The acute Lymphocytic Leukemia market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM acute Lymphocytic Leukemia market size from 2020 to 2034. The report also covers current acute Lymphocytic Leukemia treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s potential. 

Acute Lymphocytic Leukemia Disease Understanding

Acute lymphocytic leukemia Overview

Acute lymphocytic leukemia, 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 acute Lymphocytic Leukemia become more susceptible to anemia, recurrent infections, and 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).

Acute lymphocytic leukemia Diagnosis

Tests and procedures used to diagnose acute lymphocytic leukemia include:

Blood tests- The Complete Blood Count (CBC) measures the numbers of red blood cells, white blood cells, and platelets. This test is often done along with a differential that looks at the numbers of the different types of white blood cells. For the peripheral blood smear, a drop of blood is smeared across a slide and then looked under a microscope to see how the cells look. Changes in the numbers and the appearance of the cells often help diagnose leukemia.

Bone marrow test- During bone marrow aspiration and biopsy, a needle is used to remove a sample of bone marrow from the hip bone or breastbone. The sample is sent to a lab for testing to look for leukemia cells. Doctors in the lab will classify blood cells into specific types based on their size, shape, and other genetic or molecular features. They also look for certain changes in the cancer cells and determine whether the leukemia cells began from B lymphocytes or T lymphocytes.

Imaging tests- Imaging tests such as an X-ray, a computerized tomography (CT) scan, or an ultrasound scan may help determine whether cancer has spread to the brain and spinal cord or other parts of the body.

Spinal fluid test- A lumbar puncture test, also called a spinal tap, may be used to collect a sample of spinal fluid — the fluid that surrounds the brain and spinal cord. The sample is tested to see whether cancer cells have spread to the spinal fluid.

Acute lymphocytic leukemia Treatment

Treatment of acute lymphocytic leukemia includes-

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 and 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.

Preventive treatment to the spinal cord - In this phase of therapy, a patient suffering from acute lymphocytic leukemia 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.

Although, depending on the condition of a patient and the phases of treatment, it may include chemotherapy, immunotherapy, targeted therapy, radiation therapy, and stem cell transplant. Acute Lymphocytic Leukemia clinical trials are advancing innovative therapies, aiming to improve survival rates and treatment outcomes for patients.

Further details related to diagnosis and treatment are provided in the report...

Acute Lymphocytic Leukemia Epidemiology

As the market is derived using a patient-based model, the acute lymphocytic leukemia epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total incident cases of acute lymphocytic leukemia, gender-specific cases of acute lymphocytic leukemia, age-specific cases of acute lymphocytic leukemia, subtype-specific cases of acute lymphocytic leukemia, genetic-mutation specific cases of acute lymphocytic leukemia, and total treated cases of acute lymphocytic leukemia in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.

• 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.

Acute Lymphocytic Leukemia Epidemiology Segmentation

• Total incident cases of Acute Lymphocytic Leukemia
• Gender-specific cases of Acute Lymphocytic Leukemia
• Age-specific cases of Acute Lymphocytic Leukemia
• Subtype-specific cases of Acute Lymphocytic Leukemia
• Genetic-mutation specific cases of Acute Lymphocytic Leukemia
• Total treated cases of Acute Lymphocytic Leukemia

Recent Developments In The Acute Lymphocytic Leukemia Treatment Landscape

• In November 25, 2024, Shorla Oncology, a U.S.-Ireland specialty pharmaceutical company, announced that the FDA approved IMKELDI (imatinib) oral solution, the first oral liquid form of imatinib for treating certain forms of leukemia and other cancers.

Acute Lymphocytic Leukemia Drug Analysis

The drug chapter segment of the acute lymphocytic leukemia report encloses a detailed analysis of acute lymphocytic leukemia marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also helps understand the acute lymphocytic leukemia pivotal clinical trial details, recent and expected market approvals, patent details, advantages and disadvantages of each included drug, the latest news, and recent deals and collaborations. The Acute Lymphocytic Leukemia drugs market is expanding with innovative therapies, improved diagnostics, and increasing awareness driving global growth.

Acute Lymphocytic Leukemia Marketed Drug

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.

In October 2021, the US FDA approved TECARTUS for adult patients with R/R B-acute lymphocytic leukemia. It was approved by the European Commission (EC) in September 2022. Recently, in June 2024, the company announced updated, four-year overall survival data from the pivotal ZUMA-3 study evaluating TECARTUS in adult patients with relapsed or R/R B-acute lymphocytic leukemia at the 2024 American Society of Clinical Oncology (ASCO) annual meeting.

