Soft Tissue Sarcoma Market

• Soft tissue sarcomas are often locally aggressive, and local recurrence rates are reportedly 80% to 90% when simple resection is performed with inadequate or positive margins. However, with sophisticated imaging modalities, adjuvant radiotherapy, and appropriate limb salvage techniques, postoperative local recurrence rates of soft tissue sarcomas have improved from 7% to 15%.
• Soft tissue sarcomas are most common in older people. But compared to most other cancer types, it is also quite common in younger people. In the UK, an average of almost 45 out of 100 (almost 45%) cases are diagnosed in people aged 65 years and over. But around 10 in 100 (around 10%) are diagnosed in people younger than 30.
• Surgery is the standard treatment for all patients with adult-type, localized soft tissue sarcomas, and it should be performed by an appropriately trained surgeon.
• Doxorubicin is the current first-line standard of care treatment for most patients with advanced soft tissue sarcoma.
• The dynamics of the soft tissue sarcoma market are expected to change owing to a robust pipeline of products. Some of the key players involved in the development of novel drugs are Philogen, Intensity Therapeutics, Pure Biologics, Edgewood Oncology, Eli Lilly and Company, Peel Therapeutics, Medigene AG, and others.
• In February 2024, the FDA granted Orphan Drug Designation to Tigilanol Tiglate for the treatment of soft tissue sarcoma.
• More recently, in June 2025, Tigilanol Tiglate demonstrated early signs of efficacy in soft tissue sarcoma, supporting its continued clinical development.
• In May 2024, Intensity Therapeutics and the Swiss group for clinical cancer research SAKK signed a collaboration agreement to conduct a Phase II randomized clinical trial in early-stage breast cancer in Europe for INT230-6, Intensity's lead drug candidate.
• In May 2024, Blueprint Medicines Corporation announced multiple upcoming datasets across two key conferences that reinforce the significant real-world burden of systemic mastocytosis (SM) and highlight the durable clinical outcomes of AYVAKIT/AYVAKYT (avapritinib) across the spectrum of the disease.

DelveInsight's “Soft tissue sarcoma (STS)– Market Insight, Epidemiology and Market Forecast – 2034” report delivers an in-depth analysis of soft tissue sarcoma epidemiology, market, and clinical development in soft tissue sarcoma. In addition to this, the report provides historical and forecasted epidemiology and market data as well as a detailed analysis of the soft tissue sarcoma market trends in the United States, EU4 (Germany, France, Italy, and Spain ), and the United Kingdom, and Japan.

The soft tissue sarcoma market report provides real-world prescription pattern analysis, emerging drugs assessment, market share, and uptake/adoption pattern of individual therapies, as well as historical and forecasted soft tissue sarcoma market size from 2020 to 2034 in 7MM. The report also covers current soft tissue sarcoma treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s underlying potential.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Soft tissue sarcoma Understanding and Treatment Algorithm

Soft tissue sarcoma Overview and Diagnosis

Soft tissue sarcoma is a group of rare malignant tumors that arise in any of the mesodermal tissues or affect the soft tissues (fat, muscle, blood vessels, deep skin tissues, tendons, and ligaments) that connect, support, and surround other body structures, and organs. Most of them start in the arms or legs. They can also be found in the trunk, head, and neck area, internal organs, and the area in the back of the abdominal (belly) cavity (known as the retroperitoneum).

A soft tissue sarcoma is typically diagnosed by a specialized medical expert at a hospital. This diagnosis hinges on the patient's symptoms, a thorough physical exam, and the outcomes of both imaging scans and biopsies. The decision to conduct preoperative imaging and biopsy is guided by factors such as the size of the mass observed during the physical exam and the anticipated involvement of nerves and blood vessels. When it comes to imaging, MRI is generally considered the most informative option for assessing trunk and extremity soft tissue sarcomas. In cases where the potential for metastasis is high and the lungs are often affected, a chest CT scan with contrast is recommended. If a biopsy is advised, the preferred method is a core-needle biopsy. However, if this type of biopsy fails to provide a conclusive result, an incisional biopsy may become necessary.

The Soft tissue sarcoma report provides an overview of soft tissue sarcoma pathophysiology, and diagnostic approaches, along with a real-world scenario of a patient’s journey beginning from the first symptom, the time taken for diagnosis to the entire treatment process.

Further details related to country-based variations in diagnosis are provided in the report.

Soft tissue sarcoma Treatment  

Treatment options and recommendations depend on several factors, including the type, stage, and grade of sarcoma, possible side effects, and the patient’s preferences and overall health. There are many histologic subtypes, and the malignancy can be low or high grade. Soft tissue sarcoma treatments may include:

• Surgery
• Chemotherapy
• Radiation therapy
• Approved Targeted Therapy

Active drugs include doxorubicin, ifosfamide, gemcitabine, taxanes, and several others; these may be administered either as single agents or in combination regimens. The most commonly used regimen is the combination of doxorubicin and ifosfamide. Several new and experimental treatments are being tested for these cancers.

