State of Industry Clinical Trials in Brazil (Q2 2026)

By Daniel — Founder, Samba Trials (a BioAlma company). Published 2026-04-20. Data: ClinicalTrials.gov via Samba Trials Q2 2026 landscape scan.

Every quarter, Samba Trials scans ClinicalTrials.gov for the universe of industry-sponsored, actively-recruiting clinical trials that have at least one Brazilian site. Q2 2026's scan returned 582 trials across 141 unique industry sponsors. For context: three years ago the same scan would have returned fewer than 150. Brazil is in the middle of a multi-year clinical-trial expansion, and the shape of that expansion matters for how sponsors should think about it.

This piece is for biotech VPs of Clinical, Heads of Clinical Operations, and Medical Affairs directors evaluating Brazil for the first or fifth time. It's organized around four questions: how big is the market, who's in it, what is it running, and where is it going.

How big is the market, really

The clean number is 582 industry-sponsored, actively-recruiting trials with a Brazilian site. That's a floor for market size — it excludes investigator-initiated trials, NIH/NCI cooperative-group trials, observational studies, and industry trials that are no longer recruiting. It's the number that matters for a sponsor asking "is my competitor running a Brazilian arm."

Among those 582 trials, 194 started in the last 12 months. One in three trials currently active in Brazil is a 2025-or-later activation. That matters for site-capacity planning: investigators who were available to start a new protocol 18 months ago may not be available now.

The growth trajectory

Trials by year-of-first-enrollment, limited to the trials currently still recruiting in our Q2 2026 scan:

The story is blunt: the 2022 cohort still recruiting (47 trials) is smaller than the partial 2026 cohort (43 trials after four months), and less than a quarter of the 2025 cohort (207). Brazil's role in global clinical trials has materially shifted in the last three years — and the slope appears to be holding, even accounting for the fact that older trials drop out as they complete enrollment.

Who's in the market: big pharma vs. emerging biotech

Of Brazil's 582 industry trials, 434 (75%) are sponsored by big pharma and 148 (25%) by emerging biotechs. The 3:1 big-pharma-to-biotech ratio is worth sitting with. For a VP at an emerging biotech reading this, the honest read is: you are in the minority, but you're not alone. 148 trials across an emerging-biotech footprint means roughly a quarter of all Brazilian industry activity is being driven by sponsors without a historical Brazilian commercial presence.

The top of the sponsor table is heavily big-pharma weighted, as you'd expect:

But the back half of the top 25 is a different story. BeOne Medicines (11), Daiichi Sankyo (11), Alexion (8), Azafaros A.G. (4), Crinetics Pharmaceuticals (4) — these are sponsors whose global footprints are smaller but whose Brazilian programs are substantial. Crinetics has four active Brazilian trials — that's more than a 1% share of the entire Brazilian industry-trial market sitting with a single small-cap biotech. Azafaros is similar. The takeaway: emerging biotechs can and do build meaningful Brazilian positions; the barrier is knowing how, not whether.

What the market is running: Phase mix and therapeutic areas

Brazil's phase mix is heavily Phase 3 weighted:

60% Phase 3 is high. For reference, global industry-sponsored trial footprints typically run 35-45% Phase 3. Brazil's mix reflects two structural features: it's largely a late-stage geography for multinational registration-enabling programs, and early-phase (Phase 1) work is mostly done elsewhere. That's a signal for biotech sponsors: if you have a Phase 1 asset, Brazil is probably not your first-pick site. If you have a Phase 2b or Phase 3 in a high-volume TA, Brazil is probably worth serious evaluation.

Therapeutic-area concentration is also heavy. Oncology alone (solid tumors plus hematology) is 43% of the entire market (250 of 582 trials). Cardiovascular (35), neurology (29), rheumatology (26), rare disease (25), nephrology (24), and metabolic (21) round out the next tier. Dermatology (11), infectious disease (11), and psychiatry (9) are smaller but active.

Where is it going: implications for 2026-2027 program planning

Three implications come out of this data for biotech teams actively planning programs:

1. Capacity at the top sites is tightening

With 194 trials started in the last 12 months and the top 20 research centers concentrating most of the industry volume, the single biggest feasibility risk for a new protocol in Brazil in 2026 is competing-trial overlap at the sites your CRO will want to use. HCPA runs 53 active industry trials right now. Barretos runs 18. Sírio-Libanês runs 12. For a well-designed program this is workable — PIs manage multi-protocol caseloads routinely — but it requires planning earlier than sponsors are used to in markets where capacity is not the constraint.

2. Phase 3 dominance is durable

The Phase 3 share is unlikely to shift materially over the next 12-18 months because it reflects the global pipeline flow into Brazil, not a local policy choice. Sponsors with Phase 3 programs should assume the pattern holds. Sponsors with Phase 1 or early Phase 2 programs should plan other geographies as primary and consider Brazil only for specific strategic reasons (rare-disease patient aggregation, pharmacogenomic diversity).

3. Lei 14.874/2024 is reshaping timelines

The new Brazilian clinical-trial law passed in mid-2024 and is now in active implementation. The statutory target is a ~6-month end-to-end review, versus a historical 9-12 months. We're seeing well-run submissions landing inside 6-8 months in practice. That alone is changing the calculus for sponsors who wrote off Brazil in prior programs because of regulatory latency. See our companion article on the ANVISA review timeline for the operational detail.

What this means for your program

The Brazilian clinical-trial market in Q2 2026 is large, diverse, Phase-3-tilted, and growing. For a biotech sponsor, the question is not whether Brazil can run your protocol — almost certainly it can — but whether the site-capacity, competing-trial, and regulatory-timeline math works for your specific indication, mechanism, and program timeline.

Samba Trials publishes this landscape data quarterly. The full Q2 2026 landscape report (16 pages, free to qualified requesters) includes every trial, sponsor-by-TA breakouts, named-center detail, and the full growth-curve data. For protocol-specific questions — "can I recruit 120 patients for a Crohn's Phase 2b in 14 months in Brazil" — that's the feasibility-memo work we do.