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The way cancer is diagnosed, treated, and monitored is changing more rapidly than ever. In 2019, we expect there to be catalysts that fundamentally change cancer companion diagnostic biomarker testing (i.e., FDA approval of TMB and liquid biopsy assays, new pan-cancer drug approvals, and increasing payor coverage of next-generation sequencing). As we anticipate these changes, it is useful to assess the current state of emerging cancer biomarkers. Our diagnostics market researchers recently fielded pulse surveys of oncology stakeholders (one focusing on oncologists, another focusing on pathologists and lab directors) to gather feedback on the current adoption of emerging / next-generation biomarkers, as well as expectations for future adoption and landscape trends. While these surveys are not intended to provide a quantitatively representative, summary view of the entire oncology diagnostic landscape, they do provide interesting directional insights on biomarker trends. The data from these surveys can be seen in the Tableau dashboards below. Use the control panel on the left-hand side of each dashboard to explore the responses and segment the data as desired.
Note, if you participated in the survey, you can compare your responses to the overall results by selecting your Response ID from the dropdown menu and clicking on the blue circle.
While there are many interesting insights to glean from this diagnostics marker research data, a few points that caught our attention include:
1) Bioinformatics remains a barrier to NGS CDx adoption within hospitals. While the adoption of NGS is high among our surveyed population (~70%), the perceived ability to conduct various NGS-related assays in-house among hospital labs was significantly lower. For example, only ~35% of labs surveyed (~20% of community hospital labs and ~45% of academic hospital labs) indicated that they have the capability to adopt tissue-based TMB in house today or in the immediate future. Perceived ability to adopt other NGS-related biomarkers decreases with increasing panel size, blood-based testing, and RNA-based analysis (i.e., gene expression profiling). In another survey question to pathologists and lab directors (not shown in the dashboard), respondents listed “too much information without clinical implications” as the second-most significant barrier to adoption of NGS, behind “unfavorable cost-to-reimbursement ratio.”
2) Oncology stakeholders are preparing for broad adoption of TMB in the near term. Although TMB has not yet been approved as a biomarker for any indication, over a quarter of oncologists surveyed have adopted the marker into their routine care (with adoption across multiple solid tumor indications), and another 15% of oncologists expect to adopt it into practice within the next year (more than any other biomarker). Within AMCs, nearly 40% of oncologists that treat primarily lung cancer have adopted the marker. The relatively low share of labs that conduct this testing in-house today (~16% of respondents) indicates that the majority of TMB testing is currently being conducted in reference labs, however, nearly a quarter of labs (primarily AMC labs) indicated the expectation to adopt TMB in-house in the next year.
3) Oncology stakeholders largely expect NGS testing to remain centralized to AMCs and reference labs. Despite the expected approval and broad adoption of TMB, availability of increasingly inexpensive sequencers, FDA-approved CDx kits, and CMS coverage of NGS testing, most respondents, even those from the community setting, expect the majority of NGS testing volumes to remain centralized within AMCs and commercial reference labs (one exception is respondents from molecular pathology labs, who foresee broader decentralization into the community setting). While we expect to see some decentralization of targeted panels into the community, the sequencing and bioinformatics burden associated with larger panels, and the rapidly changing biomarker landscape may favor centralized settings that have the expertise to conduct more complex assays and respond better to changes, which brings me to my next observation…
4) Capacity and expectation to adopt non-genomic next-generation biomarkers in-house are low. Beyond genomic-based biomarkers, the perceived ability to adopt other types of next-generation biomarkers (e.g., multiplex / digital IHC, multiplex flow cytometry, neoepitope analysis, cytokine profiling) is even more limited within hospital labs, even among AMCs, which are generally more willing to adopt early-stage, translational technologies. While many of these emerging biomarkers are still years away from having direct clinical utility, the lack of interest in bringing these techniques in-house underscores the role that specialty service providers will play in the future of companion diagnostics and biomarker development.
We will continue to track the oncology biomarker and diagnostics space closely throughout 2019 and look forward to updating this analysis with new responses in a few months to assess changes in adoption, utilization, and perspectives. In the meantime, if you would like to see more insights and data on the oncology biomarker and technology landscape, check out some additional summary analysis of this data, our oncology biomarkers market report and liquid biopsy market report, and our Immuno-Oncology BioMAP.
Happy New Year!
Andrew Aijian is a Principal at DeciBio Consulting with expertise in the immuno-oncology, companion diagnostics, and molecular diagnostics markets. Andrew leads in a wide variety of consulting engagements in these markets, including market sizing, competitive landscape assessment, product strategy, and commercial due diligence. Connect with him on LinkedIn.
Susan Zhou is an Associate at DeciBio with experience in variety of consulting engagements within the molecular diagnostics industry, including market sizing, opportunity assessment, and go-to-market strategy. Susan is passionate about supporting innovative diagnostic technologies, with particular interest in liquid biopsies. Connect with her on LinkedIn.