The market for liquid biopsy will near $1.6 billion by 2023, according to a new report from Kalorama Information. This represents double-digit growth over the course of the period researched in the market research firm’s report. Liquid biopsies are a set of minimally invasive diagnostic methods that analyze tumor-derived materials that can be found

circulating in biological fluids, to provide information for the diagnosis, treatment, and monitoring of cancer. The market for liquid biopsy testing, still in its infancy, is rapidly evolving as vendors develop and commercialize innovative new technologies to meet the needs of the clinical diagnostic market, according to The World Liquid Biopsy Market, from Kalorama Information. https://kaloramainformation.com/product/the-world- liquid-biopsy-market/

The most frequently targeted analyte in liquid biopsy is
ctDNA, which encompasses small fragments of DNA that are
believed to originate from the natural and abnormal necrosis and
apoptosis processes undergone by solid tumor cells as well as
normal cells during regular cellular turnover. As of 2019, over 40 companies are active in the global market for liquid biopsy diagnostics and monitoring tests.

Demand Stems from Tissue Biopsy Disadvantages

Several drawbacks and limitations are associated with tissue biopsies. First, they are highly invasive surgical procedures that may expose patients to risks. The tumor site must be known and surgically accessible in the first place. Because of the invasive nature of the procedure, tissue biopsies are usually restricted to a single sample site, and repeat tissue biopsies are impractical; a single biopsy provides only a snapshot of a tumor’s characteristics. Furthermore, tissue biopsy samples may not reflect the genomic heterogeneity of tumors. Tissue biopsies are also quite costly to perform; a typical surgical biopsy can cost $15K-45K to perform.

In comparison, liquid biopsies offer several key advantages over tissue biopsies. They are less or non- invasive, lower risk, lower cost, and offer faster turnaround times for results. Moreover, liquid biopsies provide the opportunity for repeat testing, to monitor treatment progression over the course of

$1.6BN Market for Liquid Biopsy, and 20%+ growth, according to Kalorama Information’s new report.

therapy, and/or to test for recurrence after surgical removal of tumors. Liquid biopsies provide a more comprehensive picture of tumor heterogeneity, providing genomic insights for both intra-tumor, and of metastatic lesions. Liquid biopsies, in general, are better able to capture the heterogeneity of cancer than tissue biopsies, as cells, DNA, and exosomes are shed from multiple parts of the primary tumor or metastatic lesions in various locations of the body, into the vascular and lymphatic systems. With this information, clinicians can form a more comprehensive understanding of the disease burden, and druggable variants may be identified.

Liquid Biopsy Limitations

While liquid biopsies offer many advantages, the technique is still early in its development, and challenges have been identified. Several studies examining tests offered by major liquid biopsy companies have found discordance between how results compare with tissue biopsy sequencing, as well as inconsistent results between various liquid biopsy assays conducted by different companies. Discrepancies and false negative results can be attributed to low occurrence of CTCs and ctDNA, akin to looking for a needle in a haystack, which makes detection difficult. However, false positive detection of biomarkers is also a common occurrence. Discrepancies may also be a product of differing assay characteristics between providers, which are difficult to assess as tests are proprietary. Because of these issues, a joint literature review conducted by the American Society of Clinical Oncology and the College of American Pathologists conducted in 2018 concluded that there is no evidence of clinical utility for ctDNA testing in early-stage cancer, treatment monitoring, or residual detection. However, the review also noted that given the rapid pace of research into liquid biopsy, re-evaluation will be required shortly.

Yet despite these limitations, the global market for liquid biopsy diagnostic and monitoring test is expected to grow at a rapid pace over the forecast period of five years in the report.

Growth Prognosis

Kalorama forecasts growth as liquid biopsy gains clinical acceptance. A market size of 1.6 billion and growth of more than 20% is much higher revenue growth than IVDs generally experience, but it is lower than some estimates put forth by investment concerns or non-specialist market researchers. Clinical uses will drive growth. Currently, there are more than 130 approved therapeutics that target various cancer biomarkers, and a large number of drugs are in the late stages of clinical development, prompting the need for diagnostic and monitoring tests that inform the use of these therapies.

Most liquid biopsy tests commercialized in this segment focus on the detection of distinct, clinically actionable markers on single genes or small panels of genes, which offer the advantages of lower cost and complexity, faster turnaround, and easier to interpret results. The majority of companies focus on testing a single analyte, such as ctDNA, CTCs or exosomes, from blood specimens, but a few companies, such as Biocept and LungLife AI, incorporate multiple analytes, such as the combination of ctDNA and CTCs, to expand the test’s performance and the range of detectable biomarkers.

Growth for diagnostic/screening applications will be driven by several factors. As the incidents of many cancers increases globally, clinical guidelines have adopted screening recommendations, such as colonoscopies and mammograms, into regular patient management. While liquid biopsy-based screening tests have yet to be incorporated clinical care guidelines, clinicians and patients can choose to use them in place of more invasive procedures, or as a screening method to decide whether a more invasive diagnostic method is necessary.

This White Paper by necessity can only offer a limited amount of information. Our complete market assessment, reflecting our considered analysis of liquid biopsy can provide useful understanding and business planning information.