Understanding Distribution of Diagnostics inFrench Speaking Sub-Saharan Africa

‍Market Access Africa (MAA): What is the status of the diagnostics in French speaking sub-Saharan Africa (FSSA)?

Thierry Sonkoue: In terms of the overall diagnostics landscape in FSSA, the context is quite diverse, and regional harmonization is not very strong. Despite French being widely spoken, and the presence of two main economic zones (CEMAC and UEMOA), a policy, standard, directive, or even a decision made in one country rarely has significant implications in another. This lack of harmonization or standardization can be seen across most industries, including the diagnostic industry.  As a result, manufacturers aiming to expand in this region must evaluate each country individually, which significantly impacts access particularly in the smaller markets that have a lower commercial appeal. The effort and resources required to understand and unlock most of these markets just isn’t worth it to the manufacturers, so they end up focusing on the big countries like Cote d’Ivoire.

Compared to the other regions, FSSA appears to be lagging behind on the continental local manufacturing agenda, particularly in the area of In vitro Diagnostics (IVD). With the exception of DiaTropix in Senegal, there really is no other local company manufacturing IVD at scale in the region. During the Covid pandemic, a few companies sprung up promising to manufacture locally, with a couple securing manufacturing permits in Cote d’Ivoire, but none of these initiatives have taken off.

"Many countries in the region also require better-equipped laboratories to upgrade their microbiology capabilities, along with qualified engineers for equipment maintenance and reliable supply chains for reagents."

Access to microbiology testing is also another pressing issue in the region. The low number of laboratories in FSSA capable of performing these tests highlights a significant capacity gap, as microbiology labs are essential in combating infectious diseases. While human capital is available, many countries in the region lack expertise in specialized areas like molecular diagnostics and genomics, where competency gaps are clearly evident. Many countries in the region also require better-equipped laboratories to upgrade their microbiology capabilities, along with qualified engineers for equipment maintenance and reliable supply chain for reagents.

Despite these challenges, the IVD market in FSSA has witnessed steady growth over the past several years, due to increasing appreciation and demand for higher-quality diagnostic solutions that is available closer to the patient. A notable example is the segment of rapid diagnostic tests (RDTs), where we as Market Access Africa have been actively involved. Over the past decade, the market structure has evolved considerably. Abbott, formerly Alere, dominated the RDT segment between 2013 to 2023. However, growing competition has diversified the landscape, with companies like CTK Biotech and Wondfo establishing a strong presence in the region. While precise data for FSSA remains limited, we estimate the RDT market in the region to exceed $30 million, within an overall Sub-Saharan Africa market valued at roughly over $200 million. This growth is driven not only by increased adoption, accessibility, and availability of RDTs—particularly for infectious diseases such as HIV, malaria, syphilis, and hepatitis B and C—but also by a marked decline in the use of ELISA tests for screening purposes.

MAA: Could you give us a bit more insight on the structure of distribution for in-vitro diagnostic devices in FSSA countries?  

Thierry Sonkoue: The distribution model in FSSA is quite streamlined, with three key players: the manufacturer, the local distributor, and the end user. This model is also very similar to what you find in other regions in Africa. One would think that, because the number of actors in the distribution value chain is limited, the cost to the end-user will be affordable. However, in reality, patients still end up being charged exorbitant fees for testing in the laboratories for several reasons, including high transfer price from manufacturer, high cost of sales etc. The impact: patients do not get tested because they cannot afford to pay the laboratory fees.

Even insured patients are not spared. There are several examples where they are denied coverage for essential laboratory tests, because the cost of testing exceeds the reimbursable amount. This was the case, for example, during the dengue outbreak in Côte d’Ivoire last year where many insurance operators refused to cover the cost for dengue tests.

"Those that have quality assurance requirements in place mostly enforce it for Global Health donor supported products, such as HIV RDTs."

Now, when it comes to the regulation of diagnostics, most FSSA countries are still in the early stages of setting up stringent processes for regulating in-vitro diagnostics and medical devices. Today, most countries in the region have some regulation or procedures that governs how distribution companies are operated (i.e. a business license), but only a few have quality assurance requirements that the product needs to meet before it is imported. Those that have quality assurance requirements in place mostly enforce it for Global Health donor supported products, such as HIV RDTs. For the products that are not donor-funded, the enforcement of these policies are inconsistent with global standards.

