Report

Mexico In-Vitro Diagnostics Market Analysis

The Mexico In-Vitro Diagnostics Market was valued at USD 1.37 billion in 2025 and estimated to grow from USD 1.44 billion in 2026 to reach USD 1.85 billion by 2031, at a CAGR of 5.08% during the forecast period (2026-2031).

Growth reflects steady modernization of public procurement, rising chronic-disease testing volumes, and accelerated adoption of point-of-care platforms focused on underserved regions. The New Consolidated Procurement Model is steering MXN 130 billion (USD 6.86 billion) toward medical supplies for 26 public health institutions, giving scale advantages to suppliers that can satisfy large-lot tenders. Multinational firms with FDA, Health Canada, or Japan clearances enjoy shorter regulatory routes under COFEPRIS equivalency provisions, while domestic players concentrate on low-cost niches. Demand is reinforced by 12.4 million diabetes cases that underpin continuous glucose monitoring uptake and by rapid tech convergence that folds artificial-intelligence analytics into everyday laboratory workflows.

Mexico In-Vitro Diagnostics Market Trends and Insights



Rising Burden of Chronic Diseases

Mexico's 12.4 million diabetes population and cardiovascular mortality profile fuel high-frequency glucose, lipid, and HbA1c testing, pushing sustained reagent sales in the Mexico in vitro diagnostics market. Cancer incidence of 140.9 per 100,000, coupled with breast-cancer rates at 39.9 per 100,000 women, increases demand for tumor markers and molecular profiling. Post-COVID syndromes affecting 37% of survivors require long-term inflammatory and pulmonary panels, broadening test menus. Urban clustering delivers high sample volumes to large labs, whereas rural regions still rely on outreach programs. Unique genomic traits, such as a 17% KRAS mutation prevalence in Mexican colorectal cancer versus 40% globally, underline the need for localized assay design.

Expanding Adoption of Point-of-Care and Decentralised Testing

The COVID-19 response normalized rapid antigen platforms across public clinics and laid the groundwork for wider POCT use in cardiology, obstetrics, and infectious-disease triage. Emergency departments in Mexico City documented turnaround-time drops that directly improved patient throughput. For the 52% of citizens living in towns under 100,000, handheld analyzers deliver laboratory-grade answers without major infrastructure. Private-sector innovators such as Examedi, in partnership with Laboratorios Chopo, now dispatch home kits that integrate telehealth oversight. AI-augmented POCT prototypes like the Buazduino-001 cardiovascular classifier achieve 87% accuracy and cut diagnostic time to two minutes, illustrating next-generation potential.

Stringent & Evolving COFEPRIS Regulatory Pathway

Revised NOM-137-SSA1-2024 labeling rules now demand explicit self-test instructions, disposal guidance, and country-of-origin data, extending dossier compilation timelines. New submissions still average 10-18 months, and deficiency letters lengthen the cycle to 26 months, tying up working capital. Five-year license renewals with 150-day pre-expiry dossier deadlines impose recurring costs. While equivalency programs shorten reviews for devices cleared in the United States, Canada, or Japan, domestic innovators lacking foreign approvals confront a steeper slope to market entry.

Other drivers and restraints analyzed in the detailed report include:

Government Universal-Healthcare Spend Surge & Bulk Procurement ReformAI-Enabled Diagnostic Algorithms Integrated into IVD WorkflowsLow Reimbursement Rates for Advanced Molecular Tests

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Immuno-diagnostics generated the largest revenue share at 28.11% in 2025, underpinned by high-volume infectious-disease and hormone assays. In contrast, Molecular Diagnostics is set to log an 8.13% CAGR to 2031, the fastest within the Mexico in vitro diagnostics market. The segment's rise is tied to oncology sequencing, hereditary cancer panels, and pathogen detection workflows. Hereditary breast-cancer programs show that 32.7% of Mexican patients carry non-BRCA pathogenic variants that require broader gene panels. KRAS mutation testing reveals just 17% positivity in Mexican colorectal cancer, far below global averages, reinforcing the need for population-specific assay designs. Clinical Chemistry remains vital for diabetes management, while Hematology benefits from the PRONAII roadmap that strengthens childhood leukemia diagnostics in Oaxaca, Puebla, and Tlaxcala. Microbiology labs expand respiratory and Post-COVID surveillance panels, reflecting 37% prevalence of lingering symptoms among COVID survivors. Rapid-test formats advance in rural zones, leveraging AI-enabled readouts to cut operator error and improve traceability.

Reagents & Kits anchored 54.88% of 2025 revenue thanks to continuous demand for consumables in diabetes, infectious-disease, and routine chemistry testing. However, Software & Services is forecast to outpace all other categories at a 9.21% CAGR, reflecting Mexico's digital-health pivot inside the Mexico in vitro diagnostics market. Cloud-based middleware now offers real-time QC dashboards and cross-site connectivity, while AI modules such as Keiron's engine support triage and predictive maintenance. Government tenders already earmark funds for LIS upgrades under the consolidated procurement drive. Instruments/Analyzers enjoy refreshed replacement cycles in public hospitals, supported by financing models that bundle reagent rentals. BiotecMol's PCR kits, priced between USD 10,000-30,000 for varying reaction volumes, prove demand for specialized reagents, particularly when paired with laboratory automation. Convergence of hardware and software fosters integrated ecosystems that simplify accreditation and data export to national cancer registries.

The Mexico In-Vitro Diagnostics Market Report is Segmented by Test Type (Clinical Chemistry, Molecular Diagnostics, and More), Product (Instruments, Reagents & Kits, and More), Usability (Disposable IVD Devices and Reusable Systems), Application (Infectious Disease, Oncology, and More), and End Users (Stand-Alone Laboratories, Hospital-Based Laboratories, and More). The Market Forecasts are Provided in Terms of Value (USD).

List of Companies Covered in this Report:

Abbott Laboratories Beckton Dickinson bioMerieux Bio-Rad Laboratories Danaher DiaSorin Roche Genomma Lab Internacional SAB de CV Grifols Hologic HORIBA Illumina Ortho Clinical Diagnostics (Topco) QIAGEN QuidelOrtho Randox Laboratories Revvity, Inc. Seegene Siemens Healthineers Thermo Fisher Scientific Werfen Life Group SAU

Additional Benefits:

The market estimate (ME) sheet in Excel format
3 months of analyst support