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South America Companion Diagnostics Oncology Market

ID: MRFR/MED/48457-HCR
200 Pages
Rahul Gotadki
October 2025

South America Companion Diagnostics Oncology Market Research Report By Technology (Next Generation Sequencing, Polymerase Chain Reaction, In Situ Hybridization, Immunohistochemistry), By Applications (Therapeutic Monitoring, Patient Stratification, Predictive Testing, Disease Diagnosis), By End-user (Hospitals, Diagnostic Laboratories, Research Institutions, Pharmaceutical Companies), By Test Type (Genetic Tests, Protein Biomarker Tests, MicroRNA Tests, Pathological Analysis), and By Regional (Brazil, Mexico, Argentina, Rest of South America... read more

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South America Companion Diagnostics Oncology Market Summary

As per MRFR analysis, the South America companion diagnostics-oncology market Size was estimated at 571.26 USD Million in 2024. The South America companion diagnostics-oncology market is projected to grow from 613.42 USD Million in 2025 to 1250.2 USD Million by 2035, exhibiting a compound annual growth rate (CAGR) of 7.38% during the forecast period 2025 - 2035.

Key Market Trends & Highlights

The South America companion diagnostics-oncology market is poised for substantial growth driven by regulatory advancements and rising cancer incidence.

  • Brazil remains the largest market for companion diagnostics in oncology, reflecting a robust healthcare infrastructure.
  • Mexico is emerging as the fastest-growing region, indicating a rising demand for advanced diagnostic solutions.
  • Regulatory advancements are facilitating the introduction of innovative diagnostic tools, enhancing market accessibility.
  • The increasing demand for personalized medicine and growing awareness of genetic testing are key drivers propelling market expansion.

Market Size & Forecast

2024 Market Size 571.26 (USD Million)
2035 Market Size 1250.2 (USD Million)

Major Players

Roche (CH), Thermo Fisher Scientific (US), Abbott (US), Agilent Technologies (US), Illumina (US), Qiagen (DE), Myriad Genetics (US), Hologic (US), BioMérieux (FR)

South America Companion Diagnostics Oncology Market Trends

The companion diagnostics-oncology market in South America is currently experiencing notable growth, driven by advancements in personalized medicine and an increasing emphasis on targeted therapies. The region's healthcare systems are gradually adopting innovative diagnostic tools that enhance treatment efficacy and patient outcomes. Regulatory bodies are also playing a crucial role in facilitating the approval and integration of companion diagnostics into clinical practice. This trend is likely to continue as stakeholders recognize the value of precision medicine in oncology, leading to improved patient management and resource allocation. Moreover, collaborations between pharmaceutical companies and diagnostic developers are becoming more prevalent, fostering an environment conducive to innovation. The rising incidence of cancer in South America further underscores the necessity for effective diagnostic solutions. As healthcare providers seek to optimize treatment strategies, the companion diagnostics-oncology market is poised for expansion, with potential for increased investment and research initiatives. The focus on patient-centric approaches may also drive the development of novel biomarkers, enhancing the ability to tailor therapies to individual patient profiles.

Regulatory Advancements

Regulatory bodies in South America are increasingly streamlining the approval processes for companion diagnostics. This trend is likely to enhance market accessibility and encourage the adoption of innovative diagnostic solutions. As regulations evolve, they may facilitate faster integration of these tools into clinical settings, ultimately benefiting patient care.

Rising Cancer Incidence

The growing prevalence of cancer in South America is driving demand for effective diagnostic solutions. As healthcare systems respond to this challenge, the companion diagnostics-oncology market is expected to expand. This trend highlights the urgent need for tailored therapies that can improve treatment outcomes for patients.

Collaborative Innovations

Partnerships between pharmaceutical companies and diagnostic developers are becoming more common in South America. These collaborations aim to create advanced diagnostic tools that align with targeted therapies. Such innovations may enhance the effectiveness of cancer treatments and contribute to the overall growth of the companion diagnostics-oncology market.

