Biopsy Devices Market Size, Trends, and Growth Analysis 2026-2034

Market Overview:

According to IMARC Group's latest research publication, "Biopsy Devices Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2026-2034", The global biopsy devices market size was valued at USD 2.94 Billion in 2025 and is projected to reach USD 4.77 Billion by 2034, exhibiting a CAGR of 5.36% during 2026-2034.

This detailed analysis primarily encompasses industry size, business trends, market share, key growth factors, and regional forecasts. The report offers a comprehensive overview and integrates research findings, market assessments, and data from different sources. It also includes pivotal market dynamics like drivers and challenges, while also highlighting growth opportunities, financial insights, technological improvements, emerging trends, and innovations. Besides this, the report provides regional market evaluation, along with a competitive landscape analysis.

How AI is Reshaping the Future of the Biopsy Devices Market

1. AI-powered image analysis platforms are transforming biopsy guidance workflows, with tools like iCAD's ProFound AI now deployed across over 50 countries and used to analyze an estimated 40 million mammograms over the past five years, improving radiologist sensitivity and reducing reading time for 3D mammography procedures.
2. Machine learning algorithms integrated into biopsy guidance systems enable real-time lesion detection and auto-segmentation, with platforms such as Siemens Healthineers' AI-Rad Companion Prostate MR automatically marking suspicious lesions during MRI-ultrasound fusion-guided targeted biopsy procedures.
3. AI-driven pathology tools are accelerating post-biopsy tissue analysis, reducing turnaround times from days to hours, and enabling earlier treatment initiation for cancer patients across oncology, urology, and gastroenterology settings.
4. Government-supported cancer research programs are channeling funding toward AI-integrated diagnostics, with the American Cancer Society approving USD 64.5 million in grants beginning 2024 across 72 institutions in the United States, directly supporting research involving next-generation biopsy and detection technologies.
5. Predictive analytics tools embedded in hospital diagnostic workflows are helping clinicians prioritize high-risk biopsy candidates from imaging screening data, improving resource allocation in busy oncology departments across North America and Europe.

1. Minimally Invasive Procedures Replacing Open Surgical Approaches: Patients and clinicians are increasingly favoring core-needle, vacuum-assisted, and percutaneous biopsy techniques over open surgical procedures. Vacuum-assisted biopsy systems now represent a standard of care for many breast lesions, with the technique allowing larger contiguous tissue samples through a single insertion while reducing patient discomfort and enabling outpatient workflows. The ultrasound-guided biopsy segment held a dominant 42% share of the US breast biopsy devices market in 2025, reflecting the scale of this procedural shift.
2. Liquid Biopsy Emerging as a Complementary Diagnostic Modality: Blood-based ctDNA analysis is moving from research settings into routine clinical practice, opening a significant complementary channel alongside traditional tissue sampling. Guardant Health reported 53,100 clinical tests in a single quarter of 2024, and Natera's Signatera MRD test secured broad Medicare coverage in June 2025 across colorectal, breast, bladder, ovarian, and lung cancers, validating the technology across more than 100 clinical studies. The FDA approval of Guardant Health's Shield blood test as the first blood-based primary screening option for colorectal cancer in adults aged 45 and above marked a defining regulatory milestone in July 2024.
3. MRI-Guided Biopsy Adoption Accelerating Across Breast and Prostate Indications: MRI-guided procedures are gaining traction for lesions that are occult on ultrasound or conventional mammography. In February 2026, Mammotome introduced the Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System, the first system designed to be positioned inside the MRI scanner room at the patient's side during the procedure, directly addressing workflow challenges in MRI-guided breast biopsy. The MRI-guided segment held 18% of the US breast biopsy market in 2025 and is on track to register the fastest growth among all guidance technique categories.
4. Government Cancer Screening Programs Expanding Biopsy Procedure Volumes: National cancer screening mandates are steadily translating into higher biopsy volumes across multiple indications. In India, the installation of the first MR Fusion Biopsy machine in Maharashtra at Sir H.N. Reliance Foundation Hospital in July 2024 marked a significant expansion of precision biopsy infrastructure in an emerging economy. Saudi Vision 2030's healthcare investment allocation and China's hospital-tier expansion programs are similarly driving procurement of advanced biopsy guidance systems across Asia-Pacific and the Middle East.
5. Robotic-Assisted Biopsy Platforms Entering Clinical Practice: Robotic and AI-augmented biopsy systems are beginning to complement traditional interventional radiology workflows. The global robotic biopsy devices segment was valued at USD 547.6 Million in 2025, with platforms such as KOELIS Trinity for prostate and Veran SPiN for lung biopsy enabling sub-millimetre targeting accuracy. Major medical device companies expanded robotic-assisted platforms and received multiple regulatory approvals between 2023 and 2025, improving accessibility and procedural efficiency across hospital networks.

