Written by: Debjit Chakraborty

The emergence of the non-invasive liquid biopsy technique has offered a patient-friendly approach of conducting liquid biopsy tests for the screening and diagnosis of cancer by using non-invasive sample types, including stool, urine, and saliva, among others. The applicability of non-invasive liquid biopsy products and services in clinical oncology has shown impressive outcomes with respect to early-stage cancer diagnosis. The influx of high-fidelity diagnostic tests based on molecular technologies has enabled physicians and pathologists to unravel clinical insights from circulating molecular markers such as cell-free DNA (cfDNA), circulating tumor DNA (ctDNA), exosomes, and extracellular vesicles (EVs), and offer reliable diagnostic results to patients. Additionally, extensive research is also being conducted to decipher critical insights regarding the applicability of non-invasive liquid biopsy in non-oncology applications, particularly reproductive health and metabolic disorders. Further, the active involvement of the companies with respect to product and service development pertaining to non-invasive liquid biopsy is expected to support the growth of the global non-invasive liquid biopsy market in the forthcoming years.

The global non-invasive liquid biopsy market is evolving at a very rapid pace, with emerging companies entering the market. The overall non-invasive liquid biopsy ecosystem includes more than 20 companies that are developing novel products and services, respectively. These companies are massively investing in conducting research and development for unraveling the potential of circulating molecular markers to transform clinical outcomes, particularly in the field of clinical oncology.

This specific market within the healthcare ecosystem has a perfect blend of companies that are involved in the development and commercialization of products and services associated with non-invasive liquid biopsy. These companies include Bio-Techne Corporation, Endress + Hauser Group, Exact Sciences Corporation, Lonza Group AG, MDx Health, Merck KGaA, MutantDx, Norgen Biotek Corp, Nucleix Ltd., Oasis Diagnostics Corporation, OraSure Technologies, Inc. PerkinElmer Inc., Predicine, Inc. QIAGEN N.V., Thermo Fisher Scientific Inc., and Zymo Research Corporation.

The latest market study by BIS Research, titled “Global Non-Invasive Liquid Biopsy Market,” focuses on offering, sample, application, technology, end user, and region. The study offers an in-depth analysis of competitive assessment, country-level analysis, and potential market dynamics, which are shaping up the entire non-invasive liquid biopsy ecosystem.

During the report development, the analyst collaborated with various stakeholders to gain a holistic understanding of the intricacies associated with non-invasive liquid biopsy. Following is an excerpt from the conversation between Debjit Chakraborty, Senior Research Associate at BIS Research, and an industry spokesperson from the biopharma industry.

Q: How do you perceive the ecosystem of non-invasive liquid biopsy as compared with the conventional liquid biopsy landscape?

A: The entire landscape is growing tremendously, and the paradigm is shifting toward a liquid first approach reflex to tissue. It is a slow change, but it is happening. Our approach is a urine-based liquid biopsy for bladder cancer. I have learnt that there is an appetite for novel technologies to non-invasively get information regarding tumor genomic profile. Our data from a recent publication in “Journal of Urology” suggest that urine is as good as tissue. The use of urine is more effective for patients of urothelial cancers. The other aspect that we are articulating by having discussions with our clients is about longitudinal testing so that one can monitor progress either to assess the response of a certain drug and post curative situation. We think that there is a decent size market there and we think that our company has a technology that is superior to other approaches in the non-invasive liquid biopsy market.

Q: Apart from the companies such as Bio-Techne Corporation, MutantDx, Exact Sciences Corporation, and Precidine, Inc., do you think there are other companies as well who are actively involved in the market?

A: I think that there are plenty of providers coming in the field of colorectal cancer. The Freenome is striving to do analysis on blood in the same way what Exact Sciences attempted in stool analysis. That is Freenome is not just looking at the DNA but also on the other omics approaches influencing the blood.

I think the field of colorectal is huge. For us, we are specifically focused on bladder cancer. Our competitors in the bladder cancer space do not necessarily have urine-based capabilities. So, it is a unique opportunity for Predicine, Inc. to leverage a novel technology.

Q: Considering truly non-invasive sample types like urine, stool, and others, are you familiar with any company which is offering services specifically stool-based test?

A: Exact Sciences Corporation is using stool, and I am not really confirmed as who else competes in that space with Cologuard. Considering, Cologaurd pretty much own that landscape. That could be the only one that I would point to. In the space of bladder cancer, I think it is Exosome Diagnostics. Exact Sciences is the only company that is competing with us.

Q: What is your opinion on the market of non-invasive liquid biopsy (excluding blood)?

A: I think that the stool test has a huge market in which Exact Sciences is operating. I think that this will erode over time as people move toward a blood-based approach versus fecal.