South America Companion Diagnostics Oncology Market Drivers

Rising Healthcare Expenditure

The increase in healthcare expenditure across South America is a significant driver for the companion diagnostics-oncology market. Governments and private sectors are investing more in healthcare infrastructure, which includes the adoption of advanced diagnostic technologies. In 2025, healthcare spending in the region is expected to reach approximately $500 billion, with a notable portion allocated to oncology services. This financial commitment facilitates the integration of companion diagnostics into clinical practice, as healthcare providers seek to enhance treatment precision and patient care. The companion diagnostics-oncology market stands to gain from this trend, as increased funding allows for broader access to these essential diagnostic tools.

Growing Awareness of Genetic Testing

There is a notable increase in awareness regarding genetic testing among patients and healthcare professionals in South America, which is driving the companion diagnostics-oncology market. As more individuals become informed about the benefits of genetic testing in cancer treatment, the demand for companion diagnostics is likely to rise. Educational initiatives and advocacy programs are contributing to this awareness, leading to a more informed patient population that actively seeks personalized treatment options. The companion diagnostics-oncology market is expected to see a growth rate of around 12% as a result of this heightened awareness, as patients increasingly request genetic testing as part of their treatment plans.

Increasing Demand for Personalized Medicine

The growing emphasis on personalized medicine is a key driver for the companion diagnostics-oncology market in South America. As healthcare providers increasingly recognize the importance of tailoring treatments to individual patient profiles, the demand for companion diagnostics is expected to rise. This shift is reflected in the market, which is projected to reach approximately $1.5 billion by 2027, with a compound annual growth rate (CAGR) of around 10%. Personalized medicine not only enhances treatment efficacy but also minimizes adverse effects, making it a preferred choice among oncologists. The companion diagnostics-oncology market is thus positioned to benefit from this trend, as more healthcare institutions adopt these technologies to improve patient outcomes.

Regulatory Support for Innovative Diagnostics

Regulatory bodies in South America are increasingly supportive of innovative diagnostic solutions, which is positively influencing the companion diagnostics-oncology market. Streamlined approval processes and favorable policies for new diagnostic tools are encouraging companies to invest in research and development. This regulatory environment fosters innovation, allowing for the rapid introduction of new companion diagnostics that can significantly improve cancer treatment outcomes. The companion diagnostics-oncology market is likely to experience accelerated growth, with an estimated increase of 8% in market size over the next few years, as regulatory support continues to enhance the landscape for these essential diagnostic tools.

Technological Advancements in Diagnostic Tools

Technological innovations in diagnostic tools are significantly impacting the companion diagnostics-oncology market in South America. The introduction of next-generation sequencing (NGS) and advanced biomarker identification techniques has revolutionized the way oncologists approach cancer treatment. These technologies enable more accurate and rapid identification of genetic mutations, which is crucial for selecting appropriate therapies. The companion diagnostics-oncology market is witnessing a surge in investments aimed at enhancing these technologies, with projections indicating a market growth of over 15% annually. As diagnostic accuracy improves, healthcare providers are more likely to integrate companion diagnostics into their treatment protocols, further driving market expansion.

Market Segment Insights

By Technology: Next Generation Sequencing (Largest) vs. Polymerase Chain Reaction (Fastest-Growing)

In the South America companion diagnostics-oncology market, the distribution of market share among the technologies reveals that Next Generation Sequencing (NGS) holds the largest share due to its advanced capabilities in genomic profiling and mutation detection. In contrast, Polymerase Chain Reaction (PCR) is rapidly gaining traction, especially among emerging markets, attributed to its cost-effectiveness and precision in detecting oncogenic mutations, leading to a notable growth trend. Growth trends for these segments are driven by various factors including increased investment in oncology research, the rising prevalence of cancer, and technological advancements. NGS is becoming a standard practice in personalized medicine, while PCR is favored for its rapid results and high sensitivity. The demand for accurate diagnostics and personalized treatment plans continues to fuel the expansion of both segments, making them essential players in the overall market.

Technology: NGS (Dominant) vs. PCR (Emerging)

Next Generation Sequencing (NGS) continues to dominate the South America companion diagnostics-oncology market due to its ability to analyze vast quantities of genetic information, facilitating precise tumor profiling and targeted therapy selection. Its advanced technology enables healthcare professionals to make informed decisions based on complex genetic data. On the other hand, Polymerase Chain Reaction (PCR) is emerging as a crucial tool for molecular diagnostics. It offers rapid turnaround times and high sensitivity in detecting specific genetic mutations, making it invaluable for early cancer detection. The growing preference for personalized medicine is amplifying the significance of both technologies, reinforcing their roles in providing accurate and timely diagnostic solutions.

By Applications: Predictive Testing (Largest) vs. Patient Stratification (Fastest-Growing)

In the South America companion diagnostics-oncology market, predictive testing commands the largest share, reflecting its critical role in personalized medicine and treatment efficacy enhancement. Following closely are segments like therapeutic monitoring and patient stratification, which also hold significant market positions, but do not match the dominance of predictive testing. Disease diagnosis remains a vital aspect of this market, contributing to broader patient care and treatment planning. Growth trends in the applications segment are notably driven by increased healthcare investments and rising awareness regarding personalized treatment methodologies. The demand for predictive testing is further fueled by advancements in genomic technologies that enable precise patient targeting. Simultaneously, patient stratification is emerging as the fastest-growing area, as healthcare practitioners increasingly focus on optimizing therapeutic outcomes through better patient selection and tailored treatment protocols.

Therapeutic Monitoring: Dominant vs. Disease Diagnosis: Emerging

Therapeutic monitoring plays a dominant role in the South America companion diagnostics-oncology market, enabling healthcare providers to track treatment efficacy and adjust therapies as needed for individual patients. This approach enhances patient outcomes by ensuring timely interventions. On the other hand, disease diagnosis represents a crucial emerging segment that is gaining traction due to the rising incidence of cancer and the need for early detection methods. Both therapeutic monitoring and disease diagnosis are interlinked, as accurate diagnosis lays the groundwork for effective monitoring strategies. The appeal of these segments is reinforced by technological advancements that improve diagnostic accuracy and monitoring efficiency, ultimately leading to better patient management.

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

In the South America companion diagnostics-oncology market, hospitals dominate the end-user segment, holding a significant market share due to their central role in patient care and diagnostics. Diagnostic laboratories also play a crucial role in the ecosystem, but their share is comparatively smaller than that of hospitals, which benefit from integrated services, expertise, and advanced technologies in oncology diagnostics. Research institutions and pharmaceutical companies, while important contributors, occupy smaller niches within the overall market framework. Growth trends indicate a notable shift towards pharmaceutical companies as the fastest-growing segment in this landscape. This growth is driven by increased investments in personalized medicine and the expansion of targeted therapies. Furthermore, the collaboration between pharmaceutical companies and diagnostic laboratories fosters innovation in companion diagnostics, contributing to an improved understanding of cancer treatment and patient outcomes, thus elevating their market presence significantly.

Hospitals (Dominant) vs. Pharmaceutical Companies (Emerging)

Hospitals are a dominant force in the companion diagnostics-oncology landscape, offering comprehensive services that integrate diagnostics with patient management, leading to improved treatment outcomes. Their established infrastructure, access to diverse patient populations, and ability to conduct complex procedures make them key players in the market. In contrast, pharmaceutical companies represent an emerging segment, rapidly adapting to the changing landscape by focusing on the development of targeted therapeutics paired with corresponding diagnostics. This synergy not only enhances their product offerings but also strengthens their competitive edge, as they invest heavily in research and development to address specific oncological challenges, ultimately accelerating the adoption of companion diagnostics.

