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South America Clinical Trials Market

ID: MRFR/MED/48509-HCR
200 Pages
Garvit Vyas
October 2025

South America Clinical Trials Market Research Report By Phase (Phase I, Phase II, Phase III, Phase IV), By Study Design (Interventional, Observational, Expanded Access), By Therapeutic Area (Oncology, Cardiology, Neurology, Infectious Diseases, Endocrinology), By End Use (Pharmaceutical Companies, Biotechnology Companies, Contract Research Organizations) and By Regional (Brazil, Mexico, Argentina, Rest of South America)- Forecast to 2035

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South America Clinical Trials Market Summary

As per MRFR analysis, the South America clinical trials market Size was estimated at 2639.2 USD Million in 2024. The South America clinical trials market is projected to grow from 2754.53 USD Million in 2025 to 4223.6 USD Million by 2035, exhibiting a compound annual growth rate (CAGR) of 4.37% during the forecast period 2025 - 2035.

Key Market Trends & Highlights

The South America clinical trials market is experiencing robust growth driven by regulatory improvements and technological advancements.

  • Brazil remains the largest market for clinical trials in South America, showcasing a diverse range of therapeutic areas.
  • Mexico is emerging as the fastest-growing region, attracting significant investment in clinical research.
  • Regulatory improvements and increased collaboration among stakeholders are enhancing the efficiency of clinical trials.
  • Rising demand for innovative therapies and enhanced patient recruitment strategies are key drivers propelling market expansion.

Market Size & Forecast

2024 Market Size 2639.2 (USD Million)
2035 Market Size 4223.6 (USD Million)

Major Players

Covance (US), IQVIA (US), PPD (US), Charles River Laboratories (US), Medpace (US), Syneos Health (US), Parexel International (US), Wuxi AppTec (CN), KCR (PL)

South America Clinical Trials Market Trends

The clinical trials market in South America is currently experiencing notable growth, driven by a combination of factors including an increasing demand for innovative therapies and a rising number of pharmaceutical companies seeking to conduct research in the region. The diverse population and varying disease prevalence across countries provide a unique opportunity for tailored clinical studies. Furthermore, regulatory bodies in South America are progressively streamlining approval processes, which may enhance the attractiveness of the region for clinical research. This evolving landscape suggests that South America could become a pivotal hub for clinical trials in the coming years. In addition, the collaboration between local institutions and international pharmaceutical companies appears to be strengthening. This partnership may facilitate knowledge transfer and improve the quality of clinical research. Moreover, the growing investment in healthcare infrastructure and technology in South America is likely to support the efficient execution of clinical trials. As the region continues to develop its capabilities, it may attract more sponsors and researchers, thereby expanding the clinical trials market significantly.

Regulatory Improvements

Regulatory agencies in South America are enhancing their frameworks to expedite the approval process for clinical trials. This trend may lead to a more efficient pathway for researchers and sponsors, potentially increasing the number of studies conducted in the region.

Increased Collaboration

There is a noticeable rise in partnerships between local research institutions and international pharmaceutical companies. Such collaborations may enhance the quality of clinical trials and foster innovation, benefiting both local economies and global health.

Technological Advancements

The integration of advanced technologies in clinical research is becoming more prevalent. This trend could improve data collection and analysis, leading to more reliable outcomes and potentially attracting more investment into the clinical trials market.

South America Clinical Trials Market Drivers

Increasing Regulatory Support

Regulatory support is playing a crucial role in shaping the clinical trials market in South America. Governments are actively working to streamline the approval processes for clinical trials, thereby reducing the time and costs associated with bringing new therapies to market. In 2025, it is projected that regulatory timelines could decrease by up to 20%, making it more feasible for companies to conduct trials in the region. This supportive environment is likely to attract more international pharmaceutical companies to conduct research in South America, further bolstering the clinical trials market.

Growing Investment in Biotechnology

Investment in biotechnology is a significant driver of the clinical trials market in South America. The region has seen a rise in venture capital funding directed towards biotech firms, which are increasingly focusing on developing novel therapies. In 2025, it is anticipated that investments in biotechnology could exceed $500 million, reflecting a growing confidence in the potential of local companies to deliver innovative solutions. This influx of capital is likely to facilitate more clinical trials, thereby enhancing the overall research capabilities within the clinical trials market. The synergy between biotechnology and clinical research is expected to yield promising results for patients.

