New Approach Methodologies (NAMs) Market

New Approach Methodologies (NAMs) Market to 2031: Size, Share & Growth Report

The global New Approach Methodologies (NAMs) market is expected to value at ~USD 6.20 billion in 2026 and is projected to reach ~USD 13.59 billion by 2031, growing at a CAGR of approximately 17.0% during 2026–2031.

The NAMs market is supported by increasing regulatory acceptance across the US and European Union, rising NIH investment in human-based research, growing demand for more predictive safety models, and the continued shift away from animal testing in pharmaceutical, chemical, and consumer product development.

New Approach Methodologies (NAMs) refer to any non-animal technology, methodology, or combination of approaches used to assess safety, toxicity, efficacy, pharmacology, or human biological responses. NAMs span human-relevant in vitro models, engineered tissue models, organ-on-chip and microphysiological systems, NAM-specific assay systems, and NAM-specific computational/in-silico platforms, along with associated testing, validation, and contract research services.

In April 2025, the US FDA announced a landmark “Roadmap to Reducing Animal Testing in Preclinical Safety Studies,” targeting monoclonal antibodies as the first drug class for which routine animal toxicology studies will become the exception rather than the norm within three to five years. In the next few days, the NIH launched its Human-Based Science Initiative, establishing the Office of Research Innovation, Validation, and Application (ORIVA) and committing to stop issuing funding calls that require animal-only research designs. In July 2025, NIH confirmed that new funding opportunities would no longer be developed exclusively around animal models. In March 2026, NIH announced its first USD 150 million in Complement-ARIE program awards to develop and scale human-based research methods. On June 1, 2026, the European Commission adopted its own Roadmap Towards Phasing Out Animal Testing for Chemical Safety Assessments, a 22-action, three-pillar plan spanning 15 regulatory domains — including REACH, pharmaceuticals, cosmetics, food and feed additives. Together, these actions form the fastest-moving regulatory tailwind the preclinical testing industry has seen in decades.

Top 10 Key Takeaways

• North America holds the largest market share, driven by the FDA's April 2025 roadmap, the NIH's Human-Based Science Initiative and ~USD 150 million Complement-ARIE (Complement- Animal Research in Experimentation) awards, and the concentration of leading NAM technology developers (Emulate, Certara, Charles River).
• Europe is the fastest-growing region, propelled by the European Commission's June 2026 Roadmap Towards Phasing Out Animal Testing for Chemical Safety Assessments and its 22 actions across 15 regulatory domains, including REACH.
• Overall services, including NAM model development & validation, and the NAM-based testing services segment are expected to grow at the fastest CAGR during the forecast period.
• In-vitro methods lead by platform revenue; organ-on-chip / microphysiological systems (MPS) are the fastest-growing method.
• Toxicology & safety testing dominates by application and is the fastest-growing application as the EU roadmap takes effect.
• Pharmaceutical and biotechnology companies lead end users as they are focusing on building in-house NAM qualification capacity.
• Emulate's Liver-Chip is on track to become the first organ-on-a-chip-qualified FDA Drug Development Tool (DDT), a milestone that would validate organ-chip data as pivotal rather than merely supporting evidence.
• NIH's Complement-ARIE program and its USD 150 million first-round awards mark the first sustained federal funding commitment specifically earmarked for NAM development and standardization.
• The near-term opportunity lies in cross-agency harmonization: the ICH's 2025 initiative to incorporate NAMs into chemical and drug safety guidelines could open simultaneous US/EU/Japan regulatory pathways.
• The near-term risk is validation lag: most NAM data currently functions as supporting, weight-of-evidence information rather than pivotal data that fully replaces a required animal study.

