Liquid Biopsy Market

The global Liquid Biopsy Market is valued at USD 5.64 Billion in 2023 and is projected to reach a value of USD 15.75 Billion by 2032 at a CAGR (Compound Annual Growth Rate) of 12.09% between 2024 and 2032

Market Synopsis

Cancer is the second leading cause of death globally, and the increasing global incidence of cancer is driving the market. According to WHO, approximately 16.3 million cancer related deaths are likely to occur by 2040. Among various cancer indications, breast cancer is the most common type of cancer worldwide, followed by lung cancer, colorectal cancer, and prostate cancer. According to the SEER statistics, nearly 18% women are expected to be diagnosed with breast cancer at some point during their lifetime, with an estimated 297,790 new cases in 2023.

FDA-approved liquid biopsy tests are crucial as cancer is the leading cause for death globally. They have been thoroughly researched to ensure safety and accuracy. Several tests are in development and various stages of research, four are currently FDA-approved:

• CellSearch Circulating Tumor Cell (CTC) Test: Detects CTCs to predict outcomes for metastatic breast, prostate, or colon cancer. Few CTCs indicate a favorable prognosis, while many suggest an unfavorable prognosis.
• cobas EGFR Mutation Test v2: Detects ctDNA to identify a common mutation in non-small cell lung cancer (NSCLC), aiding in selecting targeted treatments.
• Guardant360 CDx: Detects ctDNA to identify common genetic errors, helping providers choose effective treatments.
• FoundationOne Liquid CDx: Detects ctDNA and mutations in various cancers to guide treatment decisions.

Monitoring minimal residual disease (MRD) represents a significant application in liquid biopsy. This involves using liquid biopsy techniques to detect and analyze residual cancer cells or DNA present in the bloodstream after treatment. This non-invasive method provides a valuable tool for evaluating treatment effectiveness and predicting the likelihood of cancer recurrence. The ongoing evolution of liquid biopsy technologies and their integration into clinical settings continues to propel the growth and adoption of liquid biopsy solutions for MRD monitoring. For instance, in November 2023, Illumina Inc. unveiled TruSight Oncology 500 ctDNA v2, an advanced version of its liquid biopsy assay tailored for comprehensive genomic profiling in oncology. This updated iteration boasts improved sensitivity and specificity in identifying cancer-related mutations found in circulating tumor DNA.

Liquid Biopsy Industry Highlights

• North America contributed 46.2% of the revenue share due to the advanced healthcare infrastructure, high adoption rates of innovative diagnostic technologies, and substantial investments in R&D
• The Asia Pacific region is expected to grow at significant CAGR projected throughout the forecast period
• Assay Kits emerged as the market leader in 2023, commanding a 52.5% market sharedue to their essential role in facilitating the accurate detection and analysis of cancer biomarkers from minimal blood sample
• Cell-free DNA (cfDNA) emerged as the leading segment in the market in 2023, capturing a notable 46.5% market share, underscoring its pivotal role within the industry
• In 2023, Multi-Gene Parallel Analysis using NGS claimed the largest market share at 76.2% within the market due to its capability to simultaneously analyze multiple genes with high accuracy and efficiency
• Cancer Applications dominated the market with 85.1% because of their critical role in oncology diagnostics and management
• Blood sample segment dominated in 2023 with market share of 68.1%
• Hospitals & Physician Laboratories dominated with the market share of 43.1% in 2023

Liquid Biopsy Market Regional Overview

North America Overview

North America led the market with market share of 46.2% due to high adoption of innovative diagnostic technologies, and substantial investments in R&D

Cancer is the leading cause of death in Canada and the second-leading cause of death in the USA. For instance, according to the International Agency for Research on Cancer, the most prevalent types of cancer include lungs cancer, breast cancer, prostate cancer, and colorectal cancer. Cancer and other infectious diseases may occur as a result of biological and environmental risk factors, including smoking, air pollution, and tobacco use. Many cancer research institutions are aggressively using cutting-edge tactics and patient-centered approaches for early cancer diagnosis and therapy in order to meet the rising cancer burden.

The increasing incidence of genetic abnormalities among neonates and fetuses has amplified the need for prenatal testing. In order to reduce the spread of infectious diseases and chronic illnesses like cancer, government programs encouraging public screening tests have increased the use of noninvasive screening tests that use biological fluids including blood, amniotic fluid, and cerebrospinal fluid (CSF).

During the screening or recurrence stages of cancer patients' disease, these tests identify indicators of malignant tumors, such as circulating biomarkers, cell-free DNA, and circulating tumor DNA (ctDNA). Appropriate regulatory agencies, such the Food and Drug Administration (FDA), have authorized diagnostic tests that can detect advanced tumors, forecast prognosis, and support medical professionals in therapy selection.

Market expansion is driven by increased R&D and the introduction of new technologies by key players to enhance patient screening for chronic disorders and abnormalities. Additionally, several life science companies are offering liquid biopsy testing solutions across various regions to provide targeted therapies for cancer patients.

Significant Growth in the North American Market Driven by Manufacturer Collaborations and New Product Approvals

• In May 2023, Labcorp launched a novel liquid biopsy test for patients with metastatic solid tumors. This test evaluates circulating DNA released by tumor cells, aiding oncologists in managing patient care through targeted therapy plans.
• In 2022, Thermo Fisher Scientific introduced digital PCR liquid-biopsy assays for its Applied Biosystems Absolute Q dPCR system and a custom design tool to facilitate cancer research in academic and clinical research institutions.

US Liquid Biopsy Market Overview

The US market, valued at USD 1.97 Billion in 2023 to USD 5.55 Billion in 2032, is anticipated to grow at a CAGR of 12.2% from 2024 to 2032.

Technological developments, rising cancer rates, and a strong emphasis on early detection and individualized medicine are driving the US industry. For instance, the American Cancer Society projects that 609,360 deaths caused by cancer and 1.9 million new cancer cases occurred in the US in 2022. The US market offers the advantages of a strong healthcare infrastructure as well as the presence of significant pharmaceutical and biotechnology businesses that are actively involved in research and development. High-profile companies such as Grail, Guardant Health, and Foundation Medicine are at the forefront of liquid biopsy innovation, contributing to the market's dynamic growth. For instance, in February 2023, Guardant Health, Inc. introduced the Guardant reveal test for patients with early-stage colorectal cancer, which measures residual disease and recurrence.

Europe Overview

Europe is the second leading region in the market. Europe’s significant share of 29.5% is attributed to increasing awareness about cancer and prenatal screening among the population. For instance, according to data published by MDPI in 2022, approximately 6,560 patients annually benefit from liquid biopsy tests for Non-Small Cell Lung Cancer (NSCLC) screening in Europe. Moreover, numerous market players are focusing on securing funding to develop advanced liquid biopsy platforms.

Strategic Initiatives by European Governments to Enhance Cancer Screening Expected to Drive Market Growth

• In March 2022, the U.K. National Health Service announced plans to offer liquid biopsy tests to certain cancer patients as a complement to anatomic pathology testing, with the goal of diagnosing 75% of all cancers at stage I or stage II by 2032. These initiatives underscore the region's commitment to advancing cancer diagnostics and improving patient outcomes through early detection.
• In March 2022, it was reported that the U.K. National Health Service began offering liquid biopsy tests to certain cancer patients as a supplement to anatomic pathology testing, aiming to diagnose 75% of all cancers at stage I or stage II by 2028.

Asia Pacific Overview

The increasing occurrence of genetic abnormalities like Down syndrome and chromosomal aneuploidies is fueling market expansion in the Asia Pacific region. It is expected to show the highest compound annual growth rate (CAGR) during the study period, driven by rising demand for predictive screening due to elevated disease prevalence. For instance, as per a ScienceDirect article from December 2022, a study reported an estimated 265 annual liquid biopsies for Down syndrome (1 in 1,158) in Australia from 2016-2020.

Liquid Biopsy Technology Overview

With 76.2% market share, Multi-Gene Parallel Analysis using NGS segment leads the market due to its comprehensive genomic profiling capabilities, high sensitivity

Multi-Gene Parallel Analysis using NGS enables the analysis of multiple genes from a single sample simultaneously, offering comprehensive insights into the genetic landscape of cancer. NGS-based multi-gene analysis is driven by its unparalleled ability to detect a wide array of genetic mutations, alterations, and biomarkers with high sensitivity and specificity. For early cancer identification, prognosis, and customized treatment planning, this makes it a priceless tool. NGS's leadership in the market is being cemented by the growing demand for its reliable and extensive genetic information, which is a result of the growing popularity of precision medicine.

The importance of NGS in liquid biopsy bolstering the market due to ongoing developments in sequencing technology, which have lowered costs and increased accessibility significantly. Its widespread application in a range of healthcare settings, including smaller clinical laboratories and larger research institutes, has been made possible by these technological advancements. Furthermore, the combination of NGS with advanced bioinformatics databases and tools improves the understanding of complex genomic data and gives physicians valuable data.

NGS technology, a variety of tumor-causing mutations used to detect and potential post-treatment resistance mechanisms originating from pre-existing clones can be identified. In addition, prominent industry participants are creating new products to fulfill the rising need for diagnostics and preserve their competitive advantage through a broader range of offerings propelling market expansion. For instance, in January 2023, Agilent Technologies collaborated with Quest Diagnostics to offer Agilent Resolution ctDx FIRST, an NGS liquid biopsy test, in the U.S.

Liquid Biopsy Market Trends

• Technological advancements: Rapid advancements in NGS technology have resulted in significant cost savings in high-accuracy sequencing. This method is used in focused panels to detect particular and very sensitive ctDNA mutations and screen for unknown variations. For instance, NGS may detect 59% of stage 1 or 2 lung cancer patients with a MAF of less than 0.1%.
• Rising government initiatives: Governments in several high-cancer-burden countries have vowed to support cancer research by allocating appropriate finances to improve results
• Increasing healthcare expenditures: Increased healthcare spending in developing nations such as India and China, as well as the utilization of liquid biopsy testing to treat uncommon malignancies, are likely to provide abundant market growth possibilities.

Innovative Liquid Biopsy Developments

• In February 2023, Dxcover Limited raised nearly USD 12.4 million (GBP 10.0 million) to develop a new liquid biopsy platform for detecting various types of cancer.
• MiRXES secured $50 million in Series D venture funding in July 2023 for developing and commercializing liquid biopsy products targeting colorectal cancer and multi-cancer early detection.
• Epic Sciences raised $24 million in Series G venture funding in April 2023 for developing liquid biopsy products aimed at metastatic breast cancer.
• In June 2021, BioMark Diagnostic Solutions, Inc. was awarded USD 825,000 to develop BioMark's liquid biopsy assay for lung cancer screening. The Consortium for Industrial Research and Innovation in Medical Technology is providing a significant portion of the funding, as are Spark awards from the Canadian Cancer Society, Brain Canada Foundation, and Canadian Institutes of Health Research - Institute of Cancer Research.

Liquid Biopsy Market COVID-19 Impact

• Cancer diagnoses were significantly delayed during the COVID-19 pandemic due to reduced diagnostic services and screening programs. The pandemic also disrupted international supply chains, resulting in shortages of cancer diagnostic kits and assays globally.
• According to an NCBI article in 2021, molecular tests decreased by 27.0% from March 15 to April 15, 2020, compared to the same period in 2019. Similarly, liquid biopsy testing for detecting epidermal growth factor receptor (EGFR) in Italy decreased by approximately 67.0% during a similar timeframe.
• Cancer patients faced numerous challenges, including increased susceptibility to severe infections and interruptions in their cancer treatment and regular medical care. These impacts were particularly pronounced in low- and middle-income countries with inadequate infrastructure, limited resources, shortages of medical supplies and personal protective equipment (PPE), and a lack of healthcare providers and organized care teams, leading to difficulties in delivering critical care.
• After lockdown restrictions lifted post-pandemic, resumed screening programs saw a surge in cancer prognostic test adoption. This trend was driven by increasing popularity of at-home tests and rising patient demand for oncology testing, accelerating market growth.
• Guardant Health, Inc.'s 2021 annual report noted a rise in precision oncology clinical tests to 87,600 by December 2021 from 63,254 in December 2020. This rebounds in cancer screening post-pandemic, coupled with high demand for at-home products, notably boosted market expansion.

Increased Investments in Clinical Trials Boosting Market Expansion

Recent advancements in liquid biopsies are leveraging new technologies in cancer screening, therapeutic selection, drug trial optimization, and recurrence monitoring. As the incidence of cancer rises and liquid biopsies become more common, major industry players are increasing their research and development (R&D) expenditures to carry out clinical studies on liquid biopsies with the goal of offering precise medication solutions. Important market participants are working together with other businesses and academic institutions to improve liquid biopsy-based treatment alternatives, which will support the market's further expansion.

• In July 2022, Delfi Diagnostics, Inc. secured USD 225.0 million for developing liquid biopsy tests for cancer detection. Research institutes are also funding manufacturing firms for R&D in early detection and screening of genetic and infectious disorders.
• In November 2021, BioMark Diagnostics Inc., a subsidiary of BioMark Diagnostic Solutions Inc., received up to USD 135,640.0 from the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP) to advance its liquid biopsy assay for early lung cancer detection.

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Liquid Biopsy Market Dynamics

Liquid biopsy offers many advantages over traditional tissue biopsy methods, driving its adoption in clinical practice

• Benefits of liquid biopsy include shorter recovery times, less discomfort for patients, and a decreased risk of infections and other problems due to its non-invasive nature. Unlike conventional biopsies, which often require surgical procedures that can be painful and carry risks of complications, liquid biopsies involve simple blood draws. As a result, liquid biopsies are particularly appealing for patients who require frequent monitoring or those who may not be suitable candidates for invasive procedures due to health conditions.
• Liquid biopsies enable repeated testing, which is crucial for continuous monitoring of disease progression and treatment response. Traditional tissue biopsies can be challenging to repeat due to the invasiveness and associated risks. In contrast, Liquid biopsies can be performed more frequently and provide real-time information on the patient's condition. The ability to routinely check on patients eventually leads to better patient outcomes since it makes it possible to detect cancer recurrences early and adjust treatment plans accordingly.

Liquid biopsy faces significant challenges related to sensitivity and specificity, which can impede its effectiveness and broader adoption

• Liquid biopsies have sensitivity issues when they are unable to identify low concentrations of ctDNA or CTCs, especially in early-stage or low-tumor-burden malignancies. This may lead to false-negative results, meaning that cancer is not detected by the test, which could postpone identification and treatment. The amount of tumor-derived material in the bloodstream varies, making it difficult to guarantee reliable and accurate detection a crucial component of effective therapeutic use.
• False-positive results may occur when the test finds CTCs or DNA alterations unrelated to tumors, which causes patients to worry unnecessarily and undergo more invasive testing. The dependability of liquid biopsy results is further complicated by technological limitations, such as the requirement for extremely specialized and sensitive detection methods. The accuracy of the test can be impacted by background noise in the samples and varying assay performance. These limitations necessitate further advancements in liquid biopsy technologies to enhance their sensitivity and specificity, ensuring that the tests can reliably differentiate between tumor-derived and non-tumor-derived materials.

Liquid Biopsy Competitive Outlook

The competitive landscape of the Liquid Biopsy is dynamic and driven by technological advancements and strategic collaborations among key players. Because it is non-invasive and has the ability to detect and monitor cancer early, liquid biopsy which analyzes biomarkers like circulating tumor DNA (ctDNA) or circulating tumor cells (CTCs) from blood or other bodily fluids—is becoming more and more popular. Prominent companies like Illumina, Bio-Rad Laboratories, Roche Diagnostics, Guardant Health, and more control the market with their extensive biomarker panels and cutting-edge testing platforms.

The key players in the global Liquid Biopsy market include - Bio-Rad Laboratories, Biocept Inc., Guardant Health, Illumina Inc., F. Hoffmann-La Roche Ltd., Johnson & Johnson, Laboratory Corporation of America Holdings, MDxHealth SA, QIAGEN N.V., Thermo Fisher Scientific Inc. among others.

Liquid Biopsy Market Developments

Twist Bioscience Corporation Introduces cDNA Library Preparation Kit for Liquid Biopsy Research

• In February 2024, Twist Bioscience Corporation introduced a cDNA library preparation kit to support liquid biopsy research.

Thermo Fisher Scientific Launches dPCR Liquid Biopsy Assays for Applied Biosystems Absolute Q dPCR System

• In November 2022, Thermo Fisher Scientific released a slew of dPCR liquid biopsy assays for their Applied Biosystems Absolute Q dPCR system and a custom design tool to help with cancer research. The business announced the availability of more than 50 Absolute Q liquid biopsy Assays for use on the fully integrated digital PCR system, which is meant to produce results in 90 minutes with minimal hands-on time.

Guardant Health, Inc. Begins Blood Sample-Based Cancer Testing Services in Europe at VHIO in Barcelona

• In May 2022, Guardant Health, Inc. announced that blood sample-based cancer testing services in Europe are operational at the Vall d'Hebron Institute of Oncology (VHIO) liquid biopsy testing facility in Barcelona.

Stilla Technologies Partners with Promega Corporation to Provide Comprehensive Digital PCR Workflow Solution for Cancer Research

• In April 2022, Stilla Technologies partnered with Promega Corporation to offer a complete digital PCR workflow solution for a wide range of applications for cancer research. These included liquid biopsies, sentinel pathogen testing, and others.

The global Liquid Biopsy market can be categorized as Product & Services, Circulating Biomarkers, Clinical Applications, Technology, Application, Sample Type, End User and Region.

Frequently Asked Questions (FAQs)?

1.How big is the market? What will be the global liquid biopsy market size by 2032?

The global liquid biopsy market is valued at $5.64 billion in 2023 and is anticipated to reach $15.75 billion by 2032, growing at a CAGR of 12.09% from 2024 to 2032.

2.What is the success rate of a liquid biopsy?

Liquid biopsies show promising potential for identifying cancer with high specificity and sensitivity. For instance, as per a research, sensitivity rates ranging from 70% to 90% in lung cancer cases, marking a significant advancement for non-invasive diagnostic tools. Similar encouraging results have been observed in prostate, colorectal, and breast cancers. Moreover, liquid biopsies have proven effective beyond diagnosis.

3.What is liquid biopsy used for?

A liquid biopsy is a simple and non-invasive alternative to surgical biopsies, allowing doctors to gather extensive information about a tumor from a simple blood sample. Traces of the cancer’s DNA in the blood can provide insights into which treatments are most likely to be effective for the patient.

4.What are the advantages of liquid biopsy Vs tissue biopsy?

Liquid biopsy offers less invasiveness compared to tissue biopsies, providing faster test results and enabling early diagnosis. It estimates metastatic risk and progression, facilitates therapy stratification and real-time monitoring, and enhances therapeutic target identification. Its ease and frequency allow for convenient repetition as needed, making it cost-effective compared to tissue biopsies.