The Executive Secretariat of the Medicinal Product Market Regulation Chamber (CMED) has published the 2025 edition of its Statistical Yearbook of the Pharmaceutical Market, based on consolidated data from the Medicinal Product Market Monitoring System (Sammed). According to the report, the sector generated R$182.8 billion in revenue in 2025, with 6.3 billion packages of medicinal products sold by 230 companies, which marketed 7,096 products across 14,371 distinct presentations.

CMED is the interministerial body responsible for the economic regulation of Brazil’s pharmaceutical market, setting the criteria for establishing and adjusting medicinal products prices in the country. It also maintains Sammed, the database that underpins continuous monitoring of the sector’s behavior and informs public health policy decisions.

A new framework for drug pricing

Although the yearbook reflects the 2025 market, it’s worth highlighting a regulatory change expected to shape the market’s behavior in the years ahead: Resolution CM-CMED No. 3/2025, published in December 2025 and in effect since April 2026, replaced Resolution CMED No. 2/2004 and established a new regulatory framework for drug pricing in Brazil, after more than two decades under the previous rules.

Among the main changes are the expansion of price classification categories to eight, including new categories specifically for biosimilars and for products undergoing marketing authorization holder transfer; the requirement to submit the Price Information Document (Documento Informativo de Preço, DIP) already during the marketing authorization process with ANVISA, rather than as a later step; and a greater focus on clinical value and international cost-effectiveness comparisons to justify the requested price. For biosimilars, the price is capped at 80% of the originator product’s price, and the entry of the first biosimilar into the market also brings the reference product’s price down to that same level.

Where the market’s value lies

Revenue distribution by regulatory category reveals a market split between innovation and access. New drug products led revenue, at R$60.66 billion, despite having far fewer products and presentations than unbranded generics and similars (branded generics). Biological products, meanwhile, concentrated R$57 billion in just 753 marketed presentations, with an average price of R$387.77, more than 13 times the market average of R$29.02.

At the other end, generics accounted for the largest sales volume, 2.9 billion of the market’s 6.3 billion packages, at the lowest average price among all categories, R$8.67. The “Other” category, which groups radiopharmaceuticals and advanced therapy products, was the market’s most restricted segment, with only 25 marketed presentations, but by far the highest average price: R$488,523.

Analysis by anatomical group reinforces this pattern of concentration: Group L (antineoplastic and immunomodulating agents), which covers oncology and immunology treatments, led revenue among all groups, at R$41 billion, ahead of Group A (digestive system and metabolism, R$30.2 billion) and Group N (central nervous system, R$22.5 billion). Among the therapeutic subclasses that exceeded R$1 billion in revenue in 2025 are several classes of antineoplastic monoclonal antibodies (PD-1/PD-L1, HER-2, and BTK inhibitors), anti-TNF products and interleukin inhibitors, as well as antiepileptics, atypical antipsychotics, and antidepressants, directly reflecting Brazil’s aging population and the growing weight of oncological, chronic, and mental health conditions in medicinal product consumption.

The performance of subclasses linked to obesity and diabetes also stands out: GLP-1 agonist antidiabetics and anti-obesity preparations, categories that include the GLP-1 analogs that have become popular in recent years, are already among the subclasses that surpassed R$1 billion in revenue in the country, even though concentrated among a small number of companies, just three manufacturers in the case of GLP-1 agonists. It’s a direct reflection of a global public health trend that has also reached the Brazilian market in full force.

Who makes up the market

Of the 230 companies that sold drug products in 2025, 95 are classified as large companies and account for R$171.9 billion in revenue, about 94% of the total. The remaining 135 companies, medium, small, and micro-sized, together account for a much smaller share of revenue, yet represent the majority of the regulated sector by company count.

Among the economic groups with the highest revenue in 2025, CMED’s ranking shows large multinationals such as AstraZeneca, Novartis, Sanofi, Merck Sharp & Dohme, Johnson & Johnson, Eli Lilly, and Novo Nordisk (the latter two, notably, among the leading players in the diabetes and obesity treatment market) operating alongside well-established Brazilian pharmaceutical groups such as Grupo NC, Eurofarma, Hypera, Aché, Libbs, Cristália, União Química, and Prati-Donaduzzi. This coexistence illustrates a Brazilian market mature enough to attract international investment, while also sustaining a robust domestic industry with its own capacity for development, manufacturing, and marketing authorization of products.

Market trends

The 2025 snapshot already points to what lies ahead. On the therapeutic side, revenue concentration in oncology, immunology, mental health, and diabetes and obesity therapies is likely to persist, if not intensify, tracking both population aging and the rising prevalence of chronic diseases in Brazil. The entry of new competitors into these classes, including biosimilars, is expected to accelerate under the new rules of Resolution CM-CMED No. 3/2025, which lowers the reference product’s price as soon as the first biosimilar is approved.

On the regulatory side, the new pricing framework demands more robust, earlier technical preparation from companies: since the DIP is now required already during the marketing authorization review process by ANVISA, pricing strategy is no longer a later step but must move in step with regulatory strategy from the earliest stages of dossier development. Companies that get ahead of this integration are likely to gain a meaningful competitive edge in upcoming launches.

On the corporate side, the coexistence of large multinationals, well-established domestic groups, and a significant number of medium and small companies suggests that the Brazilian market will continue to be contested both through innovation and through efficient regulatory execution, two factors that together determine who turns good products into meaningful revenue.

How Vita can help

Competing in such a concentrated market requires regulatory efficiency: well-structured dossiers, registration strategies suited to each product’s profile, and continuous life cycle monitoring. 

This is exactly where Vita operates, with regulatory strategy and intelligence, dossier preparation and filing with ANVISA and other authorities across Latin America and Portugal, post-authorization life cycle management, and gap analysis to identify risks before they become deficiency letters. 

Companies looking to grow sustainably in this market can count on Vita to turn regulatory strategy into results.