BREAST LESION LOCALIZATION METHODS MARKET ANALYSIS

Global breast lesion localization methods market size is projected to reach US$ 622.7 Mn by 2030 from an estimated US$ 378.2 Mn in 2023, exhibiting a compound annual growth rate (CAGR) of 7.4%.

Breast cancer is a condition caused by an uncontrolled multiplication of breast cells that form a lump, which may be malignant or non-malignant in nature. Such cells usually form tumors that can often be observed on an x-ray or felt as a lump. Increasing prevalence of breast cancer, increasing awareness for treatment, presence of favorable reimbursement policy in developed and emerging economies, and increasing product development are expected to drive growth of the global breast lesion localization methods market.

Global Breast Lesion Localization Methods Market- Regional Insights

• North America is the largest market for breast lesion localization methods, with a market share of 39% in 2022, which is primarily due to the increasing prevalence of early-stage breast cancer detection through screening mammography in the region. According to the American Cancer Society, approximately 80% of breast cancers are found through mammograms done for routine screening. Screen-detected lesions are often non-palpable as they are too small to be felt by touch alone.
• Asia Pacific is the second-largest market for breast lesion localization methods, with a market share of 28.1% in 2022. This is due to the higher prevalence of palpable tumors in the overall breast cancer cases reported from countries such as India, China, and Indonesia. For example, according to article published by the American Cancer Society around 60% of Chinese and 65% of Indonesian women were initially diagnosed with palpable breast lumps.
• Europe is the third-largest market for breast lesion localization methods, with a share of 19.9% in 2022. The market growth is being driven due to increasing prevalence of breast cancer in the region. For instance, on August 5, 2023, according to the data published, by Elsevier B.V., a Dutch academic publishing company, there were 576,000 new cases of breast cancer in the World Health Organization (WHO) European Region in 2020.

Figure 1. Global Breast Lesion Localization Methods Market Share (%), By Region, 2023

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Analyst View of the Global Breast Lesion Localization Market:

Global breast lesion localization methods market is expected to witness steady growth over the forecast period. The non-invasive localization methods segment is anticipated to dominate the market due to advantages such as shorter procedural time and fewer complications as compared to invasive techniques. North America will continue its supremacy in the market during the next few years backed by rising healthcare spending and technological developments in the region. Asia Pacific exhibits high potential for radioguided occult lesion localization due to increasing prevalence of breast cancer.

However, the lack of skilled radiologists and surgeons may impede the market expansion to some extent. High costs of advanced localization systems also remain a major concern, especially in developing nations. Nonetheless, growing awareness about early breast cancer detection and treatment presents avenues for market players. The launch of precise and wearable biopsy devices by market actors will further catalyze the revenues in the upcoming years.

The demand for wire-guided localization will reduce gradually with the emergence of advanced radioisotope tracing techniques which offer better comfort and higher precision rates. Moreover, expanding medical tourism in Asian countries like Thailand and India along with collaborations between global organizations-to improve diagnostic services in low and middle-income countries will fuel the adoption of radioisotope tracing systems. On the whole, breast lesion localization methods market will expand steadily in the long run driven by technological advancements and increased cancer screening initiatives worldwide.

