Breast Cancer Liquid Biopsy Testing Devices Market: Current Analysis and Forecast (2023-2030)

Breast Cancer Liquid Biopsy Testing Devices Market: Current Analysis and Forecast (2023-2030)

Liquid biopsy involves extracting and analyzing genetic material from a patient's bodily fluids, such as urine, blood, saliva, or stool, to detect and monitor cancer. Unlike traditional tumor biopsies, which can be invasive and risky, liquid biopsy is less invasive and can provide valuable information about the cancer without the need for a tissue sample. In the context of breast cancer, liquid biopsy involves analyzing blood samples for the presence of cancer cells or specific biomarkers that are indicative of the disease.

The Breast Cancer Liquid Biopsy Testing Devices Market is expected to grow at a strong CAGR of 23% during the forecast period owing to the rising prevalence of breast cancer. According to the American Cancer Society, an estimated 281,550 new cases of invasive breast cancer were diagnosed in women in 2021, along with 49,290 new cases of non-invasive breast cancer. Breast cancer is the most common cancer among women in the UK, with around 55,000 new cases diagnosed each year. The incidence of breast cancer in the UK has increased by around 3% over the last decade.

• Based on the circulating biomarkers, the market is segmented into circulating tumor cells (CTCs), circulating cell-free dna (cfDNA), extracellular vesicles (EVS), and other circulating biomarkers. The cfDNA held a dominant share of the market in 2022. The market dominance is attributed to the non-invasive nature of cfDNA, which makes it possible to diagnose and predict cancer recurrence or progression, detect developing genomic abnormalities that may lead to drug resistance, and monitor tumor molecular changes over time. There are several companies offering cfDNA-based products for use in scientific research, and numerous tests are in development that utilize cfDNA to detect cancer. For instance, in October 2021, Yemaachi Biotech and Lucence announced the launch of a study in Africa to evaluate the use of the Liquid HALLMARK assay for characterizing genomic alterations in African women. This aimed to increase access to liquid biopsy for these patients.
• By application, the market is categorized into early detection/screening, diagnosis, treatment selection, and monitoring. The diagnosis segment is anticipated to grow with a significant CAGR during the forthcoming years. The growth in the breast cancer liquid biopsy market is attributed to its increasing use in breast cancer diagnosis, which has significantly impacted the field of clinical oncology by providing easier monitoring and continuous sampling of tumors. This has resulted in a better approach to early cancer detection. The growth is also attributed to advancements in liquid biopsy technology, which have been facilitated by increasing awareness about non-invasive and safer testing procedures.
• For a better understanding of the market adoption of the breast cancer liquid biopsy testing devices industry, the market is analyzed based on its worldwide presence in the countries such as North America (U.S., Canada, Rest of North America), Europe (Germany, U.K., France, Spain, Italy, Rest of Europe), Asia-Pacific (China, Japan, India, Rest of Asia-Pacific), Rest of World. North America held the dominant share of the market and is expected to do so even in the forecast period. The dominance of the liquid biopsy market can be attributed to rapid technological advancements, the growing adoption of liquid biopsies for treatment selection, and government initiatives. The North America market, led by the U.S., is driven by greater investments and the presence of numerous biotechnology companies developing liquid biopsy tests. Organizations, such as the American Society of Clinical Oncology, are actively supporting the implementation of liquid biopsy, which is expected to contribute to market growth. The increasing availability of liquid biopsy tests in the region is anticipated to increase product adoption. For example, in June 2022, the Johns Hopkins University and Cepheid collaborated to make the GeneXpert system-compatible LBx-BCM test commercially available for research use.
• Some of the major players operating in the market include The Menarini Group; NeoGenomics Laboratories; F. Hoffmann-La Roche Ltd.; Myriad Genetics, Inc.; QIAGEN; Biocept, Inc.; Sysmex Corporation; Fluxion Biosciences, Inc.; Epic Sciences, Inc.; and Thermo Fisher Scientific Inc.

