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South America Preclinical CRO Market

ID: MRFR/HS/47588-HCR
200 Pages
Rahul Gotadki
October 2025

South America Preclinical CRO Market Research Report By Service Type (Biologics Testing, Small Molecule Testing, Toxicology Testing, Pharmacology Testing), By Therapeutic Area (Oncology, Neurology, Cardiology, Infectious Diseases), By Validation Type (In Vivo Studies, In Vitro Studies, Comparative Studies, Regulatory Studies), By End User (Pharmaceutical Companies, Biotechnology Companies, Academic Institutions, Research Organizations) and By Regional (Brazil, Mexico, Argentina, Rest of South America)- Forecast to 2035

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South America Preclinical CRO Market Summary

As per MRFR analysis, the South America The size was estimated at 525.6 USD Million in 2024. was estimated at 525.6 USD Million in 2024. The South America preclinical cro market is projected to grow from 556.14 USD Million in 2025 to 978.51 USD Million by 2035, exhibiting a compound annual growth rate (CAGR) of 5.81% during the forecast period 2025 - 2035.

Key Market Trends & Highlights

The South America preclinical CRO market is experiencing robust growth driven by technological advancements and increasing demand for outsourced services.

  • The South American preclinical CRO market is witnessing a rising demand for outsourced services, particularly in Brazil, which remains the largest market in the region.
  • Technological advancements are playing a crucial role in enhancing the efficiency and effectiveness of preclinical studies across the continent.
  • There is a notable focus on personalized medicine, which is gaining traction in both Brazil and Mexico, the latter being the fastest-growing market.
  • Key market drivers include increasing investment in biotechnology and regulatory support for drug development, which are fostering growth in the pharmaceutical industry.

Market Size & Forecast

2024 Market Size 525.6 (USD Million)
2035 Market Size 978.51 (USD Million)

Major Players

Charles River Laboratories (US), Covance (US), PRA Health Sciences (US), Eurofins Scientific (LU), Medpace (US), Wuxi AppTec (CN), Syneos Health (US), KCR (PL), Pharmaron (CN)

South America Preclinical CRO Market Trends

The preclinical CRO market in South America is currently experiencing notable growth, driven by an increasing demand for drug development services. This demand is largely attributed to the rising number of biopharmaceutical companies in the region, which are seeking to outsource their preclinical research to specialized organizations. The presence of a skilled workforce and favorable regulatory environments in certain countries further enhances the attractiveness of this market. Additionally, collaborations between local firms and international entities are becoming more common, fostering innovation and improving service offerings. Moreover, advancements in technology are playing a crucial role in shaping the preclinical CRO market. The integration of artificial intelligence and data analytics into research processes is streamlining operations and enhancing the accuracy of results. As a result, companies are better equipped to meet the stringent requirements of regulatory bodies. The focus on personalized medicine is also influencing the landscape, as firms aim to develop tailored therapies that address specific patient needs. Overall, the preclinical CRO market in South America appears poised for continued expansion, driven by these dynamic factors.

Rising Demand for Outsourced Services

The preclinical CRO market is witnessing an increase in demand for outsourced research services. Biopharmaceutical companies are increasingly recognizing the benefits of partnering with specialized organizations to enhance efficiency and reduce costs. This trend is particularly evident in countries with a burgeoning biotech sector, where local firms are leveraging the expertise of CROs to expedite drug development.

Technological Advancements

Innovations in technology are significantly impacting the preclinical CRO market. The adoption of advanced tools such as artificial intelligence and machine learning is streamlining research processes, improving data analysis, and enhancing the overall quality of preclinical studies. These technological advancements are enabling CROs to deliver more precise and reliable results, thereby attracting more clients.

Focus on Personalized Medicine

The growing emphasis on personalized medicine is shaping the preclinical CRO market. Companies are increasingly investing in research that targets specific patient populations, necessitating tailored preclinical studies. This shift is prompting CROs to adapt their services to meet the unique requirements of personalized therapies, thereby expanding their market reach.

South America Preclinical CRO Market Drivers

Growing Pharmaceutical Industry

The pharmaceutical industry in South America is on an upward trajectory, which is a significant driver for the preclinical CRO market. With an estimated growth rate of 10% annually, the demand for preclinical services is expected to rise correspondingly. Countries like Brazil and Mexico are leading this growth, with numerous pharmaceutical companies establishing R&D facilities. This expansion necessitates the expertise of CROs to conduct preclinical studies, thereby creating a symbiotic relationship between the pharmaceutical sector and CROs. As the pharmaceutical landscape evolves, the preclinical CRO market is poised to benefit from increased collaborations and partnerships, enhancing its overall growth prospects.

