Brazil Pharmaceutical Market Overview: Opportunities, Trends, and Challenges

Brazil is the leading pharmaceutical market in Latin America and among the top 10 in the world, and thus is a compelling strategic focus of multinational drug producers, exporters, and contract development and manufacturing organizations (CDMOs). With access to healthcare increasing in the country due to the government-created public health system (Sistema Unico de Saude - SUS), and with the increase in private healthcare spend, the Brazilian pharma market is experiencing an ongoing growth due to the prevalence of chronic diseases, biologics innovation, and booming generics segment.

Brazil is an opportunity and a complex place to global buyers. It is interesting in terms of its market size, local manufacturing push, digital transformation and government incentives, but the regulatory delays, pricing controls and logistics challenges demand a close approach to strategy. As the Brazilian Health Regulatory Agency (ANVISA) becomes more restrictive and the government promotes domestic production, the foreign entrants have to strike the balance between compliance and agility.

For a broader view of Latin America’s evolving pharma industry, explore our in-depth country reports on the Argentina Pharma Market, Mexico Pharma Market, Venezuela Pharma Market.

• Brazilian pharmaceutical market has large scale and growth potential to foreign investors and buyers.
• Revenues of the market amount to about US $34,660.4 million in 2024, with a projected US $48,616.9 million in 2030, or a CAGR of approximately 5.8 in 2025-2030.
• According to another source, the Brazilian drug market realized BRL 106.78 billion of revenues in 2022 (US $20.7 billion) and grew by an average of 16.95 percent compared to the previous year.
• The contract development/ manufacturing (CDMO) segment: is expected to earn approximately US $4,767.1 million in 2023 and will grow to approximately US $7,858.7 million in 2030.
• In a case of generics: In Brazil, the generics drug market was estimated to reach approximately US $22.4 billion in 2024 and is expected to reach approximately US $39.3 billion in the year 2033.

It is important to know the pharmaceutical market structure in Brazil to implement strategies when entering globally.

Market structure & segmentation

• The market is divided into a conventional (small molecule) drugs and large molecule (biologics and biosimilars). Data of 2024 indicates the largest revenue generator as conventional drugs, the fastest growing sub-segment, is biologics and biosimilars.
• Distribution channels are retail pharmacies, institutional/hospital sales and the public health system procurement. Examples: in 2022 the pharmacy channel (Canal Farmacia) had an important contribution to the total account.
• Ownership: Out of the pharmaceutical companies operating within Brazil, there are about 72 Brazilian capital and 28 foreign capital companies as of 2022.
• The market is partly divided: high-value patented drugs are dominated by multinationals, and volume generics dominated by domestic companies.

The market of the pharma is influenced by a number of macro and micro trends, which should be adjusted to by the offerings of global buyers in Brazil.

Key trends

Emergence of biologics & biosimilars: being one of the most rapidly developing segments.

E-commerce channel development: The e-commerce business of the pharmacy channel increased by about 37%.

Contract manufacturing outsourcing (CDMO): The frontier of growth of the CDMO segment is very high (CAGR of about 7.6 in 2025-33) in Brazil.

Local manufacturing push and import substitution: Local manufacturing drive and emphasis on local content imply that international purchasers may prefer local manufacturing, or joint ventures, over unadulterated import-sales.

Expanding chronic disease burden: Ageing, lifestyle illnesses etc, creating demand both to innovative therapies and generics.

Implication to international buyers.

• When you are a multinational capable of biologics: Brazil is a growth market - think about launching first or early.
• In case of a generics/contract manufacturer/exporter: capitalize on the outsourcing/contract manufacturing development in Brazil.
• In case you are an e-commerce/digital health player: online pharmacies and online patient interaction are a direct growth tool.

To gain access to the market: localisation of manufacturing (or strategic alliance) can strengthen competitive advantage due to pricing pressures and local procurement processes by the local government.

Regulatory and policy issues are vital to any global buyer venturing into Brazil, any failure in this regard may slow into market entry and margins will be lost.

Key regulatory/regime facts

The primary authority is the Brazilian Health Regulatory Agency (ANVISA) that is associated with the Ministry of Health.

ANVISA controls manufacture, sales, importation/export, clinical trials, GMP inspection.

Some key regulations:

APIs and risk class III/IV medicines (e.g., Normative Instruction IN No. 32/2019) of Good Manufacturing Practice (GMP) requirements.

The Law 6,360/1973 (registration of medicines) and Law 9,787/1999 (generic drugs) among others.

The requirements of filling dossiers are still maintaining the Portuguese language and certain Brazil specific data on stability (Zone IVb climate) - that is, merely translating dossiers into the foreign market might not be enough.

This market provides a variety of opportunities to global buyers, buyers, who in turn, are segmented by their types of buyers and their strategies.

Opportunity buckets

Manufacturing/export jigs

• Make Brazil a manufacturing center (to Brazil and Latin America) due to the size and the regional forces. Indicatively, the CDMO segment is projecting to increase powerfully.
• Outsource local companies through contract manufacturing or toll-manufacturing.
• The pressure on the margin of importing finished dosage forms can be an issue; local production becomes more significant.

