The diagnostic challenge of helminth infections in sub-Saharan Africa

An unmet need for the diagnostics industry—and a case for designing with African manufacturing and distribution in mind.

For diagnostic manufacturers, a significant healthcare need does not automatically become a sustainable market. A product must answer a specific question, fit the setting in which it will be used, reach a buyer with an available budget and remain operational after installation. Helminth infections in sub-Saharan Africa bring all these requirements into focus.

Parasitic worm infections remain a substantial public-health concern, while diagnostic access and performance can be insufficient for the decisions health services and control programmes need to make. The opportunity spans more than developing a more sensitive assay: it includes affordable hardware, usable workflows, dependable supplies, technical support and data that can guide action.

This is the context for DIDIDI. The project is developing a diagnostic approach for underserved African settings while exploring routes to in-country manufacturing and wider deployment. For industry, the message is clear: there is an unmet African diagnostic need, and DIDIDI is developing an approach with African manufacturing and distribution in mind. Turning that direction into sustainable access will require evidence, viable business models and partnerships across the value chain.

A substantial need, but no single “African market”

WHO estimates that approximately 1.5 billion people worldwide have soil-transmitted helminth infections. Transmission is concentrated in settings where sanitation is inadequate, including parts of sub-Saharan Africa. [1] For schistosomiasis, WHO reports that at least 253.7 million people required preventive treatment in 2024, with an estimated 93.9% of those requiring treatment living in Africa. These are indicators of public-health need, not estimates of diagnostic sales. [2]

The commercial starting point is therefore a set of unmet uses rather than a continent-wide revenue figure. Countries, regions and individual health systems differ in disease distribution, purchasing arrangements, laboratory networks and capacity to finance testing.

A manufacturer entering this field needs to establish where its product provides value. Is it intended for individual patient assessment, district-level surveys, programme monitoring or environmental surveillance? How often is that activity undertaken? Who pays for it, and what existing method must the product improve upon?

These questions matter because the potential beneficiary, user and purchaser may be different organisations or people. A rural community benefits from better surveillance; a field team performs the test; a national programme may approve the method; and a separate procurement organisation may purchase the equipment. A workable market strategy must connect these roles.

The diagnostic gap is already expressed in product requirements

The need for innovation is documented in WHO target product profiles. Its profile for monitoring and evaluating soil-transmitted helminth control programmes identifies limitations arising from sample collection, cost and the need for trained personnel and equipment. New tools are intended to support decisions about starting, adjusting or stopping preventive chemotherapy and assessing elimination as a public-health problem. [3]

The schistosomiasis profiles similarly address monitoring and surveillance. They describe requirements extending beyond test accuracy to portability, training, time to decision and the cost of carrying out a survey. They also recognise that low-intensity infections create difficulties for traditional egg-detection methods. [4]

For product-development teams, these documents provide a useful discipline: begin with the decision the customer needs to make, then define the required performance and operating characteristics. A programme-monitoring product and an individual clinical diagnostic may need different validation studies, reporting formats and distribution arrangements.

Alignment with a target product profile can strengthen a development case, but it does not itself secure regulatory approval or procurement. Companies still need to demonstrate that their product meets its intended claims and that a customer can fund and operate the service.

Identify distinct customers and buying situations

An industry strategy should separate the principal use cases before selecting pricing, channels or product architecture. The following segmentation is a planning framework; it describes potential customer groups rather than confirmed DIDIDI buyers.

Use case	Potential purchasing or commissioning organisations	Central buying question
Individual patient investigation	Health facilities, laboratory networks, public purchasing bodies	Can the service provide a reliable, actionable result within the available budget?
Programme mapping and monitoring	Health ministries, neglected tropical disease programmes, implementing partners	Can surveys produce decision-quality information at an acceptable total cost?
Community or environmental surveillance	Public-health agencies, research programmes, surveillance networks	Does the signal reliably support an agreed public-health response?
Research and evaluation	Universities, research institutions, trial sponsors	Is performance reproducible, documented and suitable for the study purpose?

