Liquid Biopsy Market Size, Share & Trends Analysis Report By Application, By Sample Type (Blood, Urine), By Biomarker Type (CTC, ctDNA, Exosomes), By Technology (NGS, PCR), By Region, And Segment Forecasts, 2018 - 2030

Industry Outlook

The global liquid biopsy market size was valued at USD 23.49 million in 2016. It is projected to expand at a CAGR of 13.4% during the forecast period. With a considerable number of successful trials, which are observing promising results, the market is poised to tread along a healthy growth track over the forecast period.

Monitoring and therapy selection of metastatic breast cancers are expected to remain the most prominent use of liquid biopsy for years to come. However, over the course of time, after validation through large scale clinical studies, it is estimated that this form of biopsy will become the first line of diagnosis for a vast variety of cancers, including CNS and pancreatic cancers.

Liquid biopsy is a fast emerging substitute for conventional tumor biopsies, developed out of the need to acquire the most amount of molecular information about cancer with the least amount of surgical invasion. With rapid enhancements in NGS technology, liquid biopsies are estimated to take prime position in the context of cancer related probe and investigation.

Furthermore, with anticipated positive results from a number of clinical trials for the development of these tests and subsequent larger scaled clinical trials demonstrating efficacy, it is likely that the testing methodology will serve a wider base of the patients in molecular monitoring settings. The three most potential biofluids under immense clinical observations for liquid biopsy sampling are blood, urine, and saliva.

Moreover, as the basis of this form of biopsy is a probe into free flowing circulating tumor cells, biomarkers most suited and being studied for viable commercial development are CTCs, circulating tumor DNA, and exosomes containing tumor DNA or RNA. Technologies under R&D include PCR-based assays for single gene analysis and NGS-based parallel gene analysis.

Application Insights

Implications of complete commercialization of liquid biopsies are projected to be considerably disruptive. Three key applications of liquid biopsy can be a therapy selection tool for metastatic breast cancers, therapy selection for other metastatic cancers, and molecular health monitoring. With the rising incidence of metastatic cancer across the globe, the therapy selection tool for metastatic breast cancers segment is poised to hold a considerable share in the market throughout the forecast period.

Post the year 2020, once a considerable number of liquid biopsy products are commercialized, it is expected that liquid biopsy will find application not only in cancer diagnosis, but also as a molecular monitoring diagnostic tool for other diseases, which can be investigated using biofluids such as blood, CSF, urine and saliva for patient screening, cancer recurrences, and other associated prognosis.

Sample Type Insights

Due to the numerous preexisting applications and methods for purification, blood sampling is the most frequently used sample for liquid biopsy studies and product developments. Cell-free DNA, circulating tumor cells, and exosomes as well as microvesicles can be detected in blood sample. This, in turn, results in higher adoption rate of liquid biopsy through blood sampling.

The next generation sequencing (NGS) technology is utilized herein for detection of multiple mutations in multiple genes. Results of certain studies and projects have indicated that saliva and plasma measurements are correlated, which thereby presents the possibility that non-invasive detection of oncogenic gene mutations in saliva is an emerging frontier. Moreover, this method of sampling offers benefits such as rapid assessment of patient health status for precise treatment of cancer.

Biomarker Type Insights

On the basis of biomarker type, the liquid biopsy market has been divided into circulating tumor cells (CTC), circulating tumor DNA (ctDNA) and exosomes (Macrovesicles with Protein, RNA, DNA). There are about 8-10 liquid biopsy tests based on CTCs and ctDNA that are currently commercialized. Furthermore, over 30 tests based on all three of these biomarkers are in clinical development by some key market participants such as Qiagen, Trovagene, and Biocept. Commercialization of these tests in the offing is estimated to benefit the growth of the overall market.

Circulating tumor cells tests are applicable in characterization of tumor cells through biochemical marker analysis. CTC isolation, detection, and molecular characterization systems find investigational application in prostate, breast, colon, head, neck, skin, lung, and pancreatic cancer.

Technology Insights

Based on type of assay technology implemented for diagnosis, single gene analysis and multi gene analysis are the two methods employed. PCR-based sequencing is employed for analysis of mutations in disease specific genes whereas analysis of multiple diseases simultaneously can be carried out using the NGS multiplex testing. PCR microarray and NGS technology are both considered important for analysis of the aforementioned biomarkers to conduct any liquid biopsy analysis.

Multigene tests have taken clinical pharmacogenomics tests away from conventional sequencing of single genes and can be marked as a significant step towards comprehensive analysis of cancer genome. This technology aids oncologists in directing patients to targeted therapy by identification of genetic aberrations.

Regional Insights

The market has been on a rise in most of the regions owing to growing prevalence of cancer and subsequently rising need for screening and increasing competition between various biotech firms to enter untapped markets around the world. Besides these, government grants for research institutes to innovate and improve available liquid biopsy testing methods are anticipated to back the growth of the market.

North America was at the forefront of the market in 2016, followed by Europe. The growth of the region can be attributed to recent regulatory approvals by CE for commercial use of these liquid biopsy tests. However, Asia Pacific is likely to register phenomenal CAGR during the forecast period as governments and companies are trying to keep growing cancer prevalence rates in the region in check. China, India, and Japan are the major contributing countries to the region’s growth.

Liquid Biopsy Market Share Insights

Some of the key players that have commercialized tests in liquid biopsy include Guardant Health, Personal Genome Diagnostics, Biocept, Adaptive Biotechnologies, Cynvenio, NeoGenomics Laboratories, Qiagen, Trovagene, and RainDance Technologies.

Many biotechnological companies have started their trials in China as clinical trial regulations are comparatively lenient. Thus, encouraging companies to shift their base from America and Europe, where costlier trials are required for approval and reimbursement.

Report Scope

Segments Covered in the Report

This report forecasts revenue growth at global, regional, & country levels and provides an analysis on the industry trends in each of the sub-segments from 2013 to 2030. For the purpose of this study, Grand View Research has segmented the global liquid biopsy market report on the basis of application, sample type, biomarker, technology, and region:

• Application Outlook (Revenue, USD Million, 2013 - 2030)

  • Therapy Selection for Metastatic Breast Cancer (MBS)

  • Therapy Selection for Other Metastatic Cancer

  • Molecular Health Monitoring

• Sample Type Outlook (Revenue, USD Million, 2013 - 2030)

  • Blood Sample based

  • Urine Sample based

  • Other Bio Fluids (Tissue fluids and Saliva) based

• Biomarker Outlook (Revenue, USD Million, 2013 - 2030)

  • Circulating Tumor Cells (CTC)

  • Circulating Tumor DNA (ctDNA)

  • Exosomes

• Technology Outlook (Revenue, USD Million, 2013 - 2030)

  • Multi-gene-parallel Analysis (NGS)

  • Single Gene Analysis (PCR Microarrays)

• Regional Outlook (Revenue, USD Million, 2013 - 2030)

  • North America

    • The U.S.

    • Canada

  • Europe

    • Germany

    • The U.K.

  • Asia Pacific

    • Japan

    • China

  • Latin America

    • Brazil

  • Middle East & Africa

    • South Africa