Latin America’s largest and most dynamic pharma market is booming. Despite sluggish macroeconomic growth, agile local firms are consolidating their positions to serve Brazilian patients, while a spate of technology transfer agreements is bolstering local manufacturing capabilities and helping these companies scale the value chain. Multinationals – with the right strategy – can also find success, with a new clinical trial law set to increase the country’s attractiveness to multinational trial sponsors and a governmental openness to creative risk-sharing agreements already making several of the most globally advanced therapies available to patients.

 

The region’s most populous country has experienced slowing economic growth in recent years. Real GDP grew by 3.4 percent in 2024 but is projected to slow to 2.2 percent in 2025 due to higher interest rates, a weaker external environment, and slower household consumption. Meanwhile, the national Central Bank is maintaining interest rates at an incredibly high 15 percent (well above the inflation rate of 4.5 percent) to fight inflation.

Despite these headwinds, there are some causes for economic optimism – only six percent of the working-age population is unemployed, and Brazil maintains a strong trade surplus, with over USD 380 billion in foreign reserves.

In terms of healthcare, Brazil stands alone in LatAm as the only country with a constitutionally mandated, fully universal, free-at-point-of-care healthcare system. Brazil’s Sistema Único de Saúde (SUS) – while imperfect and in places chronically underfunded – functionally serves over 200 million people.

Inequality remains rife, and around a quarter of higher-income Brazilians also hold private health insurance, but, as Reginaldo Braga Arcuri of local pharma association Grupo FarmaBrasil notes, for very complex procedures such as heart transplants, even wealthy individuals often rely on SUS.

 

Booming Locals, Challenged MNCs

Serving the diverse and evolving health needs of Brazil’s enormous population through both the public and private markets is a dense network of pharma multinationals and local players. LatAm’s largest pharma market by far, and with double-digit annual growth predicted for the next half-decade, Brazil has long been earmarked as a regional priority for global pharma’s largest companies, which dominate the market in terms of value, with most of the expensive cutting-edge therapies available in Brazil imported from abroad.

However, in an increasingly challenging environment, it is local Brazilian companies that have managed to display the strongest levels of growth, and which now lead the market in volume. The likes of NC Farma, Eurofarma, Hypera, and Ache – names perhaps unfamiliar to an international audience – are actually the four companies with the greatest market share in Brazil.

For international firms operating in Brazil can be incredibly difficult, as Haig Yeghiaian, general manager of Danish dermatology specialist LEO Pharma, explains. “Brazil is an unparalleled proving ground for companies to assess their ability to operate in complex and demanding environments, an acid test for global competitiveness,” he notes.

“A combination of tax complexity, competitive intensity, and geographic scale makes operations here very challenging … Operational logistics are also costly; the entire landmass of Europe would fit within Brazil, making managing the country akin to coordinating multiple distinct markets with different roles and requirements.”

Those locals who have found success have tended to do so by appreciating and working with this geographic diversity. One example is CIMED, an upstart family-owned OTC, branded generics, and consumer healthcare player, now backed by GIC, Singapore’s sovereign wealth fund, and with grand ambitions to double in size to around USD 1.88 billion by 2030. CIMED reaches 98 percent of all points of sale out of 100,000 pharmacies nationwide and even boasts its own distribution network in six states.

“We deeply understand Brazil,” proclaims CEO João Adibe Marques. “Ours is a vast country with huge geographic challenges and a population with limited purchasing power. Multinationals often bring a one-size-fits-all approach, while CIMED adapts its portfolio to the needs of each region. Every Brazilian state has its own product profile, and we build around that. That ability to act as a national company with regional thinking is CIMED’s greatest asset against multinationals.”

There are exceptions to this rule, with even multinationals in the highest-value innovative medicines space able to find success, provided they select the right strategy. AstraZeneca, the eighth largest company in the market, has been an outlier among its MNC peers in recent years, sustaining significant growth across all of its key therapeutic areas and patient segments.