Rising Focus on Innovative Therapies

There is a notable shift towards innovative therapies in South America, which is influencing the preclinical CRO market. The increasing prevalence of chronic diseases has prompted pharmaceutical companies to invest in research for novel treatment options. This trend is reflected in the growing number of preclinical studies focusing on gene therapy and biologics. As companies seek to develop cutting-edge therapies, the demand for specialized preclinical services is likely to increase. The preclinical CRO market is thus positioned to capitalize on this trend, providing essential support for the development of innovative solutions that address unmet medical needs in the region.

Increasing Investment in Biotechnology

The preclinical CRO market in South America is experiencing a surge in investment, particularly in biotechnology sectors. Governments and private entities are allocating substantial funds to enhance research capabilities. For instance, Brazil has seen a 15% increase in biotechnology funding over the past year, which directly benefits preclinical CROs. This influx of capital is likely to facilitate the development of innovative therapies and drugs, thereby expanding the preclinical CRO market. Furthermore, as more biotech firms emerge, the demand for preclinical services is expected to rise, creating a robust ecosystem for research and development. The focus on biotechnology not only enhances the capabilities of CROs but also positions South America as a competitive player in the global market.

Regulatory Support for Drug Development

Regulatory frameworks in South America are evolving to support drug development, which positively impacts the preclinical CRO market. Countries like Argentina and Chile are streamlining their approval processes, reducing the time required for clinical trials. This regulatory support is crucial, as it encourages pharmaceutical companies to engage with CROs for preclinical studies. The region has witnessed a 20% increase in the number of approved clinical trials, indicating a growing trust in local CRO capabilities. As regulations become more favorable, the preclinical CRO market is likely to expand, attracting both local and international clients seeking efficient and compliant research solutions.

Collaboration Between Academia and Industry

The collaboration between academic institutions and the pharmaceutical industry in South America is fostering growth in the preclinical CRO market. Universities are increasingly partnering with CROs to leverage their research capabilities and resources. This synergy is particularly evident in countries like Brazil, where academic research is being translated into practical applications. Such collaborations not only enhance the quality of preclinical studies but also provide CROs with access to cutting-edge research and technology. As these partnerships continue to flourish, the preclinical CRO market is likely to expand, driven by the need for high-quality research and development services.

Market Segment Insights

By Service Type: Biologics Testing (Largest) vs. Toxicology Testing (Fastest-Growing)

In the South America preclinical CRO market, the service type segment displays a varied distribution of market share. Biologics Testing retains the largest share, driven by increasing demand for biologic drugs and advanced therapies. Other services like Small Molecule Testing and Toxicology Testing also contribute significantly to the market, reflecting diverse research and development needs across the pharmaceutical landscape. The dynamic nature of these services highlights the evolving research priorities in drug development. Growth trends in the service type segment are being influenced by several factors including innovations in drug discovery and regulatory complexities surrounding preclinical trials. The rise of personalized medicine is propelling Biologics Testing, making it a dominant player. Concurrently, Toxicology Testing is gaining traction as a fastest-growing area due to increasing regulatory scrutiny and emphasis on safety assessments in drug development, leading to a robust demand for vetting drug candidates effectively.

Biologics Testing (Dominant) vs. Toxicology Testing (Emerging)

Biologics Testing stands out as the dominant service in this market, characterized by extensive testing of biological products such as monoclonal antibodies and vaccines. This segment benefits from rising investment in biologic research and strong collaboration between CROs and biopharmaceutical companies. In contrast, Toxicology Testing is emerging rapidly, driven by heightened regulatory requirements aimed at ensuring drug safety. This service type is critical as it assesses the potential toxic effects of drug candidates, making it essential for compliance. The competitive landscape in South America further encourages innovation, fostering advancements in both segments to meet the evolving needs of the pharmaceutical industry.

By Therapeutic Area: Oncology (Largest) vs. Neurology (Fastest-Growing)

In the South America preclinical CRO market, Oncology holds the largest market share among therapeutic areas, driven by an increasing prevalence of cancer and significant investment in cancer research. Neurology, on the other hand, is gaining traction with the rising incidence of neurodegenerative disorders, such as Alzheimer's and Parkinson's disease, leading to a higher demand for innovative treatment options. Treatment protocols for psychiatric and neurological conditions are also evolving, further contributing to the shift in market dynamics. Growth trends show that while Oncology remains a dominant player, Neurology is anticipated to exhibit the fastest growth due to increased funding, research initiatives, and a focus on personalized medicine. The expanding pipeline for new drugs targeting neurological disorders, coupled with collaborations between CROs and pharmaceutical companies, enhances the overall investment in this area. The South America market is recognizing the vital role of neuropharmaceuticals in addressing unmet healthcare needs, paving the way for significant advancements in this segment.

