Research and development

New product and process development and the improvement of therapies are at the core of our strategy. Research and development activities mainly take place in the Fresenius Kabi business segment. We focus our R & D efforts on our core competencies in the following areas:

• Generic IV drugs

• Biopharmaceuticals

• Infusion and nutrition therapies

• Medical devices

Apart from new products, we are concentrating on developing optimized or completely new therapies, treatment methods, and services. Research services provided by third parties are mainly used by Fresenius Kabi, especially in the field of biopharmaceuticals.

As of December 31, 2025, there were 2,532 employees in research and development (December 31, 2024: 2,510).

Our main research sites are in Europe, the United States, and India. Product-related development activities are also carried out in China.

Group research and development expenses¹ were €624 million (2024: €636 million) in the fiscal year. Research and development expenses¹ at Fresenius Kabi accounted for 7.4% of Fresenius Kabi’s total revenue (2024: 7.6%).

Fresenius Kabi

Fresenius Kabi’s research and development activities concentrate on products for the therapy and care of critically and chronically ill patients. Our products are used where the patient is most at risk: in emergency medicine, intensive care, special care, and for those who need to be treated in hospital or as an outpatient for a longer period of time. For these patient groups, every single step is essential for the success of the therapy. Fresenius Kabi’s expansive product portfolio focuses on providing access to high-quality and affordable lifesaving medicines and technologies.

We consider it our task to develop products that help to support medical advancements in acute and post-acute care and improve patients’ quality of life. At the same time, our products are intended to enable an increasing number of people worldwide to have access to high-quality, modern therapies.

Chronic diseases are on the rise worldwide; more and more people need access to high-quality therapies treating these upcoming disease patterns. In the care of critically ill patients, the requirements for successful treatment are becoming ever higher. The demand for effective therapies in conjunction with intelligent medical technology applications and devices will continue to increase in the future. We want to be the preferred point of contact for doctors and nursing staff in the care of critically and chronically ill patients.

Our development expertise includes all related components, such as drug-active pharmaceutical ingredients and raw materials, pharmaceutical formulation, primary packaging, medical devices needed for application of drugs and infusions, and the production technology.

In 2025, Fresenius Kabi’s Biopharma business advanced its leadership in biosimilars with significant progress in extending our pipeline. We received U.S. Food and Drug Administration (FDA) and European Commission approvals and launched our denosumab biosimilars, Conexxence® and Bomyntra®, in the United States and Europe for all approved indications of the originator products. Otulfi® (ustekinumab) launched earlier in the year and expanded into multiple markets, and Tyenne® (tocilizumab) continued its growth with full supply chain integration.

Our joint venture with mAbxience delivered further success, including the launch of an anti-PD-1 biosimilar in Latin America, continued growth of bevacizumab and rituximab globally, and EMA and FDA approval for denosumab biosimilars, Izamby® and Denbrayce®. Together, we accelerated tech transfers and achieved full supply chain integration for several of our molecules across our facilities in Austria, Spain, and Argentina.

In 2025, we advanced our high-impact R & D engine, leveraging complementary in-house hubs in Leon, Spain, and Eysins, Switzerland, and strategic partnerships to deliver biosimilars at speed. Our proprietary portfolio selection approach targets molecules with the greatest potential for patient impact and market differentiation, while technical development capabilities – spanning cell line engineering, advanced analytics, and device innovation – enable first-to-market launches and best-in-class product profiles. Our development timelines are being shortened by around 40% through digitalization and platform technologies, and actively collaborating with health authorities to streamline approval pathways. With more than 15 years of biosimilar expertise and nine FDA Biologics License Application approvals since 2022, our R & D teams underpin leadership in regulatory science and affordability. The pipeline was further strengthened by a global licensing agreement for a vedolizumab biosimilar candidate for Crohn’s disease and ulcerative colitis.

Strategic commercial partnerships, including an exclusive U.S. distribution agreement for unbranded ustekinumab and consistent success in European tender markets, reinforced our role as a trusted partner in biologics. We also advanced advocacy efforts to shape the future of biosimilars, supporting policy reforms such as new FDA guidance that streamlines development and approval pathways, helping make these medicines more affordable and accessible worldwide.

