Analysis of the market application prospects of the 100 billion liquid biopsy

The U.S. FDA approved the Roche cobas EGFR Mutation Test v2, an EGFR mutation-based "liquid biopsy" for the detection of EGFR exon 19 and L858R substitution mutations in exon 21 in patients with non-small cell lung cancer (NSCLC). deletions and L858R substitution mutations in exon 21 in NSCLC patients.

This move has allowed the liquid biopsy technology, which has been in the mist, to break through the barrier and present itself to the public in a high profile. It has advanced the development of precision medicine for lung cancer and further promoted the commercialization of liquid biopsy, providing a new way of thinking for patients with severe disease or those who cannot do tissue biopsy for other reasons, and bringing a boon to patients' precise choice of treatment.

Various studies have shown that liquid biopsy has powerful advantages over traditional biopsy in the field of cancer treatment. As an alternative technology to traditional biopsy and a new technology for early cancer screening, it is one of the representative diagnostic technologies in the field of "precision medicine" by obtaining tumor information through non-invasive blood sampling to assist in cancer treatment.

According to BCC's analysis, the liquid biopsy market will be worth $22 billion in 2020, and China is expected to have a market of RMB 20 billion. Jay Flatley, former CEO of sequencing giant Illumina, has previously stated in a media interview that the market for liquid biopsies is at least $40 billion and that this technology could be the most exciting breakthrough in cancer diagnosis.

Historical Review

The biopsy technique was invented by the Arab physician Abulcasis (1013-1017) as early as 1000 years ago. The benefit of biopsy was that doctors could make judgments about the disease based on the histological structure of the lesion. With the development of sequencing technology in recent years, doctors can sequence the patient's tissue to give a more accurate diagnosis.

However, as the research on tumors has intensified, scientists have found that there are certain limitations in the diagnosis and treatment of cancer. The main limitations are: tumors are heterogeneous, for patients with metastatic cancer cells, just taking tumor tissues from a certain area does not reflect the overall situation of the patient, but it is impractical to take samples of all tumor tissues for testing; some patients are not suitable for tissue biopsy due to their own conditions; some tumors have the risk of accelerated metastasis after being disturbed by surgery; the lag of tissue biopsy is also detrimental to patient treatment. It is also detrimental to the treatment of patients. Therefore, there are higher requirements for cancer diagnosis and detection technology.

The emergence of liquid biopsy technology has solved the above problems and advanced the diagnosis time of cancer. This is the reason why liquid biopsy technology was selected by MIT Technology Review as one of the "Top 10 Breakthrough Technologies of 2015".

Superior to traditional biopsies

Fast, convenient and non-invasive

In 2017, researchers at the Abramson Cancer Research Center at the University of Pennsylvania showed in the journal Clinical Cancer Research that non-invasive liquid biopsy is more effective in detecting clinically relevant mutations in patients with advanced lung cancer and is the most appropriate alternative to standard tissue biopsy.

01

Liquid biopsy results matched with tissue biopsy

Near 100% match of results

02

Liquid biopsy also captures the patient's clinical response without the discomfort and risks associated with invasive biopsy.

03

Liquid biopsy results are more helpful in guiding clinical decision making, whether it is identifying driver mutations or drug resistance mutations, or determining whether a chemotherapy regimen is good or bad, which cannot be achieved with tissue samples.

Market Analysis (Oncology Direction)

The field of liquid biopsy is a promising one. As research findings continue to accumulate, more and more diseases will be diagnosable and monitorable using body fluid testing. The more optimistic view is that liquid biopsies will gradually replace invasive solid tissue biopsies, while the relatively conservative view is that liquid biopsies will be a powerful complement to traditional biopsies. In any case, the field of liquid biopsy has great potential for the future of medical diagnosis.

Checking industry reports, information shows that the liquid biopsy field is segmented into four areas: circulating tumor DNA (cfDNA), circulating tumor cells (CTC), extracellular vesicles (EV), and others. This division is a significant change from some of the 2016 lineage studies - extracellular vesicles are starting to be divided into a separate direction. Another point we should note is the use of the term "extracellular vesicles" in the report, instead of "exosomes" which was used in a large number of line research reports in 2016, which shows that market analysts have started to realize the importance of extracellular vesicles as a large This shows that market analysts have started to realize the importance of extracellular membrane structures such as extracellular vesicles, and as researchers, we should also start to pay more attention to exosomes, microvesicles, apoptotic vesicles and other extracellular membrane structures.

Industry Research Report 1:

Liquid Biopsy Market - Global Industry Analysis: Size, Share, Growth, Trends and Forecast (2017 - 2025)

Liquid biopsy is a rapid plasma genetic analysis technique that provides a detection profile of karyotypic abnormalities in circulating tumor cells present in blood samples. Tissue biopsies are currently used for cancer diagnosis; however, the liquid biopsy technique is widely preferred and growing rapidly due to its very minimal invasiveness. Liquid biopsies are the inevitable result of many years of technological developments in cancer biomarker research identification, but there are still many promising potential test markers (e.g. extracellular vesicles) that have not yet been fully developed for their commercial application. The development of liquid biopsies, which are based on instant sequencing technology, has accelerated the advancement of cancer diagnostic techniques.

The emerging trend in the field of liquid biopsy is an alternative development to conventional tissue biopsy tools, which focuses on in-depth analysis of metastatic and prognostic aspects of specific cancer types. The global liquid biopsy market is driven by technological innovations in new tests for cancer status monitoring and the current increased sensitivity of circulating tumor cell detection technology, which is not only minimally invasive to the patient, but also has significant advantages over conventional solid tumor biopsies in terms of sensitivity for detection of genetic abnormalities; as well as growing awareness at the societal level and increasing patient acceptance of the test. However, current reimbursement policies and issues with changing government policies are expected to limit this market.

The liquid biopsy market has started segmenting and cutting based on biomarker type, cancer type, test type, application, and end user. In terms of biomarker type, the market has been categorized into circulating tumor DNA (ctDNA), circulating tumor cells (CTC), extracellular vesicles (EV), and other biomarkers. Liquid biopsies first started product development using circulating tumor cells, and since then most tests have been developed using these biomarkers. Because of the higher concentration of ctDNA in the blood stream compared to CTCs, the number of clinical trials for ctDNA analysis has now begun to increase. It is expected to create dynamic images and changes in the market within the forecast period of the line study. Based on cancer type, the market has been segmented into lung cancer, blood cancer, breast cancer, liver cancer, prostate cancer, and others. On the basis of test type, the global liquid biopsy market has been segmented into single gene assay and multi-gene assay. Based on application, the market has been categorized into diagnostic analysis, prognostic analysis, cancer surveillance, and recurrence analysis. On the basis of end user, the market has been segmented into hospital laboratories, diagnostic laboratories, academic research institutes, and others.

On the regional front, the global liquid biopsy market is segmented into five regions - North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. The market in Asia Pacific is expected to grow at a high CAGR mainly due to the increasing inclination of physicians towards the use of advanced and minimally invasive techniques in the cancer diagnosis process, rising prevalence of different cancer types, and faster growth in overall per capita health expenditure. North America is expected to dominate the global liquid biopsy market owing to the adoption of advanced products with advanced technologies, increasing R&D funding/investment, and growing demand from academic and research institutions.

The unmet medical need in cancer treatment and the need to reduce cancer mortality by providing a large number of tests in a simpler way provides an opportunity for the growth of the global liquid biopsy market. The advantages of liquid biopsies over traditional solid tissue biopsies, focused attention among key market players and research institutions, and the development of multi-protocol testing are driving the growing liquid biopsy market.

Key players in the global liquid biopsy market include QIAGEN, RainDance Technologies, Inc., F. Hoffmann-La Roche Ltd., Trovagene, Bio-Rad Laboratories, Inc., Genomic Health, Myriad Genetics, Inc., Biocept, Inc., Johnson & Johnson (Janssen Global Services, LLC), Illumina, Inc. and MDxHealth, among others.

Line Research Report 2:

Liquid Biopsy Market - Products and Services, Cancer Types, Circulating Biomarkers - Global Opportunity Analysis and Industry Forecast 2017 - 2023

Liquid biopsy is a non-invasive test that detects tumor DNA and RNA fragments and circulating tumor cells (CTCs) released into the bloodstream from the primary tumor and metastatic sites. It is a minimally invasive technique used to detect molecular biomarkers, which is relatively inexpensive and avoids invasive sampling procedures. The global liquid biopsy market size was USD 634 million in 2016 and will reach USD 3,855 million by 2023, growing at a CAGR of 28.9% from 2017 to 2023.