Global Breast Lesion Localization Methods Market- Drivers

• Increasing incidence of breast cancer: Increasing incidence of breast cancer has become a major concern globally and is one of the primary factors fueling the growth of the global breast lesion localization methods market. According to recent estimates by World Health Organization (WHO), breast cancer accounts for nearly 12% of all new cancer cases and is one of the leading causes of cancer-related deaths in women worldwide. It is estimated that over 2 million new cases of breast cancer were diagnosed in 2020 alone. With growing awareness about early detection and diagnosis being critical in improving survival rates, more and more women are opting for various breast cancer screening methods such as magnetic resonance imaging, ultrasound and mammography. As a result, more breast lesions and abnormalities are being detected at an early stage. This has significantly boosted the demand for precise breast lesion localization techniques which help surgeons and oncologists in pinpointing the location of the lesion or tumor during biopsy or lumpectomy procedures.
• Growing awareness regarding early detection: Growing awareness among women about early detection and diagnosis of breast cancer is a major factor boosting the adoption of breast lesion localization methods. Various governments and non-profit organizations around the world have launched several awareness programs to educate women about various screening and diagnostic techniques for breast cancer detection. For example, organizations like Breast Cancer Foundation and Susan G Komen Foundation conduct regular screening camps and educational sessions that are targeted towards underprivileged sections of the society in developed as well as developing nations. Such initiatives are fueling the growth of the breast lesion localization methods market as they encourage more number of women to opt for various diagnostic tests like mammography, MRI, and breast ultrasound for screening breast abnormalities at an early stage.
• Technological advancements in localization methods: Technological advancements are revolutionizing breast lesion localization methods. Novel localization methods are providing enhanced accuracy, precision, and ease of use as compared to conventional wire guided localization. Improved localization allows for more effective targeted biopsies and surgeries. For example, radio guided occult lesion localization (ROLL) utilizes a tiny radioactive seed, smaller than a grain of rice, that is placed into the breast guided by ultrasound imaging to precisely mark the site of concern. Unlike wires, the seed remains in place throughout the surgical procedure without dislodging concerns. Furthermore, recent advancements in magnetic resonance spectroscopy are enabling real time imaging guided localization. Magnetic resonance (MR)-guided breast biopsy utilizes high quality MR images to accurately localize lesions and guide the insertion of needles. MR provides three dimensional imaging of both lesions and needle insertion without exposure to radiation. It is a particularly attractive option for evaluating lesions found through breast cancer screening for women with dense breast tissue, where lesions can be difficult to identify on a mammogram.
• Rising healthcare expenditure: Rising healthcare costs have placed significant burden on individuals and governments globally. According to the estimates by WHO, overall healthcare expenditure is projected to rise substantially in most countries in the near future. With advancement in medical technologies, treatment and diagnosis of various diseases have become very sophisticated which adds to the costs. Early detection and localization of breast lesions plays a key role in effective management and positive treatment outcomes of breast cancer. With rising awareness, many women are opting for regular breast screenings. However, standard procedures for localization like wire/radioisotope guided surgery require special infrastructure and personnel training which increases the cost of treatment. This has been driving the demand for newer, affordable, and accurate localization methods that can be used in general hospital setups with minimal requirements.

Global Breast Lesion Localization Methods Market- Opportunities

• Emerging economies in Asia Pacific and Latin America: The emerging economies in Asia Pacific and Latin America present a huge potential for growth in the breast lesion localization methods market. These regions are experiencing rapid economic development and rise in disposable incomes. As living standards improve, access to quality healthcare is also increasing. Governments in many developing countries have started focusing on women's health through various initiatives. Some of the key factors driving the demand for breast lesion localization methods include growing awareness about early detection of breast cancer, increasing screening programs organized by both public and private organizations, and expanding health insurance coverage in these regions. The breast healthcare infrastructure is also witnessing considerable investments and improvement. The number of diagnostic centers, hospitals, and oncology clinics equipped with latest technology has surged rapidly across both urban and rural pockets. For example, the Indian government rolled out the Ayushman Bharat initiative in 2018 to setup 1.5 lakh health and wellness centers across the country focusing on non-communicable diseases including cancer. According to data published by National Health Profile in 2019, released by Central Bureau of Health Intelligence, Government of India, this program led to increase in cancer screening by 3 times from 2018 to 2021.
• Development of radioisotope-free localization methods: The traditional method of wire localization has relied on short half-life radioactive isotopes which present challenges from both a patient accessibility and clinical workflow perspective. With greater emphasis on providing non-invasive options and reducing healthcare costs, the development of radioisotope-free localization techniques could drive significant growth in this market. Techniques such as magnetic and radiofrequency localization offer advantages over wire and radioactive seed localization as they do not require injection of short-lived isotopes or leave behind wires that can interfere with pathological analysis. This improves the patient experience of biopsy and eliminates isotope-related supply chain issues.
• Potential of combined diagnostic and therapeutic approaches: The integration of diagnostic methods with therapeutic interventions has potential to be transformative in breast lesion localization. Current diagnostic methods primarily focus on detection of suspicious lesions, with therapeutic procedures conducted separately at a later stage. A combined approach could streamline this process by enabling diagnosis and treatment in a single session. This represents a major opportunity to improve patient outcomes and experience. Patients would benefit from faster treatment without the need for multiple visits. It could also help achieve better compliance as the full clinical pathway is compressed.

