Report

Global biopsy devices market is projected to witness a CAGR of 8.03% during the forecast period 2024-2031, growing from USD 3.1 billion in 2023 to USD 5.74 billion in 2031. The biopsy devices market is anticipated to thrive under the influence of growth factors like the growing prevalence of cancer cases globally, design and working advancements in biopsy devices, rising demand for minimally invasive procedures, and regulatory support. Additionally, the integration of artificial intelligence and machine learning is expected to play a pivotal role in the continued growth and innovation of the biopsy devices industry. The rising number of cancer cases at the global level is a major driver that drives the demand for biopsy devices. Growing healthcare infrastructure, a rising number of diagnostic laboratories, and government support for reducing the cancer disease burden through precise and rapid diagnostics are some other factors contributing to the expansion of the biopsy devices market. Furthermore, growing cancer awareness among common people and easy access to diagnostic methods propels market growth.
However, risks of infections associated with the use of biopsy devices and underdeveloped healthcare infrastructure are some factors hindering the growth of this market. During the biopsy process, the chances of infection spreading are high, posing a significant challenge for healthcare professionals as well as the patient.
In May 2023, Argon Medical Devices announced the launch of SuperCore Advantage semi-automatic biopsy instrument which is the newest addition to the company's soft tissue biopsy product portfolio in the United States. The SuperCore Advantage is a disposable soft tissue biopsy instrument that provides a larger tissue sample for more accurate analysis.
Advancements in Biopsy Devices
Recent advancements have been made in biopsy devices, with a focus on liquid biopsies and bone biopsy devices. Liquid biopsies involve the analysis of tumor-derived information from body fluids and have seen significant progress in recent years, supported by the development of microphotonics, nanophotonics, and microfluidics technologies. These technologies enable the detection of analytes, such as circulating tumor RNA, cell-free micro-RNA, and exosomes, and offer several benefits over traditional tissue biopsies, including non-invasiveness, repeatability, and quick results. Meanwhile, bone biopsy devices are designed to remove small bone samples for examination, aiding in the early detection and diagnosis of diseases such as cancer. Recent advancements in bone biopsy technology include the development of innovative devices, improvements in tissue sampling techniques, and the exploration of magnetic needles that can access difficult-to-reach tumor sites.
In November 2023, Illumina Inc. introduced a new version of its TruSight Oncology 500 ctDNA assay, which is designed to provide genomic profiling for circulating tumor DNA (ctDNA) from the blood when tissue-based testing is not possible or to complement tissue-based testing. The new research assay, known as TruSight Oncology 500 ctDNA v2, is a distributed liquid biopsy assay that offers comprehensive genomic profiling (CGP) for ctDNA.
Growing Number of Cancer Cases
The growing number of cancer cases increases the demand for biopsy devices due to the need for early disease detection and accurate diagnosis. The rising prevalence of different types of cancers, such as breast cancer, lung cancer, and leukemia, is positively impacting the demand scenario for biopsy devices. The growing number of cancer cases is attributed to the growing exposure to radiation, inadequate lifestyle, longer working hours, increasing stress, smoking, alcohol consumption, use of contraception, and many more. According to the Pan America Health Organization, globally, around 20 million new cases of cancer and 10 million cancer-related deaths were reported. This puts a considerable burden on health systems, individuals, and communities. Unfortunately, it is predicted that this burden will increase by 60% over the next two decades. This means that by 2040, there could be about 30 million new cases of cancer worldwide, with the most significant increase happening in low- and middle-income countries.
Dominance of Needle-based Biopsy Guns Segment
The needle-based biopsy guns segment dominates the biopsy devices market, with the largest market share. Needle-based biopsy guns are preferred for their precise and minimally invasive tissue collection, aiding in the diagnosis of various medical conditions, especially cancers. Ongoing advancements in needle design for improved accuracy, enhanced safety features, and the integration of imaging technologies, such as ultrasound guidance, are contributing to the growth of this segment. Needle biopsies are minimally invasive procedures that can be performed quickly and with relatively low risk, making them preferable for both patients and healthcare providers. The increasing demand for the gentle and rapid procurement of cell samples for biopsy is also contributing to the growth of this segment.
In October 2023, Praxis Medical obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its EndoCore Endobronchial ultrasound with transbronchial needle aspiration (EBUS-TBNA) fine needle biopsy device. This American medical device company has created the EndoCore EBUS-TBNA biopsy device to aid in the diagnosis and staging of lung cancer. The procedure involves inserting a long, flexible tiny needle through a bronchoscope to perform a biopsy and pathological analysis.
