The medical imaging market - Italy

1.2 The World Market

According to theWorld Health Organization (***), diagnostic imaging has developed rapidly and plays a central role in health care, supporting the diagnosis and treatment of diseases. Diagnostic imaging services include confirming, evaluating, and documenting the course of many conditions to ultimately identify response to treatment. The global diagnostic imaging market is expected to reach $**.*** billion by ****, up from $**.*** billion in ****. It is expected to grow at a CAGR of *.*% from **** to ****.

Global diagnostic imaging market value World, ****-****, in millions of dollars (***) The Insight Partners

Developing economies such as India, China, Brazil, South Korea, Turkey, Russia, and South Africa offer enormous prospects for major players in the diagnostic imaging industry. Despite the fact that cost is a concern in many developing countries, their huge populations, particularly in India and China, provide a long-term market for diagnostic imaging technologies. The need for early detection is demonstrated by the higher prevalence in these countries of chronic diseases such as cancer, stroke, neurological and cardiovascular diseases, as well as their higher mortality rates.[***]

1.3 The Italian Market

As for the Italian market, this has been steadily and sharply increasing in recent years. Companies that perform diagnostic imaging services fall under the category of Ateco Code "**.** - Other health care services."It can be seen that from **** to ****, there has been a **.*% growth in the industry's turnover.

Evolution Turnover of the Diagnostic Imaging Market Italy, ****-****, in billions of euros (***) Istat The more general medical device sector, relating to equipment used to perform clinical and diagnostic analyses, is a very heterogeneous, highly innovative and specialized industrial fabric, where small companies coexist with large groups.

Specifically, the ISTAT (***) website groups companies operating in this sector under the Ateco Code "**.** Manufacture of Electromedical Equipment" including :

manufacture of X-ray, beta, gamma and other ray equipment manufacture of CT scanners manufacture of PET scanners manufacture of magnetic resonance imaging (***) equipment manufacture of medical ultrasound equipment manufacture of electrocardiographs manufacture of laser medical equipment manufacture of endoscopic medical equipment manufacture of pacemakers manufacture of hearing aids

As the graph shows, it has increased from **** to **** in both production value and turnover. Analyzing the value of production shows an increase of **.* percent from **** to ****, and consistent with this trend, the value of turnover has also ...

1.4 Foreign trade

For the analysis of imports and exports of equipment used to perform medical imaging services, the following HS codes reported from the United Nations database were used. The HSs used are :

****: Equipment based on the use of X-rays or alpha, beta and gamma radiation for medical, surgical, dental or veterinary use, including radiography and radiotherapy equipment. ******: Ultraviolet or infrared medical instruments ******: Magnetic resonance equipment ******: Ultrasound equipment for medical scanning

Several conclusions can be drawn based on the different equipment under consideration. First, Italy is a strong exporter of x-ray equipment. In this case, the coverage rate in ****, expressed as the ratio of exports to imports, is *.* (***).

For imports, growth in value was observed in almost all categories analyzed, highlighting how, already seen, Italy is increasingly relying on foreign equipment. For X-ray equipment, Germany is the country from which Italy, ****, imported the most(***).

Evolution Imports of Medical Imaging Equipment, by type of technology used Italy, ****-****, in millions of dollars (***) UNComtrade

A more steady increase can be seen for exports. The greatest growth was in X-ray equipment, with an increase of +**.* percent during the period under review.

In the case of X-ray equipment exports, the countries with which Italy had the ...

2.1 Overview of the hospital sector in Italy

In ****, the facilities surveyed are: *** for hospital care, *,*** for outpatient specialty care, *,*** for residential territorial care, *,*** for semiresidential territorial care, *,*** for other territorial care, and *,*** for rehabilitation care (***).

