Luton, Bedfordshire, United Kingdom, Nov. 06, 2024 (GLOBE NEWSWIRE) — Biopsy device technologies have significantly advanced over time, with a strong emphasis on increasing accuracy, reducing patient discomfort, and improving diagnostic results. These improvements, coupled with the rising rates of cancer and the demand for early detection, have contributed to the growing significance of biopsy devices in the healthcare industry. As medical care evolves, these devices remain central to both diagnostic and therapeutic treatments, enhancing patient outcomes and supporting the progression of medical knowledge. The integration of imaging systems in biopsy devices continues to drive innovation and progress across various fields, ultimately benefiting healthcare systems and patients globally.

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Driver: Increasing Cancer Prevalence

The global incidence of cancer has been steadily rising, with projections indicating that the number of cancer cases will increase from approximately 19.7 million in 2020 to 28.0 million by 2040, based on GLOBOCAN estimates. Cancer continues to be the second leading cause of death worldwide, contributing to nearly 25% of all deaths in the United States. In 2017, the American Cancer Society predicted around 1.7 million new cancer cases and approximately 600,000 cancer-related deaths in the U.S., which averages about 1,650 deaths per day.

While cancer incidence is higher in more-developed regions, mortality rates are often higher in less-developed countries due to limited healthcare access and lower awareness of early detection methods. According to GLOBOCAN 2020, 56.8% of all new cancer cases and 10 million cancer-related deaths occurred in these countries. By 2025, this trend is expected to worsen, particularly in China and India, which have some of the highest mortality ratios.

The increasing cancer burden will drive a growing demand for biopsy procedures, essential for diagnosing both malignant and benign cancers. In 2022, nearly 47.5% of cancer cases were found in the elderly population, and this figure is projected to rise to 54.6% by 2030. With more than 703 million people aged 65 and above (9.1% of the world’s population), the aging global population will significantly influence the demand for cancer control measures. Projections suggest that cancer incidence among those aged 85 and older could increase fourfold by 2050, further driving the need for biopsies and cancer diagnostics.

Restraint: Risk of Infections

Biopsy procedures, crucial for detecting abnormalities in specific areas, carry an inherent risk of infection due to the incisions and cuts involved in tissue sampling. A 2014 study published in The Journal of Urology raised concerns about post-biopsy infections, especially in prostate biopsies. In Sweden, the rate of urinary tract infections (UTIs) increased from around 2% immediately following the biopsy to 6% after 30 days, with 1% of patients requiring hospitalization. The growing risk of infections after biopsy procedures presents a significant challenge, which may hinder market growth as healthcare providers strive to reduce these risks and enhance patient safety.

Opportunity: Technological Advancements

Ongoing advancements in biopsy device technology, including improved imaging capabilities, robotic assistance, and precision-guided tools, are driving new opportunities for more accurate and minimally invasive procedures. Modern imaging techniques such as ultrasound, magnetic resonance imaging (MRI), and computed tomography (CT) scans are now essential in guiding biopsy procedures, ensuring better precision and minimizing complications. For example, real-time ultrasound imaging allows healthcare providers to precisely target and collect tissue samples with reduced risk.

• Medtronic has launched the StealthStation iO navigation system, an advanced image-guided surgical platform that integrates artificial intelligence (AI) to enhance the precision and effectiveness of biopsy and other surgical procedures.
• Hologic, a prominent provider of women’s health solutions, introduced the Affirm Breast Biopsy System in September 2022. This system utilizes 3D tomosynthesis for accurate needle placement, featuring an intelligent needle guide that retracts automatically after tissue acquisition, minimizing patient discomfort and procedural complications.

Furthermore, the growing development of liquid biopsy technologies, which enable the detection of cancer biomarkers in blood and other bodily fluids, is a major breakthrough in non-invasive diagnostics. Companies like TrovaGene are working on liquid biopsy tests for early colorectal cancer detection, while Natera is advancing a test for ovarian cancer. These innovations have the potential to improve diagnostic accuracy, safety, and efficiency, paving the way for further growth in the biopsy industry.

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Challenge: Underdeveloped Healthcare Infrastructure and Lack of Resources in Developing Countries

As awareness of cancer types increases, the demand for biopsy procedures in developing countries is projected to grow. However, the lack of healthcare resources and inadequate infrastructure present significant challenges to the accessibility and effectiveness of these procedures. This issue is particularly evident in the higher mortality rates for breast cancer in low- and middle-income countries, where the absence of early detection programs contributes to delayed diagnoses.