Each segment implies a different sales cycle and utilisation pattern. A research project may purchase a small number of devices for intensive use during a study. A national programme may need equipment and supplies for geographically dispersed survey campaigns. A laboratory network may require continuous support and replenishment.

Commercial planning should therefore model separate scenarios rather than multiplying disease prevalence by a proposed test price. Relevant assumptions include the number of eligible sites, tests per site, purchasing frequency, available funding, adoption rate and the cost of providing support.

Design for the complete workflow

Diagnostic performance is essential, but it is delivered through a process. Specimens must be collected, prepared, analysed and linked to the correct patient or survey record. Results then need to reach someone authorised to act on them.

For manufacturers, every step is a potential adoption barrier. A device that shortens image analysis may leave sample preparation unchanged. An assay with strong laboratory performance may require storage or handling that is difficult at its intended deployment sites. A digital platform may be useful centrally while adding excessive data-entry work for field staff.

The product specification should address the complete workflow from the outset. This means observing ordinary users, testing realistic sample volumes and understanding the consequences of interruptions. It also means defining how the service operates when a result is uncertain, a consumable is unavailable or equipment fails.

These requirements create opportunities for several industrial capabilities. Instrument manufacturers can contribute durable hardware and repairable designs; assay developers can address preparation and detection; software providers can support reporting; and service partners can organise training and maintenance. The strongest proposition connects these contributions into a service the customer can operate.

Digital microscopy offers evidence of technical promise

Recent field research provides a basis for considering digital microscopy and artificial intelligence. A 2024 study using schoolchildren’s stool samples in rural Kenya evaluated a portable scanning and deep-learning approach in a primary healthcare laboratory. The system detected additional parasite eggs in some samples classified as negative by manual microscopy, with digital review confirming those findings. [5]

A 2025 Kenyan study compared manual microscopy, autonomous AI and expert-verified AI. Diagnostic performance differed between approaches, and expert verification improved sensitivity for the species assessed in suitable smears. [6]

The industrial implication is that the operating model matters. Autonomous analysis, assisted analysis and remote expert review are different products or services, each with its own staffing, connectivity and accountability requirements. An evaluation of one model cannot automatically substantiate the claims of another.

These studies support further development and validation; they do not establish sales volumes, universal savings or performance across all African settings. Companies should examine sample-quality requirements, reference standards and the population studied before using such findings in a commercial case. Evidence that a method works is the beginning of product translation.

Affordability must include the cost of delivering a result

Price discussions often begin with the instrument or test kit. Buyers, however, must fund the whole service: preparation materials, staff time, training, quality assurance, maintenance, reporting and replacement supplies.

A commercially useful comparison should therefore consider cost per usable result or completed survey, alongside the consequences of diagnostic errors. Equipment utilisation also matters. A device used occasionally may have a very different economic profile from the same device used throughout the year.

Manufacturers can improve affordability through several routes, including simpler preparation, longer-lasting consumables, lower power requirements and more efficient support. These benefits need measurement in the intended setting. A lower purchase price may be offset by expensive consumables; a higher initial investment may be difficult to finance even when operating costs are favourable.

Possible business models include direct purchase, leasing or a managed diagnostic service. Each requires scrutiny. Leasing creates recurring payment obligations; a service model must allocate responsibility for downtime; and consumable-linked pricing depends on predictable throughput. The appropriate arrangement should emerge from customer economics and procurement rules, rather than assumptions imported from another market.

African manufacturing starts with product architecture

Local production is receiving growing policy attention. Africa CDC describes an expanded manufacturing agenda encompassing diagnostics and other health products, alongside work on financing, procurement and regulatory collaboration. [7] This provides relevant context for industry, without guaranteeing demand or funding for a specific helminth diagnostic.

