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    South America Gene Therapy Market

    ID: MRFR/Pharma/51504-HCR
    200 Pages
    Rahul Gotadki
    October 2025

    South America Gene Therapy Market Research Report By Therapeutic Area (Oncology, Genetic Disorders, Infectious Diseases, Cardiovascular Diseases, Neurological Disorders), By Technology (Viral Vectors, CRISPR, Gene Editing, RNA Therapy, Non-Viral Methods), By Application (Research, Clinical, Commercial), By Route of Administration (Intravenous, Intramuscular, Intradermal, Intrathecal, Oral) and By Regional (Brazil, Mexico, Argentina, Rest of South America)- Forecast to 2035

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    South America Gene Therapy Market Infographic
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    South America Gene Therapy Market Summary

    As per MRFR analysis, the South America gene therapy market Size was estimated at 612.0 USD Million in 2024. The South America gene therapy market is projected to grow from 634.83 USD Million in 2025 to 916.0 USD Million by 2035, exhibiting a compound annual growth rate (CAGR) of 3.73% during the forecast period 2025 - 2035.

    Key Market Trends & Highlights

    The South America gene therapy market is poised for substantial growth driven by regulatory advancements and increasing investment in research and development.

    • Brazil remains the largest market for gene therapy in South America, showcasing a robust demand for innovative treatments.
    • Mexico is emerging as the fastest-growing region, reflecting a rising interest in advanced therapeutic solutions.
    • Regulatory advancements are facilitating faster approvals, thereby enhancing market accessibility and patient options.
    • The rising prevalence of genetic disorders and government initiatives are key drivers propelling the market forward.

    Market Size & Forecast

    2024 Market Size 612.0 (USD Million)
    2035 Market Size 916.0 (USD Million)

    Major Players

    Novartis (CH), Gilead Sciences (US), Sangamo Therapeutics (US), Bluebird Bio (US), Spark Therapeutics (US), CRISPR Therapeutics (CH), Bristol-Myers Squibb (US), Roche (CH), AstraZeneca (GB)

    South America Gene Therapy Market Trends

    The gene therapy market is currently experiencing notable growth in South America, driven by advancements in biotechnology and increasing investments in research and development. The region's healthcare systems are gradually adopting innovative treatments, which include gene therapies aimed at addressing genetic disorders and rare diseases. Regulatory frameworks are evolving to accommodate these novel therapies, fostering an environment conducive to clinical trials and product approvals. Furthermore, collaborations between academic institutions and pharmaceutical companies are becoming more prevalent, enhancing the region's capacity for innovation and development in this field. In addition, the rising prevalence of genetic disorders in South America is prompting a greater focus on personalized medicine. Patients and healthcare providers are increasingly seeking targeted therapies that can provide more effective treatment options. This shift towards personalized approaches is likely to drive demand for gene therapies, as they offer the potential for tailored solutions based on individual genetic profiles. As the market continues to mature, it appears that South America is positioning itself as a significant player in the gene therapy landscape, with the potential for further advancements and breakthroughs in the coming years.

    Regulatory Advancements

    Regulatory bodies in South America are actively updating frameworks to facilitate the approval of gene therapies. This trend indicates a commitment to fostering innovation while ensuring patient safety. Streamlined processes may encourage more companies to invest in clinical trials and bring new therapies to market.

    Increased Investment in R&D

    There is a noticeable rise in funding directed towards research and development within the gene therapy market. This trend suggests that both public and private sectors are recognizing the potential of gene therapies to address unmet medical needs, leading to enhanced innovation and product development.

    Growing Patient Awareness

    Patient advocacy groups in South America are playing a crucial role in raising awareness about genetic disorders and the potential of gene therapies. This trend indicates a shift in public perception, which may lead to increased demand for innovative treatments and greater engagement with healthcare providers.

    South America Gene Therapy Market Drivers

    Government Initiatives and Funding

    Government initiatives aimed at promoting biotechnology and gene therapy research are pivotal in shaping the gene therapy market in South America. Various countries in the region have established funding programs and grants to support innovative research projects. For instance, Brazil's National Council for Scientific and Technological Development has allocated substantial resources to biotechnology, including gene therapy. This financial backing not only encourages academic institutions and private companies to engage in gene therapy research but also fosters collaboration between public and private sectors. As a result, the availability of funding is expected to enhance the development of novel gene therapies, ultimately benefiting patients and healthcare providers alike.

    Rising Prevalence of Genetic Disorders

    The increasing incidence of genetic disorders in South America is a crucial driver for the gene therapy market. Conditions such as cystic fibrosis, hemophilia, and muscular dystrophy are becoming more prevalent, necessitating innovative treatment options. According to health statistics, genetic disorders affect approximately 1 in 200 births in the region, highlighting a significant patient population in need of advanced therapies. This growing demand for effective treatments is likely to propel investments in gene therapy research and development, as healthcare providers seek to address these unmet medical needs. Furthermore, the rising burden of genetic diseases places additional pressure on healthcare systems, prompting governments and private entities to explore gene therapy solutions as a viable alternative to traditional treatments.

    Technological Advancements in Gene Editing

    Technological advancements in gene editing techniques, such as CRISPR-Cas9, are transforming the landscape of the gene therapy market in South America. These innovations enable precise modifications to genetic material, offering new avenues for treating genetic disorders. The accessibility of these technologies is increasing, with several research institutions in South America adopting them for therapeutic applications. As a result, the cost of developing gene therapies is likely to decrease, making them more accessible to a broader patient population. Moreover, the potential for personalized medicine through gene editing could lead to more effective treatments, further driving the growth of the gene therapy market in the region.

    Increasing Demand for Personalized Medicine

    The growing demand for personalized medicine is reshaping the gene therapy market in South America. Patients are increasingly seeking tailored treatment options that address their unique genetic profiles. This trend is prompting healthcare providers to explore gene therapies that can be customized to individual patients, enhancing treatment efficacy. The rise of genomic sequencing technologies has made it feasible to identify specific genetic mutations, paving the way for targeted gene therapies. As a result, the market for personalized gene therapies is likely to expand, driven by both patient demand and advancements in genetic research. This shift towards personalized medicine is expected to play a crucial role in the future of the gene therapy market in the region.

    Collaborations Between Academia and Industry

    Collaborations between academic institutions and industry players are emerging as a significant driver for the gene therapy market in South America. These partnerships facilitate the exchange of knowledge, resources, and expertise, accelerating the development of innovative gene therapies. Universities are increasingly partnering with biotech companies to translate research findings into clinical applications. This synergy not only enhances the research capabilities of academic institutions but also provides industry players with access to cutting-edge scientific discoveries. As a result, the number of clinical trials and new gene therapy products entering the market is expected to rise, contributing to the overall growth of the gene therapy market in the region.

    Market Segment Insights

    By Vector Type: Viral Vector (Largest) vs. Non-Viral Vector (Fastest-Growing)

    In the South America gene therapy market, the segment is dominated by viral vectors, accounting for a significant market share. Their established efficacy in delivering therapeutic genes has made them a preferred choice for many therapies. Non-viral vectors, while currently holding a smaller share, are rapidly gaining traction due to advancements in technology and a growing demand for safer delivery methods. The growth trends for these vector types indicate a shift towards non-viral vectors, which are expected to witness the fastest growth in the coming years. Factors driving this trend include the increasing focus on developing safer therapeutic options and the rising prevalence of genetic disorders that necessitate innovative treatment solutions. The flexibility and cost-effectiveness of non-viral vectors further enhance their appeal among developers and researchers alike.

    Vector Type: Viral Vector (Dominant) vs. Non-Viral Vector (Emerging)

    Viral vectors have established themselves as the dominant force in the gene therapy market due to their high efficiency in gene delivery and well-understood mechanisms. They are utilized in various applications, particularly in treatments for genetic diseases and cancers. Conversely, non-viral vectors are emerging as a viable alternative, heralded for their safety profile and lower immunogenicity. As research continues, non-viral vectors are expected to leverage innovations such as improved delivery systems, making them increasingly attractive in clinical settings. This dynamic between established viral vectors and the rising potential of non-viral alternatives reshapes the landscape of gene therapy, with ongoing advancements poised to influence treatment paradigms significantly.

    By Gene Type: Antigen (Largest) vs. Cytokine (Fastest-Growing)

    The market for gene types in the South America gene therapy sector is characterized by a significant distribution among various segment values, led by Antigen, which holds the largest market share due to its widespread applicability across therapeutic areas. Other notable segments include Cytokine, Tumor Suppressor, and Growth Factors, each contributing to the overall growth but with varying degrees of acceptance and application in therapies. Growth trends in this segment are primarily driven by the increasing prevalence of genetic disorders and the rising demand for targeted therapies. The Antigen segment continues to dominate because of its established technology and trusted efficacy. Meanwhile, Cytokine is rapidly emerging, propelled by its potential in treating severe infections and autoimmune diseases, reflecting the dynamic landscape of gene therapy innovations in the region.

