Mexico Pharmaceutical Filtration Market Research Report, 2030

Since the start of the NAFTA North American Free Trade Agreement in 1994, the pharmaceutical industry in Mexico has undergone significant change. Increased trade, foreign direct investment, and regulatory harmonization with the U.S. and Canada were made possible by the agreement. This encouraged the establishment of factories in Mexico by multinational pharmaceutical corporations, who were attracted by cheaper manufacturing costs and proximity to North American markets. In addition, the agreement pushed local pharmaceutical producers to improve their quality standards in accordance with U.S. FDA and Health Canada regulations, which hastened the introduction of cutting-edge technologies such sterile filtration. The manufacture of intravenous fluids and injectable antibiotics was the first significant application of sterile filtering in Mexico. Public health organizations like IMSS and ISSSTE needed these items in huge quantities, and heat sterilization could not always ensure sterility assurance, especially for thermolabile substances. Consequently, membrane filtration emerged as the superior option, ensuring microbial removal while maintaining the effectiveness of the medication. The majority of sterile filtration applications in Mexico today are in the manufacture of vaccines, biologics, and injectables. With more public-private alliances and biotech investment, sterile filtration is now a crucial component of ensuring compliance and product safety in all therapeutic domains. The nation has established itself as a regional center for the production of biosimilars and fill-finish services. Cost concerns still make manual systems common in smaller home enterprises when comparing them to automated filtration devices. Automated systems, on the other hand, are used by large-scale or multinational manufacturers and provide better process control, efficiency, and data integrity in accordance with international quality standards. According to the research report, "Mexico Pharmaceutical Filtration Market Research Report, 2030," published by Actual Market Research, the Mexico Pharmaceutical Filtration market is anticipated to add to more than USD 130 Million by 2025–30. The expansion is driven by a combination of domestic demand and a considerable surge in exports, notably from Mexico City, which has grown into a key center for the production and distribution of pharmaceuticals. The use of pharmaceutical goods is also influenced by trends in consumer health. The growth of digital healthcare options, such online pharmacies and telehealth, is changing consumer behavior and making medications more accessible. The increasing middle class and aging population are further factors contributing to rising demand for preventative care and chronic illness treatments. The sector's development trajectory is highlighted by recent factory expansions. For example, Bayer is investing about $65 million in the State of Mexico to increase its pharmaceutical manufacturing in order to improve its capacity for Latin American and North American markets. Boehringer Ingelheim has made a similar statement, stating that it will invest $84 million over the course of three years to improve its production capacity in Mexico. Among the top companies in Mexico's pharmaceutical market are PiSA, Sanfer, Senosiain, and Siegfried Rhein, all of which are well-known national pharmaceutical businesses. These businesses provide a wide array of goods, from generic drugs to specialized therapies, serving both local and foreign markets. The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) is in charge of enforcing regulatory standards, which are essential for market entrance. Filters used in pharmaceutical production must adhere to strict standards, including compliance with Good Manufacturing Practices (GMP) and validation of bacterial retention capabilities. In order to ensure the safety and efficacy of pharmaceutical products, COFEPRIS also aligns with international standards, such as those established by the International Council for Harmonization (ICH).