AstraZeneca has done this through operating with what LatAm VP Alexandre Gibim calls “the agility and engagement of a domestic company. Our innovations constitute genuine breakthrough therapies that fundamentally transform patient outcomes, and we are deeply integrated with the local healthcare ecosystem, serving the nation’s requirements across both private and public healthcare sectors.”

Certain niches – not least skincare – have a particular relevance in Brazil, creating abundant opportunities for both locals like CIMED and multinationals such as LEO Pharma and Pierre Fabre alike. With sunny weather for ten months of the year, and a deeply ingrained culture of health and beauty, Brazil has become the third-largest beauty market globally, with one of the world’s highest concentrations of dermatologists.

However, for multinationals with dermatology portfolios, tapping into the demand for skincare products within Brazil necessitates new methods of engagement. “Historically, the dermo-cosmetics category behaved much like the pharmaceutical industry – physician prescriptions drove the primary investment, coupled with visibility at the pharmacy retail level,” explains Danielle Bibas, CEO of Pierre Fabre Brazil.

“This paradigm has shifted significantly over recent years. The influence of media spend, digital influencers, and e-commerce as a channel has grown exponentially. This category now occupies an intriguing space between mass consumer goods and mass beauty on one side, and pharmaceuticals on the other – incorporating elements of both.” Brazil has become one of Pierre Fabre’s top five markets globally, and Bibas notes that over 30 percent of her affiliate’s business is generated online.

 

Local Manufacturing & Scaling the Value Chain

In recent years, many of Brazil’s most enterprising local companies, buoyed by their successes at home, have been expanding their business beyond Brazil’s borders. Eurofarma, for example, now operates seven manufacturing facilities across LatAm, EMS purchased a biotech firm in the US and Serbia’s former state-owned laboratory, Galenika, and BIOLAB established an R&D centre in Ontario, Canada.

This internationalisation has been accompanied by some of these firms dipping their toes into more innovative waters, expanding beyond their historic generics focus.

This represents a seismic change from the past, as Grupo FarmaBrasil’s Braga Arcuri notes, “In 2010, Brazil had virtually no footprint in biotech. Today, two companies are producing seven or eight monoclonal antibody products. This progress was made possible by a coordinated alignment between public policy and the investment capacity of domestic industry.”

Several Brazilian firms have been able to scale the value chain and begin producing more technologically complex biosimilars via Brazil’s unique productive development partnership (PDP) model. Under this framework, the Brazilian Ministry of Health identifies a high-cost therapy that is already being procured for the SUS, then partners a local Brazilian company with the originator to form a development alliance to produce it domestically. The Ministry guarantees a pre-agreed purchase volume, significantly reducing investment risk, while the public system gains access to new therapies, priced in Brazilian reais rather than US dollars.

“This framework has already enabled the local development of biosimilars, and we are now entering a longer-term effort to develop New Molecular Entities (NMEs),” explains Braga Arcuri. “Its success rests on three mutually reinforcing pillars: a robust regulatory agency in ANVISA; a strong domestic generics industry; and public procurement strategies directly linked to technology transfer.”

With the COVID-19 pandemic highlighting the importance of medicinal self-sufficiency worldwide, ANVISA and the Ministry of Health have been refining this model in recent years to prepare for future crises. “The pandemic demonstrated that, despite globalisation, we require infrastructure to meet internal needs during crises,” says Romison Rodrigues Mota, director of ANVISA. “While recognising we cannot achieve complete self-sufficiency, we must develop sufficient technological capacity to rapidly expand production of essential medicines or needed products during emergencies.”

This trend seems set to continue, with health sovereignty defined as one of the six missions of the ‘Nova Indústria Brasil’ (NIB) 2033 Industrial Strategy. Launched in 2024, and with up to BRL 300 billion (USD 55 billion) in financing earmarked across all sectors, the NIP aims to raise the domestic production of medicines, vaccines, devices and equipment from 42 percent to 70 percent of national demand. Additionally, two new decrees have created mechanisms to favour national products in public tenders.

