Preclinical CRO Market Size, Share & Trends Analysis Report By Service (Bioanalysis and DMPK studies, Toxicology Testing, Compound Management, Chemistry, Safety Pharmacology, Others), By Model (Patient-Derived Organoid (PDO) Model, Patient-Derived Xenograft Model), By Applications (Oncology, Neurology, Cardiology, Infectious Diseases, Metabolic Disorders, Others), By End-User (Pharmaceutical and Biotechnological Companies, Government and Academic Institutes, Medical Device Companies, Others) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2025-2033

Preclinical CRO Market Size

The global preclinical CRO market size was valued at USD 8.62 billion in 2024. It is projected to reach from USD 9.54 billion in 2025 to USD 21.48 billion by 2033, growing at a CAGR of 14.12% during the forecast period (2025-2033). 

Substantial funding from both the public and private sectors is a key driver of growth in the preclinical Contract Research Organization (CRO) market. For example, the U.S. government allocated USD 2.3 billion towards mRNA COVID-19 vaccine research and development. At the same time, India’s Ministry of Science and Technology set aside INR 40 billion (approx. USD 427.2 million) for similar initiatives. This influx of financial resources fuels increased research activities, thereby driving higher demand for preclinical CRO services to effectively manage and execute these projects.

The COVID-19 pandemic initially disrupted research activities in early 2020; however, this period ultimately led to significant market growth. There was a dramatic rise in preclinical studies aimed at developing vaccines and therapeutics, which spurred heightened engagement of CROs in preclinical phases.

• For instance, Laboratory Corporation of America Holdings reported revenues of USD 5,845.5 million for its preclinical and clinical services in 2021, marking a 6.5% increase from 2020. This growth exemplifies the broader trend of rising investments in preclinical research as companies strive to expedite drug development processes in response to the urgent demands of the pandemic.

Preclinical CRO Market Trends

Growing trend of outsourcing r&d functions to cros

Pharmaceutical and biotechnological companies are increasingly turning to Contract Research Organizations (CROs) for outsourcing their R&D functions. This strategic shift enables these companies to cut costs, enhance operational efficiency, and tap into specialized expertise. By outsourcing, organizations can concentrate on their core activities while benefiting from the advanced capabilities and resources that CROs offer.

A notable example of this trend occurred in January 2023, when Charles River Laboratories formed a partnership with Rznomics Inc. to develop and manufacture RNA-based gene therapies for cancer. This collaboration highlights the growing reliance on CROs for specialized research and development, allowing companies to accelerate their innovation while reducing the burden of in-house R&D activities. Such partnerships are expected to continue driving growth in the preclinical CRO market as the demand for specialized services increases.

Preclinical CRO Market Growth Factors 

Increased prevalence of chronic diseases

The rising incidence of chronic diseases, such as cancer, cardiovascular diseases, and neurological disorders, is significantly driving demand for new therapies and preclinical trial activities. As these diseases become more widespread, the urgency for innovative treatments and interventions intensifies, leading to an increased focus on preclinical research.

• For instance, a report from the Pan American Health Organization in 2023 indicated that approximately 20 million new cancer cases and 10 million cancer-related deaths occur globally each year. Moreover, the cancer burden is projected to increase by about 60% over the next two decades. This alarming trend underscores the critical need for effective therapeutic solutions, propelling pharmaceutical and biotechnological companies to invest heavily in preclinical studies to develop new drugs and treatments.

As a result, the demand for preclinical CRO services is expected to continue to grow, reflecting the broader need for innovative healthcare solutions in response to the increasing prevalence of chronic diseases.

Regulatory demands fuel growth in specialized preclinical cro services

Stringent drug approval standards necessitate thorough preclinical testing to ensure safety and efficacy. Agencies like the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) mandate comprehensive evaluations for Investigational New Drug (IND) applications. These rigorous requirements drive the demand for specialized preclinical CRO services, as expertise in meeting complex regulations and providing reliable data is essential for advancing new therapies.

• For instance, the 21st Century Cures Act, a recent regulatory change, expedited drug approval processes, driving innovation and increasing demand for preclinical services. The act facilitates faster approval of breakthrough drugs and medical devices, contributing to a surge in preclinical research.

Market Restraining Factors

High costs of advanced models

While the adoption of advanced preclinical models offers significant advantages for drug development, it also comes with substantial financial burdens that may be beyond the reach of many research budgets. The expenses associated with these sophisticated models can be considerable, potentially limiting their broader application in preclinical studies.

Specifically, the costs incurred during the preclinical phases—including laboratory studies and animal testing—can range from USD 15 million to USD 100 million. This high price tag poses a significant challenge for smaller companies and research institutions, which may struggle to allocate such large sums for their R&D activities.

As a result, the high costs of advanced preclinical models can hinder market growth by restricting access to innovative research methodologies, ultimately slowing down the development of new therapies and interventions in the pharmaceutical and biotechnological sectors.

