{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,14]],"date-time":"2026-09-14T09:07:57Z","timestamp":1789376877964,"version":"build-2803163510"},"reference-count":23,"publisher":"Springer Science and Business Media LLC","license":[{"start":{"date-parts":[[2026,9,14]],"date-time":"2026-09-14T00:00:00Z","timestamp":1789344000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"},{"start":{"date-parts":[[2026,9,14]],"date-time":"2026-09-14T00:00:00Z","timestamp":1789344000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"}],"funder":[{"DOI":"10.13039\/501100003478","name":"Ministry of Health, Labour and Welfare","doi-asserted-by":"publisher","award":["25IA2010"],"award-info":[{"award-number":["25IA2010"]}],"id":[{"id":"10.13039\/501100003478","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100005405","name":"Ritsumeikan University","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100005405","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Pharm Med"],"DOI":"10.1007\/s40290-026-00636-8","type":"journal-article","created":{"date-parts":[[2026,9,14]],"date-time":"2026-09-14T09:00:30Z","timestamp":1789376430000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Manufacturer-Perceived Development and Market-Entry Risks Associated with Discontinuation and Non-launch of Generic Medicines in Japan: A Cross-Sectional Survey of Marketing Authorization Holders"],"prefix":"10.1007","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6422-2425","authenticated-orcid":false,"given":"Hiroaki","family":"Mamiya","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Harumi","family":"Tagoku","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ken-ichi","family":"Izutsu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,9,14]]},"reference":[{"issue":"3","key":"636_CR1","doi-asserted-by":"publisher","first-page":"369","DOI":"10.1017\/S1744133110000332","volume":"6","author":"T Iizuka","year":"2011","unstructured":"Iizuka T, Kubo K. The generic drug market in Japan: will it finally take off? Health Econ Policy Law. 2011;6(3):369\u201389. https:\/\/doi.org\/10.1017\/S1744133110000332.","journal-title":"Health Econ Policy Law"},{"issue":"1","key":"636_CR2","doi-asserted-by":"publisher","first-page":"63","DOI":"10.1111\/j.1468-5876.2008.00465.x","volume":"60","author":"T Iizuka","year":"2009","unstructured":"Iizuka T. Generic entry in a regulated pharmaceutical market. Jpn Econ Rev. 2009;60(1):63\u201381. https:\/\/doi.org\/10.1111\/j.1468-5876.2008.00465.x.","journal-title":"Jpn Econ Rev"},{"issue":"3","key":"636_CR3","doi-asserted-by":"publisher","first-page":"554","DOI":"10.1111\/1468-0009.12279","volume":"95","author":"OJ Wouters","year":"2017","unstructured":"Wouters OJ, Kanavos PG, McKee M. Comparing generic drug markets in Europe and the United States: prices, volumes, and spending. Milbank Q. 2017;95(3):554\u2013601. https:\/\/doi.org\/10.1111\/1468-0009.12279.","journal-title":"Milbank Q"},{"key":"636_CR4","doi-asserted-by":"publisher","DOI":"10.1787\/8f9e3f98-en","volume-title":"Health at a glance 2025: OECD indicators","author":"OECD","year":"2025","unstructured":"OECD. Health at a glance 2025: OECD indicators. Paris: OECD Publishing; 2025. https:\/\/doi.org\/10.1787\/8f9e3f98-en."},{"issue":"3","key":"636_CR5","doi-asserted-by":"publisher","first-page":"828","DOI":"10.1111\/1468-0009.12517","volume":"99","author":"RG Frank","year":"2021","unstructured":"Frank RG, McGuire TG, Nason I. The evolution of supply and demand in markets for generic drugs. Milbank Q. 2021;99(3):828\u201352. https:\/\/doi.org\/10.1111\/1468-0009.12517.","journal-title":"Milbank Q"},{"issue":"3","key":"636_CR6","doi-asserted-by":"publisher","first-page":"1449","DOI":"10.1287\/mnsc.2022.4423","volume":"69","author":"Y Wang","year":"2023","unstructured":"Wang Y, Li J, Anupindi R. Manufacturing and regulatory barriers to generic drug competition: a structural model approach. Manag Sci. 2023;69(3):1449\u201367. https:\/\/doi.org\/10.1287\/mnsc.2022.4423.","journal-title":"Manag Sci"},{"issue":"3","key":"636_CR7","doi-asserted-by":"publisher","first-page":"145","DOI":"10.7326\/M16-1432","volume":"167","author":"CV Dave","year":"2017","unstructured":"Dave CV, Kesselheim AS, Fox ER, Qiu P, Hartzema A. High generic drug prices and market competition: a retrospective cohort study. Ann Intern Med. 2017;167(3):145\u201351. https:\/\/doi.org\/10.7326\/M16-1432.","journal-title":"Ann Intern Med"},{"issue":"11","key":"636_CR8","doi-asserted-by":"publisher","first-page":"1286","DOI":"10.1016\/j.jval.2018.04.1826","volume":"21","author":"CV Dave","year":"2018","unstructured":"Dave CV, Pawar A, Fox ER, Brill G, Kesselheim AS. Predictors of drug shortages and association with generic drug prices: a retrospective cohort study. Value Health. 