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In the following table it is possible, then, to observe further characteristics of the Italian healthcare fabric. Here we have a division by region according to the type of health facility, the facilities analyzed are :

AMBULATORS AND LABORATORIES : Facilities that provide specialized activities (***) OTHER TYPES OF TERRITORIAL STRUCTURES : Limited-assistance dialysis centers, Hydrothermal Establishments, Mental Health Centers, Family Counseling Centers, District Centers, and in general facilities that carry out territorial-type activities SEMIRESIDENTIAL FACILITIES : Psychiatric day care centers and in general facilities that carry out semiresidential type activities RESIDENTIAL FACILITIES : Nursing homes, sheltered houses and in general facilities that svologono activities of residential type, including hospices. It emerges that it is the regions of northern Italy that have the largest number of health care facilities, especially Piedmont, Lombardy and Veneto.

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2.2 The type of diagnostic imaging services provided and geographic distribution

There are several types of medical imaging that can be requested by patients. The two main types are nuclear medicine and diagnostic radiology. Nuclear medicine refers to the branch of medicine that uses radioactive substances (***) for diagnostic, therapeutic, and biomedical research purposes. While diagnostic radiology uses X-rays, CT, MRI, ultrasound, etc. to obtain images that are then analyzed to diagnose a disease or health problem.

A total of *,***,*** diagnostic tests were performed by nuclear medicine and **,***,*** diagnostic radiology activities in Italy in ****.

Among the various sub-categories of diagnostics available, AGI conducted a study to observe the degree to which the Italian population knows about the ionizing radiation used in medical diagnostics. It turned out that more than ** percent of Italians consider ionizing radiation (***). Mammography was reported to be undergone by **% of women.

"Which of the following diagnostic imaging tests have you undergone in your lifetime?" Italy, ****, in % Source: ****

2.3 The machinery in different regions

In the following section, the number of certain equipment used to make imaging diagnoses will be analyzed. These are:

Echotomograph(***). Computerized Gamma Camera(***) : equipment used in nuclear medicine for scintigraphic imaging; no X-rays are used here Integrated gamma camera CT system(***) : equipment used in nuclear medicine for acquisition of scintigraphic images, the difference here is the use of X-rays Automated immunochemistry analyzer(***) Selective multiparametric analyzer(***) Hemodialysis(***) Contaglobulin(***)

In the following table it is possible to observe the number of medical imaging equipment in the different public hospital facilities. It is possible to observe that, on average, it is always Lombardy Latium and Campania that have the largest number of equipment.

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The number of medical imaging machines in different private hospital facilities is shown below . In this case, the number of equipment is markedly msggiore for each category of equipment. This can be attributed to the high cost of the equipment and the fact that private facilities perform much more medical imaging than the public sector.

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2.4 Socio demographic characteristics

There are several drivers that can drive the demand for diagnostic imaging. we can, therefore, find two main categories to keep in mind: demographic characteristics of the Italian population and income characteristics. The age distribution and median age of the Italian population are also important factors to consider in order to better understand this market and its customers.

As of December **, ****, there were ** million ***,*** residents in Italy(***).[***]

Italian population by age group Italy, ****, in millions Istat

Another determining aspect is related to the income aspect; this service is highly developed by private entities and not covered, in most cases, by the National Health Service (***). At the income level, Italian families have anaverage income between ** and ** thousand euros, depending on the number of members. The income one is an important aspect, given the high costs of private health care. Despite this, more and more people decide to allocate part of their resources to private healthcare.

Average annual household income by number of members Italy, ****, in current &euro Istat Health constitutes one of the most significant expenditure items for individuals and families, as well as for national and international health care systems. This trend is mainly explained by considering that medical services are ...

3.1 Market structure and dynamics

To analyze the size of the market, it is useful to dwell on the trend of business activity in the sector of manufacturing irradiation instruments, electromedical and electrotherapeutic equipment. The sector has been trending positively for the last five years taken into analysis, with the exception of the last year available in the Istat Databases (***).

Number of enterprises active in the manufacture of irradiation instruments, electromedical and electrotherapeutic equipment Italy, ****-****, in number Istat

In the sector of manufacturing irradiation instruments and electromedical and electrotherapeutic equipment, there is a predominance of Limited Liability Companies, accounting for **.*% of the total.

Legal form enterprises active in the manufacture of irradiation instruments, electromedical and electrotherapeutic equipment Italy, ****, % Istat Consistent with the number of enterprises active in the sector, it can be seen that the number of employees has also increased in recent years, amounting to + **.* percent.

Number of employees enterprises active in the manufacture of irradiation instruments, electromedical and electrotherapeutic equipment Italy, ****-****, in number Istat

3.2 Value Chain

The following is a simplified value chain of the diagnostic imaging industry:

The market for medical imaging equipment manufacturing in Italy is held by a handful of international players; this is caused by high R&D and manufacturing costs, which raise barriers to market entry and restrain the arrival of new players.

These imaging "giants" sign contracts for device installation and maintenance in addition to device sales. However, maintenance and service can also be performed by other operators who are not medical imaging equipment manufacturers. This practice has the advantage for customers to have a single point of contact for all maintenance of their medical imaging devices. this is the case, for example, with Sincronis, which specializes in the management and maintenance of medical technologies.

While device development and manufacturing is a highly concentrated industry, the market for additional services, particularly data processing and analysis software, is a more fragmented market in which many players are emerging, including GAFAM and med-tech start-ups. The major medical imaging groups have not lagged behind and are also providing their own software solutions, but they are now competing in this link of the value chain.

3.3 Companies offering Medical Imaging Services

Clinical testing laboratories, X-ray laboratories, and other imaging centers are a crucial distribution channel for medical imaging products. These centers provide essential diagnostic services, using a wide range of imaging products, such as equipment for radiography, magnetic resonance imaging (***), and ultrasound. There are a total of *,*** facilities in Italy surveyed under Ateco Code "**.**.** Clinical analysis laboratories, radiographic laboratories and other diagnostic imaging centers." The number of companies in this sector in Italy has been growing in the last * years, with +**.*% of laboratories between **** and ****. Interestingly, there is strong growth in the number of laboratories in ****, following the pandemic, with +*.*% of facilities in a single year.

Evolution Number of clinical testing laboratories, X-ray laboratories, and other diagnostic imaging centers Italy, ****-****, in thousands Istat

regarding the legal form of laboratories in Italy in ****, it can be seen that **.* percent of the total had the form of Individual Entrepreneur, freelancer or self-employed, while **.* percent had the legal form of Limited Liability Company.

Legal form clinical analysis laboratories, X-ray laboratories and other diagnostic imaging centers Italy, ****, % Istat

3.4 Main actors

4.1 The different types of Equipment

There are many technological modalities of medical imaging, for multiple applications, the main ones of which are listed in the table below:

PIPAME

The following is a non-exhaustive list of the main types of medical imaging equipment:

Conventional and digital radiography Radioscopy / fluoroscopy CT / CAT SCAN Magnetic resonance imaging (***) Functional magnetic resonance imaging Positron emission tomography (***) or PET scan / PET-CT PET-MRI Ultrasound Doppler High intensity focused ultrasound (***) Endoscopy Bioluminescence imaging Fluorescence imaging

Finally, medical imaging equipment is associated with PACS (***) according to the client's needs.

4.2 Equipment prices and diagnostic imaging fees

Equipment prices

Prices for major medical imaging equipment can vary widely depending on the brand, the features and modifications made to the equipment, and the customer's needs. However, SNITEM offers a range of prices for high-end equipment:

Installation costs are added to the cost of the equipment. Installation costs between €***,*** and €***,*** depending on the publisher (***) with maintenance costs of about €**,*** per year.

