Liquid Biopsy Market Gets Off to Big Start in 2016

Liquid biopsies have been likened to a Holy Grail of cancer treatment. By means of a simple blood draw, liquid biopsies aim to replace needle biopsies of solid tumors, which can be expensive for the healthcare system as well as invasive and painful for patients. For diagnosis of cancer, liquid biopsies could spare some of the risky tissue biopsies and reduce reliance on CT scans, which must be limited because of the danger posed by overexposure to radiation.

Liquid biopsies are a sequencing-based technology used to screen blood for tiny fragments of genetic material released by cancer tissue, known as circulating tumor (ct) DNA. Liquid biopsies can detect cancers very early, even before the onset of symptoms, with just a few drops of blood. Not only can blood be taken at the point of care, but successive blood draws can be easily done to monitor disease progression and to direct treatment. The promise of a liquid biopsy is to provide a cheaper, less intrusive way to track how a cancer is mutating or responding to treatment.

ILLUMINA LAUNCHES A NEW COMPANY, APTLY NAMED "GRAIL"

Spotlighting the rise of liquid biopsies, GRAIL is a new company backed by such luminaries as DNA sequencing technology company Illumina, Inc.; Microsoft co founder Bill Gates; Amazon.com founder Jeff Bezos; and ARCH Venture Partners. As described above, GRAIL aims to use a simple blood draw to detect early-stage cancer before symptoms are even visible.

GRAIL’s inception was announced in early January. It will develop a pan-cancer screening test by directly measuring circulating nucleic acids in blood. Formed as a separate company, GRAIL is majority owned by Illumina. It is initially funded by over $100 million in Series A financing from Illumina and ARCH Venture Partners, with participating investments from Bezos Expeditions, Gates, and Sutter Hill Ventures.

AN EXPLOSION OF INTEREST AND FUNDING IN LIQUID BIOPSIES 

GRAIL is joined by several other ventures that also announced the closing of finance rounds during January. In aggregate, the funds raised amount to about $300 million for the month.

Inivata Limited is using ctDNA analysis to improve personalized healthcare in oncology. Toward the end of January, Inivata announced completion of a Series A fundraising of $45 million. Existing investors Imperial Innovations, Cambridge Innovation Capital, and Johnson & Johnson Innovation – JJDC, Inc. all participated in the round, as did new investor Woodford Patient Capital Trust.

The new funds will be used to accelerate clinical studies to validate Inivata’s technology and to commercialize its first products. Inivata’s platform will initially be applied across a spectrum of solid tumors, including lung, breast, and colon cancers. Inivata’s test is designed to provide oncologists with clinically actionable genomic information to guide therapy selection, monitor treatment progress, and detect new mutations as they emerge.

On January 7, Exosome announced it had closed a $60 million Series B round of funding. Exosome said it would put the money toward getting its first oncology products on the market, expanding its diagnostics and regulatory divisions, and funding research into diagnostic tests for additional diseases. Two weeks later, Exosome launched ExoDx Lung(ALK), a liquid biopsy test designed to isolate and analyze exosomal RNA from a blood sample. ExoDx Lung(ALK) enables sensitive, accurate, and real-time detection of EML4-ALK mutations in patients with non–small-cell lung cancer. The company has received backing from Qiagen, CD Ventures, Monashee Capital, Arcus Ventures, Forbion Capital Partners, NGN Capital, Tiger Management, and Blue Ridge Capital.

The same week, Guardant Health Inc. announced it had raised almost $100 million in a Series D round (the same amount of money put forward by Illumina to launch GRAIL). Guardant seeks to expand the use of blood tests to screen for cancer DNA. The fundraising was led by healthcare investment firm OrbiMed Advisors and included Khosla Ventures, Sequoia Capital, and Formation 8. Including previous financing, Guardant has raised a total of nearly $200 million. Guardant, founded in 2012, is developing the Guardant360, a test that looks for tumor DNA (for almost every type of cancer) that is shed into the bloodstream. Guardant360 has a retail price of approximately $5,400.

DIAGNOSTIC EFFICACY OF LIQUID BIOPSY HAS MARKET BOOMING

Demonstration of its clinical utility in several key applications has spurred soaring growth in the market for liquid biopsy diagnostics. BCC Research reveals that this industry is poised to break into multiple applications, including the average-risk noninvasive prenatal testing (NIPT), cancer monitoring, and organ transplantation surveillance segments.

