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However, their general efficacy and utility for patients are often not thoroughly analyzed and, in some cases, remain questionable. The lack of systematic analysis for these parameters hinders learning from failures and successes. As a result, there is a risk of wasting resources by the pharmaceutical industry and approving new drugs that offer no additional benefit to patients in need of innovative treatments. Therefore, we set out to analyze the evolution of new drugs with innovative principles over 10 years after approval by the European Medicines Agency (EMA). We focused on drugs approved from 2004 to 2011, excluding protein kinase inhibitors and monoclonal antibodies, and identified 190 new drugs using the Arzneiverordnungsreport (AVR, Drug prescription report). With data from the Wissenschaftliches Institut der Ortskrankenkassen (WidO, Scientific Institute of the General Local Health Insurance Fund, AOK), we analyzed their number of prescriptions, sales, defined daily doses (DDD), and daily costs. We then extended our analysis with a focus on Rote-Hand-Briefe (RHB, Direct Healthcare Professional Communication). We identified factors of success, which was defined as a drug\u00a0appearing in the top 3000. We then conducted a detailed analysis of outliers in terms of sales, focusing on parameters such as indications, innovation regarding their mechanism of action, relative costs, competition, pharmacological properties, and clinical studies. The analysis of both the most and least successful, allowed us to identify clear correlations and determine potential red flags as well as green flags regarding pharmaceutical sales. Nearly half (49%) of the drugs analyzed met our success criterion, most very early (66% within the first 2 years). Most of these drugs also showed a notable progression in the drug rankings over the years. Thirty percent of all analyzed drugs received RHBs, with most of them (84% of the said 30%) receiving at least one deemed potentially influential regarding sales. The successful drugs were more often subject to these potentially influential RHBs than their non-successful counterparts, and most of the potentially influential RHBs were related to adverse drug reactions (53%) or indications or contraindications (14.8%). Based on the analysis of the tops and flops, we conclude that market success, measured by sales, is influenced by multiple factors. These include indication(s), innovation, the competitive landscape, costs, and pharmacological aspects as well as studies regarding the efficacy and the adverse drug reactions of the drug. These results underline the necessity of a multifactorial approach based on value-adding to assess potential new drugs by pharmaceutical companies.<\/jats:p>","DOI":"10.1007\/s00210-025-04178-9","type":"journal-article","created":{"date-parts":[[2025,5,8]],"date-time":"2025-05-08T06:45:28Z","timestamp":1746686728000},"page":"15515-15534","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["New drugs and their performance 10 years after approval: a systematic analysis"],"prefix":"10.1007","volume":"398","author":[{"given":"Bores","family":"Manfouo","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roland","family":"Seifert","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,5,8]]},"reference":[{"key":"4178_CR1","doi-asserted-by":"publisher","first-page":"233","DOI":"10.4337\/9781800888708.00019","volume-title":"The interaction of competition law and sector regulation : emerging trends at the national and EU level","author":"I Akker","year":"2022","unstructured":"Akker I, Sauter W (2022) Excessive pricing of pharmaceuticals in EU law: balancing competition, innovation and regulation. 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The Hanover Medical School follows the guidelines of the German Research Foundation (Deutsche Forschungsgemeinschaft, DFG).","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Not applicable because publicly available information is used as a data source.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to publish"}},{"value":"B.M. declares no competing interest. R.S. is the Editor-in-Chief of Naunyn-Schmiedebergs Archives of Pharmacology and follows the editorial guidelines for editors acting as authors (\n                      \n                      ).","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}]}}