Rising Demand for Innovative Therapies

The clinical trials market in South America is experiencing a notable surge in demand for innovative therapies, particularly in the fields of oncology and rare diseases. This trend is driven by an increasing prevalence of chronic diseases and a growing population that seeks advanced treatment options. As pharmaceutical companies aim to develop new drugs, the clinical trials market is expected to expand significantly. In 2025, the market is projected to reach approximately $1.5 billion, reflecting a compound annual growth rate (CAGR) of around 8%. This rising demand is likely to encourage more investment in clinical research, thereby enhancing the overall landscape of the clinical trials market.

Enhanced Patient Recruitment Strategies

Effective patient recruitment strategies are becoming increasingly vital in the clinical trials market in South America. With a diverse population and varying health conditions, the ability to recruit suitable participants is crucial for the success of clinical trials. Innovative approaches, such as digital outreach and community engagement, are being employed to attract participants. In 2025, it is estimated that patient recruitment costs could account for up to 30% of the total clinical trial budget. This emphasis on recruitment not only accelerates trial timelines but also improves the quality of data collected, thereby fostering a more robust clinical trials market.

Emergence of Local Research Institutions

The emergence of local research institutions is significantly impacting the clinical trials market in South America. These institutions are increasingly collaborating with pharmaceutical companies to conduct clinical trials, leveraging their expertise and local knowledge. In 2025, it is estimated that partnerships between local institutions and global companies could increase by 25%, enhancing the capacity for conducting diverse clinical trials. This trend not only fosters innovation but also contributes to the development of a skilled workforce in the region, thereby strengthening the clinical trials market.

Market Segment Insights

By Phase: Phase III (Largest) vs. Phase I (Fastest-Growing)

The market share distribution for clinical trial phases in South America showcases Phase III as the most substantial segment, commanding a significant portion of the market. Conversely, Phase I trails behind, yet it demonstrates notable growth potential, driven by an increase in early-stage clinical trials and a heightened focus on innovative treatments. The growing interest in personalized medicine further supports the evolution of this phase. Growth trends in the Phase segment reveal a robust expansion for Phase I trials due to the rising emphasis on novel therapies and regulatory support for earlier testing methods. As biopharmaceutical companies prioritize quicker development timelines, Phase I trials have become crucial for establishing safety and efficacy, leading to its recognition as the fastest-growing phase. The collaborative landscape among research institutions and the industry also propels significant advancements, enhancing overall trial efficiency.

Phase III (Dominant) vs. Phase I (Emerging)

Phase III trials in the South America clinical trials market are characterized by their rigorous design and large participant pools, essential for validating the efficacy and safety of new treatments before they reach the market. This phase is largely supported by established protocols and regulatory guidelines, making it a dominant force within this segment. In contrast, Phase I trials, while smaller in scale, represent the emerging frontier of clinical research, focusing on assessing the pharmacokinetics and pharmacodynamics of novel compounds. Their rapid growth is fueled by increased investment in early-stage research and a rise in collaboration with academic institutions, which is setting the stage for more innovative approaches to drug development.

By Study Design: Interventional (Largest) vs. Observational (Fastest-Growing)

The market share distribution among the study design segments is notably diverse, with interventional studies commanding the largest portion. This segment is favored due to its efficacy in testing new therapies and treatments in controlled environments. In contrast, observational studies, while smaller in share, are rapidly gaining traction as they allow researchers to gather real-world evidence without the constraints of experimental conditions. Growth trends indicate a noticeable shift towards observational studies, driven by the increasing demand for real-world data and post-market surveillance. The expansion of expanded access trials also contributes to this trend, as stakeholders seek to provide patients with early access to promising therapies. Factors such as regulatory support and heightened focus on patient-centric research are propelling the growth of these segments.