Preclinical CRO Market Opportunities:

Increased r&d investments

Increased R&D investments represent a significant opportunity for the global market. As pharmaceutical companies face intense competition and the need to innovate, many are allocating larger budgets toward research and development. For instance, in 2023, a major pharmaceutical firm increased its R&D budget by 15% to support the development of new oncology drugs.

This heightened investment creates a growing demand for preclinical CROs that can provide essential services such as toxicology testing, pharmacology studies, and bioanalytical support. By collaborating with preclinical CROs, these companies can expedite their drug development timelines and enhance their chances of regulatory approval.

Moreover, as the complexity of drug development increases, CROs that offer specialized expertise in niche areas—like gene therapy or rare diseases—will be particularly well-positioned to capitalize on this trend, helping clients navigate the intricate preclinical landscape while maximizing their R&D returns.

Regional Insights

North america: dominant region with 47.2% market share

North America holds a leading position in the global preclinical CRO driven by several key factors. High in-house drug development costs, ranging from USD 43.4 million to USD 4.2 billion per new drug, drive pharmaceutical companies to outsource preclinical trials to manage expenses. The rising prevalence of chronic diseases such as cardiovascular conditions, diabetes, cancer, and neurological disorders further fuels demand for preclinical research.

For instance, the incidence of lung cancer in the U.S. increased from 236,740 cases in 2022 to 238,340 in 2023, with continued growth projected. Moreover, the growing complexity of clinical trials and the high number of investigational candidates are expected to propel market expansion in the region.Bottom of Form

Asia-pacific: fastest growing region with the highest market cagr

The Asia Pacific region is expected to witness the fastest growth rate in the global market. The shift in MNC outsourcing models and rising R&D costs are driving increased preclinical outsourcing to Asia Pacific, where CROs in countries such as India and China offer cost efficiency.

Companies from Western Europe and the U.S. are increasingly utilizing the region for analytical services, site research development, and clinical activities to lower research costs. For instance, according to an August 2023 report from India’s Department of Pharmaceuticals, the aggregate R&D expenditure of the largest pharmaceutical companies in India exceeded USD 138 billion in 2022, reflecting a 1.7% increase from 2021.Top of Form

Country insights

The preclinical Contract Research Organization (CRO) market is experiencing significant growth driven by various factors across different regions. Increasing investments in pharmaceutical research and development (R&D), coupled with a rise in the number of clinical trials globally, are key factors contributing to this growth. The surge in drug development activities, particularly in oncology, cardiology, and neurology, has heightened the demand for specialized preclinical testing services.

Below is the analysis of key countries impacting the preclinical CRO market:

• U.S.- The U.S. preclinical CRO is at the forefront of medical innovation and technology, holding the largest market revenue. In 2023, according to the American Cancer Society, lung cancer cases in the U.S. rose from 236,740 in 2022 to 238,340 in 2023. This increasing cancer incidence is expected to drive demand for advanced therapeutics, boosting preclinical trial activities and supporting market growth for preclinical CRO services in the U.S.
• Japan- Japan, one of the world's largest pharmaceutical markets, is witnessing a surge in preclinical trial outsourcing. The country's growing pharmaceutical sector and supportive government measures led to an increase in clinical trials. This market trend is expected to drive demand for preclinical services, as testing needs to be conducted close to central development centers.
• India- In May 2023, Aragen Life Sciences Ltd. and Far Biotech formed a partnership to advance preclinical research in neurodegeneration. Aragen will leverage its experimental discovery platform to support FAR Biotech in achieving a critical milestone for its small molecule program targeting neurodegenerative diseases.
• China: In 2022, China reported approximately 4.8 million new cancer cases and 2.6 million cancer-related deaths. This high incidence and mortality rate drive significant demand for advanced cancer therapies, fueling growth in the market. Moreover, the rising need for effective cancer treatments accelerates preclinical research activities as pharmaceutical companies increasingly outsource these studies to specialized CROs for their expertise in drug development and regulatory compliance.
• Germany- In 2022, as per the World Health Organisation, Germany reported 11,082 clinical trials, which is 24% of the global. This large number of trials indicates a high volume of research and development activity, which increases the demand for preclinical studies to ensure drug safety and efficacy before clinical trials can proceed.
• UK- In 2023, the UK market led the European region. This dominance is due to the country's significant R&D investment, the presence of major pharmaceutical companies such as GlaxoSmithKline and AstraZeneca, and early-stage development CROs such as Charles River Laboratories and Envigo. Moreover, the UK’s regulatory environment, overseen by the Medicines and Healthcare Products Regulatory Agency (MHRA), ensures high standards for preclinical trials, enhancing data quality and integrity.
• France: As per ScienceDirect, in France, cardiovascular disease (CVD) is a major cause of death, accounting for over 25% of fatalities, with approximately 140,000 deaths annually. This high prevalence and complexity of cardiovascular diseases drive the increased demand for preclinical CRO services in the field of cardiovascular research.