Why the New Approach Methodologies (NAMs) Market Matters Now

Preclinical safety testing has relied on animal models for the better part of a century, yet the translational record is poor: FDA has noted that more than 90% of drugs that clear animal studies fail to gain approval in humans, a gap the agency cites explicitly as justification for its 2025 roadmap. That gap is now colliding with three forces at once: mounting regulatory pressure from the FDA, NIH, and European Commission; scientific maturity in human-relevant platforms (organoids, organ-chips, iPSC-derived tissue, AI/ML toxicity models); and sustained public and political pressure.

New Approach Methodologies solve the translation problem by grounding safety and efficacy testing directly in human biology instead of extrapolating from mouse, rat, dog, or primate physiology. A monoclonal antibody developer can now pair AI-based computational toxicity models with organoid or organ-chip cytotoxicity and immunogenicity data to build a weight-of-evidence safety package — shortening study timelines, lowering R&D cost, and, per FDA's own framing, improving the odds that a compound that looks safe in preclinical testing actually is safe in humans.

Market Trends Shaping New Approach Methodologies (NAMs)

The defining trend is the shift from an “animal-first” to a “human-relevant-first” preclinical testing paradigm. In silico/computational toxicology platforms such as Certara's Simcyp Simulator and Simulations Plus's GastroPlus already function as accepted PBPK tools for dose selection and pediatric extrapolation, giving the segment a regulatory head start. Organ-on-chip and MPS developers such as Emulate, CN Bio, MIMETAS, Hesperos, TissUse, InSphero, AxoSim, and newer entrant Vivodyne, are racing to convert that acceptance for laboratory-based, three-dimensional human tissue data, with Emulate's Liver-Chip closest to becoming the first organ-chip-qualified FDA Drug Development Tool for drug-induced liver injury.

A second trend is monoclonal antibody and biologics testing creating the volume case for NAM adoption. FDA identified mAbs as its first-wave use case because animal immunogenicity data has proven particularly unreliable for predicting human response, and the agency's draft guidance, “Monoclonal Antibodies: Streamlined Nonclinical Safety Studies,” gives sponsors a concrete path to reduce or eliminate long-term primate toxicity studies using NAM-based, weight-of-evidence packages.

A third trend is coordinated, near-simultaneous regulatory recognition across the FDA, NIH, EPA, and European Commission. Within three weeks in April 2025, both FDA and NIH announced parallel initiatives to reduce animal testing; EPA followed with its own reinstated phase-out plan for mammalian testing. In March 2026, FDA released draft guidance titled “General Considerations for the Use of New Approach Methodologies in Drug Development,” establishing a four-part framework — context of use, human biological relevance, technical characterization, and fit-for-purpose — for evaluating NAM submissions. In June 2026, the European Commission's own roadmap extended the same logic to chemical safety assessments across 15 regulatory domains.

A fourth trend is the emergence of integrated, multi-NAM data packages replacing single-endpoint testing. Sponsors increasingly combine PBPK/QSP modeling, organoid or organ-chip cytotoxicity data, and AI-based off-target risk prediction (such as Certara's ToxStudio and Libra DILI models) into a single weight-of-evidence submission rather than relying on any one NAM type in isolation.

A fifth trend is federal funding beginning to flow directly into NAM development and standardization, most visibly through NIH's Complement-ARIE program, which issued its first USD 150 million in awards in March 2026 to develop and standardize laboratory- and computer-based human-relevant methods, alongside a Reduction to Practice Prize launched in September 2025 to accelerate translation of NAMs into routine use.

Market Drivers Accelerating Growth

The first driver is accelerating regulatory transition from animal studies toward human-relevant methods. The FDA’s April 2025 roadmap encouraged NAM data in drug development, initially focusing on monoclonal antibodies before expanding to other biologics and new chemical entities. The agency’s April 2026 progress update, the European Commission’s June 2026 roadmap, and the EPA’s continued expansion of acceptable NAMs are creating clearer pathways for incorporating in-vitro, in-chemico, and in-silico evidence into regulatory assessments.