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.

In August 2017, the US FDA approved KYMRIAH for the treatment of patients up to age 25 years with R/R B-acute lymphocytic leukemia. It was approved by the EC in August 2018, and by the MHLW in March 2019. Recently, in April 2024, Novartis announced that the National Institute for Health and Care Excellence (NICE) has issued final draft guidance, recommending KYMRIAH for treating pediatric and young adults up to and including the age of 25 with B-cell acute lymphocytic leukemia that is refractory, in relapse post-transplant or in second or later relapse.

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. Later, in September 2023, the EC granted marketing authorization for JZP458, under the brand ‘ENRYLAZE’ for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphocytic leukemia in adult and pediatric patients.

Acute Lymphocytic Leukemia Emerging Drug

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).

Currently, WU-CART-007 is being evaluated for its safety and efficacy in patients with relapsed/refractory T-ALL/LBL in a Phase I/II study (NCT04984356). The company presented data from the Phase II cohort expansion study for WU-CART-007 in patients with R/R T-ALL/LBL at the European Hematology Association (EHA) 2024 Congress.

To be continued in the report...

2024 Conferences Key Highlights

ASCO 2024 Highlights

• Kite, a Gilead Company, presented updated four-year overall survival (OS) data from the pivotal ZUMA-3 study evaluating the CAR T-cell therapy TECARTUS in adult patients with R/R B-ALL in a poster presentation at the 2024 ASCO annual meeting. The findings showed a median OS of 25.6 months and a four-year OS rate of 40% (95% CI, 28-52) in all treated patients with a safety profile consistent with that observed in the three-year analysis.
• Autolus Therapeutics presented long-term follow-up and additional data from the pivotal Phase Ib/II FELIX study of obe-cel in adults with relapsed or refractory B-cell ALL, at the 2024 ASCO Annual Meeting. At a median follow-up of 21.3 months, 40% of responders remained in remission without the need for stem cell transplant (SCT) or other therapy. Improved event-free survival was associated with the persistence of CAR T cells and B-cell aplasia, a condition where CD19-expressing B-lymphocytes are depleted. These promising results suggest obe-cel could become a standard-of-care treatment for relapsed or refractory B-ALL, offering new hope for patients with limited options.

2024 Highlights

• Wugen presented data from the Phase II cohort expansion study for WU-CART-007 in patients with R/R T-ALL/LBL at EHA 2024 Congress. Data from EHA 2024 highlighted WU-CART-007, an allogeneic CAR-T cell targeting CD7, showing a remarkable overall response rate (ORR) exceeding 90%, surpassing current standard therapies, with a median duration of response of 6.2 months. Wugen plans to initiate follow-up studies in relapsed/refractory T-ALL/LBL, including pediatric patients under 12 years and a minimal residual disease cohort starting in Q4 2024.

Acute Lymphocytic Leukemia Drug Class Insights

In the past, targeted therapy has demonstrated impressive efficacy and the development of protein kinase inhibitors (PKIs) has a promising impact on acute leukemia patients. The role of molecular monitoring and the use of tyrosine kinase inhibitors after stem cell transplantation are areas of active investigation, and the results of ongoing trials will help to clarify the optimal management of these patients. The development and application of BCR-ABL1—targeted tyrosine kinase inhibitors (TKIs), such as GLEEVEC (imatinib mesylate), SPRYCEL (dasatinib), and ICLUSIG (ponatinib) in Ph+ ALL has dramatically changed care and improved survival. Second-generation TKIs, such as dasatinib, overcome most TKI resistance by BCR-ABL1 KD mutation although they are ineffective against the T315I mutation. Several Acute Lymphocytic Leukemia companies are working on more effective small inhibitors because previously approved inhibitors have been quite successful in certain groups of cancer patients.

In the last few years, immunotherapy has undergone a new phase of development which is linked to the development of CAR-T cell therapy, a personalized treatment involving the use of genetically modified T lymphocytes to attack the cancer cells. KYMRIAH in single perfusion has provided durable remission with long-term persistence in both pediatric and young adult patients with R/R B-cell ALL, with transient high-grade toxic effects. The CAR-T space is currently receiving a lot of attention, and competition follows attention. In the autologous CAR-T segment there is enormous competition. Allogeneic CAR T cells offer several advantages over non-allogeneic CAR T cells, including decreased time to treatment, improved T-cell subset selection, product standardization, and increased potential for redosing. Allogeneic CAR T production may allow broader patient populations to receive therapy by mitigating the need for leukapheresis, reducing antigen burden, and improving tolerability. Wugen has currently distinguished itself from its competitors. The company is focusing on the T-cell leukemia/lymphoma subpopulation instead of B-cell leukemia/lymphoma. Although the patient pool is smaller, there is still a sizable unmet need in this sector.

