Osteosarcoma Market on the Rise in the 7MM During the Forecast Period (2025-2034) with Novel Therapeutics and Technological Innovations | DelveInsight

The dynamics of the osteosarcoma market are anticipated to change due to the extensive R&D activities, entry of novel potential therapies such as HALMB-0168 (AlaMab Therapeutics in collaboration with CSPC Pharmaceutical), Naxitamab 15-096 (Y-mAbs Therapeutics), OST-HER2 (OST31-154, OS Therapies), and others into the market, and increasing awareness among care providers and givers.

LAS VEGAS, July 30, 2025 /PRNewswire/ -- DelveInsight's Osteosarcoma Market Insights report includes a comprehensive understanding of current treatment practices, osteosarcoma emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan].

Key Takeaways from the Osteosarcoma Market Report

• According to DelveInsight's analysis, the market size for osteosarcoma in the 7MM is expected to grow significantly by 2034.
• The United States accounted for the highest osteosarcoma treatment market size in 7MM in 2024, in comparison to the other major markets, i.e., EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• As per DelveInsight estimates, the total incident population of osteosarcoma in the 7MM was more than 2K in 2024.
• Among all the subtype-specific cases, around 80% were of conventional osteosarcoma in 2024.
• Leading osteosarcoma companies developing emerging therapies, such as Hansoh Pharmaceutical, OS Therapies, Y-mAbs Therapeutics, Hutchmed, MedPacto, AlaMab Therapeutics, CSPC Pharmaceutical, and others, are developing new Osteosarcoma treatment drugs that can be available in the Osteosarcoma market in the coming years.
• The promising osteosarcoma therapies in the pipeline include HS-20093, OST-HER2, Vactosertib, DANYELZA, Surufatinib, ALMB-0168, and others.
• OS Therapies plans to submit a Biologics License Application (BLA) to the US FDA for OST-HER2 in osteosarcoma by 2025. Upon approval, it may become eligible for a Priority Review Voucher, which could be sold for additional revenue.

Discover the osteosarcoma new treatment @ New Treatments for Osteosarcoma

Osteosarcoma Market Dynamics

The osteosarcoma market dynamics are expected to change in the coming years. Improvement of treatment over the years, along with newly updated guidelines, the investigation of various immunotherapies such as PD-L1 and CTLA-4 inhibitors, and the exploration of genetic and other underexplored disease-related biomarkers may bring a positive shift in the management of osteosarcoma, while the lack of approved drugs for chemo-resistant disease and maintenance therapy provides opportunities for pharmaceutical companies to enter the market.

As potential therapies are being investigated for the treatment of osteosarcoma, it is safe to predict that the treatment space will significantly impact the osteosarcoma market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the osteosarcoma market in the 7MM.

However, several factors may impede the growth of the osteosarcoma market. Around half of osteosarcoma patients exhibit or develop chemotherapy resistance during treatment, and the disease is further challenged by a lack of targeted therapies and limited options for relapsed or refractory cases, complications from current treatments such as low survival rates in older patients and adverse effects, strict pricing and reimbursement policies, the high probability of failure of emerging therapies in late-phase clinical trials, and a low patient population for conducting clinical studies.

Moreover, osteosarcoma treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, the osteosarcoma market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the osteosarcoma market growth.

Osteosarcoma Treatment Market

The standard treatment for osteosarcoma typically combines surgery, chemotherapy, and, in some cases, radiation therapy. Surgery focuses on removing the tumor while maintaining maximum function and mobility, often through limb-sparing procedures, though amputation may sometimes be necessary. In pediatric patients, rotationplasty can be an option. Chemotherapy is administered both before surgery to reduce tumor size and after surgery to destroy residual cancer cells. Commonly used chemotherapy agents include cisplatin, doxorubicin, ifosfamide, and high-dose methotrexate. Radiation therapy is less frequently employed but may be considered when surgery is not feasible or for palliative purposes.

Currently, MEPACT (mifamurtide) is the only approved therapy for osteosarcoma. It is specifically indicated for high-grade, non-metastatic osteosarcoma in patients aged 2 to 30 years following complete surgical removal of the tumor and is used in combination with post-operative multi-agent chemotherapy. In March 2009, the European Commission granted marketing authorization for MEPACT across the EU to IDM Pharma, which was later acquired by Takeda in the same year. However, MEPACT is not approved in the United States. Still, some patients in the US have accessed it through the FDA's compassionate use and personal importation programs.

