BIOPSY DEVICES MARKET ANALYSIS

The global biopsy devices market is expected to reach US$ 2,254.6 Mn by 2023, from US$ 3,503.1 Mn in 2030, at a CAGR of 6.5% during the forecast period.

Biopsy is a medical procedure in which a small sample of tissue is taken to diagnose or rule out certain diseases or conditions, and it is a crucial tool in the field of pathology. In a biopsy, a provider removes samples of tissue, cells, or fluids so a medical pathologist can examine them for signs of disease. Healthcare providers may recommend biopsies to diagnose or monitor medical conditions or to plan treatment. Biopsies are essential for diagnosing various conditions, including cancer, infections, and inflammatory diseases, as they provide important insights into the nature and extent of the disease. The instruments that are utilized to carry out a biopsy are called biopsy devices. Biopsy devices come in various sizes and configurations, and the choice of device depends on the location of the target tissue, the nature of the suspected condition, and the healthcare provider's preferences and expertise. New product launches, the growing prevalence of cancer, and supportive government regulations are anticipated to support the market development over the forecast period. For instance, on September 11, 2023, Limaca Medical, a medical device company, announced that the U.S. Food and Drug Administration (FDA) granted 510(k) approval for its Precision GI Endoscopic Ultrasound (EUS) Biopsy Device. Limaca previously received U.S. FDA Breakthrough Device Designation for its Precision GI. Precision GI gets biopsies for the conclusive diagnosis of pancreatic cancer and other life-threatening GI cancers faster and less traumatically than current products.

The global biopsy devices market is segmented into by product type, biopsy type, application, end user, and region. By biopsy type, the market is segmented into bone marrow biopsy, cone biopsy, excisional biopsy, liquid biopsy, needle biopsy, and others (punch biopsy, sentinel node biopsy, shave biopsy, etc.). The needle biopsy segment accounted for the largest market share in 2022 attributed to an increase in the number of cancer cases across the globe.  

Global Biopsy Devices Market- Regional Insights

• North America is expected to be the largest market for biopsy devices during the forecast period, accounting for 32.4% of the market share in 2023. The growth of the market in North America is attributed to factors such as the presence of key market players, the launch of novel products, and favorable reimbursement scenarios. Moreover, inorganic growth strategies such as acquisitions adopted by market players are further anticipated to support the market development over the analysis period. For instance, on April 27, 2023, Quest Diagnostics, a prominent provider of diagnostic information services, and Haystack Oncology, an early-stage oncology company, announced an all-cash equity transaction in which Quest will acquire Haystack. MRD testing is a rapidly growing category of liquid biopsy tests that detect circulating tumor DNA (ctDNA) in patients' bloodstreams following cancer surgery and treatment. Haystack, founded in 2021, has developed a ctDNA-based technology for MRD detection based on 20 years of research and development.
• Europe is expected to be the second-largest market for biopsy devices, accounting for over 23.1% of the market share in 2023. The growth of the market is attributed to the presence of skilled healthcare professionals, top notch healthcare institutes, the growing prevalence of cancer, and the adoption of inorganic growth strategies such as partnerships that are anticipated to support the market development in this region. For instance, on September 18, 2023, Roche France, a multinational healthcare company, Foundation Medicine, Inc., a company that sells genomic profiling assays based on next-generation sequencing technology, and the Institute Gustave Roussy, a cancer-research hospital in Europe, announced a unique partnership to establish in-house liquid biopsy testing at the Institute Gustave Roussy's facilities in France, by transferring technology from Foundation Medicine's FoundationOneLiquid CDx, a blood-based comprehensive genomic profiling (CGP) test. FoundationOne Liquid CDx analyzes more than 300 cancer-related genes for genomic alterations that cause cancer to grow using a simple blood sample.
• The Asia Pacific is expected to be the fastest-growing market for biopsy devices during the forecast period. The growth of the market in Asia Pacific is attributed to growing geriatric population, rise in the healthcare expenditure, and regulatory approvals is expected to support the development of the market over the analysis period. For instance, on May 30, 2023, Guardant Health, Inc., a pioneer in precision oncology, announced that Singapore's Health Sciences Authority (HSA) has approved Guardant360 CDx, a liquid biopsy test for tumor mutation profiling, also known as comprehensive genomic profiling (CGP), in patients with advanced solid cancers. The Guardant360 CDx test has also been approved as a companion diagnostic to identify patients with advanced non-small cell lung cancer (NSCLC) who have epidermal growth factor receptor (EGFR) alterations and may benefit from TAGRISSO (osimertinib) treatment.

