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, 2024, there were 2,510 employees in research and development (2023: 2,522).

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 expenses^1,2 were €636 million (2023: €607 million) in the fiscal year. Research and development expenses^1,2 at Fresenius Kabi accounted for 7.5% of Fresenius Kabi´s total revenue (2023: 7.5%).

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. In these patient groups, every single step is essential for the success of the therapy. Products of Fresenius Kabi make a crucial contribution to the success of the treatment and the interaction between medicine and technology is highly important.

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 increase worldwide; more and more people need access to high-quality therapies. 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 rise 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.

With our Vision 2026 we have defined a clear direction for Fresenius Kabi with three growth areas: the broadening of our biopharmaceutical range, the further development and global introduction of our clinical nutrition products, and expansion in the area of MedTech. In the volume-driven IV business, we will continue to expand our resilience. Our future development work will be geared toward this.

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.

We continue to grow our biosimilars pipeline, with a focus on immunology and oncology. These biologic therapies play a critical role in expanding access and enhancing care for patients and healthcare providers worldwide. Our majority acquisition of mAbxience has proven valuable in diversifying our biosimilars portfolio, bringing more manufacturing activities in-house, and in expanding opportunities for contract development and manufacturing (CDMO).

The launch of our tocilizumab biosimilar Tyenne®, across many European countries contributed to strong growth in 2024. Tyenne® became the first tocilizumab biosimilar approved by the FDA for both intravenous (IV) and subcutaneous formulations, clearing the way for the United States launch of its IV presentation in April and its subcutaneous presentation in June. Health Canada followed suit with a Notice of Compliance for Tyenne® in October, to further expand our footprint in North America.

Biopharma also made key regulatory progress in 2024. In the United States, the FDA accepted our denosumab Biologics License Application (BLA) for review in May, and EMA accepted our marketing authorization application for review in July. We also received approval for our ustekinumab biosimilar, Otulfli®, from both the FDA and EMA in September. The company also established key partnerships to strengthen its position in the biosimilar and CDMO markets. mAbxience signed an agreement with Biosidus to manufacture Agalsidase. A global licensing agreement with Teva was finalized for an oncology biosimilar candidate. Biopharma demonstrated leadership in the biosimilars sector by securing a direct agreement to supply Blue Shield of California with adalimumab-aacf in the United States through EVIO, starting in January 2025. This transparent pricing arrangement represents an innovative approach to biosimilar market access in the United States and positions Fresenius Kabi as a transformative player.

Research and development remain at the heart of Fresenius Kabi’s success, supported by state-of-the-art facilities in Switzerland, Spain, and Argentina. These centers are advancing biosimilars, targeting autoimmune and oncological conditions, to ensure life-changing medicines are accessible to more people around the globe.

Fresenius Kabi is a leading provider of clinical nutrition products as well as related medical-technical products and disposables for administering these products. Clinical nutrition provides care for patients who cannot nourish themselves normally or sufficiently. This includes, for example, patients in intensive care units (ICU) and those who are seriously or chronically ill.

There are two types of clinical nutrition therapy: parenteral nutrition and enteral nutrition. Parenteral nutrition is administered intravenously when the intestinal function is impaired. This is necessary if the condition of a patient does not allow them to absorb and metabolize essential nutrients orally or as sip and tube feed in a sufficient quantity. Enteral nutrition is administered in the form of a sip or tube feed using the gastrointestinal tract. Fresenius Kabi is one of the few companies worldwide to offer both forms of clinical nutrition.

Malnutrition is a common problem in hospitalized patients: Studies carried out in Europe show that one in four patients in hospital suffers from malnutrition or is at risk of malnutrition. The clinical significance of malnutrition results from a less favorable prognosis in terms of morbidity and mortality. Further consequences can be a longer stay in the hospital and higher associated treatment costs. Early and adequate intervention can help prevent malnutrition and its consequences.

In the parenteral nutrition product segment, we focus our research and development on products that help improve clinical treatment and the nutritional condition of patients, as well as on innovative containers such as our multi-chamber bags that are safer and more convenient in everyday use, both in a hospital and in a home care setting.

In 2024, we continued our development work on parenteral nutrition products. We are concentrating on formulations that are tailored to the needs of individual patient groups. In addition to our global development projects, we also work on tailoring our parenteral nutrition products to specific markets and regions.

The use of fish oil in parenteral nutrition continues to be a focus area. Parenteral nutrition containing fish oil has numerous beneficial effects on important biological functions, including the modulation of the immune and inflammatory response. The use of fish oil in parenteral nutrition products may help to improve clinical outcomes and shorten ICU and hospital length of stay, and consequently, result in cost savings.

