Market landscape

The first area of technological development for inPROBE^® focused on breast cancer and the measurement of HER2 biomarker expression. The company selected this area due to the aggressive nature of this cancer subtype and the availability of targeted oncology therapies, which significantly increase patients’ chances of overcoming the disease. According to reports, breast cancer is the most common malignant tumor among women worldwide, affecting nearly 2.3 million individuals annually. Each year, more than 666,000 deaths are also attributed to this disease.

The results of clinical trials on the drug fam-trastuzumab deruxtecan-nxki, confirmed by its approval from the U.S. Food and Drug Administration (FDA), have demonstrated that patients with low HER2 biomarker expression in breast cancer—previously classified as HER2-negative—also experience clinical benefits from the use of this medication. These findings are contributing to a shift in the value of markets related, among others, to diagnostic devices used in the pharmaceutical and biotechnology industries. The inPROBE^® technology represents an innovative molecular diagnostic method utilizing fiber-optic optoelectronics, which means that the Company's target market environment will depend on the chosen regulatory pathway.

The global molecular diagnostics market, which is potentially one of the key target markets, reached a value of USD 25.7 billion in 2024, with a compound annual growth rate (CAGR) of 3.9%. Oncology diagnostics is the second most valuable area after infectious diseases. In oncology diagnostics, the so-called gold standard of medical practice is most often a biopsy combined with histopathological examination (IHC) and fluorescence in situ hybridization (FISH) or another approved test from the in situ (ISH) category. Both markets (IHC+FISH) were valued at nearly USD 4 billion in 2023.

Market dynamics

The main distinguishing feature of the molecular diagnostics market is the dynamism and high level of innovation in new technologies being introduced, particularly in the application of machine learning (ML) and artificial intelligence (AI) solutions. This amplifies the need to deliver high-quality preclinical and clinical research results demonstrating usability, efficacy, and safety.

Significant impacts on the industry also stem from changes in laws and regulations related to the introduction of new medical devices to the market and ensuring appropriate quality standards. This fact imposes an obligation on companies to consistently monitor not only the regulations themselves but also their interpretation by various regulatory bodies and entities registering medical devices.

A clear trend of increased activity in mergers and acquisitions remains evident. The growing demand for precise genetic testing, the development of technologies such as PCR and next-generation sequencing (NGS), and the increasing importance of personalized medicine contribute to market consolidation and heightened investor interest. Mergers and acquisitions in the molecular diagnostics sector are driven by the need to integrate advanced technologies, expand service portfolios, and capture new markets.

A significant trend in recent years has been the intensification of collaboration between companies specializing in the development and sale of diagnostic tests and pharmaceutical companies. This is related to the intensive development of so-called targeted anti-cancer therapies (monoclonal antibodies, cell therapies, gene therapies, CAR-T, immunotherapies, etc.), which require precise and targeted biological molecular diagnostics for their increased effectiveness. An example of this is the long-term collaboration between Merck and Myriad Genetics, as well as the companies AstraZeneca and Abbott Technologies. This is an important aspect in the context of commercializing the Company's technology and the potential to build corporate partnerships with pharmaceutical companies.

Currently, there are no devices on the market that are direct equivalents of the Issuer's product. However, there are solutions that represent indirect competition on two levels: commercial (available or developed commercial solutions) and scientific (reports from institutes and universities on the directions of their work and studies). None of the solutions available on the market today offer clinically approved precise molecular detection in the intraoperative field.

In terms of competitive analysis in the commercial sphere, the Company distinguishes four areas of competitiveness:

1. FISH and ELISA methods. Histopathological tests require obtaining a tissue sample (biopsy) and are in vitro tests carried out in external laboratories, on specialized equipment and by qualified personnel (an increasing challenge is the growing shortage of qualified pathologists, which constantly increases the risk of extending the waiting time for results). There are a number of available technologies and manufacturers on the market, among which particular attention should be paid to entities such as: Roche Diagnostics (with Ventana and Cobas technologies), Agilent Technologies, Qiagen, bioMerieux, Novartis, Pfizer, Abbott Diagnostics, Myriad Genetics.
2. Light detection technologies combined with endoscopy, which are based on image analysis, including by reflecting light waves from cancer cells. The techniques used are competitive with mammography and ultrasound.
3. Biosensor technologies employing interferometric techniques enable the measurement of interactions between biological molecules and/or their concentrations. One of the leading providers of such technology is the German company Sartorius, which in 2020 acquired ForteBIO and the Octet technology from the Danaher Corporation in a transaction valued at approximately USD 800 million. This technology is currently available exclusively for research institutions and scientific purposes; it has never been tested or evaluated for use in cancer diagnostics in patients. The chemical components used in this technology are not approved for human use, and as such, the technology should presently be regarded as an indirect competitor, unavailable for clinical applications.
4. Liquid biopsies, which are equivalent to traditional biopsies, with the difference that genetic material is collected from the patient's blood. The liquid biopsy method is much more technologically complex, requiring, among other things, gene sequencing techniques (so-called NGS - Next Generation Sequencing) to detect circulating tumor cells (so-called ctDNA - circulating tumor DNA) in the bloodstream. Liquid biopsies are still very expensive, and their use in cancer diagnostics presents many problems. Currently, in many countries, it is mainly used for monitoring cancer therapies. The largest R&D projects and commercial projects in this area are currently: MDxHealth (USA), Freenome (USA), Glympse Bio (USA), Stemcell Technologies (USA), Abingdon Health (UK). Liquid biopsies should be treated as in vitro diagnostics, and currently, they are very technologically complex (expensive and specialized equipment). In addition, diagnosis often takes weeks due to the fact that tests are conducted in specialized centers.

In the context of epidemiological data regarding the increasing incidence of cancer, the increasingly common use of targeted therapies, and the development of personalized medicine, as well as issues related to currently used methods for assessing biomarker status, it seems that the search for and development of alternative methods that will make this assessment more precise while simultaneously optimizing costs is still a significant and growing need in the medical community.