Further details related to treatment are provided in the report.

Soft tissue sarcoma Epidemiology

As the market is derived using a patient-based model, the soft tissue sarcoma epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total incident cases of soft tissue sarcoma, gender-specific cases of soft tissue sarcoma, type-specific cases of soft tissue sarcoma, age-specific cases of soft tissue sarcoma, stage-specific cases of soft tissue sarcoma, Extremities-specific cases of soft tissue sarcoma, and total treated cases of soft tissue sarcoma in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain), United Kingdom, and Japan from 2020 to 2034. 

• In 2025, approximately 13,520 new cases of soft tissue sarcoma are expected to be diagnosed in the United States, including about 7,600 in males and 5,920 in females, according to the American Cancer Society.
• The most common soft tissue sarcomas in adults include undifferentiated pleomorphic sarcoma, liposarcoma, and leiomyosarcoma.
• Leiomyosarcomas most often occur in the abdomen, while liposarcomas and undifferentiated pleomorphic sarcomas are more frequently found in the legs.
• Accurately diagnosing the subtype of sarcoma can be difficult, and disagreements among pathologists are common. As a result, sarcomas of uncertain type are frequently diagnosed.

Soft Tissue Sarcoma by Stage in the United States (2024)

Soft tissue sarcoma Recent Developments

• In October 2025, the FDA granted Fast Track designation to Adcendo’s ADCE-D01, a first-in-class antibody-drug conjugate targeting uPARAP for soft tissue sarcoma (STS). ADCE-D01 delivers a Topoisomerase I inhibitor and shows promising preclinical anti-tumor activity with a favorable safety profile, addressing a high unmet need in mesenchymal cancers.

Soft tissue sarcoma Drug Chapters

The drug chapter segment of the Soft tissue sarcoma report encloses a detailed analysis of Soft tissue sarcoma marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also deep dives into the Soft tissue sarcoma's pivotal clinical trial details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations. 

Marketed Drugs

AYVAKIT (avapritinib): Blueprint Medicines

AYVAKIT is a kinase inhibitor approved by the FDA for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumors (GIST) harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations. It is the only FDA-approved type 1 inhibitor for GIST that works by directly binding to the active kinase conformation from which mutant KIT and PDGFRA signal. AYVAKIT has demonstrated inhibition of a broad range of KIT and PDGFRA mutations associated with GIST, including potent clinical activity against activation loop mutations that are associated with resistance to currently approved therapies. The FDA has also granted Breakthrough Therapy designation (BTD) to avapritinib for the treatment of unresectable or metastatic GIST harboring the PDGFRA D842V mutation. GIST is the most common sarcoma of the gastrointestinal (GI) tract.

TAZVERIK (tazemetostat): Epizyme

TAZVERIK is a methyltransferase inhibitor indicated for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. This indication is approved under accelerated approval based on the overall response rate and duration of response. Epithelioid sarcoma is a rare subtype of soft tissue sarcoma that often occurs in young adults. TAZVERIK blocks the activity of the EZH2 methyltransferase, which may help keep the cancer cells from growing.

Note: Detailed current therapies assessment will be provided in the full report of Soft tissue sarcoma.

Emerging Drugs

Fibromun (L19TNF): Philogen

Fibromun (L19TNF) is a fully human immunomodulatory product consisting of the L19 antibody and TNF (a strong pro-inflammatory cytokine). Recombinant TNF has so far been approved only for certain clinical applications. It has shown potent anti-tumor activity, both as a single agent and in combination with other drugs, in several immunocompetent preclinical models, inducing in most cases long-lasting complete responses. Currently, the drug is being studied in the Phase III trial in combination with doxorubicin for advanced or metastatic soft tissue sarcoma. The drug received ODD from the US FDA for soft tissue sarcoma.

INT230-6: Intensity Therapeutics

INT230-6 is a formulation consisting of an amphiphilic cell penetration enhancer molecule, 8-((2-hydroxybenzoyl) amino) octanoate, also referred to as SHAO, combined with cisplatin and vinblastine. The penetration enhancer facilitates the dispersion of the two drugs throughout injected tumors and enables increased diffusion into cancer cells. INT230-6 is currently undergoing multiple Phase II clinical trials in the US for various types of metastatic cancers. It has also progressed to phase III trials for the treatment of soft tissue sarcoma.

Note: Detailed emerging therapies assessment will be provided in the final report.

