Sarcoma Biopsy Market – Global Industry Size, Share, Trends, Opportunity, & Forecast Segmented By Product Type (Reusable Devices, Disposable Devices), By End User (Hospitals, Ambulatory Surgical Centers, Diagnostic Centers), By Region, Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 300.56 Million
CAGR (2026-2031)	4.01%
Fastest Growing Segment	Reusable Devices
Largest Market	North America
Market Size (2031)	USD 380.52 Million

Market Overview

The Global Sarcoma Biopsy Market will grow from USD 300.56 Million in 2025 to USD 380.52 Million by 2031 at a 4.01% CAGR. Sarcoma biopsy is a diagnostic procedure involving the extraction of tissue from mesenchymal tumors in bone or soft tissue to determine malignancy and histological subtype. The Global Sarcoma Biopsy Market is primarily driven by the rising prevalence of sarcomas, which necessitates accurate early-stage diagnosis for effective treatment planning. Additionally, the growing adoption of minimally invasive image-guided techniques, such as core needle biopsy, supports market expansion by offering reduced patient morbidity and higher diagnostic yield compared to traditional surgical excisions.

However, the market faces impediments regarding tumor heterogeneity, where improper sampling can lead to non-diagnostic results or tumor seeding. This risk requires highly specialized pathology expertise often limited in resource-constrained settings. According to the American Cancer Society, in 2024, approximately 13,590 new cases of soft tissue sarcomas were expected to be diagnosed in the United States. This high incidence underscores the critical need for precise biopsy modalities while highlighting the burden on healthcare systems to ensure accurate characterization.

Key Market Drivers

The rising global incidence of soft tissue and bone sarcomas serves as a primary catalyst for the Global Sarcoma Biopsy Market, fundamentally increasing the volume of diagnostic procedures required. As the burden of these malignancies grows, healthcare systems are compelled to scale their biopsy capabilities to ensure timely identification and staging. This escalating demand is highlighted by recent epidemiological data; according to BMC Public Health, April 2025, in the 'Global burden of soft tissue sarcomas' study, the number of soft tissue sarcoma cases globally reached approximately 96,200. This significant patient pool necessitates a proportional expansion in biopsy throughput and has spurred the development of widespread screening protocols, directly bolstering the consumption of biopsy devices and consumables across both developed and emerging healthcare markets.

Simultaneously, the integration of artificial intelligence in diagnostic imaging and pathology is revolutionizing the market by addressing critical challenges related to tumor heterogeneity and diagnostic precision. AI algorithms are increasingly deployed to assist pathologists in subtyping complex sarcomas, thereby reducing the rates of inconclusive biopsies and the need for repeat procedures. For instance, according to the American Association for Cancer Research, April 2025, in findings presented at their Annual Meeting, a new AI-based model demonstrated the ability to classify pediatric sarcoma subtypes with up to 95.1% precision. Supporting this technological shift, robust financial investment is channeling resources into advanced research; according to the National Cancer Institute, July 2025, funding for Sarcoma Specialized Programs of Research Excellence (SPOREs) totaled $2,375,406 for the fiscal year. These advancements not only enhance diagnostic confidence but also drive the adoption of premium, AI-compatible digital pathology solutions within the biopsy workflow.

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Key Market Challenges

The complexity associated with tumor heterogeneity significantly impedes the growth of the global sarcoma biopsy market by complicating the diagnostic process. Mesenchymal tumors often exhibit diverse cellular structures within a single mass, meaning that a standard tissue extraction may fail to capture representative malignant cells. This variability creates a distinct risk of obtaining non-diagnostic results, necessitating repeat procedures that increase healthcare costs and patient burden. Furthermore, the potential for tumor seeding during improper sampling discourages the adoption of needle-based biopsies in non-specialized centers, thereby limiting the addressable market to a few high-volume institutions.

This restriction is compounded by the scarcity of pathology professionals possessing the niche expertise required to interpret these complex samples accurately. The inherent rarity of the condition directly contributes to this knowledge gap, as general practitioners rarely encounter these distinct malignancies. According to the Sarcoma Foundation of America, in 2024, sarcomas represented approximately 1 percent of all adult cancer diagnoses. This low incidence rate means few pathologists accumulate sufficient experience to navigate the risks of heterogeneity, creating a bottleneck that restrains the widespread utilization of advanced biopsy products in general clinical settings.

Key Market Trends

The emergence of fusion gene detection assays is reshaping the market by addressing the molecular complexity of mesenchymal tumors. As traditional methods often fail to capture all translocation-associated subtypes, laboratories are increasingly integrating targeted next-generation sequencing panels into routine workflows. This transition is validated by clinical data highlighting the superior yield of comprehensive profiling compared to standard techniques. According to the Journal of Molecular Diagnostics, November 2024, in the 'SARCP, a Clinical Next-Generation Sequencing Assay for the Detection of Gene Fusions in Sarcomas' study, a novel NGS assay detected gene fusions in 36.5% of 652 analyzed cases, significantly enhancing diagnostic resolution for patients with ambiguous histological presentations.

