Breast Tissue Markers Market

Breast Tissue Markers Market Outlook (2023 to 2033)

The global breast tissue markers market generated revenue worth US$ 2.7 billion in 2022. The market is predicted to reach a value of US$ 6.5 billion by 2033-end, advancing at 8.4% CAGR over the decade.

Cancer is the second-leading cause of death globally, with its increased incidence in both developed and developing countries. Breast cancer is the most commonly diagnosed type and it affects the morphology of human breasts. Identifying tumor markers is crucial for clinical management, diagnostics, staging, therapeutic response evaluation, and treatment development.

Well-established molecular markers like hormone receptors, HER-2 oncogene, Ki-67, and p53 proteins, as well as genes for hereditary breast cancer, are essential for the development of effective and targeted therapies.

• Metal breast tissue markers accounted for a market share of 73% in 2022.
• Revenue from breast tissue markers accounted for 17.5% share of the global oncology biomarkers market in 2022.

Breast cancer is not one illness; rather, it is a group of illnesses with unique histological characteristics, genetic and genomic heterogeneity, and a range of prognostic outcomes.

• According to the British Journal of Radiology in 2022, breast cancer remains a significant global health challenge, with approximately 2.26 million cases reported in 2020. This disease often leads to invasive carcinoma and metastatic conditions.

Breast-conserving surgery with radiotherapy offers better survival outcomes than mastectomy. Cosmetic results are increasingly important as a parameter of surgical quality. Long-term cosmetic outcomes may be suboptimal due to delayed scarring and radiation effects, with a significant proportion of patients being unhappy about their breast cosmesis.

Image-guided core biopsy and marker placement are standard for suspicious breast lesions, but migration can hinder clear margins after surgical removal, especially in breast cancer due to high clinical response rates.

Which Factors are Driving the Market for Breast Tissue Markers?

“Increased Prevalence of Breast Cancer and Advanced Tissue Marker Diagnostics”

Breast cancer is a complex disease with diverse clinical progressions, highlighting the importance of identifying tumor markers that can predict tumor behavior. These markers assist in clinical management, diagnostic procedures, evaluation of therapeutic response, detection of recurrence, and distant metastasis and prognosis.

Numerous screening studies have been conducted to find new and less well-known cell surface indicators that can help identify invasive cancers or for diagnosing and predicting disease progression. For decades, CD44, a surface marker, has been the focus of breast cancer studies.

• According to the COSMIC database 2019, 2.8% of breast cancer samples had CD44 mutations, whereas 3.7% of breast tumors overexpress CD44. However, there is still debate over CD44's function in cancer stem cells (CSCs). The screening assessed several known clusters of differentiation (CD) markers, identifying several novel and less characterized breast epithelial markers overexpressed in at least 5% of breast cancer samples.

Nursing personnel provide routine care and management in critical care units or general wards, while skilled physicians, physician assistants, and nurse practitioners provide first entry. Each member of the healthcare team monitors the continuous need for biopsy and ensures that it is removed as soon as possible when it is no longer required.

For successful therapy, the most concerning breast lesions require further diagnostic workup, including a biopsy and pathology diagnosis. Historically, the sole approach was a surgical excisional biopsy. With increasing breast cancer prevalence globally, there is a growing demand for improved screening and diagnostic procedures.

• In 2018, 2.2 million instances were diagnosed, with imaging being the most common method of detection, as per the research article published in Cancers 2021 Journal.

All these factors are likely to push the global market for breast tissue markers forward, providing market players with lucrative growth opportunities.

What are the Hindrances to the Sales Growth of Breast Tissue Markers?

“Cellular Heterogeneity and Adverse Events Related to Tissue Markers”

Screening and diagnostic procedures for the detection of breast cancer have exhibited significant growth over the past few decades. However, there are certain limits to breast imaging examination.

Heterogeneity in breast tissues affects the expression of surface markers, leading to dysregulated features in cancer stages. Understanding normal cell transitions and different cancer subtypes is hindered by this heterogeneity, hindering the development of marker-based diagnostic methods.

The United States FDA also requires manufacturers, importers, and device users to report adverse effects, device failures, and deficiencies. Biopsy markers are generally safe, with few adverse events documented, mainly focusing on marker migration, disappearance, and allergic reactions. These problems occurring during the diagnosis of markers are expected to hinder the growth of the market.

Country-wise Insights

What Makes the United States a Lucrative Market for Companies Selling Breast Tissue Markers?

“High Mortality Rates Associated with Invasive Breast Cancer”

The United States accounted for 31.9% share of the global breast tissue markers market in 2022.

Breast cancer diagnostics have increased in the United States due to the high frequency of breast cancer. This has attracted several players to actively participate in this market.

• According to Breastcancer.org statistics for 2022, in the United States, breast cancer accounts for nearly 30% of the new cancer cases in females. About 1 in every 8 females is expected to develop invasive breast cancer in their lifetime. As of Jan 2022, more than 3.8 million females were suffering from breast cancer in the United States.

There has been tremendous growth in the adoption of diagnostic and screening practices in the United States.

• As per the National Breast Cancer Coalition 2022, between 1980 and 2000, there was a 400% increase in the diagnosis of ductal carcinoma in situ (DCIS) among women aged 20 to 49, while those over 50 years experienced a 900% increase in diagnosis rate. The number of females suffering from metastatic breast cancer is foreseen to increase from 140,230 in 2018 to 169,347 by the end of 2025.

What is the Demand Projection for Breast Tissue Markers in Germany?

“Growing Adoption of Screening Procedures Due to Increasing Cancer Prevalence”

Germany accounted for a 6.6% share of the global market in 2022.

• Breast cancer is the most common type of cancer in Germany, accounting for 11.1% of all malignancies, according to Globocan 2020. Breast cancer affected 67,697 females in 2020.

Breast cancer among females is highly prevalent in Germany, adding significantly to the economic cost of burden. Medication, inpatient care, and productivity losses add largely to this economic burden.

• As per the research article published in Frontiers Public Health 2022, In 2015, the cost of breast cancer (BC) to healthcare systems, payers, patients, and society was approximately US$ 2.41 billion, surpassing the cost associated with lung cancer. Further, the research stated that 90% of women, if detected at an earlier stage, can survive for at least 5 years.

Screening procedures have significantly helped reduce the incidence of late-stage breast cancer in Germany. Screening for early detection has the potential to save lives. However, there is still space for improvement, as a considerable proportion of new breast cancer patients are still diagnosed in advanced stages. This makes Germany a prominent market for players looking out for opportunities in the breast tissue markers market.

How is the Market for Breast Tissue Markers Shaping Up in China?

“Increasing Government Initiatives Targeting Cancer Prevention and Frequent Mass Screening”

China held 5.8% share of the global market in the year 2022. Breast cancer is a highly prevalent disease affecting women's health, with comprehensive treatment options resulting in excellent outcomes.

Chinese guidelines aim to standardize clinical practice, ensure medical service quality, and improve patient survival. Tumor markers like CA15-3 and CEA are used for monitoring metastatic breast cancer but are low in sensitivity and specificity.

For normal-risk women, monthly self-examination, clinical examination, and mass screening are recommended, followed by blood tests and tumor markers every 6 months for the first 3 years and annually after. The government’s intervention with frequent mass screening is likely to increase the demand for breast tissue markers in China.

Category-wise Insights

Which Product is Most Widely Adopted for Breast Cancer Diagnosis?

“Key Role of Metallic Markers in Efficiently Localizing Lesions and Improve MRI-guided Biopsy Outcomes”

Metal breast tissue markers occupied 73% share of the global market in 2022.

Breast tissue markers can be categorized into commercial metallic markers or non-metallic ones. During a biopsy, a metallic biopsy marker is deployed to localize lesions on conventional imaging, such as mammography and sonography. Most biopsy markers are made up of stainless steel or titanium alloys and are employed in breast biopsy to identify the area where the breast tissue was removed.

Conventional MRI cannot distinguish titanium biopsy markers from surrounding air due to high magnetic susceptibility. Post-procedure mammograms are routinely obtained to confirm successful deployment and proper positioning. However, MRI-guided breast biopsy techniques or multispectral MRI (MSI) can now accurately identify metallic biopsy markers. This eliminates the need for a post-procedure mammogram.

Why Do Coil-shaped Markers Account for Higher Sales?

“Accurate Reporting and Consistent Imaging Capabilities of Coil-shaped Markers”

Coil-shape markers held 35.7% share of overall product sales in 2022.

Biopsy markers like M-clip, X-clip, coil, heart, ribbon, and Venus-shaped are compatible with stereotactic and ultrasound-guided core biopsy. Accurate reporting is crucial to preventing mistakes. In MRI, a small radiofrequency coil regulates interventional device location. The active marker demonstrates consistent performance during measurements, and conventional diagnostic breast coils are used for image capture. These advantages make the coil shape predominant in breast tissue diagnosis.

Which Material is Extensively Used for Producing Breast Tissue Markers?

“Biodegradable Soft Tissue Biopsy Clips with Contrast Agents Enabling Efficient Noninvasive Monitoring of Polymer Degradation”

By material, the biodegradable segment occupied 65.6% market share in 2022.

Biodegradable soft tissue biopsy clips have been developed as implants for visual markers of breast tumor growth. These multidimensional markers are made from biodegradable polymers and contain contrast agents like iodixanol or barium sulfate. A preliminary in vitro and short-term in vivo study evaluated the visibility, shape, and degradation of the biodegradable implants containing Lipiodol, allowing noninvasive monitoring of polymer degradation.

Which End User Accounts for High Utilization of Breast Tissue Markers?

“Specialized Infrastructure and Comprehensive Healthcare Services in Hospitals Driving Extensive Adoption of Breast Tissue Markers”

By end user, hospitals accounted for 59.4% share of the global market in 2022.

Hospitals are well-equipped with specialized infrastructure and facilities required for breast tissue marker procedures. They have dedicated pathology laboratories, imaging centers, and skilled healthcare professionals who can perform the necessary diagnostic procedures and interpret the results. They offer comprehensive healthcare services, including breast cancer screening, diagnosis, treatment, and follow-up care.

This integrated approach allows for seamless coordination between different departments and ensures that patients receive holistic and efficient healthcare. Hence, hospital settings are the preferred end user in the breast tissue markers market.

Competition Landscape

The industry for breast tissue markers is highly fragmented, with multiple competitors offering products and services on a local level. To address the expectations of patients and strengthen their consumer base, these companies employ techniques such as increased research and development activities, product launches, and mergers.

• In May 2023, Molli Surgical, a Toronto-based company, developed Molli 2 and Re.markable magnetic surgical markers, enabling precise placement of the Molli Marker for up to 30 days under FDA 510(k) clearance.
• In April 2023, Alleima acquired Endosmart, a pioneer in the use of nitinol in medical equipment, which aids in breast cancer therapy by shortening adhesion time and avoiding the risk of marker migration.

Similarly, the team at Persistence Market Research has tracked recent developments related to companies manufacturing breast tissue markers, which are available in the full report.

Breast Tissue Markers Industry Report Scope

Key Segments of Breast Tissue Markers Industry Research

Product:

• Metal
  • Titanium Breast Tissue Markers
  • Stainless Steel Breast Tissue Markers
  • Nickel Breast Tissue Markers
• Non-metal
  • Ceramic Breast Tissue Markers
  • Zirconium Oxide Breast Tissue Markers

Shape:

• Coil
• Ribbon
• Butterfly
• V-Shape
• Others

Material:

• Biodegradable
• Non-biodegradable

End User:

• Hospitals
• Ambulatory Surgical Centers
• Cancer Research Centers
• Diagnostic Centers

Region:

• North America
• Latin America
• Europe
• South Asia
• East Asia
• Oceania
• Middle East and Africa

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About Author

Anu Jamwal

Senior Consultant

Anu is a Senior Consultant with over a decade of experience and has developed deep expertise in clinical diagnostics, biotechnology, animal health, healthcare IT, and pharmaceuticals, including pipeline assessment. She has authored comprehensive reports providing both global and regional competitive intelligence. She has also successfully led consulting assignments focused on business strategies, product launches, and medical census studies.

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