Publication date: November 07, 2025
The Act of 21 February 2019 (Journal of Laws of 2025, item 259) established a new state institution in the medical sector – the Medical Research Agency. According to Article 1, Section 7 of this Act, the Agency’s objective is to support innovative activities in healthcare, with particular emphasis on the development of non-commercial clinical trials and research experiments. One of its tasks is to support the biomedical sector by financing scientific research and development, as well as strengthening the national capacity to conduct non-commercial clinical trials. Between 2019 and 2021, the Agency contracted research projects worth approximately PLN 1 billion – 50% of the projects concerned specialization projects in oncology and cardiology, which accounted for 67% of the research budget. More importantly, the Agency was tasked with designing the Government Biomedical Sector Development Plan for 2022–2031, for which a PLN 2 billion budget was secured, originating from two sources: the National Recovery Plan and funds from the Medical Research Agency, subsidized by the Ministry of Health. Biomedicine is a field of medicine that utilizes the achievements of biological, biochemical, biophysical, and biotechnological sciences and is widely used in the early diagnosis and treatment of diseases. It utilizes innovative technologies and research results on a large scale. The global biomedical market is experiencing steady growth. Poland aspires to become a leader in this field in Eastern Europe, a goal that cannot be achieved without a unified strategy, hence the decision to create the Plan.
Diagnosis of the Polish biomedical sector
The Medical Research Agency began creating the plan by preparing a diagnosis of the Polish biomedical market, dividing it into several sectors:
• Drug manufacturing sector (pharmaceutical);
• Medical device and equipment manufacturers sector;
• Biotechnology sector;
• Start -up sector.
Pharma sector is undoubtedly the most developed in Poland in the biomedical field. According to 2019 data, domestic drug manufacturers supply patients with 48% of all reimbursed drugs, but this only generates 28% of the total reimbursement from the National Health Fund. The pharmaceutical industry generated approximately 0.8% of GDP in 2019, while in 2022 it was 0.67%. However, this decline in percentage does not reflect the actual contribution of the drug manufacturing sector to GDP, which increased from PLN 16.7 billion to PLN 20.66 billion during the same period, reflecting overall economic growth. The pharmaceutical industry directly or indirectly provides approximately 100,000 jobs, and in 2019, 36% of companies collaborated with scientists and universities. Significantly, the majority of drug production financing (75%) comes from internal funds.
Turning to the medical device and equipment manufacturing sector, this is the most dynamically developing area – in 2018, the Polish market was valued at $2.5 billion (a 40% increase over 2017), and in 2020, it reached approximately $4.7 billion. However, the picture emerging from these rather promising figures is significantly marred by the fact that domestic manufacturers only account for 15% of this market, with as much as 60% of revenue generated from device exports. The main categories of medical devices offered by Polish companies include rehabilitation equipment, orthopedic equipment and prostheses, medical and veterinary instruments, hospital furniture, operating room and intensive care equipment, diagnostic devices (ultrasound machines, X-ray machines), and disposable equipment.
The biotechnology sector is by far the least developed – in 2019, only 181 companies were involved in biotechnology, half of which employed fewer than 50 people. Importantly, however, 63% of companies conduct R&D (research and development) activities, which involves conducting their own scientific research and then using its results to develop new products and implement innovative technologies. The most important part of the biotechnology market is red biotechnology, i.e., related to healthcare and diagnostics. It is based on gene therapies, regenerative medicine, and the creation of biopharmaceuticals using living organisms. According to forecasts, the Polish medical biotechnology market is expected to grow at an average annual rate of 3.4% between 2021 and 2027, reaching a value of $4.8 billion. However, this will still be a small share compared to other countries of similar size (for example, in Spain, the market value is twice as large). The largest segments of the Polish red biotechnology market are vaccines, blood products, and recombinant gene therapies. According to forecasts, the fastest-growing sectors in Poland between 2021 and 2027 will be personalized medicine (6% CAGR) and recombinant gene therapies (5.8% CAGR).
The start-up segment also plays a minor role in the Polish biomedical market. They specialize in bioinformatics and IT applications in healthcare. Importantly, these companies are characterized by a wide variety of medical specialties, with cardiology and psychology accounting for the largest share. Over half of healthcare startups finance their development with grants from the National Centre for Research and Development (NCBR), and 30% receive support from the Polish Agency for Enterprise Development (PARP). The remainder consists of own funds, revenues, and customer contributions. Interestingly, start-ups primarily collaborate with individual scientists, not research centers such as universities, and Academic Business Incubators (ABIs) play no role in financing startups specializing in biomedicine.