Segmentation Analysis

By service

The global preclinical CRO market is bifurcated into bioanalysis and DMPK studies, toxicology testing, compound management, chemistry, safety pharmacology, and others. The toxicology testing segment is the dominant force in the market, accounting for the largest market revenue share. This segment is vital as it focuses on evaluating the safety and potential adverse effects of new drug candidates. Its leadership in the market stems from its crucial role in ensuring drug safety prior to entering clinical trials.

Moreover, regulatory agencies, such as the Food and Drug Administration (FDA), require toxicity testing for all experimental medicines as part of preclinical studies. This regulatory mandate underscores the importance of toxicology testing in the drug development process, reinforcing its dominance within the market.

Collectively, these factors highlight the segment’s pivotal role in advancing pharmaceutical safety and efficacy, making it indispensable for the success of new drug candidates.

By model

The global preclinical CRO industry is bifurcated into patient-derived organoid (PDO) model and patient-derived xenograft model. The patient-derived organoid (PDOs) segment dominates the global market, holding the largest market revenue primarily due to its advanced capability to accurately replicate human tissue architecture and predict patient-specific drug responses. PDOs offer significant advantages over traditional models by providing a more precise representation of human biology, enhancing drug efficacy and safety prediction.

• For instance, in April 2023, InSphero AG signed a distribution agreement with Bionova Supplies to introduce their Akura 96 and 384 Spheroid Microplates in India. These microplates enhance spheroid/organoid formation and analysis, meeting the increasing demand for advanced PDO models in drug development.

By application

The global market is bifurcated into oncology, neurology, cardiology, infectious diseases, metabolic disorders, and others. The oncology segment leads the market, capturing the largest share of market revenue. This dominance is primarily driven by the increasing demand for effective cancer treatments and the substantial number of research studies focused on oncology. For example, in 2021, the World Health Organization (WHO) reported that approximately 111 phase 0 clinical trials for cancer were registered in the U.S., accounting for 32.1% of all phase 0 trials conducted in the country.

This significant activity reflects the urgent need for innovative cancer therapies and highlights the ongoing commitment to advancing oncology research. As a result, the oncology segment remains a key driver of growth within the preclinical CRO industry, emphasizing its critical role in the development of new treatments for this pressing global health challenge.

By end-user

The global market is divided into pharmaceutical and biotechnological companies, government and academic institutes, medical device companies, and others. The pharmaceutical and biotechnological companies segment is the dominant player in the preclinical CRO market, driven primarily by a surge in collaborations with CROs aimed at advancing the development of novel therapeutics. These companies increasingly rely on CROs to harness specialized expertise, infrastructure, and resources, facilitating the efficient execution of preclinical studies.

This trend is further fueled by the high costs and complexity associated with drug development, which prompts these organizations to outsource critical research functions to CROs.

• For instance, in June 2023, Charles River Laboratories partnered with Curigin to enhance adenoviral vector production, leveraging Charles River's CRO expertise for both preclinical and clinical trials.

Such collaborations underscore the growing dependence on CROs within the pharmaceutical and biotechnology sectors, highlighting their vital role in accelerating the development of innovative therapies while managing the associated challenges of drug development.

Company Market Share

The global market is characterized by a dynamic mix of major multinational firms and specialized players. Key companies such as Labcorp, Charles River Laboratories, Eurofins Scientific, and Intertek Group command substantial market share due to their comprehensive service portfolios, expertise across various therapeutic areas, and extensive global reach.

• For instance, Labcorp’s Covance offers a wide range of preclinical services and has conducted numerous studies in advanced fields such as gene therapy. The market is increasingly driven by rising R&D investments in pharmaceuticals and biotechnology, with a growing emphasis on emerging areas like immuno-oncology and precision medicine.

These evolving trends highlight the need for specialized CRO capabilities to maintain competitiveness. As the landscape continues to shift, companies must adapt by enhancing their expertise and expanding their offerings to address the complex demands of modern drug development.

Pharmaron: An emerging player in the preclinical CRO market

Pharmaron is rapidly emerging as a key player in the market due to its strategic global expansion and aggressive acquisition strategy. Recently, Pharmaron's partnership with Celltrion exemplifies its commitment to enhancing its service offerings and global reach. Its extensive and innovative service portfolio, combined with a focus on technological advancements, strengthens its competitive position and marks it as an emerging leader in the industry.

Recent developments at Pharmaron include:

• In May 2022, Pharmaron acquired the FDA and EMA-approved Coventry API manufacturing site in Rhode Island from Noramco. This acquisition expands Pharmaron’s global chemistry and manufacturing capabilities, enhancing its integrated drug R&D services in North America.

Recent Developments

• September 2024 - PharmaLegacy Laboratories acquired BTS Research, a San Diego-based preclinical CRO, to enhance its preclinical services and expand operations into North America. This acquisition allows PharmaLegacy to strengthen its global research capabilities and better serve clients in the U.S. The combined expertise aims to provide rapid and reliable pharmacology data, adding GLP toxicology services to their offerings.