@article{BonakdarFrankenbergerBaderetal.2017, author = {Bonakdar, Amir and Frankenberger, Karolin and Bader, Martin and Gassmann, Oliver}, title = {Capturing value from business models: the role of formal and informal protection strategies}, volume = {73}, journal = {International Journal of Technology Management}, number = {4}, publisher = {Inderscience}, address = {Cointrin}, issn = {1741-5276}, doi = {https://doi.org/10.1504/IJTM.2017.083073}, pages = {151 -- 175}, year = {2017}, language = {en} } @article{SchuhmacherGassmannHinder2016, author = {Schuhmacher, Alexander and Gassmann, Oliver and Hinder, Markus}, title = {Changing R\&D models in research-based pharmaceutical companies}, volume = {14}, pages = {105}, journal = {Journal of Translational Medicine}, publisher = {BioMed Central}, address = {London}, issn = {1479-5876}, doi = {https://doi.org/10.1186/s12967-016-0838-4}, year = {2016}, abstract = {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.}, language = {en} } @article{SchuhmacherGassmannMcCrackenetal.2018, author = {Schuhmacher, Alexander and Gassmann, Oliver and McCracken, Nigel and Hinder, Markus}, title = {Open innovation and external sources of innovation. An opportunity to fuel the R\&D pipeline and enhance decision making?}, volume = {16}, pages = {119}, journal = {Journal of Translational Medicine}, number = {1}, publisher = {BioMed Central}, address = {London}, issn = {1479-5876}, doi = {https://doi.org/10.1186/s12967-018-1499-2}, year = {2018}, abstract = {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.}, language = {en} } @article{SchuhmacherHinderBogeretal.2022, author = {Schuhmacher, Alexander and Hinder, Markus and Boger, Nikolaj and Hartl, Dominik and Gassmann, Oliver}, title = {The significance of blockbusters in the pharmaceutical industry}, volume = {22}, journal = {Nature Reviews Drug Discovery}, number = {3}, publisher = {Springer Nature}, address = {London}, issn = {1474-1784}, doi = {https://doi.org/10.1038/d41573-022-00213-z}, pages = {177 -- 178}, year = {2022}, language = {en} } @article{SchuhmacherBriekeGassmannetal.2021, author = {Schuhmacher, Alexander and Brieke, Clara and Gassmann, Oliver and Hinder, Markus and Hartl, Dominik}, title = {Systematic risk identification and assessment using a new risk map in pharmaceutical R\&D}, volume = {26}, journal = {Drug Discovery Today}, number = {12}, publisher = {Elsevier}, address = {Amsterdam}, issn = {1878-5832}, doi = {https://doi.org/10.1016/j.drudis.2021.06.015}, pages = {2786 -- 2793}, year = {2021}, language = {en} } @article{SchuhmacherHinderBriefetal.2025, author = {Schuhmacher, Alexander and Hinder, Markus and Brief, Elazar and Gassmann, Oliver and Hartl, Dominik}, title = {Benchmarking R\&D success rates of leading pharmaceutical companies: an empirical analysis of FDA approvals (2006-2022)}, volume = {30}, pages = {104291}, journal = {Drug Discovery Today}, number = {2}, publisher = {Elsevier}, address = {Amsterdam}, issn = {1878-5832}, doi = {https://doi.org/10.1016/j.drudis.2025.104291}, year = {2025}, abstract = {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\%.}, language = {en} } @article{SchuhmacherGassmannHinderetal.2021, author = {Schuhmacher, Alexander and Gassmann, Oliver and Hinder, Markus and Kuss, Michael}, title = {The present and future of project management in pharmaceutical R\&D}, volume = {26}, journal = {Drug Discovery Today}, number = {1}, publisher = {Elsevier}, address = {Amsterdam}, issn = {1878-5832}, doi = {https://doi.org/10.1016/j.drudis.2020.07.020}, pages = {1 -- 4}, year = {2021}, language = {en} } @article{SchuhmacherGrinchenkoGassmannetal.2025, author = {Schuhmacher, Alexander and Grinchenko, Kyrylo and Gassmann, Oliver and Hartl, Dominik and Hinder, Markus}, title = {A case study assessing the impact of M\&A and licensing on FDA drug approvals of leading pharmaceutical companies}, volume = {30}, pages = {104306}, journal = {Drug Discovery Today}, number = {3}, publisher = {Elsevier}, address = {Amsterdam}, issn = {1878-5832}, doi = {https://doi.org/10.1016/j.drudis.2025.104306}, year = {2025}, abstract = {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.}, language = {en} } @article{SchuhmacherWilischKussetal.2021, author = {Schuhmacher, Alexander and Wilisch, Lucas and Kuss, Michael and Kandelbauer, Andreas and Hinder, Markus and Gassmann, Oliver}, title = {R\&D efficiency of leading pharmaceutical companies - A 20-year analysis}, volume = {26}, journal = {Drug Discovery Today}, number = {8}, publisher = {Elsevier}, address = {Amsterdam}, issn = {1878-5832}, doi = {https://doi.org/10.1016/j.drudis.2021.05.005}, pages = {1784 -- 1789}, year = {2021}, language = {en} } @article{SchuhmacherGattoHinderetal.2020, author = {Schuhmacher, Alexander and Gatto, Alexander and Hinder, Markus and Kuss, Michael and Gassmann, Oliver}, title = {The upside of being a digital pharma player}, volume = {25}, journal = {Drug Discovery Today}, number = {9}, publisher = {Elsevier}, address = {Amsterdam}, issn = {1878-5832}, doi = {https://doi.org/10.1016/j.drudis.2020.06.002}, pages = {1569 -- 1574}, year = {2020}, language = {en} }