Argentina Biosimilars Market Research Report, 2030

Argentina's biosimilars industry is experiencing significant growth, driven by a combination of regulatory advancements, strategic public-private partnerships, and a focus on cost-effective healthcare solutions. In the dynamic landscape of South America's pharmaceutical industry, Argentina stands out with its distinctive structure and policies that have shaped its biopharmaceutical sector. Over the course of this century, the biopharmaceutical industry in Argentina has emerged as a critical player in the country's healthcare sector. In Argentina, the structure of the pharmaceutical industry is different compared to other countries in South America. Here, national laboratories hold a market share of fifty per cent. This is a result of Argentine industrial policies prior to the 1980s, tariffs, and a lack of understanding of the international patent protection system. Consequently, Argentine laboratories specialized in the production of copies and generic medications. Regarding the biopharmaceutical sector, partnerships have been established between domestic and foreign laboratories for the production and export of biological medicines. Despite the trade deficit, the capacity to produce biosimilars has been successfully developed. In terms of public policies for the growth of the biopharmaceutical industry, several laws and funding initiatives stand out to promote and support research and technological development. Additionally, there is an increase in tariffs on selected biosimilar imports. These policies provide subsidies, tax credits, and preferential credits while encouraging collaboration with universities and research centres, as well as purchases by the public sector. According to the research report, “Argentina Biosimilars Market Research Report, 2030” published by Actual Market Research, the Argentina Biosimilars market is projected to reach USD 800 Million by 2030. In Argentina, the regulatory agency in charge of approving biological drugs is the National Administration of Drugs, Food and Medical Devices (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica, ANMAT). ANMAT's mission is to ensure efficacy, safety and quality in everything related to administration, guaranteeing health care, as well as the quality and sanitation of all products, processes and technologies consumed or used in medicine, human cosmetics and food. ANMAT carries out registration, control, inspection and surveillance of medicines, cosmetics, diagnostic reagents, medical products, packaged foods, dietary supplements, additives, sweeteners and ingredients, household products, disinfectants and insecticides. Argentina has established several public-private partnerships to promote the development and production of biosimilars. These collaborations aim to enhance local manufacturing capabilities, reduce dependency on imported biologics, and ensure a steady supply of essential medications. The country's focus on local production aligns with its broader economic goals of strengthening the biopharmaceutical sector and creating job opportunities. The Argentine Biopharmaceuticals Association reports a 20% increase in the number of biotech companies over the last five years, indicating a growing commitment to advancing biosimilar manufacturing capabilities. The Argentine biosimilar market has seen the entry of both domestic and international players. Local pharmaceutical companies are increasingly investing in the development and production of biosimilars, leveraging their understanding of the local market and regulatory environment. International companies, on the other hand, bring in expertise and advanced technologies, contributing to the overall growth of the industry. Collaborations between local and international firms have also become common, fostering knowledge exchange and innovation.