In the area of enteral nutrition, we are focusing our research and development activities on product concepts that support therapeutic compliance and thus the success of therapy. In particular, the flavor, texture, and formats of enteral products are known to be a critical parameter in ensuring the acceptance of the products and compliance with the nutritional therapy. For years, we have been working continuously to develop products with a wide variety of flavors to offer the users variations and thus provide them with the best possible support to complete the necessary nutritional therapy. Additionally, we are also focusing on addressing new patient segments with the rollout of the Fresubin plant-based drink. Another focus of our work is on the development of products with an increased calorie and protein concentration, as well as assessing the potential of new dietary ingredients with functional properties as well as new formats to improve patient compliance and ease of administration. This way, we make it easier for the user to take in the necessary amount of nutrients in small volumes. 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. CAR-T therapies), the administration of pharmaceuticals through infusion and nutrition pumps, 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, blood donation centers, and plasma centers. 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, a leading infusion therapy company, we have intensified research and development efforts on improving the software for its infusion pumps and infusion management systems (IMS). A key development during the reporting period was the release of the Ivenix software upgrade, which further enhances 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 and Exelia infusion management systems. For the Exelia system, we introduced additional connectivity features such as AutoDocumentation, enabling deeper integration and workflow optimization within intensive care units and operating rooms. The Agilia family of infusion pumps was enhanced with new software supporting market expansion and clinical features, including the Eleveld TCI model.

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. Additionally, we established an external partnership that integrates the CUE product into automation systems aimed at significantly increasing capacity and efficiency in manufacturing certain CAR-T therapies.

For our plasma donation product, Aurora Xi, we developed a software solution to optimize plasma yield and donor efficiency. The corresponding clinical study was successfully completed, and the software update was submitted to the FDA for review in October 2024.

In extracorporeal photopheresis (ECP), we remain focused on the rollout of the Amicus Blue system and the accompanying Phelix light box in Europe, alongside the development of a single-vascular-access ECP application method. This therapy involves treating specific blood cells outside the body with ultraviolet light (phototherapy) and is used for managing various immunological conditions, including the destruction of malignant lymphocytes outside the body.

Fresenius Kabi offers a broad range of intravenously administered generic 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. For example, in the reporting year, we launched the anti-fungal drug Posaconazole, the oncology drug Cyclophosphamide (which is used in several chemotherapy regimens), the emergency opiate overdose treatment drug Naloxone (used in life-threatening situations), and the general anesthetic drug Ketamine (which was under a market shortage). In the Europe region, we launched Thiotepa Inj. (oncology drug, used for conditioning treatment prior to hematopoietic progenitor cell transplantation & solid tumors), Lacosamide Inj. (treatment of seizures), and Rocuronium Room Temperature Stable Inj. (an adjunct to general anesthesia). In key emerging markets (Region International and Asia Pacific), 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 2024, we had more than 100 active generic drug projects.

Our research & 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 safe 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 pre-filled 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.

Within intravenous (IV) Fluids, Fresenius Kabi offers products for fluid and blood volume replacement. IV solutions are used when the body water content or electrolyte balance is impaired, as well as in cases of acute need of energy supply and a lack of salt or specific minerals. They also serve to dilute and as carrier solutions for intravenously administered drugs.

Fresenius Kabi provides a wide range of fluid therapy products, including basic infusion solutions (which consist primarily of electrolytes, carbohydrates, and water), and balanced solutions that help maintain a better acid-base balance and electrolyte levels.

Additionally, we sell blood volume substitution solutions that include hydroxyethyl starch derived from waxy maize. Artificial blood volume replacement products (colloids) are often used to treat patients suffering from hemodynamic instability due to acute blood losses, e.g. resulting from an accident or during surgery.

Fresenius Kabi offers its comprehensive range of products in several containers in different sizes and materials, such as KabiPac® plastic bottles, and our state-of-the-art freeflex® infusion bags, non-PVC and non-DEHP, featuring resealable injection and infusion ports. An increasing quantity of our freeflex® bags are being printed with data-matrix codes.

The portfolio covers irrigation solutions in bags and bottles that are used for rinsing and irrigation before, during, and after surgical procedures, and cleansing of wounds, medical instruments, and equipment.

In the United States, the company has received FDA approval to produce a broad range of IV solutions in Wilson, North Carolina.

We are also expanding our capacity in Europe, to support the increasing demand for products and reduce the risk of shortages of these crucial products in healthcare.

With our product offering, we strive to make the everyday work of healthcare professionals easier, contributing towards their safety and that of the patients.

¹ Before special items

² Before special items and excluding impairment losses from capitalized in-process R & D activities