Simultaneously, a shift toward liquid biopsy and circulating tumor DNA analysis is occurring to overcome the limitations of invasive tissue extraction. This trend is driven by the need for non-invasive modalities capable of monitoring minimal residual disease and capturing tumor heterogeneity that single-site biopsies may miss. The utility of these blood-based assays is increasingly evident for localized disease management. According to the Journal of Clinical Oncology, May 2024, in the 'Molecular residual disease detection using bespoke circulating tumor DNA assays in localized soft tissue sarcoma' study, baseline blood samples collected from patients with localized high-risk soft tissue sarcoma demonstrated a ctDNA positivity rate of 79%, underscoring the technology's viability for real-time surveillance.

Segmental Insights

Within the Global Sarcoma Biopsy Market, the Reusable Devices segment is currently emerging as the fastest-growing category, driven by a strategic shift toward cost-efficiency and operational sustainability. Healthcare facilities are increasingly adopting these instruments to mitigate the high recurrent expenses associated with single-use alternatives, particularly in resource-constrained settings. This growth is further propelled by global initiatives aimed at reducing hazardous medical waste. Additionally, advancements in material durability ensure these devices withstand rigorous sterilization protocols mandated by regulatory bodies like the FDA, making them a financially superior and compliant choice for long-term diagnostic utility.

Regional Insights

North America holds the leading position in the global sarcoma biopsy market, driven primarily by the high incidence of soft tissue and bone cancers in the region. This dominance is sustained by advanced healthcare infrastructure and the strong presence of major medical device manufacturers focusing on research. Additionally, extensive awareness campaigns by institutions like the American Cancer Society encourage early detection and screening. The market is further strengthened by favorable reimbursement frameworks and efficient regulatory clearances from the U.S. FDA, which facilitate the widespread adoption of diagnostic biopsy solutions.

Recent Developments

• In October 2024, Avacta Therapeutics entered into a strategic collaboration with Tempus AI to advance the development of oncology drugs, specifically focusing on data-driven insights for its pre|CISION platform. Through this partnership, the companies agreed to utilize multimodal datasets, including primary tumor samples and clinical data from over 200,000 patients, to better characterize the tumor microenvironment in cancers such as soft tissue sarcoma. The collaboration was established to support the clinical development of Avacta's pipeline, including its lead program AVA6000, by leveraging artificial intelligence to identify optimal patient populations and improve the precision of biopsy-derived data analysis.
• In August 2024, Agilent Technologies received approval from the U.S. Food and Drug Administration (FDA) for its MAGE-A4 IHC 1F9 pharmDx assay as a companion diagnostic for patients with synovial sarcoma. This immunohistochemistry test was developed to identify patients whose tumors express the MAGE-A4 protein, determining their eligibility for treatment with TECELRA (afamitresgene autoleucel), a newly approved T-cell receptor therapy. The approval highlighted the critical role of precise tissue diagnostics in the management of synovial sarcoma, a rare and aggressive soft tissue malignancy, by ensuring that patients are accurately matched with targeted immunotherapies.
• In July 2024, Guardant Health introduced a significant upgrade to its Guardant360 liquid biopsy test, which is widely utilized for the genomic profiling of advanced solid tumors, including sarcomas. This enhanced version, operating on the Guardant Infinity platform, expanded its scope to evaluate biomarkers in 739 genes, covering all guideline-recommended genomic alterations. The company aimed to improve the detection of actionable biomarkers and emerging variants in blood samples, offering a non-invasive diagnostic alternative for patients with solid tumors where tissue biopsy may be challenging or insufficient for comprehensive molecular analysis.
• In May 2024, Foundation Medicine announced the commercial launch of FoundationOne RNA in the United States, a tissue-based RNA sequencing test designed for the comprehensive detection of gene fusions in solid tumors. This diagnostic tool was introduced to complement DNA-based testing by identifying complex fusions that are often critical drivers in rare cancers, including sarcomas. The company stated that the test enables the reporting of fusions across 318 genes and provides valuable genomic insights for oncologists treating patients with fusion-driven malignancies such as non-small cell lung cancer and various soft tissue sarcomas, thereby supporting more personalized treatment strategies.

Key Market Players

• Becton, Dickinson, and Company
• Argon Medical Devices
• Cook Group Incorporated
• UROMED
• STERYLAB S.r.l.

By Product Type	By End User	By Region
Reusable Devices Disposable Devices	Hospitals Ambulatory Surgical Centers Diagnostic Centers	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Sarcoma Biopsy Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Sarcoma Biopsy Market, By Product Type:

• Reusable Devices
• Disposable Devices

• Sarcoma Biopsy Market, By End User:

• Hospitals
• Ambulatory Surgical Centers
• Diagnostic Centers

• Sarcoma Biopsy Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE