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The healthcare (pharmaceutical, biotech and medical technology) industry is among the sectors most actively conducting research, and the demand for new active agents is high. However, most new pharmaceuticals take over ten years to develop, and the granting of market authorization for substances studied in basic research and preclinical studies is in the order of 0.1% [1]. 30 medicinal products with a new active agent were introduced in Germany in 2023: significantly fewer than in the two preceding years (46 in 2021, 49 in 2022). Most of the new market authorizations concerned medicinal products for cancer (12), followed by immunological diseases (6) and infectious diseases (4) [2]. Of the active agents receiving new market authorization in 2022, 59% were biopharmaceuticals, i.e. genetically engineered. Major trends in active agent research and medical treatments are outlined briefly below.
Immunotherapies are a significant trend in oncology [3]. Their purpose is to boost the immune system such that it is able to destroy cancer cells by itself, for example by the use of checkpoint inhibitors, a type of antibody. Checkpoint inhibitors prevent the suppression of the immune response and cause the immune system to increase its attack on the tumour [4]. In CAR T-cell therapy (CAR: chimeric antigen receptor), white blood cells are genetically modified in the laboratory to recognize and selectively destroy cancer cells [5], for example in types of leukaemia resistant to therapy [6], or to combat metastases in the liver [7].
Cancer vaccines have the purpose of inducing an immune response to tumour antigens. To achieve this, the proteins or portions of the tumour antigens are administered as vaccines together with substances that reinforce their effect (adjuvants). Messenger RNA (messenger ribonucleic acid, mRNA) vaccines are an alternative. These use the tumour’s genetic blueprint to stimulate the body to produce specific proteins that trigger a protective immune response. An mRNA vaccine against lung cancer is currently undergoing testing [8], and market authorization for another, against high-risk melanoma, is expected to be granted in 2025 [9]. It is hoped that mRNA vaccines will also be used in the future in non-cancer treatments against autoimmune diseases or for vaccination against the West Nile virus [10].
Another approach to combating the new tropical diseases emerging as a result of climate change, such as the Zika and West Nile viruses, is also based on RNA technology, and addresses the vectors: RNA interference (RNAi) can be used to eliminate the larvae of the invasive mosquitoes selectively and with no wider environmental impact. This molecular biological process deactivates some of the genes needed by the larvae for survival [11; 12].
Genetically modified viruses are capable of multiplying in cancer cells and causing the tumour to burst. They are particularly applicable to tumours resistant to immunotherapy. In Germany As yet, market authorization has been granted in Germany for only one virotherapy, for the treatment of advanced inoperable melanoma; over 200 oncolytic viruses are currently in clinical development [13]. New medicinal products in the category of antibody-drug conjugates are also proving effective against advanced or metastasized breast cancer [14] and liver cancer [15]. Another therapeutic antibody is Lecanemab (Leqembi®), a new medicinal product for treating Alzheimer’s disease. It targets β-amyloid plaques in the brain, clears them and slows cognitive decline [16].
In 2025, researchers at Otto von Guericke University Magdeburg succeeded in synthetically recreating the naturally occurring active agent disorazol Z1, a known anti-cancer agent already the subject of research. Chemical synthesis of the natural substance constitutes a major advance in cancer research. Although the compound’s considerable cytotoxicity prevents it from being used itself as a medicinal product, the disorazol Z1 synthesized in the laboratory - unlike the variant obtained from bacteria - can be selectively modified chemically, enabling it to be bound to antibodies. Whether these future antibody-drug conjugates will prove effective is currently unclear [17].
Together with climate change, the antimicrobial resistance (AMR) of bacteria, fungi, parasites and viruses constitutes one of the greatest threats to health. For a growing number of bacterial infections (including pneumonia, tuberculosis, sepsis and food poisoning), even reserve antibiotics are proving ineffective. Resistance to antibiotics could cause more than 39 million deaths worldwide by 2050 and be a factor in a further 169 million deaths [18].
To combat AMR, not only are new antibiotics constantly being developed; the evolution of bacteria is also being selectively controlled and exploited. Treated firstly with active agent A, bacteria develop resistance to the substance and thus become more sensitive to substance B, with which they are subsequently treated (collateral sensitivity) [19]. Bacteriophages, i.e. special viruses that infect antibiotic-resistant bacteria, also present potential. However, research is still in its infancy, and is costly.
