Mexico’s healthcare sector represents an important market for many types of products and services. The country’s public health system recently underwent a series of changes in the procurement system and distribution structure. The procurement process for medicines and medical devices was consolidated under a scheme led by the United Nations Office for Project Services (UNOPS) and Mexico’s Institute of Health for Welfare (Instituto de Salud para el Bienestar or INSABI), and then was transferred to the authority of the Mexican Institute of Social Security and Welfare (Instituto Mexicano de Seguro Social y Bienestar or IMSS Bienestar). The process faced difficulties and is created uncertainty for U.S. businesses looking to sell to the Mexican public health care system.

Overview

The healthcare sector in Mexico is a complex and diverse system that provides a wide range of services to the population. Mexico has a mixed healthcare system with participation from the public and private sectors. The public sector provides healthcare services through the Mexican Institute of Social Security (Instituto Mexico de Seguro Social or IMSS), the Institute of Safety and Social Services for Public Sector Workers (Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado or ISSSTE), and the Secretary of Health (Secretaria de Salud or SSA). The private sector includes hospitals, clinics, and healthcare providers.

The system faces ongoing challenges including high rates of non-communicable diseases such as obesity, diabetes, and cardiovascular diseases. Additionally, infectious diseases, including respiratory infections, gastrointestinal diseases, and vector-borne diseases, pose significant health risks. Mexico has a thriving pharmaceutical industry that produces a wide range of generic and branded medications. The pharmaceutical market is regulated by the Federal Commission for Protection against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios or COFEPRIS).

Procedural delays at COFEPRIS may pose market barriers to U.S. companies. Approval processes and bureaucratic procedures are burdensome and can take exceedingly long periods of time, causing lengthy waits for registration and authorization of pharmaceuticals and medical devices. The negative impact on patients and industry stakeholders hinders access to innovative treatments and cutting-edge technologies. Market competition is stifled, and companies must navigate a labyrinthine system to introduce their products to the Mexican market. Industry continues to report delays of 18-24 months despite efforts to digitalize the registration process and implement an equivalence agreement, which in theory should expedite registration approvals for those products that have already been approved by other internationally recognized regulatory bodies.  

Mexico’s Healthcare System and Trends

Mexico has an employment-based healthcare system. Those employed by the private sector (around 20 million workers) are served by the IMSS. Government employees (around three million workers) are served by the ISSSTE. Unemployed and informal workers (approximately 31 million people) used to be served by a program called Popular Insurance under the SSA, but the López Obrador administration replaced this program with the INSABI. Last year the federal government announced that INSABI will transition to IMSS Bienestar, an ambitious endeavor that will reshape Mexico’s healthcare system, especially for marginalized and vulnerable populations. IMSS Bienestar, an extension of the IMSS, will assume a crucial role in providing healthcare services to underserved areas and populations previously covered by INSABI. Individual Mexican states also provide independent healthcare services, and the Mexican Armed Forces have their own independent healthcare system.

Public healthcare institutions account for 70-80 percent of all medical services provided nationwide, while private healthcare institutions serve approximately 25-30 percent of the Mexican population. This includes the overlap between the two systems and includes the 32 million people with private medical and accident insurance. In 2019 Mexico had 22,831 public health care units, including 4,629 hospitals, of which 194 were highly specialized medical centers, and 3,114 accredited private hospitals.

The private hospital sector in Mexico is a significant component of the country’s healthcare system, offering medical services to individuals who seek premium healthcare outside of the public healthcare system. These hospitals are typically owned and operated by private companies or organizations, and they cater to patients willing to pay for higher quality facilities, faster access to medical treatments, and a wider range of specialized services. The private hospital sector in Mexico has seen steady growth due to increasing demand from middle and high-income individuals who desire more personalized and efficient healthcare services, as well as from medical tourists attracted to the country’s relatively lower costs for certain medical procedures. Major private health provider groups include Grupo Empresarial Angeles, Star Medica, Hospital San José, Centro Médico ABC, Hospital Español, Amerimed Hospitales, Hospitales San Angel Inn, Grupo Christus Muguerza, and Médica Sur.