Figure 1. Global Biopsy Devices Market Share (%), By Region, 2023

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Analyst View Point:

The biopsy devices market is expected to grow steadily over the next decade due to the aging global population and rising obesity rates. As people get older, they are more likely to develop osteoarthritis, which often leads to total knee replacement procedures. The market will see steady gains in developed nations as their populations continue to age. However, emerging economies are likely to see faster growth rates as healthcare access improves. On the technology front, robotic and computer-assisted surgeries are expected to drive innovation and faster recovery times. This could help overcome reluctance towards the procedure and further fuel market expansion worldwide.

Global Biopsy Devices Market- Drivers

• Increasing prevalence of cancer: The increasing prevalence of cancer cases around the world has become a major concern for the healthcare industry and governments. Cancer is one of the leading causes of death globally, and its incidence has been rising steadily over the past few decades. As per the World Health Organization (WHO) 2022 report, cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020. Breast, lung, colorectal, prostate, and skin were the top five cancer types, accounting for 2.26 Mn, 2.21 Mn, 1.93 Mn, 1.41 Mn, and 1.20 Mn cases worldwide.
• Technological advancements in biopsy devices: Technological advancements in biopsy devices are significantly contributing to the growth of the global biopsy devices market. A biopsy is a medical procedure that involves extracting cell or tissue samples from a patient to examine them under a microscope. Traditionally, biopsy procedures involved invasive surgical methods that caused pain and discomfort for patients. However, recent technological innovations are enabling minimally invasive biopsy procedures that are faster, safer and more accurate. For instance, in July 2021, GE Healthcare, a multinational medical technology company, announced the installation of Serena Bright in five hospitals and radiology centers across the U.S. Serena Bright is the industry's first contrast-guided biopsy solution, assisting clinicians and patients in their fight against breast cancer. The technology, which received 510(k) clearance from the U.S. FDA in May 2020, allows patients to have their breast biopsy exams with contrast guidance using the same mammography equipment, in the same room, and with the same staff as the screening or diagnostic mammogram.
• Government and private funding for cancer research: The increased government and private funding for cancer research has significantly boosted the biopsy devices market. Governments across the world are allocating higher budgets for cancer research and diagnostic technologies in view of rising cancer cases. For instance, on November 13, 2023, the American Cancer Society (ACS), the U.S. largest non-government, non-profit funder of cancer research, approved funding for 131 new Extramural Discovery Science (EDS) research and career development grants totaling US$64.5 million. Beginning in 2024, the grants will support researchers at 72 institutions across the U.S.

Global Biopsy Devices Market- Opportunities

• Emerging Economies: The emerging economies in the Asia Pacific and Latin America regions provide huge growth potential for the biopsy devices market. These developing nations are witnessing improvements in healthcare access and infrastructure, backed by strong economic growth over the past decades. Countries like India, China, Brazil, and Mexico have invested heavily to strengthen primary care and introduce universal healthcare programs. This is increasing patients' ability to seek medical help and diagnostic procedures. For instance, in September 2022, AstraZeneca India, a multinational pharmaceutical and biotechnology company, collaborated with the Cancer Awareness Prevention and Early Detection (CAPED) Trust, a grass root non-profit working in healthcare since 2014, to expand its flagship initiative 'Ganga Godavari Cancer Screening Program' in Mathura, India. The event was held at the RKMSC Hospital in Vrindavan, India. The program, which is supported by the Charities Aid Foundation (CAF) India, aims to raise cancer awareness and detect oral, breast, and cervical cancers in their early stages among women through specialized screening camps.
• Launch of innovative biopsy gun devices: The introduction of innovative biopsy gun devices could provide promising growth prospects for the biopsy devices market. Biopsy gun devices allow for a less invasive tissue collection method compared to traditional biopsy needles. They utilize spring-powered technology to effectively obtain tissue samples from within the body, reducing patient discomfort and procedure time. For instance, in August 2022, Mammotome, a leader in breast care, announced the launch of the Mammotome DualCore biopsy system, the company's first dual stage core biopsy instrument. This new core biopsy device enhances the Mammotome ultrasound-guided breast biopsy portfolio, which also includes the Mammotome Elite Tetherless Vacuum-Assisted Biopsy Device (tetherless VABB) and the Mammotome Revolve Dual Vacuum-Assisted Breast Biopsy System (tethered VABB).
• Development of minimally invasive biopsy techniques: The development of minimally invasive biopsy techniques could provide a huge opportunity for growth in the biopsy devices market. Minimally invasive procedures are less traumatic for patients as they involve smaller incisions and cause less damage to tissue compared to traditional open biopsy methods. This allows for shorter procedure times, less pain and discomfort, lower risks of complications, and shorter recovery periods. As healthcare increasingly focuses on providing less invasive options that improve patient outcomes and experiences, the demand for minimally invasive tools and techniques across medical specialties is anticipated to increase over the forecasted period.

Global Biopsy Devices Market- Trends

• Adoption of robot-assisted biopsy procedures: The adoption of robot-assisted biopsy procedures is having a major influence on the biopsy devices market. With the introduction of robotic technology, biopsies can now be performed with increased precision, safety and accuracy. Robotic systems allow for minimally invasive procedures with 3D imaging and small instrument movements. This translates to reduced risk of complications for patients and shorter recovery times. For instance, in May 2022, UC Davis Health, one of America's leading cancer treatment hospitals, announced that its physicians performed the first single-anesthesia diagnosis and treatment of lung cancer in the UC Health System using a fully robotic approach. The robotic-assisted bronchoscopy approach enables the diagnosis and removal of a lung cancer mass in a single surgery. It reduces patients' anxiety and unnecessary waiting time.
• Growth in liquid biopsy: Liquid biopsy trend has significantly influenced the biopsy devices market in recent years. With advancements in genomics and precision medicine, there is a growing preference for minimally invasive procedures over surgical biopsies. Liquid biopsy is an emerging technology that analyzes blood samples to detect cancer by finding DNA from tumor cells that are circulating in the bloodstream. This provides valuable information about any genetic mutations occurring in the cancer and helps doctors choose the most effective targeted therapies. Moreover, the adoption of organic growth strategies, such as new products launched adopted by market players, is anticipated to further bolster the market development. For instance, on November 1, 2023, Illumina Inc., a leader in DNA sequencing and array-based technologies, announced the launch of a new generation of its distributed liquid biopsy assay for genomic profiling. The TruSight Oncology 500 ctDNA v2 (TSO 500 ctDNA v2) research assay offers noninvasive comprehensive genomic profiling (CGP) of circulating tumor DNA (ctDNA) from blood when tissue testing is unavailable or to complement tissue-based testing.
• Preferences shifting towards vacuum-assisted biopsy: The biopsy devices market has been witnessing a steady shift towards vacuum-assisted biopsy in recent times owing to its significant clinical benefits over traditional core needle biopsy procedures. Vacuum-assisted biopsies have emerged as a more accurate alternative for sampling breast lesions as they provide higher tissue sample quality and quantity for pathological examination. This helps achieve superior diagnostic accuracy, especially in differentiating between benign and malignant tumors, as compared to core needle biopsies.