    Antigen (Dominant) vs. Cytokine (Emerging)

    The Antigen segment is established as the dominant player in the South America gene therapy market, known for its versatility in addressing a myriad of diseases, fostering significant trust among healthcare professionals. Its ability to trigger immune responses makes it vital for therapeutic developments. Conversely, the Cytokine segment represents an emerging force, characterized by its innovative approaches to modulating immune responses and gaining traction among physicians. The surge in confirmed autoimmune diseases and the push for more personalized therapies position Cytokine as a pivotal component in future gene therapy strategies, reflecting the market's evolving demands and focus on efficacy.

    By Application: Oncological Disorders (Largest) vs. Rare Diseases (Fastest-Growing)

    The application segment of the market is primarily dominated by oncological disorders, which capture the largest share due to the rising prevalence of cancer in the region. This growing concern has led to increased investments and research in gene therapies specifically aimed at treating various types of cancers. In contrast, rare diseases, while currently smaller in market share, are emerging rapidly as developers focus on niche solutions that address unmet medical needs and leverage breakthroughs in gene therapy technologies. Growth trends in the application segment reflect a shift towards personalized medicine, especially in oncological therapies, driven by advancements in genomic research and the increasing understanding of cancer biology. Rare diseases are expected to see substantial growth due to regulatory support for orphan drugs and incentives for companies that develop gene-based treatments. The accelerating pace of clinical trials and partnerships between biotechnology firms and research institutions further bolster this trend, indicating a vibrant future for both segments in the market.

    Oncological Disorders: Dominant vs. Rare Diseases: Emerging

    Oncological disorders stand as the dominant application within the segment, reflecting a substantial focus on targeted therapies that utilize gene editing and other innovative technologies to combat cancer. The extensive prevalence of various cancers fuels demand, encouraging pharmaceutical companies to invest heavily in research and development. Conversely, rare diseases represent an emerging segment, characterized by innovative therapies that often address conditions with limited treatment options. The increasing recognition of rare diseases by governments and regulatory bodies has led to favorable policies that incentivize development, creating a promising landscape for gene therapies aimed at these conditions. Both segments illustrate the dynamic nature of the market as they cater to significant health challenges.

    By Delivery Method: In Vivo Gene Therapy (Largest) vs. Ex Vivo Gene Therapy (Fastest-Growing)

    The South America gene therapy market demonstrates a clear preference for In Vivo Gene Therapy, which commands a significant share due to its direct approach in treating genetic disorders. This method delivers therapeutic genes directly to the desired target cells within the body, thereby providing higher efficacy and convenience. Meanwhile, Ex Vivo Gene Therapy is garnering attention as an innovative approach, promising a substantial share in upcoming years as more clinical trials yield positive results and applications expand. Growth trends reveal that the market is rapidly evolving, with Ex Vivo Gene Therapy emerging as the fastest-growing segment. This growth is driven by technological advancements, increased research funding, and a rising number of successful clinical trials. Additionally, the growing prevalence of genetic disorders amplifies demand for effective therapies, further motivating investments in both delivery methods, each demonstrating unique advantages within the therapeutic landscape.

    Gene Therapy: In Vivo (Dominant) vs. Ex Vivo (Emerging)

    In Vivo Gene Therapy stands as the dominant method in the market, characterized by its direct administration of therapeutic genes to patients, which often results in immediate effects and improved treatment compliance. This approach is particularly effective for certain genetic disorders and allows for a wide range of applications in various therapeutic areas. Conversely, Ex Vivo Gene Therapy is recognized as an emerging technique, involving the modification of cells outside the body before reintroducing them to the patient. This method is gaining traction due to its specificity and the ability to target complex diseases, driven by advancements in genetic engineering and cell manipulation technologies. As research progresses, both methods are likely to coexist, addressing distinct therapeutic needs.

    Get more detailed insights about South America Gene Therapy Market

    Regional Insights

    Brazil : Strong Growth and Innovation Hub

    Brazil holds a dominant position in the South American gene therapy market, accounting for 250.0 million, representing a significant market share. Key growth drivers include increasing investments in biotechnology, favorable government policies, and a rising prevalence of genetic disorders. The Brazilian government has initiated several programs to support research and development in gene therapy, enhancing infrastructure and industrial capabilities in this sector. Demand trends indicate a growing acceptance of advanced therapies among healthcare providers and patients, driven by improved healthcare access and education.

