In Vitro Diagnostics, key to the advancement of personalized and precision medicine

  • The Federación Española de Empresas de Tecnología Sanitaria, Fenin, has held the conference “IVD Sector: Present and Future Perspectives” as a space for knowledge exchange and to highlight its value through the analysis of trends, sector evolution, improvement initiatives, and the promotion of new areas of collaboration among the various actors of the NHS.

 

  • In Spain, more than 965 million IVD tests were performed in 2024, and around 70 percent of clinical decisions are already based on the results obtained from these determinations.

 

  • Alongside personalized medicine, technological advances in IVD focus on the continuous improvement of workflows to manage the high volume of routine samples, molecular diagnostics, and the application of artificial intelligence and Big Data.

 

In Vitro Diagnostics is of great relevance in clinical practice and modern medicine, both in quantitative and qualitative terms. In Spain, more than 965 million IVD tests were performed in 2024, and around 70 percent of clinical decisions are already based on the results obtained from these determinations. Furthermore, its prominence will continue to grow as, for example, IVD represents a key element for the advancement of personalized and precision medicine when determining the most appropriate treatment. This was reflected upon during the conference “In Vitro Diagnostics Sector: Present and Future Perspectives” which, organized by the Spanish Federation of Healthcare Technology Companies, Fenin, was held at the Hospital Universitario La Paz in Madrid.

 

This conference served as a space for knowledge exchange and to highlight the value of in vitro diagnostics (IVD) through the analysis of trends, sector evolution, improvement initiatives, and the promotion of new areas of collaboration among the various actors of the NHS. The meeting was inaugurated by Rafael Pérez-Santamarina, Managing Director of the Hospital Universitario La Paz, who highlighted that “In Vitro Diagnostics is a strategic pillar for moving toward a more precise, more efficient medicine centered on the real needs of patients. For Hospital La Paz, it is a satisfaction to host this conference, which promotes reflection, analysis, and collaboration among all agents of the healthcare system.

 

For his part, Arndt Knestel, Chairman of the In Vitro Diagnostics Sector at Fenin, highlighted that “the advances in the IVD industry focus on the continuous improvement of workflows to manage the high volume of routine samples, personalized medicine, new care models —for example, as support for healthcare in the patient’s home—, molecular diagnostics, and the application of artificial intelligence and Big Data, among others.” The industry’s commitment to innovation is particularly relevant at a time when the IVD sector faces a very demanding regulatory environment. “The entry into force of regulations such as the European Regulation 2017/746 IVDR on in vitro products has introduced new standards and requirements of complex application that may impact the optimal availability of these products on the market and their access by professionals and patients,” he explained.

 

From the perspective of the clinical laboratory, Antonio Buño, Head of the Clinical Analysis Service at Hospital Universitario La Paz, highlighted that “In Vitro Diagnostics is an absolutely fundamental backbone of the healthcare system. It is not possible to understand modern medicine without Laboratory Medicine. Its contribution to prevention, early diagnosis, and patient monitoring is irreplaceable. Today we have technologies capable of providing increasingly precise information and, together with digital tools, they allow for a more proactive, personalized, efficient, and equitable medicine. The challenge now is to consolidate greater collaboration between industry, clinicians, and managers to accelerate its real implementation for the benefit of the patient.

 

Contribution to personalized medicine

 

IVD is a fundamental pillar of modern medicine, being key to preventive medicine and screening, as well as for obtaining earlier, more personalized, and accurate diagnoses, better therapeutic results, and monitoring.

 

How does IVD contribute to a personalized medicine based on early diagnosis and prevention? This question was analyzed by Fernando Bandrés, President of the Fenin Foundation. “IVD has evolved based on technological innovation, becoming a fundamental instrument for 21st-century healthcare practice, moving beyond the single concept of immediate diagnosis and reaching that of event prediction. Furthermore, it humanizes the care process by bringing decision-making closer to the patient.

 

Trends and evolution of the sector

 

The healthcare contribution of the IVD sector runs parallel to its economic contribution. During this conference, a report promoted by Fenin was presented which, among other matters, analyzes market trends and the evolution of this sector.

 

For example, the report reveals that the in vitro diagnostics market is the leading segment in the medical technology sector, contributing 13.4% of the total turnover of this entire industry in Europe. In the national analysis, Spain ranks as the 4th European market for IVD, with a strong presence of SMEs representing nearly 92 percent of the total companies operating in our country.

 

Nonetheless, as reflected in this report, expenditure on IVD only represented 1.2% of total healthcare spending in 2024, which represents 29.9 euros “per capita.”