Overview
Brazil is the largest healthcare market in Latin America and spends 9.47% of its GDP on healthcare, which represents US$161 billion. According to the Brazilian Federation of Hospitals (FBH) and the National Confederation of Health (CNSaúde), of Brazil’s 7,191 hospitals, 62% are private. As of 2022, there are 427,097 hospital beds (FBH), 710 health insurance providers (Agência Nacional de Saúde - ANS), 546,000 physicians (Conselho Federal de Medicina -CFM), 402,000 dentists (Conselho Federal de Odontologia – CFO), and 90,9000 drugstores (Associação Brasileira de Distribuição e Logística de Produtos Farmacêuticos - Abradilan) .
Brazil’s Unified Healthcare System (SUS) is the sole provider of health services to approximately 72% of the population, according to the Brazilian Institute of Geography and Statistics (IBGE). 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. It has also played a major role in Covid-19 vaccination programs around the country. Additionally, the Ministry of Health has been regulating and encouraging the expansion in the municipal level of Integrative and Complementary Health Practices (PICS), that consists of therapeutic approaches that aim to prevent health problems, promote and recover health, emphasizing welcoming listening, the construction of therapeutic bonds and the connection between human beings, the environment and society. It is estimated that 50.7 million Brazilians have access to the private healthcare system.
Brazil’s Health Regulatory Agency (ANVISA) is the counterpart of the Food and Drug Administration (FDA) and regulates all health-related products. While certain low-risk products may be exempt from registration, it is mandatory to have a local 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 meeting regulation standards is also important. Companies must meet all sanitary registration requirements to sell to the government. Foreign companies should consider cost-saving measures and give prominence to the benefits of new technologies in marketing and promotional materials in order to compete.
An aging population and poor management of resources in the healthcare sector offer opportunities for U.S. products and service specifically in the areas of assisted living, mental health, rehabilitation, and chronic diseases.
COVID-19 Impact
As of September 2023, Brazil has had more than 37.8 million people infected with COVID-19, with more than 705,000 deaths, according to the Brazilian Ministry of Health. 98% of the adult population has received at least the first dose of the vaccine and 86% have received two or more doses. Brazil started the vaccination campaign with imported vaccines from US suppliers Pfizer/BioNTech and Janssen, and local production of AstraZeneca (Fiocruz), and Coronavac (Butantan). In June 2022, ANVISA authorized Pfizer/Biontech’s vaccine for children six months and older. As of September 2023, Brazil has given more than 24.5 million doses of the bivalent vaccines.
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 research and development for the development of diagnostic kits, drugs, and vaccines.
Pharmaceuticals
According to IQVIA, Brazil ranks sixth globally for drugs and pharmaceuticals (after the United States, China, Japan, Germany, and France). In 2022, there were sales of US$20.67 billion (including taxes), which represents an increase of 26.2% from 2021 (IQVIA). Sales in 2023 are expected to increase to US$24 billion.
Growth of the Pharmaceuticals Market
| 2021 | 2022 | % Increase |
Total Market Size | 16.38 B | 20.67 B | 26.2 % |
Total Imports | 10.96 B | 9.97 B | -9.89 % |
Imports from the US | 1.5 B | 1.4 B | -.07 % |
Source: Sindusfarma, IQVIA
According to Sindusfarma, in 2022, Brazilian imports of medicines and raw materials decreased by 9.89%, totaling US$9.97 billion. For high-cost medicines, the United States and Europe are the main exporters to Brazil, while China and India are the main suppliers of raw ingredients. The United States accounts for 14% of all pharmaceutical imports into Brazil.
Regulations prohibit the sale of medicine and medical devices outside of specialized medical stores or pharmacies.
Leading Sub-Sectors and Opportunities
U.S. companies can be competitive in the Brazilian market when offering high quality, innovative, and cost-competitive products. The leading sub-sectors for pharmaceuticals are:
- Chronic diseases – blood pressure, diabetes, cardiovascular
- Contraceptives
- Rare Diseases
- Generic Drugs
Infectious Diseases – HIV and Hepatitis C. The government of Brazil is the main buyer of medicines to supply the public healthcare system. Foreign companies can participate in bids as long they have local representation. 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 fixed period, usually five years, with a reserved market share and the end-goal of making a technology transfer to a national laboratory during that time enabling the national laboratory to produce the medicine after the fixed period. Companies should be well-informed and fully investigate all terms before committing to a PDP.