The second driver is the expansion of internationally recognized NAM test guidelines. OECD adoption improves scientific confidence, enables greater cross-country recognition, and supports the use of NAM-generated data in regulated testing. New and updated OECD guidelines introduced in July 2026 covered ToxTracker-based genotoxicity, CYP induction using differentiated human hepatic cells, in-vitro immunotoxicity, and reconstructed human epidermis phototoxicity. The expanding guideline portfolio is increasing commercial demand for validated assay-ready models and regulatory testing services.

The third driver is the rising safety-testing requirements for complex therapeutic modalities. Monoclonal antibodies, antibody-drug conjugates, cell and gene therapies, and other advanced biologics can produce species-specific binding, immune activation, cytokine responses, and off-target effects that are difficult to evaluate in conventional animal models. Pharmaceutical and biotechnology companies are therefore adopting human-cell assays, immune-competent models, organoids, microphysiological systems, and computational approaches to improve candidate selection and identify safety risks earlier.

Market Challenges and Restraints

The most significant restraint is limited regulatory replacement coverage for systemic and long-term endpoints. Regulatory acceptance is relatively advanced for skin irritation, eye irritation, sensitization, and selected mechanistic toxicity endpoints. However, NAMs do not yet provide complete replacements for repeated-dose, reproductive, developmental, neurological, immune, and chronic systemic toxicity studies. Consequently, NAM data are often used as supporting or weight-of-evidence information rather than as a complete substitute for required animal studies.

A second restraint is the high cost and operational complexity of advanced models. Organoids and microphysiological systems require specialized expertise, stringent quality control, longer culture periods, and customized study designs. Their cost and lower throughput compared with conventional 2D assays can limit routine adoption, particularly among smaller companies. During the regulatory transition, sponsors may also need to conduct NAM and animal studies in parallel, increasing total development expenditure before meaningful cost savings can be achieved.

A major challenge is interoperability between organ-on-chip, in-silico, and in-vitro data streams. NAM providers frequently use different experimental protocols, endpoint definitions, data formats, quality criteria, and analysis systems. These differences make it difficult to combine results across platforms and laboratories into integrated regulatory submissions. Common reporting standards, reference datasets, transparent algorithms, and consistent metadata will be essential for scaling integrated NAM-based testing strategies.

Report Scope

The NAMs market covers revenue generated from commercially supplied, end-use testing models, assay systems, predictive software, and related services used to assess safety, efficacy, pharmacodynamics, ADME/DMPK, and chemical hazards. Products and services included in the market are assay-ready 2D cell-based tests; 3D models such as spheroids, organoids, reconstructed human tissues, and microtissues; biologically functional organ-on-chip and microphysiological systems sold as completed test models or studies; in-chemico and acellular assays; and in-silico solutions. The scope also includes outsourced NAM model development and testing services. The market excludes conventional in-vivo animal studies and related CRO revenue.

Market Segmentation

The New Approach Methodologies market segments across four key segments. By offering, products cover commercially available, ready-to-use or test-ready NAM models; instruments, systems and devices; consumables such as microfluidic chips, cartridges, assays, reagents and testing kits; and software and computational tools. Services include model development and validation services and NAM-based testing services. By application, the market covers drug discovery and development, including biologics and biosimilars development, regenerative medicine and tissue engineering, and other therapeutic-development applications. It also includes toxicology and safety testing, covering toxicity assessment, safety assessment, efficacy and safety profiling, and mechanistic toxicology. Research applications include disease modelling, personalized medicine and biomarker research, stem-cell and developmental-biology research, and basic and translational research. Other applications include cosmetic testing, food-safety and nutrition research, chemical testing, environmental safety and ecotoxicology, and medical-device and biomaterial safety testing. By end user, it serves pharmaceutical and biotechnology companies, CROs and CRDMOs, academic and research institutes, and other end users such as cosmetic and personal care companies, food and nutraceutical companies, agrochemical companies, chemical industries, environmental testing organizations, and other commercial research entities.

