Smart Biopsy Devices Global Market Report 2026

Smart biopsy devices are intelligent instruments designed to enhance the precision and efficiency of tissue sampling during medical procedures, often incorporating features such as image guidance, real-time feedback, or robotic assistance. These devices aim to improve diagnostic capabilities and patient outcomes, particularly in the context of cancer diagnosis and drug delivery.

The primary products within the category of smart biopsy devices include needle-based biopsy instruments, procedure trays, localization wires, and others. Needle-based biopsy instruments are tools used to extract a sample of the body's cells for laboratory analysis, collecting tissue or liquid samples from various organs such as bones, muscles, liver, and lungs. These devices employ guidance techniques such as ultrasound-guided biopsy, stereotactic-guided biopsy, magnetic resonance imaging-guided biopsy, and others. Smart biopsy devices find applications in various areas, including breast cancer, skin cancer, liver cancer, prostate cancer, and more. The end users of these devices include hospitals, academic and research institutes, as well as diagnostic and imaging centers.

Tariffs are impacting the smart biopsy devices market by increasing costs of imported imaging components, robotic actuators, precision needles, sensors, and control software used in advanced biopsy systems. Hospitals and diagnostic centers in North America and Europe are most affected due to reliance on imported high-precision medical components, while Asia-Pacific faces higher system integration costs. These tariffs are raising capital expenditure requirements and slowing procurement cycles. However, they are also encouraging localized manufacturing, regional supplier partnerships, and domestic innovation in smart diagnostic device development.

The smart biopsy devices market research report is one of a series of new reports from The Business Research Company that provides smart biopsy devices market statistics, including smart biopsy devices industry global market size, regional shares, competitors with a smart biopsy devices market share, detailed smart biopsy devices market segments, market trends and opportunities, and any further data you may need to thrive in the smart biopsy devices industry. This smart biopsy devices market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The smart biopsy devices market size has grown strongly in recent years. It will grow from $3.01 billion in 2025 to $3.23 billion in 2026 at a compound annual growth rate (CAGR) of 7.2%. The growth in the historic period can be attributed to rising cancer incidence rates, increased use of minimally invasive diagnostic procedures, expansion of advanced imaging infrastructure, growing adoption of core needle biopsy techniques, improved clinician training in image-guided diagnostics.

The smart biopsy devices market size is expected to see strong growth in the next few years. It will grow to $4.32 billion in 2030 at a compound annual growth rate (CAGR) of 7.6%. The growth in the forecast period can be attributed to increasing demand for precision oncology diagnostics, rising investments in smart surgical technologies, expansion of robotic-assisted intervention platforms, growing focus on early disease detection, increasing integration of AI-driven diagnostic support. Major trends in the forecast period include increasing adoption of image-guided biopsy systems, rising use of robotic-assisted biopsy procedures, growing integration of real-time tissue feedback technologies, expansion of minimally invasive diagnostic techniques, enhanced focus on diagnostic accuracy and patient safety.

The adoption of minimally invasive procedures is poised to contribute significantly to the growth of the smart biopsy devices market. Minimally invasive procedures, designed to minimize disruption to the body's normal structures, benefit from the use of smart biopsy devices to enhance precision and accuracy in tissue sampling. These devices often incorporate advanced imaging technologies such as real-time ultrasound or MRI guidance, enabling healthcare professionals to target specific areas for biopsy through smaller incisions. This reduces patient trauma and enhances diagnostic accuracy. FFor instance, in June 2024, according to the American Society of Plastic Surgeons, a US-based professional medical organization, minimally invasive procedures grew by 7 percent in 2023, surpassing the growth of surgical procedures by 2 percent, with neuromodulator injections and hyaluronic acid filler treatments reaching over 9 million and 5 million, respectively. Therefore, the growing adoption of minimally invasive procedures is a driving factor in the smart biopsy devices market.

Major companies in the smart biopsy devices market are focusing on developing advanced innovations, such as multi-modality breast biopsy markers, to enhance lesion localization, maintain long-term site visibility, and improve diagnostic confidence. Multi-modality markers are specialized biopsy site markers designed to remain clearly visible across ultrasound, mammography, and MRI, allowing clinicians to accurately track biopsy sites and support precise follow-up assessments. For instance, in March 2024, Mammotome, a US-based medical technology company, launched LumiMARK, a next-generation 510(k)-cleared breast biopsy site marker for multi-modality identification. Offered in three distinct 3D shapes-including Tulip(TM) and Rose(TM)-the marker ensures consistent visibility across imaging modalities and provides enhanced long-term detectability in both breast tissue and lymph nodes, supporting more accurate diagnosis and ongoing clinical decision-making.

In June 2023, Quest Diagnostics, a medical laboratories company, acquired Haystack Oncology for $450 million. This strategic acquisition enhances Quest Diagnostics' cancer diagnostics portfolio by incorporating Haystack's highly sensitive minimal-residual disease (MRD) testing technology based on circulating tumor DNA (ctDNA). The addition of Haystack's advanced testing capabilities allows Quest to offer improved early detection of solid tumor cancers through blood-based clinical lab services, starting in 2024. Haystack Oncology Inc. specializes in developing and utilizing advanced technologies for MRD testing in the field of cancer diagnostics.