Global Breast Lesion Localization Methods Market- Trends

• Adoption of radiofrequency identification (RFID) technology: Adoption of radiofrequency identification (RFID) technology is significantly influencing the breast lesion localization methods market. RFID allows for real-time, wireless tracking of RFID tags or sensors placed within the breast during pre-surgery localization procedures. This provides surgeons with continuous and accurate information on the precise location of lesions during breast cancer excision surgery. RFID technology offers several advantages over traditional wire or seed-based localization methods. Wire-based localization requires inserting a wire puncture into the breast to mark the location, which can shift before or during surgery and cause inaccurate localization. RFID eliminates the risk of wire displacement. It also enables surgeons to locate the lesion intraoperative from a distance without needing direct skin contact as with wires or seeds. This improves ergonomics during surgery and reduces operation time. This trend towards advanced radiofrequency technologies for accurate and real-time localization is expected to positively influence growth in the overall market.
• Integration of imaging capabilities with localization: The integration of imaging capabilities with localization methods is significantly impacting the global breast lesion localization methods market. Techniques such as stereotactic guided biopsy that combines digital mammography or ultrasound imaging with computer assistance for precise needle placement in the breast has seen rising demand. This allows real-time ultrasound imaging to help navigate the needle to the targeted lesion. It provides surgeons clear views of the breast tissue and lesions for accurate sampling with minimally invasive procedures. Similarly, magnetic resonance (MR)-guided breast biopsy is gaining popularity. MR technology produces high-quality images of breast tissue and helps to differentiate between benign and malignant lesions. Combining MR imaging with vacuum-assisted biopsy devices enables surgeons to visualize small lesions and collect multiple tissue samples under direct visualization. MR's ability to visualize lesion morphology and assess the extent of disease has made it a valuable tool in breast cancer diagnosis and staging. Many healthcare providers are well equipped with MR-guided breast biopsy suites in their facilities. The ongoing integration of high-resolution breast imaging with minimally invasive lesion localization techniques will likely transform patient management and drive heightened demand in this market space.
• Growth in number of ambulatory surgical centers: Rising number of ambulatory surgical centers in the U.S. is having a significant impact on the global breast lesion localization methods market. Ambulatory surgical centers, also known as outpatient surgery centers or same-day surgery centers, allow surgical procedures to be performed without an overnight hospital stay. Patients go home the same day they have their procedure. The popularity of ambulatory surgical centers has been growing steadily in recent years as they provide many advantages over traditional hospital-based outpatient surgery. For patients, ambulatory surgical centers offer a more convenient experience as compared to hospitals as they avoid long waits, paperwork and billing issues that are associated with hospitals. This makes the surgical process much more efficient and less stressful. From a financial perspective, procedures performed at ambulatory surgical centers tend to cost insurers and patients less money as compared to the same procedures done at hospital outpatient departments. This shift in where procedures are being performed is driving growth of alternative localization methods that align well with the workflow and capabilities that are available in ambulatory surgical centers versus traditional hospital settings.

Global Breast Lesion Localization Methods Market- Restraints

• High cost of advanced localization methods: The high cost of advanced breast lesion localization methods is proving to be a major restraint for the growth of the market. Traditional wire guided or needle localization procedures are starting to get replaced by novel techniques like radioisotope guided, electromagnetic guided, and radioactive seed localization that offer better precision and reduce human errors. However, these new advanced technologies come at a significantly higher price point. For example, radioisotope guided methods such as radioactive seed localization use specialized radioactive seeds and gamma probe localization devices that jointly can cost over US$5000 per procedure. Similarly, electromagnetic localization systems require setting up of an expensive electromagnetic field generator and compatible localization probes and sensors, pushing the total cost to around US$10000. Adoption of such costly techniques puts massive financial strain on public healthcare systems with limited budgets as well as uninsured private patients. According to the data by Organization for Economic Co-operation and Development (OECD), 59 million Americans were without health insurance for at least part of 2019 prior to the COVID-19 pandemic. For such a large uninsured population, the affordability becomes a major blocking factor for accessing advanced precision localization methods

This restrains healthcare providers from transitioning to new techniques despite their clinical advantages. Unless solutions are found to make advanced localization methods more affordable through innovations or subsidies, high prices will continue capping the market growth potential significantly in the near future.

