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.

backgroundGeneric medicines are essential for pharmaceutical affordability and access, yet some products are never launched or their development is discontinued even after patent expiry. Limited empirical evidence is available on how manufacturers perceive the development and market-entry risks associated with these outcomes.

objectiveThe aim of this study was to identify and structure manufacturer-perceived development and market-entry risk factors associated with generic medicine development discontinuation and non-launch in Japan.

methodsWe conducted a cross-sectional survey of companies involved in generic medicine development and commercialization in Japan. The primary survey outcome was company-reported experience of development discontinuation or post-approval non-launch during fiscal years 2020-2024. Respondent characteristics were compared between companies with and without such experience. Among companies with such experience, development and market-entry risk factors were assessed in terms of both experience and perceived importance. All responding companies were asked to rate policy and regulatory options on five-point importance scales.

resultsAmong 122 companies with valid outcome data, 52 (42.6%) reported experience of development discontinuation or non-launch. Such experience was more frequently reported by companies with larger generic product portfolios. The market size and profitability domain was rated highest among the risk domains (top-2 box importance, 94.2%), but regulatory and clinical-study requirements (75.0%), formulation technology and manufacturing complexity (72.5%), and competition and institutional uncertainty (48.0%) were also rated as important. Among individual risk factors, active pharmaceutical ingredient (API) supply, patient-based bioequivalence or clinical-study requirements, dedicated equipment investment, and special formulation requirements were, in an exploratory descriptive map, among the factors with relatively high reported experience and perceived importance.

conclusionsGeneric medicine development discontinuation and non-launch in Japan were perceived by manufacturers as involving multiple development and market-entry risks extending beyond pricing to include API supply, manufacturing complexity, regulatory uncertainty, and competitive dynamics. Respondents prioritized reimbursement, regulatory, and manufacturing-related options for further consideration; the study did not evaluate the effectiveness, budget impact, or net social benefit of these options.