Segment Insights

By offering, the NAMs market is segmented into products and services. Products held the largest share of the market in 2025. The large share of this segment is attributed to factors such as strong demand for commercially available NAM models, testing systems, consumables, assays, and computational tools across research and safety-testing workflows.

By Method, the NAMs market is segmented into in vitro methods, organ-on-a-chip/microphysiological systems, ex vivo and reconstructed human tissue models, in chemico methods, in silico/computational methods, and other methods. In vitro methods held the largest share of the market in 2025, supported by their widespread adoption, broad availability, relatively lower cost, and established use in drug development and safety testing.

By Application, the NAMs market is segmented into drug discovery and development, toxicology and safety testing, research applications, and other applications. Toxicology and safety testing held the largest share of the market in 2025, driven by the growing use of NAMs to identify toxicity risks, evaluate product safety, study toxicity mechanisms, and reduce dependence on animal testing.

By End user, the NAMs market is segmented into pharmaceutical and biotechnology companies, academic and research institutions, CROs and CDMOs, and other end users. Pharmaceutical and biotechnology companies held the largest share of the market in 2025, due to their extensive use of NAMs across drug discovery, preclinical development, efficacy assessment, safety testing, and regulatory decision-making.

By Region

North America

North America holds the largest share in the NAMs Market. The US dominates through the FDA's April 2025 roadmap, the NIH Human-Based Science Initiative and its USD 150 million Complement-ARIE awards, EPA's reinstated mammalian-testing phase-out plan, and the concentration of leading NAM developers including Emulate (Boston), Certara, and Charles River Laboratories. Canada contributes through academic NAM research programs and regulatory science partnerships with US agencies.

Europe

Europe is the fastest-growing region. The region's growth is anchored by the European Commission's June 2026 Roadmap Towards Phasing Out Animal Testing for Chemical Safety Assessments and its 22 actions across 15 regulatory domains. Germany and the UK host major organoid, organ-chip, and in silico toxicology developers and CRO networks; Switzerland contributes through pharmaceutical company adoption of NAM-based nonclinical strategies; and France adds academic and regulatory-science research capacity.

Asia Pacific

Asia Pacific grows strongly. Japan leads through PMDA's bilateral engagement on NAM qualification via ICH and growing organ-chip and organoid research collaborations. China brings expanding domestic biotechnology R&D investment and regulatory science capacity-building. South Korea contributes through government-backed alternative-testing research initiatives.

Latin America

Latin America grows steadily. Brazil leads the region due to its established alternative-methods network, expanding pharmaceutical research, and increasing use of in vitro and reconstructed tissue models.

Middle East and Africa

The Middle East and Africa market expands gradually. Countries like Saudi Arabia, UAE, Israel contribute significantly in the region through their strong biotechnology sector and research capabilities in organ-on-chip, computational modelling, and advanced cell-based systems. 

Key Company Insights

The competitive landscape spans four tiers: product providers including assay & reagents manufacturers, instrument providers, organ-on-chip/MPS and organoid platform developers, in silico/computational toxicology and AI-ADMET software providers, high-throughput screening and instrumentation vendors, and NAM-enabled contract testing and advisory service providers. Leading players include Emulate, CN Bio Innovations, MIMETAS, Certara, Simulations Plus, Charles River Laboratories, Instem, Molecular Devices/Danaher, InSphero, Hesperos, TissUse, AxoSim, Vivodyne, MatTek Corporation (a Bio-Rad company), and Eurofins Scientific.

• Emulate, Inc. (Organ-Chips)
• CN Bio Innovations (PhysioMimix MPS platform)
• MIMETAS (OrganoPlate platform)
• Certara, Inc. (Simcyp Simulator / ToxStudio / Non-Animal Navigator)
• Simulations Plus, Inc. (GastroPlus / PBPK and QSP modeling)
• Charles River Laboratories (NAM-enabled safety testing services)
• Instem plc (nonclinical data and SEND informatics)
• Molecular Devices / Danaher (high-throughput screening platforms)
• InSphero AG (3D microtissue and organoid models)
• Hesperos, Inc. (Human-on-a-Chip multi-organ systems)
• TissUse GmbH (Multi-Organ-Chip platform)
• AxoSim, Inc. (Nerve-on-a-Chip platform)
• Vivodyne (AI-native human tissue testing platform)
• MatTek Corporation, a Sartorius company (reconstructed human tissue models)
• Eurofins Scientific (NAM and toxicology testing services)

Emulate is the market's most closely watched platform developer: its Liver-Chip is in the final phases of FDA ISTAND qualification as a Drug Development Tool for drug-induced liver injury (DILI) assessment. Achievement of this would mark the first organ-on-a-chip technology formally qualified by FDA for regulatory use. Emulate had raised over USD 200 million as of April 2026, reflecting investor confidence in the regulatory tailwind. Certara anchors the in silico segment through its Simcyp Simulator, the most widely adopted PBPK modeling platform, alongside its ToxStudio suite and Non-Animal Navigator advisory offering, which guides sponsors through weight-of-evidence NAM strategy design. Simulations Plus's GastroPlus is the other large PBPK platform, with particular strength in absorption and formulation modeling.

CN Bio, MIMETAS, InSphero, Hesperos, TissUse, and AxoSim compete across organ-specific and multi-organ chip and organoid platforms, while newer entrant Vivodyne is pursuing an AI-native approach to human tissue-based drug testing. Charles River Laboratories and Eurofins Scientific are extending their large existing preclinical CRO footprints into NAM-enabled service lines, positioning themselves as one-stop integrators of in silico, in vitro, and organ-chip data into regulatory-ready submissions.

Key company strategy conclusions:

• Emulate appears best positioned to achieve a first-of-its-kind regulatory milestone through the FDA’s ISTAND/DDT qualification pathway for its Liver-Chip in drug-induced liver injury assessment.
• Certara and Simulations Plus hold strong positions in in silico and PBPK modelling, which has the longest history of regulatory use among NAM categories.
• Charles River Laboratories and Eurofins Scientific benefit from their large contract-testing operations. This enables them to offer integrated testing packages that combine multiple NAM methods for companies preferring to outsource.
• CN Bio, MIMETAS, InSphero, Hesperos, TissUse, and AxoSim compete mainly through organ-specific models and technical capabilities within the organ-on-chip/MPS segment.

Recent Developments

• In June 2026, the European Commission adopted its Roadmap Towards Phasing Out Animal Testing for Chemical Safety Assessments, a 22-action plan spanning 15 regulatory domains including REACH, pharmaceuticals, and food and feed additives
• In March 2026, NIH announced its first USD 150 million in Complement-ARIE program awards to develop, implement, and standardize laboratory- and computer-based new approach methodologies.
• In July 2025, FDA and NIH co-hosted a workshop on reducing animal testing, after which NIH confirmed that new funding opportunities would no longer be developed exclusively around animal-only research designs.
• In April 2025, the NIH launched its Human-Based Science Initiative and announced the creation of the Office of Research Innovation, Validation, and Application (ORIVA) to coordinate NAM development, validation, and scale-up across the agency.
• In April 2025, the FDA announced its “Roadmap to Reducing Animal Testing in Preclinical Safety Studies,” targeting monoclonal antibodies as the first drug class for phased replacement of routine animal testing with NAMs.

Real-World Use Cases

Emulate's Liver-Chip is progressing through the final phases of FDA's ISTAND Drug Development Tool qualification for drug-induced liver injury (DILI) assessment. If qualified, it would become the first organ-on-a-chip technology formally recognized by FDA for use in regulatory submissions, a milestone the industry has anticipated since the FDA Modernization Act 2.0 first opened the door to non-animal IND-supporting data in December 2022. Emulate's collaborations with Roche and AstraZeneca already use Liver-Chip and other organ-chip data to inform drug-drug interaction and hepatotoxicity risk assessments, with the FDA reporting that as of early 2026 such data has appeared in IND applications as supporting evidence rather than pivotal, study-replacing data, the frontier the qualification effort is intended to cross.

