Summary

The Breast Cancer Liquid Biopsy Market size is estimated at USD 0.41 billion in 2024, and is expected to reach USD 1.06 billion by 2029, growing at a CAGR of 21.23% during the forecast period (2024-2029).

The COVID-19 pandemic is expected to have a negative effect on the 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 lockdowns 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 the lockdowns drag on and screening services get affected, survivability due to cancer will decrease.

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.

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 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 compared to 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 is 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 the market growth is the global increase in breast cancer cases. According to the World Health Organization (WHO), breast cancer is the most frequent type of cancer among women across the globe. Approximately 2.1 million women suffer from breast cancer every year, and it leads to the highest number of cancer-related deaths among women. In 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 new cancer cases. The 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.

Breast Cancer Liquid Biopsy Market Trends

The Circulating Cell-free DNA (cfDNA) Segment is Expected to Hold a Major Market Share

Circulating cell-free DNA (cfDNA) in plasma offers a non-invasive approach to monitor tumor molecular profiling in real-time at multiple time-points, detect emerging genomic alterations associated with drug resistance, and clarify 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, Germany-based Qiagen offers the QIAamp circulating nucleic acid kit 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 2018, it was estimated that approximately 627,000 women died from breast cancer, which 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) have 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 being utilized for breast cancer diagnosis. These developments are expected to fuel the market growth during the forecast period.

North America is Expected to Hold a Significant Share in the Market During the Forecast Period

The North American region is expected to hold a major share in the breast cancer liquid biopsy market. This is primarily due to the 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 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 the market development in a positive manner.

Furthermore, the high adoption rates of advanced diagnostic technologies such as PCR and NGS among healthcare professionals and the presence of well-established healthcare infrastructure are fueling the growth of the overall regional market to a large extent.

Breast Cancer Liquid Biopsy Industry Overview

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 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.

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Table of Contents

1 INTRODUCTION
1.1 Study Assumptions
1.2 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 Rising Prevalence of Breast Cancer
4.2.2 Increasing Demand for Better Minimally Invasive Therapies
4.2.3 Technological Advancements in the Early Stage Detection of Breast Cancer
4.3 Market Restraints
4.3.1 Stringent Regulatory Issues
4.3.2 Poor Reimbursement Policies
4.4 Porter's Five Forces Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry

5 MARKET SEGMENTATION
5.1 By Circulating Biomarkers
5.1.1 Circulating Tumor Cells (CTCs)
5.1.2 Circulating Cell-free DNA (cfDNA)
5.1.3 Extracellular Vesicles
5.1.4 Other Circulating Biomarkers
5.2 Geography
5.2.1 North America
5.2.1.1 United States
5.2.1.2 Canada
5.2.1.3 Mexico
5.2.2 Europe
5.2.2.1 Germany
5.2.2.2 United Kingdom
5.2.2.3 France
5.2.2.4 Italy
5.2.2.5 Spain
5.2.2.6 Rest of Europe
5.2.3 Asia-Pacific
5.2.3.1 China
5.2.3.2 Japan
5.2.3.3 India
5.2.3.4 Australia
5.2.3.5 South Korea
5.2.3.6 Rest of Asia-Pacific
5.2.4 Middle-East and Africa
5.2.4.1 GCC
5.2.4.2 South Africa
5.2.4.3 Rest of Middle-East and Africa
5.2.5 South America
5.2.5.1 Brazil
5.2.5.2 Argentina
5.2.5.3 Rest of South America

6 COMPETITIVE LANDSCAPE
6.1 Company Profiles
6.1.1 Qiagen
6.1.2 F. Hoffmann-La Roche Ltd
6.1.3 Bio-Rad Laboratories Inc.
6.1.4 Janssen Diagnostics
6.1.5 Biocept Inc.
6.1.6 Guardant Health Inc.
6.1.7 Myriad Genetics
6.1.8 Adaptive Biotechnologies
6.1.9 Epic Sciences
6.1.10 Illumina Inc.
6.1.11 Fluxion Biosciences Inc.
6.1.12 Biodesix
6.1.13 Pathway Genomics (OME Care)
6.1.14 Exosome Diagnostics Inc.
6.1.15 PapGene

7 MARKET OPPORTUNITIES AND FUTURE TRENDS

8 IMPACT OF COVID-19 ON THE MARKET