South America Biosimilars Market Outlook, 2030

South America is primarily fueled by the rising burden of conditions such as cancer, autoimmune diseases, and diabetes, which require biologic therapies that are often financially inaccessible to large segments of the population. South America's involvement in the global biosimilars market is evolving, with several local pharmaceutical companies collaborating with multinational corporations to manufacture and commercialize biosimilars regionally. Brazil, the largest pharmaceutical market in Latin America, has established a robust regulatory pathway for biosimilars through its National Health Surveillance Agency (ANVISA), which has facilitated the approval and market entry of multiple biosimilar products. Similarly, Argentina and Colombia have introduced biosimilar guidelines to ensure safety, efficacy, and interchangeability, encouraging more players to enter the market. South America, with Brazil being a key importer of raw materials and active pharmaceutical ingredients (APIs) necessary for biosimilar production. However, local production capabilities are expanding as countries invest in biotechnology infrastructure, aiming to reduce dependency on imports and enhance self-sufficiency. Raw material availability in the region varies, with some countries having limited access to high-quality biologic production inputs, which sometimes necessitates reliance on imports from Asia and Europe. Production facilities in South America are increasingly adopting Good Manufacturing Practices (GMP) compliant technologies to meet international standards, supporting both domestic consumption and potential export opportunities. South America has made significant strides toward harmonizing biosimilar approval processes, but regulatory requirements still differ across countries. ANVISA in Brazil requires comprehensive analytical, preclinical, and clinical data for biosimilar approval, emphasizing equivalence to the reference product. Argentina’s regulatory agency, ANMAT, and Colombia’s INVIMA also maintain rigorous guidelines but vary in the extent of clinical data required. Intellectual property rights, pricing controls, and substitution policies are additional factors influencing biosimilar market dynamics.

According to the research report, ""South America Biosimilars Market Outlook, 2030,"" published by Bonafide Research, the South America Biosimilars market is anticipated to add to more than USD 2.78 Billion by 2025–30. Consumer preferences are evolving in favor of biosimilars, driven by rising healthcare costs and greater access to information about treatment options. Patients and healthcare providers are becoming more comfortable with the idea of biosimilar substitution, especially as clinical outcomes and regulatory standards continue to reassure stakeholders about their safety and efficacy. The oncology segment, in particular, remains a dominant force in biosimilar adoption, with monoclonal antibodies and TNF inhibitors being among the most in-demand therapeutic classes. In 2023, Johnson & Johnson made headlines with investments in Brazilian manufacturing to enhance local production capabilities and reduce dependence on imported biosimilars. Such moves signal a strategic shift towards strengthening regional supply chains. Other pharmaceutical companies are also forming partnerships and licensing agreements to accelerate biosimilar production and distribution. For example, Latin American firms are increasingly collaborating with Asian and European counterparts to conduct clinical trials and technology transfers that facilitate market entry. According to National Library of Medicine (NLM) in 2020, there has been an increasing prevalence of type 2 diabetes in Chile's adult population over time. According to type 1 diabetes index, in 2022, ~36,874 people are living with type 1 diabetes in Chile. Furthermore, the prevalence of gestational diabetes is being observed in Chile and Colombia. The prevalence rates are ranging from 3.18% to 11.2% in Chile, and 0.34% to 2.03% in Colombia. According to Generics and Biosimilars Initiative (GaBi) in 2022, Instituto Nacional de Vigilancia de Medicamentos y Alimentos, (INVIMA), has approved four biosimilars within the product classes of insulin, tumor necrosis factor (TNF) inhibitor, follicle stimulating hormone (FSH) for use in Colombia. Thus, increasing cases of chronic diseases and growing product approval in rest of South and Central America is driving the growth of biosimilar market.

Market Drivers

• High Healthcare Costs and the Need for Affordable Alternatives: In South America, many countries face serious constraints on public healthcare budgets, yet still experience rising demand for biologic treatments due to the growing prevalence of chronic diseases such as cancer, rheumatoid arthritis, and diabetes. Biologic therapies, while effective, are prohibitively expensive for many patients and healthcare systems in the region. As a result, biosimilars are emerging as a critical solution—offering cost-effective alternatives that can significantly reduce expenditures while maintaining therapeutic efficacy.
• Government Support and Policy Initiatives: Governments across the region are implementing policies aimed at improving access to medicines through biosimilar development and adoption. Countries like Brazil, Argentina, and Colombia have introduced regulatory frameworks to promote biosimilar approvals, aligned in part with WHO guidance. In Brazil, for instance, the national regulatory agency ANVISA has supported biosimilar development through defined pathways and partnerships between public institutions and private manufacturers. In some countries, public tenders and procurement systems actively favor biosimilars, helping drive their inclusion in national formularies and public health programs.

