The acute lymphoblastic leukemia (ALL) therapy market is growing steadily, fueled by innovations in the treatment paradigm. The availability of premium-priced branded agents prescribed in multidrug regimens, particularly Blincyto-based therapies, is impacting the disease’s treatment algorithm. Although multiagent chemotherapy remains the cornerstone of treatment, recently approved therapies (Amgen’s Blincyto and Pfizer’s Besponsa) have expanded the number of options available. CAR T-cell therapies (Novartis’s Kymriah and Kite Pharma’s Tecartus) have also expanded options in the relapse and refractory setting, offering patients additional support. The emerging therapy pipeline continues to grow with therapies such as AbbVie / Roche’s Venclexta / Venclyxto and Bristol Myers Squibb’s CAR T-cell therapy Breyanzi showing promising development. Nevertheless, clinical and commercial potential remains for ALL therapies with improved efficacy, a novel mechanism of action, and/or the ability to treat underserved patient segments, such as T-cell ALL.
Questions answered
What is the size of the drug-treatable ALL population, and how do the drug-treatment rates vary by geography, line of therapy, and by age?
How will the use of chemotherapy change over the forecast period, and what impact will the entry of generics have on the ALL market?
What are thought leaders’ opinions of anti-CD19 CAR T-cell therapies that are approved or in Phase II/III development, such as Kymriah, Tecartus, and Breyanzi?
What are the drivers of, and constraints on, the ALL market?
How will the entry of new agents shape this market?
Product description
Disease Landscape & Forecast provides comprehensive market intelligence with world-class epidemiology, keen insight into current treatment paradigms, in-depth pipeline assessments, and drug forecasts supported by detailed primary and secondary research.
Solution enhancement
Disease Landscape & Forecast will be updated throughout the year to provide timely insights and analyses as material indication-specific news and events unfold.
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Acute lymphoblastic leukemia key findings - March 2023
Key updates
March 2023
Market outlook
Key findings
Market share of drug classes for ALL: 2021
Market share of drug classes for ALL: 2031
Drug-treatable population share and major-market sales share in ALL: 2021
Drug-treatable population share and major-market sales share in ALL: 2031
Major-market sales of key agents in ALL: 2021-2031
Population positioning of current therapies in ALL
Population positioning of emerging therapies in ALL
ALL SWOT analysis
Market drivers and constraints
What factors are driving the market for ALL?
What factors are constraining the market for ALL?
Segment-specific trends
Patient-share dynamics of key regimens for first-line ALL, Ph- pediatric / AYA (0-24 years) in the United States: 2021-2031
Patient-share dynamics of key regimens for first-line ALL, Ph+ pediatric / AYA (0-24 years) in the United States: 2021-2031
Patient-share dynamics of key regimens for second-line ALL, Ph- pediatric / AYA (0-24 years) in the United States: 2021-2031
Patient-share dynamics of key regimens for third-line ALL, Ph- pediatric / AYA (0-24 years) in the United States: 2021-2031
Patient-share dynamics of key regimens for second/ third-line ALL, Ph+ pediatric / AYA (0-24 years) in the United States: 2021-2031
Patient-share dynamics of key regimens for first-line ALL, Ph- adult and older adult (u226525 years) in the United States: 2021-2031
Patient-share dynamics of key regimens for first-line ALL, Ph+ adult and older adult (u226525 years) in the United States: 2021-2031
Patient-share dynamics of key regimens for second-line ALL, Ph- adult and older adult (u226525 years) in the United States: 2021-2031
Patient-share dynamics of key regimens for third-line ALL, Ph- adult and older adult (u226525 years) in the United States: 2021-2031
Patient-share dynamics of key regimens for second/ third-line ALL, Ph+ adult and older adult (u226525 years) in the United States: 2021-2031
Forecast
Market forecast assumptions (pediatric / AYA (0-24 years))
Market forecast dashboard (pediatric / AYA (0-24 years))
Market forecast assumptions (adult and older adult (u226525 years))
