This report, The Market for In Vitro Diagnostic (IVD) Tests in Latin America, focuses on the market for reagents and instruments in the most important countries of the region. Argentina, Brazil, Chile, Colombia, Mexico, Peru and Venezuela are singled out for a deeper level of analysis; the countries of Bolivia, Costa Rica, Cuba, Dominican Republic, Ecuador, El Salvador, Guatemala, Guyana, Haiti, Honduras, Nicaragua, Panama, Paraguay, and Uruguay were also considered to provide a complete overview of the region.
Combined, these countries represent a population of 646 million; a large potential IVD market audience. Brazil and Mexico represent the two largest countries in terms of population, accounting for more than half of LATAM total population. For this reason, these two countries have been the focus for many IVD suppliers in recent years. However, as economic conditions strengthen in other countries and demand increases for quality health services, there are additional opportunities in countries such as Chile, Colombia and Peru.
The segments under analysis include reagents, consumables, calibrators and controls of the following subsegments:
- Clinical Chemistry: substrates, enzymes, homogeneous immunoassays, proteins, ISE (non POC), HBA1c (non POC).
- Critical Care: blood gas and electrolytes, including rapid tests.
- Urinalysis: manual, semi-automated and automated. Include urine strips, urine sediment reagents and disposables in automated systems.
- Microbiology Immunoassays: HIV, Hepatitis, ToRCH, COVID-19, Influenza, Syphilis, and other infectious diseases agents. Excludes tests processed in blood banks.
- Immunoassay (non-microbiology): hormones, tumor markers, bone markers, oncology markers, autoimmunity, allergy, anemia, neonatal tests, prenatal tests, interleukins, PCT. Also includes non-POC drugs of abuse testing and therapeutic drug monitoring.
- Cardiac Markers: non POC cardiac markers (Troponine, BNP, CK-MB, Homocystein, Myoglobin).
- Blood Banking: immunotyping and infectious diseases screening.
- Microbiology: manual and automated tests, culture media (to be prepared or ready to use), latex tests, transport media, blood culture, sensitivity discs, Gram and other stains, MTB culture, Mycoplasma, Ureaplasma.
- Molecular Microbiology: HIV, Hepatitis, STDs (CT, NG, HPV), MRSA, MTB, Sepsis, EBV, CMV, Respiratory Panel, COVID-19 and other infectious diseases agents. Also includes multiplex NAT.
- POC: all POC tests for allergy, autoimmune, cardiology, coagulation, fecal occult blood, fertility, HbA1c, lipid, pregnancy, toxicology, TSH. Excludes POC glucose testing and infectious disease testing.
- POC Infectious Disease Testing: COVID-19, HIV, influenza, STDs, streptococci, and other. Includes home collected test kits.
- POC Glucose Testing: diabetes glucose monitoring strips.
- Primary Staining Histology: PAP, HE and other primary stains.
- Advanced Staining Histology: IHC, ISH, FISH, primary and secondary antibodies.
- Hematology: manual, semi-automated and automated (CBC and 5 Diff).
- Coagulation: PT, APTT, coagulation factors, Fibrinogen, FDP, Lupus Anticoagulant and other analytes from the thrombosis and hemostasis pathway.
- Flow Cytometry: manual, semi-automated and automated flow cytometry for CD4/CD8 (AIDS), leukemia, lymphoma, infectious diseases, autoimmune disorders. Includes follow-up to abnormal cell count testing.
- Other Molecular: hemato-oncology, hereditary diseases, hemostasis and hematology diseases, transplant and other molecular testing not defined elsewhere. Excludes coagulation factors.
Interviews with IVD market participants, public and private laboratory operations managers, government representatives and health professionals were the primary source of information. Primary research focused on the seven countries highlighted in this report, Argentina, Brazil, Chile, Colombia, Mexico, Peru and Venezuela. Other LATAM countries’ markets were estimated using mostly secondary research – which consisted of medical journals, healthcare data from government agencies, import/export databases (specifically focusing on HS Codes 90 and 98), registered business databases (specifically focusing on NAICS code 325413) and other information. In all cases, information was compared to the previous IVD Latin America editions, which includes VA Consultora y Asociados data as well as to secondary information from other sources. As secondary source of information statistics from public tenders, as well as output data provided by the main funding entities and reagents, inputs and instrument imports made by labs were used.
Depending on the source, there are differences in the information about the countries of the region. Quality data reporting varies by country and is a primary weakness in the region. Some countries report quality data while others have low quality, incomplete information or the information is manipulated in some way. Kalorama Information has reviewed data from multiple sources, both country-reported and global databases, to generate the most reliable, current and complete information available.