Understanding AI adoption in the German pharmaceutical sector: Insights from expert interviews

Abstract

The increasing complexity and competitiveness of the pharmaceutical industry are driving the need for innovative technological solutions. This article explores the use of Artificial Intelligence (AI) in the German pharmaceutical sector, with a focus on addressing key challenges related to regulation, market dynamics, internal structures, and technological capabilities. Through a combination of systematic literature review and qualitative expert interviews, the study identifies major problem areas and derives corresponding AI-based innovation potentials in departments such as research, human resources, and quality management. The findings demonstrate that a strategically guided implementation of AI can lead to substantial process improvements and foster longterm competitive advantages. To facilitate this transformation, the study concludes with actionable recommendations aimed at advancing the integration of AI beyond isolated pilot projects and towards broad, sustainable application within the industry. By combining a systematic literature review with in-depth expert interviews, this study not only provides an overview of the current state of knowledge but, thanks to its qualitative methodology, also offers new insights into the decision-making processes and perceptions of industry experts.

Keywords

Pharmaceutical industry / Artificial intelligence / Innovation management / Implementation strategies / Regulatory frameworks / Qualitative research

References

[1] Statista Research Department . Pharmaceutical industry in Germany. Published 2025. Accessed July 28, 2025. de.statista.com/themen/1415/pharmaindustrie-indeutschland/.

[2] Association of Research-Based Pharmaceutical Companies (VFA) . AMNOG in focus-an overview. Published 2025. Accessed July 28, 2025. www.vfa.de/de/wirtschaftpolitik/amnog/amnog-im-fokus.[in German].

[3] Deloitte. Deloitte Pharma Study: rising returns in research and development -regulation could hamper innovation. Published May 12, 2024. Accessed July 28, 2025. www.deloitte.com/ch/de/about/press-room/deloitte-pharmastudie-steigende-renditen-im-bereich-forschung-und-entwicklung-regulierung-konnteinnovationen-hemmen.html.

[4] Müller A , Schmitz K , Lange J . Workforce Challenges in Pharma: A German Perspective. 2021.

[5] IQVIA. Global Trends in Clinical Trial Performance and Innovation. Published 2023. Accessed July 28, 2025.

[6] Sheikh H , Prins C , Schrijvers E . Artificial intelligence: definition and background. In: Mission AI:The New System Technology. Cham, Switzerland: Springer International Publishing; 2023: 15- 41.

[7] High-Level Expert Group on Artificial Intelligence , European Commission . A Definition of AI: Main Capabilities and Scientific Disciplines. Brussels, Belgium. 2018. Published December 18, 2018.

[8] Janiesch C , Zschech P , Heinrich K . Machine learning and deep learning. Electron Mark. 2021; 31 (3): 685- 695.

[9] LeCun Y , Bengio Y , Hinton G . Deep learning. Nature. 2015; 521 (7553): 436- 444.

[10] Intel. Artificial intelligence and robotics. Published 2024. Accessed July 28, 2025. www.intel.com/content/www/de/de/robotics/artificial-intelligence-robotics.html.

[11] Borboni A , Reddy KV , Elamvazuthi I , Al-Quraishi MS , Natarajan E , Ali SS . The expanding role of artificial intelligence in collaborative robots for industrial applications: a systematic review of recent works. Machines. 2023; 11 (1): 111.

[12] Amazon Web Services . What is natural language processing-NLP explained. Published 2024. Accessed July 28, 2025. aws.amazon.com/what-is/nlp/.

[13] Hirschberg J , Manning CD . Advances in natural language processing. Science. 2015; 349 (6245): 261- 266.

[14] O'Shea K , Nash R . An introduction to convolutional neural networks. arXiv. 2015.

[15] IBM. What is computer vision? Published 2024. Accessed July 28, 2025. www.ibm.com/de-de/topics/computer-vision.

[16] Karnowski V , Kümpel AS . Diffusion of innovations. In:Rogers Everett M, ed. Key Works of Media Effects Research. Wiesbaden, Germany:Springer Fachmedien. 1962. 2015: 97- 107.

[17] Busch E , Busch KH , Heyse V , Nobach K . Methodology of Innovation. Berlin, Germany: Springer Books; 2023[in German].

[18] Kaufmann T . Strategy Tools from Practice: Analysis and Evaluation of the Strategic Starting Position. Berlin, Germany:Springer; 2021. [in German].

[19] Day GS . Is it real? Can we win? Is it worth doing? Managing risk and reward in an innovation portfolio. PMID:18283921. Harv Bus Rev. 2007; 4 (12): 110- 120.

[20] Jia N . Corporate innovation strategy, analyst forecasting activities and the economic consequences. J Bus Finance Account. 2017; 44 (5-6): 812- 853.

[21] Fauchart E , Keilbach M . Testing a model of exploration and exploitation as innovation strategies. Small Bus Econ. 2009; 33 (3): 257- 272.

[22] Wolf V , Dobrucka R , Przekop R , Haubold S . Cooperative innovation strategies-review and analysis. LogForum. 2021; 17 (4).

[23] Cooper RG . Stage-gate systems: a new tool for managing new products. Bus Horiz. 1990; 33 (3): 44- 54.

[24] Grönlund J , Sjödin DR , Frishammar J . Open innovation and the stage-gate process: a revised model for new product development. Calif Manag Rev. 2010; 52 (3): 106- 131.

[25] Grots A , Pratschke M . Design thinking-creativity as a method. Mark Rev St Gallen. 2009; 26 (2): 18- 23.

[26] Federal Ministry of the Interior and Community . Organizational manual-CauseEffect diagram. Published September 27, 2024. Accessed July 28, 2025.www.orghandbuch.de/Webs/OHB/DE/Organisationshandbuch/6_MethodenTechniken/63_Analysetechniken/632_Ursache-Wirkungs-Diagramm/ursache-wirkungsdiagramm-node.html.[in German].

[27] Misoch S . Qualitative Interviews. Berlin, Germany:Walter de Gruyter GmbH & Co KG; 2019. [in German].

[28] Kuckartz U . Qualitative Content Analysis:Methods, Practice, Computer Support. Weinheim, Germany:Beltz Juventa; 2012. ISBN 3-7799-2815-9.[in German].

[29] Döring N , Bortz J . In: Research Methods and Evaluation. 5th ed. Heidelberg, Germany: Springer; 2016. [in German].

[30] Dresing T , Pehl T . Practical guide to interview transcription and analysis:guidelines and rule systems for qualitative researchers. Marburg, Germany:dr dresing & pehl GmbH. 2015[in German].

[31] Tausendpfund M . Research strategies in the social sciences. Hagen, Germany: FernUniversität. 2021. [in German].

[32] Ancliff S . 10 challenges facing the pharmaceutical industry in 2024. Published 2024. Accessed November 24, 2024. blog.i-nexus.com/10-challenges-facing-thepharmaceutical-industry.

[33] Dukart H , Lanoue L , Rezende M , Rutten P . Six new pharmaceutical industry trends. Published 2024. Accessed November 24, 2024. www.mckinsey.com/capabilities/operations/our-insights/emerging-from-disruption-the-future-of-pharmaoperations-strategy.

[34] U.S. Food and Drug Administration. Facts about the current good manufacturing practice (CGMP). Published 2024. Accessed November 24, 2024. www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturingpractice-cgmp.

[35] Federal Ministry of Health . GMP-good practice in the manufacturing of pharmaceuticals. Published 2024. Accessed November 24, 2024.www.bundesgesundheitsministerium.de/gmp.html.[in German].

[36] European Medicines Agency . Good manufacturing practice. Published 2024. Accessed November 24, 2024. www.ema.europa.eu/en/human-regulatoryoverview/research-development/compliance-research-development/goodmanufacturing-practice.

[37] World Pharma Today . Trends and estimates for the pharmaceutical industry in 2023. Published 2023. Accessed November 24, 2024. www.worldpharmatoday.com/news/trends-and-estimates-for-the-pharmaceutical-industry-in-2023/.

[38] European Parliament . EU AI act: first regulation on artificial intelligence. Published 2023. Accessed November 24, 2024. www.europarl.europa.eu/topics/en/article/20230601STO93804/eu-ai-act-first-regulation-on-artificial-intelligence.

[39] Federal Government of Germany . EU adopts first AI law worldwide.www.bundesregierung.de/breg-de/aktuelles/ai-act-2285944. Accessed November 24, 2024.[in German].

[40] Hohmann-Jeddi C . Pharmaceutical Industry:Germany Losing Competitiveness. Pharmazeutische Zeitung. Published 2024. Accessed November 25, 2024.www.pharmazeutische-zeitung.de/deutschland-verliert-an-wettbewerbsfaehigkeit-147622/.[in German].

[41] Brockfeld L . Top pharmaceutical companies:USA dominates the global pharmaceutical market. Pharm Ztg. Published 2024. Accessed November 25, 2024. www.pharmazeutische-zeitung.de/usa-dominieren-globalen-pharmamarkt-151145/.[in German].

[42] Marx M . The 10 largest pharmaceutical companies worldwide in 2024. Wirtschaftswoche. www.wiwo.de/unternehmen/industrie/merck-pfizer-und-codas-sind-die-zehn-groessten-pharmakonzerne-der-welt-im-ranking-2024-/30014284.html. Accessed November 25, 2024.[in German].

[43] Statista Research Department . Personalized medicine-approved drugs in 2023. Published 2024. Accessed November 25, 2024. de.statista.com/statistik/daten/studie/686759/umfrage/zugelassene-medikamente-mit-begleitendemdiagnostischem-vortest-in-deutschland/.

[44] Federal Association of the Pharmaceutical Industry (BPI) . Pharma Data 2023. Berlin, Germany; 2023[in German]. Accessed November 25, 2024.

[45] Association of Research-Based Pharmaceutical Companies (VFA) . Approved personalized medicine overview. Published 2024. Accessed November 25, 2024. www.vfa.de/de/arzneimittel-forschung/datenbanken-zu-arzneimitteln/individualisierte-medizin.html.[in German].

[46]

[47] Analytica. Life sciences:personalized medicine in focus. Published 2024. Accessed November 25, 2024. analytica.de/de/muenchen/presse/trendberichte/personalisierte-medizin/. Accessed November 25, 2024.[in German].

[48] Association of Research-Based Pharmaceutical Companies (VFA) . Pharmaceutical industry warns of skilled labor shortage:one in four positions must be refilled. Published 2024. Accessed November 25, 2024. www.vfa.de/de/presse/pressemitteilungen/pm-026-2024-pharmaindustrie-warnt-vor-fachkraeftemangeljede-vierte-stelle-muss-neu-besetzt-werden.html.[in German].

[49] Jumper J , Evans R , Pritzel A , et al. Highly accurate protein structure prediction with AlphaFold. Nature. 2021; 596 (7873): 583- 589.

[50] Fraunhofer IAIS . Secure and efficient-artificial intelligence for clinical studies. Published 2024. Accessed November 29, 2024. www.iais.fraunhofer.de/de/presse/presseinformationen/presseinformationen-2024/presseinformation-241108.html. [in German].

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The Authors. Publishing services by Elsevier B.V. on behalf of Higher Education Press and KeAi Communications Co. Ltd.