Fresenius Kabi plays a central role in global clinical nutrition, supplying not only specialized nutritional therapies, but also the medical devices and disposables required for their safe administration. These therapies are essential for patients who cannot meet their nutritional needs independently, such as those in intensive care settings or individuals living with severe or long-term illnesses.

Clinical nutrition is delivered through two therapeutic approaches. Parenteral nutrition provides nutrients intravenously when the gastrointestinal tract cannot be used, ensuring patients receive adequate nourishment even when oral or enteral intake is not possible. Enteral nutrition, by contrast, relies on the functioning gastrointestinal tract and is administered orally or through feeding tubes. Fresenius Kabi is among the few companies worldwide offering a comprehensive portfolio that covers both modalities.

Malnutrition continues to be a significant concern in hospitals. Evidence from European studies shows that roughly a quarter of all hospitalized patients either suffer from malnutrition or face a substantial risk of developing it. This condition is associated with poorer health outcomes, higher mortality, prolonged hospitalization, and increased treatment costs. Timely nutritional support therefore remains a critical component of high-quality clinical care. Fresenius Kabi pays special attention to the important topic of malnutrition and makes comprehensive educational and promotional efforts to adequately address this subject, and to further improve relevant medical nutrition practices and standards.

Within parenteral nutrition, our development and innovation efforts focus on optimizing clinical benefit and supporting patient recovery. We continue to advance container technologies – such as multi-chamber bags – that contribute to safer handling and streamlined workflows across inpatient and home-care environments, and on expanding and refining formulations designed for the specific needs of distinct patient populations, e.g., pediatric patients. Alongside our global development programs, we continued to align products with the clinical practices and regulatory landscapes of individual regions.

The use of fish oil in parenteral nutrition remains an important area of research due to its positive influence on immune and inflammatory processes. Clinical data increasingly suggest that formulations containing fish oil can support better outcomes, including shorter ICU and hospital stays, with significant potential economic benefits for healthcare systems.

In the area of enteral nutrition, we are focusing our research and development activities on new product concepts that support compliance with nutritional therapy. In particular, the flavor, texture, and formats of enteral products are known to be critical parameters in ensuring acceptance and adherence to nutrition support. With this in mind, we extended our Fresubin 2KCAL Drink range with an additional strawberry flavor, which is known to be one of the most preferred flavors globally.

For years, we have been focusing on the development of new products with increased protein and calorie content to ease patients’ enteral nutrition intake and take into consideration low volume tolerance. With this in mind, we launched the Diben 2 KCAL Drink and CRÈME ranges, a version of our original Diben product targeted at diabetes patients that has higher protein and calorie content, and added the Fresubin PROTEIN Shot at the end of 2025, catering to patients with increased protein needs.

As more individuals are adopting plant-based diets, we are adopting targeted solutions for these new patient segments with the introduction of the Fresubin PLANT-BASED tube feed in 2025, while continuing the rollout of the Fresubin PLANT-BASED Drink.

In addition to global product developments, we are continuing to work on product developments for specific market requirements.

Medical devices are employed in a broad range of applications, including the collection and processing of blood components, the preparation of cell and gene therapy products (e.g., for CAR-T therapies), the administration of pharmaceuticals and (par)enteral nutrition through infusion and nutrition pumps, respectively, and anesthesia monitoring. Most of these systems incorporate disposable components such as collection and processing sets, processing solutions, infusion sets, extension lines, enteral nutrition tubes, and monitoring electrodes, with certain products specifically designed for pediatric use.

In the field of medical devices, we prioritize the continuous enhancement of existing products alongside the development of innovative solutions to expand our portfolio. This sector is especially dynamic, driven by technological advancements. Digitalization plays a pivotal role here, more so than in any of our other product segments. Medical devices must not only evolve in functionality but increasingly integrate seamlessly into the IT ecosystems of hospitals, donation centers, and cell therapy manufacturing sites. More and more, the market is also looking toward the utilization of AI-empowered solutions to drive improvements in operational efficiencies and healthcare outcomes. We currently offer a wide range of connectivity software solutions across our portfolio and are committed to advancing this trend by developing software that enhances efficiency and delivers greater value to our customers.

