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Breast Cancer Liquid Biopsy Market - Growth, Trends, COVID-19 Impact, and Forecasts (2021 - 2026)
The Breast Cancer Liquid Biopsy Market is poised to grow at a CAGR of 14.5% by 2026.
The COVID-19 pandemic is expected to have a negative effect on market growth. The pandemic had brought several adverse impacts on breast cancer biopsy services. Hospitals, clinics, and diagnostic centers were unable to provide biopsy services, due to lockdown situations across some countries to prevent the spread of COVID-19. In a study conducted in the United Kingdom and published in The Lancet Oncology in March 2021, the consequences of delayed diagnosis of cancer due to COVID-19 were researched upon. Data from over 100,000 patients with breast, colorectal, esophageal, or lung cancer were evaluated in the study. The study showed that 1 and 5-year survival rates due to cancer will significantly reduce due to the pandemic because of the lack of access to screening services. Thus, as lockdowns drag on, and screening services get affected, survivability due to cancer will decrease.
Increase in regulatory approvals are 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.
For the detection of breast cancer, traditional methods like tissue biopsies are not comprehensive enough to predict or capture the entire genomics landscape of breast tumors. Liquid biopsy as an alternative method for the detection of breast cancer, allows for many clinical applications, that include screening, therapy selection, detection of mutations, disease prognosis and drug response and resistance in patients who are unable to undergo an invasive tumor biopsy. Liquid biopsies provide unique benefits as compared with other genetic testing methods, such as collecting samples with tumor biopsies. Collecting samples from the blood is a comparatively less invasive procedure and can provide a better understanding of cancer. Usually, taking a biopsy from one side of a tumor, rather than the other, may impact the accuracy of the results, which does not happen with liquid biopsies. Additionally, a major advantage of liquid biopsy involves the possibility to detect a tumor smaller than the ones detectable by traditional screening based on imaging techniques. In fact, liquid biopsy can analyze cancer DNA, not its mass, enabling earlier tumor diagnosis.
One of the major factors leading to market growth is the global increase in breast cancer cases. According to World Health Organization (WHO), across the globe, breast cancer is the most frequent type of cancer among women. Approximately 2.1 million women suffer from breast cancer every year, and it leads to highest number of cancer-related deaths among women. In the year 2018, it was estimated that approximately 627,000 women died from breast cancer which represented nearly 15% of all cancer deaths among women globally. According to Breast Cancer Care WA Incorporated, it was estimated that in 2019, 19,371 Australian women were diagnosed with breast cancer or approximately 53 each day, which accounts for approximately 14% of all new cancer cases diagnosed. Furthermore, according to Cancer Research UK, breast cancer is the most common cancer in the United Kingdom, accounting for 15% of all the new cancer cases. High prevalence of breast cancer and increasing demand for better minimally invasive therapies are the major driving factors in the breast cancer liquid biopsy market.
Circulating Cell-free DNA (cfDNA) Segment is Expected to Hold a Major Market Share in the Breast Cancer Liquid Biopsy Market
Circulating cell-free DNA (cfDNA) in plasma offers a non-invasive approach to monitor tumor molecular profiling in real-time at multiple time-points, detection of emerging genomic alterations associated with drug resistance, and clarifying cancer prognosis and diagnosis of cancer recurrence or progression. There are many companies that offer cfDNA based products for use in research purposes. For example, Hilden, Germany-based Qiagen offers the QIAamp circulating nucleic acid kit that is used in a column-based method to isolate cfDNA from plasma and serum. Genomics For Life Pty Ltd is a Queensland, Australia-based company that offers genetic testing for cfDNA from blood samples. It is a major private-sector company that provides cfDNA-based testing services in Australia.
According to the World Health Organization (WHO), in the year 2018, it was estimated that approximately 627,000 women died from breast cancer that is nearly 15% of all cancer deaths among women globally. Due to technological advancements in breast cancer liquid biopsy, the circulating cell-free DNA segment is anticipated to show significant development. Bio-Rad Laboratories Inc offers the 'QX200 Droplet Digital PCR (ddPCR)' system which provides absolute quantification of target DNA or RNA molecules for EvaGreen or probe-based digital PCR applications. In addition, the recent innovations leading to the introduction of better and more sensitive screening techniques (like ddPCR), has permitted the quantification and detection of low abundance targets in shorter times without requiring large numbers of replicates. This has established ddPCR as a tool of choice for liquid biopsies which is being utilized fir breast cancer diagnosis. These developments are expected to fuel market growth during the forecast period.
North America is Expected to Hold a Significant Share in the Market and Expected to do Same in the Forecast Period
The North America region is expected to hold a major market share in the global breast cancer liquid biopsy market. This is primarily due to rising incidences of breast cancer and the growing demand for non-invasive treatment in this region.
According to the National Breast Cancer Foundation of the United States, in the year 2019, 62% of breast cancer cases were diagnosed at a localized stage. Female breast cancer represented approximately 15.2% of all new cancer cases in the United States. In the United States, Biocept, a molecular oncology diagnostics company, offers advanced methods for detecting circulating cancer cells (CTCs) and oncogene mutation fragments (ctDNA) in the blood. This allows CLIA-certified and CAP-accredited laboratories to perform predictive biomarker testing and provide the most up-to-date biomarker status from a non-invasive patient blood sample in breast cancer diagnosis, opening up opportunities in breast cancer liquid biopsy.
In July 2020, a group led by Canada-based Canexia Health launched a USD 1.9 million liquid biopsy screening initiative that aimed to improve access to testing and treatment options for Canadian cancer patients during the coronavirus pandemic. Initiatives like these are expected to affect market development in a positive manner.
Furthermore, the high adoption rates of advanced diagnostic technologies such as PCR and NGS among healthcare professionals and presence of well-established healthcare infrastructure is fueling the growth of the overall regional market to a large extent.
The Breast Cancer Liquid Biopsy Market is slightly fragmented and competitive and consists of several major players. In terms of market share, few of the major players are currently dominating the market. Some of the companies which are currently dominating the market are QIAGEN, F. Hoffmann-La Roche Ltd, Bio-Rad Laboratories Inc, Janssen Diagnostics, Biocept Inc, Guardant Health, Inc, Myriad Genetics, Adaptive Biotechnologies, Epic Sciences, Fluxion Biosciences, Inc., Biodesix and Illumina, Inc.