Healthcare Resource Guide: Italy

Last Updated: October 2019

 

Italy Statistics

Summary
Market Entry

Current Market Trends

Main Competitors

Current Demand

Registration Process

Reimbursement
Barriers

Trade Events

Best Prospects

Statistics Snapshot

CS Contact

Capital: Rome

Population: 60.5 million

GDP: USD $2.1 trillion Currency: Euro

Language: Italian

Summary

Italy is a mature market for medical equipment, and its high per capita income and sophisticated healthcare system translates into demand for a broad range of cutting-edge medical equipment. The Italian market for medical equipment and supplies is the fourth largest in Europe following Germany, France, and the United Kingdom with about 3,957 companies (including 42% distributors, 53% producers and 5% service providers) and a workforce of 76,400 people. The medical device market (including dental and optical devices) was valued at approximately $9.7 billion in 2017 with imports accounting for $6.2 billion. Aside from other medical devices, consumable products represent the largest market segment (19.7%) followed by diagnostic imaging (16.7%) and patient aids (15.2%).

The Italian government is the primary purchaser of medical equipment. Public hospitals account for over 75% of medical device sales, while the remaining 25% of sales are made to the private sector. Despite having a considerable local manufacturing industry, the domestic market for medical equipment is highly dependent on imports. Major suppliers are Germany, the Netherlands, Belgium, France, and the United States, which had a 5.9% share of Italian imports, valued at $ 371 million in 2017. Major U.S. imports are in diagnostic imaging and dental and patient aids.

The budgetary pressures and escalating costs of healthcare systems are moving Italy towards value-based health care: new products need to provide better health outcomes in cost-effective ways. The public healthcare system is likely to develop value- and quality-based pricing models and request data and analytics for evidence of cost-effectiveness. Opportunities for companies with very innovative products are rising compared to traditional products. Preventive care, remote monitoring, and early identification of at-risk patients are increasingly valued.                           

Italian Medical Devices Market*

2017

2018

(Est.)

2019

(Est.)

2020

(Est.)

Total Market Size

9,728

9,873

10,021

10,170

Total Local Production

7,700

7,815

7,932

8,050

Total Exports

4,227

4,290

4,354

4,419

Total Imports

6,255

6,348

6,443

6,539

Imports from the U.S.

371

374

380

385


USD in millions: Exchange rate EUR 1 = 1.1810 USD (2018).

*The above statistics are unofficial estimates. They are based on reports and statistics from: Assobiomedica, BMI, Espicom, U.S. Dept of Commerce Bureau of Census and Eurostat.

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Market Entry

The Italian government has implemented various European Union (EU) directives and regulations related to medical devices, and U.S. companies must be prepared to comply with Italian and EU legislation.

American companies interested in entering the Italian market should carefully select their potential distributors or agents and should also consider cooperative arrangements or joint venture/licensing agreements with Italian partners.

It is up to the regional governments to issue specific regulations governing the procurement of medical equipment. Most purchases are made by public tenders open to both domestic and foreign companies. Announcements of tenders on public procurements are monitored by the U.S. Mission to the European Union and can be accessed through the webpage: www.buyusa.gov/europeanunion.

All medical devices marketed in the EU must bear the CE mark to certify conformity with EU legislation. Member States have appointed certification authorities or “notified bodies” to grant these compliance certificates. Award criteria are typically based either on the lowest price or on the most economically advantageous quotations.

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Current Market Trends

Although the Italian domestic medical market (including dental and optical medical devices) was estimated at approximately $9.7 billion in 2017, and is expected to grow by 1% in 2018, there are major constraints to the sector development. The two most significant factors are the healthcare cost-containment measures together with the late payment of public hospitals, which account for 70% of medical device sales.

Italy imports primarily from Germany (24%), The Netherlands (19.4%), Belgium (15.1%), France (9.2%), and the United States (5.9%). However, the Netherlands and Belgium are the medical devices warehouse hubs for all major multinationals, including the United States. Imports of U.S. manufactured devices are coming to Italy through these countries. From the Netherlands, Italy is mainly importing diagnostic imaging and orthopedic and prosthetics devices: from Belgium, consumables.