Liquid biopsy is a simple and accurate alternative to surgical biopsy, which allows physicians and surgeons to obtain tumor information from blood samples for monitoring and treating tumors at an early stage. It helps physicians understand the molecular changes and kinetic processes of cancer in real time. In addition, monitoring cancer recurrence through timely liquid biopsy is a very promising application scenario in the field of liquid biopsy.

A number of factors such as surge in cancer prevalence, advantages of liquid biopsy over solid tissue biopsy, increasing awareness of minimally invasive procedures, and favorable government initiatives are contributing to the growth of the liquid biopsy market. However, the ability of liquid biopsy to be a strong alternative to solid tissue biopsy and the lack of clarity regarding future reimbursement methods are hindering the growth of this market. In addition, the increase in pre-screening programs for cancer testing provides lucrative opportunities for players in the liquid biopsy segment.

The liquid biopsy market has started to be categorized on the basis of products and services, cancer type, circulating biomarkers, end user, and geography. Based on products and services, it is segmented into reagents, instruments, and services. On the basis of cancer type, it is segmented into lung cancer, breast cancer, colorectal cancer, prostate cancer, liver cancer, and other cancers. Based on circulating biomarkers, classified into circulating tumor cells, extracellular vesicles, circulating tumor DNA [ctDNA] and other biomarkers. On the basis of end users, it is divided into hospital laboratories and government and research centers. Geographically, it analyzes four regions such as North America, Europe, Asia Pacific, and Latin America.

Market Trends

The close collaboration between foreign oncology companion diagnostic companies and pharmaceutical companies.

Pfizer and Exact Sciences Collaboration

On August 22, 2018, Exact Sciences Corporation (NASDAQ:EXAS) and Pfizer Inc (NYSE:PFE) announced a partnership agreement through 2021 to jointly drive sales of Cologuard products.

Cologuard is the only FDA-approved non-invasive colorectal cancer screening test for fecal DNA.

On January 16, 2018, Foundation Medicine then announced a collaboration with Pfizer to develop companion diagnostic technology for Pfizer's oncology drugs.

On December 1, 2017, the FDA and CMS simultaneously approved Foundation Medicineqixia product FoundationOne CDx (F1CDx) for cancer clinical companion diagnostics, the first breakthrough NGS-based in vitro diagnostic product for comprehensive genomic analysis analysis of all solid tumors, covering 324 Foundation Medicine said that this companion diagnostic, developed in collaboration with Pfizer, will be launched as an upgraded version of F1CDx.

R&D Trends

Multi-gene combination testing will also become a trend

We see that both Foundation Medicine in the US and Chinese companies are promoting multi-genotype concomitant diagnostic products, but the application of specific panel size is still different between the US and China.

The U.S. FDA has approved two large panel tests from Foundation Medicine and MSK to market, and in the initial regulatory environment, with more mature technology and data, liquid biopsy companies like Guardant are mainly developing large panels, which have longer-term application scenarios. With a more long-term application scenario.

For the local situation in China, several liquid biopsy companies believe that the incidence of lung cancer in China is high, small panel will be the mainstream for a certain period of time, for pan-cancer and advanced tumors may be dominated by large panel, China in a period of time will still be dominated by small panel. At the same time, it is said that the drug use information limited to clinical guidelines, as well as accuracy, cost, medical insurance, physician education and other factors are relevant factors that limit the entry of large panels into the market, and the value of small panels will continue to exist for a long time. For liquid biopsy, excluding the very few molecular indications that must be evaluated by a large panel such as TMB, the higher sensitivity brought by a small panel is especially advantageous in the application of dynamic monitoring of the entire management, and both have their own value. If the market is sufficiently regulated, it is hoped that more small panels with clear clinical value, full clinical validation, ease of use and obvious socio-economic benefits will emerge in the industry.

In the future, as the technology improves and the cost of testing decreases and becomes affordable to patients, large panels with their more comprehensive coverage and higher efficiency will naturally become the choice of the majority of patients.

Star Company Guardant Health

Since its inception in 2012, Guardant Health (Guardant) has clearly focused on liquid biopsies for cancer, and has a number of products around liquid biopsy technology for companion diagnostics, recurrence detection and early screening.

Guardant has launched two liquid biopsy products, Guarndat360 and GuardantOMIN, and two other products in development, LUNAR-1 and LUNAR-2.

1) Guardant360: late guidance