E-commerce is a growing channel for end-users to acquire imported medicines, supplements, and other wellness products if they are for personal use. To reduce returns, sellers should inform customers that Brazilian Customs charges fees to clear imported goods.
Medical Devices/Health IT
The market size for medical equipment in 2022 was approximately US$12.1 billion, an increase of .02% from 2021. (Source: ABIIS).
Brazil’s Medical Devices and Health IT
| 2021 | 2022 | % Increase |
Total Market Size | 11.9 B | 12.1 B | .02 % |
Total Imports | 6.76 B | 6.3 B | -7.3 % |
Imports from the US | 1.28 B | 1.2 B | -6.5 % |
In 2022, Brazil reduced imports of medical devices by 7.3%, reaching $6.3 billion. The United States represents 19.1% of imported medical devices in Brazil, followed by China with 14%, and Germany with 12%. Brazil is the 14th largest market for U.S. medical devices and second in Latin America, after Mexico. In 2022, U.S. medical device exports to Brazil reached US$1.22 billion.
Total Imports of Medical Equipment into Brazil
Group of Products | 2021 Imports US$ billions | 2022 Imports US$ billions | % Variation |
Total of Medical Devices (ABIIS) | 6.69 B | 66.35 B | -5.0% |
Material and Equipment for Health (ABIMED) | 3.83 B | 33.85 B | 0.4% |
Prosthesis and Implants -OPDE (ABRAIDI) | .898 B | 1.13 B | 25.6% |
In Vitro Diagnostic Reagents and equipment (CBDL) | 3.18 B | 2.82 B | -11.3% |
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, however, ANVISA maintains their fee, in addition to the MDSAP fees. The private health sector usually leads the demand for the latest innovative medical devices.
U.S. companies can be competitive in the Brazilian market when offering high quality, innovative, and cost-competitive products. The following are the leading sub-sectors for medical devices:
- Dental Products – implants, equipment, tools, and aligners
- Healthcare IT – telemedicine, EMR, interoperability, big data, and AI
- Medical Devices – consumables, imaging diagnostic, in vitro diagnostic, and implants
For Healthcare IT, the Ministry of Health announced investment of US$200 million for the digitalization of the public basic healthcare care system (SUS) in 2023. Similar investments are expected in the next few years. The Digital Strategy for Brazil was created by the Ministry of Health to organize and boost the integration of digital solutions and platforms in the public system, with programs that will be announced periodically, over an eight-year period. Among the initiatives, the APS Digital (Digitalization of Primary Care Assistance) has the goal of providing IT equipment and software to run basic care unit to 3613 municipalities for the 26 states. In 2022, the UBS Digital public program announced US$3 million investment for telemedicine solutions in remote areas for services including 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. In October 2023, the Brazilian Ministry of Health will announce new strategies for healthcare and investment that will involve informatics and digital solutions.
During the pandemic, Brazil temporarily approved the use of telemedicine. The change become permanent in 2022 and digital solutions for healthcare consultation, diagnostics, and treatment are now widely used. In the public sector, TeleSus has been used for consultation for symptoms of Covid-19. Additionally, Internet of Things (IoT) and Artificial Intelligence (AI) are expected to play a key role in the medical IT field in coming years.
Resources
Ministry of Health and Institutes:
- Ministry of Health
- ANVISA, the National Agency for Sanitary Surveillance
- Datasus, the Department of Informatics of SUS
- Procurement opportunities
Major healthcare trade shows in Brazil:
• The Sao Paulo International Dental Congress (CIOSP): largest dental trade show and forum in Latin America. Sao Paulo, January 24-27, 2024
• Hospitalar – The largest medical trade show in Latin America, São Paulo, May 21 to 24th, 2024
• HIS – The Healthcare Innovation Show,the largest event of technology and innovation event for healthcare in Latin America, Sao Paulo, September 2024.
For more information, please reach out to Healthcare, Life Sciences, and Biotech Sectors Commercial Specialist, Jefferson Oliveira at Jefferson.Oliveira@trade.gov
Major healthcare trade shows in Brazil:
- The Sao Paulo International Dental Congress (CIOSP): largest dental trade show and forum in Latin America. Sao Paulo, January 24-27, 2024
- Hospitalar – The largest medical trade show in Latin America, São Paulo, May 21 to 24th, 2024
- HIS – The Healthcare Show, the largest event of technology and innovation event for healthcare in Latin America, Sao Paulo, September 2024
For more information, please reach out to Healthcare, Life Sciences, and Biotech Sectors Commercial Specialist, Jefferson Oliveira at Jefferson.Oliveira@trade.gov