Breast Cancer Liquid Biopsy Testing Devices Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Offerings (Assay & Reagents Kits, Instruments), By Circulating Biomarker (Circulating Tumor DNA, Circulating Tumor Cell, Extracellular Vesicles), By Application (Cancer Applications, Non-Cancer Applications), By Region & Competition, 2020-2030F

Market Overview

Global Breast Cancer Liquid Biopsy Testing Devices Market was valued at USD 835.36 million in 2024 and is anticipated to project impressive growth in the forecast period with a CAGR of 17.20% through 2030. Liquid biopsy serves as a valuable asset in the realm of breast cancer diagnosis and treatment. The analysis of mutations through liquid biopsy aids in the identification of targeted therapies tailored to individual patients based on their tumor-specific genetic alterations. To illustrate, in the case of patients grappling with metastatic breast cancer, screening for the PIK3CA mutation, which is found in around 40% of HR-positive tumors, assists in determining the most effective treatment path. For instance, according to the American Society of Cancer (ASC) Report 2023, breast cancer remains the most common cancer among women in the United States, excluding skin cancers. It accounts for 30% of all female cancers diagnosed annually. In an effort to reduce the prevalence and mortality rates of breast cancer, the government has implemented policies and introduced laws to support patients with the costs of diagnosis and treatment. Also, according to the World Health Organization 2023 report, more than 2.3 million cases of breast cancer are diagnosed annually, making it the most prevalent cancer among adults. However, approximately 80% of breast cancer-related deaths occur in low- and middle-income countries.

Key Market Drivers

Advancements in Cancer Detection Technology

The landscape of cancer detection and diagnosis is evolving rapidly, and one area of remarkable progress is the development of liquid biopsy testing devices. These devices, which have gained prominence in the healthcare industry, are offering a non-invasive, highly sensitive, and patient-friendly approach to detect and monitor cancer, with breast cancer being a significant focus.

One of the keyways advancements in cancer detection technology are boosting the growth of the global breast cancer liquid biopsy market is by enhancing sensitivity and specificity. Liquid biopsies can now detect minute traces of circulating tumor DNA (ctDNA) or other biomarkers in a patient's bloodstream. This increased sensitivity ensures that even small tumors or minimal residual disease (MRD) can be detected accurately, which was often challenging with traditional diagnostic methods.

Advancements in technology have significantly improved the early detection of breast cancer. Liquid biopsy testing devices are capable of identifying genetic alterations in a patient's tumor at a much earlier stage. This allows for timely intervention, resulting in more effective treatment outcomes. The precision offered by liquid biopsies, by identifying specific mutations and biomarkers, enables tailored and targeted treatment strategies, minimizing adverse effects and maximizing therapeutic benefits.

Traditional breast cancer diagnostic methods often involve invasive procedures, such as tissue biopsies, which can be painful, risky, and have longer recovery times. Liquid biopsy testing, on the other hand, is a minimally invasive approach that only requires a blood sample. Patients find this approach far more comfortable and are more likely to opt for regular monitoring and follow-up. This patient-centric approach is instrumental in driving the growth of liquid biopsy testing devices.

Cancer is a dynamic disease that may evolve over time, and monitoring the effectiveness of treatment is crucial. Liquid biopsy testing devices are not only instrumental in diagnosis but also in monitoring how the tumor responds to treatment. By analyzing changes in ctDNA and other biomarkers during the course of therapy, healthcare professionals can adjust treatment regimens, ensuring optimal patient outcomes.

Minimal residual disease (MRD) refers to the small number of cancer cells that may remain in the body after initial treatment. Detecting MRD early is essential for long-term management. Liquid biopsy technology holds great promise in this regard, as it can track the presence of circulating tumor DNA even when other diagnostic methods may show no sign of cancer. This is particularly important in breast cancer, as it allows for a more proactive approach to treatment and prevention of relapse.