Acute Lymphocytic Leukemia Market Outlook

The treatment options for acute Lymphocytic Leukemia 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.

Amgen’s cancer drug BLINCYTO accomplished one of the fastest approvals on record until 2014. It is a bispecific CD19-directed CD3 T cell engager (BiTE) immunotherapy. Therapies based on CAR-T cells may have a huge potential clinical impact. Golden Gate, a Phase III study of BLINCYTO alternating with low-intensity chemotherapy in older adults with newly diagnosed Philadelphia chromosome-negative (Ph-) B-ALL, continues to enroll patients. Amgen reported in mid-June 2024 that BLINCYTO has received FDA approval to treat CD19-positive Philadelphia chromosome-negative B-ALL in the consolidation phase, regardless of MRD status. This approval allowed BLINCYTO to partially meet unmet needs in the battle against B-ALL by giving patients a treatment choice that is much better than conventional chemotherapy. The company also aims to advance blinatumomab subcutaneous injection through a registration enabling trial, with beginning anticipated in H2 2025. In addition, a Phase I/II study using subcutaneous blinatumomab in adults with relapsed or refractory Ph-B-ALL continues to enroll patients.

In 2017, the US FDA made a historic decision by approving the first-ever CAR-T cell therapy for the treatment of acute Lymphocytic Leukemia, that is, KYMRIAH by Novartis. In April 2023, the US FDA approved OMISIRGE (omidubicel-onlv) for use in adult and pediatric patients with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection.

Acute Lymphocytic Leukemia Companies like AbbVie and Roche (venetoclax), Orca Biosystems (Orca-T), J&J Innovative Medicine (daratumumab), Jazz Pharmaceuticals (CPX-351), Syndax Pharmaceuticals (SNDX-5613), Autolus Therapeutics (obe-cel), Wugen (WU-CART-007), Cellectis (UCART22), and several others are testing their products for the treatment of acute Lymphocytic Leukemia.

• The total market size of acute Lymphocytic Leukemia in the 7MM was approximately USD 1,600 million in 2023 and is projected to increase during the forecast period (2024–2034).
• Amongst EU4 and the UK, Germany accounted for the largest market size in 2023, while Spain occupied the bottom of the ladder.
• Among the therapies, BLINCYTO is expected to generate the highest revenue in the 7MM by 2034.
• From USD 583 million in 2022 to USD 861 million in 2023, BLINCYTO's total sales increased by 48%. As the main driver of these sales values, the US stood out in 2023, generating USD 566 million as opposed to USD 295 million from the rest of the world. Broad prescription in academic and community settings boosted this growth. In the first quarter of 2024, BLINCYTO's total global sales were USD 224 million, up 25.8% year-on-year. This growth was partially attributed to an increase in prescriptions written in the US and increased demand for B-ALL patient treatment in Europe and Japan. The second quarter saw a 28% year-on-year increase in BLINCYTO sales to USD 264 million, primarily due to widespread prescription for B-ALL patients in the academic and community setting. 

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.

Further detailed analysis of emerging therapies drug uptake in the report...

Acute Lymphocytic Leukemia Pipeline Development Activities

The Acute Lymphocytic Leukemia pipeline report provides insights into different Acute Lymphocytic Leukemia clinical trials within Phase III and Phase II. It also analyzes key players involved in developing targeted therapeutics.

Acute Lymphocytic Leukemia Pipeline Development Activities

The Acute Lymphocytic Leukemia clinical trials analysis report covers information on collaborations, acquisitions and mergers, licensing, and patent details for acute Lymphocytic Leukemia emerging therapies. 

KOL Views on Acute Lymphocytic Leukemia Market Report

To keep up with current market trends, we take KOLs and SMEs’ opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts contacted for insights on acute Lymphocytic Leukemia evolving treatment landscape, patient reliance on conventional therapies, patient’s therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Medical/scientific writers; American Cancer Society; Hematologist and Professors; MD, FACS, Chair of the Department of Department of Hematology, University of Texas MD Anderson Cancer Center; and others.

