The global sales of breast lesion localization device is estimated to be worth USD 360.9 million in 2024 and anticipated to reach a value of USD 593.5 million by 2034. Sales are projected to rise at a CAGR of 5.1% over the forecast period between 2024 and 2034. The revenue generated by the market in 2023 was USD 343.4 million. The industry is anticipated to exhibit a Y-o-Y growth of 5.2% in 2024.
Wire localization is expected to dominate the market of breast lesion localization devices, both in terms of value, with a share of more than 40.9%. Wire localization remains the most frequently applied method for breast lesion localization since it has confirmed its efficiency, low cost, simplicity, reliability, wide applicability, and a high degree of clinical acceptance.
These are what will continue to keep it at the top of the market, even with the introduction and development of newer localization techniques. Among other driving factors, the most significant is an increase in the cases of breast cancer all over the world. This is because early detection and correct localization of breast lesions are very important for treatment purposes, hence increasing demand for advanced localization devices.
Global Breast Lesion Localization Device Industry Assessment
| Attributes | Key Insights |
|---|---|
| Historical Size, 2023 | USD 343.4 million |
| Estimated Size, 2024 | USD 360.9 million |
| Projected Size, 2034 | USD 593.5 million |
| Value-based CAGR (2024 to 2034) | 5.1% |
The breast lesion localization device industry is set to experience upward growth during the forecast period. It is projected to generate a revenue of USD 593.5 million by the end of 2034 and is predicted to rise 1.6 times the current market value through 2034.
Breast lesion localization tools are employed for detecting and pinpointing the exact locations where there are tumors affecting women’s breast lesions, which usually poses serious challenges particularly when conducting breast conserving operations like lumpectomies. They enable appropriate removal of selected abnormal tissues while retaining as many adjacent normal ones as practicable.
The high demand for these devices is greatly due to the comfort and significant safety of patients. Many of the minimally invasive localization techniques available in the market can be done under local anesthesia, making the process comfortable for the patient. These techniques are less traumatic with good recovery time compared to the conventional techniques.
Among others, the most recent techniques are radioactive and magnetic seed localization. These kinds of technologies allow for the exact localization of target tissues, like tumors, with minimal disturbance to the healthy tissues surrounding them.
In this way, such procedures can be conducted near the time of surgery, considerably reducing the waiting period and the attendant anxiety for the patient. This proximity will help in maintaining the accuracy of localization since there is less time for changes or movement of the body that may affect the target area.
These localization devices significantly improve surgical accuracy since surgeons are better placed to focus on the target area. Increased precision in performing procedures gives better patient outcomes, higher success rates for surgeries, and fewer complications. Any such improvement in outcomes means increased patient satisfaction and confidence in the procedures.
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The table below offers a comparative analysis of the Compound Annual Growth Rate (CAGR) fluctuations for the global Breast Lesion Localization Device market between the base year (2023) and the current year (2024) over six months.
This examination uncovers significant changes in market performance and highlights trends in revenue generation, giving stakeholders valuable insights into the market’s growth trajectory throughout the year. The first half (H1) encompasses January through June, while the second half (H2) covers July through December.
In the first half (H1) of the decade from 2023 to 2033, the business is predicted to surge at a CAGR of 5.9% followed by a slightly higher growth rate of 5.5% in the second half (H2) of the same decade.
| Particular | Value CAGR |
|---|---|
| H1 | 5.9% (2023 to 2033) |
| H2 | 5.5% (2023 to 2033) |
| H1 | 5.1% (2024 to 2034) |
| H2 | 4.8% (2024 to 2034) |
Moving into the subsequent period, from H1 2024 to H2 2034, the CAGR is projected to increase slightly to 5.1% in the first half and remain relatively moderate at 4.8% in the second half. In the first half (H1) the market witnessed a decrease of 80 BPS while in the second half (H2), the market witnessed an increase of 70 BPS.
The Demand for Minimally Invasive Endodontic Microsurgery to Drive the Market
An increase in the early detection of breast cancers, frequently detected as non-palpable lesions in imaging studies, due to better screening programs. Surgical management of these small deep-seated lesions is highly challenging due to their properties thus there is a high demand for breast lesion localization devices.