Market forecast dashboard (adult and older adult (u226525 years))
Etiology and pathophysiology
Disease overview
Disease pathophysiology
Overview
Hematopoiesis: healthy and ALL process
Select molecular mutations in ALL
Risk factors
Select risk factors associated with ALL
Staging and classification
WHO classification
FAB classification
Risk stratification of ALL
Key pathways and drug targets
Select pathways and drug targets
Epidemiology
Key findings
Epidemiology populations
Disease definition, methods, and sources used
Diagnosed incident cases of acute lymphoblastic leukemia: 2021-2031
Disease definition, methods, and sources used
Diagnosed incident cases of acute lymphoblastic leukemia by age distribution: 2021-2031
ALL patient flow
Drug-treatable cases of pediatric / AYA (0-24 years) ALL: 2021-2031
Drug-treatable cases of adult and older adult (u2265 25 years) ALL: 2021-2031
Drug-treated cases of pediatric / AYA (0-24 years) ALL: 2021-2031
Drug-treated cases of adult and older adult (u2265 25 years) ALL: 2021-2031
Current treatment
Key findings
Treatment goals
Key endpoints used in clinical trials for ALL
Key current therapies
Overview
Mechanism of action of key current drug classes used for ALL
Current treatments used for ALL
Market events impacting the use of key current therapies for ALL
Key results from select clinical trials investigating imatinib for the treatment of ALL
Ongoing clinical development of imatinib
Key ongoing clinical trials of imatinib in the treatment of ALL
Expert insight: imatinib
Key results from select clinical trials investigating dasatinib for the treatment of ALL
Ongoing clinical development of dasatinib
Key ongoing clinical trials of dasatinib in the treatment of ALL
Expert insight: dasatinib
Key results from select clinical trials investigating Iclusig for the treatment of ALL
Ongoing clinical development of Iclusig
Expert insight: Iclusig
Key results from select clinical trials investigating Tasigna for the treatment of ALL
Key results from select clinical trials investigating Bosulif for the treatment of ALL
Key results from select clinical trials investigating pegaspargase for the treatment of ALL
Ongoing clinical development of pegaspargase
Key ongoing clinical trials of pegaspargase in the treatment of ALL
Key results from select clinical trials investigating Asparlas for the treatment of ALL
Ongoing clinical development of Asparlas
Key ongoing clinical trials of Asparlas in the treatment of ALL
Key results from select clinical trials investigating recombinant Erwinia asparaginase for the treatment of ALL
Expert insight: recombinant Erwinia asparaginase
Key results from select clinical trials investigating vincristine sulfate for the treatment of ALL
Expert insight: vincristine sulfate
Key results from select clinical trials investigating clofarabine for the treatment of ALL
Key results from select clinical trials investigating nelarabine for the treatment of ALL
Expert insight: nelarabine
Key results from select clinical trials investigating rituximab for the treatment of ALL
Expert insight: rituximab
Key results from select clinical trials investigating Blincyto for the treatment of ALL
Ongoing clinical development of Blincyto
Key ongoing clinical trials of Blincyto in the treatment of ALL
Expert insight: Blincyto
Key results from select clinical trials investigating Besponsa for the treatment of ALL
Ongoing clinical development of Besponsa
Key ongoing clinical trials of Besponsa in the treatment of ALL
Expert insight: Besponsa
Key results from select clinical trials investigating Kymriah for the treatment of ALL
Ongoing clinical development of Kymriah
Key ongoing clinical trials of Kymriah in the treatment of ALL
Expert insight: Kymriah
Tecartus
Key results from select clinical trials investigating Tecartus for the treatment of ALL
Ongoing clinical development of Tecartus
Key ongoing clinical trials of Tecartus in the treatment of ALL
Expert insight: Tecartus
Medical practice
First-line ALL
Relapsed / refractory ALL
Patient characteristics influencing drug selection in ALL
Treatment decision tree for ALL: United States
Treatment decision tree for ALL: Europe
Treatment decision tree for ALL: Japan
Unmet need overview
Current and future attainment of unmet needs in ALL
Top unmet needs in ALL: current and future attainment