Delveinsight’s analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Their opinion helps understand and validate current and emerging therapy treatment patterns or acute Lymphocytic Leukemia market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Acute Lymphocytic Leukemia Report Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Analyst views. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

The analyst analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry.

In efficacy, the trial’s primary and secondary outcome measures are evaluated. Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials.

Acute Lymphocytic Leukemia Market Access and Reimbursement

Reimbursement is a crucial factor affecting the drug’s market access. Often, the decision to reimburse comes down to the price of the drug relative to the benefit it produces in treated patients. To reduce the healthcare burden of these high-cost therapies, payers and other industry insiders are considering many payment models. Understanding insurance and out-of-pocket costs shouldn’t be overwhelming. JazzCares supports patients at every step of their journey. With a JazzCares Savings Card, pay as little as USD 10 for RYLAZE medication. If insurance is a concern, RYLAZE may be available at no cost.

Patients whose healthcare professionals have prescribed TECARTUS therapy can work with Kite Konnect. This integrated technology platform provides information and assistance throughout the therapy process for Kite’s commercialized CAR-T therapies, including courier tracking for shipments and manufacturing status updates. Kite Konnect provides support for eligible patients receiving TECARTUS, and it includes information for the healthcare teams supporting their patients.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

In April 2024, Novartis announced that the National Institute for Health and Care Excellence (NICE) has issued final draft guidance, recommending KYMRIAH for treating pediatric and young adults up to and including the age of 25 with B-cell acute Lymphocytic Leukemia that is refractory, in relapse post-transplant or in second or later relapse.

Scope of the Acute Lymphocytic Leukemia Market Report

• The report covers a segment of key events, an executive summary, descriptive overview of Acute Lymphocytic Leukemia, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight into the epidemiology segments and forecasts, disease progression, and treatment guidelines has been provided.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the Acute Lymphocytic Leukemia market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM Acute Lymphocytic Leukemia market.

Acute Lymphocytic Leukemia Market Report Insights

• Acute Lymphocytic Leukemia Patient Population
• Acute Lymphocytic Leukemia Therapeutic Approaches
• Acute Lymphocytic Leukemia Pipeline Analysis
• Acute Lymphocytic Leukemia Market Size and Trends
• Existing and future Market Opportunity
• Acute Lymphocytic Leukemia Drugs Market

Acute Lymphocytic Leukemia Market Report Key Strengths

• Eleven Years Forecast
• The 7MM Coverage
• Acute Lymphocytic Leukemia Epidemiology Segmentation
• Key Cross Competition
• Acute Lymphocytic Leukemia Drugs Uptake
• Key Acute Lymphocytic Leukemia Market Forecast Assumptions

Acute Lymphocytic Leukemia Market Report Assessment

• Current Acute Lymphocytic Leukemia Treatment Practices
• Acute Lymphocytic Leukemia Unmet Needs
• Acute Lymphocytic Leukemia Pipeline Product Profiles
• Acute Lymphocytic Leukemia Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)
• Acute Lymphocytic Leukemia Market Drivers
• Acute Lymphocytic Leukemia Market Barriers

FAQs

• What was the Acute Lymphocytic Leukemia total market size, the market size by therapies, and market share (%) distribution in 2020, and what would it look like in 2034? What are the contributing factors for this growth?
• Which class is going to be the largest contributor in 2034?
• What are the pricing variations among different geographies for approved and off-label therapies?
• What are the disease risks, burdens, and unmet needs of Acute Lymphocytic Leukemia? What will be the growth opportunities across the 7MM concerning the patient population of Acute Lymphocytic Leukemia?
• What is the historical and forecasted Acute Lymphocytic Leukemia patient pool in the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan?
• What are the current options for the treatment of Acute Lymphocytic Leukemia? What are the current guidelines for treating Acute Lymphocytic Leukemia in the US and Europe?
• How many emerging therapies are in the mid-stage and late stage of development for the treatment of Acute Lymphocytic Leukemia?
• What are the recent novel therapies, targets, mechanisms of action, and technologies being developed to overcome the limitations of existing therapies?
• What key designations have been granted for the emerging therapies for Acute Lymphocytic Leukemia?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios.
• What are the country-specific accessibility issues of expensive, current therapies? Focusing on the reimbursement policies.

Reasons to Buy Acute Lymphocytic Leukemia Market Forecast Report

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the Acute Lymphocytic Leukemia market.
• Insights on patient burden/disease incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the Analyst view section to provide visibility around leading classes.
• Highlights of Access and Reimbursement policies of current therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.