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DelveInsight's "CAR-T in ALL-Market Insight, Epidemiology and Market Forecast - 2032" report delivers an in-depth understanding of ALL, historical and forecasted epidemiology as well as the CAR-T in ALL market trends in the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan.
The CAR-T in ALL market report provides current treatment practices, emerging CAR-Ts, market share of individual CAR-Ts, and current and forecasted 7MM CAR-T in ALL market size from 2019 to 2032. The report also covers current treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.
Study Period: 2019-2032
CAR-T in ALL Overview
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 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). Tests and procedures used to diagnose ALL include blood tests, bone marrow tests, imaging tests, and spinal fluid tests.
The treatment options for ALL 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 ALL.
Further details related to diagnosis and treatment are provided in the report...
As the market is derived using a patient-based model, the CAR-T in ALL epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total incident cases of ALL, gender-specific cases of ALL, age-specific cases of ALL, subtype-specific cases of ALL, genetic-mutation specific cases of ALL, and total treated cases of ALL in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan from 2019 to 2032.
The drug chapter segment of the CAR-T in ALL report encloses a detailed analysis of marketed and late-stage (Phase III and Phase II) CAR-Ts. It also helps understand the CAR-T in ALL 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
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. Studies demonstrated that following anti-CD19 CAR-T cell engagement with CD19-expressing target cells, the CD28 and CD3-zeta costimulatory domains activate downstream signaling cascades that lead to T cell activation, proliferation, acquisition of effector functions, and secretion of inflammatory cytokines and chemokines. This sequence of events leads to the killing of CD19-expressing cells. In October 2021, the US FDA approved TECARTUS for adult patients with R/R B-ALL. It was approved by the EC in September 2022.
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. The CAR is comprised of a murine single-chain antibody fragment that recognizes CD19 and is fused to intracellular signaling domains. Upon binding to CD19-expressing cells, the CAR transmits a signal to promote T cell expansion, activation, target cell elimination, and persistence of the KYMRIAH cells. In August 2017, the US FDA approved KYMRIAH for the treatment of patients up to age 25 years with R/R B-ALL. It was approved by the EC in August 2018, and by the MHLW in March 2019.
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. Autolus Therapeutics recently announced that the FELIX Phase II trial of obe-cel in R/R adult ALL has continued to progress well, and the company is on track to report initial results from the trial in the fourth quarter of 2022. In March 2022, obe-cel was granted Orphan Medical Product Designation by the EMA for the treatment of ALL, having previously received ODD by the US FDA for B-ALL. In April 2022, the US FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to obe-cel for the treatment of adult B-ALL. 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.
UCART22: Cellectis
UCART22 is an allogeneic-engineered T-cell product candidate designed for the treatment of CD22-expressing hematologic malignancies and is currently being developed for the treatment of B-ALL. Currently, the company is evaluating the drug in Phase I/II BALLI-01 Study in patients with R/R ALL. As of the December 2021 report, the company is enrolling patients in the third dose level of the BALLI-01 Study with a fludarabine cyclophosphamide alemtuzumab lymphodepletion regimen. In December 2021, the company presented preliminary results from this Study at the American Society of Hematology annual meeting.
Traditional cytotoxic chemotherapy-containing regimens have been the backbone of treatment for adults with ALL for decades. Common complications of traditional chemotherapy can be fatal and include infection, bleeding, thrombosis, neuropathy, osteonecrosis, and the development of secondary cancers, including AML and MDS.
Since the first successful report of CAR-T cell therapy for pediatric ALL more than a decade ago, the field has exploded with new constructs and targets, insights into CAR T-cell persistence, and novel antigen escape mechanisms; first came KYMRIAH (tisagenlecleucel, or tisa-cel, Novartis) for pediatric and young adult patients who had received at least two prior lines of therapy, followed by TECARTUS (brexucabtagene autoleucel, or brexu-cel, Kite) for adults following first relapse. It is anticipated that CAR-T cells will bring out the next big leap forward in leukemia immunotherapy.
Obecabtagene autoleucel (obe-cel; AUTO1), a novel, second-generation CAR product, is currently the most advanced candidate in the CAR-T in the ALL emerging pipeline. CD19 negative relapse is a major cause of treatment failure after CD19 CAR T-cell therapy for pediatric B-ALL. To address this, Autolus has designed AUTO1/22 to target both CD19 and CD22 using the fast-off rate CD19 CAR from obecabtagene autoleucel (obe-cel) combined with a novel CD22 CAR capable of effective signaling in response to low antigen density.
Several companies advancing allogeneic CAR-T cell therapies in ALL include key players such as Precision Biosciences (PBCAR0191), Cellectis (UCART22), Wugen (WU-CART-007), and Cellectis/Servier/Allogene (UCART19), and others.
CAR-T in ALL Uptake
This section focuses on the rate of uptake of the potential CAR-Ts expected to be launched in the market during the study period 2019-2032. The analysis covers market uptake by CAR-Ts; patient uptake by CAR-Ts; and sales of each CAR-T in ALL.
Further detailed analysis of emerging therapies drug uptake in the report...
CAR-T in ALL 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 CAR-T in ALL 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 CAR-T in ALL 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 30+ 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 CAR-T in ALL 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, target population, 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.
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.
FAQs
Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.