Oncology (Dominant) vs. Cardiology (Emerging)

Oncology is the dominant therapeutic area in the South America preclinical CRO market, reflecting the urgent need for effective cancer treatments and the continuous developments in oncology research. CROs focusing on oncology are experiencing a robust demand due to innovative therapeutic approaches and the prioritization of oncology in many pharmaceuticals' R&D agendas. In contrast, Cardiology is viewed as an emerging segment, reflecting a growing concern for cardiovascular diseases in the region. While it is not yet at the forefront, the increasing prevalence of heart-related illnesses and a greater emphasis on preventive care and lifestyle interventions are propelling the cardia CRO offerings. Investment in cardiology research is expected to grow as stakeholders recognize the importance of addressing cardiovascular health issues, stimulating innovation within this therapeutic area.

By Validation Type: In Vivo Studies (Largest) vs. In Vitro Studies (Fastest-Growing)

The market for validation types in the preclinical CRO environment is diverse, featuring significant contributions from in vivo studies, in vitro studies, comparative studies, and regulatory studies. Among these, in vivo studies hold the largest market share, driven by their extensive application and reliable outcomes in drug development processes. In vitro studies, however, are rapidly gaining traction due to advancements in technology and the increasing preference for cheaper, more efficient testing methods. Growth trends indicate a proactive shift towards in vitro studies as they reflect the demand for accelerated drug development pipelines and reduced costs. Additionally, the rise in funding for research and development bolsters the comparative studies segment, while regulatory studies maintain a steady growth due to the ever-evolving healthcare landscape. Overall, the validation type segment is poised for dynamic growth as innovation and efficiency become central themes in drug development.

In Vivo Studies (Dominant) vs. In Vitro Studies (Emerging)

In vivo studies serve as the dominant force in validation types in preclinical research, offering the ability to observe the effects of treatments in a biological context. These studies are indispensable in understanding pharmacokinetics and pharmacodynamics, which makes them a preferred choice among researchers and sponsors. On the other hand, in vitro studies are emerging as a vital component, recognized for their speed and cost-effectiveness. While in vivo studies often require extensive resources and compliance with ethical standards, in vitro methodologies allow parallel testing of multiple drug candidates, thereby enhancing productivity. As the industry embraces technological advancements, in vitro studies are likely to expand their footprint further, supporting the overall trend towards more efficient drug discovery processes.

By End User: Pharmaceutical Companies (Largest) vs. Biotechnology Companies (Fastest-Growing)

In the South America preclinical CRO market, the distribution of market share among end users reveals that pharmaceutical companies hold the largest share, primarily due to their extensive R&D investments and established infrastructures. In contrast, biotechnology companies are rapidly gaining traction, thanks to innovative therapies and an increasing number of clinical trials, capturing significant market attention and resources. This trend highlights the competitive dynamics within the segment, showcasing how both end users contribute to the market landscape. The growth trends for these segments are influenced by several factors, including the rising demand for outsourcing services among pharmaceutical companies seeking to reduce costs and improve efficiency. Biotechnology companies are supported by increased funding from investors and partnerships, driving further growth. As the healthcare landscape evolves, the collaboration between academic institutions and research organizations is also fostering innovation, creating a fertile ground for development and advancement in the preclinical landscape.

Pharmaceutical Companies (Dominant) vs. Biotechnology Companies (Emerging)

Pharmaceutical companies represent a dominant force in the South America preclinical CRO market, characterized by their established presence, substantial R&D expenditures, and comprehensive portfolios of services. They primarily focus on drug development and regulatory processes, leveraging advanced technologies to expedite research and minimize risks. In contrast, biotechnology companies are emerging as agile innovators, often equipped with specialized expertise in developing novel therapeutic solutions. Their growth is fueled by partnerships with established pharmaceutical firms and increasing investments in biotech research, enabling them to rapidly advance from concept to clinical trials. This dynamic creates a competitive environment where both segment values can thrive and reshape the CRO landscape.

Get more detailed insights about South America Preclinical CRO Market

Regional Insights

Brazil : Leading Growth in South America

Brazil holds a commanding market share of 250.0, representing a significant portion of the South American preclinical CRO market. Key growth drivers include a robust pharmaceutical sector, increasing R&D investments, and favorable government policies promoting innovation. Demand trends indicate a rising need for outsourcing preclinical services, driven by the growing number of biotech firms and a focus on personalized medicine. Regulatory frameworks are evolving to support faster approvals, enhancing the industrial landscape.