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In the last stage of filtration, particularly in the manufacture of sterile injectables, membrane filters are still considered the gold standard. Because of their excellent chemical resistance and microbiological retention, these filters, which are often made of PVDF, PES, or PTFE, are utilized in both domestic and export-oriented manufacturing. They are essential for adhering to the requirements of COFEPRIS and worldwide sterility laws. The initial line of defense in pharmaceutical operations are prefilters and depth media, which remove larger particles from process water, raw materials, and buffer solutions. These filters are essential for protecting more expensive final-stage filters in Mexico, where cost-efficiency is still a major concern for many local producers, which lowers operational costs while preserving quality. Contract manufacturing firms (CMOs) and vaccine manufacturers are increasingly using single-use systems. These systems allow for quick turnaround, which is especially helpful for multi-product facilities or clinical trial production, due to low maintenance needs and low cross-contamination hazards. Capsules and cartridges allow for versatility in both laboratory-scale development and large-scale industrial manufacture. Because they are easily integrated into diverse filtration systems, Mexican pharmaceutical companies that are expanding the production of novel drug formulations, particularly in the biosimilars and generics industries, often use them. Not frequently valued, filter holders are essential to preserving the integrity of filtration. They are critical for GMP-compliant environments because they guarantee proper pressure distribution and leak-free operation. In Mexico, there is an increasing trend towards domestic manufacturers producing these parts in order to lessen reliance on imports. Pressure gauges, tubing connectors, integrity testers, and other filtration accessories are critical for monitoring and validating filtration procedures. They are often paired with main systems to increase compliance and performance. The others category includes specialty filters for gas and solvent sterilization applications that are essential to sterile processing and research and development as well as high-efficiency particulate air (HEPA) filters for cleanroom environments. The use of cutting-edge filtration technology in Mexico's changing pharmaceutical filtering industry is crucial to drug development and manufacturing, helping the nation maintain its position as a major provider in Latin America. Due to its capacity to eliminate bacteria and tiny particles without compromising the integrity of the medication, microfiltration is frequently employed in the manufacturing of injectable and ophthalmic pharmaceuticals for filtering air, water, and liquid solutions. Its minimal energy needs and great dependability make it particularly appealing to producers looking for affordable, scalable sterile processing solutions that adhere to COFEPRIS regulations. In Mexico's expanding biopharmaceutical and biosimilar industries, ultrafiltration is becoming more prevalent. It works exceptionally well for isolating enzymes, proteins, and antibodies from smaller molecules. This method is employed by Mexican biotech businesses during the purification phases of hormone and vaccine manufacturing. Ultrafiltration is now a critical component of downstream processing because it concentrates valuable therapeutic compounds while preserving biological activity thanks to the emergence of biosimilars. Particularly in facilities that handle large quantities or high-viscosity products, cross flow filtration, also known as tangential flow filtration (TFF), is becoming more and more prevalent in continuous processing environments in Mexico. TFF allows for multiple filtration cycles without clogging the membrane, extending filter life and minimizing downtime, unlike direct flow techniques. This is especially beneficial for Mexican producers who follow lean manufacturing strategies. Nanofiltration has distinct advantages for solvent purification and pharmaceutical water treatment since it removes viruses and divalent salts while allowing smaller solvents to pass through. The local need for high-purity biologics and excipients is fueling its niche use in plasma fractionation and specialized pharmaceutical purification. The others category covers dialysis-based and reverse osmosis (RO) methods, which are frequently employed in pre-filtration processes and in the creation of Water for Injection (WFI). In Mexico's pharmaceutical business, the regulatory environment established by COFEPRIS and the nature of end-use products dictate that sterile and non-sterile filtration methods serve very different manufacturing needs. Sterile filtration is an essential step in the production of vital parenteral medications, biologicals, vaccines, and eye drops, all of which are administered directly into sterile bodily environments. Businesses are investing in membrane filters with a 0.22-micron rating that provide complete assurance of sterility without the deterioration hazards associated with heat sterilization as Mexican pharmaceutical exports to controlled markets like the U.S. and EU increase. Integrity testing, such as bubble point or pressure decay techniques, is frequently part of the procedure to confirm filter performance, which is required in GMP-certified cleanrooms. Conversely, in the production of goods where sterility is not as important as clarity, consistency, and the removal of impurities, non-sterile filtering is used. This comprises topical lotions, oral suspensions, and specific kinds of over-the-counter (OTC) drugs. The majority of Mexico's home pharmaceutical manufacturing, where cost-effectiveness and high throughput are valued, is supported by non-sterile filtration. To comply with safety and shelf-life regulations, these filtration systems usually concentrate on eliminating particulates, undissolved excipients, or microbial bioburden. Mexico is distinguished by its dependence on both kinds of filtration in common production systems. To prevent cross-contamination, several facilities, especially contract manufacturers, must switch between sterile and non-sterile processes while adhering to validated cleaning methods and equipment separation. The trend toward modular systems and continuous production has also resulted in an increase in hybrid filtration configurations, allowing manufacturers to adapt to changing market needs with flexibility.

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Nikita Jabrela

Business Development Manager

Considered in this report • Historic Year: 2019 • Base year: 2024 • Estimated year: 2025 • Forecast year: 2030 Aspects covered in this report • Pharmaceutical Filtration Market with its value and forecast along with its segments • Various drivers and challenges • On-going trends and developments • Top profiled companies • Strategic recommendation By Product • Membrane Filters • Prefilters & Depth Media • Single-use Systems • Cartridges & Capsules • Filter Holders • Filtration Accessories • Others

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By Technique • Microfiltration • Ultrafiltration • Cross Flow Filtration • Nanofiltration • Others By Filteration Type • Sterile • Non-sterile The approach of the report: This report consists of a combined approach of primary as well as secondary research. Initially, secondary research was used to get an understanding of the market and listing out the companies that are present in the market. The secondary research consists of third-party sources such as press releases, annual report of companies, analyzing the government generated reports and databases. After gathering the data from secondary sources primary research was conducted by making telephonic interviews with the leading players about how the market is functioning and then conducted trade calls with dealers and distributors of the market. Post this we have started doing primary calls to consumers by equally segmenting consumers in regional aspects, tier aspects, age group, and gender. Once we have primary data with us we have started verifying the details obtained from secondary sources. Intended audience This report can be useful to industry consultants, manufacturers, suppliers, associations & organizations related to this industry, government bodies and other stakeholders to align their market-centric strategies. In addition to marketing & presentations, it will also increase competitive knowledge about the industry.