TY - JOUR A1 - Schuhmacher, Alexander A1 - Gassmann, Oliver A1 - Hinder, Markus T1 - Changing R&D models in research-based pharmaceutical companies JF - Journal of Translational Medicine N2 - New drugs serving unmet medical needs are one of the key value drivers of research-based pharmaceutical companies. The efficiency of research and development (R&D), defined as the successful approval and launch of new medicines (output) in the rate of the monetary investments required for R&D (input), has declined since decades. We aimed to identify, analyze and describe the factors that impact the R&D efficiency. Based on publicly available information, we reviewed the R&D models of major research-based pharmaceutical companies and analyzed the key challenges and success factors of a sustainable R&D output. We calculated that the R&D efficiencies of major research-based pharmaceutical companies were in the range of USD 3.2–32.3 billion (2006–2014). As these numbers challenge the model of an innovation-driven pharmaceutical industry, we analyzed the concepts that companies are following to increase their R&D efficiencies: (A) Activities to reduce portfolio and project risk, (B) activities to reduce R&D costs, and (C) activities to increase the innovation potential. While category A comprises measures such as portfolio management and licensing, measures grouped in category B are outsourcing and risk-sharing in late-stage development. Companies made diverse steps to increase their innovation potential and open innovation, exemplified by open source, innovation centers, or crowdsourcing, plays a key role in doing so. In conclusion, research-based pharmaceutical companies need to be aware of the key factors, which impact the rate of innovation, R&D cost and probability of success. Depending on their company strategy and their R&D set-up they can opt for one of the following open innovators: knowledge creator, knowledge integrator or knowledge leverager. UR - https://doi.org/10.1186/s12967-016-0838-4 Y1 - 2016 UR - https://doi.org/10.1186/s12967-016-0838-4 UR - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:573-53816 SN - 1479-5876 VL - 14 PB - BioMed Central CY - London ER - TY - JOUR A1 - Schuhmacher, Alexander A1 - Gassmann, Oliver A1 - McCracken, Nigel A1 - Hinder, Markus T1 - Open innovation and external sources of innovation. An opportunity to fuel the R&D pipeline and enhance decision making? JF - Journal of Translational Medicine N2 - Historically, research and development (R&D) in the pharmaceutical sector has predominantly been an in-house activity. To enable investments for game changing late-stage assets and to enable better and less costly go/no-go decisions, most companies have employed a fail early paradigm through the implementation of clinical proof-of-concept organizations. To fuel their pipelines, some pioneers started to complement their internal R&D efforts through collaborations as early as the 1990s. In recent years, multiple extrinsic and intrinsic factors induced an opening for external sources of innovation and resulted in new models for open innovation, such as open sourcing, crowdsourcing, public–private partnerships, innovations centres, and the virtualization of R&D. Three factors seem to determine the breadth and depth regarding how companies approach external innovation: (1) the company’s legacy, (2) the company’s willingness and ability to take risks and (3) the company’s need to control IP and competitors. In addition, these factors often constitute the major hurdles to effectively leveraging external opportunities and assets. Conscious and differential choices of the R&D and business models for different companies and different divisions in the same company seem to best allow a company to fully exploit the potential of both internal and external innovations. UR - https://doi.org/10.1186/s12967-018-1499-2 Y1 - 2018 UR - https://doi.org/10.1186/s12967-018-1499-2 UR - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:573-53862 SN - 1479-5876 VL - 16 IS - 1 PB - BioMed Central CY - London 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 - 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 - 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 - 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 -