Advancements in cancer detection technology continue to open doors for innovation in liquid biopsy devices. Researchers and manufacturers are investing in the development of new, more precise, and cost-effective testing devices, expanding the range of applications for liquid biopsy technology. As these devices become more accessible and affordable, their adoption in clinical practice is expected to rise, further propelling market growth.

Minimal Residual Disease (MRD) Monitoring

In the quest to combat breast cancer, healthcare professionals and researchers are continually seeking innovative methods to enhance early diagnosis and treatment efficacy. One groundbreaking development is the utilization of Minimal Residual Disease (MRD) monitoring through liquid biopsy testing devices. This approach is poised to play a pivotal role in driving the growth of the global breast cancer liquid biopsy testing devices market.

Conventional methods for breast cancer diagnosis and monitoring often involve tissue biopsies and imaging studies. While these methods are effective to some extent, they may not detect the presence of residual cancer cells, especially at very early stages of the disease or after initial treatment. MRD monitoring, on the other hand, focuses on identifying the presence of cancer at the cellular level, providing a more precise and comprehensive understanding of the disease progression. As more clinicians recognize the value of MRD monitoring, the demand for liquid biopsy testing devices is on the rise.

MRD monitoring, enabled by liquid biopsy testing devices, allows for the early detection of cancer cells that may remain in the body after initial treatment. Detecting MRD at its inception is critical for timely intervention and the adjustment of treatment regimens. By identifying MRD, healthcare professionals can implement treatment modifications that are tailored to the specific genetic characteristics of the remaining cancer cells, ultimately improving patient outcomes.

One of the key drivers for the growth of the breast cancer liquid biopsy testing devices market is the shift towards personalized treatment. MRD monitoring facilitates personalized medicine by providing insights into the genetic mutations and alterations present in residual cancer cells. This information empowers clinicians to select the most appropriate and effective targeted therapies, minimizing the risk of ineffective treatments and their associated side effects.

Regular MRD monitoring through liquid biopsy devices also aids in assessing the response to ongoing treatment. Clinicians can track changes in the levels of circulating tumor DNA (ctDNA) and other biomarkers, allowing them to make informed decisions regarding treatment adjustments. This dynamic approach to patient care ensures that the therapy remains effective and is customized to the patient's evolving needs.

The ability to detect MRD early not only improves treatment outcomes but also holds the potential for relapse prevention. By identifying and addressing residual cancer cells promptly, clinicians can work towards preventing the recurrence of breast cancer. This proactive approach significantly enhances the quality of life for patients and can reduce the economic burden associated with recurrent cancer treatment.

Growing Incidence of Breast Cancer

Breast cancer remains a global health concern with significant impacts on patients, families, and healthcare systems. The growing incidence of this disease has put an increasing burden on healthcare providers to develop more efficient and less invasive diagnostic and monitoring methods. One significant response to this challenge is the development of Breast Cancer Liquid Biopsy Testing Devices. For instance, according to the NIH Report 2021, the mortality rates among women with breast cancer are notably higher in South Asia and Sub-Saharan Africa. Countries in South Asia allocate between 0.05% to 0.08% of their GDP annually to combat breast cancer. This economic burden could be alleviated through the use of cost-effective diagnostic procedures, such as needle-based techniques. For example, fine needle aspiration and core needle aspiration are among the most common diagnostic practices in pathology centers across Sub-Saharan African countries, as highlighted in a 2021 NIH report study.

Breast cancer is the most frequently diagnosed cancer among women worldwide, and it is a leading cause of cancer-related deaths. As the global population continues to grow and age, the incidence of breast cancer is on the rise. This increase in disease prevalence results in an expanding pool of patients who require regular diagnostic and monitoring services.