Mexico : Growth Amidst Regulatory Changes

With a market value of 100.0, Mexico is witnessing a burgeoning preclinical CRO market. Key growth drivers include an expanding pharmaceutical industry and increasing foreign investments. Demand for preclinical services is on the rise, particularly in oncology and rare diseases, as local firms seek to enhance their R&D capabilities. Recent regulatory reforms aim to streamline processes, making it easier for companies to conduct clinical trials and access funding.

Argentina : Strengthening Biotech Ecosystem

Argentina's preclinical CRO market is valued at 75.0, reflecting a growing interest in biotechnology and pharmaceutical research. Key growth drivers include government initiatives to support biotech startups and an increase in public-private partnerships. Demand trends show a focus on innovative therapies, particularly in neurology and immunology. The regulatory environment is becoming more favorable, with efforts to simplify approval processes for new drugs and therapies.

Rest of South America : Regional Growth Beyond Major Markets

The Rest of South America holds a market value of 100.6, showcasing diverse opportunities across various countries. Key growth drivers include increasing healthcare investments and a rising number of clinical trials. Demand for preclinical services is growing, particularly in countries like Chile and Colombia, where local firms are expanding their R&D capabilities. The competitive landscape features both local and international players, with a focus on tailored services for specific regional needs.

South America Preclinical CRO Market Regional Image

Key Players and Competitive Insights

The preclinical contract research organization (CRO) market in South America is characterized by a dynamic competitive landscape, driven by increasing demand for drug development services and a growing emphasis on innovation. Key players such as Charles River Laboratories (US), Covance (US), and Eurofins Scientific (LU) are strategically positioned to leverage their extensive expertise and global networks. Charles River Laboratories (US) focuses on enhancing its service offerings through technological advancements and strategic partnerships, while Covance (US) emphasizes its capabilities in integrated drug development solutions. Eurofins Scientific (LU) appears to be concentrating on expanding its geographical footprint, particularly in emerging markets, which may enhance its competitive edge in the region.

The market structure is moderately fragmented, with several players vying for market share. Key business tactics include localizing manufacturing and optimizing supply chains to enhance operational efficiency. The collective influence of these major players shapes the competitive environment, as they continuously adapt to the evolving needs of the pharmaceutical and biotechnology sectors.

In October 2025, Charles River Laboratories (US) announced a strategic partnership with a leading biotechnology firm to enhance its preclinical services, particularly in the area of gene therapy. This collaboration is expected to bolster Charles River's capabilities in providing comprehensive solutions for complex therapeutic areas, thereby reinforcing its market position. The strategic importance of this partnership lies in its potential to accelerate the development timelines for clients, which is increasingly critical in the fast-paced biopharmaceutical landscape.

In September 2025, Covance (US) launched a new suite of digital tools aimed at streamlining the preclinical research process. This initiative reflects Covance's commitment to integrating technology into its operations, which may lead to improved data management and analysis capabilities. The introduction of these tools is likely to enhance client satisfaction by providing more efficient and transparent research processes, thereby solidifying Covance's reputation as a leader in the preclinical CRO market.

In August 2025, Eurofins Scientific (LU) expanded its laboratory facilities in Brazil, a move that underscores its commitment to meeting the growing demand for preclinical services in South America. This expansion is strategically significant as it positions Eurofins to better serve local clients and respond to regional market needs. By increasing its operational capacity, Eurofins may enhance its competitive advantage and foster stronger relationships with pharmaceutical companies in the region.

As of November 2025, current trends in the preclinical CRO market include a pronounced shift towards digitalization, sustainability, and the integration of artificial intelligence (AI) in research processes. Strategic alliances among key players are shaping the competitive landscape, facilitating knowledge sharing and resource optimization. Looking ahead, competitive differentiation is likely to evolve from traditional price-based competition to a focus on innovation, technological advancements, and supply chain reliability. This shift may redefine how companies position themselves in the market, emphasizing the importance of agility and responsiveness to client needs.

Key Companies in the South America Preclinical CRO Market market include

Industry Developments

The South America Preclinical Contract Research Organization (CRO) Market has witnessed notable developments recently, showcasing a dynamic landscape. Companies such as Syneos Health and Charles River Laboratories have been expanding their presence, reflecting the growth in biopharmaceutical development in the region.

A significant merger occurred in June 2023 when Labcorp Drug Development acquired a local CRO to enhance its service capabilities in the market. Eurofins Scientific has also shown interest in expanding its preclinical services across South America, capitalizing on the increasing demand for drug development services in Brazil and Argentina, as these nations support the biotech sector through favorable regulations.

