Region/Countries: Mexico, North America Industry: Biosciences / Medical Devices Date: June 2016

Why this is important to Wisconsin businesses: Pharmaceutical research is an area of particular growth potential.

Mexico does not currently play a major role in clinical research, but because of its strategic importance, established infrastructure, and large population of potential research subjects, it could easily host many more clinical trials. In the past, cumbersome regulatory and quality issues discouraged the global pharmaceutical industry from conducting pivotal drug-approval studies in Mexico, but the situation is changing, and there is interest and potential to solve the issues standing in the way of studies by major pharmaceutical players.

Mexico’s medical infrastructure consists of a massive social security organization called Instituto Mexicano del Seguro Social (IMSS), which provides medical care to more than 50 million working Mexicans. IMSS includes a network of hospitals, clinics and full-time physicians, and also a number of federal government-financed public hospitals that provide medical care to indigent people. Additionally, 10 national health institutes are devoted to medical education, research and excellence in health care.

Mexico has two major public teaching institutions, the Universidad Nacional Autónoma de México (UNAM) and the Instituto Politécnico Nacional (IPN). Many talented clinical scientists are on the faculties of UNAM and IPN, but their participation in clinical research is limited. Several private and prestigious teaching institutions also do not participate in clinical research activities to a great extent. Currently in Mexico there are 20 laboratories with highly recognized dedication to clinic research.

The Mexico pharmaceutical market is the second largest in Latin America, after Brazil. It accounts for around 1.5 percent of the country’s GDP and a quarter of its health care spending. After slowing in 2012-13, pharmaceutical sales growth is forecast to average 5.6 percent for 2014-2018, rising from an estimated $16.4 billion in 2013 to $21.5 billion in 2018.

An aging population, a growing middle class, and better access to health care services are greatly increasing consumer demand for pharmaceutical products. In addition, Mexico has been experiencing an epidemiological transition from communicable diseases to chronic degenerative diseases.

Mexico’s generics segment growth is being supported by the expiration of a number of drug patents, improvements in controlling production of counterfeit drugs, and new laws on bioequivalents. In addition, the government is encouraging transnational and Mexican pharmaceutical companies to introduce generic medicines at affordable prices into the domestic market. To help control costs, large multinational laboratories are acquiring or forming alliances with smaller laboratories dedicated to research, especially in the field of biotechnology. Concurrently, smaller laboratories are seeking financial support from larger labs. Around 300 companies account for the vast majority of Mexico’s pharmaceutical sales; these include most major multinationals. About 80 percent of sales are from domestic production and the rest are imports. Mexico also has a large pharmaceutical export industry, which has been boosted by the country’s network of free trade agreements.

The main export destinations are Venezuela, the U.S., Brazil, Colombia and Panama. U.S. tourists also continue to purchase Mexican prescription drugs, which are less expensive than their U.S. counterparts. To further increase local production and exports, the government is seeking to develop biotech clusters in collaboration with the private sector (both local and foreign firms) and universities. Regulators are also continuing efforts to boost the quality of pharmaceutical production, as evidenced by the issuance of the Official Mexican Standard NOM-059-SSA1-2013 for good manufacturing practices, which is equivalent to existing international standards.

Mexico’s highest-ranked educational institution is the Universidad Nacional Autónoma de México (UNAM), at 175th in the world and sixth in Latin America. UNAM is a public university with a huge student population of over 300,000 across a number of campuses in Mexico City and beyond, including 28,000 postgraduates.