Market Challenges

• Fragmented and Evolving Regulatory Environment: One of the biggest challenges in South America is the lack of regulatory harmonization across countries. Each nation maintains its own standards for biosimilar approval, which often vary in terms of clinical data requirements, interchangeability policies, and manufacturing guidelines. While some countries like Brazil and Argentina have developed relatively advanced regulatory systems, others still lack detailed frameworks. This fragmentation makes it difficult for manufacturers to efficiently navigate the region, increasing costs and time to market, and limiting cross-border collaboration or distribution.
• Limited Market Awareness and Clinical Confidence: Awareness and understanding of biosimilars among healthcare providers and patients in South America are still developing. Many physicians remain cautious about prescribing biosimilars due to concerns about their clinical equivalence, immunogenicity, and the absence of long-term local data. Patients often share similar reservations, especially when biosimilars are substituted without clear communication. Additionally, interchangeability policies are either unclear or underdeveloped, leading to low switching rates from originator biologics. The need for stronger education, training programs, and real-world evidence is critical to improving market confidence.

Market Trends

• Public-Private Partnerships to Boost Local Production: Several South American governments are promoting public-private partnerships (PPPs) to build domestic biopharmaceutical capabilities. Brazil, for example, has pursued ""Productive Development Partnerships"" (PDPs) in which public institutions collaborate with private firms to manufacture biosimilars locally. These initiatives are designed to reduce reliance on imports, lower costs, and increase local access to essential medicines. This trend reflects a strategic shift toward self-sufficiency and sustainable biomanufacturing, particularly for countries that heavily rely on public health systems.
• Growing Investment from Multinational and Regional Players: There is increasing interest from international biopharma companies and regional firms to tap into the South American biosimilar market. Global players are partnering with local companies or setting up manufacturing and distribution networks to expand their footprint. At the same time, regional firms in countries like Argentina and Mexico are scaling up their biosimilar portfolios for domestic and Latin American markets. This trend is driving greater competition, innovation, and availability of biosimilars in therapeutic areas such as oncology, endocrinology, and autoimmune diseases.

Monoclonal antibodies (mAbs) lead the South American biosimilars industry due to their high therapeutic demand in treating prevalent chronic diseases like cancer and autoimmune disorders, combined with strong government incentives to reduce healthcare costs through biosimilar adoption.

In South America, the dominance of monoclonal antibodies (mAbs) in the biosimilars market is driven by a convergence of clinical necessity, economic pressures, and strategic healthcare reforms. Monoclonal antibodies have become essential in the treatment of widespread and life-threatening conditions such as cancers (including breast, colorectal, and lymphoma) and autoimmune diseases like rheumatoid arthritis and psoriasis—ailments that are increasingly prevalent across the continent due to aging populations and changing lifestyles. This therapeutic significance has naturally led to high demand for these biologics. However, the cost of original mAb therapies developed by major pharmaceutical innovators is prohibitively high for many national healthcare systems in South America, which are already burdened by constrained budgets and limited access to advanced treatments for much of the population. In response, governments and health authorities across the region have adopted supportive policies to encourage the use of biosimilars, particularly for costly biologics like mAbs. For instance, regulatory bodies in Brazil, Argentina, and Colombia have streamlined approval processes for biosimilars and introduced procurement strategies that favor lower-cost alternatives to originator biologics. This regulatory environment has created a fertile ground for the expansion of mAbs biosimilars, helping domestic and international manufacturers meet the region's growing healthcare needs more affordably. Moreover, public-private partnerships, local production incentives, and health technology assessments have played a role in legitimizing and accelerating the uptake of biosimilar mAbs. Countries like Brazil have invested in technology transfer agreements to boost local production capacity, ensuring sustainability and affordability in the long term. In clinical practice, the increasing physician and patient confidence in biosimilars—fueled by real-world evidence of their safety and efficacy—has also been crucial in accelerating their market penetration.

The moderate growth of Growth Hormonal Deficiency (GHD) applications in South America's biosimilars industry is primarily due to increasing awareness and diagnosis rates, balanced against high treatment costs and limited public healthcare coverage.

The application of biosimilars for Growth Hormonal Deficiency (GHD) is witnessing moderate growth, driven by improved awareness and diagnostic capabilities, yet tempered by financial and systemic constraints within public healthcare systems. GHD is a condition that, if left untreated, can significantly affect the physical development of children and the metabolic health of adults. Over the past decade, there has been a gradual rise in the diagnosis of GHD across South American countries, supported by enhanced medical training, better access to endocrinology services, and growing awareness among parents and healthcare professionals. This has led to a more consistent identification of patients who can benefit from recombinant human growth hormone (rhGH) therapies, including biosimilar versions. Biosimilars, which offer clinically comparable efficacy and safety to originator biologics at a lower cost, present a promising option for managing GHD in the region. However, the uptake of these therapies remains moderate due to several limiting factors. The cost of long-term hormone therapy, even with biosimilars, is still substantial for many families, especially in lower-income and rural areas where healthcare funding is stretched thin. Public health systems in countries such as Brazil, Peru, and Bolivia often prioritize funding for more life-threatening conditions, leaving GHD treatment underfunded or reliant on private insurance or out-of-pocket payments. This economic barrier restricts widespread adoption, despite the clinical benefits and cost-effectiveness biosimilars offer in the long run. Furthermore, while biosimilars for GHD have been proven effective, there remains a degree of hesitancy among some healthcare providers and parents regarding switching from originator products to biosimilars, often due to misconceptions or lack of familiarity with biosimilar regulatory standards and clinical performance.

