The cancer diagnostics market is estimated to reach over USD 311 billion by 2027. In 2019, 7.5 million HER2 tests with a total value of more than USD 4 million were performed globally. We are well prepared for the future commercialisation of our technology.

Breast cancer is the most commonly occurring malignant cancer in women worldwide, with about 1.8 million cases annually, accounting for about 25.2% of all malignant cancers (data for 2019). This is also the leading cause of cancer deaths in women worldwide (Ferlay J, Shin HR, Bray F, et al. Estimates of worldwide burden of cancer in 2008). In Poland in 2019, more than 18,000 women suffered from breast cancer, making 89 cases per 100,000 women (standardised rate). Considering the incidence growth rate, it is estimated that by the end of this decade, over 20,000 of new breast cancer cases will have been reported annually (Didkowska J., Wojciechowska U., Zatoński W. Nowotwory 2009).

Due to a lack of effective primary prevention in breast cancer, most efforts are focused on effective forms of early detection with the chance for a full recovery. When breast cancer affects only a gland, the chance for a full recovery is more than 98.6%. When the cancer is located in the locoregional lymph nodes, the 5-year survival rate is 83.8%. In the case of distal metastases, the 5-year survival rate drops to 23.3% (Howlander N, Noone A, Krapcho M, et al. SEER Cancer Statistics Review). Early detection is of key importance for a full recovery, yet the advantage obtained thereby can be wasted if the interval between the invasive diagnostics and commencement of treatment is too long (Smith R. Duffy S., Tabar L. Breast Cancer Screening: the evolving evidence).

Proper oncological diagnostics should allow:

• the evaluation of the extent of spread of the cancer, i.e. the determination of the clinical advancement,
• the evaluation of the level of physical function of the patient,
• the determination of prognostic and predictive factors to influence the selection of an appropriate oncological therapy
• the confirmation or exclusion of secondary cancer.

HER2 is a glycoprotein fulfilling the function of a membrane receptor, belonging to the family of receptors for epidermal growth factors. HER2 receptor overexpression and/or HER2 gene amplification (HER2-positive breast cancer) occur in about 20%-30% of invasive breast cancers, and is associated with a more aggressive course of the disease and a shorter survival time. The evaluation of HER2 status should be routinely performed in all patients suffering from invasive breast cancer, and an element of a standard pathomorphological examination (Hackshaw A. EUSOMA review of mammography screening).

The histopathological diagnostics market (in the area of all diagnosed markers and cancer mutations) are more than 34 million tests globally, of the total value of USD 16.7 billion. The largest share of this market is for PSA (prostate cancer) and HER2 (breast cancer) tests, BRCA, CEA, CA tests, and KRAS and EGFR mutations, occurring mostly in breast, lung, stomach and large intestine cancers. The total value of all HER2 tests in 2019 was nearly 25% of the total value of all diagnoses of cancer markers and mutations.

The market for HER2 molecular diagnostics is in the growth phase. The annual growth rate of the global market is estimated to be 12% in 2019-2025, and above USD 6.4 billion in 2025. In 2019, more than 7.5 million HER2 tests with a total value of USD 4.1 billion were performed. It is estimated that in 2025 this testing market will increase to USD 6.4 billion.
Source: Transparency Market Research (Cancer Diagnostics Market 2014-2020) / Own assumptions

The North American market (mainly the United States) is largest of the global histopathological diagnostic markets, accounting for about 45% of the global market. The second largest market (22% of the global market) is the key European market: France, Italy, Great Britain, Spain, the Benelux countries, Scandinavia, and the DACH countries (Germany, Austria and Switzerland). The fastest developing markets are China (about 11% of the global market), with the highest annual increase rates due to the intensive development of epidemiology for cancers. Poland accounts for less than 0.5% of the global market, with less than 200 thousand histopathological tests for cancer biomarkers annually.
Source: Transparency Market Research (Cancer Diagnostics Market 2014-2020) / The Issuer’s own assumptions

The current market lacks direct equivalents to the Issuer’s product, but there are solutions that constitute indirect competition at two levels:
commercial (available or developed commercial solutions) and scientific (reports from institutes and universities on the direction of their works and studies).