The incidence of cervical cancer is also rising, yet screening coverage remains alarmingly low in many developing regions. For instance, in Sub-Saharan Africa, only 5% of women at risk undergo cancer screenings. In India, despite established screening guidelines based on visual inspection, the coverage remains insufficient. Various factors, including a shortage of trained healthcare professionals, limited laboratory resources, poor access to healthcare facilities, and cultural barriers, hinder the progress of cancer diagnosis in these regions. These obstacles present a significant challenge to the growth of the global biopsy market.

By Product: The needle-based biopsy instruments segment led the biopsy devices market in 2022, holding the largest market share. Needle-based biopsies are minimally invasive, offering quick procedures with relatively low discomfort for patients, which makes them an attractive option for both healthcare providers and patients. The rising cancer incidence and the need for early diagnosis have driven the demand for tissue sampling, especially for lesions that are hard to reach using traditional methods.

By Application: The breast biopsy application segment is expected to experience significant growth in the near future. As the number of cancer cases increases, breast biopsies are increasingly used for diagnostic purposes. This trend is contributing to the growth of the biopsy devices market in this segment.

By End User: The hospitals and breast care centers segment accounted for the largest market share in 2022. However, the diagnostic imaging centers segment is projected to grow at the highest compound annual growth rate (CAGR) during the forecast period, driven by increasing demand for precise and early-stage diagnostics.

By Region: North America is expected to remain the largest market for biopsy devices during the forecast period. This growth is fueled by the region’s technological advancements, robust healthcare infrastructure, a high prevalence of chronic diseases, and an aging population. Additionally, North America’s ample financial resources for advanced medical equipment, well-established regulatory frameworks, and active research collaboration are contributing to its dominance. The region’s insurance coverage for diagnostic procedures and its competitive market environment further foster the adoption of biopsy technologies.

Key Players

• ardinal Health Inc.
• Hologic, Inc.
• Danaher Corporation
• CONMED Corporation
• Cook Medical
• DTR Medical
• INRAD, Inc.
• Devicor Medical Products Inc.
• Gallini Srl
• TransMed7, LLC.

Recent Developments of Biopsy Devices Market

• March 2024: Medtronic announced the launch of the Fusion Biopsy System, a robotic-assisted platform for enhanced precision in prostate biopsies. This new system integrates advanced imaging and AI to improve diagnosis accuracy and patient outcomes.
• February 2024: Hologic introduced its new Selenia Dimensions 3D Mammography System, designed to improve breast cancer detection with advanced biopsy technology. The system’s enhanced imaging and biopsy capabilities offer improved tissue sampling for more accurate diagnostics.
• January 2024: Boston Scientific received FDA clearance for its new Exalt Model D Single-Use Biopsy Forceps, offering improved tissue sample collection in gastrointestinal procedures. The forceps provide enhanced precision and patient safety with a single-use design.
• November 2023: Cook Medical expanded its range of biopsy needles with the launch of the BiopsyPro Plus Needle. This device features a new ergonomic design, ensuring greater control and comfort during biopsies of soft tissues in various clinical applications.
• October 2023: Abbott Laboratories launched a next-generation core needle biopsy device aimed at improving the speed and accuracy of tissue sampling in breast cancer diagnosis. This device integrates advanced imaging guidance to reduce procedure time and enhance patient comfort.

Market Segmentations

By Product

• Needle Based Biopsy Instruments
• Liquid Biopsy Instruments
• Localization Wire
• Biopsy Forceps
• Procedure Tray
• Biopsy Table
• Other Biopsy Products

By Guidance Technique

• Image Guided Biopsy
  • Ultrasound Guided Biopsy
  • Stereotactic Guided Biopsy
  • MRI Guided Biopsy
  • Other Biopsy
• Non-Image Guided Biopsy
  • Liquid Biopsy
  • General Biopsy

By Application

• Breast Cancer
• Lung Cancer
• Kidney Cancer
• Prostate Cancer
• Bone Marrow Biopsy
• Other Applications

By End User

• Hospitals and Breast Care Centers
• Diagnostic Imaging Centers
• Research and Academic Institutes
• Other End Users

By Region

• North America
• Europe
  • Germany
  • France
  • UK
  • Italy
  • Spain
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • South Korea
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East and Africa

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