For a company considering African manufacturing, the practical question is which activities can be performed sustainably, where and by whom. Possibilities include component production, assembly, assay preparation, packaging, quality control, software support and maintenance. These activities require different equipment, expertise and investment.

Design choices influence their feasibility. A modular instrument with accessible components may support local assembly and repair more readily than a tightly integrated unit dependent on proprietary parts. Assay manufacture introduces its own requirements for materials, batch consistency, stability and release testing.

Localisation should therefore be planned through a staged assessment of capabilities, volumes and quality obligations. It may begin with selected activities while critical components continue to be sourced internationally. Clear agreements on documentation, intellectual property, training and change control are needed if technology transfer is to produce dependable manufacturing capability.

Distribution is part of the value proposition

Manufacturing closer to users can support access, but products still need to reach facilities and remain usable there. Distribution planning should cover warehousing, stock visibility, transport, shelf life, replenishment and technical support.

A distributor’s value extends beyond sales coverage. The partner may need to coordinate installations, train users, maintain spare parts and manage returns. Manufacturers should assess these capabilities directly, including whether support reaches rural deployment sites and how quickly faults can be resolved.

Campaign-based testing presents another planning challenge. Orders may be concentrated around survey periods, while replenishment depends on programme schedules and funding. Such a channel needs a different inventory model from continuous routine testing.

For African and international companies alike, credible distribution arrangements can become an important source of differentiation. A procurement proposal that explains who keeps the service running is more complete than one describing only analytical performance. The costs of that support must be incorporated into the commercial model from the beginning.

Build an evidence package for regulators, users and buyers

Different stakeholders evaluate different questions. Regulators assess the evidence supporting safety and performance claims. Users need to know whether the workflow is practical. Purchasers need to understand costs, support commitments and fit with their service priorities.

Development plans should address all three audiences. Studies should investigate relevant species, sample types and deployment conditions, while documenting invalid results, operator training and quality requirements. Economic evaluation should use observed workflow data wherever possible and make utilisation assumptions explicit.

Regional initiatives may help reduce regulatory duplication. Africa CDC and AUDA-NEPAD have described work on harmonising in-vitro diagnostic regulation, including dossier assessment and independent performance verification. [8] Manufacturers should follow the applicable routes for their product and target countries; regional cooperation does not remove the need to establish country-specific requirements.

Claims also need to remain aligned with intended use. An environmental test, for example, cannot be presented as an individual patient diagnostic simply because it detects parasite material. Similarly, software updates or changes in locally produced components require appropriate control so that performance evidence remains relevant to the product supplied.

Connected data can add value when it serves a decision

Diagnostic information becomes more useful when it reaches clinical records, programme reports or national surveillance systems without unnecessary duplication. For software and instrumentation companies, this creates scope to support traceability, reporting and quality oversight.

Interoperability should begin with the receiving system’s requirements. Customers need clear arrangements for identifiers, data formats, access rights and support. Where connectivity is intermittent, products should specify what can operate locally and how records are synchronised later.

The commercial value of a dashboard depends on its use. A programme manager may need comparable results across sites; a laboratory supervisor may need to identify quality problems; a purchasing team may need consumption data. Each function should be linked to an actual decision and an accountable user.

Data services also create continuing costs and responsibilities. Hosting, updates, security and technical support need a sustainable plan. Transparent terms help customers judge the long-term implications of adopting a platform, including whether their information remains accessible if a contract ends.

How DIDIDI addresses the translation challenge

DIDIDI’s official programme brings together individual digital diagnostics, community environmental testing and links to health-information systems. Its individual diagnostic work includes ruggedised hardware, smartphone-linked operation, on-device algorithms and user-centred development in Uganda and Kenya. Planned field studies address accuracy, speed and usability. [9]

The project also explores business models enabling in-country manufacturing, alongside regulatory and quality-management pathways. Health-economic work is intended to examine cost-effectiveness and budget impact, while stakeholder engagement supports future deployment. [9] These are development objectives, rather than claims that manufacturing agreements, commercial distribution networks or procurement contracts are already in place.