Certara's Non-Animal Navigator solution has guided pharmaceutical sponsors through cross-functional NAM roadmap development, combining in vitro, in silico, in vivo, and real-world evidence strategies into a single weight-of-evidence plan, including toxicology consulting, Simcyp Simulator-based PBPK modeling, and validated monoclonal antibody QSP models built specifically to support sponsors responding to FDA's monoclonal antibody first-wave initiative.

Conclusion and Future Outlook

Through 2031, New Approach Methodologies will mature from a scientifically promising but regulatorily supplementary toolset into a core, and in some domains mandatory, component of preclinical and chemical safety assessment. The forces driving the market include FDA's three-to-five-year roadmap timeline, the EU's 22-action chemical safety roadmap, NIH's USD 150 million Complement-ARIE commitment, and the prospect of the first organ-on-a-chip-qualified FDA Drug Development Tool, are structural, coordinated across agencies and continents, and mutually reinforcing. AI usage is expected to grow significantly. Increasingly sophisticated computational toxicity models, automated weight-of-evidence assembly, and predictive validation frameworks are expected to help close the gap between NAM data as supporting evidence and NAM data as pivotal, study-replacing evidence.

For nonclinical development heads, regulatory affairs leaders, toxicologists, and investors, the NAMs market represents a major shift toward human-relevant drug and chemical safety testing. Market success will depend on whether NAM platforms can generate reliable evidence for key regulatory submissions, rather than only supporting data, and help make animal testing the exception instead of the standard approach.

Frequently Asked Questions (FAQ)

1. How big is the New Approach Methodologies (NAMs) market?

The New Approach Methodologies market is valued at ~USD 6.20 billion in 2026 and is projected to reach about ~USD 13.59 billion by 2031. North America accounts for the largest share, driven by the FDA's April 2025 roadmap, NIH's Human-Based Science Initiative, and the concentration of leading NAM developers.

2. What is the New Approach Methodologies market growth rate?

The market is forecast to grow at a CAGR of approximately 17.0% from 2026 to 2031. Europe is the fastest-growing region, driven by the European Commission's June 2026 chemical safety roadmap.

3. Which segment leads the New Approach Methodologies market?

By offering, the products segment leads the NAMs market. Its leading position is supported by strong demand for commercially available NAM models, instruments and systems, NAM-specific consumables, and software and computational tools across drug development, safety testing, and research applications.

4. Who are the key players in the New Approach Methodologies market?

Leading players include Emulate, CN Bio Innovations, MIMETAS, Certara, Simulations Plus, Charles River Laboratories, Instem, Molecular Devices/Danaher, InSphero, Hesperos, TissUse, AxoSim, Vivodyne, MatTek Corporation, and Eurofins Scientific.

5. What are the factors driving the New Approach Methodologies market?

The primary drivers are the FDA's April 2025 Roadmap to Reducing Animal Testing in Preclinical Safety Studies, the EU's June 2026 chemical safety roadmap, and the NIH Human-Based Science Initiative together with its USD 150 million Complement-ARIE program awards. Also, growing adoption of non-animal models for preclinical testing by developing economies is supporting market growth.

Speak With Our Analyst

The New Approach Methodologies market is where regulatory science is being rewritten in real time, and platform-level detail on qualification pathways, weight-of-evidence frameworks, in silico versus organ-chip adoption, and application-specific validation requirements is where strategic decisions are won or lost. MarketsandMarkets can help you go deeper: request a sample of the full study, speak with our analyst about your specific questions, or customize the scope to your target platform types, applications, and geographies. Reach out to explore how this intelligence can inform your NAM adoption strategy, platform selection, or investment thesis.