5 Trends to Watch in the Liquid Biopsy Market

5 Trends to Watch in the Liquid Biopsy Market

Liquid biopsy has grabbed the attention of people seeking a novel approach to cancer testing, and many predictions regarding the liquid biopsy market's future have been made. Non-invasive approaches to cancer testing provide advantages over surgical biopsies. Liquid biopsy testing is an attractive alternative to the high costs and undesirable side effects as well as financial pressure from public and private payers associated with other cancer treatment therapies. Liquid biopsy tests determine a patient's suitability to a particular therapy, reducing or eliminating the use of unnecessary and ineffective drugs as well as their undesirable effects. 

Cancer treatment’s growing complexity is prompting demand for more liquid biopsy tests during patient care. The liquid biopsy market's available medical technologies use the analysis of various analytes, including circulating tumor DNA (ctDNA), circulating tumor cells (CTCs), extracellular vesicles (exosomes), proteins, miRNA, and mRNA. ctDNA and CTCs have so far been the most explored and commercially developed technologies among these analytes.

Kalorama Information's new report, The Worldwide Market for Liquid Biospy, estimates the liquid biopsy market size, and divides the market into technology and application segments. 

Liquid biopsy is experiencing four trends driving growth, and one trend that should be watched as a limited trend: 

1. Personalized Medicine to Spur Use of Liquid Biopsy Tests in Clinical Practice 

In oncology, patient treatment is shifting from non-specific, cytotoxic chemotherapy to immunotherapy and targeted approaches, which focus on specific genetic characteristics of patients that are determined through either tissue or liquid biopsy methods prior to or during cancer therapy. There are 80 approved and commercially available therapeutics that target cancer biomarkers; these cancer therapeutics are undergoing late stage development, prompting the need for diagnostic and monitoring tests that accompany these cancer therapies. 

The liquid biopsy market's general focus has been, given these aspects, on developing diagnostic and monitoring tests for clinically-actionable molecular targets for which therapies have been approved and commercialized, or are currently in development. Liquid biopsy's focus on these tests is expected to exert major market influence in the near future. 

2. Liquid Biopsy Market's Use of Tests to Increase Due to decreasing Genetic Testing Costs

Molecular diagnostics' (particular next-generation sequencing's) improvements and costs improvements have decreased in recent years. For molecular diagnostics, this means application in clinical diagnostics is more feasible from a commercial standpoint, making molecular diagnostics more accessible to a larger number of patients. The expansion of leading next-generation sequencing companies, such as Illumina, into clinical diagnostics, is expected to lead to further decreases in the cost of genetic testing in clinical settings.

Liquid biopsy company Illumina, through its startup GRAIL, plans to develop affordable blood-based pan-cancer screening tests for early cancer detection, to be launched by 2019 at $1000 or less. It remains to be seen how Illumina's endeavor will work in the liquid biopsy market, but it's expected to considerably advance the science and technology behind next-generation sequencing and biopsy testing, further lowering liquid biopsy diagnostics' costs. 

3. Cancer Testing Volumes to Increase Due to Rising Global Life Expectancies and Cancer Incidences 

The World Health Organization reports that about 32.6 million people suffered from cancer in 2012 given the latest global data, with global incidence of new cancer cases estimated at 14.1 million. Geographically, the highest incidence of all cancer types occurs in the Western Pacific and European & American regions. Cancer incidence seems to rise with increasing incomes. Lung, breast, colorectal, prostate, and stomach cancers are the five most prevalent cancer types worldwide. 

Rising incidence of all cancer types is attributed to an aging global population and longer life expectancies. Cancer incidence is also associated with the majority of geographical regions' - especially developed countries' - rising life expectancies. Europe's population of people over 65 years of age is projected to rise to about 20-25% of the entire population by 2025. The U.S.' 65+ population segment is estimated to reach 72 million by 2030. 

The Asia Pacific region is expected to see an increase of its 65+ population segment, from approximately 420 million in 2010 to nearly 1.3 billion by 2050, which will represent about 25% of the region's total population. Japan's government projects the 65+ population segment to increase from 22% in 2008 to around 40% by 2050. 

The estimated incidence of 14.1 million new cancer cases in 2012 is projected to rise by approximately 51% to reach 21.3 million cases by 2030, given population and life expectancy trends as well as cancer risk factors such as sedentary lifestyles and poor diets. General cancer monitoring and diagnostic tests are expected to experience a large catalyst for their demand in the form of rising disease incidences. Tissue biopsies' and imaging-based cancer diagnostics & monitoring tests' current limitations are expected to strengthen the case for liquid biopsy testing, especially if liquid biopsy testing's clinical applications are demonstrated. 