Following Fresenius Kabi’s acquisition of Ivenix in 2022, a leading infusion therapy company, we have continued research and development efforts focused on improving the software for its infusion pumps and infusion management systems (IMS). A key development during the reporting period was the release of further Ivenix software upgrades, which further enhance the system’s capabilities, including improvements in cybersecurity, workflow optimization, and connectivity with diverse electronic medical record (EMR) systems.

During the reporting year, we also advanced the development of our Agilia infusion management system. The Agilia family of infusion pumps was enhanced with new software supporting market expansion and clinical features, including the Eleveld TCI model. We also further developed connectivity features on our Conox anesthesia monitoring system, adding WiFi connectivity to improve integration in hospital networks as an initial step.

In transfusion technology, our R & D efforts are centered on cell therapy products, particularly for the automated washing and concentration of cell concentrates used in CAR-T and similar therapies. Over the reporting period, we further enhanced the software for our cell therapy products, Lovo and Cue, starting with connectivity via DXT for the Lovo device, which is also planned for Cue in the near future.

Additionally, we progressed external partnerships that integrate the Cue product into automation systems aimed at significantly increasing capacity and efficiency in manufacturing certain CAR-T therapies.

For our plasma collection system, Aurora Xi, we launched the Adaptive Nomogram, a software solution aimed at optimizing plasma yield and collection efficiency. In parallel, we continued to develop additional connectivity features that are intended to further improve operational efficiencies, including enhanced tools for reporting, service, and fleet management. We are also further rolling out our new Compoguard Advance – a state-of-the-art blood mixing and weighing device incorporating a touch screen, data connectivity, and planned RFID functionality – helping to improve blood collection and enrich our portfolio.

Fresenius Kabi offers a broad range of intravenously administered Generic IV Drugs across a wide array of therapeutic categories: oncology drugs, anesthetics & analgesics, anti-infectives, and critical-care drugs. Fresenius Kabi also provides related devices for the administration of these products. The portfolio is geared toward the treatment of and care for chronically and critically ill patients. Fresenius Kabi has a global network of production centers. Fresenius Kabi manufactures finished medicines in its own plants and, at some sites, also active pharmaceutical ingredients (API). Fresenius Kabi’s investments aim, among other things, to continuously modernize and automate the production processes at its plants.

In the area of Generic IV Drugs, we are continuously working on the extension of our product portfolio. In the reporting year, we launched 15 products in the United States, including the anti-infective dalbavancin, the bone health drug Calcitonin Salmon, potassium phosphate bags, the room-temperature-stable formulation of rocuronium, and the prefilled syringe versions of succinylcholine (adjunct to general anesthesia) and ephedrine (treatment of hypotension during anesthesia). In official regions, we launched, among others, penicillin G, azacitidine (an oncology drug mainly used for treatment of myelodysplastic syndrome), and the convenient ready-to-use formulation of tranexamic acid in a KabiPac® (used to combat hemorrhages due to fibrinolysis). In key emerging markets (official regions), we had more than 15 new geographical launches to strengthen our future portfolio pipeline and drive profitable growth.

In addition, we are working on the continuous improvement of IV drugs already on the market. For example, we are developing IV drugs with new formulations and dosage forms, as well as improved primary packaging. In 2025, we had more than 100 active generic drug projects.

Our research and development activities focus on complex formulations, such as a combination anti-infective drug that has already been confirmed as a shared first-to-file abbreviated new drug application (ANDA) submission in the United States, as well as premix formulations, among others. In addition, we are constantly working on product improvements that bring additional benefits to both medical personnel and patients. For example, we develop ready-to-use products that are convenient and are designed to help prevent administration errors in day-to-day medical care. These include ready-to-use solutions in our freeflex® infusion bags, the cost-effective KabiPac® infusion bottle, and prefilled syringes.

To improve drug safety, Fresenius Kabi is implementing a global program to introduce data matrix barcodes on our generic drugs. This initiative is intended to help improve inventory management and reduce errors in the manual entry of drug information in hospital data management systems. We are expanding manufacturing capacities for Generic IV Drugs in Europe and Asia to address the growing demand for essential hospital injectable drugs and to enable the launch of future pipeline projects.

¹ Before special items and excluding impairment losses from capitalized in-process R & D activities