Breast Biopsy Segment to Dominate the Market
The breast cancer segment is expected to dominate the global biopsy devices market. Breast cancer, being the most prevalent type of cancer, takes up the major share in the biopsy device market. The increasing number of breast cancer screening programs and the emergence of liquid biopsy and promising clinical trials are driving this growth. Manufacturers are attempting efforts to cater to the significantly high demand for breast cancer biopsy devices. For instance, in March 2023, TransMed7, LLC announced the first clinical use of VacuPac, which is a new self-contained external vacuum-assist attachment. It comes with a SpeedBird Universal and a Concorde US from the SpeedBird and Concorde families of vacuum-assisted, Single Insertion - Multiple Collection (SIMC) breast biopsy devices. This announcement comes after the previous announcements made by TransMed7 in August 2022 and February 2023 about the first clinical uses of SpeedBird and Concorde biopsy devices. These announcements were made as part of the commercial launch of TransMed7's vacuum assisted, SIMC breast biopsy devices.
North America to be the Dominating Region
North America is the leading region in the biopsy devices market, which is due to several factors. The region has a high healthcare expenditure, a robust research and development ecosystem, and an emphasis on early disease detection. Additionally, North America benefits from a strong healthcare infrastructure, a well-established system for insurance and co-payment, and a proactive regulatory framework, which further reinforces its dominance. The region also has a high prevalence of cancer and other chronic diseases, leading to a robust demand for biopsy devices. Furthermore, the presence of key market players and a focus on regulatory approvals in North America contributes to its leading position in the biopsy devices market.
For instance, in September 2023, Limaca Medical received clearance from the United States Food and Drug Administration (FDA) for its Precision GI endoscopic ultrasound (EUS) biopsy device. The FDA granted the device a breakthrough device designation, and with this new approval, Limaca Medical's automated device can obtain biopsies for definitive pancreatic cancer and gastrointestinal cancer diagnoses more quickly and with less trauma than existing products.
Future Market Scenario (2024 - 2031F)
The regulatory emphasis on biopsy devices is evident in the FDA regulations, which classify biopsy devices used in gastroenterology and urology under three categories, gastroenterology-urology biopsy instruments, endoscopes and accessories, and endoscopic electrosurgical units and accessories. The development of liquid biopsies for cancer screening also requires careful planning to meet regulatory demands, with evolving regulatory pathways and the need for analytical and clinical validation studies. The regulatory strategies for liquid biopsy diagnostics depend on a framework developed by the US Food and Drug Administration, with evolving guidance documents and regulatory approval precedents. The complexity of regulatory permutations for liquid biopsy diagnostics is influenced by specific indications and companion diagnostic claims associated with the products. Conclusively, a rising number of regulatory-approved biopsy devices is anticipated to cultivate healthy competition in the market and contribute to its expansion.
For instance, in November 2023, Single Pass, Inc. announced that it has received a CE Mark under EU MDR for its Kronos Biopsy Closure device. The cautery device is useful in stopping bleeding caused by biopsy tools during co-axial biopsy procedures. It is most used in liver, kidney, lung, and breast biopsy procedures.
Key Players Landscape and Outlook
The key players in the biopsy devices market include both global as well as local companies that operate in the market through a vast network of distributors. Some of the major players in the global biopsy devices market are Becton, Dickinson and Company, Hologic Inc., Danaher Corporation, Cook Medical, Boston Scientific Corporation, Argon Medical Devices, and B. Braun Melsungen AG. These companies are mainly involved in the strategic product development, research, and approval process. Various mergers and acquisitions and collaborations have been observed in recent years, showing the activeness of the key market players.
In June 2023, Quest Diagnostics, a prominent provider of diagnostic information services, announced the completion of its acquisition of Haystack Oncology. The latter is a company that has developed a highly sensitive minimal-residual disease (MRD) testing technology, which is based on circulating tumor DNA (ctDNA). This technology can aid in the early detection of residual or recurring cancer and better inform therapy decisions. Quest plans to incorporate this MRD technology into the development of new blood-based clinical lab services for solid tumor cancers, which will be available starting in 2024.
In March 2023, OraSure collaborated with nRichDx to offer products for researchers who are developing urine-based liquid biopsy assays. Colli-Pee, a sample collection and preservation device, is created by OraSure's subsidiary Novosanis. This device uses a proprietary reagent that allows hygienic collection of a consistent, volumetric first-void urine sample. It also preserves cell-free nucleic acids, such as cfDNA and cfRNA. At the same time, the Revolution Sample Prep System, which has been developed by nRichDX in Irvine, CA, is a semi-automated cfDNA sample prep system. It can process up to 20 mL of urine in a single extraction.