Performance costs

In order to estimate the cost of an MRI, one must distinguish between three different modes of delivery:

Facilities affiliated with the SSN: Diagnostics through MRI is defined as an outpatient specialist service that, according to the provisions of the National Health Service (***), should cost around **€ Ticket, in addition to the additional ticket on prescriptions calculated according to income. However, there are some categories of patients who can enjoy MRI free of charge, such as - in addition to those who are relieved by income - those with rare or chronic diseases, the disabled, pregnant women and in case of early diagnosis of cancer. In order to be eligible, one must go to the health district to which they belong and present all the necessary documentation. Private facilities: due to long waiting lists, patients turn to facilities ...

4.3 An obsolete fleet

By ****, there are **,*** obsolete imaging equipment such as MRIs, PET scans, CT scans, angiographs, and mammograms. **% of conventional mammograms are more than ** years old, **% of PET scans are more than * years old, and **% of closed *.* T MRIs are still more than ** years old. A positive sign can be seen among portable ultrasound machines, which in **% of cases were purchased less than * years ago, as well as **% of digital arch surgery systems and **% of digital mobile radiographers.

Mammography equipment

Forty-three and a half percent of the mammography equipment in the installed base is of the conventional type, thus not digital. Considering that the period of adequacy is * years for conventional and * years for digital, OPI reports that:

The average age of conventional type mammograms is **.* years; The average age of digital-type mammograms is *.* years; **% of conventional mammography equipment is beyond the period of adequacy; **% of conventional ones are over ** years old; **% of the digital version exceeds the adequacy threshold.

Compared with previous years, conventional mammograms show a deterioration in average age from ** years at the end of **** to **.* years in the latest survey at the end of ****. More moderate is the increase in the average age of digital mammograms over the same ...

4.4 The Future of Artificial Intelligence in Diagnostic Imaging

Artificial intelligence (***), the area that focuses on image and video analysis and interpretation.

Artificial Intelligence at the heart of Diagnostic Imaging

The medical discipline of Diagnostic Imaging has found itself at the center of a scientific and productive fervor. Using AI in Radiology shows remarkable successes in the process of detecting and classifying abnormalities on X-rays, performing computed tomography (***) scans, leading to more accurate diagnoses and more efficient decision making.

AI in Radiology: PACS, RIS and DICOM

Radiology is in a more favorable position to adopt AI algorithms and infrastructure. The key factors are the presence of an established digital workflow and universal standards for image archiving: think of PACS (***) standard.

Radiologists' fears in using these technologies are mainly related to lack of knowledge and trust and from possible changes in professional identity and autonomy.

Elements that can help overcome the above concerns include:

presence of experienced AI colleagues education and training support.

Artificial Intelligence Models in Cardiology and Oncology

Among the areas in which these generalist AI models could have a significant impact are early stroke identification and cancer detection.With their ability to analyze large amounts of radiological data, these models can detect early signs of stroke and provide ...

5.1 Regulation

European regulations

At the European level, new regulations were approved in ****, enforced from **** for medical imaging equipment.

This new regulation:

Strengthens controls on high-risk devices through the establishment of an expert committee to verify the risks of a device before it is placed on the market. Improves transparency in the industry through the creation of a European database to enable traceability of equipment. Strengthens the post-market surveillance that manufacturers must perform on their equipment. Strengthens clinical evidence standards by allowing clinical trials throughout Europe.

Regarding patents, Manufacturers of equipment and software must obtain CE marking from a notified body under the Medical Device Directive **/**/EEC

Risk Reduction To reduce the risks associated with exposures in the medical field, it is necessary to carefully assess the need for the diagnostic e- same (***). Evaluation before prescribing a diagnostic investigation with radiation To this end, before prescribing a diagnostic assessment with radiation, it is important to assess: - That the examination being requested is useful for the patient. - That it is not possible to obtain information from investigations already performed by the patient.- That it is not possible to obtain the same information from an examination that carries less risk to his ...

6.1 Segmentation

• Gruppo San Donato
• Synlab Italia SRL
• Deep Trace Technologies
• D- EYE
• General Medical Merate SPA
• ESAOTE SPA
• Bracco Imaging SPA
• AGFA Group