While biomedical research is subsidized, the Medical Research Agency, the National Centre for Research and Development, and the National Science Centre spent over PLN 4.2 billion on research and development between 2014 and 2021. However, this doesn’t translate into Poland’s innovation in biomedicine compared to Europe. According to the European Research Index, Poland’s research and innovation intensity index, which measures total domestic research and development expenditure as a percentage of GDP, is 1%, compared to the EU average of 2.1%. Research conducted by the Medical Research Agency (ABM) shows that entrepreneurs identify numerous obstacles to the development of the biomedical market and its innovation, including:
• Legal and administrative – entrepreneurs’ opinions indicate that administrative procedures (reimbursement, tenders) are long and complicated, and legal solutions are inadequate and slow down or even block decision-making, operational and investment processes in enterprises;
• Financial – limited access to financial resources for research and development, inappropriate financing to the specific nature of the business and high costs of operation and development;
• Infrastructure – limited access to research infrastructure, insufficient national know-how and lack of systemic education for the needs of the sector;
• the lack of a comprehensive development strategy for the biomedical sector, which translates into a lack of coordination between individual ministries, as well as the lack of a mechanism to support the domestic production of drugs and medical devices necessary to ensure drug safety.
It follows that the development of the biomedical sector in Poland requires the creation of a supportive system with clearly defined development goals, involving entities conducting scientific research and development (such as universities, research institutes, biotechnology enterprises, start-ups, and scale -ups). In the field of biomedical innovation, we are observing an unprecedented alliance of information technology and computational technologies with biological sciences (e.g., the use of artificial intelligence to model processes at the genome level). The Polish system should adapt to changes in technological development in biomedicine, respond to needs, and remove obstacles to innovation – this role was intended to be fulfilled by the “Biomedical Sector Development Plan for 2022-2031,” completed in 2022.
Biomedical sector development plan for 2022-2031 – planned changes and investments
ABM conducted an analysis of the market situation and market indicators, and also used recommendations from stakeholders in the biomedical sector in the country, which allowed for the definition of priorities towards which the development of the sector should be directed (so-called development domains):
• targeted/personalized medicine developed in the context of gene and cell therapies, immunotherapy and vaccines, small molecule and biological drugs supported by bioinformatics tools and pharmacogenomics;
• biological drugs, innovative methods of producing APIs (active drug substances) and innovative solutions in the field of generic drugs;
• translational medicine, clinical research and solutions supporting treatment effectiveness in the context of patient data and treatment management, legal and governance infrastructure for VBM/EBM (evidence-based medicine that uses the best available scientific evidence, physician clinical experience and patient preferences to make decisions);
• diagnostic, therapeutic and treatment and rehabilitation support tools in the context of patient data and treatment management, legal and management infrastructure for VBM/EBM and the application of bioinformatics solutions.
Key areas related to the health needs of both Polish society and the healthcare system have also been identified – the Plan focuses on research development and protection, primarily in areas such as:
• oncology, in particular: malignant tumors of the trachea, bronchi and lungs, female breast and prostate;
• cardiology, in particular: ischemic heart disease, atherosclerosis and cerebrovascular disease;
• respiratory diseases, in particular: influenza, pneumonia, COPD and asthma;
• infectious diseases;
• metabolic diseases, especially diabetes;
• neurology and psychiatry, in particular depression and dementia.
The Plan therefore takes into account both the market and economic aspects (directional priorities – development domains) as well as the development needs of the healthcare system. It is also intended to address the problems identified by biomedical entrepreneurs, as outlined above. The actions planned for implementation within the Plan are aimed at implementing the so-called “escape forward” scenario – achieving a strong position in one of the biomedical niches and building R&D potential that will spill over into other areas of the economy. In theory, this will allow for the achievement of easily noticeable development effects with a relatively small funding stream. By 2031, the Plan’s authors aim for Poland to become a leader in the biomedical sector in Central and Eastern Europe, leading to the development of the first innovative Polish drug, and leading Poland from a fragmented and inefficient biomedical sector to a Polish Medical Valley.
To achieve its goals, the Agency has identified four areas of development and the actions that must be taken in each. These are:
• Management system;
• Innovative therapies and medicines of the future;
• Medical Devices and Digital Health;
• Developing the sector’s potential.
