This is a best prospect industry sector for this country. Includes a market overview and trade data.
Last Published: 8/10/2017

Overview
Drugs and Pharmaceuticals

Brazil is ranked among the top ten largest pharmaceutical markets in the world. While Brazil hosts manufacturing plants of some of the largest U.S. pharmaceutical companies, local industries are mostly focused on the production of generic and similar brand medicines. Also, public laboratories supply chronic disease medicines that are distributed for free or at discounted prices to the public. Foreign companies can participate in partnership programs with local laboratories for the manufacturing of strategic drugs for the public system.

ANVISA is the Brazilian Health Regulatory Agency (equivalent to the U.S. FDA) that controls the registration, commercialization, post market surveillance and in some cases, the price of medicines. According to Interfarma, the Brazilian Research-based Pharmaceutical Manufacturers Association, despite the efforts to reduce bureaucracy in the process for registration and clinical trials, new medicines may take up to 18 months for approval in contrast to the six month period stipulated by law. Pharma companies also have expressed concern about a recent fee increase for registration of medicines. INPI, the Brazilian Institute for Industrial Property (equivalent to the U.S. Patent and Trademark Office), reviews patent applications for new drugs and new uses of traditional medicines in Brazil.

Foreign companies must establish a local office or assign a local company to submit the petition for the registration of medicines. To access the complete requirements for the registration, visit the website.
Market revenues of pharmaceutical products in dollar value increased six percent from 2015 to 2016, with sales around US$14 billion. The first three months of 2017 showed an expansion of two percent for this year. Due to currency fluctuations in the Brazilian Real, the same period showed an increase of 13.7 percent in sales and growth of 13 percent is expected in 2017. Imports of pharmaceutical raw materials reached US$2.5 billion in 2016, representing a decrease of 1.6 percent.  Major imported products in this category are for alpha tocopheryl acetate, cephalosporins, and amoxicillin. For medicines, imports increased 0.7 percent to a total of US$5.96 billion. Generics comprise 29 percent of the market. U.S. exports of pharmaceutical preparations (HC 40100) to Brazil doubled since 2006 and reached US$1.1 billion in 2015. Statistics were sourced from Brazilian Association, Sindusfarma.

The Brazilian market for nutritional supplements and natural products is expected to grow 25 percent per year. ANVISA requires that nutritional products make no therapeutic claims (other than the ones that are authorized by law for nutritional supplements) and ingredients should be limited to daily intake values, in order to not be classified as medicines.

Medical Equipment and Devices
There are broad opportunities in the Brazilian Medical Equipment and Devices market: medical devices and equipment, in vitro diagnostics, and e-health solutions. Private and public healthcare expenses in Brazil roughly correspond to 9.6 percent of the GDP. Of this amount, US$10.4 billion was related to the purchase of medical equipment and devices. In 2016, imports of medical products and devices were US$4.6 billion, a reduction of 16 percent from the previous year. A few notable growth areas were in dental products, where imports increased 10.6 percent, and in imaging diagnostics, where imports increased by 32.4 percent.

According to the Brazilian Association of Innovation in Healthcare (ABIIS), the segmentation of the market for medical equipment and devices is: reagents for in vitro diagnostics, 20 percent; materials and consumables, 19 percent; prosthesis, implants and parts, 15 percent; lab equipment, 14 percent; imaging equipment and consumables, eight percent; dental equipment, three percent; furniture, two percent; other, 19 percent.

There are 6,742 hospitals in Brazil, with 494,000 beds. Of these hospitals, 70 percent are private/not for profit hospitals. Approximately 55 percent of healthcare expenditures are performed by the private sector, while the other 45 percent are under the public budget.

ANVISA regulates commercialization and registration, and monitors the price of medical products in Brazil. Other government bodies involved in the introduction of new medical products are the National Institute of Metrology, Quality and Technoloy (INMETRO) (certifies electromedical devices and implants), and the National Commission for Incorporation of Technologies in the Brazilian public health care system (CONITEC) (incorporates new medical technologies in the public health system).

For registration purposes, products classified as risk grade I and II require the cadastro, which is the simplified form for new medical products. Class III and IV products require a more detailed registration process that includes the certificate of Good Manufacturing Practices (GMP). ANVISA accepts the single audit program, where, in conjunction with other international health agencies, the agency recognizes the GMP certificate audited by third party companies. Also, to reduce bureaucracy, ANVISA allows the transfer of registration of products among companies. Foreign companies must assign a Brazilian representative or establish a local office in order to submit the registration/cadastro petitions to ANVISA. Products considered as essential for the government may have an expedited registration process.

For further information about registration of medical products at ANVISA, visit their website. There are nearly 4,000 manufacturers of medical products in Brazil and 10,400 distributors. Some of the largest multinational companies established manufacturing facilities in Brazil in order to reduce costs and be more competitive with the public system. Foreign companies can participate in partnership programs for technology transfer with local manufacturers for development and production of medical products. Some of those programs grant at least 30 percent of market share for private companies for a period of five years with the government purchase.


Leading Sub-Sectors

Medical Equipment and Devices

  • Medical devices and equipment
  • In vitro diagnostics
  • E-health solutions 

Opportunities
Drugs and Pharmaceuticals

In the pharmaceutical industry, there are opportunities for innovative drugs, raw ingredients, and equipment. U.S. companies have improved their market competitiveness when partnering with local pharma companies. Both multinational and Brazilian companies have been investing in R&D and clinical trials.

Best prospects are innovative medicines to treat chronic diseases and modern life disorders, such as weight loss and erectile dysfunction. Medicines that are not commercialized in Brazil are being imported by judicial procurement for the treatment of rare diseases through the public system.

Medical Equipment and Devices
Brazil has some of the highest quality hospitals in Latin America and attracts patients from neighboring countries, mostly for plastic surgery, cancer, and cardiovascular treatment. U.S. hospitals have been partnering with Brazilian hospitals for education, telemedicine, and second opinion programs.

U.S. companies may also consider joint-ventures with local industries for the assembling or manufacturing of medical products in Brazil. This strategy may help to reduce duties and allow companies to use Brazil as a springboard to reach other Mercosur countries.

ANVISA provides an expedited process for products related to the diagnostics or treatment of the Zika virus. For further information, visit the weblink.

There is strong demand for eHealth solutions in Brazil, including some of the most basic protocols for patient records to the most modern analytics solutions. For further information regarding the U.S. Commercial Service activities to promote the health IT segment in Brazil, visit the link.


Web Resources

Drugs and Pharmaceuticals:

Medical Equipment and Devices:

Major international medical events in Brazil:

Events supported by the U.S. Commercial Service Brazil:

 
The U.S. Commercial Service — Your Global Business Partner
With its network of offices across the United States and in more than 80 countries, the U.S. Commercial Service of the U.S. Department of Commerce utilizes its global presence and international marketing expertise to help U.S. companies sell their products and services worldwide. Locate the U.S. Commercial Service trade specialist in the U.S. nearest you by visiting our site.

For more information about export opportunities in this sector, contact U.S. Commercial Service Industry Specialist: Jefferson.Oliveira@trade.gov

Prepared by our U.S. Embassies abroad. With its network of 108 offices across the United States and in more than 75 countries, the U.S. Commercial Service of the U.S. Department of Commerce utilizes its global presence and international marketing expertise to help U.S. companies sell their products and services worldwide. Locate the U.S. Commercial Service trade specialist in the U.S. nearest you by visiting http://export.gov/usoffices.



Brazil Healthcare Trade Development and Promotion