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Trends in Oncology Biomarker Testing in the U.S. Introduction Over the last two decades, advances in cellular and molecular understanding ofcancer have significantly accelerated, leading to better characterization of tumorbiology. This has paved the way for a transition towards increasing use of targeted The report concludes with actions that stakeholderssuch as physicians, laboratory directors, and hospitalsystems can potentially utilize to ensure eligible Prior IQVIA Institute research published in2020identified major barriers that limit biomarker testing forsolid tumors in the U.S. The research assessed biomarker The purpose of this report is to understand how thebiomarker testing landscape has changed since thatpublication. In addition to NSCLC — which was theprimary tumor of focus for the 2020 report —testing rates in breast, ovarian, and prostate cancers The study was produced independently by theIQVIA Institute for Human Data Science. Funding forthis work and report has been provided by AstraZeneca. Find Out More If you wish to receive future reports from the IQVIAInstitute for Human Data Science or join our mailing list, MURRAY AITKENExecutive Director The research also assesses several inflection points thatappear to trigger successful integration of a biomarker REFERENCING THIS REPORTPlease use this format when referencing content from this report:Source: IQVIA Institute for Human Data Science. Advancing Precision Oncology: Trends in Oncology Biomarker Testing in the U.S. March 2026. ©2026 IQVIA and its affiliates. All reproduction rights, quotations, broadcasting, publications reserved. No part of this publication may be reproduced ortransmitted in any form or by any means, electronic or mechanical, including photocopy, recording, or any information storage and retrieval system, without Table of Contents OverviewPredictive biomarker testing in precision oncologyVariation of biomarker testing across tumor typesBiomarker testing trends in the U.S.Inflection pointsCase Study: ALK and NTRK biomarker testing rates in NSCLC Overview Advances in cellular and molecular oncology haveaccelerated the adoption of precision medicine,positioning biomarker testing as a cornerstone fordelivering targeted therapies across multiple tumortypes. Since the previous IQVIA Institute reportin time period. Diffuse large B cell lymphoma (DLBCL),as a hematological malignancy, presents uniquediagnostic complexities due to the heterogeneousnature of the disease resulting in a high unmet needfor streamlined biomarker testing for diagnostic and Three key events, or ‘inflection points,’ can enable thesuccessful adoption of oncology biomarkers. First, robustclinical evidence must demonstrate the biomarker’spredictive value for therapeutic response. This is typicallyfollowed by regulatory approval and downstreamprocesses, including payer coverage, laboratorystandardization, real-world evidence generation, andpost-marketing learning around the precision therapytargeting that biomarker along with its companiondiagnostic. After gaining stakeholder consensus, The analysis provides an assessment of biomarkertesting trends from 2020 to 2024, focusing on NSCLCand breast cancer. Broad testing rates are included forovarian and prostate malignancies. Real-world data Testing rates for established biomarkers in non-smallcell lung cancer (NSCLC), breast and ovarian cancerapproach 95%, 80% and 80% respectively as of Dec Up to 76% of patients acrossthe assessed tumor typesreceive oncology care at a A case study using ALK and NTRK biomarker testing asexamples showcases how targeted therapies translateinto clinical practice through the mediating steps ofregulatory approval and guideline endorsement. The their timely accessibility for clinical decision-making.Additionally, poor interoperability between systems 5. Clinician and patient awareness and education •Provider familiarity with emerging biomarkers isoften limited, particularly in the community practicesetting, which can slow adoption in clinical practice. However, barriers to biomarker testing persist despitethe significant increase in testing rates observed inoncology over the past five years. These barriers can be Insights from stakeholder engagement highlight bestpractices such as rapid onsite evaluation of biopsysamples to ensure integrity for accurate diagnosis anddownstream biomarker testing, reflex testing protocolsthat automatically trigger biomarker testing upon 1. Biospecimen quality •The integrity of biopsy tissue can vary significantly,which directly impacts the validity and even ability to 2. National guidelines and clinical pathway integration •Clinical guidelines often lag behind emergingbiomarkers, delaying their incorporation into standardpractice. Decision-making is further complicated To fully realize the promise of precision oncology,coordinated action is required across the healthcareecosystem. Identified best practices include standardiz