{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,31]],"date-time":"2026-10-31T02:31:22Z","timestamp":1793413882497,"version":"4.5.0"},"reference-count":17,"publisher":"Springer Science and Business Media LLC","issue":"6","license":[{"start":{"date-parts":[[2026,8,7]],"date-time":"2026-08-07T00:00:00Z","timestamp":1786060800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,8,7]],"date-time":"2026-08-07T00:00:00Z","timestamp":1786060800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Ther Innov Regul Sci"],"published-print":{"date-parts":[[2026,11]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>For several decades, the United States (U.S.) has been the leader in biopharmaceutical advancements. Recently, the U.S. has increased government interventions to limit prices for patent-protected medicines. While it is unclear whether ongoing efforts to implement international reference pricing in the U.S. could have similar effects, descriptive measures of global biopharmaceutical market dynamics can help benchmark future assessments. In this analysis, we analyzed trends in the geographic distribution of select measures of biopharmaceutical leadership from 2004 through 2024. Using the PharmaProjects database from Citeline, we found that 43.1% of first launches of small-molecule and biologic drugs occurred in the U.S., 15.3% occurred in Europe, and 9.9% occurred in China. Over this time, the share of drugs launched first in the U.S. went from 45.9 to 37.8%, the share of drugs launched first in Europe fell from 26.7 to 8.5%, while this share in China grew from 3.3 to 28.7%. The share of first-launched therapeutics developed by U.S.-headquartered companies and by companies based in Europe declined while the share developed by companies based in China increased. Though additional research is needed on the measurement of biopharmaceutical leadership, and impacts of government intervention, this descriptive study suggests that over several decades, there has been a strong decline in European measures of leadership. At the same time, China is becoming increasingly important in the global biopharmaceutical space. This analysis supports the view that the U.S remains a leader, and offers a benchmark and context for future evaluations that consider potential unintended consequences of ongoing proposals to increase government intervention in the prices of patent-protected medicines.<\/jats:p>","DOI":"10.1007\/s43441-026-01031-w","type":"journal-article","created":{"date-parts":[[2026,8,7]],"date-time":"2026-08-07T18:02:21Z","timestamp":1786125741000},"page":"1687-1696","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["The Changing Landscape of Global Biopharmaceutical Leadership, 2004\u20132024"],"prefix":"10.1007","volume":"60","author":[{"given":"Yevgeniy","family":"Feyman","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John M.","family":"O\u2019Brien","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan D.","family":"Campbell","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,8,7]]},"reference":[{"issue":"2","key":"1031_CR1","doi-asserted-by":"publisher","first-page":"452","DOI":"10.1377\/hlthaff.25.2.452","volume":"25","author":"HG Grabowski","year":"2006","unstructured":"Grabowski HG, Wang YR. 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Does adoption of pharmaceutical innovation respond to changes in the regulatory environment? Appl Econ Perspect Policy. 2012;34(3):531\u201353. https:\/\/doi.org\/10.1093\/aepp\/pps027.","journal-title":"Appl Econ Perspect Policy"},{"key":"1031_CR8","doi-asserted-by":"crossref","unstructured":"Andrew Mulcahy. Comparing new prescription drug availability and launch timing in the United States and other OECD countries [Internet]. RAND Corporation; 2024. Available from: https:\/\/www.rand.org\/pubs\/research_reports\/RRA788-4.html","DOI":"10.7249\/rhq-11-03-04"},{"issue":"1","key":"1031_CR9","doi-asserted-by":"publisher","DOI":"10.1016\/j.drudis.2025.104588","volume":"31","author":"MS Kinch","year":"2026","unstructured":"Kinch MS, Alawi A, Schwartz T, Kraft Z. Geopolitical contributions to pharmaceutical innovation. Drug Discov Today. 2026;31(1):104588. https:\/\/doi.org\/10.1016\/j.drudis.2025.104588.","journal-title":"Drug Discov Today"},{"key":"1031_CR10","doi-asserted-by":"publisher","unstructured":"Stergiopoulos S, Getz KA, Blazynski C. Evaluating the completeness of ClinicalTrials.gov. Ther Innov Regul Sci. 2019;53(3):307\u201317. https:\/\/doi.org\/10.1177\/2168479018782885","DOI":"10.1177\/2168479018782885"},{"issue":"5","key":"1031_CR11","doi-asserted-by":"publisher","first-page":"344","DOI":"10.1038\/d41573-023-00058-0","volume":"22","author":"Q Ge","year":"2023","unstructured":"Ge Q, Xu L, DiMasi JA, Kaitin KI, Shao L. Impact of regulatory system changes on the availability of innovative drugs in China. 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