2018;21(11):1286\u201390. https:\/\/doi.org\/10.1016\/j.jval.2018.04.1826.","journal-title":"Value Health"},{"key":"636_CR9","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2021.693426","volume":"12","author":"S Shukar","year":"2021","unstructured":"Shukar S, Zahoor F, Hayat K, et al. Drug shortage: causes, impact, and mitigation strategies. Front Pharmacol. 2021;12:693426. https:\/\/doi.org\/10.3389\/fphar.2021.693426.","journal-title":"Front Pharmacol"},{"key":"636_CR10","unstructured":"U.S. Food and Drug Administration. Drug shortages: root causes and potential solutions. 2020. https:\/\/www.fda.gov\/drugs\/drug-shortages\/report-drug-shortages-root-causes-and-potential-solutions. Accessed 16 May 2026."},{"issue":"1","key":"636_CR11","doi-asserted-by":"publisher","first-page":"74","DOI":"10.7326\/M18-1137","volume":"170","author":"I Hernandez","year":"2019","unstructured":"Hernandez I, Sampathkumar S, Good CB, Kesselheim AS, Shrank WH. Changes in drug pricing after drug shortages in the United States. Ann Intern Med. 2019;170(1):74\u20136. https:\/\/doi.org\/10.7326\/M18-1137.","journal-title":"Ann Intern Med"},{"key":"636_CR12","unstructured":"U.S. Food and Drug Administration. Drug Competition Action Plan. https:\/\/www.fda.gov\/drugs\/guidance-compliance-regulatory-information\/fda-drug-competition-action-plan. Accessed 16 May 2026."},{"key":"636_CR13","unstructured":"U.S. Food and Drug Administration. Product-specific guidances for generic drug development. https:\/\/www.fda.gov\/drugs\/guidances-drugs\/product-specific-guidances-generic-drug-development. Accessed 16 May 2026."},{"issue":"7","key":"636_CR14","doi-asserted-by":"publisher","first-page":"1763","DOI":"10.1016\/j.xphs.2023.03.006","volume":"112","author":"K-I Izutsu","year":"2023","unstructured":"Izutsu K-I, Ando D, Morita T, Abe Y, Yoshida H. Generic drug shortage in Japan: GMP noncompliance and associated quality issues. J Pharm Sci. 2023;112(7):1763\u201371. https:\/\/doi.org\/10.1016\/j.xphs.2023.03.006.","journal-title":"J Pharm Sci"},{"key":"636_CR15","doi-asserted-by":"publisher","first-page":"1312","DOI":"10.1208\/s12248-015-9777-x","volume":"17","author":"R Kuribayashi","year":"2015","unstructured":"Kuribayashi R, Matsuhama M, Mikami K. Regulation of generic drugs in Japan: the current situation and future prospects. AAPS J. 2015;17:1312\u20136. https:\/\/doi.org\/10.1208\/s12248-015-9777-x.","journal-title":"AAPS J"},{"key":"636_CR16","doi-asserted-by":"publisher","first-page":"1023","DOI":"10.1007\/s43441-024-00678-7","volume":"58","author":"H Mamiya","year":"2024","unstructured":"Mamiya H, Izutsu K-I, Mitani D. Draft guideline for industry to manage drug shortages in Japan. Ther Innov Regul Sci. 2024;58:1023\u20136. https:\/\/doi.org\/10.1007\/s43441-024-00678-7.","journal-title":"Ther Innov Regul Sci"},{"issue":"2","key":"636_CR17","doi-asserted-by":"publisher","first-page":"50","DOI":"10.1248\/bpbreports.8.2_50","volume":"8","author":"H Maegawa","year":"2025","unstructured":"Maegawa H, Moore K. Enhancing value of global pharmacopoeia standards: summary of Joint USP-MHLW\/PMDA workshop. BPB Rep. 2025;8(2):50\u201363. https:\/\/doi.org\/10.1248\/bpbreports.8.2_50.","journal-title":"BPB Rep"},{"issue":"387","key":"636_CR18","doi-asserted-by":"publisher","first-page":"531","DOI":"10.1080\/01621459.1984.10478080","volume":"79","author":"WS Cleveland","year":"1984","unstructured":"Cleveland WS, McGill R. Graphical perception: theory, experimentation, and application to the development of graphical methods. J Am Stat Assoc. 1984;79(387):531\u201354. https:\/\/doi.org\/10.1080\/01621459.1984.10478080.","journal-title":"J Am Stat Assoc"},{"key":"#cr-split#-636_CR19.1","unstructured":"European Parliament and Council of the European Union. Directive 2001\/83\/EC on the Community code relating to medicinal products for human use (consolidated version), Articles 10"},{"key":"#cr-split#-636_CR19.2","doi-asserted-by":"crossref","unstructured":"(1) and 10(3). https:\/\/eur-lex.europa.eu\/eli\/dir\/2001\/83\/2025-01-01\/eng. Accessed 23 July 2026.","DOI":"10.1142\/S0950609801000415"},{"key":"636_CR20","unstructured":"European Medicines Agency. Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms (EMA\/CHMP\/EWP\/280\/96 Rev1). Amsterdam: EMA; 2014. https:\/\/www.ema.europa.eu\/en\/pharmacokinetic-clinical-evaluation-modified-release-dosage-forms-scientific-guideline. Accessed 23 July 2026."},{"key":"636_CR21","unstructured":"Pharmaceuticals and Medical Devices Agency. Guideline for bioequivalence studies of generic products (2020 partial revision). Tokyo: PMDA; 2020. Japanese. https:\/\/www.pmda.go.jp\/review-services\/drug-reviews\/about-reviews\/p-drugs\/0017.html. Accessed 23 July 2026."},{"key":"636_CR22","unstructured":"Mamiya H. Research to inform the design of measures to promote development toward securing a stable supply and a sustainable industry structure for generic medicines. Health Labour Sciences Research Grant (25IA2010) report, Document No. 202521063A. Tokyo: Ministry of Health, Labour and Welfare; 2025. Japanese. https:\/\/mhlw-grants.niph.go.jp\/project\/183336. Accessed 23 July 2026."}],"container-title":["Pharmaceutical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40290-026-00636-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40290-026-00636-8","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40290-026-00636-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,14]],"date-time":"2026-09-14T09:00:36Z","timestamp":1789376436000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40290-026-00636-8"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9,14]]},"references-count":23,"alternative-id":["636"],"URL":"https:\/\/doi.org\/10.1007\/s40290-026-00636-8","relation":{},"ISSN":["1178-2595","1179-1993"],"issn-type":[{"value":"1178-2595","type":"print"},{"value":"1179-1993","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9,14]]},"assertion":[{"value":"19 August 2026","order":1,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"14 September 2026","order":2,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"This work was supported by the Health Labour Sciences Research Grant 25IA2010 from the Ministry of Health, Labour and Welfare, Japan. An official Japanese-language report of the grant project, including the survey findings, is publicly available in the MHLW Grants System database [\n                      \n                      ]. The present article provides a separate, focused, peer-reviewed academic analysis of the survey data. The funder had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.","order":1,"name":"Ethics","label":"Funding","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The authors declare no competing interests.","order":2,"name":"Ethics","label":"Conflicts of interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This study was based on a survey of companies regarding their business decisions and did not involve individual patient data, personal health information, or individual-level personal information. Institutional review board approval was therefore not sought under applicable Japanese ethical guidelines for medical and biological research involving human subjects.","order":3,"name":"Ethics","label":"Ethics approval","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable. Responses were submitted on behalf of companies, and no individual-level personal information was collected.","order":4,"name":"Ethics","label":"Consent to participate","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":5,"name":"Ethics","label":"Consent for publication","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Aggregated data supporting the findings are available in this article and Online Resource 1. The company-level survey data are not publicly available because they contain confidential business information and were collected under conditions of confidentiality. Additional aggregated data may be available from the corresponding author on reasonable request.","order":6,"name":"Ethics","label":"Availability of data and material","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The R code used to generate the tables and figures is available from the corresponding author on reasonable request.","order":7,"name":"Ethics","label":"Code availability","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"HM had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Concept and design: HM, HT, and KI. Acquisition, analysis, or interpretation of data: HM. Drafting of the manuscript: HM. Critical revision of the paper for important intellectual content: HT and KI. Administrative, technical, or logistic support: HM and KI. Supervision: KI. All authors have read and approved the final version of the manuscript and agree to be accountable for the work.","order":8,"name":"Ethics","label":"Authors\u2019 contributions","group":{"name":"EthicsHeading","label":"Declarations"}}]}}