TY - CHAP A1 - Schuhmacher, Alexander A1 - Gassmann, Oliver A1 - Hinder, Markus ED - Schuhmacher, Alexander ED - Hinder, Markus ED - Gassmann, Oliver T1 - A Review of the Pharmaceutical R&D Efficiency: Costs, Timelines, and Probabilities T2 - Value Creation in the Pharmaceutical Industry: The Critical Path to Innovation UR - https://doi.org/10.1002/9783527693405.ch4 Y1 - 2016 UR - https://doi.org/10.1002/9783527693405.ch4 SN - 978-3-527-69343-6 SN - 978-3-527-33913-6 SP - 61 EP - 79 PB - Wiley CY - Weinheim ER - TY - CHAP A1 - Bader, Martin A1 - Gassmann, Oliver ED - Hinder, Markus ED - Schuhmacher, Alexander ED - Goldhahn, Jörg ED - Hartl, Dominik T1 - Patents in the Biomedical Sciences and Industry – The Case of the Swiss Life Science Company Prionics T2 - Principles of Biomedical Sciences and Industry: Translating Ideas into Treatments UR - https://doi.org/10.1002/9783527824014.ch16 Y1 - 2022 UR - https://doi.org/10.1002/9783527824014.ch16 SN - 978-3-527-34571-7 SN - 978-3-527-82401-4 SP - 305 EP - 315 PB - Wiley-VCH CY - Weinheim ER - TY - JOUR A1 - Schuhmacher, Alexander A1 - Hinder, Markus A1 - Boger, Nikolaj A1 - Hartl, Dominik A1 - Gassmann, Oliver T1 - The significance of blockbusters in the pharmaceutical industry JF - Nature Reviews Drug Discovery UR - https://doi.org/10.1038/d41573-022-00213-z Y1 - 2022 UR - https://doi.org/10.1038/d41573-022-00213-z SN - 1474-1784 VL - 22 IS - 3 SP - 177 EP - 178 PB - Springer Nature CY - London ER - TY - JOUR A1 - Schuhmacher, Alexander A1 - Brieke, Clara A1 - Gassmann, Oliver A1 - Hinder, Markus A1 - Hartl, Dominik T1 - Systematic risk identification and assessment using a new risk map in pharmaceutical R&D JF - Drug Discovery Today UR - https://doi.org/10.1016/j.drudis.2021.06.015 Y1 - 2021 UR - https://doi.org/10.1016/j.drudis.2021.06.015 SN - 1878-5832 SN - 1359-6446 VL - 26 IS - 12 SP - 2786 EP - 2793 PB - Elsevier CY - Amsterdam ER - TY - JOUR A1 - Schuhmacher, Alexander A1 - Hinder, Markus A1 - Brief, Elazar A1 - Gassmann, Oliver A1 - Hartl, Dominik T1 - Benchmarking R&D success rates of leading pharmaceutical companies: an empirical analysis of FDA approvals (2006–2022) JF - Drug Discovery Today N2 - Previous analyses provide an industry benchmark of ∼10% for the success rate in clinical development. However, prior analyses were limited by a narrow timeframe, a diverse research focus, biases in phase-to-phase transition methodology or a focus on specific use cases. We calculated unbiased input:output ratios (Phase I to FDA new drug approval) to analyze the likelihood of first approval using data from clinicaltrials.gov, encompassing a total of 2092 active ingredients, 19 927 clinical trials conducted by 18 leading pharmaceutical companies (2006–2022) and 274 new drug approvals. Our study reveals an average likelihood of first approval rate of 14.3% across leading research-based pharmaceutical companies, broadly ranging from 8% to 23%. UR - https://doi.org/10.1016/j.drudis.2025.104291 Y1 - 2025 UR - https://doi.org/10.1016/j.drudis.2025.104291 UR - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:573-56382 SN - 1878-5832 N1 - Corrigendum verfügbar unter https://doi.org/10.1016/j.drudis.2025.104326 VL - 30 IS - 2 PB - Elsevier CY - Amsterdam ER - TY - JOUR A1 - Schuhmacher, Alexander A1 - Gassmann, Oliver A1 - Hinder, Markus A1 - Kuss, Michael T1 - The present and future of project management in pharmaceutical R&D JF - Drug Discovery Today UR - https://doi.org/10.1016/j.drudis.2020.07.020 Y1 - 2021 UR - https://doi.org/10.1016/j.drudis.2020.07.020 SN - 1878-5832 VL - 26 IS - 1 SP - 1 EP - 4 PB - Elsevier CY - Amsterdam ER - TY - JOUR A1 - Schuhmacher, Alexander A1 - Grinchenko, Kyrylo A1 - Gassmann, Oliver A1 - Hartl, Dominik A1 - Hinder, Markus T1 - A case study assessing the impact of M&A and licensing on FDA drug approvals of leading pharmaceutical companies JF - Drug Discovery Today N2 - Despite a recent increase in FDA new drug approvals, leading pharmaceutical companies continue to face R&D productivity challenges. This highlights the need to better understand the context of their R&D concepts and related R&D outputs. Consequently, we conducted a systematic assessment of the impact of R&D expenditures, R&D intensities, mergers & acquisitions (M&A) deals and licensing agreements on new drug approvals of leading pharmaceutical companies between 2012 and 2021. Our analysis provides key insights into differentiating R&D factors: whereas R&D expenditures and the number of M&A deals correlate with the number of new drug approvals, our analysis shows no correlation with R&D intensity or the number of licensing agreements. UR - https://doi.org/10.1016/j.drudis.2025.104306 Y1 - 2025 UR - https://doi.org/10.1016/j.drudis.2025.104306 UR - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:573-57756 SN - 1878-5832 VL - 30 IS - 3 PB - Elsevier CY - Amsterdam ER - TY - JOUR A1 - Schuhmacher, Alexander A1 - Wilisch, Lucas A1 - Kuss, Michael A1 - Kandelbauer, Andreas A1 - Hinder, Markus A1 - Gassmann, Oliver T1 - R&D efficiency of leading pharmaceutical companies – A 20-year analysis JF - Drug Discovery Today UR - https://doi.org/10.1016/j.drudis.2021.05.005 Y1 - 2021 UR - https://doi.org/10.1016/j.drudis.2021.05.005 SN - 1878-5832 VL - 26 IS - 8 SP - 1784 EP - 1789 PB - Elsevier CY - Amsterdam ER - TY - JOUR A1 - Schuhmacher, Alexander A1 - Gatto, Alexander A1 - Hinder, Markus A1 - Kuss, Michael A1 - Gassmann, Oliver T1 - The upside of being a digital pharma player JF - Drug Discovery Today UR - https://doi.org/10.1016/j.drudis.2020.06.002 Y1 - 2020 UR - https://doi.org/10.1016/j.drudis.2020.06.002 SN - 1878-5832 VL - 25 IS - 9 SP - 1569 EP - 1574 PB - Elsevier CY - Amsterdam ER - TY - JOUR A1 - Schuhmacher, Alexander A1 - Germann, Paul-Georg A1 - Trill, Henning A1 - Gassmann, Oliver T1 - Models for open innovation in the pharmaceutical industry JF - Drug Discovery Today UR - https://doi.org/10.1016/j.drudis.2013.07.013 Y1 - 2013 UR - https://doi.org/10.1016/j.drudis.2013.07.013 SN - 1878-5832 VL - 18 IS - 23-24 SP - 1133 EP - 1137 PB - Elsevier CY - Amsterdam ER - TY - JOUR A1 - Schuhmacher, Alexander A1 - Hinder, Markus A1 - Boger, Nikolaj A1 - Gassmann, Oliver A1 - Hartl, Dominik T1 - Is the blockbuster imperative broken? JF - Drug Discovery Today UR - https://doi.org/10.1016/j.drudis.2023.103789 Y1 - 2023 UR - https://doi.org/10.1016/j.drudis.2023.103789 SN - 1878-5832 VL - 28 IS - 11 PB - Elsevier CY - Amsterdam ER - TY - JOUR A1 - Schuhmacher, Alexander A1 - Gassmann, Oliver