The global Liquid Biopsy Market is projected to be valued at USD 580.0 Million in 2016 and is expected to grow at a CAGR of 23.4% to reach to USD 2,047.9 Million by 2022, as per a report by MarketsandMarkets.
How growing interest in liquid biopsy offering opportunities for market participants?
The growing demand for noninvasive and easy sample collection and the faster diagnosis of cancer is driving the growth of the liquid biopsy market. With huge investments and growing evidence of the uses/applications of liquid biopsy, companies are increasingly looking to move into the liquid biopsy market. Over the last few years, many studies have been published demonstrating ctDNA or CTCs giving a better representative picture of tumors than traditional biopsies. As a result, many startup companies and spinouts from academic research teams have come up, including Guardant Health (US), Inivata (UK), and Pathway Genomics (US), and Personal Genome Diagnostics (US). Large players in cancer genomics have also all announced their interest in entering the market. For instance, Illumina formed a spinoff company, GRAIL, to experiment with simple blood tests for the early detection of all types of cancer. The company is Illumina’s first independent business and has access to enormous resources to experiment with liquid biopsy as a preventative test in stage one and two cancers.
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In addition, the number of these publications focusing on or pertaining to liquid biopsy has witnessed significant growth; this is a key indicator of growing interest in this field.
Why unclear regulatory and reimbursement scenario is a challenge?
Liquid Biopsy’s market growth is plagued by many challenges. Liquid biopsies are classified as laboratory-developed tests (LDT). The US FDA recently proposed a draft to increase regulations on LDTs; however, till date, the LDT regulation remains unclear. Increased regulations on LDTs by the FDA could dramatically slow the growth of the molecular diagnostics industry as well as liquid biopsy technologies. This is also likely to increase the costs associated with introducing new tests and delay their introduction in the market. Besides regulatory challenges, reimbursement challenges also exist in the liquid biopsy market.
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