Biopsy Devices Market: Global Industry Analysis and Forecast (2024-2030) by Product, Application, End User and Region

Biopsy Devices Market Overview

Biopsy machines are medical devices used to take tissue samples from the body for diagnostic testing, usually to determine the presence or extent of disease such as cancer. These devices include needles, probes, and systems designed for minimally invasive tissue sampling.

 

The term "biopsy devices market" describes a global industry that includes the production, marketing and distribution of medical equipment used to obtain tissue samples from patients for diagnostic purposes; This industry mostly serves the needs of healthcare facilities.

 

The growing need for accurate diagnostic tools and advances in less invasive technologies are driving the global biopsy devices market. With shorter recovery times and less patient suffering, innovations such as endoscopic ultrasound-guided fine-needle aspiration and needle biopsy are becoming increasingly popular over traditional surgical techniques. At the forefront of change are companies like Becton Dickinson and Hologic, whose state-of-the-art biopsy solutions incorporate imaging technology to improve accuracy. The need for effective diagnostic technologies is driven by the increasing incidence of cancer across the world, which is fueling the growth of the market. Obstacles include regulatory issues that require significant clinical data for product approval in multiple jurisdictions.

 

The global biopsy devices was growing rapidly in North America due to sophisticated healthcare systems, significant investments in research and development, and regulatory policies that promote technological breakthroughs. With rising healthcare costs, a rise in the prevalence of chronic diseases, and improved healthcare infrastructure, particularly in China and India, Asia Pacific is leading the way in growth of global biopsy devices market.

 

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Biopsy Devices Market Trend

The global biopsy devices market shows a key trend towards less invasive treatments, supported by technological advances and improved patient outcomes. Compared to open surgery, minimally invasive biopsies (such as core needle biopsies and fine needle aspiration) involve less incision or needle insertion, causing less discomfort to patients and speeding recovery.

 

• For instance, in cancer diagnosis, needle biopsies are becoming more popular than open surgical biopsies. These treatments minimize damage to adjacent tissues by taking tissue samples with thin, hollow needles. This enables precise targeting and reduces the risk of consequences. Patients can return to their normal activities sooner because they usually recover faster and with less discomfort. One notable instance of a company that has contributed significantly to the adoption of needle biopsy technologies in cancer diagnosis is Becton Dickinson (BD). BD is a global medical technology company known for its innovations in healthcare, including biopsy devices.
• Another instance is how tissue sampling of gastrointestinal and pancreatic lesions has been revolutionized in the field of gastroenterology by endoscopic ultrasound-guided fine needle aspiration (EUS-FNA). This method allows patients to receive an accurate diagnosis with minimal discomfort, avoiding the need for more invasive treatments and using endoscopy and ultrasound to guide fine needles.

 

Overall, the transition to less invasive biopsy techniques underscores the broader shift in healthcare toward patient-centered and personalized care, where reducing procedural injuries and improving recovery outcomes are critical. The introduction of these techniques and continuous technological improvements are expected to drive the growth of the global biopsy devices market during the forecast period.

 

Biopsy Devices Market Dynamics

Driving Growth in Biopsy Devices: Meeting the Global Demand for Precise, Minimally Invasive Cancer Diagnostics

Rising incidence of cancer and growing need for fast and accurate diagnostic methods are two major factors influencing the global biopsy devices market. The global incidence of cancer continues to increase, highlighting the need for efficient and reliable biopsy methods to support treatment planning and early detection.

 

Biopsy device companies like Hologic have responded by creating modern technology that improves the accuracy and efficiency of biopsy operations. For instance, doctors can perform real-time image-based biopsies with Hologic's Brevera Breast Biopsy System, which combines imaging and biopsy capabilities into a single platform. For early detection of breast cancer, it shortens the operation time and improves the accuracy of diagnosis.

 

The trend toward personalized healthcare has led to advances in biopsy tools. Another major company, Veracyte, focuses on genomic testing solutions that help assess the likelihood of cancer spreading or recurring based on biopsy tissue samples. Using molecular profiling to increase diagnostic accuracy in lung cancer, their Percepta Genomic Atlas^TM product is designed to provide personalized treatment options.