    Mexico : Innovative Approaches in Healthcare

    Mexico's gene therapy market is valued at 150.0 million, showcasing a robust growth trajectory. The market is driven by increasing healthcare expenditure, a rising number of clinical trials, and partnerships with international biotech firms. Regulatory bodies are streamlining approval processes for gene therapies, fostering a conducive environment for innovation. The demand for personalized medicine is also on the rise, reflecting changing consumption patterns among patients and healthcare providers.

    Argentina : Focus on Rare Diseases and Innovation

    Argentina's gene therapy market is valued at 100.0 million, with a steady growth outlook. The country is focusing on addressing rare diseases through innovative therapies, supported by government initiatives aimed at enhancing healthcare access. Regulatory frameworks are evolving to accommodate new therapies, which is crucial for market expansion. The demand for gene therapies is increasing, particularly in urban areas where healthcare infrastructure is more developed, leading to higher consumption rates.

    Rest of South America : Regional Variations and Growth Potential

    The Rest of South America holds a gene therapy market value of 112.0 million, characterized by diverse opportunities across various countries. Growth is driven by increasing healthcare investments and collaborations with global biotech companies. Regulatory environments vary, with some countries adopting more progressive policies to facilitate gene therapy approvals. Demand is rising in urban centers, where healthcare access is improving, leading to a shift in consumption patterns towards advanced therapies.

    Key Players and Competitive Insights

    The gene therapy market in South America is characterized by a dynamic competitive landscape, driven by advancements in technology and increasing investment in research and development. Major players such as Novartis (CH), Gilead Sciences (US), and Bristol-Myers Squibb (US) are actively engaged in innovative strategies that emphasize regional expansion and partnerships. Novartis (CH) has focused on enhancing its portfolio through strategic collaborations, which appear to bolster its market presence. Meanwhile, Gilead Sciences (US) is concentrating on developing therapies for rare diseases, indicating a targeted approach that may enhance its competitive edge. Collectively, these strategies contribute to a competitive environment that is increasingly characterized by innovation and collaboration.

    Key business tactics within this market include localizing manufacturing and optimizing supply chains to enhance efficiency and reduce costs. The competitive structure of the gene therapy market in South America is moderately fragmented, with several key players exerting influence. This fragmentation allows for a diverse range of therapeutic options, although it also necessitates that companies remain agile and responsive to market demands.

    In October 2025, Novartis (CH) announced a partnership with a local biotech firm to develop gene therapies tailored for South American populations. This strategic move is likely to enhance Novartis's ability to address specific regional health challenges, thereby solidifying its market position. Such collaborations may also facilitate faster regulatory approvals and market entry, which are critical in the rapidly evolving landscape of gene therapy.

    In September 2025, Gilead Sciences (US) launched a new gene therapy aimed at treating a rare genetic disorder prevalent in South America. This initiative not only underscores Gilead's commitment to addressing unmet medical needs but also positions the company as a leader in the region's gene therapy sector. The introduction of this therapy could potentially capture significant market share, particularly among patients seeking innovative treatment options.

    In August 2025, Bristol-Myers Squibb (US) expanded its clinical trials for a novel gene therapy in Brazil, focusing on a specific demographic that has been historically underserved. This expansion reflects a strategic emphasis on inclusivity and accessibility, which may enhance the company's reputation and foster patient trust. By prioritizing diverse patient populations, Bristol-Myers Squibb is likely to strengthen its competitive stance in the market.

    As of November 2025, current trends in the gene therapy market include a pronounced shift towards digitalization and the integration of artificial intelligence in research and development processes. Strategic alliances are increasingly shaping the competitive landscape, allowing companies to pool resources and expertise. Looking ahead, it appears that competitive differentiation will 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 sustainable practices and cutting-edge solutions.

    Key Companies in the South America Gene Therapy Market market include

    Industry Developments

    Recent developments in the South America Gene Therapy Market have been noteworthy, with several companies making significant strides. Amgen and Pfizer have been actively involved in Research and Development initiatives to enhance gene therapies for various genetic disorders. Bluebird Bio has also been expanding its collaborations within the region to increase access to its innovative therapies. A significant acquisition was reported in July 2023, when Novartis acquired an emerging biotech firm specializing in gene therapy, thereby strengthening its position in the Latin American market.