Major companies operating in the smart biopsy devices market are Becton Dickinson and Company, Boston Scientific Corporation, Hologic Inc., Cook Medical Inc., Medtronic Plc, Olympus Corporation, B. Braun Melsungen AG, CONMED Corporation, FUJIFILM Holdings Corporation, Argon Medical Devices Inc., SOMATEX Medical Technologies GmbH, TSK Laboratory Europe B.V., INRAD Inc., Esaote SpA, Planmed Oy, Canon Medical Systems Corporation, Siemens Healthineers, General Electric Company, Intuitive Surgical Inc., Karl Storz SE And Co KG, Stryker Corporation

North America was the largest region in the smart biopsy devices market in 2025. 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, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.

The countries covered in the smart biopsy devices market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, UK, USA, Canada, Italy, Spain

The smart biopsy devices market consists of revenues earned by entities by providing services such as collecting biopsy samples, real-time cancer tissue characterization, minimally invasive biopsy, and precise tissue targeting. The market value includes the value of related goods sold by the service provider or included within the service offering. The smart biopsy devices market also includes sales of image-guided biopsy devices, core biopsy devices, bone biopsy needles and devices, and molecular biopsy devices which are used in providing collecting biopsy samples, real-time cancer tissue characterization services. Values in this market are 'factory gate' values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

Smart Biopsy Devices Market Global Report 2026 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.

This report focuses smart biopsy devices market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.

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Where is the largest and fastest growing market for smart biopsy devices ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The smart biopsy devices market global report from the Business Research Company answers all these questions and many more.

The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, total addressable market (TAM), market attractiveness score (MAS), competitive landscape, market shares, company scoring matrix, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.

• The market characteristics section of the report defines and explains the market. This section also examines key products and services offered in the market, evaluates brand-level differentiation, compares product features, and highlights major innovation and product development trends.
• The supply chain analysis section provides an overview of the entire value chain, including key raw materials, resources, and supplier analysis. It also provides a list competitor at each level of the supply chain.
• The updated trends and strategies section analyses the shape of the market as it evolves and highlights emerging technology trends such as digital transformation, automation, sustainability initiatives, and AI-driven innovation. It suggests how companies can leverage these advancements to strengthen their market position and achieve competitive differentiation.
• The regulatory and investment landscape section provides an overview of the key regulatory frameworks, regularity bodies, associations, and government policies influencing the market. It also examines major investment flows, incentives, and funding trends shaping industry growth and innovation.
• The market size section gives the market size ($b) covering both the historic growth of the market, and forecasting its development.
• The forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.
• The total addressable market (TAM) analysis section defines and estimates the market potential compares it with the current market size, and provides strategic insights and growth opportunities based on this evaluation.
• The market attractiveness scoring section evaluates the market based on a quantitative scoring framework that considers growth potential, competitive dynamics, strategic fit, and risk profile. It also provides interpretive insights and strategic implications for decision-makers.
• Market segmentations break down the market into sub markets.
• The regional and country breakdowns section gives an analysis of the market in each geography and the size of the market by geography and compares their historic and forecast growth.
• Expanded geographical coverage includes Taiwan and Southeast Asia, reflecting recent supply chain realignments and manufacturing shifts in the region. This section analyzes how these markets are becoming increasingly important hubs in the global value chain.
• The competitive landscape chapter gives a description of the competitive nature of the market, market shares, and a description of the leading companies. Key financial deals which have shaped the market in recent years are identified.
• The company scoring matrix section evaluates and ranks leading companies based on a multi-parameter framework that includes market share or revenues, product innovation, and brand recognition.

Scope

• Markets Covered:1) By Product: Needle-Based Biopsy Instruments; Localization Wires
• 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 Localization Wires: Hook Wire Localization Devices; Radar Localization Devices; Magnetic Localization Devices
• Companies Mentioned: Becton Dickinson and Company; Boston Scientific Corporation; Hologic Inc.; Cook Medical Inc.; Medtronic Plc; Olympus Corporation; B. Braun Melsungen AG; CONMED Corporation; FUJIFILM Holdings Corporation; Argon Medical Devices Inc.; SOMATEX Medical Technologies GmbH; TSK Laboratory Europe B.V.; INRAD Inc.; Esaote SpA; Planmed Oy; Canon Medical Systems Corporation; Siemens Healthineers; General Electric Company; Intuitive Surgical Inc.; Karl Storz SE And Co KG; Stryker Corporation
• Countries: Australia; Brazil; China; France; Germany; India; Indonesia; Japan; Taiwan; Russia; South Korea; UK; USA; Canada; Italy; Spain
• Regions: Asia-Pacific; South East Asia; Western Europe; Eastern Europe; North America; South America; Middle East; Africa
• Time Series: Five years historic and ten years forecast.
• Data: Ratios of market size and growth to related markets, GDP proportions, expenditure per capita,
• Data Segmentations: country and regional historic and forecast data, market share of competitors, market segments.
• Sourcing and Referencing: Data and analysis throughout the report is sourced using end notes.
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