Progress is also being made with vaccines: a new live vaccine against dengue fever has been available in Germany since February 2023 [20]; market authorization for a vaccine against chikungunya fever was granted in the EU at the end of June 2024; and vaccines against West Nile fever and Crimean-Congo hemorrhagic fever are under development [21]. A novel and safe vaccine against COVID-19 is expected to provide a sustained immune response of significantly longer duration than to date [22].
A major focus of modern natural substance research lies upon active agents of marine origin, as aquatic organisms defend themselves with an extensive arsenal of biochemical substances that offer considerable potential as antibiotics, antiviral medicinal products or antitumour agents [23; 24]. For example, marizomib extracted from marine bacteria is currently being tested for its anti-tumour effect against glioblastoma. Natural substances of non-marine origin, too, offer new active agents against infectious diseases and cancer. Bee venom, hesperidin and piperine, for instance, can have a synergistic enhancing effect on the treatment of breast cancer by means of tamoxifen [25].
Glycobiotechnology studies the functions of sugar molecules (glycans/polysaccharides) in living processes and creates new opportunities for the diagnosis and treatment of a range of diseases. Glycans are found in almost all cells and have an important function in cell-cell communication, immune response and tissue organization [26].
Proximity-inducing drugs (PiDs) are one of the most promising categories of active agents. Rather than inhibiting pathogenic proteins in the manner of conventional medicinal products, they destroy them and have a long-term effect by ensuring that proteins associated with disease are broken down. The focus is on cancer, infections and Alzheimer’s disease. Researchers hope to find new medicinal products against multidrug-resistant bacteria [27]. Studies conducted to date suggest that around 80% of harmful proteins associated with disease can be broken down selectively by the use of proximity-based medicinal products [28].
Medicinal products in the category of incretin mimetics (GLP-1 receptor agonists and GIP receptor agonists), antihypertensives originally used for the treatment of type 2 diabetes, are now also being used to combat overweight and obesity. The active agents semaglutide (Ozempic®, Rybelsus®, Wegovy®) and tirzepatide (Mounjaro®) have also been granted market authorization for combating overweight and have been available since 2023 [29; 30]. Similar active agents are currently undergoing clinical trials [31; 32].
Artificial intelligence (AI) can make all phases of medicinal product development significantly shorter and more efficient, from the search for potential active agents to safety assessment and the performance of clinical trials [33]. A pilot study demonstrated the potential of AI in identifying antibiotic-resistant bacteria [34]. An AI-based system (DrugCam®) uses video technology to improve safety and accuracy in the manufacture of cytostatic medicinal products [35]. AI is also being used in the development of new cancer therapies based on mRNA. However, the use of AI in the pharmaceutical industry is still in its infancy and is not yet competitive [36].
The number of systems in the field of robotic-assisted surgery has increased enormously. Robots are being used in a growing number of areas of surgery. They ensure greater precision, improve outcomes and shorten patients’ recovery times. AI-based assistance systems are expected to increase the quality of surgical procedures further [37]. The HUGO RAS robotic-assisted surgery system was used for a urological operation for the first time in Germany in 2023; since 2024, it has also been used for abdominal surgery [38]. 2024 was also the year of the world’s first fully robotic-assisted double lung transplant [39].
Proton therapy is used to treat tumours that are barely accessible, if at all. The energy of the protons, which are accelerated to extreme velocities in the proton accelerator (cyclotron), is released with pinpoint accuracy in the tumour, thereby protecting the surrounding tissue from harm. A new item of equipment that combines real-time, whole-body magnetic resonance imaging (MRI) with proton therapy is expected to improve the precision of treatment for cancer patients [40]. Interventional radiological oncology also uses imaging techniques such as CT or MRI to visualize the exact location of tumours during treatment. These tumours are then destroyed precisely by minimally invasive methods [41].
Xenotransplantation is the use of organs from animals to compensate for a shortage or absence of donor organs. Initial trials with pig hearts and kidneys have been medically successful. Considerable research is still needed, for example with regard to the transmission of pathogens and the risk of recombination of animal and human viruses [42].