Biopsy

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• Virtual biopsy

2025

Global Breast Biopsy Devices Market Size Reaches $1.51 Billion

At the end of 2025, global sales of breast biopsy devices in monetary terms reached $1.51 billion. More than 40% of this amount fell on the North American region. Such data are provided in a Fortune Business Insights study, the results of which were published on January 21, 2026.

A breast biopsy is a minimally invasive procedure to collect a sample of suspicious tissue or fluid from the breast (supervised by ultrasound, mammography, or MRI) for laboratory analysis. It is the most accurate method for confirming or excluding malignancy . To perform the procedure, various types of devices are used - fine needle aspiration systems, biopsy guns, vacuum biopsy systems, etc.

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Фото: Freepik

Among the key drivers of the market in question is the increase in the incidence of breast cancer. It is one of the main types of malignancies worldwide. According to the World Health Organization (WHO), in 2022, 2.3 million women were diagnosed with breast cancer and caused 670 thousand deaths. Such cancers occur in women of any age after reaching puberty, with incidence rates increasing with age. In about half of cases, breast cancer affects women who, with the exception of gender and age (over 40), are not exposed to other well-defined risk factors. Against the background of an increase in the burden of this type of malignancy, the number of diagnostic procedures increases, as a result of which the demand for biopsy devices increases.

The increasing prevalence of breast cancer is associated with an aging population. According to WHO forecasts, the global number of people aged 60 and over will increase from 1.1 billion in 2023 to 1.4 billion in 2030. It is expected that in the period from 2020 to 2050, the population aged 80 years and older will triple and reach 426 million people. At the same time, it is age that is one of the main risk factors for the development of breast cancer: most cases are diagnosed in women over 50 years old.

The expansion of the industry is facilitated by the development of minimally invasive technologies. Patients and doctors prefer procedures with a lower risk of complications, faster recovery and a better cosmetic result: this increases the demand for vacuum aspiration biopsy. However, the expansion of screening programs and the availability of mammography lead to the detection of more neoplasms in the early stages that require histological confirmation.

In 2025, the largest share of revenue was provided by systems for puncture biopsy - 33.9%. At the same time, the most common procedures under the control of ultrasound. Geographically, North America leads with 41.05%, or $0.62 billion. Major industry players on a global scale are:

• Hologic;
• Becton Dickinson;
• Danaher;
• Argon Medical Devices;
• Merit Medical Systems;
• Fujifilm;
• Hoffmann-La Roche;
• Qiagen;
• Cook;
• Devicor Medical Products;
• GE HealthCare.

In 2026, the breast biopsy devices market size is expected to reach $1.59 billion. At the same time, the United States will have $0.56 billion, Europe - $0.43 billion, Asia-Pacific - $0.36 billion. Fortune Business Insights analysts forecast a CAGR of 6.5% going forward. As a result, by 2034, costs could increase to $2.64 billion.^[1]

Released esophageal endoscopic imaging system that detects tumors without biopsy

At the end of August 2025, Pavmed, through a specially created subsidiary structure, licensed esophageal endoscopic imaging technology developed by American specialists from Duke University. This system allows the detection of malignant lesions without biopsy. Read more here.

The first Russian device for brain biopsy was developed and began to be used

In Russia, the first domestic guiding device for conducting a brain biopsy has been created, which completely replaces imported analogues in neurosurgical operations. The development was carried out by specialists of the Institute of Innovative Development of Samara State Medical University as part of the creation of the AUTOPLAN surgical navigation system. The device successfully passed its first test in a leading medical institution on August 20, 2025. Read more here.

Russia's first production of sternal needles for bone marrow biopsy launched

On April 19, 2025, it became known that the second stage of the Mass Production Center was opened at the Samara State Medical University (SamGMU) of the Russian Ministry of Health, where the country's first line of sternal needles for bone marrow biopsy will be produced. The solemn event was attended by Minister of Health of the Russian Federation Mikhail Murashko, Minister of Industry and Trade of the Russian Federation Anton Alikhanov and Governor of the Samara Region Vyacheslav Fedorishchev. Read more here.

2024: Biopsies using robots began for the first time in the Moscow region

On July 24, 2024, it became known that biopsies using robotic technologies began for the first time in the Moscow Region. This achievement was realized at the M.F. Vladimirsky Moscow Regional Research Clinical Institute (MONICA), where they successfully performed the first liver puncture under the control of a robotic navigation system. Read more here

2023: Biopsy CT robot enters the market

On October 19, 2023, the Austrian company Interventional Systems announced the release of the Micromate robotic medical platform. This system allows surgeons to remotely perform various operations with visual control through computed tomography. Read more here.

2022

A soft tissue biopsy system has emerged that takes 72% more material than analogues in one procedure

On September 27, 2022, Merit Medical Systems announced the launch of the TEMNO Elite soft tissue biopsy system. We are talking about taking materials from places such as the liver, lungs, lymph nodes, kidneys, etc. According to the developers, the disposable device complements a wider range of products, which also includes the TEMNO, Achieve and Tru-Cut models. Read more here.

Breast biopsy device released in minutes

On August 10, 2022, TransMed7 announced that the first clinical cases of the final commercial version of the Sparrow device (a member of the new SpeedBird family - vacuum assisted single-injection multiple-sampling breast biopsy (SIMC) devices) were successfully conducted by Dr. Edgar Staren, a reputable surgeon and former president of the American Society of Breast Surgeons (ASBrS). Read more here.

2021: Quick-Core Auto Biopsy System Announcement - Devices for Automatic Soft Tissue Biopsy

In mid-March 2021, the manufacturer of medical devices used in interventional radiology and interventional oncological procedures, IZI Medical Products released the Quick-Core Auto Biopsy System ("Quick-Core Auto") for soft tissue biopsy. Read more here.