1. Rising Global Cancer Burden Creating Sustained Procedure Demand: The WHO recorded over 20 million new cancer cases globally in 2022, with projections estimating that figure will rise to 35 million by 2050. In the United States alone, the American Cancer Society estimated over 316,950 new cancer cases in 2025, with breast cancer accounting for more than 310,720 diagnoses in 2024. This volume of new diagnoses directly translates into mandatory tissue sampling requirements across oncology, gastroenterology, urology, and gynaecology, sustaining structural demand growth for biopsy devices across all major geographies.
2. Expanding Cancer Screening Infrastructure in Emerging Economies: Healthcare infrastructure investment in Asia-Pacific, Latin America, and the Middle East is materially increasing biopsy device uptake in markets previously underserved by advanced diagnostic technology. India's growing private hospital diagnostic network and China's hospital-tier expansion programs are accelerating procurement of image-guided biopsy platforms. In July 2024, the installation of Maharashtra's first MR Fusion Biopsy machine at a leading Mumbai hospital demonstrated how emerging markets are closing the technology gap with established healthcare systems.
3. Continuous Product Innovation Driving Clinical Adoption: A sustained pipeline of new product launches is expanding procedural options and improving diagnostic yield across biopsy applications. In November 2024, Mammotome launched the Mammotome AutoCore, offering significant operational and clinical advantages over traditional core needle devices. In January 2026, BD received FDA 510(k) clearance for the EnCor EnCompass Breast Biopsy and Tissue Removal System, a multi-modality platform giving clinicians flexibility across various breast imaging techniques. In April 2024, the FDA approved Single Pass's Kronos biopsy closure device, addressing a persistent procedural challenge in post-biopsy site management.
4. Favorable Reimbursement Landscapes Incentivizing Advanced Technique Adoption: Reimbursement expansion for advanced biopsy modalities in developed markets is reducing financial barriers to technology adoption at the hospital and ambulatory center level. Natera's Signatera MRD liquid biopsy test receiving broad Medicare coverage in June 2025 across five major cancer types and pan-cancer immunotherapy monitoring represents one of the most significant reimbursement milestones for next-generation biopsy techniques to date. The hospital segment commands a 52% share of the US breast biopsy devices market in 2025, anchored by comprehensive reimbursement structures covering image-guided and vacuum-assisted procedures.
5. Aging Global Population Amplifying Cancer Incidence and Diagnostic Volumes: Demographic aging across North America, Europe, and Asia-Pacific is structurally increasing cancer prevalence in older age cohorts, which carry the highest per-capita incidence rates for breast, prostate, colorectal, and lung malignancies. Japan's universal health coverage system supports high cancer-screening adherence within an aging population, sustaining consistent biopsy device demand. Europe holds a 26.3% share of the global biopsy devices market in 2025, with aging population dynamics across Germany, France, the United Kingdom, and the Nordics contributing meaningfully to procedure volume growth.

