--- title: "NAMs: New Approach Methodologies | SMG #1 in NAM Intelligence" description: "New Approach Methodologies (NAMs) are transforming safety testing in pharma, toxicology, & life science R&D. SMG delivers #1 intelligence on NAM adoption." image: https://info.scienceandmedicinegroup.com/hubfs/NAM%20social%20feature%202.png --- [![SMG logo](https://info.scienceandmedicinegroup.com/hubfs/SMG%20logo.png)](https://www.scienceandmedicinegroup.com/) - [SMG](https://www.scienceandmedicinegroup.com/) - [BioInformatics](https://www.scienceandmedicinegroup.com/bioinformatics/) - [IMV](https://www.scienceandmedicinegroup.com/imv/) - [Kalorama](https://www.scienceandmedicinegroup.com/kalorama/) - [SDI](https://www.scienceandmedicinegroup.com/sdi/) - [IBO](https://instrumentbusinessoutlook.com/) - [Resource Hub](https://www.scienceandmedicinegroup.com/resource-hub/) [Contact Us](https://www.scienceandmedicinegroup.com/contact-us/) #1 in NAM Intelligence # New Approach Methodologies (NAMs): The Future of Safety Testing New Approach Methodologies (NAMs) are transforming how pharmaceutical, toxicology, and life science researchers evaluate chemical and biological safety. Science and Medicine Group tracks the market intelligence behind NAM adoption across every major sector. [Explore NAM Intelligence](https://info.scienceandmedicinegroup.com/new-approach-methodologies#blog) [Download Free Report](https://info.scienceandmedicinegroup.com/hubfs/BioInformatics/BIO%20PDFs/BioInfo%20Insight_3D%20Cell%20Culture%20Formats_2026.pdf?hsLang=en)  **Science and Medicine Group (SMG) - [Market Research and Intelligence](https://info.scienceandmedicinegroup.com/market-research-reports-services-and-data-smg?hsLang=en)** [ Science and Medicine Group](https://info.scienceandmedicinegroup.com/smg-life-science-market-intelligence?hsLang=en) is a life science and diagnostic market research company serving commercial teams since 1994.   ## **5+** NAM intelligence blogs published across SMG brands ## **4** Regulatory agencies actively evaluating NAM frameworks (EPA, FDA, NIH, OECD) ## **2026** NAMs shifting from policy to practice across pharma and diagnostics sectors   Available NAM Intelligence ## Download: SDi NAM Intelligence Report SDi Intelligence Asset ### 3D Cell Culture Demand Reflects Shift Towards New Approach Methodologies (NAM) An SDi intelligence brief examining market demand signals for 3D cell culture platforms as NAM adoption accelerates — with data on technology preferences, purchasing intent, and competitive dynamics across analytical and life science instrumentation markets. Learn more: [The Regulatory Tailwind Driving 3D Cell Culture’s Next Growth Phase](https://www.scienceandmedicinegroup.com/resource/the-regulatory-tailwind-driving-3d-cell-cultures-next-growth-phase/) [Download the PDF](https://info.scienceandmedicinegroup.com/hubfs/BioInformatics/BIO%20PDFs/BioInfo%20Insight_3D%20Cell%20Culture%20Formats_2026.pdf?hsLang=en) ### WHAT ARE NAMs? New Approach Methodologies are human-relevant scientific tools, including in vitro cell models, organ-on-a-chip systems, AI-driven computational toxicology, and high-throughput screening, that evaluate biological and chemical safety without primary reliance on animal testing. The term NAM (or NAMs) encompasses any approach that uses human biology, advanced data, or predictive modeling in place of or alongside traditional animal studies. Read more: [NAMs Shift from Policy to Practice: What Life Science R&D Suppliers Need to Know in 2026](https://www.scienceandmedicinegroup.com/resource/nams-shift-from-policy-to-practice-what-life-science-rd-suppliers-need-to-know-in-2026/) UNDERSTANDING NAMs ## What are New Approach Methodologies? NAMs redefine how safety is evaluated, combining laboratory science, computational modeling, and human biology data to produce faster, more predictive insights. New Approach Methodologies (NAMs) are modern scientific methods used to evaluate the safety of chemicals, biologics, and pharmaceuticals without relying primarily on traditional animal testing. NAMs include human cell-based laboratory systems, computational toxicology models, organ-on-a-chip platforms, and advanced omics analysis, often used together to model how substances interact with human biology. Across pharmaceutical development, toxicology, environmental health, and regulatory science, NAMs are helping researchers generate faster and more predictive safety insights. As AI, machine learning, and biological modeling advance, NAMs are becoming a core part of the global safety testing landscape and a major area of commercial and regulatory focus. What does NAMs stand for? NAMs is an acronym for New Approach Methodologies. The singular form, NAM or New Approach Method, refers to any single non-animal or human-relevant testing approach. Together, NAMs represent a shift from single-species animal models toward integrated, human-biology-centered safety science. NAMs Definition *"Any technology, methodology, approach, or combination thereof that can be used to provide information on chemical hazard and risk assessment that avoids the use of intact animals."