| Study Period | 2019 - 2030 |
| Base Year For Estimation | 2024 |
| Forecast Data Period | 2025 - 2030 |
| Historical Data Period | 2019 - 2023 |
| CAGR | 7.50 % |
Major Players
*Disclaimer: Major Players sorted in no particular order |
Italy In-vitro Diagnostics Market Analysis
The Italy In-Vitro Diagnostics Market is expected to register a CAGR of 7.5% during the forecast period.
The studied market was significantly affected by the COVID-19 pandemic, with adverse effects during the initial phase due to lockdowns and shutdowns. For instance, according to a report by the Higher Institute of Health in 2022, it was reported that the screening tests for breast, colorectal, and cervical cancer decreased by 37.6%, 45.5%, and 43.4% in Italy during the pandemic. However, with the sudden outbreak of COVID-19 in Italy, the demand for IVD products increased significantly during the pandemic in Italy. For instance, according to a report by European Centre for Disease Prevention and Control (ECDC), the total number of COVID-19 tests performed in Italy in 1st four weeks of 2021 was 5.5 million, which was increased to 7.5 million in the next four weeks of 2021. Thus, the pandemic increased the utilization of in-vitro diagnostic testing for COVID-19 detection, and it was instrumental in market growth during the pandemic. However, the decreased number of COVID-19 cases and the increased vaccination in Italy reduced the demand for in-vitro diagnostics for COVID-19 detection in the post-pandemic phase.
The rising prevalence of chronic diseases is one of the primary factors driving market growth significantly. An increasing number of patients suffering from several chronic and infectious diseases is increasing the demand for early diagnosis using IVD devices. This is, in turn, increasing the adoption of in-vitro diagnosis for several conditions. For instance, according to an article published by Nova Agency in December 2022, the estimated number of new cancer cases was 390,700 in Italy in 2022. Similarly, according to the International Diabetes Federation (IDF), 4.47 million people in Italy had Diabetes in 2021, which was anticipated to increase to 4.59 million by 2045. Hence, the high disease prevalence among the Italian population is resulting in the increasing demand for early detection of diseases and driving the adoption of in-vitro diagnostic devices in the country.
Moreover, the major players in the country are actively focused on the innovation of technically advanced products, which is expected to benefit the country's target populationuntry for early disease detection. For instance, in May 2022, Mainz Biomed N.V., a molecular genetics diagnostic company, and Dante Labs, a genomics and precision medicine manufacturer, partnered to commercialize ColoAlert in Itoim to detect colorectal cancer at home. Thus, such developments are anticipated to fuel the adoption rate of these devices among the Italian population and drive market growth.
Therefore, the increasing prevalence of chronic diseases in the country and the availability of technically advanced products are expected to boost the in-vitro diagnostics market in Italy. However, the strict regulations applied to diagnostic products are expected to hinder market growth over the studied period.
Italy In-vitro Diagnostics Market Trends
Molecular Diagnostics Segment is Expected to Hold a Major Share in the Market Over the Forecast Period
Molecular diagnostics in in-vitro diagnostics offer several advantages, including high sensitivity, specificity, accuracy, and the ability to detect diseases early. They also provide faster results than traditional methods, critical for timely diagnosis and treatment. Additionally, molecular diagnostics enable targeted therapy and personalized medicine approaches, improving patient outcomes and reducing healthcare costs. Thus, due to the advantages mentioned above, molecular diagnostics is anticipated to have a higher adoption than the other techniques during the forecast period.
In addition, factors such as large outbreaks of bacterial and viral epidemics in Italy, increasing demand for point-of-care diagnostics, and rapidly evolving technology are also expected to impact the molecular diagnostics segment's growth significantly. For instance, according to an article published by the National Center for Biotechnology Information (NCBI) in December 2022, it was estimated that approximately 398,610 individuals in Italy were suffering from hepatitis C virus infection by January 2021. This significant patient population in Italy is fueling the demand and adoption of molecular diagnostic technologies for precise diagnosis and early screening and is subjected to segment growth.
Moreover, advancements in molecular diagnostics followed by new product launches and continuous engagement of the major players in the market are among the key factors expected to boost the segment's growth. For instance, in October 2021, ELITechGroup, an Italy-based company, launched the new CE-IVD stand-alone "Sample-to - Result" real-time (RT) PCR solution called ELITe BeGeniustoo. Similarly, in July 2021, DiaSorin S.p.A., an Italian manufacturer of diagnostics reagents and kits, acquired Luminex Corporation to broaden its position in the molecular diagnostics segment.
Thus, the benefits offered by molecular diagnostics, high disease prevalence, and strategic initiatives by the major players for increasing the availability of IVD instruments are expected to contribute to the segment's growth over the forecast period.
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Instrument Segment is Anticipated to Have a Significant Share in the Market
In In-vitro diagnostics, instruments play a crucial role in the accurate and timely diagnosis of diseases and running various assays. These instruments are designed to perform multiple tasks, such as sample preparation, analysis, and result interpretation. They come in different types, including analyzers, spectrophotometers, chromatography systems, and mass spectrometers. Moreover, the instruments are one of the most essential components of any diagnostic center or clinic, so they are in huge demand.
Increasing initiatives by the Government and private organizations for investment in primary and community care are restructuring healthcare facilities and installation of advanced medical instruments. This is further increasing the demand for in-vitro diagnostic devices in Italy's healthcare settings and supporting the market's growth. For instance, according to an article by European Parliament in December 2021, it was stated that Italy's National Recovery and Resilience Plan includes the establishment of 380 new community hospitals and 1,350 new community health houses. Also, the plan consists of the structural upgradation of hospitals and purchasing of 3,133 state-of-the-art equipment items. Hence, establishing new centers and expanding existing ones are expected to drive the demand for in-vitro diagnostic instruments in Italy over the forecast period.
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Italy In-vitro Diagnostics Industry Overview
The in-vitro diagnostics market in Italy is competitive due to the presence of many global players. Moreover, some domestic players have also been competing in the Italian market. These factors have made the region very competitive. Some of the key players in the market are Abbott Laboratories, Becton, Dickinson and Company, BioMerieux, Bio-Rad Laboratories, Inc., Danaher, F. Hoffmann-La Roche AG, among others.
Italy In-vitro Diagnostics Market Leaders
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Thermo Fischer Scientific Inc.
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Abbott Laboratories
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F. Hoffmann-La Roche AG
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Siemens Healthineers AG
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QIAGEN
- *Disclaimer: Major Players sorted in no particular order
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Italy In-vitro Diagnostics Market News
- In April 2023, Biovica International signed a commercial partnership with IT Health Fusion with an aim to commercialize the DiviTum TKa assay in Italy. This is an in-vitro-diagnostic device that is used for semi-quantitative measurement of thymidine kinase activity (TKa) in human serum.
- In May 2022, the new EU In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR) became effective in Italy with effect from May 26, 2022. Whereas certain legacy devices will benefit from transition periods, all new IVDs and certain low-risk IVDs already on the market are now subject to the IVDR requirements.
Italy In-vitro Diagnostics Industry Segmentation
As per the scope of this report, in vitro diagnostics involves medical devices and consumables that are utilized to perform in vitro tests on various biological samples. They are used for the diagnosis of various medical conditions, such as infectious diseases, cardiovascular diseases, diabetes, and cancer, among other diseases. The Italy In-Vitro Diagnostics Market is Segmented By Test Type (Clinical Chemistry, Molecular Diagnostics, Immuno Diagnostics, and Other Techniques), Product (Instrument, Reagent, and Other Products), Usability (Disposable IVD Devices and Reusable IVD Devices), Application (Infectious Disease, Diabetes, Cancer, Cardiology and Other Applications), and End-users (Diagnostic Laboratories, Hospitals and Clinics and Other End-users). The report offers the value (in USD million) for the above segments.
| By Test Type | Clinical Chemistry |
| Molecular Diagnostics | |
| Immuno Diagnostics | |
| Other Techniques | |
| By Product | Instrument |
| Reagent | |
| Other Products | |
| By Usability | Disposable IVD Devices |
| Reusable IVD Devices | |
| By Application | Infectious Disease |
| Diabetes | |
| Cancer | |
| Cardiology | |
| Other Applications | |
| By End-users | Diagnostic Laboratories |
| Hospitals and Clinics | |
| Other End-users |
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Italy In-vitro Diagnostics Market Research FAQs
What is the current Italy In-Vitro Diagnostics Market size?
The Italy In-Vitro Diagnostics Market is projected to register a CAGR of 7.5% during the forecast period (2025-2030)
Who are the key players in Italy In-Vitro Diagnostics Market?
Thermo Fischer Scientific Inc., Abbott Laboratories, F. Hoffmann-La Roche AG, Siemens Healthineers AG and QIAGEN are the major companies operating in the Italy In-Vitro Diagnostics Market.
What years does this Italy In-Vitro Diagnostics Market cover?
The report covers the Italy In-Vitro Diagnostics Market historical market size for years: 2019, 2020, 2021, 2022, 2023 and 2024. The report also forecasts the Italy In-Vitro Diagnostics Market size for years: 2025, 2026, 2027, 2028, 2029 and 2030.
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Statistics for the 2025 Italy In-Vitro Diagnostics market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. Italy In-Vitro Diagnostics analysis includes a market forecast outlook for 2025 to 2030 and historical overview. Get a sample of this industry analysis as a free report PDF download.
