Breast cancer is the most common cancer in women worldwide and is the second most common type of cancer. It is one of the leading cause of cancer deaths in less developed countries and the second most leading cause of cancer deaths in women that exceeds only by lung cancer.

According to the Breast Cancer Research Foundation, in 2018, nearly 2 million new cases of breast cancer were diagnosed worldwide. In addition, breast cancer is the most frequently diagnosed cancer among women in 140 of 184 countries globally. Breast cancer in men is rare accounting for less than 1% of breast cancer cases in the US. The death rate for male breast cancer is less over the year’s worldwide.

Market Insights

In December 2020, the United States Food & Drug Administration (USFDA) approved the targeted therapy “Margenza (chemical name:margetuximab-cmkb)” in combination with chemotherapy to treat people diagnosed with metastatic HER2-positive breast cancer.

In June 29, 2020, USFDA approved “Phesgo”—a combination of “pertuzumab”, “trastuzumab” and “hyaluronidase–zzxf”. It is administered via injection under the skin to treat adult patients with HER2-positive breast cancer that has spread to other parts of the body, and for the treatment of adult patients with early HER2-positive breast cancer.

What’s New in Breast Cancer Research?

Some human epidermal growth factor receptor 2 (HER-2) breast cancer patients do not respond or become resistant to current treatment. As per the Clinical Trials, DS-8201a is a new experimental product that is used as a combination of an antibody and a drug. Currently, it is under Phase-2 Clinical trials. The pharmacological applications involve slowing down tumor growth that might improve the patient outcomes. As per the records, actual study start date was August 25, 2017 and estimated study completion date is March 31, 2021.

Market Dynamics

Surge in demand for technologically advanced products rendered with cost-effectiveness, accuracy, and speed likely to gain traction among the Patient Base

Digital Breast Tomosynthesis (DBT) has grabbed a strong attention for the breast cancer screening. DBT sometimes referred as 3D mammography played a vital role in detecting cancers in women of all age groups. Also, DBT proves better as compared to screening process while detecting cancers in women with high breast density that makes screening process complicated. DBT received approval from FDA in 2011. As per the statistics released by Harvard Medical Schools, more than 50,000 breast screenings are performed with DBT and 129,369 performed with digital mammography that represents 96,000 women (average age 54 to 56) from 2011 to 2014.  DBT perform more efficiently than digital mammography and is better technique when it comes to finding small cancers.

Rising insurance coverage and reimbursement policies by the government for breast cancer diagnostic market

American Cancer Society released state and federal policymakers that address cancer patient cost. This is done by ensuring cancer patients, survivors, and those at risk for cancer has complete access to health insurance that is adequate, available, affordable, and easy to understand. As per the 2017 data released by the organization is insurance plan limit is US$ 7,150 for individual plan and US$ 14,300 for a family plan.

Rising awareness among the patient base regarding early detection of breast cancer

According to the American Cancer Society finding breast cancer early and starting state-of-art cancer treatment is the most important strategy to prevent deaths from breast cancer. Getting regular screening tests is the most reliable gateway to detect breast cancer at early stage. The American Cancer Society has released screening guidelines for women suffering from average risk of breast cancer and for those suffering from high risk of breast cancer. 

Breast Cancer Diagnostic Market: Business Opportunities

Big Calls for “Digitalization”

Hoffmann-La Roche AG announced launching of two AI powered image analysis system that helps with breast cancer detection. The two new automated algorithms namely, “uPath HER2 (4B5) image analysis” and “uPath Dual ISH image analysis”.

The “uPath HER2 (4B5) image analysis” directs pathologists quickly detect positively stained tumors cell membranes with clear visual overview for easy reference. In addition, second algorithm, “uPath HER2 Dual ISH”, helps pathologists to identify cells that need targeting. These two new algorithms were launched in summer 2020. Both new algorithms are ready-to-use and integrated with “Roche uPath enterprise software”.

Rising innovations in clinical medicine and personalized medicine to improve patient outcomes with Triple Negative Breast Cancer-Ongoing Project

Triple Negative Breast Cancer is an aggressive form of breast cancer that is frequently detected in younger women. Due to its aggressive form it spreads to other parts of body quickly. Currently, clinical trials are ongoing for new treatments for such aggressive type of breast cancer for discovering biomarkers and molecular signature that will enhance predicting risk and uplift prognosis and treatment for such fatal disease. There is collaboration between FDA, City of Hope, and the University of Tennessee Health Science Center for this particular project. The collaboration enhances identification of early signaling chances in high-risk women and delivers individualized targeted prevention strategies. In addition, Mammographic CAD device testing computationally inserted microcalcification clusters and masses and Spectral photo acoustic tomography (PAT) for breast tumor oximetry Test method development, in vivo validation, and computational modeling are the pipeline projects for bringing new innovative technique for treatment of breast cancer. 

Segmental Outlook

Breast cancer diagnostic market is based on type. By type, the market is categorized into biopsy, genomic test, imaging, blood test, and others.

Based on type, imaging segment is expected to be a largest revenue segment and will continue its trend in the forthcoming years. Rising screening program, increasing prevalence of breast cancer, and technological advancement acts as driving factors for imaging segment. 

Mammography remains the mainstay of breast imaging this area is substantially increasing with influx of advanced technologies. Technologies such as ultrasound and MRI have foster huge attention for breast imaging practices couple with breast interventional radiology. 

In February 2020, University of Buffalo, announced launching of new breast imaging system to identify breast cancer in women with dense breast tissue. The newly developed imaging system namely, “Dual Scan Mammoscope” combines light and ultrasound technology. The product possesses potential to detect breast cancer at early stage that will help to improve survival rates.

Regional Overview

North America is embossing significant market share for breast cancer diagnostic market from the past and will continue its trend in the coming years. The factors attributed technologically advanced products, fast FDA approvals for the new research and product approvals, presence of active players, and well established diagnostic infrastructure.

In addition, high patient base suffering from breast cancer in the US and other countries residing in North America acts as a key diver for the gaining high popularity for innovations in breast cancer diagnostic market.

According to the Centers for Disease Control and Prevention (CDC) in 2017, in United States 250,520 new cases of female breast cancer were recorded and 42,000 women died of cancer. The accelerated approval by the FDA depends on promising therapies comprising with therapeutic benefits. This factor enhances the capability of approval of medical diagnostic method to treat breast cancer.

On the other hand, Asia Pacific is predicted to be the fastest growing region in the forecast period in the breast cancer diagnostic market. Growing healthcare infrastructure and awareness regarding early diagnosis enhances the regional growth of breast cancer diagnosis market.

Competitive Landscape

Key companies profiled in this report involve Genomic Health, Myriad Genetics, Inc., NanoString Technologies, Inc. Hologic Inc., Koninklijke Philips N.V., Danaher; Becton, Dickinson and Company, C.R. Bard, Inc., and Devicor Medical Products Inc., and among others.

Market Segmentation

Market By Type

Biopsy

Genomic test

Imaging

Blood test

Others

Market By Geography

North America

• U.S.
• Canada

Europe

• U.K.
• Germany
• France
• Spain
• Rest of Europe

Asia-Pacific

• China
• Japan
• India
• Australia
• South Korea
• Rest of Asia-Pacific

Latin America

• Brazil
• Mexico
• Rest of Latin America

Middle East & Africa

• GCC
• South Africa
• Rest of Middle East & Africa