Go to Market Strategy for Non-sputum TB Assay

Company A is developing a non-sputum Tuberculosis (TB) molecular assay that uses a tongue swab. This assay can be run on another instrument, also developed by Company A, which many countries are already using to diagnose a range of other pathogens. This simple, easy-to-use diagnostic tool is very well suited and adapted for use in low- and middle-income countries (LMICs) and provides a diagnosis within 20 minutes.

The Problem

The main challenge in the early detection and treatment of patients with TB in LMICs is the lack of easy-to-use, point-of-care diagnostic tools that have high sensitivity. For this reason, TB remains significantly under-diagnosed worldwide. There are several excellent methods to diagnose TB including smear and culture, radiological examination, and molecular tests, but these are not all readily available at the primary healthcare level. The tools that are currently available on the market are less sensitive when the patient is co-infected with the human immunodeficiency virus (HIV), or may require more complex laboratories that may be far from rural communities, therefore delaying diagnosis.

Interruptions in electricity supply, lack of cold chains, training, timing, and multiple factors need to be addressed to speed up diagnosis and initiate treatment before losing the patient to follow-up. 

The World Health Organization recommends the use of molecular nucleic acid amplification tests for TB detection instead of smear microscopy, as this technology is able to detect TB more accurately, particularly in patients with paucibacillary disease and in people living with HIV. 

The Solution

Market Access Africa, together with Halteres Associates, helped Company A to prioritize a set of 15 LMICs for market entry for their TB and related assays. We convened our team of TB country experts to: research and distill insights on the registration and adoption pathways; assess the size of the unmet need for TB diagnostics; identify relevant influencers and strategic partnerships; as well as estimate revenue potential from both public and private sector buyers. In each country, we developed a tailored go-to-market strategy, detailing strategic and operational guidance for launching the new TB diagnostic tool. 

By leveraging their local knowledge and experience with TB, our country experts helped Company A to gain a thorough understanding of the health system and the levels of healthcare where molecular testing could be conducted in both the public and the private sectors.

We detailed the policy and regulatory considerations for introducing the product at global, national and sub-national levels – a critical step that allowed the client to fully understand the next steps of getting their product approved, and launched into the market.

The Outcome

Molecular tests represent a significant improvement in the diagnosis of TB. This opens up more opportunities to dramatically improve treatment outcomes and reduce mortality. Our contribution towards accelerating molecular testing tools for TB brings molecular testing closer to patients in poorer parts of many African countries, and plays an integral role in closing the gap between the vision of molecular testing and the reality of widespread TB under-diagnosis.