The in vitro diagnostics market - Italy (2024)

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 a value of $**.** billion in ****. In the European context, the industry is also expected to grow in the near future, albeit at a slower pace than that expected for the world market. A compound annual growth rate (***) of *.* percent is projected for the period ****-****, under which the European in vitro diagnostics market could reach a value of $**.** billion.

In vitro diagnostics (***) market Europe, ****-****, in billions of dollars ResearchandMarkets

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 billions of dollars Insights***

In ****, in vitro diagnostics accounts for *.*% of the market for the broader medical device market. It is topped by the biomedical (***) compartments. These three compartments alone together gather **.*% of the market.

Medical device sector by size Italy, ****,percent Source: ****

Regarding the detected public spending on in vitro diagnostic medical devices, there is a sharp increase between **** and ****. During the period analyzed, the value of spending increased from ***.* million to ***.* million, representing a growth of ***.* percent. The outbreak of the pandemic in **** contributed decisively to the increase in spending: between **** and **** this grew by ***.*%.

Detected spending on in vitro diagnostic medical devices Italy, ****-****, in millions of euros MinistryofHealth

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, there are sectors that have declined by up to ** percent, such as urinary tests. Urinary tests precisely suffered the greatest loss, followed by tumor markers, -**.**%, tests for autoimmune disorders,- **.**%, and clinical chemistry, -**.**%.

Sectors that suffered the most during the Covid pandemic Italy, ****, percent Medtech

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 analyzed.

Italy's trade position falls into the category of net importer. In fact, between **** and ****, the export coverage ratio, determined by the ratio of exports to imports multiplied by ***, is consistently below *** percent, fluctuating between **.* percent and **.* percent. As for exports, these increased from $***.* million to $***.* million (***).

Import - export products under HS Code **** "Diagnostic or laboratory reagents on any medium, prepared diagnostic or laboratory reagents, including those presented in kit form" Italy, ****-****, in millions of dollars and % Uncomtrade

In terms of exports, Germany is Italy's main trading partner collecting **.*% of the total value alone. It is followed by Spain (***). Main countries of export destination of products under HS Code "Diagnostic or laboratory reagents on any media, prepared diagnostic or laboratory reagents, also presented on media, also presented in kit form" Italy, ****, % Uncomtrade Regarding imports, Germany, the United States and the Netherlands together contribute more than ** percent of the total ...

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 EU Countries Europe, ****, as a % of countries' GDP Eurostat Regarding public healthcare, the Italian state in **** spent ***,*** million euros on public healthcare. This value is ***,*** million for ****, ***,*** million for **** and ***,*** million for the year ****. The COVID-** epidemiological emergency had raised this level for **** to ***,*** million, while for **** the NHS funding was ***,*** million. Between **** and ****, NHS funding is expected to grow by **.* percent.

SSN Expenditure Italy ****-**** billion Source: ****

In Italy, public health care complements private health care. Of the *.* percent of GDP used for spending on healthcare, it is estimated that in ****, when *.* percent of GDP was spent on healthcare, *.* percent came from public sources while *.* percent came from private sources.

Public vs. private spending on health care Italy, ****, percent Santagostino

In **** it was ****.* euros per citizen, and from this point of view the growth compared to ****, when it was ****.* euros, is evident. After all, the population did not increase, ...

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 Italy, the percentage of people over ** has increased .In ***** the share of individuals aged ** or older is **.*% of the total population.

For the past ** years or so, Italy has been facing a negative natural turnover, underlying the population reduction, despite the partial counterpart of positive foreign migration dynamics. The projected scenarios of births and deaths are linked to this process, measuring the tendency to record negative balances for natural population movement annually. Not even in the most favorable birth and death scenarios would the projected number of births come to offset that of deaths.

Evolution Population age ** and older, percentage of total population Italy, **** - ****, in percent Source: ****

Among the most common diseases in the elderly Italian population are hypertension and arthrosis and heart disease, detectable by some in vitro tests.

Most common diseases in Italy, by age group Italy, ****, in thousands Source: ****

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 of those who go to a specialist has been growing over the past two years (***). The pharmacist confirms this perception: ** percent agree on an increase in the value of the pharmacy's role during the pandemic period[***].

Where Italians seek medical information Italy, ****, percent HealthDesk

Finally, according to research by Euromedia Research, the most preventive medical examinations performed by Italians are general examinations, **.* percent; eye examinations, **.* percent; gender-specific examinations, e.g., gynecological examinations, **.* percent .

Preventive exams voluntarily performed by Italians Italy, ****, percent Source: ****

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 and ***.* euros, respectively. They are followed by Umbri and Tuscany dova the average per capita spending was ***.* euros and ***.* euros. On the other hand, the lowest values were recorded in Lombardy, Latium and Calabria, with values of **.* euros, **.* euros and **.* euros, respectively.

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 design: devising new devices or improvements to existing ones based on scientific and technological innovations. Prototyping and preclinical evaluation: development of prototypes and their evaluation through preclinical studies to determine safety and efficacy. Regulatory approval: Documentation and submission: preparation and submission of all necessary documentation to regulatory bodies to obtain marketing approvals. Evaluation by regulatory bodies : Review of documentation by regulatory bodies to ensure that the product meets all required standards. Production: Manufacturing process development: definition and optimization of manufacturing processes to ensure efficiency, quality and compliance. Mass production: manufacturing of devices according to quality standards and applicable regulations. Marketing and sales: Market strategy: development of marketing strategies based on market analysis, segmentation and product positioning. Promotion and distribution: promotional activities to increase product awareness and distribution through selected channels to reach the target market. Post-sales and monitoring: Support and training: provision of technical support, maintenance and training to end ...