By Test Type: Genetic Tests (Largest) vs. Protein Biomarker Tests (Fastest-Growing)

In the South America companion diagnostics-oncology market, Genetic Tests command a significant portion of the market share, being the largest segment due to their crucial role in personalized medicine and targeted therapies. In contrast, Protein Biomarker Tests are rapidly gaining traction, carving out a growing niche as more oncology treatments become reliant on biomarker identification for efficacy and safety, reflecting a shift towards integrated diagnostic approaches. The growth trends in this segment are driven by increasing investment in oncology research, technological advancements in diagnostic methodologies, and heightened demand for personalized healthcare solutions. Regulatory agencies are also pushing for more comprehensive companion diagnostics to aid treatment decisions, which bolsters the adoption rates of these tests. Emerging technologies, especially in Protein Biomarker Tests, underline the significance of precision medicine in oncology care, further fueling this market's expansion.

Genetic Tests (Dominant) vs. Pathological Analysis (Emerging)

Genetic Tests remain dominant in the South America companion diagnostics-oncology market due to their established application in detecting mutations and guiding patient-specific treatments. Their ability to provide insights into genetic predispositions has made them invaluable for oncologists. On the other hand, Pathological Analysis, though historically fundamental in cancer diagnosis, is now emerging as a vital complement to genetic services. As advancements in pathology techniques enhance diagnostic accuracy and efficiency, Pathological Analysis gains importance, particularly in integrating multi-omics approaches in cancer treatment. Both segments rely on robust clinical data and collaborations with healthcare professionals to ensure effective patient outcomes.

Get more detailed insights about South America Companion Diagnostics Oncology Market

Regional Insights

Brazil : Strong Growth Driven by Innovation

Key markets within Brazil include São Paulo, Rio de Janeiro, and Minas Gerais, where major healthcare institutions are located. The competitive landscape features significant players like Roche, Abbott, and Thermo Fisher Scientific, which have established strong footholds. Local market dynamics are characterized by a growing demand for precision medicine, with oncology being a primary focus. The presence of research institutions further supports the development of sector-specific applications, enhancing the overall business environment.

Mexico : Growing Demand for Precision Medicine

Key markets in Mexico include Mexico City, Guadalajara, and Monterrey, where healthcare facilities are rapidly adopting new technologies. The competitive landscape features major players like Illumina and Qiagen, which are gaining traction in the market. Local dynamics are influenced by a growing awareness of precision medicine among healthcare providers and patients. The oncology sector is particularly benefiting from these advancements, leading to increased collaboration between public and private sectors.

Argentina : Focus on Personalized Healthcare Solutions

Key markets in Argentina include Buenos Aires, Córdoba, and Mendoza, where healthcare institutions are increasingly adopting companion diagnostics. The competitive landscape features players like Myriad Genetics and Hologic, which are establishing a presence in the region. Local market dynamics are characterized by a growing emphasis on research and development, with collaborations between universities and biotech firms. The oncology sector is a primary focus, with significant investments in diagnostic technologies.

Rest of South America : Varied Growth Across Multiple Countries

Key markets include Santiago, Bogotá, and Lima, where healthcare systems are evolving to incorporate advanced diagnostics. The competitive landscape is diverse, with local and international players like BioMérieux and Agilent Technologies making significant inroads. Local dynamics vary widely, influenced by economic conditions and healthcare policies. The oncology sector is gaining traction, with increasing demand for personalized treatment options driving market growth.

