Overview

Brazil is the largest healthcare market in Latin America and spends 9.1% of its GDP on healthcare. Of Brazil’s 6,642 hospitals, 63% are private. As of 2021, there are 532,645 hospital beds, 88,000 healthcare supplementary services, 502,000 physicians, 331,000 dentists, and 89,000 drugstores.

Brazil’s Unified Healthcare System (SUS) is the primary provider of health services to at least 70% of the population. In addition to medical diagnostics and treatment, the public system provides free medication for some chronic diseases and promotes national vaccination programs, mostly focused on the elderly and children. Additionally, the Ministry of Health has been regulating and encouraging the expansion of Complementary and Integrative Practices in the public system, mostly at the municipal level.

ANVISA is the counterpart of the FDA and regulates all health-related products. While certain low-risk products may be exempt from registration, it is mandatory to have an importer or distributor for product liability. It is recommended that foreign companies have technical staff and replacement parts available locally for customer support.

In Brazil, the healthcare market is price-driven, with products that are manufactured in-country having a distinct price advantage. Quality is also important; companies must meet all sanitary registration requirements to sell to the government. Foreign companies should consider cost-saving measures and make the benefits of new technologies in marketing and promotional materials abundantly clear.

An aging population and poor management of resources in the healthcare sector offer opportunities for U.S. products and services.

COVID-19 Impact

As of November 2022, Brazil has had more than 34.8 million people infected with COVID-19, with more than 687,000 deaths.  87% of the population has received at least the first dose of the vaccine and 80% have received two or more doses. Brazil started the vaccination campaign with imports from suppliers Pfizer/BioNTech and Janssen, as well as ingredient imports with local production of Astrazeneca (Fiocruz), and Coronavac (Butantan).  In June 2022, Anvisa authorized Pfizer/Biontech’s vaccine for children six months and older.

Brazilian public laboratories have partnered with international institutions for the development and testing of vaccines and drugs to combat the pandemic. Universities played a key role in R&D for the development of diagnostic kits, drugs, and vaccines.

Pharmaceuticals

Brazil ranks among the top six markets globally for drugs and pharmaceuticals. In 2021, there were sales of $16.37 billion (including taxes – Source: Sindusfarma), which represents an increase of 14.26% from 2020 (IQVA). Sales in 2022 are expected to increase to $20 billion.

In 2020, Brazilian imports of medicines and raw materials decreased by 3.26%, totaling $7.06 billion. For high value-added medicines, the United States and Europe are the main exporters to Brazil, while China, India, and Ireland are the main suppliers of raw ingredients. The United States accounts for 14% of all medicinal imports into Brazil. 

Regulations prohibit the sale of medicine and medical devices outside of specialized medical stores or pharmacies.

Leading Sub-Sectors

• Chronic diseases – blood pressure, diabetes, cardiovascular
• Contraceptives
• Rare Diseases
• Generic Drugs
• Infectious Diseases – HIV and Hepatitis C

Opportunities

The Government of Brazil is the main buyer of healthcare products to supply the public healthcare system. Foreign companies can participate in bids as long they have local representation, with some exceptions. It is also possible to participate in a Productive Development Partnership (PDP). PDPs are designed to allow international companies to partner with local laboratories to supply the public system for a period of up to five years, with a reserved market share, with the goal of a technology transfer at the end of the contract. Companies should be well-prepared and fully investigate all terms before committing to a PDP.

E-commerce is a growing channel for end-users to acquire imported products if they are for personal use. To reduce returns, sellers should inform customers that Brazilian Customs charges fees to clear imported goods.

Cannabidiol medicines

ANVISA has published regulations that authorized importation of pharmaceutical grade cannabidiol (CBD) oil. It requires a medical prescription for patients. Any CBD product must be imported from countries where it is legal to produce CBD. In Brazil, the use of CBD is authorized for therapeutic use only, in the form of oil or nasal spray. All other types of applications are prohibited.

Medical Devices/Health IT

The market size for medical equipment in 2021 was approximately $11.9 billion, an increase of 6.9% from 2020. (Source: ABIIS).

In 2021, Brazil increased imports of medical devices by 7.3%, reaching $6.2 billion. The United States represents 19.5% of imported medical devices in Brazil, followed by China with 14%, and Germany with 13%. Brazil is the 14th largest market for U.S. medical devices and second in Latin America, after Mexico. In 2021, U.S. medical device exports to Brazil reached $947 million (Source: Census Bureau, U.S. Department of Commerce - DOC).

 

2021 Total Imports of Medical Equipment into Brazil

 Source: ABIIS

Brazil is part of the Medical Devices Single Audit Program (MDSAP), in conjunction with the United States, Japan, Canada, and Australia for the acceptance of a mutually recognized international audit program performed by a third-party company. This can expedite approval processes for new products in the country, though ANVISA maintains their fee, in addition to the MDSAP fees.

Leading Sub-Sectors

U.S. companies can be competitive in the Brazilian market when offering high quality products, innovative products, and lower-cost products.

Dental Products – implants, equipment, tools, and aligners.

Healthcare IT – telemedicine, EMR, interoperability, big data, and AI.

Medical Devices – consumables, imaging diagnostic, in vitro diagnostic, implants

Opportunities

For Healthcare IT, the Ministry of Health announced investments of $83 million for the digitalization of the public basic healthcare care system (SUS) for the period of 2020 to 2028.  The “Digital Strategy for Brazil” was created to organize and boost the integration of digital solutions and platforms in the public system, with programs that will be announced periodically, following an agenda of eight years. Among the initiatives, the APS Digital (Digitalization of Primary Care Assistance) had the goal of providing IT apparatus and software to run basic care units by the end of 2022, but results may be reviewed due the impact of COVID-19 on the implementation of new technologies. In 2022, the UBS Digital public program was announced offering $3 million for telemedicine solutions in remote areas to provide services for cardiology, dermatology, endocrinology, and geriatrics. Private hospitals are also investing in technology and several new hospitals are formalizing their progress by obtaining international certificates for data management and reduction of paper use. 

Due to the COVID-19 global pandemic, Brazil temporarily approved the use of telemedicine in several areas, which helped speed up efforts to implement and broaden the use of digital solutions for healthcare consultation, diagnostics, and treatment - this change was made permanent this year.  In the public sector, TeleSus has been used for consultation for symptoms of Covid-19. Additionally, Internet of Things and Artificial Intelligence are expected to play a key role in the medical field in coming years.

Contact

Jefferson Oliveira - Commercial Specialist
Healthcare, Life Sciences, and Biotech Sectors
Jefferson.Oliveira@trade.gov