 

Progress on regulations and compensation guidelines is also crucial. Biopsy needle and system companies like BD benefit from official certificates that confirm the safety and efficacy of their products and facilitate market access. The global biopsy devices market is growing due to attractive reimbursement rules for minimally invasive biopsy treatments, which encourage healthcare providers to invest in advanced biopsy technology.

 

Basically, the main drivers for the growth of the global market are the growing need for accurate and minimally invasive biopsy instruments, and the technological advancements and regulatory frameworks supporting this industry.

 

Navigating Global Regulatory Challenges in the Biopsy Devices Market: Impacts and Strategies

The complexity of regulatory approval procedures and regional differences are a major hindrance in the global biopsy devices market. Regulatory barriers can hinder innovation and market competitiveness, bringing innovative biopsy techniques to global market much later than otherwise.

 

• For instance, extensive clinical data demonstrating the safety, efficacy and functionality of biopsy devices are required to obtain regulatory approval from organizations such as the FDA in the United States and the EMA (European Medicines Agency) in Europe. Extensive testing, paperwork and sometimes clinical trials are part of the process, which can be expensive and time-consuming for companies within the global biopsy devices market.

 

Laws can also vary greatly from place to place. Devices approved in one country may require additional research or modifications to meet criteria in another country, leading to different market access methods and higher development costs. For biopsy device manufacturers, this unpredictability makes it difficult to expand into global biopsy devices markets, especially for companies with smaller budgets.

 

The changing standards and regulatory environment make it difficult for manufacturers to maintain compliance and modify their products accordingly. Schedules and budgets can be affected by the need to make costly changes to production methods or product design due to changing regulatory requirements in the market.

 

Companies often invest in regulatory expertise and engage early with regulators to expedite approval processes to effectively meet these challenges within the global biopsy devices market. Strong clinical evidence is generated through partnerships with clinical researchers and healthcare professionals, supporting regulatory action. In addition, to effectively navigate the complex global regulatory landscape of the biopsy device industry, it is important to maintain flexibility in product development methodologies and develop a thorough awareness of regional regulatory specifics.

 

Biopsy Devices Market Segment Analysis

Based on Product, the biopsy needle segment among the needle-based biopsy instruments dominated the global biopsy devices market in 2023. Because they are essential for minimally invasive tissue sampling in many medical specialties, biopsy needles have established their dominance in this field. Compared to traditional surgical biopsies, these instruments are more affordable due to their precision, minimal tissue damage and ability to shorten recovery time and minimize patient suffering. Due to their adaptability, they are important tools in modern healthcare, enabling applications in the diagnosis of diseases such as cancer, infections and autoimmune diseases.

 

The demand for biopsy needles has increased due to several reasons such as the prevalence of chronic diseases and cancer has increased worldwide, requiring accurate diagnostic methods. Biopsy needles allow medical professionals to collect tissue samples that are important for diagnosing and staging cancer, planning treatment, and monitoring disease progression. Because minimally invasive treatments are less painful and require less recovery time, patient preferences have changed, leading health care facilities around the world to use biopsy needles more often.

 

• For instance, the incidence of cancer has been rising gradually on a global scale, the World Health Organization (WHO) estimates that 20 million new instances of cancer would be diagnosed worldwide in 2022.With an increasing number of cases of cancer, precise diagnostic tools like biopsy needles are essential for early identification, staging, and therapy strategizing.

 

Advances in technology have played a major role in the widespread use of biopsy needles. Integration has improved the accuracy and diagnostic productivity of image guidance systems such as MRI and ultrasound. Companies like BD and Medtronic, for example, have created biopsy needle solutions that use these imaging techniques to ensure precise targeting and better diagnostic results.

 

Biopsy guns is expected to be the fastest growing market segment of the global biopsy devices market. Specializing in breast and prostate biopsies, biopsy guns are known for their efficient tissue collection capabilities thanks to their spring-loaded mechanism. Physicians performing biopsies at anatomically sensitive sites have embraced them for their simplicity, speed, and rapid acquisition of appropriate tissue samples.

