Global Smart Biopsy Devices Market
Medical Equipment

Smart Biopsy Devices Market Outlook 2025–2034: Identifying Growth Drivers, Technology Trends, and Policy Impact

Discover trends, market shifts, and competitive outlooks for the smart biopsy devices industry through 2025-2034 with The Business Research Company’s reliable data and in-depth research

How Has the Smart Biopsy Devices Market Growth Performance Trended Historically, And What Lies Ahead?

In recent times, the market size for smart biopsy devices has seen significant growth. The value is projected to increase from $2.85 billion in 2024 to $3.04 billion in 2025, boasting a compound annual growth rate (CAGR) of 6.4%. The growth during the historic period can be attributed to a rise in cancer incidents, a preference for minimally invasive procedures, advancement in medical devices, and enhanced diagnostic precision.

Over the coming years, the smart biopsy devices market size is predicted to experience considerable growth, escalating to a value of $4.05 billion in 2029, with a compound annual growth rate (CAGR) of 7.5%. The surge in this forecasted period can be ascribed to several factors such as the rise in personalized medicine, advancements in imaging modalities, an increase in biopsy for biomarker analysis, the entry of new players into the market, and superior data connectivity. Significant trends to look out for during the forecast period encompass robot-aided biopsies, AI-enabled biopsy assistance, the emergence of wireless biopsy instruments, utilization of portable and handheld devices, and real-time guidance systems.

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What Are the Core Market Drivers Propelling Growth in the Smart Biopsy Devices Industry?

The increase in cancer incidences is anticipated to boost the expansion of the smart biopsy devices market. Cancer encompasses a wide range of diseases that can originate in almost any organ or tissue. This occurs when rogue cells multiply without control, exceeding their normal confines, and either migrate to other organs or encroach upon nearby body sections. This surge in cancer cases has intensified the demand for accurate and targeted tissue specimens, which in turn has fueled the development of sophisticated biopsy tools with enhanced molecular, imaging, and precision capabilities to facilitate diagnostic and treatment procedures. For example, the World Health Organization, a Switzerland-based Intergovernmental organization, predicted in January 2024 that there will be more than 35 million new cancer cases by 2050, representing a 77% increase from the estimated 20 million cases and 9.7 million fatalities noted in 2022. Hence, the escalating number of cancer cases is stimulating the expansion of the smart biopsy device market.

How Is the Smart Biopsy Devices Market Segmented?

The smart biopsy devices market covered in this report is segmented –

1) By Product: Needle-Based Biopsy Instruments, Procedure Trays, Localization Wires, Other Products

2) By Guidance Technique: Ultrasound-Guided Biopsy, Stereotactic-Guided Biopsy, Magnetic Resonance Imaging-Guided Biopsy, Other Guidance Techniques

3) By Application: Breast Cancer, Skin Cancer, Liver Cancer, Prostate Cancer, Other Applications

4) By End-User: Hospitals, Academic And Research Institutes, Diagnostic And Imaging Centers

Subsegments:

1) By Needle-Based Biopsy Instruments: Core Needle Biopsy Devices, Fine Needle Aspiration (FNA) Devices, Vacuum-Assisted Biopsy Devices

2) By Procedure Trays: Pre-Packaged Biopsy Procedure Trays, Customizable Procedure Trays

3) By Localization Wires: Hook Wire Localization Devices, Radar Localization Devices, Magnetic Localization Devices

4) By Other Products: Biopsy Markers, Biopsy Imaging Systems, Biopsy Guidance Systems

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Which Regions Are Driving the Next Phase of the Smart Biopsy Devices Market Growth?

North America was the largest region in the smart biopsy devices market in 2024. Asia-Pacific is expected to be the fastest-growing region in the smart biopsy devices market report during the forecast period. The regions covered in the smart biopsy devices market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.

What Key Market Trends and Innovations Are Shaping the Future of the Smart Biopsy Devices Industry?

Leading firms in the smart biopsy device market are focusing on the creation of sophisticated products such as breast biopsy markers, with the aim of augmenting the accuracy and efficiency of breast cancer diagnosis procedures. These markers are specifically engineered to locate exactly the spot from which a tissue sample was taken during a biopsy, thereby informing future treatment plans and facilitating close monitoring of the right region for any potential transformation into malignant cells. For example, Mammotome, a medical device manufacturer based in the United States, introduced the Mammotome DualCore Dual Stage Core Biopsy System in August 2022. As a minimally invasive breast biopsy device, it employs a two-stage methodology to deliver precision and high-quality tissue samples, typically with ultrasound guidance to enable accurate, safe, and effective diagnosis of breast cancer. By integrating this system with advanced breast biopsy markers, healthcare professionals have access to an all-encompassing and progressive approach for performing ultrasound-guided breast biopsies.

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How Is the Smart Biopsy Devices Market Defined and What Are Its Core Parameters?

Smart biopsy devices refer to intelligent instruments intended to increase the precision and efficiency of tissue samples during medical procedures. It has features such as image guidance, real-time feedback, or robotic help to improve diagnostic capabilities and patient outcomes. It is used for diagnosing cancer and delivering therapeutic drugs.

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