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AI agents in pharma production: what has been announced, and what slows scale

Company announcements of AI agents in pharmaceutical clinical operations, manufacturing and quality up to September 2026, survey evidence on how many AI pilots reach scaled use, and what the sources say slows scale, including a 2025 survey in which 9% of respondents named regulation as a barrier to AI.

Compiled from public sources, 28 September 2026. Information, not legal advice.

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1. Announced uses and products

Company statements, listed as announced. Figures are the companies' own claims.

Company Domain What was announced Status as announced
IQVIA Clinical operations, commercial, real-world evidence IQVIA says it has "deployed more than 150 intelligent agents across internal teams and client environments" and that "19 of the top 20 pharmaceutical companies have begun incorporating IQVIA agents into their workflows" (IQVIA, 16 Mar 2026). A clinical trial start-up orchestrator agent, and clinical data review cut "from seven weeks to as little as two weeks", with "human experts in the loop" (NVIDIA blog, 11 Jun 2025) In use (company claim)
Eli Lilly Discovery, manufacturing, commercial Lilly's AI supercomputer is to "support new and advanced applications in manufacturing, medical imaging and scientific AI agents"; a co-innovation lab with NVIDIA will "explore opportunities to apply AI across clinical development, manufacturing and commercial operations", including agentic AI, robotics and digital twins of manufacturing lines (NVIDIA newsroom, 12 Jan 2026) Planned
Roche and Genentech Manufacturing, research Digital twins of production lines (Roche, 16 Mar 2026), described as "already helping accelerate the development of Roche's new GLP-1 manufacturing facility in North Carolina" (NVIDIA blog, 16 Mar 2026). The gRED Research Agent, built with AWS, is "expected to help Genentech automate over 43,000 hours of manual effort in biomarker validation" (AWS case study) Digital twins in use (company statement); hours saved are a projection
Aizon Manufacturing, quality, batch release Users "can converse with the platform to instantly generate complex tools like batch release cockpits, OEE trackers, and Product Quality Review (PQR) templates", to be "available to all customers in early Q1, 2026" (Aizon, 27 Oct 2025) Product pre-announcement
Mareana Manufacturing records, deviations "Deviation descriptions, investigation summaries, and batch record narrative sections are drafted by AI from the underlying structured data"; "The quality reviewer edits and approves rather than writes from scratch" (Mareana, updated 22 Apr 2026) Capability described; no named deployment
Ketryx Regulatory and quality workflows (mainly medtech) Agents launched May 2025: complaint intake and categorisation, redundancy detection, test coverage analysis, anomaly review and change request review (Ketryx, 1 May 2025). Ketryx says its agents "cut manual work by 90 percent" and that four of the top five Fortune 500 medtech companies "now run on Ketryx" (Ketryx, 26 Feb 2026) Product available (company claim)

2. From pilot to production

  • ZS, pharma and biotech. An online survey by The Harris Poll for ZS in July 2025 of 115 technology executives at pharmaceutical and biotechnology companies found "just 40% of those pilots make it to scaled deployment". 68% "say to neglect data quality and governance early is the main reason AI initiatives fail"; 67% "warn that launching an AI initiative without clear goals and success metrics is a mistake"; 63% cite lack of business ownership (ZS, October 2025).
  • McKinsey, pharma and medtech. In a late-summer 2024 survey of more than 100 pharma and medtech leaders, about 75% said their organisations lack a comprehensive vision for generative AI or a strategic road map with clearly defined success measures (McKinsey, Scaling gen AI in the life sciences industry).
  • ISPE, an estimate. ISPE writes that "too many AI initiatives have been failing or stopping at pilot stages" and that "The failure rate of AI projects is estimated at 80%, which is considerably higher than general IT projects 10 years ago". The estimate is cited from a 2024 CX Network article (ISPE, 24 Jul 2025).
  • McKinsey, all industries. 23% of respondents said their organisations are scaling an agentic AI system somewhere in the enterprise, and a further 39% are experimenting with AI agents (McKinsey, The state of AI in 2025, November 2025).
  • Gartner, all industries, a prediction. Over 40% of agentic AI projects will be cancelled by the end of 2027, "due to escalating costs, unclear business value or inadequate risk controls" (Gartner, 25 Jun 2025).
  • Healthcare and life sciences adoption. In NVIDIA's 2026 survey, 70% of respondents said their organisations are actively using AI, up from 63% in 2024, and 47% are using or assessing agentic AI (NVIDIA, 24 Feb 2026).
  • No study separating pilot-to-production rates in GxP work from those in discovery was found in this pass.

3. Regulation as a named barrier

The Pistoia Alliance Lab of the Future 2025 survey, of more than 200 experts in pharma, biotech, software, services, academia and non-profits across Europe, the Americas and APAC, reported (Pistoia Alliance, 25 Sep 2025; survey results PDF):

  • "Only 9% now see regulation as a barrier to AI, down from 23% last year".
  • 34% cite a lack of people as a barrier to AI adoption, up from 23% in 2024.
  • "Data silos remains the top challenge (57%)"; cultural issues around data sharing and collaboration stand at 34%; insufficient management encouragement rose to 20%, from 7%.
  • Data standards and ontologies are where help is most needed to make data FAIR (49%).