South America Companion Diagnostics Oncology Market Regional Image

Key Players and Competitive Insights

The companion diagnostics-oncology market in South America is characterized by a dynamic competitive landscape, driven by increasing demand for personalized medicine and advancements in genomic technologies. Key players such as Roche (CH), Thermo Fisher Scientific (US), and Illumina (US) are strategically positioned to leverage their innovative capabilities and extensive product portfolios. Roche (CH) focuses on integrating diagnostics with therapeutic solutions, enhancing patient outcomes through tailored treatment approaches. Meanwhile, Thermo Fisher Scientific (US) emphasizes its commitment to expanding its molecular diagnostics offerings, which aligns with the growing trend towards precision oncology. Illumina (US) continues to lead in next-generation sequencing technologies, which are pivotal for the development of companion diagnostics, thereby shaping the competitive environment through innovation and technological advancements.

In terms of business tactics, companies are increasingly localizing manufacturing and optimizing supply chains to enhance operational efficiency and reduce costs. The market appears moderately fragmented, with several players vying for market share. However, the collective influence of major companies is significant, as they drive innovation and set industry standards. This competitive structure fosters an environment where collaboration and strategic partnerships are essential for growth and market penetration.

In October 2025, Roche (CH) announced a partnership with a leading South American biotechnology firm to co-develop a novel companion diagnostic for a specific cancer type. This collaboration is expected to enhance Roche's capabilities in the region, allowing for more localized solutions that cater to the unique genetic profiles of South American populations. Such strategic alliances are crucial for expanding market reach and improving patient access to personalized therapies.

In September 2025, Illumina (US) launched a new software platform designed to streamline the analysis of genomic data for companion diagnostics. This platform aims to enhance the efficiency of clinical workflows and improve the accuracy of diagnostic results. The introduction of this technology underscores Illumina's commitment to innovation and positions the company favorably in a competitive market increasingly focused on data-driven solutions.

In August 2025, Thermo Fisher Scientific (US) expanded its product line by introducing a new range of liquid biopsy tests aimed at early cancer detection. This strategic move not only diversifies Thermo Fisher's offerings but also aligns with the growing trend towards non-invasive diagnostic methods. The potential for early detection could significantly impact patient outcomes, thereby reinforcing the company's competitive edge in the oncology diagnostics space.

As of November 2025, current trends in the companion diagnostics-oncology market include a strong emphasis on digitalization, sustainability, and the integration of artificial intelligence (AI) into diagnostic processes. Strategic alliances are increasingly shaping the landscape, enabling companies to pool resources and expertise to drive innovation. Looking ahead, competitive differentiation is likely to evolve, with a shift from price-based competition towards a focus on technological advancements, innovation, and supply chain reliability. This transition suggests that companies that prioritize these areas will be better positioned to thrive in an increasingly complex and competitive environment.

Key Companies in the South America Companion Diagnostics Oncology Market market include

Industry Developments

The South America Companion Diagnostics Oncology Market has seen significant developments recently, with heightened activity from key players such as Illumina, Exact Sciences, and Myriad Genetics. For instance, in October 2023, Roche collaborated with several hospitals in Brazil to enhance the application of personalized medicine in oncology, aiming to improve patient outcomes through tailored therapies.

Furthermore, Abbott Laboratories made strides in the diagnostics segment by launching a new test for lung cancer in Argentina, which has been welcomed by medical professionals aiming for earlier detection.

The market has experienced growth in its valuation, attributed to increasing investments in Research and Development from companies like Thermo Fisher Scientific and Agilent Technologies, who are focusing on innovative testing solutions.

There has been a notable merger in the region as well: in September 2023, F. Hoffmann-La Roche acquired a local diagnostics firm to strengthen its foothold in South America.

Over the past two to three years, the region has witnessed a rising demand for advanced genomic testing, driven by elevated cancer incidences, prompting companies like BioMérieux and Qiagen to enhance their offerings in the companion diagnostics sector.

Future Outlook

South America Companion Diagnostics Oncology Market Future Outlook

The companion diagnostics-oncology market is projected to grow at a 7.38% CAGR from 2024 to 2035, driven by technological advancements, increasing cancer prevalence, and personalized medicine initiatives.