Italy also maintains a strong position in major subsectors including biomedical instruments and electromedical diagnostics. Regions with the highest concentration of medical devices companies are in Northern Italy.

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Main Competitors

Foreign companies represent 8.2% of the total number of companies producing medical devices. Industry giants such Siemens, Philips, Hitachi and Toshiba are well represented in the market. A significant number of U.S. manufacturers of medical equipment are also present in the Italian healthcare market (about 60 companies with 5,700 employees and $2.7 billion domestic revenue). Some U.S. suppliers maintain wholly-owned subsidiaries in Italy and sell equipment imported from the U.S. or from plants in other foreign countries, such as Johnson & Johnson, Medtronic, and GE Healthcare.

Italian companies are typically small or medium sized and are mainly concentrated in six regions: Lombardy, Emilia Romagna, Veneto, Lazio, Toscana, and Piemonte. The sector is highly innovative and there are about 334 start-ups, among which 67% receive public financing.

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Current Demand

  • Medical Devices

The best sales potential for U.S. manufactured medical equipment is in the following areas: home care equipment, remote monitoring equipment, high frequency medical lasers (for multiple applications), endoscopes and diagnostic imaging equipment, non-invasive and micro-surgery devices and equipment, anesthesiology equipment, EKG, stimulators and defibrillators, ophthalmic equipment, monitoring equipment, and telemedicine equipment and services. The Italian market is receptive to high quality and technologically advanced diagnostics and therapeutic equipment and products.

With increasing attention on reforming and improving healthcare management, medical device companies providing services and solutions as add-ons to their products will also have opportunities in the Italian market. The services will enhance the value proposition of existing products for patients (e.g. services to identify the appropriate patients for the use of a device, training for nurses on new procedures and products, partnership with hospitals to increase efficiency).

  • E-Health

The European e-health market has an estimated annual value of around $20 billion with an annual growth of 3%. Considering that the demand for healthcare products and services will rise significantly in coming years, the information technology applied to healthcare systems is a key enabler for delivering more effective and efficient healthcare.

In Italy, ICT expenditures in healthcare in 2018 were estimated at $ 1.6 billion corresponding to 1.4% of total healthcare expenditures, which is limited compared to other countries (2.5% to 3%). Despite the 7% increase compared to 2017 expenditures, the adoption of digital instruments in healthcare remains fragmented.

Italy’s investments in e-health in USD:

E-HEALTH INVESTMENTS

2017

2018

2017/2018 %

Healthcare Facilities

1,051

1,145

+9%

Regions

378

389

+3%

General Practitioners

86

89

+4%

Ministry of Health

19.7

19.9

+1%

Source: Milan Politecnico School of Management

The hospital departments systems and the Electronic Medical Record (EMR) system are the areas of digital innovation that collect the highest budgets, respectively $114 and $59 million. Experts expect to see investments over the coming years in electronic health records, cloud computing, administrative management, digital management of drugs, ePresciption, mobile health and business intelligence, and clinical governance.

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Registration Process

All medical products and equipment imported into Italy require a notification to the Italian Ministry of Health (MoH). The designated competent authority for medical devices is the Directorate General of Medical Devices and Pharmaceutical Services at the MoH.

All new–to-market medical devices must go through an online device registration process with the Italian MoH to be placed in the Italian market. Information on registration procedures is available on the MoH’s website (in English) as follows:

http://www.salute.gov.it/portale/temi/p2_6.jsp?lingua=italiano&id=395&area=dispositivi-medici&menu=registrazione

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Reimbursement

In October 2012, the MoH determined the maximum reimbursement rates for the compensation of services provided in the hospital sector and in rehabilitation and long-term care.

Both public and private health providers are reimbursed through a fee-for-service system based on the relevant tariffs. The reimbursement rates are defined in three tariffs at the national level.

  • Nomenclature tariff of specialty ambulatory care (Nomenclatore tariffario dell'assistenza specialistica ambulatoriale);
  • Nomenclature tariff for prostheses (Nomenclatore tariffario protesi);
  • Tariff of care in acute hospitals under the diagnosis related group (DRG) system (Tariffe delle prestazionidi assistenza ospedaliera per acuti (sistema DRG)).

Italy has, in the past, faced payment delays from the public healthcare institutions. In the last few years, the average time to pay has gradually been reduced. According to Assobiomedica (the Italian trade association for medical devices), the average payment time was 133 days in 2017

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Barriers

There are no significant trade barriers or limitations on imports of U.S. goods. Technical specifications are essentially those established by the EU, which have been incorporated into Italian law.

Official technical norms are issued by UNI, the Italian Standards Institute, and electrical norms are from CEI, the Italian Electrotechnical Standards Institute. Information on EU standards is available from the Commercial Service Office at the U.S. Mission to the European Union at the following address: 40 Boulevard du Regent, 1000 Brussels, Belgium, tel.: 32 2 5082746; fax: 32 2 5131228.

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Procurement & Tenders

Healthcare procurement has been rationalized and reorganized at the regional level with a procurement organization for each region. Several tenders for medical equipment are handled at the national level by Consip, a company of the Ministry of Finance.

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Trade Events

EXPOSANITÀ – April 2020

The second largest trade show for medical devices in Europe, with about 29,200 visitors and 720 exhibitors.

https://www.exposanita.it/en/

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FAQs

1. Is the CE mark enough to export a medical device to Italy?

No. In order to export a medical device to Italy, the device, bearing a CE mark, needs to be registered with the Italian Ministry of Health (see info above). It is a registration, not an approval. It is very important that the device is registered otherwise it may not enter the country. The registration can be done either by the manufacturer or the distributor. In any case the device registration is in the name of the manufacturer, even if the administrative paperwork is submitted by the distributor.

2. What is the custom import health clearance (nulla osta sanitario)?

All medical devices entering the Italian market will be checked at customs, which will issue an import health and safety clearance. To obtain the clearance the following documents are required: Declaration of Conformity, CE certificate, Registration Number from the Italian Medical Device Registry, Product labeling (as required in the EU directive): CE marking, authorized representative, Serial number/lot number, Lot numbers (all lot numbers need to be reported, preferably on the invoice but if this is not possible on the bill of entry).

3. What are the major sales channels in Italy?

There are two principal sales channels for medical devices served by a diverse group of distributors, one for the hospitals/clinics and one for the pharmacies/orthopedic shops. Regarding the expanding online sales channel, Italian customers are still cautious, despite the increasing use of the internet.

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Best Prospects

  • Medical devices companies providing services and solutions as add-ons to their products will have opportunities in the Italian market.
  • Highly innovative products improving patient treatments or providing cost-efficient outcomes are in demand.
  • Telemedicine and e-health are slowly developing but will be in demand soon.
  • Focus on preventive care will increase demand for POC diagnostic products.

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Statistics Snapshot

Market Size

Healthcare spending (including investment)

USD 185.3 bn

... as percent of GDP

8.8 %

... of which spent on inpatient services (including long-term care)

109,934 mln

... of which spent on pharmaceuticals/consumables

35,250 mln

Hospitals, Procedures, Healthcare Professionals

Number of hospitals

965

…Public

487

…Private

478

Number of hospital beds

205,229

... available beds per capita (per 000 population)

3.5

...of which in general hospitals

131,213

...of which in specialized clinics and rehabilitation centers

62,852

Number of surgical procedures

11,183,000

...of which [Cataract surgery]

563,741

...of which [Caesarean section]

154,962

…of which [Transluminal Coronary Angioplasty]

130,522

Physicians

245,514

...of which surgeons

59,830

...of which pediatricians

17,711

Dentists

44,993

Demographics

Population

60.5 million

Life expectancy men/women

81.1/85.2

Infant mortality (000 live births)

2.3

Percent of population older than 65

22.6%

...projection, 2030

26.1%

Annual deaths

631,400

...caused by [cardiovascular diseases]

239,527

...caused by [cancer]

178,872

Data sources: BMI, Istat, OECD Stat.

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U.S. Commercial Service Contact Information

Name: Kira Migliorini

Position: Commercial Specialist

Email: Kira.Migliorini@trade.gov

Phone: +39 06 4674 2204


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