As LATAM battles the growing infectious and chronic disease rates, governments and non-governmental organizations (NGOs) are launching healthcare initiatives to improve disease control and increase diagnoses rates. They’re doing this by implementing less traditional methods such as Point of Care (POC) testing. The most common of these are “rapids”, which are typically conducted at the patient bedside and provide results in around 10 minutes. At the same time, an interesting trend has also started to emerge: the creation of public-private partnerships (PPPs) focused on “homebrew” test development, which may pose a threat to established rapids manufacturers.

The Rise in Rapid Testing and Decentralized Health Care

Throughout the region, patients are benefiting from government-led and NGO-sponsored campaigns and programs that provide disease screening for asymptomatic or at-risk-patients. The most common are health fairs; bringing together healthcare providers (HCPs), industry representatives and policy makers to screen patients for high-burden diseases, such as HIV and diabetes, and educate them on disease prevention and management. Screening and educational materials are free of charge, as the main goal is to reach patients who have little access to health care or those who may not approach a local HCP due to the stigma associated with select diseases.

Given the widespread presence of HIV and STIs in LATAM, some major country markets have also created decentralized healthcare units dedicated to HIV and STI screening, with select units offering additional confirmatory testing. In these units, rapids are typically used to screen patients, while ELISA and immunoassay technologies are used as confirmatory tests. Patients with positive results are referred to the appropriate institutions, such as Level II and III hospitals, for disease monitoring (e.g. CD4, viral load and genotyping tests) and treatment. In Mexico, these units are known as CAPASITS and there are approximately 75 units throughout the country. Argentina has a similar program comprised of a network of Centros de Testeo (Testing Centers), providing free HIV and STI counseling and screening.

Rapid Test Manufacturers

When it comes to the supply of rapid tests in LATAM, few multi-national companies (MNCs) have a presence in this market, with Abbott Rapid Diagnostics (formerly Alere) being the most renowned competitor. However, over the last couple of years, several domestic players have emerged; mainly based in Brazil, partly due to its large and most developed rapids market in LATAM.

The largest domestic players in Brazil include:

• WAMA
• known as a dedicated POC company

• Bioclin
• focuses on the development and manufacturing of ELISA and chemistry reagents in addition to rapid test kits

• OrangeLife
• smaller than WAMA and Bioclin, but gains share by offering products at a low price-point

• ECO Diagnostica (ECO)
• a newer player with a product portfolio that consists of digital readers and rapid tests, including a Zika rapid test.

Most of their rapid-testing products are for infectious disease diagnosis, catering to the high incidence of infections in the region. Among the four companies, WAMA and Bioclin have been in the market the longest and have positive brand recognition.

Overall, most of these local companies find success at the municipal level, especially in cost conscious countries that tend to focus primarily on budget-friendly products. Due to manufacturing limitations, some companies are unable to supply the needs of large-scale federal tenders. As a result, MNCs often dominate the federal tender market in Brazil, however, the threat of domestic competitors is forcing MNCs, at times, to lower pricing.

Barriers to Adoption

Despite greater adoption of POC solutions, some barriers remain.

• Push-back from HCPs and laboratory professionals
  HCPs and laboratory professionals believe testing should only take place in the core laboratory. This apprehension is attributed to a perception that these tests are not as sensitive as traditional testing methods and could provide misleading results.

• The ability of HCPs (e.g. nurses and physicians) to conduct testing using POC instruments
  This is another concern expressed by laboratory professionals, as HCPs don’t have the same qualifications and certifications as laboratory professionals. This raises questions related to the misuse of this technology, such as improper sample handling and inaccurate quality control and validation practices.

• Physicians and nurses feel that laboratory testing should not be part of their job
  As they’re already struggling with high patient volume and heavy workloads.

• Other POC solutions, such as handheld instruments are considered costly
  Such as Abbott i-Stat and Quidel Triage, and thus are prohibitive, given budget constraints in many LATAM countries.

Overall, the regulation surrounding the use of rapids or other testing methods outside of the core laboratory remains an area for improvement.

The Future of POC Testing in LATAM

In summary, there’s great opportunity to adopt decentralized health care and POC testing in LATAM, especially in remote regions with limited access to core laboratory testing. The use of POC instruments and rapid tests will likely continue to grow in these areas, as more countries work to address high infectious and chronic disease prevalence, and poor healthcare infrastructure.

Conversely, commercial opportunity for MNCs may be time-limited as domestic players are quickly gaining ground, and PPP efforts to increase domestic production of “homebrew” tests are growing. Despite the cost-savings generated by these PPPs, the products can be lower quality as associated R&D and manufacturing efforts are not as well established or validated as those of larger rapids players and MNCs. Nevertheless, these projects could lead to pricing pressure and directly impact MNC rapids suppliers in LATAM, whose premium-priced products may be challenged by PPPs’ more affordable solutions.

If you’re interested in POC testing and are looking for opportunities to drive decentralized healthcare, IQVIA’s BBC IVD Solutions could help you.