The prognosis and success of breast cancer treatment are closely linked to early detection. Patients who are diagnosed at an earlier stage of the disease generally have a wider range of treatment options and better survival rates. Liquid biopsy testing devices offer a less invasive means of detecting breast cancer, making early diagnosis more accessible to a larger population. This capacity to identify breast cancer at an earlier stage drives the demand for these devices, ultimately boosting the market. For instance, in early 2022, about 287,850 new cases of invasive breast cancer were diagnosed in women in the US, along with 51,400 new cases of non-invasive breast cancer.

Traditional methods for breast cancer diagnosis often involve invasive procedures such as tissue biopsies, which can be painful, stressful, and associated with certain risks. Liquid biopsy testing devices, however, require only a blood sample, making the process far less distressing for patients. The minimally invasive nature of liquid biopsy testing devices aligns with patient preferences and contributes to their increasing adoption.

As the number of breast cancer survivors grows, the need for ongoing monitoring and follow-up becomes critical. Liquid biopsy testing devices not only facilitate diagnosis but also enable regular monitoring of treatment effectiveness and the detection of minimal residual disease (MRD). This capability allows healthcare providers to intervene promptly if the cancer recurs or progresses, ultimately improving patient outcomes.

The rising incidence of breast cancer has spurred research and development efforts to enhance the sensitivity and accuracy of liquid biopsy testing devices. Researchers and manufacturers are continually working to improve technology, expand the range of applications, and reduce costs. As a result, the market for these devices is continuously evolving and expanding.

The global healthcare industry is witnessing increased collaborations among healthcare providers, research institutions, pharmaceutical companies, and diagnostic device manufacturers. These collaborations are vital for advancing the development and adoption of liquid biopsy testing devices. As breast cancer incidence continues to rise, the need for such collaborations becomes more pronounced, benefiting both patients and the growth of the market.

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Key Market Challenges

Limited Sensitivity and Specificity

While liquid biopsy testing devices have advanced considerably, they may still face challenges related to sensitivity and specificity. Detecting circulating tumor DNA (ctDNA) or other biomarkers in the bloodstream can be challenging, especially for small or early-stage tumors. Improving the sensitivity and specificity of these tests remains a priority for the industry.

Integration into Clinical Practice

Adopting new diagnostic methods often requires changes in clinical practice, which can be met with resistance. Healthcare professionals may need additional training to effectively use liquid biopsy testing devices, and hospitals may need to invest in the infrastructure to support these tests. Integrating liquid biopsy into standard clinical practices is a challenge that requires time and effort.

Regulatory Approvals

Achieving regulatory approval for new liquid biopsy tests can be a lengthy and expensive process. The industry must navigate complex regulatory pathways in different countries and regions. Ensuring that liquid biopsy tests comply with various regulatory requirements while maintaining a focus on patient safety is a continuous challenge.

Key Market Trends

Integration with Conventional Diagnostics

The trend is moving towards the integration of liquid biopsy testing devices with traditional diagnostic methods. Combining liquid biopsies with imaging and tissue biopsies can provide a more comprehensive understanding of the disease. This integrated approach offers greater diagnostic accuracy and opens up new avenues for treatment decisions.

Ethical and Data Privacy Considerations

With the collection and analysis of genetic data, there is a growing focus on ethical and data privacy concerns. Ensuring the secure handling of patients' genetic information is a trend that will continue to gain attention. The development of strict data protection measures is crucial to address these concerns.

Expanding Clinical Utility

The clinical utility of liquid biopsy testing devices is expanding. Beyond diagnosis and monitoring, these tests are being explored for applications such as treatment response assessment, predicting disease recurrence, and monitoring treatment resistance. These extended applications are expected to gain prominence in the coming years.