The market for breast lesion localization devices are being driven by the rapid technological advancements which is replacing the traditional methods for lesion localization.
These new technologies include radioactive seed localization (RSL), magnetic seed localization (MSL) and radiofrequency identification (RFID) tags. These modern methods have better imaging quality as compared to the old ones and they are precise in marking for lesion removal with sufficient margins.
The shift towards minimally invasive procedures further boosts the adoption of these devices. Techniques like radioactive and magnetic seed localizers can be placed closer to surgery, reducing patient anxiety and discomfort, and shortening recovery times. Clinical guidelines and regulatory approvals support the use of advanced localization techniques, enhancing their credibility and encouraging widespread use.
Better patient outcomes with the localization devices including complete lesion removal which eliminate the need for re-excision surgeries and lowers the recurrence rate. They also streamline surgical procedures, improving efficiency in healthcare settings.
As there is increase in the number of non-palpable lesions detected early through imaging techniques; breast lesion localization device market is expanding significantly due to technological advancements with precise detection.
Market Consolidations to Improve Breast Lesion Localization Devices is an Escalating Trend
Acquisitions allow a company to expand its product portfolio and grow its geographic reach. The company that is acquired often possesses well-established diagnostic products and solutions, which become a good revenue source for the acquirer.
Acquisitions bring appropriate revenue growth and research solutions in the market. The distribution network of the acquirer may also improve. This also enables the acquirer to enter new emerging markets as well as existing markets.
Acquisitions can create valuable synergies in R&D. By bringing together the technological competencies and innovative abilities of the firms involved, the company can give further impetus to the development of new products and solutions.
This close integration of R&D could very well come up with break-through that might not otherwise be feasible; such results, then, promote innovation and help to maintain the leading edge in technological developments.
For instance, in Feb 2021, Becton, Dickinson and Company, a prominent global medical technology firm, has finalized its acquisition of Cytognos, a privately held company based in Salamanca. This acquisition is to improve the portfolio with additional cancer treatment products.
In Oct 2021, Toronto-based MOLLI Surgical is acquired by Coordinated Accessible National (CAN) Health Network, which enable them to expand and promote their patient-centered solution throughout Canada for cancer treatments.
Emerging Economies Drive Growth Opportunities in Breast Lesion Localization Device Market
Emerging economies including China, South Africa, Brazil, Turkey and India offer significant business opportunities to leading players in breast lesion localization devices market. Environmental changes particularly observed in India and China have fueled increased vulnerability to autoimmune diseases, as well as the high prevalence of breast cancer.
Therefore, there will be an extended period of time where such firms will have stable clients. GLOBOCAN 2020 statistics project that 178,000 women were diagnosed with breast cancers and it will increase up to 272,000 new cases in 2040. However more alarming predictions have shown that in 2025 there will be a 61% increase among Indian women aged 65 years old or above who will suffer with breast cancer.
One of the key drivers of the breast cancer cases is the aging population in emerging market economies. Older women are at an elevated risk of contracting this disease; therefore, as life expectancy increases, more elderly women are diagnosed with breast cancer.
This continued demand for access to appropriate localization devices required to facilitate proper diagnosis and treatment is expected to further solidify the customer base for companies operating in this market.
This escalating incidence rate creates significant opportunities for market players in emerging regions.
Logistical Challenges in Breast Lesion Localization Device Restrict Breast Lesion Localization Device Market Growth
Logistical constraints and potential wire migration pose significant challenges for wire-guided localization devices, which have limited use in the breast lesion localization device market. These logistical challenges often result from the necessity of preoperative localization procedures that are time-consuming and need harmony between radiology and surgical teams.
Additionally, during surgical process, there is risk of wire migration, where the wire shifts its position which leads to the wrong lesion localization. These problems boosts the complication in the process and need for repeat procedures resulting in complication in the market growth.
Moreover, the intraoperative use of ultrasonography to localize lesions is only feasible if they are visible on ultrasonography thereby limiting their utility only to those instances where the lesion can be easily found using such diagnostic method.
