Supporting the Commercialization of an African-made COVID-19 Diagnostic Kit
June 19, 2024
Our collaboration resulted in a robust business development plan that provided multiple pathways for product distribution, built brand awareness, and mitigated the risk of product expiry
Our client, a not-for-profit diagnostic company, specializes in manufacturing diagnostic kits for diseases prevalent in Africa. Originally, the client aimed to produce regionally relevant rapid diagnostic tests (RDTs) for niche markets not typically targeted by global in-vitro diagnostic (IVD) companies due to small market sizes and irregular demand. However, the COVID-19 pandemic provided an opportunity for the client to receive technology transfers for COVID-19 tests. This allowed them to build out their manufacturing facilities, invest in necessary infrastructure and equipment, and begin scaling their RDT business.
Despite successfully producing millions of COVID-19 antigen professional use RDTs, the client faced several challenges in selling their tests. Entering the market later than other companies meant that key distribution partnerships were already established by competitors. The test also struggled to compete on price against other available products, and the lack of CE marking, combined with limited marketing authorization from national regulatory authorities, further hindered sales efforts. These challenges posed a high risk of the stock expiring on the shelf, which would have significantly impacted the company's working capital. Market Access Africa was engaged to rapidly assess the market opportunity and recommend distribution models to effectively introduce the product into both public and private sectors.
The project was executed in two phases. Initially, we shortlisted countries with the highest potential for sales through government tenders or private sector channels. Our selection criteria included the ease of importing products without CE mark or stringent regulatory authority (SRA) approval, historical procurement patterns by government and private sectors, and the speed of in-country clinical validation and verification studies. Based on these criteria, seven target countries were selected for product introduction.
Following the market assessment, we developed detailed product introduction playbooks for each selected country. These playbooks analyzed market size and potential buyers, outlined the business development steps and actions required to sell the product, and identified key stakeholders and engagement strategies. Additionally, we detailed the clinical validation study processes and timelines. In some countries, we organized scientific advice meetings with regulators on behalf of the client, supported the completion of regulatory dossiers, and identified local representatives who could serve as marketing authorization holders.
Our collaboration resulted in a robust business development plan that provided multiple pathways for product distribution, built brand awareness, and mitigated the risk of product expiry. We crafted clear strategies for entering each target market, including identifying potential buyers and establishing key relationships. By successfully navigating regulatory requirements and facilitating scientific advice meetings, we ensured that necessary documentation was completed efficiently. Multiple distribution models were proposed to ensure the products reached both public and private sector buyers effectively. Our efforts enhanced the visibility of the client’s products through targeted stakeholder engagement and participation in relevant events.
This case study underscores the importance of strategic market assessment, tailored country-specific strategies, and proactive regulatory engagement in successfully introducing new diagnostic products in competitive and complex markets