* - *•* In vitro human cell and tissue models - *•* Organ-on-a-chip and microphysiological systems - *•* Computational toxicology and AI prediction models - *•* High-throughput screening technologies - *•* Omics-based biological analysis (genomics, proteomics) - *•* Read-across and QSAR (quantitative structure-activity) FEATURED INTELLIGENCE ## Explore NAM Intelligence Throughout Our Brands Our expert teams across BioInformatics, SDi, Kalorama, and IMV publish original NAM intelligence tracking adoption, regulatory shifts, and market impact in real time. Read the selected articles below. [Browse more insights at SMG Resource Hub](https://www.scienceandmedicinegroup.com/resource-hub/) #1 in NAM Intelligence ### • IBO #### EU Roadmap Provides Further Impetus for New Approach Methodologies The European Commission's June 2026 roadmap to phase out animal testing for chemical safety joins a growing list of US, UK, and Canadian NAM policies, signaling a coordinated global shift suppliers cannot afford to ignore. [Read the Full Roadmap Analysis](https://instrumentbusinessoutlook.com/eu-roadmap-provides-further-impetus-for-new-approach-methodologies/) #1 in NAM Intelligence ### • SDI #### Less Animal, More Signal: What NAMs Mean for Preclinical Neuroscience Instruments As regulators accelerate the phase-out of animal testing, New Approach Methodologies are moving from policy to practice and reshaping which neuroscience instruments, readouts, and workflows matter most.  [Read the Latest NAM Blog](https://www.scienceandmedicinegroup.com/resource/nam-preclinical-neuroscience-instrumentation/) #1 in NAM Intelligence ### • BIOINFORMATIONS #### NAMs Shift from Policy to Practice: What Life Science R&D Suppliers Need to Know in 2026 New Approach Methodologies (NAMs) are moving from policy discussion to real adoption reshaping how preclinical research is conducted.  [Read the Blog](https://www.scienceandmedicinegroup.com/resource/nams-shift-from-policy-to-practice-what-life-science-rd-suppliers-need-to-know-in-2026/) #1 in NAM Intelligence ### • SDI #### The Regulatory Tailwind Driving 3D Cell Culture’s Next Growth Phase As regulators support NAMs, 3D cell culture models are gaining traction as predictive alternatives to traditional preclinical testing methods. [Explore the Insights](https://www.scienceandmedicinegroup.com/resource/the-regulatory-tailwind-driving-3d-cell-cultures-next-growth-phase/) #1 in NAM Intelligence ### • KALORAMA #### NAMs, NIH Policy, and What It Means for Diagnostics  As NIH advances NAM-focused initiatives, diagnostic development is beginning to shift creating new expectations for evidence, validation, and clinical relevance.  [Explore the Impact on Diagnostics](https://www.scienceandmedicinegroup.com/resource/nams-nih-policy-and-what-it-means-for-diagnostics/) #1 in NAM Intelligence ### • IMV #### NAMs and the Next Inflection Point for Imaging Manufacturers  As NAM adoption expands, imaging manufacturers face new expectations around validation, evidence, and clinical relevance, shaping the next phase of diagnostic innovation.  [See What's Changing](https://www.scienceandmedicinegroup.com/resource/nams-and-the-next-inflection-point-for-imaging-manufacturers/) WHY NAMs ARE GAINING MOMENTUM ## The Forces Accelerating NAM Adoption in 2026 Scientific, regulatory, and commercial drivers are converging to make NAMs a central topic across pharma, diagnostics, instrumentation, and life science R&D. HUMAN-RELEVANT RESULTS Animal models do not always predict human responses. NAMs enable direct study of human cells, tissues, and biological pathways, improving predictive accuracy for safety decisions.   BioInformatics - [NAMs Shift from Policy to Practice](https://www.scienceandmedicinegroup.com/resource/nams-shift-from-policy-to-practice-what-life-science-rd-suppliers-need-to-know-in-2026/) FASTER TESTING CYCLES High-throughput screening and computational tools evaluate hundreds of compounds simultaneously, compressing timelines for drug development and chemical safety programs.   