Non-Clinical Trials Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Study Type (Pharmacodynamics (PD) studies, Pharmacokinetics (PK) studies, Toxicology studies), By Test (In silico, In vitro, In vivo), By Therapeutic Area (Oncology, Cardiovascular, Neurology, Immunology, Others), By End User (Pharmaceutical and Biotechnology Companies, Contract Research Organizations (CROs), Academic and Government Research Institutes, Others), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 11.23 Billion
CAGR (2026-2031)	6.78%
Fastest Growing Segment	Pharmacokinetics (PK) studies
Largest Market	North America
Market Size (2031)	USD 16.65 Billion

Market Overview

The Global Non-Clinical Trials Market will grow from USD 11.23 Billion in 2025 to USD 16.65 Billion by 2031 at a 6.78% CAGR. Non-clinical trials, encompassing essential in vitro and in vivo studies, are conducted to evaluate the safety, toxicity, and efficacy of pharmaceutical candidates prior to human clinical testing. The primary driver supporting this market's growth is the escalating global investment in drug discovery pipelines, necessitated by the rising prevalence of chronic and complex diseases. This heightened financial commitment to innovation ensures a steady demand for rigorous safety testing services. According to the European Federation of Pharmaceutical Industries and Associations, in 2024, the pharmaceutical industry invested approximately €55 billion in research and development across Europe.

Despite these strong growth factors, the market faces a significant challenge regarding the ethical implications and regulatory pressures associated with animal testing. Stringent mandates aiming to replace, reduce, and refine animal usage are compelling companies to transition toward alternative methods such as computer modeling or organ-on-a-chip technologies. While ethically progressive, the complex validation processes and high costs required to fully integrate these non-animal alternatives into regulatory frameworks can create operational delays and impede immediate market expansion.

Key Market Drivers

Surge in Pharmaceutical and Biotechnology R&D Expenditure functions as the primary catalyst for the Global Non-Clinical Trials Market, as heightened investment correlates with an increased volume of drug candidates requiring rigorous safety assessments. Pharmaceutical developers are aggressively expanding pipelines to address complex therapeutic areas, necessitating extensive in vitro and in vivo studies prior to human testing. This financial commitment is evident in major industry players; according to AstraZeneca, February 2025, in the 'Full Year and Q4 2024 Results', the company’s total research and development expense rose by 24% to $13.6 billion. Such capital infusion ensures a continuous flow of molecular entities, a trend validated by regulatory output. According to the FDA, January 2025, in the 'Novel Drug Approvals for 2024' report, the Center for Drug Evaluation and Research approved 50 novel drugs in 2024, underscoring the requisite non-clinical testing preceding each approval.

Increasing Outsourcing of Non-Clinical Studies to Contract Research Organizations (CROs) is the second major driver, allowing companies to leverage specialized external expertise. By delegating early-stage toxicology studies to CROs, developers optimize costs and focus internal resources on core discovery. This reliance on external partners maintains substantial revenue for service providers, even amidst broader economic fluctuations. According to Charles River Laboratories, November 2025, in the 'Third-Quarter 2025 Results', the company reported revenue of $1.00 billion, reflecting enduring demand for outsourced safety assessment services. This strategic shift accelerates development timelines and provides access to advanced testing technologies that individual pharmaceutical companies may find prohibitively expensive to maintain in-house.

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Key Market Challenges

The stringent regulatory landscape driven by ethical concerns regarding animal welfare presents a substantial hurdle to the Global Non-Clinical Trials Market. Regulatory bodies are increasingly enforcing frameworks that compel pharmaceutical companies to reduce their reliance on established in vivo testing models. This forced transition creates a significant bottleneck, as the validation of non-animal alternatives remains a resource-intensive and prolonged process that disrupts established workflows. The immediate impact is a contraction in traditional testing volumes, which complicates the continuity of safety data generation and slows the overall drug development timeline.

Evidence of this regulatory tightening is visible in recent industry data. According to the UK Home Office, in 2024, the total number of scientific procedures involving living animals in Great Britain decreased to approximately 2.64 million, marking the lowest level recorded since 2001. This decline underscores the operational pressure on firms to limit animal usage. However, because alternative methodologies often lack universal regulatory acceptance or require costly customization to match the efficacy of traditional models, this shift extends development timelines and increases operational expenditures, directly impeding the market's ability to scale efficiently.

Key Market Trends

The Integration of Artificial Intelligence for Predictive Toxicology and Safety Assessment is fundamentally reshaping non-clinical workflows by shifting the focus from reactive observation to predictive analysis. Pharmaceutical companies are increasingly deploying machine learning algorithms to analyze vast historical datasets, allowing for the early identification of potential toxicity risks before physical testing begins. This technological shift not only accelerates candidate selection but also enhances the precision of safety profiles, reducing the high attrition rates associated with later-stage failures. For instance, according to Sanofi, May 2024, in the 'Sanofi, Formation Bio and OpenAI announce first-in-class AI collaboration' press release, the company entered a strategic partnership to build AI-powered software specifically designed to accelerate drug development and create custom models across the lifecycle.