According to the Mexican National Institute of Statistics and Geography (Instituto Nacional de Estadística y Geografía or INEGI), from January to June 2022, Mexico´s main premature death causes were heart disease (30.6%), diabetes (27.6%), malignant tumors (11%), influenza and pneumonia (6%), liver disease (5.8%), cerebrovascular disease (3%), homicides and accidents (10%), and pulmonary disease (6%). Both the Organization for Economic Co-operation and Development (OECD) and World Health Organization (WHO) maintain a wide range of health indicators for Mexico and other countries that may be useful for U.S. companies assessing this sector.

Market Access for Healthcare Products

Mexican public healthcare does not use a reimbursement system like in the United States. Public healthcare institutions purchase the products for their services and do not charge patients per product or event. Patients receive all the products included in their treatment at no charge. Reimbursement only exists for patients with private insurance coverage. There is not a general reimbursement policy for all insurance companies. Each company determines prices and reimbursement according to its own policies.

Previously, all purchasing for government healthcare drew from two annually updated official government supply and pricing lists called the Basic Formulary (Cuadro Básico) and the Catalog of Medicines (Catálogo de Medicamentos). SSA recently announced the replacement of these two lists with a single list called National Health Supplies Compendium (Compendio Nacional de Insumos para la Salud). Also, the Secretariat of Finance (Secretaría de Hacienda y Crédito Público or SHCP) has taken steps to establish a centralized procurement system for all government purchasing of medical devices, supplies, medications, and services. Please see our Selling to the Government section of this guide for further information.

Under current Mexican law, government purchasing rules provide preference to suppliers from countries with which Mexico has a free trade agreement. This benefited U.S. suppliers under NAFTA, and the new United States-Mexico-Canada Agreement (USMCA) provides additional benefits. However, it is unclear how the Government of Mexico (GOM) will adapt its health sector changes to its trade treaty obligations. The USMCA entered into force on July 1, 2020. With respect to the healthcare sector, the agreement contains significant improvements and modernized approaches to rules of origin and intellectual property issues. For more information, please visit the Office of United States Trade Representative (USTR) website and the International Trade Administration’s USMCA landing page.

The functions of procuring medicines and medical devices in Mexico have undergone a significant transition. With the disappearance of INSABI, IMSS Bienestar has assumed the responsibility of overseeing procurement activities. This change came into effect after the GOM signed an agreement with UNOPS, granting the latter the authority to directly purchase medications on behalf of Mexican health institutions. As part of the UNOPS agreement, a tender was announced on December 4, 2021, for the acquisition of medicines by the GOM. This strategic shift aligns with President López Obrador’s objectives of combating corruption, implementing austerity measures, and improving the management of public resources. Industry has reported concerns with the speed and lack of transparency concerning how the awards were granted in the tender process.

In terms of regulatory approvals and market access, Mexico remains sovereign as to setting and maintaining its regulations. For anything applied to or entering the country —whether a device, instrument, or pharmaceutical— a sanitary registration issued by COFEPRIS is mandatory. However, COFEPRIS is undergoing major restructuring due to alleged corruption concerns, which has caused a significant backlog of registrations, import permits, and Good Manufacturing Practices (GMP) certifications. Part of COFEPRIS’ transformation strategy includes plans to digitalize its procedures and go paperless by 2030. In the meantime, companies continue to struggle with delayed response times.

COFEPRIS regulates approximately 14 percent of Mexico’s economy, including industries such as food and beverages, health supplies, health services, cosmetics, pesticides, plant nutrients, natural emergencies, occupational health, and environmental risks. It is estimated that COFEPRIS regulates 45 cents of every peso spent by Mexican households, primarily goods that fall into the following main categories: food and beverages, health care, personal care, and tobacco.

In November 2021 COFEPRIS became a new member of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). Through membership in the ICH, Mexico becomes a strategic and competitive destination for clinical trials, eliminating the need to duplicate tests carried out during the research and development of new drugs, with processes mirroring the ones used in Europe, the United States, Canada, and Japan.

The Mexican regulatory framework for the medical and pharmaceutical sectors includes the following norms and registration requirements:

• Mexican Official Standards. Compliance with Mexican Official Standards (Normas Oficiales Mexicanas or NOMs) is mandatory for all products sold in the Mexican territory.

