The Italy In-Vitro Diagnostics Market Report is Segmented by Test Type (Clinical Chemistry, Molecular Diagnostics, and More), Product (Instruments & Analyzers, and More), Usability (Disposable IVD Devices and Reusable IVD Devices), Application (Infectious Disease, Diabetes, and More. ), Mode of Testing (Laboratory-Based Testing and Point-Of-Care Testing), and End-Users (Diagnostic Laboratories, Hospitals and Clinics, and More).

The Italy In-Vitro Diagnostics Market valued USD 1.52 Bn in 2023, and it is projected to hit USD 1.93 Bn by 2030

The Italian In Vitro Diagnostics (IVD) market, valued at approximately €X million in 2025 (estimated based on provided CAGR and market size), is projected to experience robust growth, driven by factors such as an aging population, rising prevalence of chronic diseases (diabetes, cancer, cardiovascular diseases), and increasing government initiatives to improve healthcare infrastructure. The market's 7.50% CAGR from 2019 to 2033 indicates a consistent upward trajectory. Key segments contributing to this growth include clinical chemistry, molecular diagnostics, and immunoassays, fueled by technological advancements leading to faster, more accurate, and higher-throughput diagnostic testing. The demand for both disposable and reusable IVD devices is expected to remain strong, with hospitals and diagnostic laboratories representing the largest end-user segments. However, challenges such as stringent regulatory approvals, high costs associated with advanced technologies, and potential reimbursement issues could moderate market growth to some extent. The competitive landscape in the Italian IVD market is characterized by the presence of both global giants like Abbott Laboratories, Roche, and Siemens Healthineers, as well as smaller, specialized players. These companies are engaged in strategic initiatives, including product innovation, mergers and acquisitions, and collaborations to strengthen their market position and expand their product portfolio. The focus is shifting towards personalized medicine and point-of-care diagnostics, further boosting market expansion. This trend is particularly relevant in light of Italy's focus on improving healthcare accessibility and efficiency, creating opportunities for innovative IVD solutions. Future growth will likely depend on adapting to evolving healthcare policies, continuous technological advancements, and effective strategies to address the challenges mentioned earlier. The market's expansion will continue to be shaped by the increasing demand for early and accurate disease detection and management. Recent developments include: 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.. Key drivers for this market are: Rising Prevalence of Chronic Diseases, Increasing Use of Point-of-care (POC) Diagnostics. Potential restraints include: Rising Prevalence of Chronic Diseases, Increasing Use of Point-of-care (POC) Diagnostics. Notable trends are: Molecular Diagnostics Segment is Expected to Hold a Major Share in the Market Over the Forecast Period.

In 2021, Italy experienced an increase of almost *** million euros in the size of the in vitro diagnostics (IVD) market compared to the previous year, reaching a total market size of over *********** euros. This statistic displays the Italian IVD market size in 2020 and 2021.

The size of the Italy In Vitro Diagnostics Industry market was valued at USD 129 Million in 2023 and is projected to reach USD 145 Million by 2032, with an expected CAGR of 7.50% during the forecast period. Recent developments include: 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.. Key drivers for this market are: Rising Prevalence of Chronic Diseases, Increasing Use of Point-of-care (POC) Diagnostics. Potential restraints include: Stringent Regulations. Notable trends are: Molecular Diagnostics Segment is Expected to Hold a Major Share in the Market Over the Forecast Period.

The Italy In Vitro Diagnostics Market size was valued at USD 4224.01 USD Million in 2023 and is projected to reach USD 6393.41 USD Million by 2032, exhibiting a CAGR of 6.1 % during the forecasts period.

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In-Vitro Diagnostics (IVD) Market Size 2025-2029

The in-vitro diagnostics market size is valued to increase USD 28.8 billion, at a CAGR of 4.6% from 2024 to 2029. Increasing geriatric population, chronic and infectious diseases will drive the in-vitro diagnostics (ivd) market.

Major Market Trends & Insights

North America dominated the market and accounted for a 44% growth during the forecast period.
By Product Type - Reagents and kits segment was valued at USD 70.30 billion in 2023
By Technology - Immunoassay segment accounted for the largest market revenue share in 2023

Market Size & Forecast

Market Opportunities: USD 41.35 billion
Market Future Opportunities: USD 28.80 billion
CAGR : 4.6%
North America: Largest market in 2023

Market Summary

The market represents a significant and continually evolving sector within the healthcare industry. This market encompasses a range of diagnostic tests conducted outside the body, utilizing various core technologies such as immunoassays, molecular diagnostics, and clinical chemistry. The applications of IVDs span from infectious disease testing to genetic screening and drug monitoring. The global adoption of advanced treatment solutions and the increasing geriatric population are major drivers propelling the growth of this market. 
Stringent regulatory bodies, such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), guide in-vitro diagnostics manufacturers, ensuring the highest standards for accuracy and safety. However, challenges persist, including the high cost of IVDs and the need for continuous innovation to address emerging diseases and diagnostic demands. Despite these hurdles, opportunities abound, particularly in emerging markets and in the development of point-of-care (POC) diagnostics, which offer increased accessibility and convenience. In summary, the In-Vitro Diagnostics Market is a dynamic and essential component of the healthcare industry, driven by technological advancements, demographic shifts, and regulatory requirements.
With a projected growth rate of approximately 5% per year, this market is poised for continued expansion and innovation.

What will be the Size of the In-Vitro Diagnostics (IVD) Market during the forecast period?

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How is the In-Vitro Diagnostics (IVD) Market Segmented and what are the key trends of market segmentation?

The in-vitro diagnostics industry research report provides comprehensive data (region-wise segment analysis), with forecasts and estimates in 'USD billion' for the period 2025-2029, as well as historical data from 2019-2023 for the following segments.

Product Type

  Reagents and kits
  Instruments
  Others


Technology

  Immunoassay
  Molecular diagnostics
  Clinical chemistry
  Hematology
  Others


Application

  Oncology
  Cardiology
  Autoimmune diseases
  Neurology
  Others


End-user

  Hospitals and clinics
  Research institutes
  Diagnostics laboratories
  Others


Geography

  North America

    US
    Canada


  Europe

    France
    Germany
    Italy
    UK


  Middle East and Africa

    Egypt
    KSA
    Oman
    UAE


  APAC

    China
    India
    Japan


  South America

    Argentina
    Brazil


  Rest of World (ROW)

By Product Type Insights

The reagents and kits segment is estimated to witness significant growth during the forecast period.

The global IVD market is experiencing significant growth, with reagents and diagnostic kits being key components driving this expansion. Reagents, as chemical substances, play a crucial role in the detection and measurement of target analytes in patient samples. They facilitate various diagnostic tests, ranging from clinical chemistry to molecular diagnostics. Clinical chemistry applications account for a substantial portion of the market, with reagents used to measure substances like glucose, cholesterol, and enzymes in blood samples. These measurements contribute to the assessment of medical conditions such as diabetes and cardiovascular diseases.

Molecular diagnostics, another burgeoning segment, utilizes reagents for techniques like polymerase chain reaction (PCR) and next-generation sequencing. These advanced methods enable the identification of genetic mutations and infectious agents, offering valuable insights for personalized medicine and disease management. Diagnostic kits, which include reagents along with calibrators, controls, and sometimes instruments, provide a complete solution for specific diagnostic tests. They cater to diverse applications, such as urinalysis systems, immunofluorescence assays, microbiology systems, and hematology analyzers. Test performance metrics, such as sensitivity and specificity, are critical in ensuring diagnostic accuracy. Technological advancements, like real-time PCR, digita

The Italy In-Vitro Diagnostics Market size was valued at USD 2.8 Billion in 2024 and is projected to reach USD 5.07 Billion by 2032, growing at a CAGR of 7.7% from 2026 to 2032.

Key Market Drivers Aging Population and Chronic Disease Burden: Italy's aging population and the rising prevalence of chronic diseases are driving demand for in-vitro diagnostics to enable early detection and effective disease management. According to the Italian National Institute of Statistics (ISTAT), Italy's population aged 65 and above reached 23.8% of the total population in 2022, making it one of Europe's oldest populations. The prevalence of chronic diseases has increased by 32% between 2020-2022, with diabetes affecting approximately 3.5 million Italians, driving demand for regular diagnostic testing and monitoring.

In 2023, the leading key player in the Italian in-vitro diagnostic (IVD) market was Roche Diagnostic, followed by Abbott Laboratories and Danaher. This statistic displays the key players in the Italian in-vitro diagnostic market in 2023.

Europe in vitro diagnostics market size is expected to grow from USD 32 billion in 2024 to USD 34 billion in 2025 and USD 57 billion by 2035, at a CAGR of 5.4%

In 2023, Germany held the largest share of the in vitro diagnostics market in Europe. This share amounted to approximately **** percent. France and Italy followed at **** and **** percent, respectively.

In 2021, Germany had the largest in vitro diagnostics (IVD) market size in Europe at over *** billion euros. This was followed by France with a market size of *** billion euros, and Italy at *** billion euros.

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In Vitro Diagnostics (IVD) Contract Manufacturing Market Size 2025-2029

The IVD contract manufacturing market size is forecast to increase by USD 12.97 billion, at a CAGR of 13.1% between 2024 and 2029.

The market is a dynamic and evolving landscape, characterized by increasing demand from various sectors for comprehensive solutions. One-stop-shop contract manufacturing services have gained significant traction, enabling diagnostic companies to focus on their core competencies while outsourcing production and testing processes. However, the market is not without challenges. Intellectual property (IP) rights infringement poses a significant threat, with the increasing number of players in the market and the complexities involved in IP protection. This necessitates stringent measures and robust IP management strategies from contract manufacturers. Moreover, the leasing of IVD equipment has emerged as a popular trend, offering cost savings and flexibility to diagnostic companies.
This model allows them to access advanced equipment without the burden of upfront capital investments. Despite these trends, the IVD contract manufacturing market continues to unfold, with new patterns and dynamics emerging. As diagnostic companies seek to optimize their operations and reduce costs, the demand for contract manufacturing services is expected to remain strong. However, the market's competitiveness and the threat of IP infringement necessitate a strategic approach from both diagnostic companies and contract manufacturers. Comparatively, the number of IVD service providers has grown by 23.3%, indicating a competitive landscape. This growth underscores the importance of differentiating factors, such as advanced technology, quality assurance, and strong IP protection, in attracting and retaining clients.

Major Market Trends & Insights

Asia dominated the market and accounted for a 38% growth during the forecast period.
The market is expected to grow significantly in North America as well over the forecast period.
By the Device, the IVD consumables sub-segment was valued at USD 6.39 billion in 2023
By the Service Type, the Assay development sub-segment accounted for the largest market revenue share in 2023

Market Size & Forecast

Market Opportunities: USD 183.13 billion
Future Opportunities: USD 12.97 billion 
CAGR : 13.1%
Asia: Largest market in 2023

What will be the Size of the In Vitro Diagnostics (IVD) Contract Manufacturing Market during the forecast period?

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The market exhibits a significant presence in the healthcare industry, with a current market share of approximately 25%. This figure represents a substantial portion of the overall healthcare manufacturing sector. Looking ahead, the market is projected to experience a steady growth rate of around 7% annually. The IVD contract manufacturing landscape is characterized by a focus on process optimization and validation, material handling, change control, supply chain management, and quality control. These elements are essential for ensuring the production of high-quality IVD products. Inventory control, scale-up manufacturing, and preventive maintenance are also critical components of the manufacturing process.
When comparing key numerical data, the market's growth rate outpaces the average annual growth rate of the overall healthcare manufacturing sector by nearly 3 percentage points. This discrepancy underscores the dynamic and evolving nature of the IVD contract manufacturing market. Moreover, the market's continuous improvement initiatives, such as personnel training programs, quality improvement plans, and regulatory filings, contribute to the sector's ongoing development. The importance of these initiatives is further emphasized by the rigorous testing protocols and stringent regulatory affairs that IVD products must adhere to. In conclusion, the In Vitro Diagnostics contract manufacturing market demonstrates a robust presence in the healthcare industry, with a current market share of 25% and an expected annual growth rate of 7%. The market's focus on process optimization, validation, and quality control sets it apart from the overall healthcare manufacturing sector.

How is this In Vitro Diagnostics (IVD) Contract Manufacturing Industry segmented?

The in vitro diagnostics (ivd) contract manufacturing industry research report provides comprehensive data (region-wise segment analysis), with forecasts and estimates in 'USD million' for the period 2025-2029, as well as historical data from 2019-2023 for the following segments.

Device

  IVD consumables
  IVD equipment/instrument


Service Type

  Assay development
  Manufacturing
  Others


Technology

  Immunoassays
  Molecular diagnostics
  Clinical chemistry
  Hematology
  Microbiology


Service

  Design & Development
  Assembly
  Packaging


Geography

  No

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Medical Diagnostics Market Size 2025-2029

The medical diagnostics market size is forecast to increase by USD 79.3 billion, at a CAGR of 6.7% between 2024 and 2029.

The market is driven by the high prevalence of infectious diseases and the global adoption of advanced treatment solutions. The increasing incidence of chronic diseases and the growing need for early and accurate diagnosis are key factors fueling market growth. However, the lack of trained laboratory technicians poses a significant challenge to the industry. This shortage can lead to misdiagnosis, delayed diagnosis, or even incorrect diagnosis, which can have serious consequences for patients. To overcome this obstacle, companies can invest in training programs or partner with academic institutions to attract and develop skilled professionals. Additionally, the integration of automation and artificial intelligence technologies into diagnostic processes can help mitigate the impact of the labor shortage and improve overall efficiency. Companies that effectively address these challenges while leveraging the latest technological advancements are well-positioned to capitalize on the growing demand for accurate and timely diagnostic services.

What will be the Size of the Medical Diagnostics Market during the forecast period?

Explore in-depth regional segment analysis with market size data - historical 2019-2023 and forecasts 2025-2029 - in the full report.
Request Free SampleThe market continues to evolve, driven by advancements in technology and the growing demand for early and accurate detection of various health conditions. The application of data analytics and artificial intelligence (AI) in diagnostics is revolutionizing the industry, enabling predictive diagnostics and improving test accuracy. Urine tests, ELISA tests, and PCR testing are being complemented by in-vitro diagnostics, point-of-care testing, and molecular diagnostics. In-vivo diagnostics and imaging technologies, including digital pathology and medical imaging, are providing valuable insights into the human body. Data security remains a critical concern as diagnostic data is increasingly being stored in the cloud. Remote diagnostics and wearable sensors enable disease management from a distance, while turnaround time is being reduced through automation and machine learning. Flow cytometry and clinical chemistry are essential tools in the diagnostics toolbox, providing valuable information on cellular and biochemical processes. The market for diagnostic yield is growing as researchers and healthcare providers seek to optimize diagnostic procedures and improve patient outcomes. Infectious disease diagnostics and preventive diagnostics are key areas of focus, with mass spectrometry and genetic testing playing important roles. The ongoing unfolding of market activities reveals a dynamic industry, with continuous innovation and evolving patterns shaping the future of medical diagnostics. The integration of AI-powered diagnostics, data analytics, and digital technologies is transforming the landscape, offering new opportunities and challenges for stakeholders. The application of these technologies across various sectors, from research institutions to healthcare providers, is driving growth and improving patient care.

How is this Medical Diagnostics Industry segmented?

The medical diagnostics industry research report provides comprehensive data (region-wise segment analysis), with forecasts and estimates in 'USD billion' for the period 2025-2029, as well as historical data from 2019-2023 for the following segments. TypeIVDDiagnostic imagingOthersEnd-userHospitals and clinicsDiagnostic centersResearch laboratories and institutesOthersGeographyNorth AmericaUSCanadaEuropeFranceGermanyItalyUKAPACChinaJapanSouth KoreaSouth AmericaBrazilRest of World (ROW)

By Type Insights

The ivd segment is estimated to witness significant growth during the forecast period.The In Vitro Diagnostics (IVD) segment is experiencing notable growth in the diagnostics market, surpassing diagnostic imaging and other segments. This expansion is primarily fueled by the increasing significance of molecular, clinical, and immunoassay diagnostic techniques. IVD solutions enable clinicians, researchers, and scientists to identify cellular components for disease diagnosis, providing valuable insights into cell biology. For example, tumor markers, identified through immunohistochemistry (IHC) technology, aid physicians in diagnosing malignancies and determining tumor type, origin, and stage. The demand for IVD tools is escalating due to the growing requirement for advanced real-time diagnostic solutions to facilitate early detection of communicable and chronic diseases. Additionally, cloud computing, machine learning, and artificial intelligence are transforming the diagnostics landscape by improving test accuracy and turnaround time. Predictive diagnostics, digital patho

Between 2017 and 2021, the level of public spending on in vitro diagnostic medical devices in Italy increased considerably. According to the data, in fact, in 2017 the public expenditure on this kind of devices was equal to roughly *** million euros, while by 2021 this figure surpassed *** million euros.

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Bacterial Disease Diagnostics Market Size 2025-2029

The bacterial disease diagnostics market size is forecast to increase by USD 4.91 billion at a CAGR of 7.2% between 2024 and 2029.

The market is experiencing significant growth, driven by the integration of digital health in rapid diagnostics and the increasing demand for portable analytical instruments. The global health crisis has underscored the importance of accurate, timely bacterial disease diagnoses, leading to increased investment in innovative diagnostic solutions. Portable diagnostic devices, in particular, are gaining popularity due to their convenience and ability to provide results quickly, enabling early intervention and improved patient outcomes. However, the market is not without challenges. Traditional methods, such as electrophoresis systems, have limitations in terms of speed, cost, and complexity. These limitations can hinder the widespread adoption of bacterial disease diagnostics, particularly in resource-limited settings.
To capitalize on market opportunities and navigate these challenges effectively, companies should focus on developing cost-effective, user-friendly, and high-performance diagnostic solutions. By doing so, they can meet the growing demand for accurate and timely bacterial disease diagnoses, while also addressing the limitations of existing technologies. The Bacterial Disease Diagnostics Market is evolving with advancements in microbial typing and precise strain identification techniques. Tools like multiplex assays, realtime PCR, and digital PCR streamline the diagnostic process, while innovations like whole genome sequencing and bioinformatic analysis enhance accuracy and insights.

What will be the Size of the Bacterial Disease Diagnostics Market during the forecast period?

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The market is experiencing significant growth and innovation, driven by the increasing demand for clinical decision support and disease management solutions. Remote diagnostics, enabled by mobile devices and wearable sensors, are revolutionizing healthcare, particularly in home healthcare settings. Strain typing and antibiotic susceptibility testing are crucial components of disease outbreak management, while Data Analytics and molecular epidemiology facilitate infection control and epidemic preparedness. Multidrug resistance poses a major challenge, necessitating the development of new drugs and diagnostic methods. Big data and cloud computing are transforming the industry, enabling cost-effective, real-time diagnostic validation and personalized healthcare.
Clinical trials and diagnostic cost analysis are essential for ensuring the clinical utility and economic impact of new diagnostic tools. Disease outbreaks, including pandemics, require swift and accurate diagnosis, making diagnostic solutions an essential part of public health initiatives. The integration of infection control and patient engagement strategies further enhances the clinical utility of these solutions. The market is dynamic, with ongoing advancements in technology, regulatory frameworks, and market trends shaping its evolution.

How is this Bacterial Disease Diagnostics Industry segmented?

The bacterial disease diagnostics industry research report provides comprehensive data (region-wise segment analysis), with forecasts and estimates in 'USD million' for the period 2025-2029, as well as historical data from 2019-2023 for the following segments.

Product

  Consumables
  Instruments


End-user

  Hospitals
  Labs


Method

  Culture and isolation
  Microscopy
  Molecular diagnostics
  Serological testing
  Others


Disease Type

  Respiratory infections
  Gastrointestinal infections
  Genitourinary infections
  Skin and soft tissue infections
  Others


Geography

  North America

    US
    Canada


  Europe

    France
    Germany
    Italy
    UK


  Middle East and Africa



  APAC

    China
    India
    Japan
    South Korea


  South America



  Rest of World (ROW)

By Product Insights

The consumables segment is estimated to witness significant growth during the forecast period. The market for additive manufacturing in the realm of diagnostics is experiencing notable advancements, driven by the increasing demand for quicker turnaround times and improved diagnostic accuracy. Consumables, including test kits, assays, and reagents, play a pivotal role in this sector. These consumables are repeatedly used by end-users, such as healthcare providers and microbiology laboratories, for various diagnostic tests, including antigen and antibody detection, pathogen identification, and disease surveillance. The preference for in-vitro diagnostics and the growing importance of personalized medicine have boosted the demand for a diverse range of consumables. Advanced technologies like artificial intelligence, machine learning, and next-generation s

Over the last two observations, the revenue is forecast to significantly increase in all segments. Concerning the two selected segments, the segment Medical Devices has the largest revenue with 14.07 billion euro. Contrastingly, In Vitro Diagnostics is ranked last, with 2.73 billion euro. Their difference, compared to Medical Devices, lies at 11.34 billion euro. The Statista Market Insights cover a broad range of additional markets.

In 2024, within the medical technology market in Italy, the medical devices segment generated the highest revenue, amounting to approximately ************ U.S. dollars. The in vitro diagnostics segment followed, with a revenue of about ************ U.S. dollars.