Italy In-Vitro Diagnostics Market will reach US$ 3.59 Billion in 2028, according to Renub Research. In vitro means "in glass," indicating that the tests are conducted in controlled laboratory conditions rather than within a living organism. IVD, or In Vitro Diagnostics, are medical tests performed in a lab on samples like blood or urine. They help diagnose diseases, monitor treatment progress, and provide health information. IVD encompasses various tests like clinical chemistry, immunoassays, molecular diagnostics, microbiology, hematology, and histopathology. Common examples include glucose monitoring, cholesterol testing, pregnancy tests, HIV testing, genetic testing, and cancer biomarker analysis. IVD is vital for disease screening, early detection, patient management, and treatment monitoring, leading to improved outcomes and personalized medicine.


Italy In-Vitro Diagnostics Market shall grow at a CAGR of 6.65% during the forecast period of 2022 to 2028

The rising number of cases of chronic and infectious diseases and the aging population majorly add to Italy in-vitro diagnostics market growth. The publication titled "cardiovascular disease (CVD) Burden: Italian and global perspectives," available on Europe PMC, highlighted that Italy exhibits a substantially higher prevalence of cardiovascular disease (CVD) in comparison to the global average. The report indicates that Italy CVD prevalence is nearly double the global average (12.9% vs. 6.6%), while age-standardized figures show relatively similar rates (6.2% vs. 6.3%).

Additionally, technological advancements, government initiatives, healthcare reforms, growing emphasis on personalized medicine, and increasing awareness and patient empowerment will further improve Italy in-vitro diagnostics market in the future. Hence, the market value for Italy’s in-vitro Diagnostics Market was US$ 2.44 Billion in 2022.


Services shall thrive in the Italy in-vitro diagnostics market

Italy’s in-vitro diagnostics market is categorized into three product segments: Services, Instruments, and Reagents. Services dominate the Italy in-vitro diagnostics market due to factors such as the complexity of IVD tests and devices, regulatory compliance, training and education needs, customization and integration services, and value-added support. With sophisticated technologies requiring specialized expertise, service providers are relied upon for proper handling and maintenance. In addition, strict regulations ensure patient safety and reliability, increasing the demand for technical services. Providers also offer training programs, customization, and additional support beyond installation and maintenance. These factors collectively drive the leadership of services in Italy in-vitro diagnostics market.


PCR tests shall continue to have the highest market share in the Italy in-vitro diagnostics market

In the Italy in-vitro diagnostics market, there is a range of test types available, including ELISA & CLIA, PCR, Rapid Test, Fluorescence Immunoassays (FIA), In Situ Hybridization, Transcription Mediated Amplification, Sequencing, Colorimetric Immunoassay, Radioimmunoassay (RIA), Isothermal Nucleic Acid Amplification Technology, and Others.PCR tests are known for their high sensitivity and specificity, allowing for accurate detection and identification of pathogens or genetic material, contributing to their widespread adoption. PCR technology has many applications beyond infectious disease diagnosis, including genetics and forensics.

PCR tests offer relatively quick turnaround times and have the advantage of being available on various platforms, which facilitates scalability. Furthermore, PCR tests have a long-established track record of diagnostics validity and regulatory approval, which has instilled confidence in healthcare providers. Finally, the COVID-19 pandemic has played a central role in the widespread adoption of PCR tests, further contributing to their high share in the Italy in-vitro diagnostics market.


Infectious diseases application is fastest growing in the Italy In-vitro diagnostics market

In the Italy In-vitro diagnostics market, various applications are of significant importance, including Infectious Diseases, Diabetes, Cardiology, Oncology, Nephrology, Autoimmune Diseases, Drug Testing, and other applications. Increased global travel and migration have facilitated the spread of infectious diseases across borders, making Italy susceptible to their introduction and transmission. Additionally, changing demographics and lifestyle factors, such as urbanization, population density, and high-risk activities, contribute to transmitting infectious agents.

Antimicrobial resistance has also played a significant role, highlighting the need for accurate diagnostics to guide appropriate treatment decisions. Outbreaks and epidemics, such as influenza, measles, and COVID-19, have increased the demand for rapid and accurate diagnostics for timely intervention and public health management. Increased awareness and proactive screening programs have further contributed to the growth, as they help identify infected individuals early and initiate appropriate treatment. Technological advancements, including molecular diagnostics and rapid point-of-care testing, have improved infectious disease diagnostics’ capabilities and accuracy, fuelling their market growth.


Molecular Diagnostics/Genetics shall flourish during the forecast period

In the Italy In-vitro diagnostics market, various technologies are utilized, including Immunoassay, Clinical Chemistry, Molecular Diagnostics/Genetics, Hematology, Microbiology, Coagulation, and other technologies. Technological advancements like PCR, NGS, and gene expression profiling have improved genetic testing accuracy and accessibility. A greater understanding of genetics in disease development has increased the demand for molecular diagnostics. Precision medicine tailors’ treatment based on genetics, biomarkers, and disease characteristics, contributing to growth.

In cancer diagnostics, molecular diagnostics enable early detection, accurate diagnosis, and personalized treatment plans. Government initiatives support molecular diagnostics adoption through research investment and reimbursement policies. The rising demand for early disease detection and prevention fuels molecular diagnostics growth in the market. These factors drive growth, enhancing diagnostics capabilities and personalized medicine approaches, especially in cancer diagnostics.


Hospitals continue to have sovereignty in the Italy In-vitro diagnostics market

Segmentation of Italy’s in-vitro diagnostics market based on end-users can break into four divisions: Hospitals, Laboratories, Home-Care, and Other sectors. Hospitals dominate the Italy in-vitro diagnostics (IVD) market due to their comprehensive healthcare services and seamless integration of diagnostics with other specialties. They possess the necessary infrastructure, resources, and skilled personnel for a robust IVD operation.

Being primary points of care, hospitals offer a wide range of medical services and act as referral centers. Their diverse clinical specialties ensure accurate diagnosis and interpretation of IVD test results. In addition, hospitals benefit from favorable reimbursement and funding mechanisms and adhere to stringent regulatory requirements, ensuring patient safety and test accuracy.


Key Players

In the Italy in-vitro diagnostics market, notable companies include Roche Diagnostics, Abbott Diagnostics, Siemens Healthineers, Danaher Corporation, Thermo Fisher Scientific, and Sysmex Corporation.

In May 2022- The European Union’s new In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR) took effect in Italy on May 26, 2022. While some existing devices are granted transition periods, the IVDR requirements now apply to all new in vitro diagnostics (IVDs) and specific low-risk IVDs already available in the market.


Renub Research report titled ?Italy in-vitro diagnostics Market Global Forecast by Products (Services, Instruments, and Reagents), Test Types (ELISA & CLIA, PCR, Rapid Test, Fluorescence Immunoassays (FIA), In Situ Hybridization, Transcription Mediated Amplification, Sequencing, Colorimetric Immunoassay, Radioimmunoassay (RIA), Isothermal Nucleic Acid Amplification Technology, and Others), Application (Infectious Diseases, Diabetes, Cardiology, Oncology, Nephrology, Autoimmune Diseases, Drug Testing, and Others), Technology (Immunoassay, Clinical Chemistry, Molecular Diagnostics/Genetics, Hematology, Microbiology, Coagulation, and Others), End-Users (Hospitals, Laboratories, Home - Care, and Others), Company Analysis (Roche Diagnostics, Abbott Diagnostics, Siemens Healthineers, Danaher Corporation, Thermo Fisher Scientific, and Sysmex Corporation)" provides a detailed analysis of Italy in-vitro Diagnostics Market.


Products - Market breakup from 3 Viewpoints:

1. Services
2. Instruments
3. Reagents


Test types - Market breakup from 11 Viewpoints:

1. ELISA & CLIA
2. PCR
3. Rapid Test
4. Fluorescence Immunoassays (FIA)
5. In Situ Hybridization
6. Transcription Mediated Amplification
7. Sequencing
8. Colorimetric Immunoassay
9. Radioimmunoassay (RIA)
10. Isothermal Nucleic Acid Amplification Technology
11. Others


Application - Market breakup from 8 Viewpoints:

1. Infectious Diseases
2. Diabetes
3. Cardiology
4. Oncology
5. Nephrology
6. Autoimmune Diseases
7. Drug Testing
8. Others


Technology - Market breakup from 7 Viewpoints:

1. Immunoassay
2. Clinical Chemistry
3. Molecular Diagnostics/Genetics
4. Hematology
5. Microbiology
6. Coagulation
7. Others


End-Users - Market breakup from 4 Viewpoints:

1. Hospitals
2. Laboratories
3. Home – Care
4. Others


Company has been covered from 3 Viewpoints:


  • • Overview
    • Recent Development
    • Revenue




Company Analysis:

1. Roche Diagnostics
2. Abbott Diagnostics
3. Siemens Healthineers
4. Danaher Corporation
5. Thermo Fisher Scientific
6. Sysmex Corporation