 

In conclusion, biopsy guns are becoming increasingly popular, although biopsy needles are expected to still dominate the largest share of the global biopsy devices market during the forecast period due to their efficiency, adaptability and endurance. These two divisions are excellent examples of continuous innovation in biopsy device technology, responding to changing healthcare needs and expanding diagnostic capabilities worldwide. As technology advances, biopsy devices will likely continue to be important in improving patient outcomes and diagnostic accuracy in many areas of medicine.

 

Based on Application, breast biopsy segment dominated the global biopsy devices market in 2023 owing to the high incidence of breast cancer worldwide and the important role of biopsy instruments in both diagnosis and treatment planning.

 

Specimens taken from suspected breast lesions found by screening methods such as mammography or ultrasound require the use of breast biopsy instruments. These samples are important to determine the presence of malignant cells, determine the stage of the cancer and choose the best treatment. The need for accurate and reliable biopsy instruments has increased as breast cancer remains one of the most common female malignancies worldwide.

 

The use of breast biopsy instruments has increased dramatically due to the increase in breast cancer incidence, increased awareness, and screening programs.

 

For instances

• According to the American Cancer Society, the incidence of breast cancer has increased worldwide, highlighting the need for effective diagnostic instruments such as biopsy machines.
• According to National Breast Cancer Foundation Over one million people have breast biopsies each year in the United States. Approximately 20% of the biopsies reveal a breast cancer diagnosis.

Technological development has also significantly affected the spread of breast biopsy instruments. The accuracy and diagnostic yield of breast biopsies has increased due to innovations such as vacuum-assisted biopsy devices that allow more efficient tissue sampling with fewer needle punctures and imaging techniques such as MRI and ultrasound guidance systems. Leading innovators in this field, such as Siemens Healthineers, Hologic and Devicor Medical Products, are leading market expansion with their advanced biopsy systems.

 

The global biopsy devices market was dominated by breast biopsy devices in 2023 due to their important role in breast cancer diagnosis and treatment planning, enhanced by increasing incidence and technological advancement. Global health system investments in cancer screening and early detection programs are projected to increase the demand for biopsy devices in various applications, but at different rates for different types of biopsies

 

Biopsy Devices Market Regional Insights

According to SMR analysis, North American Biopsy Devices Market, mainly led by the United States, dominated the global market in 2023. Many important variables influence the dominance of North America. First, the region benefits from high healthcare costs and advanced healthcare infrastructure, which encourages early adoption of advanced medical technologies such as biopsy equipment. Second, in terms of clinical use, regulatory support for biopsy devices, and R&D spending, the United States leads all other North American Biopsy Devices Markets, although it is the largest. Major companies such as Hologic, BD (Becton, Dickinson and Company) and Medtronic, based in the United States, contribute to market leadership through continuous technological development and strategic expansion.

 

Asia Pacific Biopsy Market is expected to be the fastest growing region of the global biopsy devices market during the forecast period. Rising healthcare costs, increasing prevalence of chronic diseases such as cancer and improving healthcare infrastructure in countries such as China, India and Japan are the main drivers behind this growth. Increasing availability of healthcare services, general awareness about early detection of diseases, and increasing disposable income in these countries are driving the demand for biopsy instruments.

 

Due to its highly developed healthcare system and stable market situation, North America was leading the global market in 2023. However, the Asia Pacific region, especially China, was growing the fastest due to increasing disease and increased healthcare costs.

 

Biopsy Devices Market Competitive Landscape

Recent mergers and acquisitions (MandAs), partnerships and continuous technological improvements have created a dynamic competitive landscape in the market. There have been many mergers and acquisitions in global biopsy devices market. Large companies such as Medtronic and BD (Becton, Dickinson and Company) have expanded their portfolios by strategically purchasing smaller companies specializing in biopsy technology. These efforts improved their capabilities in image guided biopsy systems and precision medicine.

 

Collaboration between technology companies and healthcare workers was also important. Collaborations between organizations such as Hologic and university medical centers have accelerated the creation of new biopsy solutions that incorporate imaging techniques such as ultrasound and MRI to improve diagnostic accuracy in the global biopsy devices market.

 

Robotic biopsy systems within the biopsy devices market are the latest innovations that improve accuracy and shorten procedure times. To optimize processes and improve patient outcomes, companies are also focusing on the miniaturization of biopsy devices and their integration with diagnostic platforms.