This limitation excludes lesions that may only be detectable through other imaging modalities, such as mammography or MRI, thereby reducing the versatility and effectiveness of ultrasound-based localization devices in certain clinical scenarios.
The imposition of these constraints results in difficulty with the smooth integration of breast lesion localization devices into surgical practice, therefore making it hard to have a reliable system in place to locate appropriate lesions.
Therefore, health care providers could find themselves unable to achieve best results in terms of surgery and may be induced into looking for other methods of localizing these tissue defects, which may include using additional imaging techniques.
Principal Consultant
The global breast lesion localization device industry recorded a CAGR of 4.7% during the historical period between 2019 and 2023. The growth of Breast Lesion Localization Device industry was positive as it reached a value of USD 343.4 million in 2023 from USD 269.9 million in 2019.
The predominant driver of growth in the breast lesion localization devices market in the previous term was the transition from invasive to non-invasive surgical procedures, propelled by a surge in breast cancer cases and a preference for less intrusive treatments due to reduced hospital stays and cost-effectiveness.
Breast lesion detection devices have greatly increased the popularity of minimally invasive techniques which in turn benefited from the technical advancements of these tools with improved patient results. The change came with advantages such as reduced irritation after operations alongside lesser complications, shorter periods in hospitals, recovering faster as well as low scarring.
Breast lesion localization devices have made it possible for these techniques to be conducted with accuracy and minimal disturbance, often with the help of imaging techniques. In addition, these devices’ recent advances have rendered cost of image-guided procedures and easily accessible hence resulted in an increased market during the last quarter.
Tier 1 companies consist of the leading companies in the market with a market revenue of over USD 210.2 million, gaining a significant market share of 61.2% in the global market.
The main characteristics of these industry leaders are extensive manufacturing capabilities and a diversified product line. The reputation they have built in cancer diagnostics and treatment is the best and was realized over time through consistency in the quality of the products coupled with superb customer support.
They are known for pioneering technological innovations in localization equipment, materials, and procedures that set benchmarks for the industry and advance it in its evolution. Prominent companies within tier 1 include Merit Medical Systems, BD, ARGON MEDICAL and Hologic, Inc.
Tier 2 companies include mid-size players with revenue of USD 98.6 million having presence in specific regions and highly influencing the local market. Their expansion is driven by their adeptness in comprehending regional intricacies, adept navigation of regulatory landscapes, and delivery of bespoke solutions tailored to their target demographics.
Prominent companies in tier 2 include Endomagnetics Ltd., MatekMedikal, Sirius Medical Systems B.V., Izi Medical Products, LLC, Molli Surgical Inc, Elucent Medical, Intramedical Imaging and Isoaid.
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The section below covers the industry analysis for the breast lesion localization device market for different countries. Market demand analysis on key countries in several regions of the globe, including North America, Asia Pacific, Europe, and others, is provided. The United States is anticipated to remain at the forefront in North America, with a CAGR of 2.4% throughout forecasted period. In Asia Pacific, India is projected to witness a CAGR of 8.6% by 2034.
| Countries | Value CAGR (2024 to 2034) |
|---|---|
| India | 8.6% |
| China | 7.6% |
| South Korea | 6.0% |
| Spain | 4.4% |
| Canada | 4.1% |
North America, spearheaded by the USA anticipated to grow at a CAGR of 2.0% throughout the forecast period, accounting for highest share in North America.
The presence of key players in the United States is driving continuous product development efforts, thereby fueling growth in the market for breast lesion localization devices within the region.
Organizations such as MOLLI Surgical Inc. are playing a vital role in advancing this sector. In earlier May 2021, the United States FDA granted clearance to MOLLI Surgical Inc. after introducing their new wire-free localization technology that has been designed to help in surgery cases involving breast cancers specifically known as MOLLI™.
This is an important step forward as it provides another choice besides wires when localizing lesions at its earliest stages which could possibly reduce traditional ones at some point.
Innovative products or devices introduced by industry are meeting doctors and patient needs. These factor is making breast cancer treatment accurate and efficient which is boosting the market in this region.