According to a BCC Research analysis, the global liquid biopsy market, which totaled $1.6 billion in 2015, is growing at a five-year compound annual growth rate (CAGR) of 22.3%. At this pace, its value will be nearly $4.5 billion by 2020. The cancer lipid biopsy market, the fastest-growing segment with a five-year CAGR of 36.2%, was $414.5 million in 2015 and should reach $1.9 billion by 2020. The global non cancer market for liquid biopsies (reproductive health and organ transplant diagnostics) totaled $1.2 billion in 2015. Growing at a five-year CAGR of 15.7%, this larger segment should reach $2.5 billion by 2020.

Growing support by the medical communities is helping to drive this growth for the liquid biopsy market. For NIPT, the key medical societies have endorsed its application for high-risk pregnant women. For other markets in cancer or transplantation medicine, a growing body of clinical evidence is critical to garner the support of key stakeholders for liquid biopsy diagnostics.

“A main objective of post-transplant surveillance is to improve the outcomes for patients,” says BCC Research analyst John Bergin. “A key driving force for the use of liquid biopsy is clinical evidence that it does. During the past several years, this evidence has become stronger as a result of multiple studies using cfDNA [cell-free DNA] as a biomarker. It is expected that this evidence, together with ongoing efforts by companies developing these biomarkers, will contribute to the market growth of this application in the future."

PUBLIC COMPANIES DEVELOPING LIQUID BIOPSY CANCER TESTS 

That cancer screening could be as simple as a blood test during an annual physical exam is an exciting medical breakthrough, with products already on the market. A number of companies working in this area have been long established and are publicly traded. Some of them are described in the following paragraphs.

Founded in 1992, Myriad Genetics’ initial product was a 25-gene test called myRisk, which identifies an elevated risk for eight cancers using a blood sample. Since then, Myriad has developed an entire suite of liquid biopsy tests. Upward of 90,000 physicians have ordered Myriad’s tests, with more than 2 million tests having been performed so far.

Oncocyte, which was founded in 2009, is developing liquid biopsy diagnostic tests in areas of high unmet need in oncology, specifically lung and breast cancers. With an IPO that just took place at the beginning of this year, Oncocyte has yet to generate any revenues.

Formed in 1993, Vermillion has developed the first FDA-cleared, multimarker blood test that helps assess the risk of ovarian cancer prior to surgery. Using five biomarkers and the patient’s menopausal status, the OVA1 liquid biopsy test helps detect more ovarian cancer than standard testing.

Veracyte’s market debut was in 2013. Its liquid biopsy tests target lung and thyroid cancers. The Afirma Thyroid FNA Analysis uses a proprietary 142-gene signature to preoperatively determine whether thyroid nodules previously deemed by cytopathology as indeterminate can be reclassified as benign. The Percepta Bronchial Genomic Classifier is for use in lung cancer diagnosis.

Foundation Medicine's IPO was on September 25, 2013. Although its first product, FoundationOne, required a tissue biopsy, its second product, FoundationOne Heme, is a liquid biopsy. FoundationOne Heme simultaneously detects all classes of genomic alterations in 405 cancer-related genes.

Genomic Health’s market debut was in 2005. Similar to Foundation Medicine, Genomic Health has made a strong business of detecting cancer in tissues obtained from biopsies, using its Oncotype DX test suite. This month, Genomic Health announced plans to launch its first liquid biopsy test, Oncotype SEQ, in mid-2016. The test is a blood-based mutation panel that uses next-generation sequencing to identify select actionable genomic alterations for the treatment of patients with late-stage lung, breast, colon, melanoma, ovarian, or gastrointestinal cancers.

Biocept uses liquid biopsy for analysis of circulating tumor cells and biomarkers in blood. Biocept is developing its OncoCEE platform, which it claims offers 10–100 times the sensitivity of competing platforms in detecting cancer mutations in the bloodstream. Biocept continues to strengthen its patent portfolio and sign commercial agreements. Its IPO was on February 4, 2014.

LIQUID BIOPSY RESEARCH TOOLS, SERVICES AND DIAGNOSTICS: GLOBAL MARKETS

BCC Research’s new study examines biopsy technologies, clinical applications, industry structure, key liquid biopsy funding initiatives, global markets, patent statuses, and companies. Analyses of global market drivers and trends, with data from 2014, estimates for 2015, and projections of CAGRs through 2020, are also provided. For more, see also Liquid Biopsies for Cancer Screening: An Emerging Sector of the POC Blood Testing Market.