Niche treatments / niche markets

• Biologics and biosimilars: As it grows faster, foreign companies possessing advanced capabilities can focus on the segments.
• The therapy of chronic diseases (diabetes, cardiovascular, oncology, immunology) is highly demanded, and it is based on demographics and lifestyle.
• Rare diseases and orphan drugs: the lack of competition can allow Accessing the premium segment, but the regulation process can be more complicated.

Generics & value offerings

• In the case of generic firms, there is an opportunity of volume in the growing Brazilian generics market (e.g., generics -29.4% of total market value in 2021).
• ​​​​​​​Local manufacturing/packaging and good distribution would be useful in capturing market share in generics.

There are no challenges in any market, Brazil has huge potential, but the global buyers need to be aware of the particular threats and mitigation measures.

The major issues facing foreign purchasers

Regulatory approval: Although there is a positive shift in regulation, product registration, importation licensing, audit of GMPs may take long. To get around the processes of ANVISA, you need a domestic knowledge.

Risk of pricing and reimbursement: Government bidding and price-control can restrict the margins, particularly in imported or non-local goods.

Currency and macroeconomic instability: The volatility and economic cycles of the Brazil currency (real) can have an impact on margins, cost of doing business, and returns on investments.

Competition locally and generics: Local manufacturers are healthy particularly in generics and multinationals experience price restraint as well as active rivalry.

Risk mitigation strategies

• Early involvement of local regulatory advisors to chart dossier requirements, timelines, stability-zone factors.
• Form local joint ventures or production in a bid to reduce import margin risk and regulatory overheads.
• Construct pricing models which include procurement breaks, domestic collection lags, currency fluctuations.
• Establish the resilience of supply-chain: various logistics, local warehousing, regional centers.

One-size-fits-all is not an option to the global buyer. The following is a segmentation of tactical suggestions by the type of buyer.

In the case of multinationals (innovator pharma)

• Biologics / specialty therapies Wider growth and lower price erosion should be prioritized.
• Establish a local affiliate or partner-joint venture in Brazil to grant regulatory, distribution, marketing and pricing locally.
• Start early communication with ANVISA and CMED regarding pricing/ reimbursement and domestic manufacturing expectations.

In the case of contract manufacturers / CDMO players

• Capitalise on the CDMO growth prognosis (US7.86 billion by 2030) - establish or form an alliance with Brazilian manufacturing plantations.
• Target APIs and drug-product outsourcing: APIs is the biggest proportion of CDMO.
• Produce services that are specific to local companies and export-oriented international clients (Latin America, USA, EU).
• Take advantage of local incentives/regional manufacturing centres (e.g. states in Brazil with tax breaks).
• Reduce the risk through: diversified customer base, high quality/GMP history, export application.

In the case of generics/Export-oriented players

• Establish scale in generics either through local production or through collaborating with Brazilian generics companies.
• Concentrate on low-cost manufacturing and tap Brazilian potential huge latent demand of generic products.
• Into parallel export: manufacture in Brazil to serve local Latin American markets.
• Follow the competitor dynamics - Brazilian companies are competitive and enjoy good networks in the country.
• Make sure that there are distribution alliances with established pharmacy-chains and hospital networks in Brazil in order to reach volume channels.

Brazil has a promising growth opportunity in pharmaceutical market both in production and sales by foreign purchasers. It provides massive potential and scale with a projected growth of approximately US $34.7 billion to approximately US $48.6 billion in 2024 to 2030. However, to succeed, a custom approach is needed: bypassing regulation with ANVISA, negotiating pricing and reimbursement, considering manufacturing/in-country requirements, matching the local market structure.

In case of multinationals, the niche-therapy and biologics are the most suitable targets. Brazil is a strategic entry point to the CDMO demand of the contract manufacturers. To the success of generics/export-players and digital health entrants, smart partnerships, local distribution networks and digital-first models will distinguish success.

International consumers must not perceive Brazil as an isolated new market but a localized center with its regulatory, trading and logistical peculiarities in the region. Brazil has the potential of forming a strong pillar of a pharma growth strategy that targets Latin America with proper due diligence, integrated locally and acted tactically.

• Brazil pharmaceutical market size & outlook (2024-2030) – Grand View Research: https://www.grandviewresearch.com/horizon/outlook/pharmaceutical-market/brazil
• Brazil pharmaceutical CDMO market size & outlook – Grand View Research: https://www.grandviewresearch.com/horizon/outlook/pharmaceutical-cdmo-market/brazil
• Profile of the pharmaceutical industry in Brazil (2022 data) – Sindusfarma PDF: https://sindusfarma.org.br/uploads/files/229d-gerson-almeida/Publicacoes_PPTs/PROFILE_IF_2023.pdf
• “The Brazilian Pharma Market: Key information…” – TannerPharma: https://tannerpharma.com/the-brazilian-pharma-market-key-information-and-what-may-change/
• Brazil pharmaceutical industry and regulatory market profile – Pharmexcil PDF: https://pharmexcil.com/uploads/countryreports/Brazil-_Regulatory_Market_Profile.pdf