• Scarce skilled labor and technical know-how: The shortage of skilled healthcare professionals with appropriate technical expertise is posing a significant challenge for the expansion of the breast lesion localization methods market. Breast lesion localization utilizes advanced imaging technologies like wire localization, radioisotope localization, and magnetic localization for accurate identification and removal of breast lesions. However, operating and analyzing these complex systems requires radiologists, surgeons and technicians with specialized training. The scarcity of technicians and medical practitioners with required technical know-how has repercussions on the uptake of advanced breast lesion localization techniques. Hospitals and clinics have to grapple with delays in treatment and extended patient wait times due to lack of trained professionals to operate the specialized systems. Some may be reluctant to invest in the latest wire, radioisotope or magnetic localization devices if qualified operators are not available. Unless concerted efforts are made by countries to increase enrollment in healthcare education and bridge the wide skills gap, the shortage of skilled manpower would remain a drag on further penetration of advanced breast lesion localization methods especially in developing regions.

Counterbalance: The key market players need to solve the shortage of skilled manpower in healthcare by providing them proper education and training, so that they can operate or analyze the complex systems that are associated to global breast lesion localization methods market.

• Risks and complications associated with procedures: The risks and complications associated with breast lesion localization procedures are presenting significant restraints on the growth of the breast lesion localization methods market. All medical procedures carry a certain degree of risk to the patient and breast lesion localization is no exception. Although, the intent is to safely guide surgeons to the affected area with maximum accuracy and minimal invasiveness, there is always a possibility of errors or unintended harm being caused to adjacent healthy tissues or delicate structures like nerves, blood vessels, and ducts in the breast. Even minor complications and side effects like bleeding, infection, pain, scarring, or necrosis can negatively impact the patient experience and cause anxiety about undergoing further treatment. This discourages some women from opting for vital pre-surgical localization that aids complete removal of the tumor.

Figure 2. Global Breast Lesion Localization Methods Market Share (%), By Lesion Type, 2023

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Recent Developments

New product launches

• On April 4, 2023, MOLLI Surgical, a medical equipment manufacturer, launched the product MOLLI 2 to simplify breast cancer surgery and deliver a better patient experience. MOLLI 2 significantly improves the patient experience by enabling surgeons to identify malignant tissue for a quicker, more precise, and possibly better cosmesis.
• On August 17, 2022, Devicor Medical Products, Inc., a medical device company, launched the Mammotome Revolve EX Dual Vacuum-Assisted Breast Biopsy System. This vacuum-assisted biopsy device designed specifically for the excision of benign breast lesions and is twice as fast as traditional vacuum-assisted breast biopsy systems. The Mammotome Revolve EX device is a minimally invasive solution and enables physicians to provide better care for patients with benign lesions by avoiding the risks and trauma of an open surgical procedure and thereby creating little to no scarring.
• In March 2022, Baptist Health, a management services company, announced that they used U.S. Food and Drug Administration (U.S. FDA) approved system which guides surgeons in locating and removing breast tumors, known as the sentimag magnetic localization system. Sentimag is a simpler and more effective alternative to traditional methods of guide wires for tissue localization and radioactive traces for sentinel node biopsy procedures, thus creating a less invasive experience for the patient

Top Companies in Global Breast Lesion Localization Methods Market

• Cook Medical Incorporated
• C.R. Bard Inc.
• Endomagnetics Ltd.
• SOMATEX Medical Technologies GmbH.
• Cianna Medical
• Argon Medical Devices Inc.
• Hologic Inc.
• STERYLAB

Definition: An abnormal growth or lump inside the breast tissue is called a breast lesion. It may be present as a single lump or as a group of lumps that are either malignant (i.e., cancerous) or benign (i.e., non-cancerous). Any change in breast tissue can be extremely distressing. It becomes alarming when from a sudden and intense ache in the breast region; it gradually changes or develops into a cyst or hard lump.