Oncology is, by a wide margin, the largest therapeutic area for industry-sponsored clinical trials in Brazil. Samba Trials' Q2 2026 landscape scan identified 188 solid-tumor trials and 62 hematologic-oncology trials — 250 in total, 43.0% of the country's 582 actively-recruiting industry trials. For context, the next-largest TA (cardiovascular) accounts for 35 trials, about a seventh of the oncology volume.
For biotechs evaluating Brazil as a site option, the takeaway is simple: the oncology infrastructure already exists, it is working at scale, and your competitors are already using it. The question is not whether Brazil can host an oncology trial — it is which protocols will recruit fastest and which centers to target first.
Why Brazil for oncology
- A Latin-American oncology reference center. Fundação Pio XII — the Hospital de Câncer de Barretos — is one of the largest cancer-dedicated hospitals in Latin America, treats tens of thousands of new cases per year, and shows up in our data with 18 active industry trials. Barretos anchors a regional referral network that pulls treatment-naïve patients from across São Paulo state, Minas Gerais, Mato Grosso and beyond.
- Treatment-naïve patient populations for specific tumor types. Later-line standard-of-care access in SUS (the public system) is unevenly distributed. That creates, honestly, both an ethical question and a practical recruitment edge: for some tumor types patients enroll in trials without the heavy prior-line exposure common in U.S. and Western European cohorts, giving sponsors cleaner efficacy reads for front-line and second-line protocols.
- Integrated academic oncology units. Hospital de Clínicas de Porto Alegre (HCPA), Hospital Sírio-Libanês, Hospital Alemão Oswaldo Cruz and Hospital São Lucas da PUCRS run dedicated oncology research units with full PI rosters, GCP-trained coordinators, and established IRB/CEP pathways.
- Phase-3-friendly volume. 60% of Brazilian industry trials across all TAs are Phase 3 (351 of 582). Oncology is the engine of that mix — large, multinational, registration-enabling protocols fit Brazilian site capacity well.
Where the oncology trials run
The oncology map is less concentrated than the overall trial map. A protocol aiming to recruit quickly in Brazil will typically combine a Barretos arm for solid-tumor volume, an HCPA or São Lucas PUCRS arm for academic-oncology quality and hematology coverage, and one or two São Paulo metro sites (Sírio-Libanês, Oswaldo Cruz, Santo André) for the patient density advantage of the country's largest metro.
| Center | City / State | Role in oncology portfolio |
|---|---|---|
| Fundação Pio XII — Hospital de Câncer de Barretos | Barretos, SP | Latin-American reference cancer center; 18 active industry trials in our dataset across solid and hematologic tumors. |
| Hospital de Clínicas de Porto Alegre (HCPA) | Porto Alegre, RS | Federal teaching hospital, 53 industry trials across all TAs; strong hematology and solid-tumor units. |
| Hospital São Lucas da PUCRS | Porto Alegre, RS | PUCRS-affiliated; 30 active industry trials with established oncology research arm. |
| Hospital Alemão Oswaldo Cruz | São Paulo, SP | Private-academic hybrid with 20 trials; oncology and hem-onc track record with big-pharma sponsors. |
| Hospital Sírio-Libanês | São Paulo, SP | Premier private oncology center; 12 trials in our dataset; strong investigator bench. |
| Liga Norte Riograndense Contra O Câncer | Natal, RN | Regional cancer center; 29 trials — high for a non-southeast site, with strong solid-tumor recruitment. |
| Hospital Erasto Gaertner | Curitiba, PR | Paraná's principal cancer reference hospital; 14 active trials. |
Geographically, oncology trials cluster in São Paulo (the state with 252 total trials, the largest anywhere in Brazil), Rio Grande do Sul (189), Paraná (93), Bahia (78) and Minas Gerais (75). Natal (111 total city-level trials) punches above its weight on cancer specifically, driven by the Liga Norte Riograndense infrastructure.
Who's sponsoring oncology trials in Brazil
The top-25 sponsor list in Brazil is oncology-tilted at the head: AstraZeneca leads with 67 active trials, followed by Merck Sharp & Dohme LLC (45), Novartis (33), Hoffmann-La Roche (31), and Janssen Research & Development (28). Bristol-Myers Squibb (24), Daiichi Sankyo (11) and BeOne Medicines (11) round out a group whose oncology franchises drive the bulk of the Brazilian footprint.
Honest framing: these are overall counts across all TAs, not oncology-only counts. We don't publish a sponsor-by-TA breakout in the free data. That said, if you know the pipelines — AstraZeneca's TROPION/ADC programs, MSD's Keytruda combinations, Roche's targeted-therapy portfolio, Daiichi Sankyo's ADCs — it's clear oncology is the single biggest driver of these numbers. TA-specific sponsor rankings are available in the full quarterly landscape report.
Emerging-biotech footprint
Of Brazil's 141 unique industry sponsors in Q2 2026, 148 trials (25%) come from emerging-biotech sponsors versus 434 (75%) from big pharma. Oncology-focused emerging biotechs like BeOne Medicines and Daiichi Sankyo already run double-digit Brazilian portfolios — showing that Brazil is not exclusively a big-pharma geography for oncology.
Regulatory path: what oncology sponsors should plan for
Brazilian clinical trial regulation runs on three tracks that operate in parallel: local CEP (Comitê de Ética em Pesquisa) ethics review at each site, CONEP (Comissão Nacional de Ética em Pesquisa) central ethics review for international and genetic studies, and ANVISA (the regulatory agency) for the drug-specific clinical-trial dossier.
Historically, end-to-end activation for a first-in-country oncology protocol ran 9 to 12 months. Under Lei 14.874/2024 (Brazil's new clinical trial law, passed mid-2024 and now in active implementation), the target is a ~6-month pathway with statutory review windows and clearer parallel submission. In practice, we're seeing protocols activated inside 6-8 months when the CRO and local consultancy handle CEP/CONEP/ANVISA in parallel from day one — and still 10+ months when teams try to run them sequentially.
Oncology-specific nuances worth flagging: biological-sample export (particularly for genomic sequencing and PK analysis) requires CONEP authorization and a formal Termo de Transferência de Material Biológico; radiopharmaceuticals require CNEN coordination alongside ANVISA; and combination-product protocols (ADC + checkpoint, for example) need explicit combination-arm justification in the dossier.
How Samba Trials helps
Samba Trials is the clinical-trials consultancy arm of BioAlma. We are a medical-affairs and market-intelligence team, not a CRO. Sponsors typically engage us before CRO selection, during feasibility, and through site activation:
- TA-specific feasibility memos. A 2-3 week review of your protocol synopsis against Brazilian oncology-site capacity, competing-trial overlap, SUS standard-of-care access for your comparator, and realistic enrollment timelines by region.
- Site identification and activation support. Named-center shortlists with PI profiles, active-trial load, and historical sponsor relationships. We coordinate initial contact and scope conversations.
- ANVISA submission strategy. Parallel-track planning for CEP/CONEP/ANVISA, dossier review against current reviewer expectations, and liaison with local regulatory consultants. For oncology specifically, biospecimen-export strategy from day one.
Get an oncology feasibility memo
Send us your protocol synopsis (or just the target indication and comparator). We'll return a Brazil-specific feasibility memo within two weeks.
Request a memo →