To know more about FDA-approved drugs for osteosarcoma, visit @ Approved Osteosarcoma Drugs

Osteosarcoma Pipeline Therapies and Key Companies

The emerging pipeline drug for osteosarcoma includes OST-HER2 (OS Therapies), Vactosertib (MedPacto), Surufatinib (Hutchmed), and others.

Naxitamab 15-096 is a monoclonal antibody targeting GD2, developed by researchers at Memorial Sloan Kettering Cancer Center (MSK) and exclusively licensed to Y-mAbs Therapeutics. This drug acts against the human tumor-associated antigen GD2 and exhibits potential antitumor activity. By binding to GD2, naxitamab triggers antibody-dependent cell-mediated cytotoxicity (ADCC) against tumor cells expressing this antigen.

OST-HER2 is a biologic therapeutic candidate utilizing an off-the-shelf Listeria monocytogenes (Lm) vector-based immunotherapeutic vaccine platform, designed to prevent metastasis, delay recurrence, and improve overall survival in osteosarcoma patients. The company reported positive Phase IIb AOST-2121 clinical trial results in June 2024, and by October 2024, the final patient had been enrolled.

The drug has received Orphan Drug Designation from both the FDA and the European Medicines Agency (EMA), as well as Fast Track designation from the FDA and PRIME designation from the EMA. It has also been awarded Rare Pediatric Disease Designation (RPDD) by the FDA. Under the RPDD program, if accelerated approval is obtained before September 30, 2026, the company will be eligible for a Priority Review Voucher (PRV), which it plans to sell.

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

Discover more about osteosarcoma marketed and pipeline drugs @ Osteosarcoma Clinical Trials

Recent Developments in the Osteosarcoma Market

• In July 2025, OS Therapies granted end of Phase II Meeting by US FDA for OST-HER2 Program in the Prevention or Delay of Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma. The Company expects the meeting to occur in the third quarter of 2025. The End of Phase II Meeting marks a pivotal point in the drug development process, and a significant milestone towards market access. The Company intends to seek alignment with FDA to begin a Rolling Review process for the forthcoming BLA submission for OST-HER2.
• In March 2025, Y-mAbs Therapeutics announced the new data from a Phase II clinical trial evaluating naxitamab with granulocyte-macrophage colony-stimulating factor (GM-CSF) in patients with relapsed/refractory high-risk neuroblastoma and residual disease in the bone/bone marrow.
• In January 2025, GSK's B7-H3-targeted antibody-drug conjugate, GSK'227, received the Breakthrough Therapy Designation from US FDA in late-line relapsed or refractory osteosarcoma.

Osteosarcoma Overview

Osteosarcoma is the most common type of primary bone cancer, predominantly affecting children, teenagers, and young adults. It originates in the osteoblast cells responsible for bone formation and typically arises in the long bones, such as the femur, tibia, or humerus, near the growth plates. While the exact cause of osteosarcoma is not fully understood, genetic mutations, inherited cancer syndromes, previous radiation therapy, and rapid bone growth during adolescence are considered major risk factors.

The symptoms of osteosarcoma often begin subtly and may include persistent localized bone pain, which tends to worsen at night or during activity. Swelling, tenderness, or the appearance of a lump near the affected bone is common, along with restricted movement of nearby joints. In advanced stages, fractures can occur due to weakening of the bone.

Diagnosis involves a combination of imaging tests and biopsy. X-rays, MRI, and CT scans are commonly used to evaluate bone structure and detect tumor spread, while PET scans help assess metastasis. A definitive diagnosis is made through a biopsy, where a tissue sample is examined microscopically to confirm cancerous cells. Blood tests, though not diagnostic, may support evaluation by indicating markers like elevated alkaline phosphatase or lactate dehydrogenase (LDH).

Osteosarcoma Epidemiology Segmentation

The osteosarcoma epidemiology section provides insights into the historical and current osteosarcoma patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders.

The osteosarcoma market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into:

• Total Incident Cases of Osteosarcoma
• Site-specific Cases of Osteosarcoma
• Sub-types Specific Cases of Osteosarcoma
• Stage-specific Cases of Osteosarcoma
• Age-specific Cases of Osteosarcoma
• Gender-specific Cases of Osteosarcoma

Scope of the Osteosarcoma Market Report

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

Download the report to understand which factors are driving osteosarcoma treatment market trends @ Osteosarcoma Market Forecast

Table of Contents

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