1. Market Research

Brazil: Clinical Development Country Profile

  • February 2014
  • 79 pages
  • Industry Standard Research
Report ID: 2440464

Summary

Table of Contents

In this report, ISR provides insight into the clinical trial regulation and development environment, sponsor and service provider activities, and population “health status” for Brazil.

What you will learn in this report:

How you can use this report:
- How population health status, regulations and clinical trial activity, and international and domestic company partnerships make Brazil one of the top emerging global
pharmaceutical markets
- Insights from domestic service provider organizations on conducting clinical trials in Brazil
- Clinical trial operational metrics for Brazil-only clinical studies
- Compiled lists and contact details for domestic and international service providers in Brazil
- Understand how Brazil compares to other countries on a variety of health condition scales so the reader can best consider the areas in which Brazil may be beneficial as a
trail site
- Understand the legal, logistical, and regulatory details for conducting Brazilian trials, and illustrate the benefits and drawbacks of conducting trials in Brazil

Introduction
Welcome to ISR’s second Investigator Payments report highlighting Europe’s clinical trial compensation. In this report, ISR wanted to gain a better understanding of what drives investigator payments so that sponsors and CROs can benchmark their payment levels and better plan for study costs. Determinants of investigator payments come in many forms such as therapeutic area, compound orientation, trial complexity, and patient needs. Is there a one-sizefits-all formula that can be applied uniformly across studies to produce the most effective compensation plan? Perhaps not, but by using this array of compensation averages provided by site personnel and by understanding their non-monetary motivations for trial participation, ISR believes a sponsor or CRO can recruit and retain high quality sites without breaking the budget.

Brazil’s population is approximately 200 million and represents enormous potential for the pharmaceutical industry. The country is beginning to build a reputation for high-quality clinical trials and biodiversity, and is attracting multinational pharmaceutical companies as it continues to develop its domestic providers as well. According to IMS Health’s Medicines Outlook Through 2016 Report, the pharmaceutical market in Brazil has experienced, on average, a 15.6% compound annual growth rate (CAGR) from 2007-2011. IMS forecasts that Brazil will experience a CAGR of 12-15% from 2012-2016. It is also estimated that Brazil’s pharmaceutical spend per capita will be $180. The Brazilian pharmaceutical market does pose a number of challenges due to its diverse nature. A challenge for foreign players planning to enter the market is the legal framework of
the country. This forces the companies into partnering with local companies, resulting in profit and control sharing. The legal and regulatory framework for patents is limited, leading to a lack of protection for intellectual property rights.

In the process of writing this report, ISR reached out the CROs profiled in this report. Questionnaires were sent to contacts within these companies that asked questions regarding the company’s profile, the benefits and shortcomings of conducting trials in Brazil, and trends they’ve noticed in those planning to outsource clinical studies in Brazil. Not all of the CROs profiled in this report provided answers to the questionnaire that was sent. The complete responses from the CROs that responded are included in their entirety in this report. However, there were a few trends ISR noticed in the responses that we believe are worth highlighting in this portion of the report. Primarily, ISR noticed that regulatory related concerns are the primary concerns respondents voiced with regard to conducting clinical trials in Brazil.

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