Italy In-Vitro Diagnostics (IVD) Market Size, Share, Growth, Trends, and Country Industry Analysis: By Product (Reagents & Kits, and Instruments), By Test Type (Clinical Chemistry, Molecular Diagnostics, Immunodiagnostics, Hematology, and Others),  By Usability (Disposable IVD Devices, and Reusable IVD Devices), By Application (Infectious Disease, Diabetes, Cancer/Oncology, Cardiology, Autoimmune Disease, Nephrology, and Others), By End User (Hospitals Laboratories, Clinical Laboratories, Point-of-care Testing Centers, Academic Institutes, Patients, and Others) and Country

Italy In-Vitro Diagnostics Market size was valued at US$ 3,829.2 million in 2023 and is projected to reach US$ 4,489.9 million by 2030, at a CAGR of 2.3% from 2024-2030. The key factors fuelling are technological advancements, an aging population, and the prevalence of chronic diseases intensifying demands for accurate and efficient diagnostic tests thus, sustaining market growth in IVD. However, some of the major factors restraining the market growth are regulation complexity and strong competition among the players. The trend in point-of-care testing, new applications of artificial intelligence and automation, and investment in health infrastructure, especially from emerging markets provides huge opportunities for the market.

Key Players

Key players in the Italy in-vitro diagnostics (IVD) market include Roche Diagnostics, Abbott Laboratories, Siemens Healthineers, Beckman Coulter (Danaher Corporation), Thermo Fisher Scientific, Qiagen, BioMérieux, Grifols, Hologic, and Mindray. 

Key Takeaways

• Based on the product reagents and kits segment holds a 54.9% market share
• Based on the test type immunodiagnostics segment holds a 32.8% market share
• Based on usability disposable IVD devices segment holds a 64.3% market share
• Based on application cancer/oncology segment holds a 28.9% market share
• Based on end users clinical laboratories segment holds 25.8% market share
• As of September 2024, about 40% of hospitals in Italy have integrated advanced laboratory automation systems, improving efficiency in testing processes.

Facts & Figures

• As of January 2024, approximately 50% of Italian laboratories have adopted point-of-care testing solutions, reflecting a shift towards rapid diagnostics.
• In March 2024, over 25 million molecular diagnostic tests were performed in Italy in the previous year, highlighting the high demand for these technologies
• As of September 2024, about 40% of hospitals in Italy have integrated advanced laboratory automation systems, improving efficiency in testing processes.

Key Developments

• In January 2024: Roche Diagnostics introduced a new line of point-of-care testing devices aimed at enhancing rapid diagnostics in outpatient settings
• In March 2024: Abbott Laboratories launched an advanced version of its molecular diagnostic system, significantly improving testing speed and accuracy for infectious diseases.
• In May 2024: Siemens Healthineers announced the opening of a new research and development center in Italy, focusing on digital health solutions and diagnostics.

Italy In-Vitro Diagnostics Market Segmentation

By Product: In the market, Reagents and Kits and Instruments is the segmentation that would generally indicate that reagents and kits are usually on top in terms of share and revenue. This is primarily because of the role they play across a range of diagnostic applications, such as infectious diseases and oncology, and the need for their frequent replenishment in laboratories. However, the enormous up-front investment and servicing costs of reagents and kits can influence adoption in comparison with more frequently purchased instruments.

By Test Type: The IVD segment has clinical chemistry in a dominating position because routine diagnostics and monitoring of many health conditions including metabolic and organ functions cannot be performed without it. Molecular diagnostics, the next largest segment, has shown very rapid growth with advancing technology and increasing demands for infectious disease and genetic testing. The immunodiagnostic segment also takes on an important role, especially if it is the case of looking for antibody-activity-based assays, while hematology, refers to blood-related tests and hence covers a smaller market share. Overall, however, clinical chemistry will remain the largest segment; molecular diagnostics is one of the ones that will most prominently show strong growth.

By Usability: Segmentation in the market by Usability, Disposable IVD Devices hold the largest share and share in demand. Major reasons are the convenience offered, reducing the potential risk for cross-contamination, and the resulting higher level of care regarding safety and hygiene in health and medicine. Disposable products are widely used in various testing situations ranging from point-of-care testing to laboratory diagnostics. Whereas Reusable IVD Devices include cost-saving and sustainability benefits, above all especially for high-throughput lab operations. However, the adoption of this reagent may be hindered by some protocols in cleaning and care. Overall, although both segments are significant, Disposable IVD Devices are ahead in the market currently, mainly being influenced by disposable's practicality and safety aspects.

By Application: Application is another segmentation type applied to the market, through which the Infectious Disease segment is holding the greatest share and exhibits an especially huge growth trend. Fundamental factors have included the significant upsurge in the spread of infectious diseases and the pace and accuracy of diagnostic solutions, especially highlighted by the pandemic nature of COVID-19. The Diabetes segment remains important as the incidence of diabetes continues to rise and continued monitoring is an absolute necessity. The Cancer/Oncology application also boasts a significant number of patients and is expected to grow, with improvement in personalized medicine combined with targeted therapies. Other important applications include Cardiology, related to the health of one's heart, as well as Autoimmune Disease and Nephrology applications targeting more specific diagnostic requirements. Category of Others This category encompasses a wide variety of applications but constitutes only a small share of the total market.

By End User: Segmentation by End Users in the market, Hospitals and Laboratories remain the largest segment, considering their vast testing capacities and high patient volumes. These settings demand enormous spreads of diagnostic tests for proper patient management and treatment options. Clinical Laboratories are also huge and largely involve routine and specialized testing services that continue to be a huge share of the market. Point-of-Care Testing Centers are witnessing increasing popularity due to the growing demand for timely and accessible testing solutions, especially in remote or underserved regions. Academic Institutes are part and parcel of all research and development that is helping move diagnostic technologies ahead. The Patients segment materializes with home testing solutions for individual patient healthcare needs.