A1 - Kuss, Michael A1 - Hinder, Markus T1 - The Art of Virtualizing Pharma R&D JF - Drug Discovery Today UR - https://doi.org/10.1016/j.drudis.2019.07.004 Y1 - 2019 UR - https://doi.org/10.1016/j.drudis.2019.07.004 SN - 1878-5832 VL - 24 IS - 11 SP - 2105 EP - 2107 PB - Elsevier CY - Amsterdam ER - TY - JOUR A1 - Schuhmacher, Alexander A1 - Hinder, Markus A1 - Dodel, Alexander A1 - Gassmann, Oliver A1 - Hartl, Dominik T1 - Investigating the origins of recent pharmaceutical innovation JF - Nature Reviews Drug Discovery UR - https://doi.org/10.1038/d41573-023-00102-z Y1 - 2023 UR - https://doi.org/10.1038/d41573-023-00102-z SN - 1474-1784 SN - 1474-1776 VL - 22 IS - 10 SP - 781 EP - 782 PB - Springer CY - London ER - TY - JOUR A1 - Schuhmacher, Alexander A1 - Gassmann, Oliver A1 - Bieniok, Doria A1 - Hinder, Markus A1 - Hartl, Dominik T1 - Open innovation: A paradigm shift in pharma R&D? JF - Drug Discovery Today UR - https://doi.org/10.1016/j.drudis.2022.05.018 Y1 - 2022 UR - https://doi.org/10.1016/j.drudis.2022.05.018 SN - 1878-5832 VL - 27 IS - 9 SP - 2395 EP - 2405 PB - Elsevier CY - Amsterdam ER - TY - JOUR A1 - Schuhmacher, Alexander A1 - Gassmann, Oliver A1 - Hinder, Markus A1 - Hartl, Dominik T1 - Comparative analysis of FDA approvals by top 20 pharma companies (2014–2023) JF - Drug Discovery Today N2 - This article addresses the research and development (R&D) productivity challenge of the pharmaceutical industry, focusing on United States Food and Drug Administration (FDA)-related new drug approvals of the top 20 pharmaceutical companies (2014–2023). We evaluated the degree of innovation in new drugs to determine the innovativeness of these leading companies. A key finding of our analysis is the decline in the number of new drugs approved by the FDA for these leading companies over the investigated time period. This trend suggests that some of the leading companies are losing ground in R&D innovation, raising concerns about their ability to sustain competitive advantage, ensure long-term market success, and maintain viable business models. UR - https://doi.org/10.1016/j.drudis.2024.104128 Y1 - 2024 UR - https://doi.org/10.1016/j.drudis.2024.104128 UR - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:573-50058 SN - 1878-5832 VL - 29 IS - 9 PB - Elsevier CY - Amsterdam ER - TY - JOUR A1 - Schuhmacher, Alexander A1 - Haefner, Naomi A1 - Honsberg, Katharina A1 - Goldhahn, Jörg A1 - Gassmann, Oliver T1 - The dominant logic of Big Tech in healthcare and pharma JF - Drug Discovery Today UR - https://doi.org/10.1016/j.drudis.2022.103457 Y1 - 2022 UR - https://doi.org/10.1016/j.drudis.2022.103457 SN - 1878-5832 VL - 28 IS - 2 PB - Elsevier CY - Amsterdam ER - TY - JOUR A1 - Schuhmacher, Alexander A1 - Hinder, Markus A1 - von Stegmann und Stein, Alexander A1 - Hartl, Dominik A1 - Gassmann, Oliver T1 - Analysis of pharma R&D productivity – a new perspective needed JF - Drug Discovery Today UR - https://doi.org/10.1016/j.drudis.2023.103726 Y1 - 2023 UR - https://doi.org/10.1016/j.drudis.2023.103726 SN - 1878-5832 VL - 28 IS - 10 PB - Elsevier CY - Amsterdam ER - TY - JOUR A1 - Schuhmacher, Alexander A1 - Gatto, Alexander A1 - Kuss, Michael A1 - Gassmann, Oliver A1 - Hinder, Markus T1 - Big Techs and startups in