by Ken Powell, President, Genesis Business Development
Laboratory diagnostics are essential to the delivery of healthcare. Over 70% of all clinical decisions are based on a diagnostic test result, highlighting the critical nature of this medical care delivery segment. Yet spending on diagnostics accounts for less than 3% of the annual US healthcare spend. New daily developments present those familiar with diagnostics numerous opportunities to participate in high-growth segments such as liquid biopsy.
The diagnostics market consists of two key areas; clinical diagnostics and anatomical pathology. Clinical diagnostics generate a test result and an accompanying normal range used by clinicians to guide treatment therapy. Anatomical pathology involves the microscopic examination of surgically removed tissue samples by a highly-trained pathologist to make a diagnosis to rule in/out cancer. According to Philips Healthcare, new cancer cases will rise 70% from 14 million in 2012 to over 22 million in the next two decades. Non-invasive diagnostic methods are rapidly replacing conventional, invasive procedures as evidenced by the Non-Invasive Prenatal Testing (NIPT) market that has surpassed the $1 billion-dollar mark in just a few years since introduction.
Recently, new technological developments such as next-generation sequencing and bioinformatics have given birth to the liquid biopsy market. It has emerged as an attractive and advantageous alternative to conventional surgical removal of tissue for examination by anatomical pathologists. Liquid biopsy only requires a sample of blood from the patient. The sample undergoes several pre-analytical and analytical steps to identify circulating tumor DNA. There are numerous benefits to this approach to diagnose a potential tumor. First and foremost is the non-invasive nature of liquid biopsy. In addition, it is far less costly, offers faster turnaround time to result and can be leveraged for use on other bodily fluids, among many other advantages. Just like the procedural benefits, there are many liquid biopsy applications including therapy monitoring, disease recurrence, and personalized medicine, to name a few.
MARKET GROWTH AND OPPORTUNITIES
Combined with the global aging demographics, growing cancer incidence and faster, lower cost technologies, the liquid biopsy market is expected to reach more than $2 billion by 2022. The International Association for the Study of Lung Cancer recommends that liquid biopsy should be considered for newly diagnosed patients with non-small cell lung cancer. There are dozens of companies that have entered the liquid biopsy market, given its high growth potential. M&A activity has begun, the most notable being Roche’s acquisition of Foundation Medicine for $2.4 billion for shares not already owned by Roche. Grail, a spin-off from Illumina, has already raised more than $1 billion to support its liquid biopsy research and planned tests for later this year. This is by far the largest investment raised by a diagnostic company in history.
The liquid biopsy market is a high-growth opportunity for those understanding both the benefits and challenges that remain to drive global conversion. Every indication is that liquid will follow the vertical trajectory of the NIPT market along with the automation cascade that has accompanied traditional diagnostic segments such as clinical chemistry, immunoassay and molecular diagnostics. For more information on liquid biopsy, please contact your Guidepoint representative and schedule an individual consult.
Please note: This article contains the sole views and opinions of Ken Powell and does not reflect the views or opinions of Guidepoint Global, LLC (“Guidepoint”). Guidepoint is not a registered investment adviser and cannot transact business as an investment adviser or give investment advice. The information provided in this article is not intended to constitute investment advice, nor is it intended as an offer or solicitation of an offer or a recommendation to buy, hold or sell any security. Any use of this article without the express written consent of Guidepoint and Ken Powell is prohibited.