 

A New Era of Clinical Research?

Beyond technology transfers, a key element of any country’s attempt to become medicinally self-sufficient, educate physicians in cutting-edge technologies, and provide broader and earlier access to new medicines is clinical trials. Last year, Brazil passed its first comprehensive law regulating clinical research, replacing the patchwork system that previously existed and covering everything from standardising and modernising ethics and regulatory reviews, speeding up approvals, improving patient protection, creating legal certainty, and attracting investment into R&D.

The country already boasts strong fundamentals for clinical research, including its large population of 200 million, high level of urbanisation, excellent universities, strong regulation, and competitive research costs. “Brazil ranks among the world’s most ethnically and genetically diverse nations, an extraordinary asset for our clinical development programmes,” notes Sylvester Feddes of Novartis, which has around 100 ongoing clinical trials in Brazil already.

“Brazil, the region’s largest market, conducts significant research with considerable sophistication and has led the way in terms of the adoption of decentralised modalities,” adds Mitchell Parrish, CEO & co-founder of LatAm-focused decentralised clinical trial experts, H Clinical.

Moreover, data generated in Brazil can be used to support regulatory applications throughout the region. As AstraZeneca’s Alexandre Gibim points out, “Latin American countries generally do not impose restrictions on utilising clinical data generated in Brazil, Argentina, Mexico, Colombia, or other regional markets, nor data originating outside the region.”

However, Brazil has been failing to capitalise on these fundamentals; a recent study from Interfarma, which represents the multinational industry in the country, found that Brazil lost around 694,000 clinical trial participants over the past four years in open trials that did not attract enough patients.

“With this new law, we now have a much more attractive environment capable of generating significant investment and accelerating access at the same time,” proclaims Interfarma President Renato Porto. “The greatest incentive we can offer is legal certainty, regulatory clarity, and economic stability – all essential when developing a medicine takes ten years or more. The new Clinical Research Law has been a major turning point. It brought clear timelines, harmonised requirements, and greater predictability to how studies are conducted in the country.”

ANVISA’s Rodrigues Mota expects the kinds of clinical research conducted in Brazil to shift in the coming years thanks to this legislation. “These regulations position Brazil to attract additional clinical research, particularly Phase I and II studies,” he says. “While we already have reasonable volumes of Phase III research here, we anticipate improvement across all phases. Brazil is establishing a regulatory environment that provides fertile and secure conditions for sponsor investment in clinical research implementation.”

Rogerio Frabetti of Biogen – which has around ten ongoing Phase II and III protocols in Brazil – agrees, adding that “Brazil possesses population diversity, numerous centres receptive to innovation, and governmental incentives capable of attracting substantially more clinical trials to the country – not merely Phase III, but Phase II and Phase I studies. This represents tremendous opportunity.”

Frabetti also contends that clinical research represents a truer form of innovation than the previously discussed tech transfers. “When studies come to Brazil, we import capital, knowledge, and innovation simultaneously. This is genuine innovation – engaging companies with compelling, innovative products to establish investment partnerships, rather than investing in technology transfer of antiquated molecules with globally commoditised technology.”

Naturally, there is also a commercial rationale behind conducting clinical research in Brazil, with locally generated data standing a better chance of making it through the regulatory and health technology assessment processes. “Conducting trials in Brazil enables us to understand precisely how our therapeutics perform in Brazilian patient populations,” says Feddes, whose company has been busy building clinical trial capabilities away from the main industrial centres.

“This knowledge proves invaluable for market introduction strategies, informing not only treatment efficacy but access model design. We gain critical insights into care pathway challenges and access barriers. The patient experience in São Paulo differs dramatically from Amazônia, necessitating differentiated approaches.”

