Therapy selection tests are a form of liquid biopsy, which involve sequencing substrates isolated from bodily fluids, such as blood, saliva, or urine. This approach is less invasive, can be used more often, and is more cost effective than tests involving tissue sampling through invasive procedures like surgery.
Once a fluid sample is collected, substrates—including circulating tumor cells, circulating free DNA, circulating tumor DNA, or exosomes—are isolated, and further sample purification and extraction is conducted to prepare the sample for sequencing and analysis.
In the case of therapy selection liquid biopsy tests, the results inform extremely specific treatment decisions. For example, a test can assess a patient for the presence of a specific genetic mutation that would indicate that their cancer is likely to respond to a particular targeted therapy.
Several factors are driving increased demand for premium-priced therapy selection tests, including the shift toward value-based care, the proliferation of orphan drugs, and ongoing R&D.
Value-Based Care and Reimbursement
Overall, value-based care models are more outcome-oriented and are focused on the entire patient pathway.
As a result, there is increasing emphasis on personalized medicine, including the ability to not only detect cancers early but also to identify an appropriate targeted therapy that will best benefit the patient, given that early detection and the identification of a treatment method with the greatest likelihood of success for a patient have the potential to improve outcomes, enable less costly interventions, and reduce the need for retreatment and downstream costs of care.
In the US, for example, recent updates to Medicare, including the rollout of programs such as Medicare Advantage and specialty tier drug spending under Section D, have been driving the transition toward value-based care and thereby supporting the uptake of personalized medicine, including liquid biopsy tests like those used for therapy selection.
As a result, market expansion is not only being backed by increasing sophistication in diagnostic and sequencing technology, but also by reimbursement policies in some countries that ensure widespread market access and accessibility for these in vitro diagnostic and laboratory-developed tests.
Proliferation of Orphan Drug Development
Therapy selection tests can identify actionable biomarkers that uniquely correspond to one or more orphan drugs. Because of this capability, therapy selection tests have the ability to enhance treatment decisions for advanced cancer patients.
As result, as more orphan drugs are developed, demand for therapy selection tests will rise with little risk of market cannibalization between therapy selection tests.
High and Rising ASPs
Therapy selection tests provide increasingly high value through their ability to inform extremely specific and timely treatment decisions with the best potential to improve patient lives.
As a result, therapy selection tests have high baseline ASPs, and average prices are generally trending upward. The table below outlines how differently ASP growth in the therapy selection test market is compared to average medical device ASP growth in the US.
Development Partnerships and Increased Commercialization
Therapy selection tests and companion diagnostics to date have traditionally been developed using tissue-based samples, and therefore the field of liquid biopsy therapy selection tests is still nascent and requires more research and development.
Moving forward, an increasing number of key industry partnerships will be centered on the development of companion diagnostics, thereby enhancing the rate at which the field of therapy selection develops. Recent partnership and collaboration announcements include:
- QIAGEN announced a partnership with Illumina to develop and market companion diagnostics (QIAGEN, press release, October 7, 2019)
- Biodesix announced a collaboration with Thermo Fisher Scientific to develop companion diagnostics (Biodesix, press release, July 9, 2019)
- Guardant Health announced a strategic collaboration with Amgen for AMG 510, an investigational oral therapy that inhibits KRAS G12C mutant protein (Guardant Health, press release, January 13, 2020).
In addition, other upcoming entrants to the market, such as Exosome Diagnostics—which now benefits from parent company Bio-Techne's resources—continue to develop companion diagnostics.
Overall, the therapy selection test market represents a highly innovative space with several competitors developing products that have the potential to greatly improve patient experience and treatment outcomes. Market growth is also set to rise 20-30% by 2028, making this a key part of the liquid biopsy market that is definitely one to keep watch of.
For more details, see DRG Part of Clarivate’s US Markets for Liquid Biopsy report Click Here.