The global in vitro diagnostics (IVD) market, estimated at $97.12 billion in 2023, is on a trajectory of sustained growth with a projected compound annual growth rate (CAGR) of 7.1% from 2024 to 2030, potentially reaching over $156 billion. The European market, valued at $25.36 billion in 2022, is also expected to grow, albeit at a slower CAGR of 2.2% through 2028, potentially reaching $28.90 billion. The COVID-19 pandemic significantly impacted the market, with a spike in spending on diagnostic medical devices, and without COVID-19 diagnostic tools, the market would have seen a decline. 

Analysis of the In Vitro Diagnostics Market Demand in Italy

The demand for in vitro diagnostic (IVD) devices in Italy has been experiencing significant growth, a trend that's projected to continue for the coming years. This rise in demand is reflected by the numbers, with the Italian IVD market valued at approximately $3.19 billion in 2022 and expected to see an increase to around $5.05 billion by 2030. The annual growth rate (CAGR) is estimated at nearly 6% during the period from 2023 to 2030. A major driver of this upsurge in demand was the Covid-19 pandemic, which led to a remarkable boost in the market due to the need for diagnostic tests. However, it is worth noting that if Covid-19 diagnostic tools were excluded, the market would have shown a decline of approximately 5%. The Italian demographics play a crucial role in shaping the IVD market with an aging population where around 24% are aged 65 or older as of 2023. This indicates a higher propensity for diseases associated with old age, increasing the need for diagnostics. Furthermore, the most common ailments in this demographic, including hypertension, arthrosis, and heart disease, are typically monitored and diagnosed using IVD technology. Preventive health measures are also gaining traction among Italians, with most of the population actively seeking information on health and prevention—a number that has nearly doubled since 2016. This rise in health awareness is expected to result in continued demand for diagnostic services and devices. From the supply side, Italy's IVD market is complemented by a robust manufacturing sector with over 4,500 companies, employing more than 110,000 people. The industry demonstrates an innovative and specialized profile with ongoing growth in the number of enterprises, particularly in the manufacturing of medical devices for IVD. The distribution channels for IVD in Italy include hospitals, analysis laboratories, and pharmacies. The hospitals show a declining trend in number, yet the laboratories and private pharmacies reflect growth, suggesting a shifting landscape in diagnostic service provision. The regulatory landscape in Italy and the broader European Union has undergone substantial changes with the introduction of the In Vitro Diagnostic Medical Devices Regulation (IVDR). This new framework is expected to influence market dynamics by restructuring the classification of IVD devices based on risk and impacting the processes for conformity assessments and market placement. In terms of market segmentation, the IVD market comprises various offerings which include devices intended for high individual and public health risks to self-diagnostic tests.

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Summary and extracts

1 Market Overview

1.1 Definition and presentation

In vitro diagnostics are an essential part of health care, which can provide critical information at every stage of the patient's journey, from prognosis, screening, diagnosis, monitoring disease progression, and predicting treatment responses, contributing to the available medical information regarding a patient, enabling early and targeted treatments, and helping to reduce hospital stays and convalescence, and improving the well-being of the general public.
it has been estimated that the results of in vitro diagnostic tests influence up to 70 percent of clinical decisions, while accounting for only 0.8 percent of total health care expenditures.
In vitro diagnostic medical devices (IVDs) can consist of devices (e.g., reagent equipment kits) that are simple or of sophisticated technology to perform assays on samples taken from the human body (e.g., blood, urine, saliva, and tissues taken by biopsy). They can be used in different settings ranging from Testing Laboratories, to the home environment for self-tests (e.g., glucose meters) that can be used directly by the patient (lay user).

In 2023 the global in vitro diagnostic (IVD) market is estimated at 97.$12 billion. Sustained growth of the industry is expected in the near future. For the period 2024-2030 a compound annual growth rate is estimated (CAGR) of 7.1 percent under which the global market could reach a total value of more than 156 billion dollars.As for the European market, this reached a value of $25.36 billion in 2022.

This study focuses on the specific in vitro diagnostic (IVD) market in Italy, analyzing consumption trends, competitive dynamics, and growth prospects for the sector. For information on related markets, such as medical biology laboratories, see the specific studies available in the Businesscoot catalog.

1.2 World market

In ****, the global in vitro diagnostic (***) of *.*% is estimated for the period ****-****, under which the world market could reach a total value of more than $*** billion by the end of the period. In Vitro Diagnostics (***) Market World, ****-****, in billions of dollars FortuneBusinessInsights As for the European market, this reached ...

1.3 Italian market

Regarding the Italian in vitro diagnostics market, in **** this reached a total value of $*.** billion. For the period ****-****, the industry is expected to grow, with a compound annual growth rate (***) estimated at *.*%. In ****, the Italian in vitro diagnostics market is estimated at $*.** billion.

In vitro diagnostics (***) market Italy, ****-****, in ...

1.4 Impact of Covid

The growth of the Italian market was caused solely by the Covid pandemic and the instruments for its diagnosis. If these devices were to be excluded, the Italian market would have declined by -*.*% .

Italian market growth between **** and **** with and without Covid diagnostic tools Italy, ****-****, percentage Medtech

In particular, ...

1.5 Import - Export

In order to analyze the trade flows in and out of Italy related to the in vitro diagnostics sector, products under HS Code **** "Diagnostic or laboratory reagents on any substrate, prepared diagnostic or laboratory reagents, whether or not presented on a substrate, whether or not presented in kit form" are ...

2 Demand analysis

2.1 Health spending in Italy and Europe

In ****, the average spending of EU member countries was **.* percent of GDP. In particular, the highest values are in Germany, France and Austria, with expenditure shares of **.*%, **.*% and **.*% of GDP, respectively. Italy's spending as a ratio of GDP is lower than the European average, standing at *.* percent in ****. Health Expenditure of ...

2.2 Demographic changes

IVD market activity islargely influenced by the demographic situationof the country concerned. The greater the number of elderly people, the greater the risk of disease. Among the diseases that develop with age are cardiovascular diseases, neurodegenerative diseases and even cancers.

Italy is concerned about this trend, as according to Istat in ...

2.3 Italians and prevention

Italians are increasingly informing themselves about health and prevention, and many are doing so online. In ****, ** percent of Italians informed themselves about health and prevention, up from ** percent in **** and ** percent in ****.

Percentage of Italians doing prevention Italy, ****-****, percent Source: ****

Sixty-six percent go to a general practitioner, and the share ...

2.4 Geographical distribution of demand

To analyze the geographical distribution of the demand for in vitro diagnostic instruments, the per capita public expenditure on medical devices in each Italian region is analyzed.

In ****, Friuli Venezia Giulia and Trentino Alto Adige had the highest per capita public spending values on medical devices in the peninsula at ***.* euros ...

3 Market structure

3.1 Value chain

The value chain for the in vitro diagnostic medical device market can be structured into several key stages, spanning from product conception and development to commercialization and use. Here is one possible articulation:

Research and Development (***): Need identification: understanding unmet clinical needs or possible improvements to current diagnostic devices. Conception and ...

3.2 Production overview

The medical device sector in Italy generates a market worth **.* billion euros between exports and the domestic market and has *,*** companies, employing ***,*** people. It is a very heterogeneous, highly innovative and specialized industrial fabric, where small companies coexist with large groups(***)

There are *,*** manufacturing companies that, together with *,*** distribution and *** service ...

3.3 Distribution

IVD devices are normally used in hospitals, medical testing laboratories, and some types can be purchased by the customer directly from the pharmacy.


The official number of hospital institutions in Italy was *** in ****, a number that has been steadily decreasing over the previous ten years: between **** and **** there was a ...

3.4 The main manufacturers

A list of leading Italian manufacturers of in vitro diagnostic medical devices is offered below:

Diasorin s.p.a: is a global company in the biotechnology sector that specializes in the development, production and marketing of in vitro diagnostic tests intended for laboratory diagnostics. Founded in ****, the company is headquartered in ...

4 Supply analysis

4.1 Type of the offer

An in vitro diagnostic medical device (***) is any device consisting of a reagent, reagent product, assembly, instrument, apparatusor system used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens from the human body to provide information on physiological states or states of ...

4.2 The prices

The price of in vitro diagnostic medical devices can vary widely depending on several factors, including:

Type of device: There are different types of diagnostic devices, such as laboratory test kits, analytical instruments, reagents, and consumables. Each category has a specific price range. Complexity and technology used: Devices that use more ...

4.3 Startup

The IVD sector is very innovative, where millions are spent on research. The world of start-ups is wedded to this sector, and innovations mainly concern new devices for analysis.

Diadem s.r.l is a start-up that received *.* million euros from the European Investment Bank for their product. Diadem has created ...

5 Regulations

5.1 Regulations

On May **, ****, EU Regulation No. ****/*** on In Vitro Diagnostic Medical Devices Regulation (***), which replaces from Directive **/**/EC, came into force.

The IVDR introduced a new classification system for IVDs, replacing the "list-based" system of Directive **/**/EC. IVDs are in fact classified according to specific rules, based on their intended use and ...

6 Positioning of actors

6.1 Segmentation

  • Diasorin s.p.a
  • Instrumentation Laboratory s.p.a
  • A. Menarini Diagnostics s.r.l
  • Ortho-Clinical Diagnostics Italy s.r.l
  • Cepheid s.r.l
  • DIESSE Diagnostica Senese s.p.a
  • D.I.D Diagnostic International Distribution s.p.a
  • Euroimmun Italia s.r.l

List of charts

  • In vitro diagnostic (IVD) market
  • In vitro diagnostic (IVD) market
  • Medical device sector, breakdown by type of activity
  • Detected expenditure on in vitro diagnostic medical devices
  • In vitro diagnostic (IVD) market
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Companies quoted in this study

This study contains a complete overview of the companies in the market, with the latest figures and news for each company. :

Diasorin s.p.a
Instrumentation Laboratory s.p.a
A. Menarini Diagnostics s.r.l
Ortho-Clinical Diagnostics Italy s.r.l
Cepheid s.r.l
DIESSE Diagnostica Senese s.p.a
D.I.D Diagnostic International Distribution s.p.a
Euroimmun Italia s.r.l

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