Interventional (Dominant) vs. Expanded Access (Emerging)

Interventional studies are recognized as the dominant force within the South America clinical trials market, primarily due to their structured approach in assessing interventions. They involve assigning participants to specific treatment groups and are essential for regulatory approval processes. On the other hand, expanded access trials are emerging as a vital aspect of clinical research, catering to patients who do not have viable treatment options. These trials are gaining popularity as they facilitate broader access to investigational therapies, reflecting a shift towards personalized healthcare solutions. The contrast between these segments highlights the ongoing evolution in study design preferences, emphasizing the need for a balance between rigorous clinical testing and patient access initiatives.

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

In the South America clinical trials market, Oncology emerges as the largest therapeutic area, commanding significant attention from both researchers and pharmaceutical companies. The prevalence of various cancer types and the escalating demand for innovative treatments have driven an impressive market share within this sector. Conversely, Neurology, while smaller, is quickly gaining traction, spurred by increasing awareness and the rising incidence of neurological disorders, thus positioning itself as a rapidly growing field within the market. The growth trends in these therapeutic areas are influenced by several crucial factors. Oncology remains a dominant focus due to the persistent efforts toward breakthroughs in cancer treatments and the prioritization of research funding. Neurology's expansion is driven by a surge in clinical trials addressing critical issues such as Alzheimer's and Parkinson's disease, as well as advancements in technology, allowing for more efficient patient recruitment and data gathering in trials. These drivers reflect a shift towards addressing unmet medical needs within the region.

Oncology (Dominant) vs. Neurology (Emerging)

Oncology stands as the dominant therapeutic area, characterized by a robust pipeline of clinical trials aimed at developing innovative cancer treatments. This segment benefits from substantial investments by biopharmaceutical companies and a critical focus on personalized medicine, significantly enhancing patient outcomes. Neurology, on the other hand, is emerging rapidly, spurred by increased funding and research initiatives targeting various neurological conditions. The demand for new therapeutics is propelled by the rising prevalence of neurodegenerative diseases, making Neurology an area of promising growth. Both segments underline the dynamic nature of clinical research, catering to the evolving healthcare landscape in South America.

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

In the South America clinical trials market, Pharmaceutical Companies maintain a significant share, positioning themselves as the largest end-user segment. Their established infrastructure and extensive capabilities allow them to effectively manage and conduct clinical trials across various therapeutic areas. Conversely, Biotechnology Companies are emerging rapidly, capitalizing on innovative research and development strategies, which contribute to their expanding influence in the market. As biotech firms pave the way for novel therapies, they are steadily increasing their presence in clinical trial operations. The growth trends in this segment are fueled by various factors, including the rising demand for advanced and personalized medications driven by an increase in chronic diseases. Moreover, favorable regulatory environments and enhanced investment in research and development are propelling both Pharmaceutical and Biotechnology Companies forward. The agility and innovation brought by Biotechnology Companies allow them to adapt to the fast-paced market, making them a vital player in shaping the future of clinical trials in the region.

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

Pharmaceutical Companies dominate the South America clinical trials market due to their vast resources, established market reputation, and strong relationships with regulatory authorities. Their comprehensive understanding of regulatory requirements allows them to efficiently navigate complex trial processes. On the other hand, Biotechnology Companies are rapidly becoming an emerging force, leveraging cutting-edge research to develop novel therapies and treatments. Their focus on innovative solutions enables them to fill gaps left by traditional pharmaceuticals, making them crucial for future advancements in healthcare. This dynamic creates a competitive landscape where Pharma and Biotech must continually evolve, ensuring that they both meet regulatory demands while addressing the growing need for effective treatments.

Get more detailed insights about South America Clinical Trials Market

Regional Insights

Brazil : Robust Growth and Infrastructure Development

Brazil holds a commanding market share of 54.5% in South America, valued at $1200.0 million. Key growth drivers include a large patient population, increasing investment in healthcare, and supportive government policies aimed at enhancing clinical research. The Brazilian Health Regulatory Agency (ANVISA) has streamlined approval processes, fostering a conducive environment for clinical trials. Additionally, the country's expanding healthcare infrastructure and technological advancements are pivotal in meeting rising demand for innovative therapies.