4. The draft EU limit on generative AI in critical GMP uses

Draft Annex 22 to the EU GMP guide (consultation 7 July to 7 October 2025; still a draft) is covered in the library report on regulatory and quality frameworks. Three points bear on scale:

  • The draft limit. EMA says the draft "had indicated" that dynamic, adaptive and probabilistic models, such as generative AI or LLMs, "should not be used in critical GMP applications" (EMA; European Commission consultation).
  • ISPE's comments (7 October 2025) say restricting the annex to static models in critical GMP would restrict innovation, and ask that advanced models be allowed in critical GMP applications when justified by science and quality risk management (ISPE comments, PDF).
  • EMA workshop, 30 June and 1 July 2026. EMA says the 2025 consultation "suggested support for potentially enabling the use of technologies such as generative AI (GenAI) or large language models (LLMs) in medicines manufacturing", and that its drafting group "is seeking expert input on possible control and mitigation measures such as guardrails" for a risk-based approach (EMA).

Sources

  • IQVIA, IQVIA unveils IQVIA.ai, a unified agentic AI platform, 16 March 2026. https://www.iqvia.com/newsroom/2026/03/iqvia-unveils-iqvia-ai-a-unified-agentic-ai-platform
  • NVIDIA blog, IQVIA AI agents for clinical research, 11 June 2025. https://blogs.nvidia.com/blog/iqvia-ai-agents-clinical-research/
  • NVIDIA and Lilly announce co-innovation AI lab, 12 January 2026. http://nvidianews.nvidia.com/news/nvidia-and-lilly-announce-co-innovation-lab-to-reinvent-drug-discovery-in-the-age-of-ai
  • Roche, Roche launches NVIDIA AI factory, 16 March 2026. https://www.roche.com/media/releases/med-cor-2026-03-16
  • NVIDIA blog, Roche scales NVIDIA AI factories globally, 16 March 2026. https://blogs.nvidia.com/blog/roche-ai-factories-omniverse/
  • AWS, Genentech leverages generative AI (case study). https://aws.amazon.com/solutions/case-studies/genentech-generativeai-case-study
  • Aizon, Aizon pre-announces next era of pharma manufacturing with agentic AI, 27 October 2025. https://www.aizon.ai/blog/aizon-pre-announces-next-era-of-pharma-manufacturing-with-agentic-ai
  • Mareana, AI in pharma manufacturing: a deep dive, updated 22 April 2026. https://mareana.com/blog/ai-in-pharma-manufacturing/
  • Ketryx, Ketryx launches first validated AI agents, 1 May 2025. https://www.ketryx.com/press-release/ketryx-launches-first-validated-ai-agents-to-accelerate-safety-critical-product-development
  • Ketryx, Ketryx enters 2026 with record momentum, 26 February 2026. https://www.newsfilecorp.com/release/285490/Ketryx-Enters-2026-with-Record-Momentum-as-Demand-for-Validated-AI-Surges
  • ZS, Scaling AI in pharma and biotech: 2026 ZS CDIO research, October 2025. https://www.zs.com/insights/scaling-ai-in-pharma-cdio-2026
  • McKinsey, Scaling gen AI in the life sciences industry. https://www.mckinsey.com/industries/life-sciences/our-insights/scaling-gen-ai-in-the-life-sciences-industry
  • ISPE, New GAMP Guide addresses challenges posed by AI-enabled computerized systems, 24 July 2025. https://ispe.org/pharmaceutical-engineering/ispeak/new-gampr-guide-addresses-challenges-posed-ai-enabled
  • McKinsey, The state of AI in 2025: agents, innovation, and transformation, November 2025. https://www.mckinsey.com/capabilities/quantumblack/our-insights/the-state-of-ai
  • Gartner, Gartner predicts over 40% of agentic AI projects will be canceled by end of 2027, 25 June 2025. https://www.gartner.com/en/newsroom/press-releases/2025-06-25-gartner-predicts-over-40-percent-of-agentic-ai-projects-will-be-canceled-by-end-of-2027
  • NVIDIA, survey on AI in healthcare and life sciences, 24 February 2026. https://blogs.nvidia.com/blog/ai-in-healthcare-survey-2026/
  • Pistoia Alliance, Lab of the Future survey, 25 September 2025. https://pistoiaalliance.org/news/survey-ai-adoption-life-sciences-labs-skills-gap/
  • EMA, GMP multistakeholder workshop on AI guidance development (Annex 22), 30 June to 1 July 2026. https://www.ema.europa.eu/en/events/good-manufacturing-practice-multistakeholder-workshop-expert-contributions-artificial-intelligence-guidance-development-annex-22
  • European Commission, stakeholders' consultation on EudraLex Volume 4, Chapter 4, Annex 11 and new Annex 22. https://health.ec.europa.eu/consultations/stakeholders-consultation-eudralex-volume-4-good-manufacturing-practice-guidelines-chapter-4-annex_en
  • ISPE, comments on draft Annex 22, 7 October 2025. https://ispe.org/sites/default/files/regulatory/ISPE-Commenting/2025/ISPE_Comments_-_Annex%2022%20AI%20-%20EMA_PICs_Final%20.pdf
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