Soft tissue sarcoma Market Outlook

Treatment options for advanced soft tissue sarcoma have historically been limited, relying primarily on cytotoxic chemotherapy, with doxorubicin and ifosfamide being the most common regimen. However, recent FDA approvals have introduced new drugs, providing progress against the disease. VOTRIENT (pazopanib) was approved in 2012 for second-line treatment, and YONDELIS (trabectedin) in 2015 for liposarcoma and leiomyosarcoma. Regorafenib, AYVAKIT (avapritinib), and TAZVERIK (tazemetostat) have also been approved for various sarcoma-related indications. Surgical resection remains crucial for localized disease, with radiotherapy as an adjunct. Despite advancements, conventional chemotherapy for recurrent or metastatic disease shows limited efficacy, prompting ongoing research into new therapeutic agents and immunotherapy.

Sintilimab plus doxorubicin is a promising and safe treatment for advanced soft tissue sarcoma patients who have failed previous therapies, including anthracycline-based chemotherapy. Advances in next-generation sequencing will improve the identification of actionable targets in later lines of soft tissue sarcoma treatment. The goal is to develop treatments that minimize toxicity while maximizing efficacy. If sarcoma recurs distantly, options include chemotherapy, targeted therapy, or immunotherapy. For metastasis confined to the lungs, surgical removal of all affected areas may be possible. Oncolytic viruses, especially adenovirus-based ones like T-VEC, offer a promising new direction for cancer therapy and are under clinical development for soft tissue sarcoma. Most therapies for soft tissue sarcoma are currently in late-phase development.

Key players, such as Philogen, Intensity Therapeutics, Pure Biologics, Edgewood Oncology, Eli Lilly and Company, Peel Therapeutics, and others are evaluating their lead candidates in different stages of clinical development, respectively. They aim to investigate their products for the treatment of soft tissue sarcoma.

• In 2024, the United States accounted for the largest market size of Soft tissue sarcoma, in comparison to EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
• Among the EU4 and the UK, Germany had the highest market size, while Spain had the smallest market size for Soft tissue sarcoma in 2024.

Soft tissue sarcoma Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2024–2034, which depends on the competitive landscape, safety, and efficacy data, along with the order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake. 

Further detailed analysis of emerging therapies drug uptake in the report…

Soft tissue sarcoma Cancer Activities

The report provides insights into different therapeutic candidates in Phase III and Phase II stages. 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 Soft tissue sarcoma emerging therapies. 

KOL Views

To keep up with the real-world scenario in current and emerging market trends, we take opinions from Key Industry leaders working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility, including Medical/scientific writers, Professors, and Others.

DelveInsight’s analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as UT Health San Antonio MD Anderson Cancer Center, University of Michigan, and Sarcoma Oncology Center etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or Soft tissue sarcoma market trends. 

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. 

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

In efficacy, the trial’s primary and secondary outcome measures are evaluated; for instance, in event-free survival, one of the most important primary outcome measures is event-free survival and overall survival. 

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. In addition, the scoring is also based on the probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided. 

Market Access and Reimbursement

Reimbursement may be referred to as the negotiation of a price between a manufacturer and payer that allows the manufacturer access to the market. It is provided to reduce the high costs and make the essential drugs affordable. Health technology assessment (HTA) plays an important role in reimbursement decision-making and recommending the use of a drug. These recommendations vary widely throughout the seven major markets, even for the same drug. In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs including Medicare, Medicaid, Health Insurance Program (CHIP), and the state and federal health insurance marketplaces are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs), and third-party organizations that provide services, and educational programs to aid patients are also present.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of currently used 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.

Scope of the Report

• The report covers a segment of key events, an executive summary, descriptive overview of Soft tissue sarcoma, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, and disease progression along treatment guidelines.
• Additionally, an all-inclusive account of both the current and emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
• A detailed review of the Soft tissue sarcoma market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM Soft tissue sarcoma market.

Soft tissue sarcoma Report Insights

• Patient Population
• Therapeutic Approaches
• Soft tissue sarcoma Pipeline Analysis
• Soft tissue sarcoma Market Size and Trends
• Existing and future Market Opportunity 

Soft tissue sarcoma Report Key Strengths

• 10-Years Forecast
• 7MM Coverage 
• Soft tissue sarcoma Epidemiology Segmentation
• Key Cross Competition 
• Conjoint analysis
• Drugs Uptake and Key Market Forecast Assumptions

Soft tissue sarcoma Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs

• What is the historical and forecasted Soft tissue sarcoma patient pool/patient burden in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
• Which combination treatment approaches will have a significant impact on the Soft tissue sarcoma drug treatment market size?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
• What are the current and emerging options for the treatment of Soft tissue sarcoma? 
• How many companies are developing therapies for the treatment of Soft tissue sarcoma?

• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies? 
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies? 

Reasons to buy

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Soft tissue sarcoma market.
• Insights on patient burden/disease Incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.