Germany’s breast lesion localization device market is poised to exhibit a CAGR of 2.4% between 2024 and 2034. Currently, it holds the highest share in the European market, and the trend is expected to continue during the forecast period.
Rising incidences and mortality related to breast cancer are on the alarming stage in Germany. For instance, Germany has reached more than 74 thousand new cases of breast cancers which is highest among all other cancers touching to the 12% of total cancer cases. This sudden rise in the patient population resulting in the high diagnosis and cancer screening rate.
This high awareness regarding the breast cancer contributing the adoption of breast lesion localization devices within the country. The importance of early detection and proper localization of breast lesion are being considered by healthcare professionals and patient as they are crucial factors for effective treatments.
These factors are resulting in the high demand for advanced medical technologies such as breast lesion localization device that facilitate accurate detection and localization of breast lesion.
China with high incidences of breast cancer, the market for breast lesion localization device in to grow at 7.6% CAGR to dominate the in Asia region. In China, the high prevalence of breast cancer has a significant impact on the country’s breast lesion localization market development.
Currently, breast cancer leads in terms of most cancer incidents, which results in a high demand for precise and efficacious ways to localize breast lesions. Consequently advanced localization methods incorporating special equipment are commonly employed by medical institutions so as to accurately direct biopsy sampling at the questionable radical formations.
In China, 7.4% of cancer patients have breast cancer, and this represents approximately 2 million cases in 2022 as per the Global Cancer Observatory report. Therefore, there is considerable availability for growth of the market concerning breasts lesion localization primary due to the high prevalence of breast cancer in china. This factors are contributing for the growth of breast lesion localization device market in China.
The section contains information about the leading segments in the industry. By technique, the wire localization segment is estimated to hold 40.9% of market share in 2024.
| Product | Wire Localization |
|---|---|
| Value Share (2024) | 40.9% |
The wire localization segment is the highest contributor to the market and is projected to account for nearly 40.9% of the market share in 2024. Wire localization can be used for a variety of breast lesions, including those that are non-palpable or deep-seated within the breast tissue.
Numerous clinical situations can thus benefit from the versatility. Further, various surgeons who have had a long experience in this area contributes to its continued popularity in breast surgery.
Similarly, the demand for wire localization is boosting due to its effectiveness, cost-effective and high level of clinical acceptance. These factors contribute to its continued dominance in the market, even as newer localization techniques are developed and introduced.
One of the main reasons that justify the continued demand for wire localization is its relatively low cost. With its cost considerably lower than that of newly developed localization techniques, it remains more accessible to healthcare facilities, making it a rather popular option for use-especially in settings working on relatively tight budgets for healthcare. This provides ease of access and broad usage even in areas with a small budget for health care.
| Application | Breast Biopsy |
|---|---|
| Value Share (2024) | 59.8% |
The breast biopsy segment is forecast to account for a revenue of over USD 215.8 million in the breast lesion localization device market by 2024 end. Breast lesion localization devices improve diagnostic yield of breast biopsies through accurately locating suspicious lesions in the breast. This in turn enhances precision in the diagnosis thus decreasing chances of receiving false negative results which helps avoid errors in treatment.
Devices for locating breast lesions are commonly used with imaging modalities like mammography and ultrasound. This allows for real time guidance during biopsy procedures, so that health care people can accurately hit or pick samples from suspicious images based masses; thereby leading to increased efficiency and precision of biopsies in general.
Companies use collaboration agreements and partnerships to increase their market presence and improve their range of products. These collaborations might take the form of distribution agreements, joint ventures and licensing agreements to tap into fresh markets or exploit complementary technologies.
In order to access the emergent markets and satisfy the increasing need for breast healthcare solutions, companies focus on geographical expansion. Setting up regional offices, innovation centers as well as distribution networks helps firms establish a better local healthcare provider and patient service in key markets.
Recent Industry Developments in Breast Lesion Localization Device Market
In terms of technique, the industry is divided into wire localization, non-wire localization, radar reflector localization, magnetic seed localization, RFID tag localization and radioisotope localization.