Leading Companies Operating in the Global Biopsy Devices Industry:

1. BD (Becton, Dickinson and Company)
2. Hologic, Inc.
3. Boston Scientific Corporation
4. Cook Medical
5. Medtronic
6. Olympus America
7. Argon Medical Devices
8. Devicor Medical Products, Inc.
9. INRAD, Inc.
10. Mauna Kea Technologies

Biopsy Devices Market Report Segmentation:

Breakup By Procedure Type:

1. Surgical Biopsy
2. Needle Biopsy

Surgical Biopsy accounts for the majority of shares at 54.6% in 2025, on account of its diagnostic gold-standard status for many tumour types, including breast, lymph-node, and complex lesion staging cases where excisional or incisional sampling provides definitive histopathology.

Breakup By Product:

1. Biopsy Guidance Systems
2. Biopsy Needles
3. Needle-Based Biopsy Guns
4. Biopsy Forceps
5. Others

Biopsy Guidance Systems dominate the product segment with a 29.8% share in 2025, driven by the capital-intensive adoption of stereotactic, ultrasound, and MRI-guided platforms across hospital and ambulatory center settings globally.

Breakup By Application:

1. Breast Biopsy
2. Liver Biopsy
3. Kidney Biopsy
4. Lung Biopsy
5. Colorectal Biopsy
6. Prostate Biopsy
7. Others

Breast biopsy leads the application segment owing to the high global incidence of breast cancer, widespread national mammography screening programs, and the growing adoption of image-guided and vacuum-assisted biopsy techniques in both hospital and outpatient settings.

Breakup By Guidance Technique:

1. Stereotactic Guidance
2. Ultrasound Guidance
3. MRI Guidance
4. Others

Ultrasound guidance holds the leading position across the guidance technique segment due to its real-time imaging capability, cost efficiency, widespread equipment availability, and ability to precisely target suspicious lesions with minimal patient discomfort during procedures.

Breakup By End User:

1. Hospitals
2. Diagnostic Imaging Centers
3. Research and Academic Institutes
4. Others

Hospitals enjoy the leading position owing to their advanced imaging infrastructure, availability of skilled interventional radiologists and oncologists, and high patient inflow for cancer diagnosis and screening procedures.

Breakup By Region:

1. North America (United States, Canada)
2. Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, Others)
3. Europe (Germany, France, United Kingdom, Italy, Spain, Russia, Others)
4. Latin America (Brazil, Mexico, Others)
5. Middle East and Africa

North America enjoys the leading position with a 39.6% revenue share in 2025, owing to high cancer screening adherence, broad Medicare and private insurance reimbursement coverage for biopsy procedures, and the strong domestic presence of leading manufacturers including BD and Hologic.

Recent News and Developments in the Biopsy Devices Market

1. February 2026: Mammotome, a part of Danaher Corporation, introduced the Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System, the first system designed to be positioned inside the MRI scanner room at the patient's side during biopsy, improving clinician coordination and workflow efficiency in MRI-guided breast procedures.
2. January 2026: BD (Becton, Dickinson and Company) received FDA 510(k) clearance for the EnCor EnCompass Breast Biopsy and Tissue Removal System, a next-generation multi-modality platform engineered to provide clinicians with flexibility across various breast imaging modalities for the diagnosis of breast disease.
3. January 2026: iSono Health commercially launched ATUSA, an FDA-cleared wearable and automated 3D quantitative breast ultrasound platform, expanding access to non-invasive breast imaging and biopsy guidance outside traditional clinical settings.
4. September 2025: Resitu received FDA 510(k) clearance for its RESL09 breast biopsy device, marking a significant milestone in advancing its innovative breast biopsy technology for clinical use across the United States.
5. July 2025: SimonMed Imaging unveiled Mammogram+ and Mammogram+ Heart, two new AI-powered mammogram services focused on enhancing early detection and advancing preventative care across breast and cardiac health indications.
6. November 2024: Mammotome launched the Mammotome AutoCore, offering significant clinical and operational advantages over traditional core needle biopsy devices, expanding the company's portfolio of minimally invasive breast biopsy solutions.

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