[Edaily Reporter Kim Jinsoo ] Liquid biopsy—a method of diagnosing cancer using only bodily fluids such as blood—has established itself as an essential technology in precision medicine and is expanding its scope of application to include new drug development. As it moves beyond simple diagnosis to be used in clinical trials and biomarker discovery by pharmaceutical and biotech companies, the commercial value of liquid biopsy companies is also on the rise.

Unlike tissue biopsies—which involve removing cancerous tissue—liquid biopsy is a technology that diagnoses and monitors cancer by analyzing circulating tumor DNA (ctDNA) in bodily fluids such as blood, urine, and cerebrospinal fluid. Its strengths include reduced burden on patients since it does not require surgical procedures, and the ability to track treatment progress in real time through repeated sampling.

The market outlook is also bright. According to market research firm Grand View Research, the global liquid biopsy market is projected to grow from $13.6 billion (approximately 19 trillion won) in 2025 to $32.57 billion (approximately 46 trillion won) in 2033. The compound annual growth rate (CAGR) during this period is expected to reach 11.5%.

In particular, precision oncology is driving market growth, with 86.5% of all liquid biopsy tests used for cancer diagnosis and analysis. By technology, next-generation sequencing (NGS)-based tests—which analyze multiple genes simultaneously—account for 76.7% of the total and are leading the market.

For certain types of cancer, such as non-small cell lung cancer, where obtaining tissue samples is often difficult, liquid biopsy is effectively the only option. Last May, the UK’s National Health Service (NHS) became the first in the world to introduce a “blood test first” policy, under which lung and breast cancer patients undergo a blood test (ctDNA) before a tissue biopsy.

Big Pharma Utilizes Liquid Biopsy for New Drug Development Liquid biopsy

has gone beyond simple cancer diagnosis and analysis to be actively used in

new drug development,

further enhancing its commercial value. As the discovery of biomarkers—which determine which drugs are effective for which patients—has emerged as a key factor in anticancer drug development, liquid biopsy is being actively used as a tool for selecting clinical trial participants and monitoring treatment responses.

Guardant Health, the world’s leading liquid biopsy company, signed a multi-year strategic collaboration agreement with Pfizer in April of last year. Under this agreement, Guardant Health’s “Guardant Infinity” liquid biopsy platform will be utilized in Pfizer’s global oncology clinical trials, and ctDNA levels will be validated as a surrogate marker for assessing treatment response.

Prior to this, Guardant Health also signed a joint development agreement with Merck (MSD) for next-generation liquid biopsy-based patient screening and companion diagnostics. Additionally, Grail has partnered with AstraZeneca, Amgen, and BMS, while Natera has teamed up with Roche to utilize liquid biopsy technology in new drug clinical trials.

There have even been cases where liquid biopsy directly led to new drug approval. In a global clinical trial led by Genentech, a subsidiary of Roche, Natera used its minimal residual disease (MRD) test, “Signatera,” to identify high-risk patients for recurrence—those in whom ctDNA was detected following surgery for muscle-invasive bladder cancer—and demonstrated improved survival rates by administering the immunotherapy Tecentriq to these patients. Based on these results, the U.S. Food and Drug Administration (FDA) simultaneously approved an expanded indication for Tecentriq and the Signatera companion diagnostic (CDx) last May. This marks the first approval of a companion diagnostic for a blood-based MRD test, demonstrating that liquid biopsy has evolved beyond a diagnostic tool to become a key instrument for validating the value of new drugs.

Collaboration with Big Pharma extends beyond the narrow scope of joint companion diagnostic development to include △ patient selection for clinical trials (trial matching), △ biomarker discovery and research and development (R&D), and △ licensing of genomic data and real-world data (RWD).

The market size for collaborations with big pharma based on comprehensive genomic profiling (CGP) is estimated to be approximately $1.5 billion to $2.5 billion (about 2 trillion to 3.5 trillion won) for 2024–2025. The projected compound annual growth rate (CAGR) is 18–31%, and the market is expected to grow to $4–6 billion (approximately 6–8 trillion won) by 2030.

IMBDX Leads the Domestic Market… “Analyzing 1,000 Genes”

In South Korea, IMBDX is recognized as a leading player in the application of liquid biopsy technology for new drug development. IMBIDX is set to launch “AlphaLiquid1000,” which analyzes approximately 1,084 genes; this technology can be used not only to support targeted therapy but also for advanced research such as cancer genomics and biomarker discovery. Last year, Guardant Health introduced a comprehensive panel product that analyzes approximately 740 genes; in terms of numbers, AlphaLiquid1000 far surpasses this.

In fact, iMBDX is actively collaborating with new drug developers. It has signed a comprehensive memorandum of understanding (MOU) with ImmuneOncia, an immunotherapy developer and subsidiary of Yuhan Corporation, to utilize the ctDNA analysis platform AlphaLiquid in the development of the new drugs “IMC-001” and “IMC-002.” In addition, the company is conducting research collaborations with other domestic drug developers, such as HK InnoN.

The company is also steadily expanding its presence on the global stage. In 2022, IMBDX signed a partnership agreement with global pharmaceutical giant AstraZeneca for its profiling products and, building on this, has focused its efforts on markets in Central America, the Caribbean, and the Middle East. Furthermore, by expanding its reach to Taiwan, Thailand, and India, the company is expected to drive substantial revenue growth.

An IMBDX official stated, “We have secured trust in the global market by successfully executing a screening partnership with AstraZeneca for prostate cancer treatments,” adding, “We are now actively pursuing biomarker-based joint research as we expand into the research and precision medicine markets, including efficacy validation of new drug pipelines and screening of clinical trial participants.”