This closer integration between clinical research, regulatory evaluation, and real-world care pathways is increasingly shaping how access decisions are made in Brazil.

 

Access & Risk Sharing

Finally, a major challenge for innovator companies in Brazil – even those well-embedded in the country and with tailored strategies – is market access. The main issues seem to lie post-registration in reimbursement negotiations, with almost half of the drugs approved by ANVISA never making it to market, according to recent data cited by Brazil’s Regulatory Chamber of the Drug Market (CAMED).

“ANVISA is a technically strong agency, and the regulatory environment is robust,” opines Renato Porto, President of MNC association Interfarma. “With recent improvements, regulatory approval now takes around two to three years. However, the time for that same medicine to reach the population is closer to five years. We also saw an 18 percent increase in access timelines from last year to this year; The real bottleneck today is not regulatory performance but incorporation processes and the steps that follow market authorisation.”

Rogerio Frabetti, general manager at Biogen goes even further. “We face considerable challenges regarding access in Brazil,” he states. “CONITEC (Brazil’s HTA body, in place since 2011) functions as an important technical agency, though there need to be improvements in its technical capabilities. Beyond approvals, we must accelerate incorporation into Ministry of Health programmes, as patients experience excessive delays in accessing approved and incorporated products.”

“Many innovative medicines still reach only the private sector, which covers roughly a quarter of the population, while the majority of patients in the public system remain excluded,” adds Matthieu Mendil, general manager at Servier.

Arturo de la Rosa, VP for Latin America at Gilead agrees. “Brazil’s private market offers decent access levels, but its public sector faces significant gaps,” notes de la Rosa, who is attempting to establish the firm as a key player in the innovative breast cancer treatment space within Brazil.

de la Rosa does, however, note that Brazil stands apart from its regional counterparts in its appreciation of innovative new medicines for HIV. “While many LatAm countries have shifted to older generic alternatives that underperform compared to newer products, Brazil is striking a better balance,” he opines. “Despite utilising many generic options, the Brazilian authorities are engaging in intelligent treatment selection, evaluating innovative treatments for specific patient populations not achieving optimal results with older alternatives.”

The main option being proposed by the Brazilian industry to increase the availability of new medicines to patients is managed access agreements, including risk-sharing models and outcome-based contracts.

“We are exploring performance-based contracts, where reimbursement is linked to clinical outcomes,” notes Mendil. “For instance, an oncology treatment could be paid for only once it delivers the survival benefit demonstrated in trials.”

There has already been one highly notable example and potential precedent of how a high-cost innovative therapy can be made available in Brazil. Novartis’ Zolgensma, a one-time gene therapy for spinal muscular atrophy (SMA) in children, was approved by ANVISA in 2020 and a performance-based risk-sharing agreement subsequently eventually agreed with SUS.

“Genuine partnership development begins with trust cultivation – transparent, long-term, patient-centric partnerships,” says Sylvester Feddes, country president of Novartis. “Getting to this agreement required three years of collaborative governmental engagement to establish a model providing payment predictability and risk-sharing. If the treatment proves ineffective, the government incurs no ongoing costs; only successful treatment triggers payment, meaning that we share the therapeutic risk directly.”

While still exceptional, such agreements are increasingly viewed as templates for how Brazil may approach ultra-high-cost innovation going forward.

 

Future Prospects

Brazil’s pharma market rewards execution, not intent. The country’s huge scale, its universal health system, and renewed policy momentum create real opportunity, but access remains slow and uneven. Local companies are gaining ground by aligning closely with pricing realities, distribution, and public procurement, while multinationals succeed only when they localise and tailor their approach across clinical research, access strategy, and partnerships.

The next phase will hinge on delivery: whether the new clinical trial framework, manufacturing incentives, and risk-sharing models translate into faster, more predictable patient access. If they do, Brazil can shift from being merely large and complex to strategically consequential.