In terms of application, the industry is segregated into breast biopsy and breast lumpectomy.
The industry is classified by end user as hospitals, ambulatory surgical centres and specialty clinics.
Key countries of North America, Latin America, East Asia, South Asia, Western Europe, Eastern Europe and Middle East and Africa (MEA) have been covered in the report.
The global Breast Lesion Localization Device industry is projected to witness CAGR of 5.1% between 2024 and 2034.
The global Breast Lesion Localization Device industry stood at USD 343.4 million in 2023.
The global breast lesion localization device industry is anticipated to reach USD 593.5 million by 2034 end.
India is set to record the highest CAGR of 8.6% in the assessment period.
The key players operating in the global Breast Lesion Localization Device industry include Merit Medical Systems, BD, ARGON MEDICAL, Hologic, Inc., Endomagnetics Ltd., MatekMedikal, Sirius Medical Systems B.V., Izi Medical Products, LLC, Molli Surgical Inc, Elucent Medical, Intramedical Imaging, Isoaid, Vigeosrl, Medax Medical Devices, MDL SRL, BPB Medica, Sterylab S.R.L., Tsunami Medical Srl, Laurane® Medical LLC and Biomedical Srl.
1. Executive Summary
2. Industry Introduction, including Taxonomy and Market Definition
3. Market Trends and Success Factors, including Macro-economic Factors, Market Dynamics, and Recent Industry Developments
4. Global Market Demand Analysis 2019 to 2023 and Forecast 2024 to 2034, including Historical Analysis and Future Projections
5. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034
5.1. By Technique
5.2. By Application
5.3. By End User
5.4. By Region
6. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, by Technique
6.1. Wire Localization
6.2. Non-Wire Localization
6.3. Radar Reflector Localization
6.4. Magnetic seed Localization
6.5. RFID Tag Localization
6.6. Radioisotope Localization
7. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, by Application
7.1. Breast Biopsy
7.2. Breast Lumpectomy
8. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, by End User
8.1. Hospitals
8.2. Ambulatory Surgical Centres
8.3. Specialty Clinics
9. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, by Region
9.1. North America
9.2. Latin America
9.3. East Asia
9.4. South Asia and Pacific
9.5. Western Europe
9.6. Eastern Europe
9.7. Middle East and Africa
10. North America Sales Analysis 2019 to 2023 and Forecast 2024 to 2034, by Key Segments and Countries
11. Latin America Sales Analysis 2019 to 2023 and Forecast 2024 to 2034, by Key Segments and Countries
12. East Asia Sales Analysis 2019 to 2023 and Forecast 2024 to 2034, by Key Segments and Countries
13. South Asia & Pacific Sales Analysis 2019 to 2023 and Forecast 2024 to 2034, by Key Segments and Countries
14. Western Europe Sales Analysis 2019 to 2023 and Forecast 2024 to 2034, by Key Segments and Countries
15. Eastern Europe Sales Analysis 2019 to 2023 and Forecast 2024 to 2034, by Key Segments and Countries
16. Middle East and Africa Sales Analysis 2019 to 2023 and Forecast 2024 to 2034, by Key Segments and Countries
17. Sales Forecast 2024 to 2034 by Technique, Therapeutic Area, Storage Status, Application and End User for 30 Countries
18. Competition Outlook, including Market Structure Analysis, Company Share Analysis, By Key Players, and Competition Dashboard
19. Company Profile
19.1. Merit Medical Systems
19.2. BD
19.3. ARGON MEDICAL
19.4. Hologic, Inc.
19.5. Endomagnetics Ltd.
19.6. MatekMedikal
19.7. Sirius Medical Systems B.V.
19.8. Izi Medical Products, LLC
19.9. Molli Surgical Inc
19.10. Elucent Medical
19.11. Intramedical Imaging
19.12. Isoaid
19.13. Vigeosrl
19.14. Medax Medical Devices
19.15. MDL SRL
19.16. BPB Medica
19.17. Sterylab S.R.L.
19.18. Tsunami Medical Srl
19.19. Laurane® Medical LLC
19.20. Biomedical Srl
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Breast Lesion Localization Device Market