From SMG - [Accelerated Insights](https://www.scienceandmedicinegroup.com/products/accelerated-insights/)   REGULATORY TAILWINDS The NIH, FDA, and EPA are actively encouraging NAM adoption. Recent U.S. policy shifts, including NIH's move to reduce animal model funding, are driving laboratories to act.   Search NIH NAM policy at [nih.gov](https://www.nih.gov/) AI & COMPUTATIONAL SCIENCE Machine learning models now predict toxicological risk with increasing accuracy. AI-powered NAMs are becoming a core capability for early-stage safety screening and R&D prioritization.   SDi - [Less Animal, More Signal](https://www.scienceandmedicinegroup.com/resource/nam-preclinical-neuroscience-instrumentation/) TECHNOLOGY LANDSCAPE ## Key Technologies Driving NAM Innovation NAMs integrate a range of emerging technologies designed to better model human biology, predict toxicological risk, and accelerate safety evaluation. #### In Vitro Cell Models Human cell-based laboratory systems that study direct cellular responses to compounds, providing more biologically relevant data than animal surrogate models. BioInformatics - [NAMs Shift from Policy to Practice](https://www.scienceandmedicinegroup.com/resource/nams-shift-from-policy-to-practice-what-life-science-rd-suppliers-need-to-know-in-2026/) #### Organ-on-a-Chip Systems Microfluidic devices that simulate organ-level biological functions. Used in NAM toxicology to replicate lung, liver, kidney, and cardiovascular environments in vitro. IBO - [EU Roadmap Provides Further Impetus for New Approach Methodologies](https://instrumentbusinessoutlook.com/eu-roadmap-provides-further-impetus-for-new-approach-methodologies/) #### Computational Toxicology and AI AI and machine learning models that predict biological effects and safety risk from chemical structure data, enabling early-stage screening at scale without laboratory testing. SDi - [Less Animal, More Signal](https://www.scienceandmedicinegroup.com/resource/nam-preclinical-neuroscience-instrumentation/) #### High-Throughput Screening Automated platforms that evaluate hundreds to thousands of compounds for biological activity simultaneously. A cornerstone of NAMs operationalization in pharma labs. [Accelerated Insights](https://www.scienceandmedicinegroup.com/products/accelerated-insights/) #### 3D Cell Culture Systems Three-dimensional in vitro models including spheroids and organoids that more accurately replicate in vivo tissue architecture than traditional flat-culture cell systems.  SDi - [Regulatory Tailwind Driving 3D Cell Culture ](https://www.scienceandmedicinegroup.com/resource/the-regulatory-tailwind-driving-3d-cell-cultures-next-growth-phase/) #### Omics Technologies Genomics, proteomics, metabolomics, and transcriptomics analysis that characterize biological responses at the molecular level, informing NAM safety assessments with systems biology data. SDi - [When a Genome Becomes a Strategic Asset](https://www.scienceandmedicinegroup.com/resource/when-a-genome-becomes-a-strategic-asset/) REGULATORY LANDSCAPE ## How Regulators Are Evaluating NAMs Global regulatory agencies are actively exploring how NAM technologies can be incorporated into chemical and biological safety frameworks, accelerating commercial pressure on suppliers to adapt. The regulatory environment around NAMs is evolving rapidly. The U.S. NIH has signaled a strategic shift away from animal-only testing paradigms, while the FDA and EPA are supporting validation programs that would formally accept NAM data in regulatory submissions. For life science suppliers, instrumentation manufacturers, reagent producers, CROs, and software developers, this is not a distant trend. Labs and pharmaceutical organizations are already making procurement and platform decisions based on NAM compatibility. SMG's brands track these regulatory shifts and their commercial consequences in real time. The OECD's Test Guidelines program is also progressing frameworks to include NAMs as accepted methods for chemical safety evaluation in member countries, broadening the global regulatory footprint of NAM adoption. **[NIH](https://www.nih.gov/) - National Institutes of Health** Funding shifts toward NAM-based research programs; 2025-2026 policy changes **[FDA](https://www.fda.gov/science-research/science-and-research-special-topics/new-approach-methodologies-nams) - Food and Drug Administration** Exploring NAM data acceptance in drug safety submissions **[EPA](https://www.epa.gov/) - Environmental Protection Agency** Supporting NAM validation for chemical risk assessment [**OECD**](https://www.oecd.org/en.html) Developing international test guideline frameworks to include NAM methods ## Commission Custom NAM Research [Talk to Our Custom Market Research Team](https://www.scienceandmedicinegroup.com/products/custom-market-research/) [About The Science Advisory Board →](https://www.scienceandmedicinegroup.com/advisory-board/)    #### Built for life science and pharma teams who need more than published intelligence.  