MAA: What are some dynamics that make the management of IVD and medical devices unique in FSSA countries? 

Thierry Sonkoue: In FSSA countries, the distribution of IVDs is predominantly controlled by local distributors, who hold significant influence over distribution and accessibility. Alternative channels often see limited uptake—even for recommended self-testing tools like HIV and malaria kits. While there are initiatives to expand these channels, progress remains limited.

"...the lack of a favorable ecosystem has hindered the growth of local manufacturing projects in FSSA countries."

Furthermore, regulatory enforcement for diagnostic products presents a major challenge. IVD regulation in FSSA countries is still in its early stages, and a significant proportion of diagnostic tools in use are unregistered, reflecting this gap inregulatory maturity.

Lastly, the lack of a favorable ecosystem has hindered the growth of local manufacturing projects in FSSA countries – factors such as human resources capability, financing, sufficient demand, dependable procurement signals from government, favorable policy environment supporting purchase of locally made products etc. Without this, it is inconceivable to expect manufacturers to invest in local production, even though everyone recognizes it is the right thing to do. Consequently, the market continues to heavily rely on imports from Europe, the United States, and China.

MAA: One thing we observe is that there's a large collaboration between FSSA countries and France. Why does this collaboration exist?  

Thierry Sonkoue:  The significant influence of France on diagnostics in FSSA countries stems from several factors. Historically, many of the leading professionals and specialists in diagnostics—such as researchers, pathologists and lab technicians—completed their studies in francophone countries like France, Belgium, and Switzerland. These professionals developed their expertise based on France’s frameworks and continue to collaborate with mentors and professional groups from these countries. This has meant that the diagnostic landscape in FSSA has been shaped in the image of the French framework.

"With institutes in Senegal, Cameroon, Côte d’Ivoire, Central African Republic, and Madagascar, this network has historically provided disease surveillance, public health support, and diagnostic projects, further strengthening France’s influence inthe region."

Another contributing factor is the Institut Pasteur’s extensive network of specialized laboratories across the continent. With institutes in Senegal, Cameroon, Côte d’Ivoire, Central African Republic, and Madagascar, this network has historically provided disease surveillance, public health support, and diagnostic projects, further strengthening France’s influence in the region. These labs continue to play a vital role in addressing public health challenges and improving diagnostics services.

Additionally, French universities, such as the University of Bordeaux and the University of Montpellier, have launched numerous projects that support professionals working in FSSA. Suppliers also play a significant role; for example, bioMérieux has operated in French-speaking Africa for a long time, offering microbiology support and training. Other companies with strong French roots have expanded tothe region, maintaining ties to France for their diagnostic products.

MAA: What is your opinion on this FSSA-France collaboration?

Thierry Sonkoue: In my view, this collaboration has both its strengths and weaknesses.

The benefits of collaboration with France are considerable in research, diagnostic practice, and access to products. For example, the Institute Pasteur network hosts numerous research units and projects that support diagnostic professionals. Some, like the Centre Pasteur of Cameroon, even include training centers for laboratory technicians—key to building human resources in diagnostics. Also, academic exchanges between France and FSSA countries remains very strong and contributes greatly to continuous training.

French companies in the IVD industry often bring their innovations to FSSA region faster than other global players, because there is an intrinsic understanding and pathway-to-market that has remained unchanged since the colonial days. The more competitive these companies become, the quicker the region gains access to advanced technologies. Take Vitek MS Prime solution from bioMérieux; this product was launched in EU and FSSA only a year apart, which is shorter than what you see in other regions in Africa.

I also believe that the monopoly of medical acts—specific to the Francophone model—remains an advantage, despite ongoing debate. In this model, doctors prescribe, pharmacists dispense, and medical biologists oversee laboratory tests. This clear division of responsibilities helps ensure the quality of care.

"Companies in non-French speaking countries (think USA, South Korea, China) also struggle to understand, penetrate and build relationships in the region due to the language barrier."