    The impact of these advancements is evident, as there has been a marked growth in market valuation, driven by increased investment and public-private partnerships. 

    For instance, Roche and Genentech are establishing new facilities in Brazil to foster local manufacturing capabilities, thereby improving patient access. Trends indicate a growing acceptance and demand for gene therapies across South America, reflecting a shift in healthcare investment priorities. Over the past two years, regulatory bodies have been working diligently to streamline approval processes for novel gene therapies, which has been critical in expediting treatment availability for rare genetic conditions throughout the region.

     

    Future Outlook

    South America Gene Therapy Market Future Outlook

    The gene therapy market in South America is projected to grow at a 3.73% CAGR from 2024 to 2035, driven by technological advancements and increasing healthcare investments.

    New opportunities lie in:

    • Development of localized gene therapy manufacturing facilities
    • Partnerships with biotech firms for innovative treatment solutions
    • Expansion of telehealth services for patient monitoring and support

    By 2035, the market is expected to achieve substantial growth and innovation.

    Market Segmentation

    South America Gene Therapy Market Gene Type Outlook

    • Antigen
    • Cytokine
    • Tumor Suppressor
    • Suicide
    • Deficiency
    • Growth Factors
    • Receptors
    • Others

    South America Gene Therapy Market Application Outlook

    • Oncological Disorders
    • Rare Diseases
    • Cardiovascular Diseases
    • Neurological Disorders
    • Infectious Diseases
    • Others

    South America Gene Therapy Market Vector Type Outlook

    • Viral Vector
    • Non-Viral Vector

    South America Gene Therapy Market Delivery Method Outlook

    • In Vivo Gene Therapy
    • Ex Vivo Gene Therapy

    Report Scope

    MARKET SIZE 2024612.0(USD Million)
    MARKET SIZE 2025634.83(USD Million)
    MARKET SIZE 2035916.0(USD Million)
    COMPOUND ANNUAL GROWTH RATE (CAGR)3.73% (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["Novartis (CH)", "Gilead Sciences (US)", "Sangamo Therapeutics (US)", "Bluebird Bio (US)", "Spark Therapeutics (US)", "CRISPR Therapeutics (CH)", "Bristol-Myers Squibb (US)", "Roche (CH)", "AstraZeneca (GB)"]
    Segments CoveredVector Type, Gene Type, Application, Delivery Method
    Key Market OpportunitiesEmerging gene therapies targeting rare genetic disorders present substantial growth potential in the gene therapy market.
    Key Market DynamicsGrowing investment in Research and Development drives innovation in gene therapy across South America.
    Countries CoveredBrazil, Mexico, Argentina, Rest of South America

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    FAQs

    What is the expected market size of the South America Gene Therapy Market in 2024?

    The South America Gene Therapy Market is expected to be valued at 800.0 USD Million in 2024.

    What will the market size reach by 2035?

    By 2035, the South America Gene Therapy Market is anticipated to reach a valuation of 3000.0 USD Million.

    What is the expected CAGR for the South America Gene Therapy Market from 2025 to 2035?

    The expected CAGR for the South America Gene Therapy Market from 2025 to 2035 is 12.768%.

    Which therapeutic area is predicted to dominate the South America Gene Therapy Market by 2035?

    By 2035, the Oncology therapeutic area is predicted to dominate the South America Gene Therapy Market, valued at 900.0 USD Million.

    How much is the Genetic Disorders segment expected to contribute in 2024?

    The Genetic Disorders segment is expected to contribute 200.0 USD Million to the market in 2024.

    What are the market values for Gene Therapy by region in Brazil for 2024?

    In 2024, the Gene Therapy market value for Brazil is projected to be 220.0 USD Million.

    Which company is a key player in the South America Gene Therapy Market?

    Amgen is among the key players in the South America Gene Therapy Market.

    What is the market size for the Cardiovascular Diseases segment in 2035?

    The Cardiovascular Diseases segment is expected to reach a market size of 450.0 USD Million by 2035.

    How much is the market for Infectious Diseases projected to be worth in 2024?

    The market for Infectious Diseases is projected to be worth 160.0 USD Million in 2024.

    What will be the market size for Argentina by 2035?

    By 2035, the market size for Argentina is expected to reach 450.0 USD Million.

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