• Sanitary Registration. In addition to NOMs, medical devices, as well as pharmaceutical products, must be registered with COFEPRIS. Intellectual property protection is a separate process with a different government agency (see the Intellectual Property section of this guide). Under the USMCA, COFEPRIS has established an equivalence procedure. This allows for market authorizers to streamline product approvals for devices and pharmaceuticals containing active ingredients that have not been commercialized before in Mexico. Industry sources have indicated that this process has not been as fast as expected. While the USMCA states that the equivalence determination should take between five and six working days, the process currently takes between five and seven months. For the registration of generic drugs, there is a requirement to conduct the corresponding bioequivalence studies in Mexico. Only in some cases, such as personal use or research, are products exempted from being registered.

• Import Permit. Once the product has obtained a sanitary registration code, the importer must file an import permit application with COFEPRIS to have access to the Mexican territory. This process also applies to the import of products for personal use or research exempted from sanitary registration.

• Certificate of Origin. Products qualifying as North American under USMCA require a minimum set of nine data elements be submitted to prove origin and receive USMCA beneficial treatment. This certification may be issued by the importer, exporter, or producer, and does not have to be validated or formalized. Contact the U.S. Commercial Service Mexico for a sample of the required data. Only North American products, as defined by the rules of origin, are eligible for preferential tariff treatment. For information on certification of origin and to ensure to qualify for USMCA preferential treatment, visit U.S. Customs and Border Protection USMCA Center.

Leading Sub-Sectors

As noted above, the entire healthcare sector is facing numerous ongoing challenges which have contributed to a decrease in the market size as the following figures show.

Medical Devices, Equipment, and Instruments

Medical Device and Equipment Market Size in Mexico
(Figures in USD Billions)

*Estimated based on market trends and economic forecasts

Source: Secretariat of Economy’s Tariff Information System via Internet (SIAVI)

Mexico’s market for medical equipment, instruments, disposable, and dental products has fluctuated significantly in recent years in the mix of local production, exports, and imports. Imports of these products totaled nearly USD 5.4 billion in 2022, which represented an 8.1 percent increase from 2021. In addition, the U.S. share represented the 32 percent of the import total. The change in policies regarding investing in new equipment for hospitals and the change in the procurement systems directly impacted the volume of products purchased for public healthcare institutions.

The main third-country suppliers of medical devices are Brazil, Canada, China, France, Germany, Israel, Italy, Japan, the Netherlands, South Korea, and the United Kingdom. A growing competitive problem for U.S. suppliers is low-cost and frequently lower-quality supply from third countries. According to Mexico’s Ministry of Economy (Secretaría de Economía or SE), the states with the highest numbers of international imports of instruments and appliances used in medical sciences were Baja California (USD 380 million), Tamaulipas (USD 295 million), Mexico City (USD 210 million), Jalisco (USD 93.1 million), and Nuevo León (USD 74.1 million).

Medical products from the United States are highly regarded in Mexico due to high quality, after-sales service, and pricing, compared to competing products of similar quality. Consequently, U.S. medical equipment and instruments have a competitive advantage and are in high demand in Mexico.

Large public and private hospitals regularly seek out the most modern and highly specialized medical devices. Some medium and small private hospitals with limited budgets buy used or refurbished equipment. By law, public hospitals cannot buy used or refurbished products.

The 103 medical schools located nationwide represent an additional market. The most important are housed at the National Autonomous University of Mexico (UNAM), Universidad La Salle, the Popular University of Puebla, the National Polytechnics Institute (IPN), the University of Guadalajara, and the schools of the Army and the Navy.

Healthcare Services

In a drive to reduce costs and improve healthcare outcomes, there has been a trend towards outsourcing specialized procedures and care. For instance, most dialysis services in Mexico are provided by private sector companies under contract to public healthcare agencies. There have also been an increasing number of agreements with U.S. healthcare providers to deliver cardiac care, cancer treatment, and other specialized care either in Mexican facilities or for patients to travel to the United States. Many public and private hospitals outsource surgical procedures to companies that offer integral surgery services or surgery centers. These services are delivered as “pay-per-event” and include all the necessary equipment and personnel required to perform a surgery. Thus, hospitals have been able to avoid big capital investments in plants and equipment, materials, pharmaceuticals, and instruments, while gaining access to some of the most modern specialized surgical procedures.

