Mexico Biosimilar Market Size, Share & Industry Report | 2033

Market Overview 2025-2033

The Mexico biosimilar market size reached USD 417.4 Million in 2024. Looking forward, IMARC Group expects the market to reach USD 1,560.8 Million by 2033, exhibiting a growth rate (CAGR) of 14.60% during 2025-2033. The market is growing due to rising chronic disease prevalence, increasing need for affordable biologic therapies, and strengthened regulatory frameworks. Growth is driven by oncology biosimilars, enhanced provider trust, and government cost-control measures, making the industry more accessible, efficient, and competitive.

Key Market Highlights:

✔️ Strong market growth driven by rising healthcare demand and need for cost-effective biologic treatments
✔️ Increasing approvals and availability of biosimilars for oncology, autoimmune, and chronic diseases
✔️ Expanding support from government policies and healthcare providers to enhance biosimilar adoption and accessibility

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Mexico Biosimilar Market Trends and Drivers:

The Mexico Biosimilar Market is undergoing notable transformation, driven by regulatory reforms implemented by COFEPRIS (Federal Commission for Protection against Health Risks). In 2023, updated guidelines aligned with EMA and FDA standards introduced a streamlined approval process, cutting biosimilar authorization timelines from 36 to approximately 18 months. As a result, 12 new biosimilar products entered the market in early 2024, with a concentration in oncology and immunology treatments such as trastuzumab, rituximab, adalimumab, and infliximab. Both domestic companies, including Probiomed and Landsteiner, and international firms such as Biocon and Celltrion, are contributing to a broader therapeutic portfolio.

Although biosimilars are typically priced 25-35% lower than reference products, pricing remains a concern. However, the expiration of key patents-for example, those for insulin glargine and etanercept-is expected to increase biosimilar uptake. Challenges persist, particularly regarding pharmacovigilance infrastructure and adverse event traceability. A major growth factor in the Mexico Biosimilar Market Report is demand from the public healthcare sector. Institutions like IMSS and INSABI now include biosimilars in roughly 90% of procurement tenders. As of early 2024, biosimilars accounted for 43% of all biologics dispensed, up from 28% in 2033.

The rise in chronic diseases-such as diabetes, which affects nearly 17% of adults, and approximately 190,000 new cancer diagnoses annually-is driving the need for more affordable treatment options. However, access remains uneven; urban healthcare centers report up to 95% formulary inclusion, while rural areas still face obstacles due to cold-chain logistics. In the private healthcare system, biosimilar penetration remains relatively low at around 22%, though initiatives like step-therapy protocols are gradually improving uptake. The inclusion of biosimilars for rheumatoid arthritis under the expanded Seguro Popular program reflects broader policy support. Nevertheless, high out-of-pocket costs continue to be a barrier for over one-third of households.

Manufacturing capacity is growing, supported by foreign direct investment and national incentives. In 2024, seven contract development and manufacturing organizations (CDMOs) began construction in Guanajuato and Querétaro, aimed at reducing import dependence. This expansion aligns with Mexico's Pharma 4.0 strategy, which includes tax incentives and technology transfer initiatives. Notable developments include a Biocon-Neolpharma joint venture focused on fill-finish operations for monoclonal antibody products. Despite progress, only three domestic companies received WHO prequalification in 2024, underlining challenges in analytical validation and product comparability.

External disruptions, such as API import delays during the 2024 hurricane season, have accelerated nearshoring strategies. Exports to countries like Colombia and Peru now make up 41% of national biosimilar production. However, regulatory differences under the USMCA continue to pose challenges for exports to the U.S. market. The Mexico Biosimilar Market Report highlights consistent market expansion. Valued at over $480 million in early 2024, the market has experienced a CAGR of 14.3% since 2021-far surpassing the broader pharmaceutical sector's average growth of 5.8%.

An aging population, with 14.3% over the age of 60, is contributing to demand across therapeutic areas such as oncology, diabetes, and autoimmune diseases Interchangeability guidelines introduced in 2024, based on ICH Q5E standards, supported wider clinical use of eight monoclonal antibodies, although automatic substitution remains a point of contention among healthcare professionals With the expiration of additional patents, including those for bevacizumab and pegfilgrastim, the market saw an average price drop of 28% in the second half of 2024. Locally produced biosimilars now represent 37% of national sales, up from 19% in 2022.

This growth has been fueled by initiatives like the Strategic Health Industries Fund, which allocated $650 million to boost domestic biomanufacturing. Still, logistics issues-such as the Veracruz port strikes in Q3 2024-exposed supply chain weaknesses, delaying nearly half of biosimilar deliveries during that period. Looking forward, the Mexico Biosimilar Market is projected to represent 58% of the country's biologics market by 2026. Reaching this target will require further investments in rural healthcare distribution, improved reimbursement policies, and enhanced pharmacovigilance systems. With expanding production capabilities, regulatory support, and growing healthcare demand, Mexico is emerging as a leading force in the Latin American biosimilar industry.

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Mexico Biosimilar Market Segmentation:

The market report segments the market based on product type, distribution channel, and region:

Study Period:

Base Year: 2024
Historical Year: 2019-2024
Forecast Year: 2025-2033

Breakup by Molecule:

• Infliximab
• Insulin Glargine
• Epoetin Alfa
• Etanercept
• Filgrastim
• Somatropin
• Rituximab
• Follitropin Alfa
• Adalimumab
• Pegfilgrastim
• Trastuzumab
• Bevacizumab
• Others

Breakup by Manufacturing Type:

• In-house Manufacturing
• Contract Manufacturing

Breakup by Indication:

• Auto-Immune Diseases
• Blood Disorder
• Diabetes
• Oncology
• Growth Deficiency
• Female Infertility
• Others

Breakup by Region:

• Northern Mexico
• Central Mexico
• Southern Mexico
• Others

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Competitive Landscape:

The market research report offers an in-depth analysis of the competitive landscape, covering market structure, key player positioning, top winning strategies, a competitive dashboard, and a company evaluation quadrant. Additionally, detailed profiles of all major companies are included.

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