Brazil market entry

Brazil, understood as an operating environment.

Brazil is not one market. It is a continental clinical system with distinct regulatory, institutional and reimbursement dynamics. We navigate it as insiders.

The Brazilian paradox

Brazil holds unmatched phenotypic diversity, world-class tertiary centers and a public health system covering more than 200 million lives — yet remains structurally underused for rare disease innovation.

What Brazil may offer

Phenotypic diversity

A population that broadens signal detection across rare presentations.

Tertiary medical excellence

Centers whose investigators publish at international standards.

Scale of care

SUS coverage that enables meaningful cohort discovery.

Real-world evidence potential

Longitudinal data sources when governed correctly.

From market entry to market activation

Eight steps from disease landscape to long-term adoption.

  1. 01

    Understand the disease landscape

    Epidemiology, natural history, existing clinical experience.

  2. 02

    Identify physicians and centers

    Specialists and institutions with real disease-area expertise.

  3. 03

    Map potential patient cohorts

    Phenotypic and geographic mapping of relevant populations.

  4. 04

    Evaluate regulatory and access pathways

    ANVISA, CONITEC, RENAME, expanded and compassionate use.

  5. 05

    Generate local evidence

    Real-world data and Brazilian clinical credibility.

  6. 06

    Engage institutions and stakeholders

    Academic, public-sector and private-sector alignment.

  7. 07

    Structure access and development opportunities

    Early access, clinical collaboration and evidence generation.

  8. 08

    Build the long-term adoption pathway

    Reimbursement, distribution and continuity of care.

Local evidence & real-world data

Real-world evidence generated with Brazilian rigor supports both access decisions and international regulatory dossiers.

Pharma²⁸

Building rare disease infrastructure, together.

If you are advancing a therapy, investing in the space, running a clinical program or coordinating patient identification — start a conversation with us.