Segmental Insights

Offerings Insights

Based on the category of Offerings, the Instruments was poised to capture a substantial market share in the Global Breast Cancer Liquid Biopsy Testing Devices Market during the forecast period due to several key factors. Firstly, the company's innovative and cutting-edge technology in liquid biopsy testing has established it as a frontrunner in the industry. Their commitment to research and development ensures that their products remain at the forefront of technological advancements. The Instruments' strategic partnerships with leading healthcare institutions and its strong distribution network have extended its market reach. This, combined with a reputation for delivering accurate and reliable results, fosters trust among healthcare professionals and patients alike. As the global demand for non-invasive and early-stage cancer detection solutions continues to grow, The Instruments is well-positioned to make a significant impact in this dynamic market segment.

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Regional Insights

North America was poised to dominate the Global Breast Cancer Liquid Biopsy Testing Devices Market for several compelling reasons. The region boasts a robust healthcare infrastructure with advanced diagnostic and treatment facilities, and it places a strong emphasis on early cancer detection. This commitment to proactive healthcare is driving the adoption of liquid biopsy technologies for breast cancer screening and monitoring. North America is home to a substantial number of pharmaceutical and biotechnology companies, fostering innovation and investment in liquid biopsy research and development. The presence of regulatory bodies like the FDA ensures that products entering the market meet stringent quality and safety standards, instilling trust in the technology among healthcare professionals and patients. Moreover, the region has a high prevalence of breast cancer cases, prompting increased demand for accurate and less invasive diagnostic solutions. All these factors combined make North America a dominant force in the global breast cancer liquid biopsy market.

Recent Developments

• In February 2022, TeesuVac ApS, a company based in Denmark, launched a new needle biopsy device called TeesuVac Breast Biopsy Device Mark 1. This device is designed to obtain percutaneous core biopsy specimens from soft tissue and tumors in the breast. As a result, the introduction of new products is likely to drive the growth of the breast biopsy needles segment, which is projected to experience significant expansion over the forecast period.

• In August 2022, the FDA approved the Guardant360 CDx (Guardant Health, Inc.), a liquid biopsy test designed to identify advanced or metastatic breast cancer patients with ESR1 mutations. In April 2022, the FDA approved the HydroMARK Breast Biopsy Site Marker (Devicor Medical Products, Inc.), which is used to mark tissue during percutaneous breast biopsy procedures.
• In June 2023, Quest Diagnostics, a leading provider of diagnostic information services, acquired Haystack Oncology. This acquisition expanded Quest Diagnostics' Diagnostics Portfolio with Sensitive MRD Liquid Biopsy Technology, enhancing its capabilities in cancer diagnostics.
• In 2021, the Chinese startup AnchorDx established a partnership with a leading Chinese hospital to co-create a liquid biopsy examination designed for the early identification of breast cancer, relying on circulating cell-free DNA (cfDNA).

Key Market Players

• A Menarini AG
• NeoGenomics Laboratories Inc
• F Hoffmann-La Roche AG
• Myriad Genetics Inc
• QIAGEN NV
• Biocept Inc
• Sysmex Corp
• Fluxion Biosciences Inc
• Thermo Fisher Scientific Inc
• Epic Sciences Inc

Report Scope:

In this report, the Global Breast Cancer Liquid Biopsy Testing Devices Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Breast Cancer Liquid Biopsy Testing Devices Market, By Offerings:

o   Assay & Reagents Kits

o   Instruments

• Breast Cancer Liquid Biopsy Testing Devices Market, By Circulating Biomarker:

o   Circulating Tumor DNA

o   Circulating Tumor Cell

o   Extracellular Vesicles

• Breast Cancer Liquid Biopsy Testing Devices Market, By Application:

o   Cancer Applications

o   Non-Cancer Applications

• Breast Cancer Liquid Biopsy Testing Devices Market, By Region:

o   North America

§  United States

§  Canada

§  Mexico

o   Europe

§  Germany

§  United Kingdom

§  France

§  Italy

§  Spain

o   Asia-Pacific

§  China

§  Japan

§  India

§  Australia

§  South Korea

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

§  Kuwait

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Breast Cancer Liquid Biopsy Testing Devices Market.

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Global Breast Cancer Liquid Biopsy Testing Devices market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).