MEXICO Trends and Developments Contributed by: Roxana Aispuro and Mónica Sánchez, BC&B Law & Business
Modernising Mexico’s Pharmaceutical Regulation and Intellectual Property Framework Context and outlook of the pharmaceutical industry in Mexico Mexico is one of the largest pharmaceutical markets in Latin America, second only to Brazil. The coun- try forms part of the fastest-growing pharmaceuti- cal region in the world, with growth rates surpass- ing those of other emerging markets such as Eastern Europe and the Asia-Pacific region. Although Mexico remains a net importer of phar- maceutical products, it maintains a strong and well- established domestic industry. The country has a sta- ble base of manufacturing facilities and a workforce that has expanded steadily in recent years, reflecting the sector’s continuous development and its strategic importance to the national economy. At the global level, Mexico ranks among the leading pharmaceutical markets and functions as a major high-value manufacturing hub, attracting significant investment in biotechnology and related fields. It pro- duces a broad range of products, including patented medicines, generics and over-the-counter medicines, while expanding into the production of medical devic- es. Furthermore, initiatives such as the Mexico Plan aim to strengthen the national industry by prioritising local production in public procurement and reducing dependence on imports, with the objective of posi- tioning the country as a global hub for pharmaceutical innovation. Looking ahead, the pharmaceutical market in the country is expected to continue expanding steadily. Projections suggest that the market could reach rev- enues of approximately USD35 billion by 2033, with a compound annual growth rate (CAGR) of around 8.6% between 2026 and 2033. Innovation, intellectual property, and the growth of generic medicines in Mexico. Mexico is increasingly attracting international pharma companies and contract manufacturers. Recent gov- ernment interventions have helped make the country more competitive in the R&D of new drugs and the
generic market. According to recent reports, Mexico’s healthcare expenditure continues to rise, reflecting both public and private sector investments in health- care infrastructure, which is improving access to phar- maceuticals for the population. Conventional drugs (small molecules) were the largest segment in 2025, with a revenue share of 58.24%. The local pharmaceutical market is segmented based on biologics and biosimilars (large molecules), conven- tional drugs (small molecules) covering the revenue growth of each sub-segment from 2021 to 2033. The national pharmaceutical market is experiencing significant growth, driven by a combination of fac- tors such as rising healthcare expenditure, an aging population and the increasing prevalence of chronic diseases. The country’s healthcare system has seen substantial improvements, fostering a greater demand for both branded and generic medications across a range of therapeutic areas. Chronic conditions like heart disease, diabetes and cancer are driving the need for more innovative treatments and medications. Recent developments indicate that the local pharma- ceutical sector is undergoing an important transfor- mation aimed at increasing the share of generic medi- cines in order to improve affordability and access to treatment. Although patented medicines still represent the largest segment of the market, the government has promoted the entry of off-patent pharmaceuti- cals, thereby encouraging greater domestic produc- tion of generics. According to recent market analyses, the national pharmaceutical market is composed of approximately 51% patented medicines, 35% gener- ic prescription medicines and 14% over-the-counter products by market value, although generics repre- sent more than 80% of medicines sold by volume. In the regulatory sphere, a series of reforms and newly introduced procedures aim to streamline the approval of pharmaceutical products and bring regulatory pro- cesses into alignment with international standards. By enhancing procedural efficiency and regulatory trans- parency, these measures strengthen the competitive- ness of the domestic pharmaceutical sector while ensuring higher standards in the quality and safety of medicines produced locally. Furthermore, aligning
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