Brazil Biosimilars Market Research Report, 2030

The Brazil Biosimilars market will grow with The increased incidence of chronic illnesses, rising healthcare expenses, and the demand for affordable biologic medicine substitutes. Brazil is the ninth-largest economy in the world, and it boasts one of the biggest and most complicated healthcare systems in the region. The service industry makes up the majority of Brazil's economy, contributing to over 70% of its GDP. Public and commercial healthcare services are both provided under Brazil's mixed healthcare system. Brazilian people can receive free medical treatment through the public healthcare system, known as the Brazilian Unified Health System (SUS), while those who can afford to pay for it can receive care from the private healthcare industry. With a population of over 200 million, the SUS is the world's biggest public healthcare system. Biosimilars are biological medications that, although not exact replicas of the reference biologics are quite similar to them. Brazil has seen steady growth in the usage of biosimilars over the years as the nation works to improve patient access to low-cost, high-quality medical care. The biosimilar market in Brazil presents significant opportunities for both multinational and local manufacturers, as the country seeks to expand access to affordable and effective treatments for patients. The first biosimilar approved in Brazil by ANVISA was Remsima, a biosimilar of infliximab, in April 2015. To date, more than 52 biosimilars have been launched in Brazil. This number includes a variety of products to treat different diseases such as cancer, rheumatic diseases as well as autoimmune diseases such as diabetes. According to PróGenéricos CEO Tiago de Moraes Vicente, the growth reflects the demand for more treatment alternatives for a wide range of other diseases. Biosimilar medicines offer an effective and economical alternative to biotechnological medicines, with a rapidly expanding global market. Cost-effectiveness, patent expirations of reference biologics, increasing demand for biologic medicines, a supportive regulatory environment, and increased acceptance by healthcare professionals are all main drivers in the biosimilars market. According to the research report, “Brazil Biosimilars Market Research Report, 2030” published by Actual Market Research, the Brazil Biosimilars market is projected to grow with 17.73% CAGR by 2025-30. In Brazil, several of the original biologic medications that are used to treat illnesses are losing their patent protection, allowing biosimilars to reach the market. Additionally. Because biosimilars are often more affordable than reference biologics, individuals and healthcare systems can save a lot of money by using them. Biosimilars can expand patient access to necessary therapies by lowering costs and increasing availability. The Brazilian government has taken a number of steps to encourage the use of biosimilars, including urging doctors to prescribe them instead of reference biologics and fostering the growth of a biosimilar sector there. The National Health Surveillance Agency (ANVISA) in Brazil is the regulatory body in charge of authorizing biosimilars. The stringent approval procedure for biosimilars calls for extensive preclinical and clinical research. Similar to reference biologics, biosimilars are paid in Brazil through the Brazilian Public Health System (SUS). The same pricing and reimbursement rules that apply to reference biologics also apply to biosimilars. These rules include a reference price system and prices that producers and the Brazilian government have agreed upon. The Brazilian Biosimilar Policy, which intends to encourage the use of biosimilars in the Brazilian healthcare system, also includes biosimilars. The Brazil biosimilars market is gaining strong traction as healthcare systems seek cost-effective alternatives to branded biologic therapies. Biosimilars are biologic medical products that are highly similar to already approved reference biologics, with no clinically meaningful differences in terms of safety, purity, and efficacy.

