Advancing Precision Oncology

Institute Report

Trends in Oncology Biomarker Testing in the U.S.

Mar 09, 2026

Report Summary:

Advances in cellular and molecular oncology have accelerated the adoption of precision medicine, positioning biomarker testing as a cornerstone for delivering targeted therapies across multiple tumor types. Since the previous IQVIA Institute report in 2020, the biomarker testing landscape has evolved, marked by increased testing rates, expanded clinical evidence enabling the identification of novel biomarkers, and broader integration of into national guidelines. However, persistent gaps remain, leaving some eligible patients without timely access to personalized treatments.

Prior IQVIA Institute research published in 2020 identified major barriers that limit biomarker testing for solid tumors in the U.S. The research assessed biomarker testing evolution over time and offered solutions to help reduce the identified testing barriers in oncology.

The purpose of this report is to understand how the biomarker testing landscape has changed since that publication. In addition to NSCLC - which was the primary tumor of focus for the 2020 report - testing rates in breast, ovarian, and prostate cancers are included. Insights obtained from oncologists treating these cancers, pathologists, and lab directors are also discussed.

Key findings:

There is an expanding use of predictive biomarkers across tumor types. Testing rates for established biomarkers in non-small cell lung cancer (NSCLC), breast and ovarian cancer approach 95%, 80% and 80% respectively as of Dec 2024, while prostate cancer lags at ~75% for the same time period.

NGS adoption continues to rise across all tumor types. NSCLC remains the most mature setting, with consistently high NGS utilization above 90%
Testing turnaround times differ by tumor type and care setting. In breast cancer, academic centers generally return PCR, IHC, and FISH results up to one to two days faster than community hospitals. For NSCLC, community practices deliver PCR results six days earlier and NGS results two days earlier than academic institutions.

Stakeholder interviews highlight three events, or “inflection” points that accelerate biomarker integration into clinical practice:
- Robust clinical evidence demonstrating predictive value, followed by FDA approval and payer alignment
- Formal inclusion in national guidelines, particularly NCCN and ASCO
- Institution‑level advocacy, typically led by an oncologists or pathologist who champions adoption through tumor boards and workflow integration

Barriers to biomarker testing persist despite the significant increase in testing rates observed in oncology over the past five years. These barriers can be broadly categorized into main areas including biospecimen quality, national guideline and clinical pathway integration, insurance coverage and reimbursement, clinical information and technology interoperability, clinician and patient awareness and education

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