Since the listing on Nasdaq First North Growth Market in the autumn of 2020, Prostatype Genomics AB has implemented the company's defined commercialization strategy by initiating establishment in the geographic target markets of the Nordic countries, Germany, Italy, the United Kingdom and Spain (including Portugal). The company will conduct operations in these markets in collaboration with partners and under its own auspices with key people contracted. In total, these markets are estimated to have an annual potential of SEK 2.9 billion, of which the addressable market for Prostatype Genomics is estimated to amount to SEK 2.2 billion.
“During the year, we have focused our efforts on building our market organization. By establishing ourselves in our geographical target markets, we now have an infrastructure that creates good conditions for growth. In addition, we have made medical advances in our clinical validation studies that reduce risk and increase our opportunities. With the announcement of our strategy for each market, we want to highlight the potential and the way forward for Prostatype Genomics ", comments Fredrik Persson, CEO of Prostatype Genomics.
Prostate cancer is the second most common form of cancer among men globally with approximately 1.3 million newly diagnosed men each year. The Board estimates that the total addressable global market for Prostatype Genomics amounts to approximately SEK 9 billion. The market is estimated to grow by about 4-6 percent annually.
Prostatype® is the only genetic test for prostate cancer available in kit format. The test shows with high precision how aggressive the prostate cancer is, which makes it possible for the patient and treating doctor to choose the right treatment. Prostatype® can thereby contribute to a better individualized prognosis, the right treatment and large savings for healthcare.
In 2021, Prostatype Genomics has focused on broadening the company's market presence in order to realize the company's potential and conduct validation studies that strengthen Prostatype Genomics's base. During the year, the company successfully expanded its operations to another five markets. The corona pandemic has during the year had a negative impact, with healthcare personnel obviously focusing on conducting tests for the Covid-19 virus, which has resulted in delays in our commercialization process.
However, the pandemic also creates opportunities for Prostatype Genomics. With patients reluctant to visit hospitals or being asked not to visit come if not necessary, a queue of patients have accumulated. The health care systems have a need for implementing new solutions and diagnostic tools to be able to more efficient cut the patient queues and with a higher certainty be able to decide which patients should be treated or not. In this scenario Prostatype® fits very well. We do for example notice a quick and rapid increase of interest for smart and efficient solutions in countries like Germany where specific actions are taken to implement new tools to create more efficient operations.
Prostatype Genomics is now receiving strong indications that the markets are opening and that healthcare personnel are becoming available for additional assignments and therefore assesses that this will have a positive impact on the company's opportunities in the future.
Medical advances in Asia
Prostatype Genomics is currently conducting a clinical validation study in Taiwan. The study is conducted in collaboration with Professor Jacob See-Tong Pang at the prestigious Chang Gung Memorial Hospital in Linkou, Taoyuan. The purpose of the study is to build a network of key people and clinics and facilitate the work of being approved for national compensation systems.
Interim results, presented this year from the study in Taiwan, include 28 patients with an average follow-up period of approximately five years from diagnosis. The results are in line with previous external validation studies that have been conducted in Europe, which means that approximately one third of the patients are reclassified using the Prostatype® test.
The company is also conducting the first pilot study with Prostatype® in Mainland China in collaboration with Nanjing Gulou Hospital, comprising approximately 100 patients. The parties are in the final phase of work on this initial study, which will hopefully open opportunities for initiating a major registration study in this very interesting market.
This means that Prostatype® further strengthens its position as a powerful gene-based biomarker that supports healthcare, patients and physicians in making more accurate, individualized and precise decisions regarding which form of treatment best suits the individual patient.
Established presence in strong geographic target markets
In 2021, Prostatype Genomics has begun establishing itself in the geographic target markets of the Nordic countries, Germany, Italy, the United Kingdom, Spain and Portugal. All these markets have an extensive patient base. Every year, about 450,000 men are diagnosed with prostate cancer in the geographic target markets. The total addressable market is therefore estimated to amount to approximately SEK 2.2 billion. The strategy for processing these is presented below:
In the Nordic region, the market is approached by the company's experienced sales manager Ulrika Flock (PhD), who previously worked at e.g., Sigma-Aldrich, Qiagen and TrioLab. At TrioLab, Flock worked with urology departments and thus has an extensive contact network. Prostatype Genomics believes that direct sales are most effective because the tests will be carried out in a first stage at the company's own laboratory.
In Germany, Prostatype Genomics has established operations by contracting Karlheinz Dewald as Director of Market Development Germany for the company. Dewald has many years of experience from commercial roles in leading companies in areas such as biotechnology, oncology and urology. Most recently, Dewald led the implementation of a new molecular biomarker for oncological diagnostics and treatment monitoring in Germany, Switzerland and Austria.
At the same time, Prostatype Genomics intends to use existing relationships with its partner Proteomedix in Germany and Switzerland to penetrate the market even more efficiently.
The goal is to build market shares through clinical validation studies and by focusing on the private healthcare market. The validation studies will be carried out together with reference clinics using retrospective data in line with the studies that the Company has already presented. As a first step, Prostatype Genomics intends to identify reference clinics together with its local representative. In the longer term, these can lead to publications such as investigator-sponsored studies. In parallel, the company intends to conduct sales, with a focus on private uro-oncology healthcare facilities that invoice patients as well as private healthcare insurance companies.
In Italy, Prostatype Genomics has established operations by contracting Maurizio Ballerini (MD) as Senior Director of Market Development Italy for the company. Ballerini is a medical doctor and has, among other things, worked for medical technology companies such as Abbott Diagnostics and Randox with successful results as responsible for sales of PCA3 tests (tests to determine the risk of developing prostate cancer).
Prostatype Genomics is currently investigating the opportunities in the Italian market in consultation with Ballerini. The company intends to penetrate the market by identifying key people and decision-makers among urologists and pathologists and processing them directly. As in Germany, the Company's focus is initially on the private healthcare market, where the opportunities for rapid growth are clearest.
In August 2021, Prostatype Genomics entered into an agreement with Cambridge Clinical Laboratories ("CCL"). Since 2005, CCL has been a leader in finding and implementing innovative diagnostic and prognostic tools for the benefit of caregivers and patients in the UK and Ireland. Under this agreement, CCL will now offer Prostatype® in its own laboratories, as well as market the test to private uro-oncology facilities across the UK and Ireland.
CCL will target private uro-oncology clinics which provide healthcare to UK citizens who have private health insurance (approximately 12% of the population). In a second stage, when a patient base has been built up, Prostatype Genomics intends to approach public healthcare decision-makers.
Spain and Portugal
In August 2021, Prostatype Genomics entered into an agreement with Eligen Diagnostica and BioPortugal Lda. as the company's distributors in Spain and Portugal. These companies are leading distributors of advanced healthcare solutions in Spain and Portugal and will market and distribute Prostatype®. As for other target markets, the focus is on the private healthcare market in terms of processing. The agreement extends until 2024.
Further geographical expansion in the coming years
Prostatype Genomics intends to establish operations in additional countries in the coming years. Target markets include France, the Benelux countries, the United States, China and the markets in the Middle East and Gulf region. Information about the company's objectives for the coming years is also presented in the company's investment document issued in connection with the company's listing issue.