4. New Liquid Biopsy Product Launches to Augment Market Revenues 

Tissue biopsies are surgical procedures that pose certain risks and conveniences to patients, and are expensive as well as difficult (sometimes impossible) to obtain in certain situations. Given tissue biopsy's limitations on prospective patients, oncological clinical practice has a high unmet need for non-invasive testing, which has spurred development of liquid biopsy tests for the diagnosis and monitoring of cancer patients. Diagnostic companies in the liquid biopsy market have responded to this need by undertaking technological approaches to develop these diagnostics tests for an array of applications and cancer types. Many diagnostic companies of various sizes and capabilities have also recently entered the biopsy field, pursuing novel technologies or setting ambitious goals such as the diagnosis of all cancer types at early stages. For example, Illumina, the largest player in the next-generation sequencing market, has expanded its reach into clinical diagnostics in general and liquid biopsy in particular.

QIAGEN, another major molecular and clinical diagnostics & genetic analysis technologies player, has established its presence in the liquid biopsy market, and is expected to consolidate it through its multiple diagnostic technologies and expertise in developing new liquid biopsy tests. QIAGEN activates in the market on multiple fronts, such as ctDNA, CTCs and miRNA. QIAGEN currently markets the CE-marked ctDNA-based therascreen EGR RGQ Plasma PCR kit, a companion diagnostic test for AstraZeneca’s tyrosine kinase inhibitor Iressa in non-small cell lung cancer treatment, and the CTC-based AdnaTests for prognosis and therapy monitoring in breast, ovarian, colorectal, and prostate cancers.

Many commercial liquid biopsy tests are addressed to therapy selection and monitoring, and involve the molecular characterization of analytes such as ctDNA, CTCs, or exosomes, looking in particular for expression of clinically-validated, treatment-associated biomarkers. This trend has become predominant even in the field of circulating tumor cells, which initially focused on cell enumeration for prognosis purposes. For example, Biocept introduced to the liquid biopsy market their Target Selector blood-based tests that intend to assist oncologists in deciding the optimal therapy for cancer patients. The molecular characterization of CTCs has been facilitated also by the development of technologies that are capable of capturing intact, viable CTCs with high yields.  Besides complementing or replacing tissue biopsies, such new products are also expected to be widely used to enhance the management of cancer patients and therapeutic outcomes, and thus lead to a substantial growth of market revenues. However, an extensive validation of these tests in clinical trials is definitely required before they are expected to gain widespread adoption in clinical practice.

5. Limitations in Third-Party Payer Coverage to Restrict Test Utilization and Liquid Biopsy Market Growth 

Liquid biopsy's market growth is beset by challenges. Third-party public and private payers have not included many liquid biopsy tests in their coverage guidelines, due to insufficient clinical validation and utility of many existing liquid biopsy tests. Liquid biopsy companies usually seek coverage for their tests under the existing CPT codes for tissue-based biomarker tests, typically using stacked codes methodologies. However, in most cases there is no automatic reimbursement and payers have great latitude in determining coverage and reimbursement rates for these tests.

U.S. cancer patients’ main insurer is currently Medicare, which exerts strong influence on private insurers’ coverage decisions. Liquid biopsy tests can vary significantly and change every year as determined by regional Medicare contractors, given that Medicare coverage and reimbursement rates are revised on an annual and geographic basis. Furthermore, even if coverage of a particular test has been available at some point, third-party payers can limit it based on factors such as lack of health outcomes improvement data following the use of such assays in clinical practice, as the Medicare contractor Palmetto GBA decided in the case of CellSearch in 2014.

Additionally, many liquid biopsy tests are not among standard clinical guidelines for cancer patient management, which impacts reimbursement decisions by third-party public and private payers, limiting coverage and hindering liquid biopsy's growth.  In order to gain inclusion in treatment guidelines, liquid biopsy, as any other diagnostic tests, should demonstrate medical necessity and improvement in patient and clinical management outcomes, and not just the ability to detect a specific biomarker.

To compound these challenges, the cancer diagnostics market in general has been impacted by falling or stagnant reimbursement rates in recent years in major markets. The reimbursement rate for the CellSearch test has remained constant at a median price of $334.37 in 2015, 2016, and 2017.  These third-party payor reimbursement challenges are expected to continue during the forecast period of this study and exert a restrictive effect on the growth of the liquid biopsy market.

More information can be found in Kalorama's report on liquid biopsy markets at: https://www.kaloramainformation.com/Worldwide-Liquid-Biopsy-Analyte-ctDNA-cfDNA-Application-Screening-Drug-Monitoring-Diagnostic-Region-Europe-Asia-ROW-Type-Cancer-10975987/.