Accelerating the Introduction of New TB Diagnostics at Primary Healthcare and Community Level

A Product Development Partnership (PDP) committed to ensuring equitable access to reliable diagnostics worldwide, embarked on a new initiative to accelerate the introduction of new tuberculosis (TB) diagnostics at primary healthcare and community levels. The client aimed to support the development of three new TB product classes and sought manufacturers with significant technical and commercial potential to deliver these diagnostic platforms.

The Problem

TB remains a major global health problem, with high rates of morbidity and mortality. The World Health Organization (WHO) Global TB Report 2021 indicated that approximately 10 million individuals contracted TB in 2020. The COVID-19 pandemic exacerbated reduced access to diagnostics and subsequent delays in diagnoses and treatment, leading to an increase in TB-related deaths (1.3 million in 2020, levels last seen in 2017). Existing TB screening and diagnostic tools are inadequate for reaching individuals with active TB and fail to address geographic variations in healthcare access.

The client-supported companies developing products that fit into one of three new TB product classes: third-generation lipoarabinomannan (LAM) rapid diagnostic tests (RDTs), point-of-care (PoC) molecular diagnostics (MDx), and near-PoC MDx with alternative sampling approaches. Part of the client’s support involved developing go-to-market strategies for target markets, given that some of the supported companies had limited experience deploying products into the target markets

Market Access Africa (MAA) was commissioned to estimate the current and potential market size for key TB diagnostic tests (3rd-gen LAM, near-POC, and PoC) in target countries. The analysis aimed to provide insights on market dynamics and trends, key players and respective market shares, distribution channels, and category trends, as well as assess the implications for market share of new entrants.

The Solution  

MAA conducted an in-depth examination comprising several key components. Firstly, we delved into sales data analysis, meticulously reviewing historical sales records of specific products or analogues. This analysis unveiled patterns in sales volume corresponding to fluctuations in pricing, providing valuable insights into consumer behavior and market dynamics.

Secondly, we conducted comprehensive market research by engaging public health professionals from both public and private sector entities that procure the product. Through surveys and interviews, we sought to understand preferences, willingness to pay, and other pertinent factors influencing purchasing decisions. Additionally, where feasible, we conducted interviews with actual buyers to enrich our understanding of market dynamics and consumer perspectives.

Lastly, we developed a detailed market sizing model for the different classes of products, leveraging insights from our market research, previous industry studies, and academic research. By collating relevant assumptions and conclusions on key economic indicators, we were able to estimate the Total and Served Addressable Market (TAM and SAM) for each product class, which in turn helped the client and their supported companies make informed decisions on their product launch planning.

The Outcome  

MAA delivered a comprehensive TB diagnostic market report and model for the designated countries, integrating key insights from interviews with public and private sector stakeholders. This model, to the best of our knowledge, is the first to assess the market potential for specific TB product classes (i.e., 3rd-gen LAM, near-POC, and PoC). This comprehensive market analysis and model provided the client with the critical data and insights needed to support the introduction of innovative TB diagnostics, ultimately aiming to improve TB detection and treatment outcomes in primary healthcare and community settings.

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