Global Biopsy Devices Market- Restraints

• High cost of biopsy procedures: The increasing cost of biopsy procedures is a major factor restraining the growth of the biopsy devices market. Biopsy procedures can be an expensive diagnostic option owing to the sophisticated biopsy instruments and equipment used during the procedures. The high costs associated with biopsy procedures make it inaccessible for many patients across the world, especially in developing regions with weak economic conditions. The biopsy procedure usually involves using specialized biopsy needles, guides, sampling devices, and other auxiliary equipment, which adds to the overall cost. According to a study titled “Costs of Biopsy and Complications in Patients with Lung Cancer” published by the National Center for Biotechnology Information in March 2021, the overall cost of lung biopsies was high. The conclusions were made using data from IBM Marketscan Databases collected between July 2013 and June 2017. The database comprised 22,870 patients who had a total of 37,160 biopsies. Inpatient surgical biopsies had the greatest median total costs (US$ 29,988), while outpatient percutaneous biopsies had the lowest (US$ 1028). Repeat biopsies of the same type increased costs by 40-80%.
• Lack of reimbursement policies: Lack of reimbursement policies for biopsy procedures is a major restraint on the growth of the biopsy devices market. When insurance plans do not adequately cover the costs of these procedures, it disincentivizes both patients and healthcare providers. For patients, the out-of-pocket costs of a biopsy can be prohibitively expensive. This discourages them from getting tested even if clinically recommended. As a result, many potentially cancerous or other conditions may go undiagnosed.

Global Biopsy Devices Market- Segmentation

Global Biopsy Devices Market Recent Developments

• In December 2022, Agilent Technologies Inc. announced that the U.S. FDA approved Agilent Resolution ctDx FIRST as a companion diagnostic (CDx) for identifying advanced non-small cell lung cancer (NSCLC) patients with KRAS G12C mutations who may benefit from treatment with KRAZATITM (adagrasib). This is the first liquid biopsy NGS test approved by the U.S. FDA as a CDx for the recently licensed KRAZATI in advanced NSCLC, and it was developed in partnership with Mirati Therapeutics, a targeted oncology business focused on cancer treatment research.
• In October 2022, nRichDX, an emerging leader in sample preparation solutions, announced the launch of two new products to assist researchers in the development of liquid biopsy assays. Both products are intended for use with the nRichDX Revolution Sample Prep System.
• In September 2022, Guardant Health, Inc., a leading precision oncology company, announced the launch of GuardantINFINITY, a next-generation liquid biopsy that provides new, multi-dimensional insights into the complexities of tumor molecular profiles and immune responses to advance cancer research and therapy development.

Collaborations and Partnerships:

• On April 14, 2023, Agena Bioscience, a Mesa Labs, Inc. subsidiary, and nRichDX expanded their existing technical collaboration into a commercial collaboration that will co-promote their products to researchers developing liquid biopsy applications on the Agena MassARRAY platform.
• On March 27, 2023, nRichDX and OraSure Technologies, Inc., a medical device company, expanded a commercial partnership to validate and co-promote their products for researchers developing liquid biopsy applications using first-void urine samples. Notably, first-void urine is rich in indicators useful for molecular investigation in applications such as sexually transmitted infections, human papillomavirus, and early stage cancer.
• In October 2020, Epic Sciences, Inc., a cancer diagnostics company, and Predicine, Inc., a global molecular insights company, announced a global strategic partnership to provide biopharmaceutical companies with access to both Predicine's ctDNA-based testing and Epic's CTC-based testing. Predicine, Inc. is a molecular insights firm based in California, U.S., that has developed an NGS liquid biopsy technique for measuring ctDNA and ctRNA genomic alterations in blood or urine.

Figure 2. Global Biopsy Devices Market Share (%), By Biopsy Type, 2023

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Top companies in Global Biopsy Devices Market:

• Merit Medical Systems, Inc
• Hologic, Inc.
• Becton, Dickinson and Company
• Medtronic plc
• Stryker Corporation
• Leica Biosystems Nussloch GmbH
• Gallini Srl
• TSK Laboratory
• Remicalm
• Meditech Devices
• Agilent Technologies Inc.
• Guardant Health, Inc.
• Agena Bioscience
• nRichDX
• Epic Sciences, Inc.
• Predicine, Inc.
• Argon Medical Devices
• Cook Medical
• Hologic Inc.
• Intact Medical Corporation

Definition: A biopsy is a surgical process that involves the removal of cells, tissue, or fluid for analysis by a medical pathologist. Biopsies are performed by healthcare professionals when areas of concern are identified or when an individual exhibits symptoms or signs of certain disorders, such as cancer, etc. The devices that are utilized to carry out these procedures are called biopsy devices.