推进精准肿瘤学：美国肿瘤学生物标志物检测趋势

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 targetedtherapeutics in oncology. Predictive biomarkers enable the use of these therapies.However, gaps remain in achieving optimal biomarker testing across tumor types,potentially resulting in eligible patients not receiving timely treatment. Prior IQVIA Institute research published in2020identified major barriers that limit biomarker testing forsolid tumors in the U.S. The research assessed biomarkertesting evolution over time and offered solutions to helpreduce the identified testing barriers in oncology. The report concludes with actions that stakeholderssuch as physicians, laboratory directors, and hospitalsystems can potentially utilize to ensure eligiblepatients are tested and subsequently treated withappropriate interventions. 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 cancersare included. Insights obtained from oncologiststreating these cancers, pathologists, and lab directorsare also discussed. While data on DLBCL biomarkertesting rates are not included due to limitedpredictive biomarkers, perspectives from interviewedstakeholders are used to understand current testingpractices and perceived barriers to adoption in thathematological malignancy. The study was produced independently by theIQVIA Institute for Human Data Science. Funding forthis work and report has been provided by AstraZeneca.The contributions to this report of Heena Darira,Sarah Frieman, Esha Hase, Jen Karweit, and others atIQVIA are gratefully acknowledged. Find Out More If you wish to receive future reports from the IQVIAInstitute for Human Data Science or join our mailing list,visit iqviainstitute.org. MURRAY AITKENExecutive DirectorIQVIA Institute for Human Data Science The research also assesses several inflection points thatappear to trigger successful integration of a biomarkerin cancer clinical care and identifies persistent barriers tobiomarker testing. REFERENCING THIS REPORT Please 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.Available from www.iqviainstitute.org ©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, withoutexpress written consent of IQVIA and the IQVIA Institute. Advancing Precision Oncology: Trends in Oncology Biomarker Testing in the U.S. Table of Contents Overview2Predictive biomarker testing in precision oncology5Variation of biomarker testing across tumor types7Biomarker testing trends in the U.S.10Inflection points11Case Study: ALK and NTRK biomarker testing rates in NSCLC14Barriers to biomarker testing and proposed best practices16Notes on sources21Appendix22References24About the authors26About the Institute27 Overview 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 andprognostic purposes. Up to 76% of patients acrossthe assessed tumor types receive oncology care at acommunity-based hospital (compared to academicinstitutions) signaling the imperative to ensure equitablebiomarker testing adoption across practice settings. 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 reportin2020, the biomarker testing landscape has evolved,marked by increased testing rates, expanded clinicalevidence enabling the identification of novel biomarkers,and broader integration of biomarkers into nationalguidelines. However, persistent gaps remain, leavingsome eligible patients without timely access topersonalized treatments. 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 therapytarget