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 companies, produce or distribute medical devices in our country. Regarding the distribution of enterprises active in the in vitro diagnostics industry by type, in ****, **.* percent of enterprises are medium to large, *.* percent are SMEs while *.* percent are innovative start-ups.

Medical device manufacturing enterprises by type Italy, ****, percent Confindustria

With thousands of enterprises belonging to ** main sectors, the sector has high market and product differentiation, which are fundamental to the development of healthcare and the Italian economy.

In particular, medical device enterprises for in vitro diagnosis are growing, between **** and ****, the population of enterprises grew by **.* percent, from *** in **** to *** in ****. However, between **** and ****, there is a *.*% contraction in the number of enterprises.

IVD diagnostic device manufacturing enterprises Italy, ****-****, units Confidustria

Regarding the entire medical device industry, employment in **** is highly skilled, with **.* percent of employees with a university degree and **.* percent of employees with a diploma. Those with PhD ...

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.

HOSPITALS

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 **.*% decrease.

Evolution Number of Hospitals in Italy Italy, **** - ****, in number of hospitals Source: ****

MEDICAL ANALYSIS LABORATORIES

Medical analysis laboratories (***) are growing strongly. Between **** and ****, the total number of enterprises increased from *,*** to ****, representing a growth of *.* percent. Even more sustained is the growth in the number of employees in the industry: between **** and **** these grew by **.*%.

Italy, ****-****, units Istat

PHARMACIES

As for the pharmacy sector, there is an increase in the number of enterprises between **** and ****. During the period analyzed, the total number of enterprises grew by *.* percent, from **,*** in **** to **,*** in ****.

Number of private pharmacies in Italy and employees in the sector Italy, ****-****, units Source: ****

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 Saluggia, Italy, and is one of the most important players in the international medical diagnostics scene. The company offers a wide range of products covering several areas, including tests for the diagnostics of infectious diseases, endocrinological tests, tests for the determination of tumor markers, tests for the diagnosis of autoimmune diseases, and tests for the management of metabolic diseases. With a strong emphasis on research and development, DiaSorin aims to provide innovative solutions that meet the evolving needs of the diagnostics market. Through its network of subsidiaries and distributors, the company has a significant presence in more than ** countries worldwide, confirming it as one of the leaders in the field of in vitro diagnostic testing.

Instrumentation Laboratory s.p.a: is a leading company in the field of in vitro diagnostics, specializing in the production and marketing of instruments and reagents for hemostatic and blood gas analysis. Founded in **** in ...

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 health or congenital disease or abnormality.

IVDs, for the purpose of conformity assessment, are classified into four categories based on the intended use indicated by the manufacturer and the risk to public health and/or patient treatment in the event of failure in the performance for which they are intended.

IVDs are classified according to the risk associated with the type of analysis performed and the type of reagents used to perform it:

In vitro medical-diagnostic devices included in Annex II List A of Legislative Decree No. ***/****: high individual and public health risk; In vitro medical-diagnostic devices included in Annex II list B of Legislative Decree No. ***/****: high individual and/or moderate risk to public health; Devices for self-diagnostic testing: any device intended by the manufacturer to be used at home by laypersons, persons not experienced in diagnostic testing; Other type of devices: all other devices that do not belong ...

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 advanced technology or are able to provide faster and more accurate results tend to have higher prices. Purchase volume: Buying in large quantities can affect price, with possible discounts for bulk purchases. Market and region: Price may vary depending on the target market and local regulations. In some countries, costs may be affected by taxes, customs duties and other charges. Supplier: Prices may also differ by manufacturer and supplier, depending on their pricing policy, product quality, and level of service. With regard to the production of in vitro diagnostic-medium devices, between **** and ****, the producer price index for the manufacture of medical instruments and supplies shows an increase of *.* points, representing an average increase in production costs of *.* percent. Specifically, while between **** and **** the increase stands at *.* percent, between January **** and December **** the index shows an increase in production costs of *.* percent, which is double the increase over the entire previous ...

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 the first blood test that predicts the likely progression of Alzheimer's disease up to six years in advance of definitive symptoms, a device with the CE-IVD mark. Diadem, based near Milan, Italy, was founded in **** as a spin-out from the University of Brescia with support from the Ministry of Education, University and Research. it is considered one of the most promising small and medium-sized Italian companies in the field of biotechnology.

AlzoSure® Predict is a noninvasive biomarker-based blood test that can detect, up to six years in advance of the onset of definitive symptoms and with a high degree of accuracy, whether or not people over ** with symptoms of cognitive impairment will develop Alzheimer's disease. Its usefulness is confirmed by clinical data collected through a large longitudinal study, thanks to which AlzoSure® Predict recently obtained the CE-IVD mark, which allows the test to be marketed in the EU, and designation ...

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 potential risk. The IVDR does not list in detail the IVDs that fall into each class, but provides a set of rules for the inclusion of each IVD in them (***).

The classification of a device is primarily the responsibility of the manufacturer. If the NAO disagrees with the manufacturer's classification, the matter is referred to the competent authority of the country where the manufacturer (***) is located. Two competent authorities may intervene if the manufacturer and the NAO are based in different countries and thus answer to different competent authorities

The IVDR has significantly changed the procedure for issuing the CE marking of IVDs, referred to as "conformity assessment." Before placing a device on the market, the manufacturer must complete the conformity assessment of the device, which is necessary to obtain the CE marking.

As the risk class increases, the complexity of the requirements for obtaining CE marking increases, as the ...

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