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Brazil's biosimilars industry is experiencing significant growth, with key cities playing pivotal roles in this expansion. São Paulo, as the country's economic powerhouse, leads in pharmaceutical production, hosting major companies like EMS, Eurofarma, and Aché. The state's favorable tax incentives have attracted both domestic and international investments, bolstering biosimilar development and manufacturing. Rio de Janeiro, despite higher operational costs, remains a critical hub with a substantial pharmaceutical market share, housing facilities of global players such as GSK, Roche, and Merck. The Southeast region, encompassing São Paulo and Rio de Janeiro, contributes significantly to Brazil's industrial GDP. This concentration of industry and infrastructure supports the growth of biosimilars. Additionally, cities like Campinas and Sorocaba in São Paulo state are emerging as biotech centers, with Campinas hosting research institutions and Sorocaba being a key player in the pharmaceutical sector. These cities, along with the Southeast region's industrial strength, form a robust foundation for Brazil's biosimilars market, positioning the country as a leader in South America's pharmaceutical industry. Monoclonal antibodies (mAbs) are leading the biosimilars industry in Brazil due to a combination of regulatory advancements, strategic public-private partnerships, and the high burden of diseases such as cancer and autoimmune disorders. In 2010, Brazil established a comprehensive regulatory framework for biosimilars through ANVISA’s RDC No. 55, which outlines stringent requirements for demonstrating similarity to reference biologics, including rigorous clinical trials. This regulatory clarity has fostered confidence among both domestic and international stakeholders in the development and commercialization of mAb biosimilars. A pivotal initiative contributing to the growth of mAb biosimilars is the Partnership for Productive Development (PPD) program. This program facilitates technology transfer between private companies and public laboratories, enabling local production of high-cost biologics. For instance, the collaboration between Janssen-Cilag Farmacêutica Ltda., Bionovis S.A., and Bio-Manguinhos led to the development of an infliximab biosimilar, significantly reducing costs and improving access within Brazil's Unified Health System (SUS). Such partnerships have been instrumental in addressing the financial challenges associated with biologic therapies in the public healthcare sector. The Brazilian government's active role in promoting biosimilars, particularly mAbs, is further evidenced by its substantial procurement of these therapies. In 2015, over 80% of infliximab vials purchased by the Ministry of Health were sourced through the PPD program, amounting to approximately 180,000 vials and a financial commitment of BRL 175 million. This large-scale procurement underscores the government's commitment to enhancing patient access to essential treatments while managing healthcare expenditures effectively. Additionally, the high prevalence of chronic diseases such as non-Hodgkin’s lymphoma, rheumatoid arthritis, and Crohn's disease in Brazil has driven the demand for effective treatments. mAb biosimilars offer a cost-effective alternative to original biologics, making them increasingly accessible to a broader patient population. As of December 2021, Brazil had approved biosimilars for several mAbs, including rituximab, trastuzumab, infliximab, adalimumab, and bevacizumab, positioning the country as a leader in the Latin American biosimilars market. Oncology is leading the biosimilars industry in Brazil primarily due to the increasing burden of cancer within the country, coupled with the high cost of original biologic therapies that treat various malignancies. Brazil faces a rising incidence of cancers such as breast, lung, colorectal, and hematologic malignancies, which creates significant demand for effective and affordable treatment options. Biologic therapies, particularly monoclonal antibodies used in oncology, have revolutionized cancer treatment but are often prohibitively expensive for widespread use, especially in a developing economy with resource constraints like Brazil. Biosimilars offer a more cost-effective alternative without compromising clinical efficacy or safety, thereby enabling broader patient access to essential oncology treatments. The Brazilian government’s commitment to incorporating biosimilars into the public healthcare system (SUS) and initiatives such as the Partnership for Productive Development (PPD) program facilitate local production and reduce dependency on expensive imports, driving growth in oncology biosimilars. Additionally, regulatory advancements by ANVISA have streamlined biosimilar approvals, encouraging domestic and international companies to invest in this segment. The combination of a high cancer prevalence, strong governmental support, expanding local manufacturing capabilities, and the pressing need for affordable oncology therapies positions oncology biosimilars at the forefront of Brazil’s biosimilars industry growth, ensuring that more patients receive timely and effective cancer care.

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Nikita Jabrela

Business Development Manager

In-house manufacturing is leading the biosimilars industry in Brazil due to several critical factors that align with the country’s strategic healthcare priorities and industrial capabilities. Brazil’s emphasis on self-reliance in pharmaceutical production, particularly for high-cost biologics, has driven investments in domestic manufacturing infrastructure and technology. The government’s Partnership for Productive Development (PPD) program exemplifies this approach by fostering collaborations between public institutions and private companies to locally produce biosimilars, reducing dependency on costly imports and ensuring more predictable supply chains. This in-house production model allows Brazilian manufacturers to maintain stringent quality control and regulatory compliance with ANVISA’s rigorous biosimilar approval framework, which demands extensive comparability studies and clinical evidence. Furthermore, localized manufacturing enables faster responsiveness to the country’s unique market demands and healthcare system requirements, including integration with the Unified Health System (SUS), which prioritizes accessibility and affordability. In-house producers benefit from reduced logistical complexities, lower transportation costs, and minimized risks associated with international supply disruptions, which have become more apparent in recent global crises. Additionally, investments in biotechnology hubs around key cities such as São Paulo and Campinas have created a skilled workforce and research ecosystem that supports innovation and scale-up in biosimilar manufacturing. Combined with government incentives, funding for biotech innovation, and increasing domestic expertise, in-house manufacturing remains the backbone of Brazil’s biosimilars industry, ensuring steady growth by providing cost-effective, high-quality biosimilar therapies that align with national health priorities and economic goals. 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

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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.