Mexico : Strategic Location and Cost Efficiency

Mexico captures a market share of 27.3%, valued at $600.0 million. The country benefits from a strategic geographical position, making it an attractive site for multinational clinical trials. Key growth drivers include a growing pharmaceutical sector, favorable regulatory environment, and a diverse patient population. Government initiatives to promote research and development are also significant, alongside increasing collaborations with international organizations to enhance clinical trial capabilities.

Argentina : Investment in Healthcare and Innovation

Argentina accounts for a market share of 22.7%, valued at $500.0 million. The growth in clinical trials is driven by increased investment in healthcare infrastructure and a rising number of clinical research organizations. The government has implemented policies to support clinical research, including tax incentives for foreign investments. Demand for innovative treatments is on the rise, particularly in urban centers like Buenos Aires and Córdoba, where healthcare facilities are expanding rapidly.

Rest of South America : Varied Growth Across Sub-regions

The Rest of South America holds a market share of 12.4%, valued at $339.2 million. This sub-region includes countries like Chile, Colombia, and Peru, each with unique market dynamics. Growth drivers vary, with some countries focusing on improving regulatory frameworks while others enhance healthcare infrastructure. The competitive landscape is fragmented, with local and international players vying for market share. Cities like Santiago and Bogotá are emerging as key players in clinical trials, driven by increasing healthcare investments.

South America Clinical Trials Market Regional Image

Key Players and Competitive Insights

The clinical trials market in South America is characterized by a dynamic competitive landscape, driven by increasing demand for innovative therapies and a growing emphasis on patient-centric approaches. Key players such as Covance (US), IQVIA (US), and Charles River Laboratories (US) are strategically positioned to leverage their extensive experience and technological capabilities. Covance (US) focuses on enhancing operational efficiencies through digital transformation, while IQVIA (US) emphasizes data analytics to optimize trial designs. Charles River Laboratories (US) is actively pursuing regional expansion to tap into emerging markets, thereby shaping a competitive environment that is increasingly collaborative and innovation-driven.

The market structure appears moderately fragmented, with a mix of large multinational corporations and smaller, specialized firms. Key players are adopting various business tactics, such as localizing operations and optimizing supply chains, to enhance their competitive edge. This collective influence of major companies fosters a competitive atmosphere where agility and responsiveness to market needs are paramount.

In October 2025, Covance (US) announced a partnership with a leading biotechnology firm to streamline the clinical trial process for rare diseases. This collaboration is expected to enhance patient recruitment and retention, thereby accelerating the development of novel therapies. The strategic importance of this partnership lies in its potential to address unmet medical needs while positioning Covance (US) as a leader in specialized clinical trials.

In September 2025, IQVIA (US) launched a new platform that integrates artificial intelligence (AI) into clinical trial management. This innovative solution aims to improve data accuracy and reduce trial timelines. The introduction of AI signifies a pivotal shift in how clinical trials are conducted, suggesting that IQVIA (US) is at the forefront of technological advancements that could redefine operational efficiencies in the market.

In August 2025, Charles River Laboratories (US) expanded its facilities in Brazil to enhance its service offerings in preclinical and clinical research. This expansion reflects a strategic move to capitalize on the growing demand for clinical trials in South America. By increasing its footprint, Charles River Laboratories (US) is likely to strengthen its competitive position and better serve local clients.

As of November 2025, current trends in the clinical trials market include a pronounced shift towards digitalization, sustainability, and the integration of AI technologies. Strategic alliances are increasingly shaping the competitive landscape, enabling companies to pool resources and expertise. Looking ahead, competitive differentiation is expected to evolve from traditional price-based competition to a focus on innovation, technological advancements, and supply chain reliability, underscoring the importance of adaptability in a rapidly changing environment.

Key Companies in the South America Clinical Trials Market market include

Industry Developments

The South America Clinical Trials Market has witnessed significant developments recently, particularly in Brazil and Argentina, which are now emerging as key players in the global clinical research landscape. In September 2023, Covance announced an expansion of their clinical trial capabilities in Brazil, aiming to streamline patient recruitment processes and improve operational efficiencies in the region. Medpace followed suit by opening a new research facility in So Paulo in August 2023, targeting the growing demand for innovative therapies in the region.

