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Few industries are evolving as dynamically as diagnostics. Technological advancements are leading to increasingly precise analytical methods, while global healthcare needs and new forms of therapy are redefining the requirements for testing systems. At the same time, product complexity is growing: more test formats, more variants, more packaging materials, and significantly stricter regulatory frameworks. For manufacturers, this means an increasing need to automate processes, rethink packaging, and make production lines more flexible.
In this interview, Katrin Müller, Business Development Manager Diagnostics, explains which developments are shaping the industry and how production concepts must adapt to them.
Katrin Müller: The diagnostics market has been growing steadily for years, currently at a rate of about 4–5% annually. This growth is driven primarily by chronic diseases including cancer and diabetes, as well as increased awareness of prevention. In addition, personalized medicine is coming into focus: Companion diagnostics will play a key role in many therapies in the future. Furthermore, point-of-care testing (POCT) is gaining importance. For example, through rapid hemoglobin measurements or rapid cardiac marker tests performed directly at the patient’s location. Overall, the IVD market spans clinical chemistry, immunodiagnostics and molecular diagnostics, hematology, microbiology, and tissue diagnostics.
Katrin Müller: Two developments stand out: Containers are becoming more specialized, and processes are increasingly automated. In terms of packaging, there is a shift from open systems to closed, cartridge-based formats. Customers are increasingly considering serialization and security codes to ensure that only authorized products can be used in their analytical systems. In addition, particularly in molecular diagnostics, the product variety is increasing for many customers, which often requires smaller batches and shorter changeover times in production.
Katrin Müller: Yes. The requirements are increasingly aligning with those of the pharmaceutical industry. The European IVDR (In Vitro Diagnostic Regulation) and FDA guidelines (Food and Drug Administration) in the U.S. are significantly raising regulatory standards. Purity plays a crucial role, particularly in molecular diagnostics, because even the smallest traces of DNA or RNA contamination can lead to erroneous test results. The processes must therefore be designed to be highly secure.
Katrin Müller: Sustainability is clearly gaining in importance. Paper-based alternatives to conventional plastic films are already being discussed and tested. Customers are also exploring the possibility of replacing paper-based labels with digital solutions such as QR codes. Optimized concepts are also being developed in the packaging sector: The goal is to use less packaging material and rely more heavily on sustainable materials.
Katrin Müller: Diagnostics is becoming more specialized, diverse, and regulated. Accordingly, manufacturers need a broad technological portfolio - from filling and sealing to labeling or coding, all the way through to end-of-line processes, freeze-drying, and containment.
Optima is currently integrating technologies from other business areas into diagnostics. This results in modular, highly flexible systems that support new test formats while ensuring high process reliability.