Expert insight: unmet need in ALL
Drug pipeline
Pipeline
Regulatory milestones
Indication comparison
Emerging therapies
Key findings
Key emerging therapies
Key therapies in development for ALL
Estimated market authorization dates of key emerging therapies for the treatment of ALL
Key results of select clinical trials investigating Venclexta / Venclyxto for the treatment of ALL
Analysis of the clinical development program for Venclexta / Venclyxto
Key ongoing clinical trials of Venclexta / Venclyxto in the treatment of ALL
Expert insight: Venclexta / Venclyxto
Expectations for market authorization and sales opportunity of Venclexta / Venclyxto in ALL
Analysis of the clinical development program for navitoclax
Expectations for market authorization and sales opportunity of navitoclax in ALL
Key results of select clinical trials investigating obecabtagene autoleucel for the treatment of ALL
Analysis of the clinical development program for obecabtagene autoleucel
Expert insight: obecabtagene autoleucel
Expectations for market authorization and sales opportunity of obecabtagene autoleucel in ALL
Key results of select clinical trials investigating Breyanzi for the treatment of ALL
Analysis of the clinical development program for Breyanzi
Key ongoing clinical trials of Breyanzi in the treatment of ALL
Expert insight: Breyanzi
Expectations for market authorization and sales opportunity of Breyanzi in ALL
Analysis of the clinical development program for CTX-110
Key ongoing clinical trials of CTX-110 in the treatment of ALL
Expectations for market authorization and sales opportunity of CTX110 in ALL
Key results of select clinical trials investigating revumenib for the treatment of ALL
Analysis of the clinical development program for revumenib
Key ongoing clinical trials of revumenib in the treatment of ALL
Expert insight: revumenib
Expectations for market authorization and sales opportunity of revumenib in ALL
Key results of select clinical trials investigating Darzalex / Darzalex Faspro for the treatment of ALL
Analysis of the clinical development program for Darzalex / Darzalex Faspro
Key ongoing clinical trials of Darzalex / Darzalex Faspro in the treatment of ALL
Expert insight: Darzalex / Darzalex Faspro
Expectations for market authorization and sales opportunity of Darzalex / Darzalex Faspro in ALL
Key results of select clinical trials investigating Sarclisa for the treatment of ALL
Analysis of the clinical development program for Sarclisa
Expert insight: Sarclisa
Expectations for market authorization and sales opportunity of Sarclisa in ALL
Key results of select clinical trials investigating bortezomib for the treatment of ALL
Analysis of the clinical development program for bortezomib
Key ongoing clinical trials of bortezomib in the treatment of ALL
Expectations for market authorization and sales opportunity of bortezomib in ALL
Early-phase pipeline analysis
Select compounds in early-phase development for acute lymphoblastic leukemia
Access & reimbursement overview
Region-specific reimbursement practices
Key market access considerations in ALL: United States
General reimbursement environment: United States
Key market access considerations in ALL: EU5
General reimbursement environment: EU5
Key market access considerations in ALL: Japan
General reimbursement environment: Japan
Appendix
Abbreviations
ALL bibliography
Elliott Puttock, Ph.D
Elliott Puttock, M.Res., Ph.D., is an analyst on the Oncology team at Clarivate. He has experience working in the pharmaceutical sector developing novel therapeutics for ongoing oncology projects. While earning his Ph.D., he specialized in metastatic ovarian cancer and focused on targeting the extracellular matrix to develop new treatments for patients. He obtained his doctorate from Barts Cancer Institute in London.
Yueyao (Alex) Li
Yueyao (Alex) Li, M.D., Ph.D., M.S.P.H.,is an associate epidemiologist at Clarivate. Previously, she was a postdoctoral researcher at Brown University, where she worked on projects relating to skin cancer and chronic skin conditions. Dr. Li holds a medical degree specializing in general surgery from China Medical University. She also holds a Ph.D. in epidemiology from Indiana University and a master’s degree in public health from the University of South Carolina.