In the past couple of years, the South American market has seen investment increases, with several firms reporting revenue growth attributed to rising clinical trial activities, indicative of a burgeoning biotechnology landscape. Companies like Medpace and PRA Health Sciences have also reported strategic partnerships aimed at advancing their service offerings.

As research and development initiatives intensify, the preclinical CRO market in South America is poised for significant expansion, driven by local government support and an increase in healthcare investments in the region.

Future Outlook

South America Preclinical CRO Market Future Outlook

The preclinical CRO market is projected to grow at a 5.81% CAGR from 2024 to 2035, driven by increasing R&D investments and technological advancements.

New opportunities lie in:

  • Expansion of in vivo testing services for biopharmaceuticals
  • Development of AI-driven data analytics platforms
  • Partnerships with academic institutions for innovative research initiatives

By 2035, the market is expected to achieve robust growth and enhanced service offerings.

Market Segmentation

South America Preclinical CRO Market End User Outlook

  • Pharmaceutical Companies
  • Biotechnology Companies
  • Academic Institutions
  • Research Organizations

South America Preclinical CRO Market Service Type Outlook

  • Biologics Testing
  • Small Molecule Testing
  • Toxicology Testing
  • Pharmacology Testing

South America Preclinical CRO Market Validation Type Outlook

  • In Vivo Studies
  • In Vitro Studies
  • Comparative Studies
  • Regulatory Studies

South America Preclinical CRO Market Therapeutic Area Outlook

  • Oncology
  • Neurology
  • Cardiology
  • Infectious Diseases

Report Scope

MARKET SIZE 2024525.6(USD Million)
MARKET SIZE 2025556.14(USD Million)
MARKET SIZE 2035978.51(USD Million)
COMPOUND ANNUAL GROWTH RATE (CAGR)5.81% (2024 - 2035)
REPORT COVERAGERevenue Forecast, Competitive Landscape, Growth Factors, and Trends
BASE YEAR2024
Market Forecast Period2025 - 2035
Historical Data2019 - 2024
Market Forecast UnitsUSD Million
Key Companies Profiled["Charles River Laboratories (US)", "Covance (US)", "PRA Health Sciences (US)", "Eurofins Scientific (LU)", "Medpace (US)", "Wuxi AppTec (CN)", "Syneos Health (US)", "KCR (PL)", "Pharmaron (CN)"]
Segments CoveredService Type, Therapeutic Area, Validation Type, End User
Key Market OpportunitiesEmerging biotechnologies and regulatory advancements drive growth in the preclinical cro market.
Key Market DynamicsGrowing demand for preclinical services in South America driven by increased Research and Development investments and regulatory support.
Countries CoveredBrazil, Mexico, Argentina, Rest of South America

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FAQs

What is the projected market size of the South America Preclinical CRO Market in 2024?

The South America Preclinical CRO Market is expected to be valued at 657.0 million USD in 2024.

What will the market value of the South America Preclinical CRO Market be by 2035?

By 2035, the South America Preclinical CRO Market is projected to reach 1200.0 million USD.

What is the expected CAGR for the South America Preclinical CRO Market from 2025 to 2035?

The anticipated compound annual growth rate (CAGR) for the South America Preclinical CRO Market from 2025 to 2035 is 5.629%.

Which region holds the largest market share in the South America Preclinical CRO Market in 2024?

In 2024, Brazil is projected to have the largest market share, valued at 250.0 million USD.

What is the market value of the Toxicology Testing segment in 2024?

The Toxicology Testing segment is valued at 200.0 million USD in 2024.

Which companies are considered key players in the South America Preclinical CRO Market?

Key players in the market include Safire, Syneos Health, Genoa Healthcare, and Charles River Laboratories.

How much is the Small Molecule Testing segment expected to be valued at by 2035?

By 2035, the Small Molecule Testing segment is expected to reach 300.0 million USD.

What is the projected value of the Argentina market for Preclinical CRO in 2035?

Argentina's Preclinical CRO market is projected to be valued at 165.0 million USD by 2035.

What market growth opportunities exist for the Pharmacology Testing segment from 2025 to 2035?

The Pharmacology Testing segment will likely see growth opportunities as it is expected to increase from 117.0 million USD in 2024 to 170.0 million USD by 2035.

What growth challenges might the South America Preclinical CRO Market face in the coming years?

Challenges may arise from regulatory hurdles and the competitive landscape among key players in the South America Preclinical CRO Market.

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