The rhabdomyosarcoma market is expanding as unmet needs in pediatric and young-adult populations drive increased R&D and clinical activity. Additionally, the launch of emerging therapies such as Cabozantinib (Exelixis/Ipsen), PEEL-224 (Peel Therapeutics), Orotecan (Edison Oncology), ONIVYDE (St. Jude Research Hospital), and others will further propel the market growth.

LAS VEGAS, Nov. 27, 2025 /PRNewswire/ -- DelveInsight's Rhabdomyosarcoma Market Insights report includes a comprehensive understanding of current treatment practices, rhabdomyosarcoma emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into leading markets (the US, EU4, UK, and Japan). 

Rhabdomyosarcoma Market Summary

• The market size for rhabdomyosarcoma in the leading markets is expected to grow significantly by 2034.
• The United States accounted for the highest rhabdomyosarcoma treatment market size in 7MM in 2024, in comparison to the other major markets, i.e., EU4 countries, the United Kingdom, and Japan.
• Rhabdomyosarcoma is one of the most common STS in children, representing ∼50% of STS cases.
• Leading rhabdomyosarcoma companies developing emerging therapies, such as Exelixis, Ipsen, Peel Therapeutics, Edison Oncology, St. Jude Research Hospital, and others, are developing new therapy for rhabdomyosarcoma that can be available in the rhabdomyosarcoma market in the coming years. 
• The promising rhabdomyosarcoma therapies in clinical trials include Cabozantinib, PEEL-224, Orotecan, ONIVYDE, and others.

Discover the rhabdomyosarcoma new treatment @ New Treatments for Rhabdomyosarcoma

Key Factors Driving the Growth of the Rhabdomyosarcoma Market 

Pediatric Prevalence and Clear Clinical Need

Rhabdomyosarcoma is the most common soft-tissue sarcoma in children, with a measurable (though rare) incidence that keeps it a distinct clinical priority in pediatric oncology.

Genetic Profiling and Risk Stratification in Rhabdomyosarcoma

Recent genetic and molecular profiling of rhabdomyosarcoma has enhanced risk stratification and individualized treatment. Identifying subtypes, such as alveolar rhabdomyosarcoma with PAX3/7-FOXO1 fusion, enables more accurate prognostic predictions and informs targeted therapy strategies in clinical trials.

Novel Agents and Immuno-Oncology Approaches for Relapsed or Metastatic Rhabdomyosarcoma

New drugs targeting IGF1R, ALK, and FGFR pathways, as well as immune-based strategies such as checkpoint inhibitors, CAR-T cells, and cancer vaccines, hold promise for improving outcomes in relapsed or metastatic rhabdomyosarcoma. Early-phase clinical trials are expanding rapidly, presenting opportunities for breakthroughs in previously hard-to-treat cases.

Launch of Emerging Rhabdomyosarcoma Drugs

The rhabdomyosarcoma pipeline is advancing, with several key candidates currently in early-stage clinical development. Notable drugs in progress include Cabozantinib (Exelixis/Ipsen), PEEL-224 (Peel Therapeutics), Orotecan (Edison Oncology), and ONIVYDE (St. Jude Research Hospital), among others.

Rhabdomyosarcoma Market Analysis

Currently, treatment options for rhabdomyosarcoma remain limited, with the VAC regimen, comprising an alkylating agent (such as cyclophosphamide or ifosfamide) combined with vincristine and dactinomycin, serving as the standard of care across all risk categories: low, intermediate, and high.

In children with localized disease, rhabdomyosarcoma is often curable through combined-modality therapy, yielding 5-year survival rates above 70%. Patients who remain event-free for 5 years rarely relapse, with the 10-year late-event rate around 9%. However, the risk of recurrence is significantly higher in those presenting with unresectable tumors, unfavorable primary sites, or metastatic disease at diagnosis.

Early efforts to apply adult immunotherapy approaches to pediatric rhabdomyosarcoma have shown limited benefit, primarily due to the typically low mutational burden and non-inflammatory tumor microenvironment of pediatric solid tumors. The scarcity of robust clinical trial data underscores a persistent unmet need in rhabdomyosarcoma management. Emerging companies addressing this gap include Peel Therapeutics, Ipsen Pharma, Edison Oncology, and others.

To know more about rhabdomyosarcoma treatment options, visit @ Approved Rhabdomyosarcoma Drugs

Rhabdomyosarcoma Competitive Landscape

The rhabdomyosarcoma clinical trial landscape is advancing, with several major products in early-stage clinical development. The current drugs in the pipeline include Cabozantinib (Exelixis/Ipsen), PEEL-224 (Peel Therapeutics), Orotecan (Edison Oncology), ONIVYDE (St. Jude Research Hospital), and others.

Exelixis/Ipsen's Cabozantinib is an orally administered tyrosine kinase inhibitor used to treat several types of cancer. It acts on multiple signaling pathways that drive tumor growth and angiogenesis. The drug is currently in Phase II clinical development for rhabdomyosarcoma, with ongoing studies in collaboration with Nationwide Children's Hospital (NCT05135975) and the National Cancer Institute (NCT02867592).

Peel Therapeutics' PEEL-224 is a nanocarrier-based therapy incorporating four small molecules for cancer treatment. Its active component is derived from camptothecin, a natural compound from the Chinese Happy Tree, initially thought to serve as a plant defense molecule. Through molecular engineering and conjugation with a synthetic polymer, PEEL-224 is designed to enhance therapeutic efficacy while minimizing toxicity. It is presently being evaluated in Phase I/II clinical trials in collaboration with the Dana-Farber Cancer Institute (NCT06709495) and the Children's Hospital of Philadelphia (NCT06721689).

Edison Oncology's Orotecan (oral irinotecan HCl, VAL-413) is a novel, patented liquid oral formulation of irinotecan hydrochloride developed to enable oral administration with improved tolerability. It is currently undergoing Phase I clinical development. In April 2024, Edison Oncology presented interim data from its ongoing orotecan trial in recurrent pediatric cancers at the AACR 2024 conference.

ONIVYDE is a cancer therapy that inhibits the TOP1 enzyme, which is essential for DNA replication and cell division. By blocking this enzyme, the drug prevents cancer cell proliferation, leading to cell death. In ONIVYDE, irinotecan is encapsulated in liposomes—tiny lipid particles that accumulate in tumors and release the drug gradually. It is administered intravenously over 90 minutes every two weeks, with specific dosing adjustment guidelines. ONIVYDE is currently in Phase I/II clinical development.

The anticipated launch of these emerging therapies are poised to transform the rhabdomyosarcoma market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the rhabdomyosarcoma market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.

Discover more about therapy for rhabdomyosarcoma @ Rhabdomyosarcoma Clinical Trials 

What is Rhabdomyosarcoma?

Rhabdomyosarcoma is a rare and aggressive malignant tumor that arises from skeletal muscle progenitor cells. It primarily affects children and adolescents, though it can also occur in adults. RMS is categorized into several histological subtypes, including embryonal, alveolar, and pleomorphic, each with distinct genetic and clinical characteristics. Common sites of origin include the head and neck region, genitourinary tract, and extremities. The disease often presents as a rapidly growing, painless mass, sometimes accompanied by symptoms related to local invasion or metastasis. Diagnosis involves imaging studies, biopsy, and immunohistochemical analysis, while treatment typically includes a combination of surgery, chemotherapy, and radiation therapy. Advances in molecular profiling have improved understanding of the disease's biology, paving the way for targeted and personalized therapeutic strategies.

Rhabdomyosarcoma Epidemiology Segmentation

The rhabdomyosarcoma epidemiology section provides insights into the historical and current rhabdomyosarcoma patient pool and forecasted trends for the leading markets. Rhabdomyosarcoma is a soft tissue malignant tumor of mesenchymal origin. It accounts for approximately 2.7% of cancer cases among children aged 0 to 14 years and 1.4% of the cases among adolescents and young adults aged 15 to 19 years.

The rhabdomyosarcoma market report proffers epidemiological analysis for the study period 2020–2034 in the leading markets, segmented into:

• Total Incident Cases of Soft Tissue Sarcoma 
• Total Incident Cases of Rhabdomyosarcoma 
• Type-specific Incident Cases of Rhabdomyosarcoma 
• Site-specific Incident Cases of Rhabdomyosarcoma 
• Age-specific Incident Cases of Rhabdomyosarcoma 
• Total Treated Cases of Rhabdomyosarcoma

Scope of the Rhabdomyosarcoma Market Report

• Therapeutic Assessment: Rhabdomyosarcoma current marketed and emerging therapies
• Rhabdomyosarcoma Market Dynamics: Key Market Forecast Assumptions of Emerging Rhabdomyosarcoma Drugs and Market Outlook
• Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
• Unmet Needs, KOL's views, Analyst's views, Rhabdomyosarcoma Market Access and Reimbursement

Download the report to understand which factors are driving rhabdomyosarcoma therapeutics market trends @ Rhabdomyosarcoma Market Trends

Table of Contents

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