The project’s broader objective is to connect low-cost diagnostics and data systems with improved understanding of helminth and schistosomiasis dynamics in underserved rural communities, including climate-related influences. [10]

For industry, this creates a setting in which product performance can be considered alongside usability, manufacturability and access. The business questions discussed throughout this article explain why those elements matter: a diagnostic becomes valuable when it can be produced consistently, supplied reliably and used for a funded purpose.

Opportunities across the industrial value chain

Companies do not need to manufacture an entire platform to contribute useful capability. Potential areas for industrial engagement include engineering, component supply, assay development, production quality systems, software integration, distribution and field support. The appropriate role would depend on the project’s needs and any agreed partnership arrangements.

Early engagement can help identify issues that are expensive to correct later: unavailable components, difficult assembly steps, uncertain reagent supply or a maintenance model that cannot reach intended users. African partners should help shape these decisions, bringing knowledge of production capacity, purchasing practices and service delivery.

A sensible commercial development sequence begins with a defined use case and customer, proceeds through field evidence and production planning, and then tests the distribution and financing model. Scale should follow demonstrated demand and support capacity. Public-health benefit and commercial sustainability can reinforce each other when these assumptions are made explicit.

A case for building access into the product

The diagnostic challenge of helminth infections in sub-Saharan Africa is a product-development and market-access challenge as well as a scientific one. The unmet need concerns reliable information that health services and programmes can obtain, afford and act upon.

DIDIDI is developing an approach with African manufacturing and distribution in mind. For diagnostic companies, the opportunity is to help turn that direction into a practical supply and service model, supported by appropriate evidence and local partnerships.

Success will depend on the connection between the test and the system delivering it. Performance, production quality, distribution, maintenance and financing all influence whether innovation reaches its intended users. Addressing them together offers the strongest route from an unmet need to sustained diagnostic access.

References

1. World Health Organization. Soil-transmitted helminth infections. Fact sheet, 18 January 2023. WHO.

2. World Health Organization. Schistosomiasis. Fact sheet, 23 February 2026. WHO.

3. World Health Organization. Diagnostic target product profile for monitoring and evaluation of soil-transmitted helminth control programmes. Geneva: WHO; 2021. WHO.

4. World Health Organization. Diagnostic target product profiles for monitoring, evaluation and surveillance of schistosomiasis control programmes. Geneva: WHO; 2021. WHO.

5. Lundin J, Suutala A, Holmström O, et al. Diagnosis of soil-transmitted helminth infections with digital mobile microscopy and artificial intelligence in a resource-limited setting. PLOS Neglected Tropical Diseases. 2024;18(4):e0012041. doi.org/10.1371/journal.pntd.0012041.

6. von Bahr J, Suutala A, Kucukel H, et al. AI-supported versus manual microscopy of Kato-Katz smears for diagnosis of soil-transmitted helminth infections in a primary healthcare setting. Scientific Reports. 2025;15:20332. doi.org/10.1038/s41598-025-07309-7.

7. Africa Centres for Disease Control and Prevention. Africa’s Progress Towards Sustainable Local Manufacturing Health Products. 11 February 2025. Africa CDC.

8. Africa Centres for Disease Control and Prevention. Africa Lists Diagnostics for Priority Diseases. 12 December 2024. Africa CDC.

9. DIDIDI consortium. Project description. Official project website. DIDIDI.

10. European Commission, CORDIS. DIGITAL DASHBOARDS IN DIAGNOSTIC INNOVATIONS—DIDIDI. Grant agreement 101190614. CORDIS project factsheet.

Sources accessed on 13 October 2026. Commercial segmentation, business-model options and industrial implications are analytical proposals, not measured market estimates or confirmed DIDIDI commercial arrangements. Project activities are described as research and development objectives.