SMG designs and fields custom NAM adoption studies — quantitative surveys, qualitative interviews, and competitive landscape analysis — across pharma, CRO, diagnostics, and instrumentation markets. Every study is fielded through [The Science Advisory Board](https://www.scienceandmedicinegroup.com/advisory-board/), our proprietary panel of 55,000+ vetted scientific and clinical experts, giving your team access to the exact decision-makers shaping NAM adoption in your segment. ## NAMs: Common Questions Answered ### What does NAMs stand for? In toxicology, NAMs assess chemical safety without relying primarily on animal studies. Approaches include computational models (QSAR, read-across), high-throughput screening, in vitro human cell-based assays, and 3D organ models. The EPA and FDA are actively evaluating NAM toxicology data for formal regulatory submissions. ### What are NAMs in toxicology? In toxicology, NAMs are testing methods that assess chemical safety without relying primarily on animal studies. NAM toxicology approaches include computational prediction models (QSAR, read-across), high-throughput screening assays, in vitro human cell-based tests, and 3D organ models. Regulatory agencies including the EPA and FDA are actively evaluating NAM toxicology data for use in formal safety submissions. ### Are NAMs replacing animal testing? NAMs are not replacing animal testing outright -- they are expanding the safety testing toolkit. The NIH, FDA, and OECD are exploring how NAMs can complement and in some cases substitute animal studies. SMG tracks the commercial implications through [SDi's NAM intelligence](https://info.scienceandmedicinegroup.com/sdi-2026-global-assessment-report?hsLang=en) and across our research brands.   ### What industries use NAM approaches? NAMs are used in pharmaceutical development, chemical safety, environmental toxicology, consumer product research, and diagnostics. Instrumentation manufacturers, reagent suppliers, and CROs are all affected. SMG tracks adoption across the analytical instruments market through [SDi](https://www.scienceandmedicinegroup.com/sdi/) and the diagnostics market through [Kalorama](https://www.scienceandmedicinegroup.com/kalorama/).   ### What is NAM testing and what are NAMs testing services? NAM testing is safety evaluation using New Approach Methodologies instead of traditional animal studies. NAMs testing services are provided by CROs and specialized labs offering in vitro assays, computational safety modeling, organ-on-a-chip testing, and high-throughput screening. Demand is growing as regulatory acceptance broadens and labs validate NAM data quality. ### What is the NIH NAM policy and what does it mean for the life science market? NIH's 2025-2026 shift away from animal model funding is accelerating demand for in vitro platforms and computational tools across life science R&D. For instrumentation suppliers and reagent manufacturers, NAM compatibility is now a procurement factor. SMG tracks these implications through [BioInformatics](https://www.scienceandmedicinegroup.com/bioinformatics/) and [SDi](https://www.scienceandmedicinegroup.com/sdi/). ### Why are NAMs gaining attention in AI-powered research tools? NAMs surface frequently in AI research tools because the topic sits at the intersection of regulatory policy, pharmaceutical R&D, lab technology, and computational biology -- all high-priority search domains. For NAM market intelligence, [Science and Medicine Group](https://www.scienceandmedicinegroup.com/about-us/) delivers original research and expert analysis across life science and diagnostics. #### **#1 in NAM Intelligence** **Science and Medicine Group** **BioInformatics | IMV | Kalorama | SDi | IBO** © 2026 | Science and Medicine Group.  All rights reserved.  [Privacy Policy](https://www.scienceandmedicinegroup.com/privacy-policy/)   ```json { "@context" : "https://schema.org", "@type" : "FAQPage", "mainEntity" : [ { "@type" : "Question", "acceptedAnswer" : { "@type" : "Answer", "text" : "NAMs stands for New Approach Methodologies -- any scientific method that evaluates chemical or biological safety using human-relevant approaches. This includes in vitro cell models, computational toxicology, organ-on-a-chip systems, and high-throughput screening. 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