Breast Cancer Diagnostics Market

Market Overview

The global breast cancer diagnostics market revenue was valued at USD 4,545.12 million in 2022. It is estimated to reach USD 8,215.11 million by 2031, growing at a CAGR of 6.8% over the forecast period (2023–2031). The primary growth driver during the forecast period is anticipated to be the increasing demand for technologically advanced products that offer enhanced precision, faster performance, and improved cost efficiency.

Breast cancer originates from live cells found in the ducts or lobules of the breast glandular tissue. The cancerous growth usually shows no symptoms at first and only affects the duct or lobule. In cases of breast cancer, early detection is crucial for the most effective treatment options. Cancers that have progressed from breast tumors to other parts of the body typically require a combination of radiation treatment, medicine, and surgery to eradicate. The development and spread of cancer can be halted by this treatment, which ultimately saves lives.

The breast cancer market expands in tandem with the development of new treatments, which in turn raises the frequency of the disease among female patients. Modern approaches to the detection of breast cancer using established protocols and enhancing breast cancer diagnostic tools by making them more reliable, faster, more accurate, and more efficient in their results and in their ability to spot diseases.

Market Dynamics

Global Breast Cancer Diagnostics Market Drivers:

Increasing Incidence of Breast Cancer

The most common cancer in the world is breast cancer. According to the American Cancer Society, in 2021, 281,550 new breast cancer cases were diagnosed, and around 49,290 related deaths occurred in the U.S. Similarly, according to the WHO, there were over 2.31 million new cases of breast cancer in 2021, making it the most common cancer worldwide.

Breast cancer, the most common cancer in women, is also on the rise in developing countries, where most cases are discovered much later in the disease's progression. Approximately half of all cases and 58% of fatalities from breast cancer occur in developing countries, contrary to the common misconception that the disease is more common in developed countries. This is expected to stimulate the demand for breast cancer diagnostics from developing economies over the forecast period.

Technological Advancements

Growing demand for technologically advanced products, as they enable accuracy, speed, and cost-effectiveness, is expected to be the dominant growth factor during the forecast period. For instance, Direct-To-Consumer (DTC) testing is one of the fastest-growing breast cancer diagnostics market segments. In 2018, 23and Me introduced the first DTC test after receiving approval for the BRCA test from the U.S. Food and Drug Administration. It was one of the first DTC tests for BRCA gene mutations, known to boost the risk of breast and ovarian cancers.

Additionally, introducing 3D mammography or digital breast tomosynthesis, which is more accurate than 2D mammography, can further support market growth. This advanced technology can detect 40% more cancers than 2D mammograms and reduce patient recalls. In the upcoming years, rapid technological advancements are expected to propel the breast cancer diagnostics market.

Global Breast Cancer Diagnostics Market Restraint:

Adverse Effects of Screening Procedures

Numerous screening processes, such as endoscopy and imaging, can examine breast cancer at an early stage. However, there are particular risk factors associated with these imaging procedures. Radiation exposure and the use of high doses of fluorescent and barium contrast agents are two of the risks associated with imaging and endoscopic procedures. These agents can cause nausea, diarrhea, and other side effects. Such screening methods may be constrained by the dangers of ionizing radiation exposure from CT, MRI, and X-rays, as well as from the use of radioactive tracer injections in PET. These imaging tests can pose a risk to patients with implants, surgical clips, metallic chips, and foreign materials. Patients implanted with pacemakers cannot be scanned using MRI. The cost of breast cancer tests is also relatively high. Therefore, factors like high costs and adverse imaging effects could hinder market growth over the forecast period.

Global Breast Cancer Diagnostics Market Opportunities:

Early Detection and Increasing Awareness of Breast Cancer

Early detection is key for effective management of breast cancer. It can enhance life quality, offer a variety of therapeutic alternatives, and boost survival. A 2018 Research Fast Facts article states that routine screening and early mammography detection can reduce the incidence of breast cancer by 30%. Meanwhile, research being done to create tests for early breast cancer detection should accelerate market expansion. For instance, in November 2019, researchers at the University of Nottingham conducted a study to develop a blood test that detects breast cancer five years before its occurrence. The study used screening technology to rapidly screen blood samples to examine the presence of antibodies against 40 Tumor-associated Antigens (TAAs).

Furthermore, increasing breast cancer awareness is estimated to propel the market for diagnostic and prognostic tools. For instance, several countries marked October as Breast Cancer Awareness Month. Moreover, these organizations conduct free diagnostic tests for breast cancer, which is expected to fuel market growth. For instance, National Breast Cancer Foundation, Inc. conducts the National Mammography Program to provide free mammograms and other diagnostic services for breast cancer.

Regional Analysis

North America Dominates the Global Market

Region-wise, the global breast cancer diagnostics market is segmented into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.

North America is the most significant global breast cancer diagnostics market shareholder and is estimated to exhibit a CAGR of 6.71% during the forecast period. Increasing awareness about breast cancer and highly established healthcare infrastructure are among the key factors contributing to market growth. Rising demand for genomic tests in personalized healthcare for diseases like cancer is also expected to drive market growth. Currently, breast cancer diagnostics are the fastest growing market in the region. Moreover, blood testing and genomic tests are growing markets in North America and are anticipated to show a lucrative growth rate over the forecast period. Advanced diagnostic tests available in the region can provide better sensitivity, specificity, and accuracy, rapidly increasing demand.