Pharmaceuticals

Mexico is the 15th-largest market for pharmaceuticals in the world and the second largest in Latin America after Brazil. The pharmaceutical market in Mexico is divided into patented medicines, which represent 51 percent of the market by value, generics with 35 percent, and over the counter products with the remaining 14 percent. COFEPRIS reports that generics represent more than 80 percent of the market in terms of volume. Following the same trend as medical devices, the Mexico’s decrease in pharmaceutical imports is directly related to changes in the procurement process, increased market participation of generics and low-cost providers, uncertain product approval and registration timings, and continued issues in intellectual property protection. From 2019 to 2021, several public health institutions faced shortages of medicines due to these issues.

The United States is still the largest foreign supplier of pharmaceutical products to the Mexican market. In 2022, the United States exported USD 875 million to Mexico, accounting for 19 percent share of the total import market. Imports from the United States declined six percent compared to 2021.

In 2022, the states with the highest imports of pharmaceutical products were Mexico City (USD 640 million), State of Mexico (USD 195 million), Jalisco (USD 169 million), Morelos (USD 90 million), and Tamaulipas (USD 53 million). Imports of pharmaceutical products originate primarily from the following countries: United States (including Puerto Rico) (USD 1.07 billion), Germany (USD 780 million), France (USD 464 million), and Switzerland (USD 272 million).

Pharmaceutical Products Market in Mexico
(Figures in USD Billions)

*Note that the total market size cannot be calculated as local production figures are not available; the pharmaceutical sales figures come from local industry sources and the Secretariat of Economy

Approximately 400 laboratories manufacture pharmaceuticals in Mexico, mostly in the Mexico City metropolitan area, as well as the states of Jalisco, Mexico, Puebla, and Morelos. The Mexican pharmaceutical industry stands out because of the presence of 20 out of the 25 largest companies worldwide.

The GOM has expressed significant interest in expanding policies to promote generic pharmaceuticals in Mexico. This could reduce the long-term market size for original and brand-name medications in the country. Please contact the U.S. Commercial Service Mexico for updated information.

Mexico has an extensive tradition in research in biological applications and life sciences. There are about 180 firms that develop and/or use modern biotechnology in Mexico. Many of these firms are international corporations that have biotechnology-related activities with important applications in the following sectors: human healthcare, agriculture, marine resources, energy production, and other areas. The sector benefits from government and private sector modernization and research and development programs involving research institutions and private industry.

There are four strategic life science regions identified in Mexico: Guanajuato, Jalisco, Morelos, and Nuevo León. Each boasts strong clinical research clusters along with other clusters driven by foreign investment specifically oriented to pharmaceutical manufacturing. More recently, Baja California has developed industrial and academic potential in biotechnology. For instance, the city of Ensenada has cultivated R&D centers focusing on areas such as marine science and marine biotechnology, optics, applied physics, and agricultural biotechnology.

Mexico’s pharmaceutical market growth will be driven in part by growth in biosimilars, for which sales are expected to surge in the coming years. Since June 2012, when Mexico published new guidelines for bio-comparable medicines, local R&D, and production in the biosimilars sub-sector have significantly improved, and several multinational companies have announced investment and product launches.

Opportunities

The U.S. Commercial Service in Mexico is ready to assist you in exploring healthcare market opportunities. The pharmaceutical sector in Mexico presents significant opportunities for growth and investment. With a large population and increasing healthcare needs, the demand for pharmaceutical products and services is continuously expanding. Mexico has a well-established regulatory framework and a robust healthcare system, providing a favorable environment for companies to operate. The country’s proximity to the United States also offers advantageous market access, enabling companies to tap into North American markets. Additionally, Mexico boasts a strong manufacturing infrastructure and a skilled workforce, making it an attractive destination for pharmaceutical companies looking to establish production facilities or engage in contract manufacturing. Overall, the pharmaceutical sector in Mexico offers a promising landscape for companies to contribute to the country’s healthcare needs while capitalizing on its potential for growth.

Resources

Public Institutions

Private Hospital Chains

Private Institutions

Events

• Greater New York Dental Meeting, November 26-29, 2023. New York, NY
• Florida International Medical Expo, June 19-21, 2024. Miami, FL
• CPHI North America, May 7-9, 2024. Philadelphia, PA  

Contacts

For more information on the healthcare sector in Mexico, please contact:

Paulo Camposeco

Commercial Specialist

U.S. Commercial Service —Mexico City

Tel.: +52 (55) 5080-2000

Tel.: +52 (55) 5537 27 7520

Paulo.Camposeco@trade.gov