For diagnostic companies to successfully commercialise their first product, they will have to navigate through a plethora of decisions that are essential to enable market entry. To enable these companies to formulate an effective commercialisation strategy, we identified relevant aspects of the business strategy that have to be addressed when developing a diagnostic product.
In recent years, personalised medicine has become more and more important; it enables improved patient care and has the potential to substantially decrease healthcare costs. Biomarkers and their related diagnostic tests enable the identification of the right patient for the right treatment at the right dose. However, while diagnostic tests are able to influence 60% of the clinical decision-making, only 1% of the total healthcare costs are spend on diagnostic testing in Europe.
The development of non-invasive In-Vitro Diagnostic (IVD) tests that allow accurate and early detection of numerous diseases is very attractive; in particular, as there are several issues with the current mostly in-vivo (e.g. to measure within the living body) based diagnostic procedures. However, to properly validate a molecular diagnostic test (and the related biomarkers) to enable market entrance, several steps are essential, such as the establishment of clear cut-offs for treatment decisions and obtaining sufficient sample sizes.
Research performed by Deloitte has previously shown that molecular diagnostic companies should excel in certain business capabilities in order to be successful. The key business capabilities for a successful company include properly addressing compliance, the pricing and reimbursement pathways, regulatory affairs and the involvement in publications and medical affairs. At PNO we now show that successful molecular diagnostic companies should expand these capabilities in order to thoroughly understand and meet the needs of the different stakeholders in the molecular diagnostic market.
An important capability to expand is R&D, and in particular high quality sample database. One of the first findings of this study was that, according to venture capitalists, many molecular diagnostic companies fail to move from retrospective- towards prospective validation. A proposed reason by one of the experts was that many sample databanks that are used for retrospective analysis contain samples that do not have specific and detailed registered patient information. This lack of information could influence, and possibly bias, the retrospective validation of the diagnostic test, especially when ‘profiles’ or ‘fingerprints’ of patients (e.g. the analysis of multiple markers) are generated.
One proposed solution to minimise this introduced bias, is to standardise the registration of patient information. This can be established by introducing a uniform sample registration protocol that applies to all organisations, comparable to patient registration during clinical trials. As a result, retrospective sample analysis could be improved and samples could be sufficiently compared. For the time being, it is important that molecular diagnostic SMEs carefully identify and select their sample databanks.
A major problem is the high costs often associated with sample collection from clinical trials. In order to obtain samples cost-effectively, it is essential to form collaborations and or partnerships with universities and organisations that have high quality sample databanks. To further support these collaboration sit might be worthwhile to invest in relationships with patient organisations of the applicable disease area.
Succesfully commercialising a molecular diagnostic product requires not only robust scientific validation, but also the strategic capability to align with stakeholder needs. By focusing early on high-quality data, standardisation, and smart collaboration, diagnostics companies can strenghten their path to market.
References:
23/09/2025
10/06/2025
28/05/2025
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