Europe is estimated to exhibit a CAGR of 6.3% during the forecast period. The increasing prominence of breast cancer, coupled with growing investments in R&D for diagnostics, is expected to drive the European market. According to The European Breast Cancer Coalition, in the WHO European region and EU-28, the estimated incidence of breast cancer in 2018 was 562,500 and 404,920, respectively, whereas mortality was 150,700 and 98,735, respectively. About 1 in 8 women aged 85 and below is predicted to develop breast cancer in their lifetime. Moreover, factors supporting the growing incidence rate of breast cancer are also rising. For instance, obesity is responsible for ~33% of breast cancer cases. EU countries experience an overall rate of 10% to 30% for obesity, which is anticipated to increase the target population for breast cancer diagnostics in the coming years.

Asia-Pacific is estimated to expand at the fastest CAGR during the forecast period. Clinicians use diagnostic techniques like imaging and biopsy to diagnose breast cancer at a nascent stage. Techniques like genomic tests are used to understand the genetic makeup of patients. In some of the more developed economies from the Asia-Pacific, hospitals receive reimbursement from the government for diagnostic tests. On the other hand, underdeveloped economies provide very little to no reimbursement, making patients accountable for the financial burden of treatments. However, these countries are expected to develop their guidelines over the forecast period. A sizable target market, better healthcare reimbursement policies, and a high level of unmet clinical needs are anticipated to present manufacturers with a promising growth platform in this area.

Moreover, rapid growth in the demand for personalized therapy has encouraged significant market players to sell novel companion diagnostic products in the region. Populations and disposable incomes are rising in developing nations like China and India. This region also has a high cancer incidence rate, which has raised demand for better diagnostics. These factors are expected to drive the Asia-Pacific market over the forecast period.

Latin America is expected to grow at a significant rate during the forecast period. Major factors anticipated to drive regional market growth over the forecast period include a rise in breast cancer incidence and rapid economic development, particularly in Mexico. Nonetheless, innovations in technology are anticipated to fuel market expansion. Moreover, the market is expected to be driven by higher government spending, an abundance of qualified healthcare professionals, a greater emphasis on untapped markets by multinational diagnostics companies, and an uptick in patient awareness during the forecast period.

Segmental Analysis

The global breast cancer diagnostics market has been bifurcated into products, types, and applications. 

Based on type, the global breast cancer diagnostics market is segmented into imaging, biopsy, genomic tests, blood tests, and others. 

The imaging segment dominates the global market and is estimated to exhibit a CAGR of 6.01% during the forecast period. The imaging segment accounted for a significant market share due to a large volume of procedures, easy accessibility, and enhanced effectiveness. The most common imaging procedures for breast cancer diagnosis are mammograms, ultrasounds, and MRIs. Similarly, many advanced imaging techniques, such as Molecular Breast Imaging (MBI), CT, 3D breast tomosynthesis, and PET, are expected to change the landscape of breast imaging. In January 2019, the U.S. subsidiary of Fujifilm Holdings Corporation, FUJIFILM Medical Systems U.S.A., Inc., introduced its Tomosynthesis Biopsy option for the ASPIRE Cristalle mammography system. This technique is expected to enable physicians to detect breast cancers more efficiently than others by providing an enhanced 3D image and a digital mammogram.

Moreover, the various screening programs that are in place for breast cancer diagnosis in various countries are also expected to boost the demand for mammography equipment. For instance, as per the United States Preventive Services Task Force (USPSTF), women between 50 and 74 years are at a higher risk of developing breast cancer. Therefore, USPSTF recommends that women above 40 undergo mammography every two years.

Based on application, the global breast cancer diagnostics market is segmented into screening, diagnostics and predictive, prognostic, and research. 

The diagnostics and predictive segment owns the highest market share and is anticipated to exhibit a CAGR of 6.9% during the forecast period. Diagnosis of breast cancer involves finding a lump in the breast after screening mammography, which displays abnormalities, followed by confirmatory procedures such as biopsy (of any type). The diagnostic stage is usually the second stage after screening. Diagnostic tests, such as biopsy, MRI, CT, and PET, are prescribed in women suspected of having breast cancer due to positive screening results or symptoms. These tests determine the presence of breast cancer and the proliferation of tumor cells. These tests are also useful for gathering information to guide decisions about the treatment.

Furthermore, the predictive application usually involves genetic testing to predict the chances of acquiring breast cancer. This is usually done for women with a strong history or family lineage of breast cancer to analyze the associated risks. As per the American Journal of Physiology-Cell Physiology in 2020, technological advancements have made predictive diagnosis highly trustworthy. Moreover, detecting predictive biomarkers like HER-2/neu makes the prediction more accurate, going slightly over 90%. Thus, the reliability of predictive and diagnostic tests drives segment growth.

Based on product, the global breast cancer diagnostics market has been further segmented into platform- and instrument-based products. 

The instrument-based products segment dominates the global market and is expected to exhibit a CAGR of 6.1% during the forecast period. It is further segmented into biopsy and imaging. These are some of the most used techniques and products for diagnosing breast cancer. Numerous organizations, including the National Breast Cancer Foundation, Inc., are launching campaigns to raise public awareness of breast cancer, the benefits of early detection, and the range of treatment options. When it comes to screening patients for breast cancer in the general population, imaging is the preferred method. Biopsy is an invasive procedure, whereas imaging is noninvasive. One confirmatory test for the diagnosis of breast cancer is a biopsy. Moreover, the involvement of major players, such as BD, Hologic, and Danaher, who are continuously trying to bring new products into the market, is expected to propel market growth.

Recent Developments

• December 2023– Gentle Scan Health, LP, a venture capital firm that is committed to promoting better breast imaging options, and Koning Health, the market leader in breast CT technology, announced their strategic alliance. In 2024, the first three installations of the twenty-plus state-of-the-art Koning Vera Breast CT devices will be held in Southern California, Atlanta, and Metropolitan New York City. The goal of this partnership is to transform breast cancer imaging nationwide.