Furthermore, PR Health Sciences has been in the spotlight due to its partnerships with local universities to foster Research and Development efforts.

Notably, in July 2023, Celerion was involved in a strategic acquisition, enhancing its presence in the South American market. This region's market valuation has been on the rise, driven by increasing investment in healthcare infrastructure and a higher prevalence of chronic diseases necessitating advanced clinical trials. In the last couple of years, significant strides have been made to adopt regulatory frameworks, facilitating quicker approval processes for clinical trials that further accelerate growth in this vital sector.

Future Outlook

South America Clinical Trials Market Future Outlook

The clinical trials market is projected to grow at a 4.37% CAGR from 2024 to 2035, driven by technological advancements, regulatory support, and increasing demand for innovative therapies.

New opportunities lie in:

  • Development of decentralized trial platforms for enhanced patient recruitment.
  • Investment in AI-driven data analytics for real-time trial monitoring.
  • Partnerships with local healthcare providers to streamline patient access.

By 2035, the market is expected to be robust, driven by innovation and strategic collaborations.

Market Segmentation

South America Clinical Trials Market Phase Outlook

  • Phase I
  • Phase II
  • Phase III
  • Phase IV

South America Clinical Trials Market End Use Outlook

  • Pharmaceutical Companies
  • Biotechnology Companies
  • Contract Research Organizations

South America Clinical Trials Market Study Design Outlook

  • Interventional
  • Observational
  • Expanded Access

South America Clinical Trials Market Therapeutic Area Outlook

  • Oncology
  • Cardiology
  • Neurology
  • Infectious Diseases
  • Endocrinology

Report Scope

MARKET SIZE 20242639.2(USD Million)
MARKET SIZE 20252754.53(USD Million)
MARKET SIZE 20354223.6(USD Million)
COMPOUND ANNUAL GROWTH RATE (CAGR)4.37% (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["Covance (US)", "IQVIA (US)", "PPD (US)", "Charles River Laboratories (US)", "Medpace (US)", "Syneos Health (US)", "Parexel International (US)", "Wuxi AppTec (CN)", "KCR (PL)"]
Segments CoveredPhase, Study Design, Therapeutic Area, End Use
Key Market OpportunitiesAdoption of digital health technologies enhances patient recruitment and data collection in the clinical trials market.
Key Market DynamicsRising demand for innovative therapies drives competitive dynamics in South America's clinical trials market.
Countries CoveredBrazil, Mexico, Argentina, Rest of South America

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FAQs

What is the expected market size of the South America Clinical Trials Market in 2024?

The South America Clinical Trials Market is expected to be valued at 5.5 USD Billion in 2024.

What will the market size of the South America Clinical Trials Market be by 2035?

By 2035, the South America Clinical Trials Market is projected to reach 9.0 USD Billion.

What is the expected CAGR for the South America Clinical Trials Market from 2025 to 2035?

The South America Clinical Trials Market is expected to grow at a CAGR of 4.579% from 2025 to 2035.

Which country holds the largest market share in the South America Clinical Trials Market?

Brazil is expected to hold the largest market share, valued at 2.1 USD Billion in 2024.

What is the projected market growth for Brazil in the Clinical Trials Market by 2035?

The market for Brazil is projected to grow to 3.4 USD Billion by 2035.

Who are the key players in the South America Clinical Trials Market?

Key players in the market include Covance, Medpace, Principia and PAREXEL International among others.

What is the expected market value for Phase I Clinical Trials in 2024?

The market value for Phase I Clinical Trials is anticipated to be 1.26 USD Billion in 2024.

How much is the market for Phase III Clinical Trials expected to be in 2035?

The market for Phase III Clinical Trials is expected to reach 2.36 USD Billion by 2035.

Which region besides Brazil is significant in the South America Clinical Trials Market?

Mexico is another significant market, valued at 1.5 USD Billion in 2024.

What challenges could impact the growth of the South America Clinical Trials Market?

Challenges such as regulatory hurdles and competition among CROs could impact market growth.

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