• Management system – at the initial stage, the most important thing is to properly support the development of innovations during the research phase and the consistent commercialization of emerging medical and technological solutions. The role of the ABM is to ensure coordination, information flow, and actions taken by establishing and launching a monitoring and coordination center for biomedical sector projects in the Republic of Poland, as well as by mapping and verifying biomedical projects in the Republic of Poland with the help of a coordination and monitoring committee – for now, this is only theoretical, as neither has been established to date.
However, at the initiative of the ABM, there was established Health Innovation Hub – this entity is intended to be a place for the exchange of experiences, the flow of ideas, and the establishment and shaping of appropriate relationships between economic, public, and scientific entities collaborating within the biomedical sector. As part of its activities, Health Innovation Hub will review and recommend innovative research and implementation projects conducted by individual partners and their consortia.
Innovative therapies and medicines of the future – the Plan places a strong emphasis on scientific development and the creation of innovative solutions in the field of targeted/personalized medicine – creating medicinal products based on nucleic acids, cell therapy, and protein products, as well as strengthening the pharmaceutical and biotechnology sectors. The challenge currently faced by European countries, including Poland, is drug safety, which should be ensured not only by securing supply chains in crisis situations, but primarily through the development and domestic production of active substances, the development of new pharmaceutical forms of authorized drugs, biosimilars, and innovative solutions in the field of generic drugs. The goal is to implement at least 40 projects that advance to at least Phase I of clinical trials. PLN 750 million (37.5% of the budget) has been allocated to this area, of which PLN 650 million from state funds and PLN 100 million from the National Treatment Programme (KPO).
Medical Devices and Digital Health – the development of telemedicine will be particularly dynamic in the areas of primary care and clinical trials. This involves the development of digital analytical platforms that collect patient health data and analyze it based on AI algorithms, including machine learning. The use of artificial intelligence for disease detection, diagnosis, and treatment is intended to improve the efficiency of the healthcare system – shortening patient treatment times, increasing treatment efficacy, and lowering costs. Development in this area would also involve the development of new diagnostic methods, increasing the accuracy and speed of diagnosis at an acceptable market cost, particularly in oncology and infectious diseases. It is assumed that at least 51 projects will be implemented, reaching at least the MVP/ scale -up phase – creating a minimum viable product and establishing a successful business model. PLN 524.5 million (26.23% of the budget) has been allocated to this area, of which PLN 364 million from state funds and PLN 160 million from the National Health Fund (KPO).
Developing the sector’s potential – at the time the Plan was created, the biomedical innovation system was fragmented, with individual entities focusing solely on tasks within their own areas of activity. Integrating individual areas requires a strong link between the various stages of development, as well as a shift in the ethos of strategic collaboration and thinking in terms of measurable end results (such as patient health and well-being, treatment costs, social costs and impacts, and the economy). In short, in order to develop, the biomedical sector must define the effects it wants to achieve and, to this end, create links between the individual stages of the “chain.” To this end, the plan will create financial instruments for R&D companies, such as grants for companies implementing projects at early TRL levels (a scale used to assess the maturity and technological readiness of a project or technology), acceleration programs for companies supporting start-ups at early TRL, grants for companies with identified technological solutions, and grants for Technology Transfer Centers to support start-up development. The development of a network of Clinical Research Support Centers is also planned. In this area, it is assumed that at least 55 projects will be implemented and 40 new Clinical Research Support Centers (CWBK) will be created, an IT platform for the Polish Clinical Research Network (PSBK), an IT platform for the Polish Clinical Research Network (PSBK), a Polish-language clinical trial search engine will be launched, and awareness and acceptance of clinical trials will be raised. PLN 702.6 million (35.13% of the total) has been allocated to this area. budget), of which PLN 4 million from state funds and PLN 698.6 million from KPO.
Funding will largely be allocated through a competitive process. The Medical Research Agency website features a dedicated “Competitions” tab, which provides access to all current applications (currently one) and completed applications, of which 25 have been completed since 2019.
Sources:
1. Annex to resolution No. 141/2022 of the Council of Ministers of 21 June 2022 – GOVERNMENTAL DEVELOPMENT PLAN FOR THE BIOMEDICAL SECTOR FOR 2022–2031;
2. Polish Agency for Enterprise Development – The Medical Devices and Pharma Sector in Poland Report 2024.