Product Commercialization
Tuberculosis or TB
Diagnostics
Market Sizing
Regulatory
Go-to-market Strategy

Next Generation Tuberculosis Point of Care Test

Kudzai Makomva
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Next Generation Tuberculosis Point of Care Test

Kudzai Makomva

Kudzai specializes in helping public and third sector organizations develop compelling strategies, finance and scale social impact initiatives, and generate rigorous evidence to drive change.

Our go-to-market strategy helped our client create the greatest possible impact through the introduction of their next generation LAM test in Africa.

Our client is a multinational conglomerate that develops innovative products across several sectors including health. They have developed the next generation LAM (lipoaribomannan - a constituent of the cell wall of TB bacteria) test that is a significant improvement on the current LAM product on the market. Existing studies have shown that it is easy-to-use, has good acceptance by the point-of-care users and is practical in resource-poor settings. In addition, the sensitivity of clinical diagnosis is superior compared to the current market availability. This tool is particularly well-suited for diagnosing TB among people living with Human Immunodeficiency Virus (HIV), given that other existing tools do not perform as well in the context of HIV. The same LAM tool, with some modifications, may also be used in the protocol for HIV negative patients.

The Problem

Tuberculosis (TB) is one of the leading causes of death among people living with HIV. According to the World Health Organization , in 2020, an estimated 10 million people fell ill with TB, and 1.5 million people died. 

Rapid diagnosis and effective treatment are vital for stopping the transmission of the disease. There are several highly advanced methods for diagnosis; however, not all of these tests are available in low-resource settings, or at the primary healthcare level, introducing challenges such as slow and complex diagnosis, reduced access to treatment, and the emergence of drug-resistant strains. 

There has been a lack of effective, sensitive true point-of-care diagnostic tools that can be used by healthcare workers in primary healthcare settings with limited resources to diagnose TB in HIV patients. The TB-LAM diagnostic tool that is currently available in the market, and recommended by WHO, has limited sensitivity.  

The Solution

Our client commissioned Market Access Africa to develop a comprehensive TB diagnostic market landscape for ten key African countries, and to develop a comprehensive go-to-market roadmap for each target country.  

We initially performed a competitive landscape assessment, by evaluating the pipeline of emerging products, and a willingness-to-pay analysis, providing a comprehensive overview on the cost threshold perceived as acceptable by different sectors that procure TB LAM.

This informed our go-to-market strategy, which detailed the policy and regulatory requirements for product placement in the public and private sectors. This was accompanied by a practical operational plan, with key recommendations to improve the positioning and competitiveness in the current market. To support this strategy, Market Access Africa further developed an advanced quantitative model to estimate the total addressable market of the South African TB private sector for the period of 2022-2026. These additional insights enabled the client to better understand the market potential beyond just the clinical value but also to support the business case.

The Outcome

Market Access Africa delivered an analysis that allowed our client to prioritize and guide their plans for launching their TB LAM product in the African market. Based on our report, the client has decided to focus their efforts on launching their product in a subset of countries where they can have the greatest impact and where the experience of early adopter countries can support greater adoption across the continent. 

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