 

Overall, the biopsy equipment market is competitive due to technological breakthroughs, market expansion and strategic alliances fueled by the growing need for minimally invasive diagnostic procedures and improvements in medical imaging technology.

 

• In May 2023, Argon Medical Devices, Inc. announced the launch of the SuperCore Advantage Semi-Automatic Biopsy instrument as the latest inclusion in its portfolio of soft tissue biopsy products in the U.S.
• In April 2023, GE Healthcare introduced the bkActiv system for surgical applications. This ultrasound imaging system provides surgeons with the confidence to make informed decisions during their surgical procedures.
• In January 2023, GE Healthcare successfully completed an acquisition agreement with the France-based company IMACTIS. In its announcement, GE Healthcare emphasized the potential of IMACTIS' computerized tomography (CT) navigation product, which has received approval for use in both Europe and the U.S. for safety in many ways.
• In July 2022, the Food and Drug Administration granted approval for the incorporation of Siemens Healthineers' mobile imaging technology into Intuitive's robotic-assisted platform for minimally invasive lung biopsies.
• In May 2022, Terumo India partnered with Argon Medical in the Indian market. Its complementary product lines enabled Terumo to provide comprehensive medical solutions, addressing the growing demand for advanced tools in procedures such as biopsies and deep vein thrombosis treatments.
• In February 2022, Dxcover Limited secured the U.S. patent for cancer diagnostic devices, namely, the Dxcover autosampler and the Dxcover brain cancer liquid biopsy. The patent covers all of Dxcover Limited’s hardware, including the Dxcover sample slides and autosampler accessories.
•  On 1 ^st December 2021, Quest Diagnostics announced that it would now offer Biocept Inc.’s liquid biopsy test for lung cancer, thereby expanding its product portfolio of advanced cancer diagnostics.

 

Biopsy Devices Market Scope

Biopsy Devices Market
Market Size in 2023	USD 3.66 Bn.
Market Size in 2030	USD 7.05 Bn.
CAGR (2024(2030)	7.67%
Historic Data	2018-2022
Base Year	2023
Forecast Period	2024-2030
Biopsy Devices Market Segments	By Product Needle based Biopsy Instruments Devices Guns Needles Localised wires Procedure Tray Others
	By Application Breast Biopsy Lung Biopsy) Colorectal Biopsy Others
	By End User Hospitals Academic and Research Institutes Diagnostic and Imaging Centers Others
Regional Scope	North America (United States, Canada, and Mexico Europe – UK, France, Germany, Italy, Spain, Russia, Austria, and Rest of Europe Asia Pacific – China, India, Japan, South Korea, Australia, ASEAN, Rest of APAC Middle East and Africa (South Africa, GCC, Egypt, Nigeria, Rest of the Middle East and Africa South America – Brazil, Argentina, Rest of South America

 

Biopsy Devices Market Key players

North America

1. Becton, Dickinson and Company (BD) - USA
2. Medtronic plc - USA
3. Hologic Inc. - USA
4. Boston Scientific Corporation - USA
5. Danaher Corporation (including Leica Biosystems) - USA
6. Intuitive Surgical, Inc. – USA
7. Johnson & Johnson - USA
8. Thermo Fisher Scientific Inc. - USA
9. Varian Medical Systems, Inc. - USA
10. Abbott Laboratories - USA

Europe

1. Siemens Healthineers - Germany
2. Olympus Corporation - Japan (major operations in Europe)
3. Cook Medical LLC - USA (significant presence in Europe)
4. Stryker Corporation - USA (operations in Europe)
5. Cardinal Health Inc. - USA (operations in Europe)
6. GE Healthcare - USA (operations in Europe)
7. Philips Healthcare - Netherlands

Asia Pacific

1. Fujifilm Holdings Corporation - Japan
2. Mindray Medical International Limited - China
3. Terumo Corporation - Japan
4. Canon Medical Systems Corporation - Japan
5. Shimadzu Corporation - Japan
6. HOYA Corporation - Japan
7. Nipro Corporation - Japan
8. Hitachi Medical Corporation - Japan
9. Samsung Medison - South Korea

Middle East and Africa (MEA)

1. Roche Diagnostics Middle East - UAE