The Mexico biosimilars market was valued at USD 203.09 Million in 2025. It is expected to grow at a CAGR of 7.30% during the forecast period of 2026-2035 and attain a market value of USD 410.85 Million by 2035, driven by the rising burden of chronic diseases such as cancer and autoimmune disorders, creating strong demand for affordable treatment alternatives across the region. Government initiatives to reduce healthcare expenditure and improve access to biologics further open doors for biosimilar adoption. Moreover, partnerships between domestic firms and global players are fostering technology transfer and innovation, accelerating market expansion.
Base Year
Historical Period
Forecast Period
Expanding healthcare coverage and cost-containment policies in Mexico are boosting biosimilar adoption across public institutions.
The market demand is driven by the growing prevalence of chronic diseases like cancer and diabetes increases demand for affordable biosimilar therapies in Mexico.
Major market trends include regulatory improvements and faster approval timelines are encouraging biosimilar manufacturers to enter and invest in the Mexican market.
Compound Annual Growth Rate
7.3%
Value in USD Million
2026-2035
*this image is indicative*
The incidence of Mexico-manufactured biosimilars entering the United States market is gradually increasing due to growing cross-border pharmaceutical collaboration and demand for affordable biologics. While U.S. regulatory requirements remain stringent, some Mexico-based manufacturers are exploring FDA approvals through partnerships or licensing agreements. This trend supports wider biosimilar adoption in the U.S., especially in therapeutic areas like oncology and rheumatology. The push for cost-effective treatment options continues to attract attention to biosimilars from Mexico, influencing long-term market dynamics.
Rise in Oncology Biosimilar Approvals Accelerate Market Growth
The growing cancer prevalence and demand for affordable oncology treatments are key drivers advancing the market. For instance, in July 2024, Zydus Lifesciences announced the approval of its bevacizumab biosimilar in Mexico for multiple cancer types, including glioblastoma, renal cell carcinoma, and ovarian cancer. This regulatory milestone highlights the expanding oncology-focused biosimilar pipeline. It is expected to significantly enhance market growth by improving treatment access and stimulating competition among biosimilar manufacturers during the forecast period.
Major market trends include rising regulatory reforms and affordability initiatives, driving strong growth in the market.
Regulatory Reforms Accelerating Biosimilars Market Development and National Competitiveness
Government incentives and regulatory clarity are key drivers bolstering market growth. For instance, in March 2024, COFEPRIS‑led Regulatory Certainty Strategy (2024-2026) introduced dedicated biosimilars units, harmonized international standards, streamlined approval pathways, and enhanced pharmacovigilance. By simplifying regulatory hurdles and improving institutional infrastructure, this initiative is poised to foster domestic production, attract foreign investment, and accelerate time‑to‑market. Consequently, the Mexican biosimilars sector is expected to experience significant expansion and value growth throughout the forecast period.
Expanding Affordability Initiatives Support Mexico Biosimilars Market Demand
The rising healthcare cost pressures and increasing demand for affordable biologic treatments are key drivers boosting Mexico’s biosimilars market. For instance, in July 2024, Boehringer Ingelheim partnered with GoodRx to offer its FDA-approved unbranded adalimumab biosimilar at a significantly reduced price USD 550 per 2-pack, marking a 92% discount from Humira’s list price. Alongside this, Mexican authorities approved a bevacizumab biosimilar. These developments are expected to improve treatment accessibility and accelerate biosimilar adoption across Mexico during the forecast period.
Oncology to Lead the Market Segmentation by Indication
The oncology segment is likely to hold the largest share in the Mexico biosimilar market due to the high cancer incidence. According to the World Cancer Research Fund 2023, Mexico reported over 207,000 new cancer cases in 2020, with breast, prostate, and colorectal cancers being most prevalent. Oncology treatments are often costly, making biosimilars a more affordable alternative that improves access across public and private sectors. Meanwhile, growth hormone deficiency and infectious disease segments remain smaller, while inflammatory and chronic disease treatments show steady growth.
The key features of the market report comprise clinical trials analysis, funding and investment analysis, and strategic initiatives by the leading players. The major companies in the market are as follows:
Founded in 1938 and headquartered in Mexico City, Liomont is a prominent Mexican pharmaceutical company with over 80 years of operational excellence. Its portfolio encompasses prescription medicines, OTC products and advanced biologics. Recently, Liomont has entered biosimilar development through collaborations: a licensing deal with LeukoCare in 2018 for monoclonal antibody formulations and an exclusive partnership with Oncobiologics to co-develop and commercialize two biosimilars in Mexico.
Headquartered in Basel, Switzerland, and established in 1996 through the merger of Ciba-Geigy and Sandoz, Novartis is now a pure-play medicines company. Through its Sandoz division, it is a global leader in generics and biosimilars. In Mexico, Sandoz offers biosimilars across oncology, immunology, and hormone therapies, leveraging its extensive development pipeline and regulatory approvals, including products such as biosimilar rituximab and insulins, responding to increasing demand for affordable biologics.
Founded in 1876 in Indianapolis, Indiana, Eli Lilly is a global biopharmaceutical leader with a strong emphasis on endocrinology and oncology. It is actively expanding its biosimilar portfolio, particularly in insulin products. In the biosimilar insulin market, Lilly is positioned alongside giants like Sanofi and Novo Nordisk, targeting cost-effective alternatives to branded insulin worldwide. Its efforts support expanded access in Mexico through distribution partnerships and regulatory filings aimed at affordability.
Based in Paris, France, and founded in 2004 via the merger of Sanofi-Synthélabo and Aventis, Sanofi is a global healthcare leader. It is engaged in developing biosimilar insulins, such as insulin aspart, to address rising diabetes prevalence. Sanofi’s biosimilar programs focus on cost-efficient biologics, supporting broader patient access in markets including Mexico and the U.S., backed by global scale and partnerships.
*Please note that this is only a partial list; the complete list of key players is available in the full report. Additionally, the list of key players can be customized to better suit your needs.*
Other key players in the market include Bayer AG, Pfixer Inc., Bristol Myers Squibb Company, Assertio Holdings Inc., and Bioventus LLC.
The market report offers a detailed analysis of the market based on the following segments:
Market Breakup by Drug Class
Market Breakup by Indication
Market Breakup by Distribution Channel
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| REPORT FEATURES | DETAILS |
| Base Year | 2025 |
| Historical Period | 2019-2025 |
| Forecast Period | 2026-2035 |
| Scope of the Report |
Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:
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| Breakup by Drug Class |
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| Breakup by Indication |
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| Breakup by Distribution Channel |
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| Market Dynamics |
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| Supplier Landscape |
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| Companies Covered |
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