The Expansion of Specialized Safety Testing for Biologics and Advanced Therapies is gaining momentum as the drug development pipeline pivots toward complex cell and gene therapies. Unlike small molecules, these advanced modalities require bespoke testing protocols to assess risks such as immunogenicity and tumorigenicity, creating a demand for highly specialized toxicology services. This trend is supported by substantial capital inflows into the sector, ensuring that developers can finance the rigorous non-clinical studies required for these novel agents. Highlighting this financial resilience, according to BioSpace, October 2024, in the 'Cell and Gene Therapy Investment Ticks Up After Hard Few Years' article, the Alliance for Regenerative Medicine reported that sector investments reached $10.9 billion in the first half of 2024, driven by late-stage clinical progress.

Segmental Insights

The Pharmacokinetics (PK) studies segment constitutes the fastest-growing area within the Global Non-Clinical Trials Market, driven by the critical industry focus on mitigating late-stage drug failure. Pharmaceutical developers are prioritizing early-stage Absorption, Distribution, Metabolism, and Excretion (ADME) profiling to validate drug viability before expensive human testing begins. This surge in demand correlates directly with stringent guidelines from regulatory bodies, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), which mandate comprehensive PK data to verify safety profiles. By adhering to these rigorous standards, companies ensure that only robust candidates progress to clinical development, significantly optimizing pipeline efficiency.

Regional Insights

North America maintains a dominant position in the non-clinical trials market, driven by a high density of established pharmaceutical and biotechnology companies engaged in drug discovery. This leadership is reinforced by strict regulatory standards set by the U.S. Food and Drug Administration, which require extensive safety and toxicology data before clinical testing can commence. Furthermore, significant financial support for medical research from the National Institutes of Health fosters a steady pipeline of new therapeutic candidates. Consequently, the region sustains high demand for preclinical contract research services.

Recent Developments

• In October 2025, Evotec SE announced a significant milestone in its strategic collaboration with Esperion Therapeutics, involving the nomination of a preclinical development candidate for the treatment of primary sclerosing cholangitis. This achievement utilized the company's integrated small molecule drug discovery platform and triggered an undisclosed payment from the partner. The collaboration focused on exploring new therapeutic opportunities in ATP citrate lyase biology to develop next-generation inhibitors. This progression highlighted the effectiveness of the partnership in identifying novel targets and advancing potential therapies through the critical non-clinical phases required before investigational new drug applications can be submitted to regulatory authorities.
• In June 2025, Emulate, Inc. officially launched the AVA Emulation System, a next-generation platform designed to facilitate high-throughput organ-on-a-chip experiments. This new technology addressed a critical need for scalability in non-clinical research by integrating microfluidic control with automated imaging and incubation capabilities. The system enabled pharmaceutical researchers to generate robust and reproducible data more efficiently, supporting the transition from pilot studies to large-scale screening. This product launch aimed to accelerate the adoption of human-centric models in drug development, allowing for better prediction of human responses and reducing the attrition rate of candidates during pre-clinical phases.
• In June 2024, Inotiv, Inc. provided a business update confirming that the expansion of its facility in Hillcrest, United Kingdom, was substantially complete. The company focused on finalizing occupancy for new customers at this upgraded site, which specializes in non-clinical and analytical drug discovery services. Following this milestone, the organization initiated the transition of operations from its Blackthorn facility to the expanded Hillcrest location. This consolidation was part of a broader strategy to optimize the company's operational footprint, enhance service delivery, and support the growing demand for research models and safety assessment services in the global pharmaceutical market.
• In April 2024, Charles River Laboratories International, Inc. launched the Alternative Methods Advancement Project (AMAP), a strategic initiative designed to develop and implement alternatives to animal testing in drug discovery. This program represented a significant commitment, building upon a prior investment of $200 million, with the company pledging to invest an additional $300 million over the subsequent five years. The initiative aimed to integrate advanced technologies and partnerships to create new standards for non-clinical development. By focusing on reducing reliance on in vivo models, the company sought to provide clients with more predictive, efficient, and ethical testing solutions for their research programs.

Key Market Players

• Thermo Fisher Scientific Inc.
• Charles River Laboratories International, Inc.
• Covance Inc.
• IQVIA Holdings, Inc.
• WuXi AppTec Co., Ltd.
• Eurofins Scientific
• Evotec SE
• Envigo RMS, LLC
• Absorption Systems, LLC

By Study Type	By Test	By Therapeutic Area	By End User	By Region
Pharmacodynamics (PD) studies Pharmacokinetics (PK) studies Toxicology studies	In silico In vitro In vivo	Oncology Cardiovascular Neurology Immunology Others	Pharmaceutical and Biotechnology Companies Contract Research Organizations (CROs) Academic and Government Research Institutes Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Non-Clinical Trials Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Non-Clinical Trials Market, By Study Type:

• Pharmacodynamics (PD) studies
• Pharmacokinetics (PK) studies
• Toxicology studies

• Non-Clinical Trials Market, By Test:

• In silico
• In vitro
• In vivo

• Non-Clinical Trials Market, By Therapeutic Area:

• Oncology
• Cardiovascular
• Neurology
• Immunology
• Others

• Non-Clinical Trials Market, By End User:

• Pharmaceutical and Biotechnology Companies
• Contract Research Organizations (CROs)
• Academic and Government Research Institutes
• Others

• Non-Clinical Trials Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE