PUBLISHER: DelveInsight | PRODUCT CODE: 1632467
PUBLISHER: DelveInsight | PRODUCT CODE: 1632467
DelveInsight's "Acute Lymphocytic Leukemia (ALL)-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 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.
Study Period: 2020-2034
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.
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.
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.
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.
Marketed Drug
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.
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.
ASCO 2024 Highlights
EHA 2024 Highlights
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 pharmaceutical 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.
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.
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.
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.
Acute Lymphocytic Leukemia Pipeline Development Activities
The report provides insights into different therapeutic candidates in Phase III and Phase II. It also analyzes key players involved in developing targeted therapeutics.
Pipeline Development Activities
The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for acute Lymphocytic Leukemia emerging therapies.
KOL Views
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.
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.
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.