In-house manufacturing leads the South American biosimilars industry because it enables greater control over production costs, regulatory compliance, and supply chain resilience, while aligning with government incentives to boost local pharmaceutical capabilities and reduce reliance on imports.

The dominance of in-house manufacturers in the biosimilars industry stems from a strategic convergence of economic, regulatory, and political imperatives. Developing biosimilars in-house where companies oversee the entire production process from research and development to commercialization provide a significant advantage in controlling production costs, ensuring product quality, and maintaining a stable supply chain. This control is crucial in a region where healthcare budgets are constrained and the volatility of international supply lines can disrupt access to essential medicines. Countries such as Brazil, Argentina, and Colombia have actively promoted local pharmaceutical manufacturing through public-private partnerships, tax incentives, and technology transfer agreements, creating a favorable environment for in-house production. For instance, Brazil’s Productive Development Partnerships (PDPs) are designed to encourage domestic production of biosimilars by facilitating collaborations between state-run laboratories and private manufacturers, reinforcing the growth of local capabilities. Moreover, in-house manufacturing supports regulatory alignment, which is critical in the biosimilar space where demonstrating equivalency to originator biologics requires stringent quality standards and clinical testing. By maintaining control over development and production, companies can better adhere to the regulatory requirements set by national health agencies, such as ANVISA in Brazil, INVIMA in Colombia, and ANMAT in Argentina. This not only accelerates the approval process but also builds trust among healthcare providers and patients in the safety and efficacy of locally produced biosimilars. Additionally, governments are increasingly viewing biosimilar manufacturing as a strategic asset to improve public health outcomes while reducing dependency on expensive imported biologics. The COVID-19 pandemic further underscored the importance of local manufacturing capacity, prompting renewed investment and policy support for the domestic pharmaceutical sector.

Brazil is leading the South American biosimilars industry due to its well-established biopharmaceutical infrastructure, proactive government policies promoting biosimilar development, and a large public healthcare system driving demand for affordable biologic therapies.

Brazil’s leadership in the South American biosimilars industry stems from its unique combination of a strong domestic biopharmaceutical sector, supportive regulatory environment, and a vast public healthcare network that collectively foster the growth and adoption of biosimilars. As the largest economy in Latin America with a significant population, Brazil represents a critical market where the demand for affordable biologic treatments is particularly acute, especially given the high costs associated with originator biologics. The country’s unified public healthcare system, Sistema Único de Saúde (SUS), covers over 70% of the population, emphasizing universal access to medicines and cost containment, which makes biosimilars an attractive solution to expand access to life-saving biologics while managing healthcare expenditures. To support this, the Brazilian government has actively implemented policies designed to accelerate biosimilar development and market entry. The Brazilian Health Regulatory Agency (ANVISA) has established clear regulatory guidelines for biosimilar approval that align with international standards, including requirements for clinical trials and comparability studies. These guidelines have increased industry confidence and transparency, encouraging both domestic and multinational pharmaceutical companies to invest in biosimilar R&D and manufacturing within Brazil. Furthermore, Brazil boasts a well-developed pharmaceutical manufacturing infrastructure with several local companies specializing in biopharmaceuticals, enabling cost-effective production of biosimilars that meet rigorous quality standards. This industrial capacity is supported by investments in biotechnological innovation, as public-private partnerships and academic collaborations have been promoted to boost research capabilities in biosimilar science and technology. Additionally, government incentives, including funding programs and tax benefits, help stimulate innovation and scale-up manufacturing capacity.

Considered in this report
• Historic Year: 2019
• Base year: 2024
• Estimated year: 2025
• Forecast year: 2030

Aspects covered in this report
• Biosimilars Market with its value and forecast along with its segments
• Various drivers and challenges
• On-going trends and developments
• Top profiled companies
• Strategic recommendation

By Product
• Monoclonal Antibodies
• Insulin
• Erythropoietin
• Others (Includes recombinant glycosylated and non-glycosylated proteins)

By Application
• Oncology
• Chronic & Autoimmune Disorders
• Blood Disorders
• Growth Hormonal Deficiency
• Infectious Disease
• Others (Filgrastim/Pegfilgrastim, Teriparatide, Somatropin, Etanercept)

By Manufacturer
• In-house
• Contract Research and Manufacturing Services

The approach of the report:
This report consists of a combined approach of primary as well as secondary research. Initially, secondary research was used to get an understanding of the market and listing out the companies that are present in the market. The secondary research consists of third-party sources such as press releases, annual report of companies, analyzing the government generated reports and databases. After gathering the data from secondary sources primary research was conducted by making telephonic interviews with the leading players about how the market is functioning and then conducted trade calls with dealers and distributors of the market. Post this we have started doing primary calls to consumers by equally segmenting consumers in regional aspects, tier aspects, age group, and gender. Once we have primary data with us we have started verifying the details obtained from secondary sources.

Intended audience
This report can be useful to industry consultants, manufacturers, suppliers, associations & organizations related to this industry, government bodies and other stakeholders to align their market-centric strategies. In addition to marketing & presentations, it will also increase competitive knowledge about the industry.

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