pharmaceutical R&D – A 2020 perspective on artificial intelligence JF - Drug Discovery Today UR - https://doi.org/10.1016/j.drudis.2021.04.028 Y1 - 2021 UR - https://doi.org/10.1016/j.drudis.2021.04.028 SN - 1878-5832 VL - 26 IS - 10 SP - 2226 EP - 2231 PB - Elsevier CY - Amsterdam ER - TY - JOUR A1 - Kwisda, Sebastian A1 - Kremer, Malte A1 - Sievertsen, Niels A1 - Gassmann, Oliver A1 - Hartl, Dominik A1 - Schuhmacher, Alexander T1 - Does pharma R&D need a strategic reset? Adapting to a changing US landscape JF - Drug Discovery Today N2 - R&D productivity has long challenged research-based pharmaceutical companies, raising concerns about the sustainability of their research-driven business models. These firms have traditionally relied on the U.S. as a stable hub for biomedical innovation, skilled talent, and high-price markets—supporting the biotech-leveraged pharma company (BIPCO) model However, recent geopolitical shifts—especially under the new Trump administration, including FDA budget cuts, reduced U.S. research funding, and pharmaceutical tariffs—are destabilizing this foundation. The once-reliable “safe harbor” is no longer secure. As a result, pharma R&D now faces strategic risks beyond its prior scope. With the weakening of the U.S.-centered innovation model, companies must rethink R&D pipelines, secure key technologies, maintain global clinical networks, and adjust supply chain and tax strategies. The viability of the current R&D model—rooted in U.S. leadership and premium markets—is now uncertain, requiring urgent strategic realignment. UR - https://doi.org/10.1016/j.drudis.2025.104442 Y1 - 2025 UR - https://doi.org/10.1016/j.drudis.2025.104442 UR - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:573-61966 SN - 1878-5832 VL - 30 IS - 9 PB - Elsevier CY - Amsterdam ER - TY - JOUR A1 - Schuhmacher, Alexander A1 - Gassmann, Oliver A1 - Kwisda, Sebastian A1 - Kremer, Malte A1 - Hinder, Markus A1 - Hartl, Dominik T1 - The R&D productivity challenge: transforming the pharmaceutical ecosystem JF - Drug Discovery Today N2 - The persistent decline in pharmaceutical R&D productivity has been extensively analyzed and debated for over two decades, with profound implications for the structure and strategy of the pharmaceutical industry. This systemic challenge forced many leading companies to adapt their R&D models, influencing internal capabilities and external innovation strategies. In response, the industry has evolved into a complex, interdependent biopharmaceutical ecosystem encompassing large pharmaceutical corporations, biotech innovators and specialized service providers. Although R&D productivity affects all research-driven companies, its consequences are particularly pronounced for large pharmaceutical firms, because the scale and capital intensity of their R&D activities make productivity a crucial determinant of long-term competitiveness and sustainability. By contrast, other stakeholders are only partially adversely affected, whereas some can even obtain value from it. UR - https://doi.org/10.1016/j.drudis.2025.104494 Y1 - 2025 UR - https://doi.org/10.1016/j.drudis.2025.104494 UR - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:573-64218 SN - 1878-5832 VL - 30 IS - 11 PB - Elsevier CY - Amsterdam ER -