However, the use of French in scientific research and within the broader global health environmentcan be a barrier for Francophone professionals. Publishing is already a demanding process, and doing so in English requires additional effort, as it involves translating work into another language in order to reach high-impact journals. Because of this, some francophone professionals’ work and research fail to reach a wider global audience and fails to have the influence on the landscape that it should.

Companies in non-French speaking countries (think USA, South Korea, China) also struggle to understand, penetrate and build relationships in the region due to the language barrier, which significantly restricts the regions access to mostly the French companies.

MAA: What feedback from major distributors do you think would be useful to know for those interested in entering and engaging the FSSA market?  

Thierry Sonkoue: The distributors have played and continue to play a big role in securing access and availability to diagnostic tools. I will simply say that the best way to approach a distributor in French speaking Africa is to really think about the landscape in terms of diseases and come with a portfolio of products. What are the unmet needs? How are the products in your arsenal responding to these needs? And what portfolio of products would be considered attractive to the local distributors? It is important that they think about their portfolio and not just a product.  

"I find that most manufacturers do not do enough analysis of the local market before setting their transfer price."

FSSA region is highly price sensitive like most regions in Africa, and it is extremely important to approach the distributors with a well-informed price in mind. I find that most manufacturers do not do enough analysis of the local market before setting their transfer price. They do not conduct their own local market research before deciding which markets are commercially viable to enter.  Consequently, when a local distributor approaches them to buy their product, they don’t know what price to apply for the market, often resulting in a mismatch in pricing expectations between manufacturer and local distributor. This is something manufacturers need to take seriously and consider while building their global marketing activities, and not after the fact.

In many cases across FSSA, the distributor contracts are not fully understood by the distributors themselves. Quite often, both distributors and manufacturers focus narrowly ontransactions—buying and selling—while overlooking the importance of clearly defined agreements. It is crucial for manufacturers to take the lead in developing contracts that clearly outline roles, responsibilities, and expectations, ensuring that distributors fully grasp the terms before signing. When this clarity is established, it not only builds trust but also enhances business performance—because while distributors care deeply about what they sign, they may not always fully comprehend the implications.

MAA: How then does one achieve success in engaging stakeholders in FSSA?  

Thierry Sonkoue: In Europe and other high-income markets, efforts are underway to reduce the volume of diagnostic tests performed, and to move to a more targeted personalized approach. Africa is the opposite. We need to increase both the quantity and quality of testing. Many tests conducted in FSSA countries lack value, and the current testing volume is insufficient to effectively combat diseases on the continent. By increasing the quantity and quality of tests, FSSA countries increase the chances of having reliable data to effectively respond to disease outbreaks.

"Collaboration with public health agencies and organizations like Africa CDC and ASLM is also vital."

To achieve this, engaging in discussions with physicians is essential. By training manufacturers and distributors to collaborate with healthcare providers, a strong relationship between clinicians and lab professionals can be established, ensuring patient-centered decision-making. This approach can significantly enhance the quality and quantity of tests.

Collaboration with public health agencies and organizations like Africa CDC and ASLM is also vital. It's important for key decision-makers to recognize that investing in diagnostics can ultimately reduce treatment and healthcare costs.

MAA: Is there a final thought you would like to share?  

Thierry Sonkoue: Manufacturers, especially those facing language barriers with FSSA countries, must recognize that these regions face similar health challenges as other countries, sometimes with even greater intensity. In French-speaking Africa, there's a pressing need to address diseases like malaria, HIV, tuberculosis, and hepatitis B and C, as well as the growing issue of antimicrobial resistance.

Understanding the potential from an external perspective can be challenging. While manufacturers can easily access top distributors, the real challenge lies in developing a market-appropriate plan before engaging with them. Those aiming to enter French-speaking Africa should craft a comprehensive strategy, leveraging the right data and context-driven insights.

The demand exists; the key is capturing it and working closely within a country to make this demand more apparent.

About Thierry Sonkoue

Thierry Sonkoue is a Senior Specialist in Diagnostic and Medical Device Access at Market Access Africa.

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