The Breast Cancer Liquid Biopsy Testing Devices market was valued at USD 3265 Million and is expected to grow at a strong CAGR of around 16% during the forecast period (2023-2030). Liquid biopsy is a valuable tool in the diagnosis and treatment of breast cancer. Mutational analysis of liquid biopsy can help identify appropriate targeted therapy for patients based on the specific mutations present in their tumors. For instance, in patients with metastatic breast cancer, testing for the PIK3CA mutation, which is present in approximately 40% of all HR-positive tumors, can aid in determining the most effective course of treatment. Additionally, the detection of minimal residual disease (MRD) through circulating tumor DNA in liquid biopsy holds promising and transformative applications within oncology. Further, an increase in regulatory approvals is expected to have a positive effect on the market. For example, in June 2019, the United States Food and Drug Administration (FDA) provided regulatory approval to QIAGEN's therascreen PIK3CA RGQ PCR Kit. The approval was granted with the device's use as a companion diagnostic assay to detect PIK3CA mutations in breast cancer for both tissue and liquid biopsies.

Some of the major players operating in The Menarini Group; NeoGenomics Laboratories; F. Hoffmann-La Roche Ltd.; Myriad Genetics, Inc.; QIAGEN; Biocept, Inc.; Sysmex Corporation; Fluxion Biosciences, Inc.; Epic Sciences, Inc.; and Thermo Fisher Scientific Inc. Several M&As along with partnerships have been undertaken by these players to facilitate customers with hi-tech and innovative products/technologies.

Insights Presented in the Report

“Amongst circulating biomarkers, the circulating tumor cells segment to grow with high CAGR during the forecast period”

Based on the circulating biomarkers, the market is segmented into circulating tumor cells (CTCs), circulating cell-free DNA (cfDNA), extracellular vesicles (EVS), and other circulating biomarkers. The circulating tumor cells (CTCs) is anticipated to grow with significant CAGR during the forecast period. As CTCs monitoring progresses, their levels can provide insight into the effectiveness of treatments. Recent studies have explored the potential of CTCs as biomarkers for early cancer detection, with higher CTC counts indicating a higher risk of developing cancer. The detection of CTCs in early-stage breast cancer has been a focus of ongoing research, with the FDA-approved CellSearch system being used to isolate CTCs from peripheral blood samples. In recent years, significant advancements have been made in improving the efficiency and accuracy of CTC isolation techniques, providing hope for more accurate detection and monitoring of cancer in the future.

“Amongst application, the treatment selection category held a significant share of the market in 2022”

By application, the market is categorized into early detection/screening, diagnosis, treatment selection, and monitoring. The treatment selection segment held a significant share of the market in 2022 due to the importance of providing early treatment options. Liquid biopsies have emerged as a crucial tool for detecting, characterizing, and managing breast cancer in its early stages, making this clinical setting the most suitable for improving treatment selection and prognosis. For instance, in August 2020, FoundationOne Liquid CDx received FDA approval for its ctDNA-based CGP assay intended to be used in conjunction with other diagnostic tests to help doctors decide which patients will benefit from receiving targeted medicines.

“Asia Pacific to grow with high CAGR during the forecast period”

The Asia Pacific region is expected to experience significant growth over the forecast period due to a combination of factors, including healthcare reforms, improving healthcare infrastructure, a growing population, and the entry of more companies into the market. With a large population and high cancer prevalence, as per Global Cancer Statistics 2020, an estimated 58.3% of cancer deaths occurred in Asia in 2020, making cancer screening a growing priority in the region. As a result, the use of screening tests for cancer has increased in recent years, with governments implementing initiatives such as free breast cancer screening and companies collaborating to increase the distribution and supply of these tests. For example, in 2021, Chinese startup AnchorDx collaborated with a top-tier hospital in China to develop a liquid biopsy test for early detection of breast cancer based on cfDNA.

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