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Insulin is experiencing steady growth within Argentina’s biosimilars industry due to a convergence of demographic, regulatory, and healthcare infrastructure factors that emphasize accessibility, affordability, and self-reliance. Argentina, like many countries in Latin America, is witnessing a rising prevalence of diabetes, driven by urbanization, sedentary lifestyles, aging population, and changing dietary habits. According to health authorities and global diabetes organizations, Argentina has a diabetes prevalence rate of over 10%, with projections suggesting continued increases in the years ahead. This growing patient population has placed significant strain on the country’s public health system, which provides free or subsidized medications through the National Health Insurance scheme and other public programs. As a result, there is a heightened demand for affordable, effective treatment options, including insulin, a cornerstone therapy for diabetes management. The introduction and expansion of biosimilar insulin products offer a viable solution to managing both the economic burden and clinical demands posed by this chronic condition. Argentina's national regulatory agency, ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica), has established a well-defined biosimilar approval pathway that supports the development and marketing of high-quality insulin biosimilars. The country’s relatively early adoption of biosimilar policies, combined with governmental initiatives aimed at strengthening the domestic pharmaceutical industry, has encouraged local manufacturers to invest in insulin production. Public-private partnerships and incentives have further bolstered this segment, ensuring a stable supply of biosimilar insulin products for both the public and private healthcare sectors. In addition, Argentina's pharmaceutical sector has been increasingly focused on improving manufacturing capabilities and reducing reliance on costly imports, especially in light of economic volatility and currency fluctuations. Producing insulin biosimilars domestically provides a strategic advantage by minimizing import costs, improving supply chain resilience, and allowing for pricing structures that are more accessible to the local population. Moreover, biosimilar insulin products that meet ANMAT’s rigorous standards for safety and efficacy have gained greater acceptance among healthcare providers and patients, contributing to their growing market share. The government’s promotion of biosimilars as a means of ensuring sustainability in public health spending further underpins the steady growth of insulin in the Argentine market. Blood disorders are experiencing steady growth in Argentina’s biosimilars industry due to a combination of rising disease burden, healthcare policy evolution, and increased focus on cost-effective biologic therapies. Conditions such as anemia, hemophilia, and other hematologic abnormalities—many of which are chronic or lifelong—have seen increased diagnostic rates in recent years due to improvements in medical awareness, access to diagnostic services, and government-led health screening programs. In particular, Argentina’s public health sector has placed significant emphasis on early detection and continuous management of hematologic conditions, which in turn has heightened the demand for biologic treatments like erythropoietin, filgrastim, and other growth factors that are essential in managing blood cell production and immune system restoration. However, the high cost of original biologic therapies has historically posed a significant challenge to Argentina’s healthcare system, which serves a large portion of the population through government-subsidized programs. To address this issue and ensure sustainability of care, Argentina has increasingly turned toward biosimilars—offering nearly equivalent efficacy and safety profiles as their reference biologics, but at a significantly reduced cost. This is particularly critical in treating blood disorders, which often require long-term or repeated administration of biologic drugs. The affordability of biosimilars has allowed broader inclusion of such therapies in national treatment guidelines, thereby accelerating their uptake across public hospitals and clinics. Furthermore, the Argentine government and its regulatory body ANMAT have progressively refined the biosimilar approval process to support local manufacturing and ensure patient safety. This has led to increased production of biosimilars tailored specifically for prevalent blood conditions within the country. Domestic manufacturers, often supported by public-private partnerships, have ramped up efforts to produce biosimilars targeting hematologic conditions, reducing reliance on costly imports and ensuring more consistent local supply. As confidence in biosimilar safety and efficacy grows among clinicians and patients alike, so too does their adoption, especially in treating anemia related to chronic kidney disease, chemotherapy-induced neutropenia, and rare genetic blood disorders.

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Nikita Jabrela

Business Development Manager

Contract Research and Manufacturing Services (CRAMS) are experiencing steady growth in Argentina’s biosimilars industry due to a confluence of economic, structural, and strategic factors that favor outsourcing and collaborative development. Argentina has long held a strong pharmaceutical manufacturing base, and in recent years, it has emerged as a key hub in Latin America for cost-efficient biologics research, development, and production. The steady rise in biosimilar development has further stimulated demand for specialized services provided by CRAMS providers—ranging from preclinical and clinical research to process optimization, analytical testing, and full-scale biomanufacturing. As both domestic and international companies seek to enter or expand in Argentina’s biosimilar market, the availability of experienced CRAMS partners allows them to accelerate timelines, control costs, and navigate complex regulatory requirements more effectively. One of the major drivers of CRAMS growth in Argentina is the economic advantage it offers. Conducting biosimilar R&D and manufacturing in-house is capital-intensive and demands advanced infrastructure, skilled personnel, and regulatory expertise. For many local biotech startups and even multinational firms operating in Argentina, partnering with contract service providers offers a leaner and more flexible alternative. The country's relatively lower operational costs, combined with its highly educated workforce and established pharmaceutical ecosystem—particularly in cities like Buenos Aires, Córdoba, and Rosario—make it an ideal location for outsourcing. This has resulted in an increase in clinical trial activity and biologics production contracts being funneled through Argentine CRAMS organizations. Additionally, Argentina's regulatory framework, overseen by ANMAT, supports biosimilar development with clear and scientifically sound guidelines. CRAMS providers in the country have developed significant expertise in complying with these local requirements, and they are often well-versed in international standards as well, making them attractive partners for companies aiming to launch biosimilars not just in Argentina, but across Latin America and other emerging markets. This dual-market strategy—targeting both domestic consumption and regional exports—further boosts demand for local CRAMS capabilities. Government initiatives have also played a role in reinforcing this growth. Public policies that promote innovation, strengthen domestic production, and support international collaboration have encouraged investment in biopharmaceutical infrastructure. The result is an ecosystem where contract manufacturers are increasingly sophisticated, offering end-to-end solutions for biosimilar development including formulation, scale-up, fill-and-finish, and packaging. Their role has become even more prominent as biosimilar development becomes more complex and specialized, particularly in fields like monoclonal antibodies and therapeutic proteins. Considered in this report • Historic Year: 2019 • Base year: 2024 • Estimated year: 2025 • Forecast year: 2030

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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.