艾昆纬-扩大美国新兴生物制药的选择：变革的十年（英）

OCTOBER2 0 2 5A Decade of ChangeExpanding Options for Emerging Biopharma in the U.S.Emerging biopharma companies — those with R&D spending less than $200Mn and revenues less than $500Mn a year — have become central to biomedical innovation over the past decade, driving the majority of novel drug launches, notably in specialty, orphan, and first-in-class categories. Their agility, resilience, strategic diversity, and focus on unmet needs position them as engines of progress in the health system. Increasingly these companies are exploring commercial markets on their own and there have been demonstrated successes with these efforts. However, challenges remain in funding, commercialization, and achieving sustained market success. This report examines the evolving landscape of emerging biopharma (EBP) companies in the U.S. over the past 10 years. Emerging biopharma companies are those with R&D spend less than $200Mn per year and revenue below $500Mn globally, and includes companies which are still pre-commercial as well as those with products in the market. It explores their growing role in drug innovation, clinical development, commercialization, and bringing new treatment options for patients. The analysis is grounded in proprietary and third-party data sources, aiming to inform stakeholders about macro trends, strategic shifts, and the implications for healthcare delivery and policy. The study was produced independently by the IQVIA Institute for Human Data Science as a public service, without industry or government funding. The contributions to this report of Tanya Bhardwaj, Dean Giovanniello, Urvashi Porwal, Adam Ureneck and dozens of others at IQVIA are gratefully acknowledged. Find Out MoreIf you wish to receive future reports from the IQVIA Institute for Human Data Science or join our mailing list, visit iqviainstitute.org. MURRAY AITKENExecutive Director IQVIA Institute for Human Data ScienceIntroduction©2025 IQVIA and its affiliates. All reproduction rights, quotations, broadcasting, publications reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopy, recording, or any information storage and retrieval system, without express written consent of IQVIA and the IQVIA Institute.Expanding Options for Emerging Biopharma in the U.S.: A Decade of ChangeREFERENCING THIS REPORTPlease use this format when referencing content from this report:Source: IQVIA Institute for Human Data Science. Expanding Options for Emerging Biopharma in the U.S.: A Decade of Change. October 2025. Available from www.iqviainstitute.orgTable of ContentsOverview 2EBPs definition and classification 5Funding and strategic transactions 8Clinical trial activity 15Clinical development productivity 22New drug launches originated by EBPs 31Commercialization by EBPs of new drugs 42Methodology 60Notes on sources 61About the authors 62About the Institute 63OverviewDEFINING EMERGING BIOPHA