New opportunities lie in:

  • Development of AI-driven diagnostic platforms for enhanced accuracy.
  • Expansion of partnerships with pharmaceutical companies for co-development.
  • Investment in telehealth solutions for remote patient monitoring and diagnostics.

By 2035, the market is expected to achieve substantial growth, reflecting evolving healthcare needs.

Market Segmentation

South America Companion Diagnostics Oncology Market End User Outlook

  • Hospitals
  • Diagnostic Laboratories
  • Research Institutions
  • Pharmaceutical Companies

South America Companion Diagnostics Oncology Market Test Type Outlook

  • Genetic Tests
  • Protein Biomarker Tests
  • MicroRNA Tests
  • Pathological Analysis

South America Companion Diagnostics Oncology Market Technology Outlook

  • Next Generation Sequencing
  • Polymerase Chain Reaction
  • In Situ Hybridization
  • Immunohistochemistry

South America Companion Diagnostics Oncology Market Applications Outlook

  • Therapeutic Monitoring
  • Patient Stratification
  • Predictive Testing
  • Disease Diagnosis

Report Scope

MARKET SIZE 2024571.26(USD Million)
MARKET SIZE 2025613.42(USD Million)
MARKET SIZE 20351250.2(USD Million)
COMPOUND ANNUAL GROWTH RATE (CAGR)7.38% (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["Roche (CH)", "Thermo Fisher Scientific (US)", "Abbott (US)", "Agilent Technologies (US)", "Illumina (US)", "Qiagen (DE)", "Myriad Genetics (US)", "Hologic (US)", "BioMérieux (FR)"]
Segments CoveredTechnology, Applications, End User, Test Type
Key Market OpportunitiesEmerging biomarker technologies enhance personalized treatment strategies in the companion diagnostics-oncology market.
Key Market DynamicsRising demand for personalized medicine drives growth in the companion diagnostics-oncology market across South America.
Countries CoveredBrazil, Mexico, Argentina, Rest of South America

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FAQs

What is the projected market size of the South America Companion Diagnostics Oncology Market in 2024?

The South America Companion Diagnostics Oncology Market is projected to be valued at 285.5 million USD in 2024.

What is the expected market size of the South America Companion Diagnostics Oncology Market by 2035?

By 2035, the South America Companion Diagnostics Oncology Market is expected to reach a valuation of 625.0 million USD.

What is the anticipated CAGR for the South America Companion Diagnostics Oncology Market from 2025 to 2035?

The anticipated compound annual growth rate (CAGR) for the South America Companion Diagnostics Oncology Market is 7.383% from 2025 to 2035.

Which region is expected to dominate the South America Companion Diagnostics Oncology Market in 2024?

In 2024, Brazil is expected to dominate the South America Companion Diagnostics Oncology Market with a value of 100.0 million USD.

What will be the market value of the Companion Diagnostics Oncology Market in Brazil by 2035?

By 2035, the Companion Diagnostics Oncology Market in Brazil is projected to grow to 210.0 million USD.

Who are the key players in the South America Companion Diagnostics Oncology Market?

Key players in the South America Companion Diagnostics Oncology Market include Illumina, Exact Sciences, Myriad Genetics, and Abbott Laboratories.

What is the market segment size for Next Generation Sequencing technology in 2024?

In 2024, the market segment for Next Generation Sequencing technology is valued at 100.0 million USD.

What will the market size for Polymerase Chain Reaction technology be in 2035?

By 2035, the market size for Polymerase Chain Reaction technology is expected to be 170.0 million USD.

Which technology segment is anticipated to have significant growth in the coming years?

The Next Generation Sequencing segment is anticipated to exhibit significant growth within the South America Companion Diagnostics Oncology Market.

What challenges may affect the growth of the South America Companion Diagnostics Oncology Market?

Challenges such as regulatory hurdles and market access may affect the growth of the South America Companion Diagnostics Oncology Market.

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