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Healthcare Resource Guide: Italy

 

Italy Statistics

Summary
Market Entry

Current Market Trends

Main Competitors

Current Demand

Registration Process

Reimbursement
Barriers

Trade Events

CS Contact

Best Prospects

Market Size

Capital: Rome

Population: 61 million

GDP*: US $1.8 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 UK with about 4,480 companies (including 43% distributors, 53% producers and 4% service providers) and a workforce of 68,200 people. The medical device market (including dental and optical devices) was valued at approximately USD 8.7 billion in 2015 with imports accounting for USD 5.8 billion and is expected to grow by 1% in 2017 after a reduction of 0.8% in 2016.Aside from other medical devices, consumable products represent the largest market segment (20.6%) followed by diagnostic imaging (16.1%), patient aids (14.7%).

The Italian government is the primary purchaser of medical equipment. Public hospitals account for over 75 percent of medical device sales, while the remaining 25 percent 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 6.5% share of Italian imports, valued at USD 377,960 million in 2015. Major US imports are in diagnostic imaging, 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. In fact, the public healthcare system is likely to develop value- and quality-based pricing models and request data and analytics for cost-effective evidence. 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*

2015

2016

Estimated

2017

Estimated

2018

Estimated

Total Market Size

8,724

8,646

8,732

8,776

Total Local Production

6,674

6,615

6,681

6,747

Total Exports

3,750

3,717

3,754

3,791

Total Imports

5,800

5,748

5,805

5,863

Imports from the U.S.

377

373

390

420


USD in millions: Exchange rate EUR 1 = 1.1095 USD (2015).

*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.

Market Entry

The Italian government has implemented various European Union (EU) directives 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.

Current Market Trends

Although the Italian domestic medical market (including dental and optical medical devices) was estimated at approximately USD 8.7 billion in 2015, and is expected to grow by 1% in 2017, 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 percent of medical devices sales.

Italy imports primarily from The Netherlands (22.6%), Germany (19.9%), Belgium (15.2%), France (10.4%), and the United States (6.5%).

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

Main Competitors

Foreign companies represent 8.2 percent 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 USD 2.7 billion domestic revenue). Some U.S. suppliers maintain wholly owned subsidiaries in Italy and sell equipment imported from the United States 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 214 start-ups among which 67 percent received public financing.

 

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, 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 USD 20 billion with an annual growth of 3 percent. Considering that the demand for healthcare products and services will rise significantly in coming years, the information technology applied to the healthcare systems is a key enabler for delivering more effective and efficient health care.

In Italy, the ICT expenditures in healthcare are estimated at USD 1.4 billion corresponding to 1.2% of the total healthcare expenditures, which is limited compared to other countries (2.5% to 3%). Following a slight growth of the ICT budget in 2014, in 2015 expenditures in digital health has declined and the adoption of digital instruments in healthcare remain fragmented.

eHealth Expenditure Trends* in Italy (2016-2020)

 

Years

GDP

Healthcare expenditures/GDP %

Healthcare expenditures

eHealth expenditures mln Euro

eHealth expenditures/public healthcare expenditures %

2016

1,671,584

6.80

112,385

1,385

1.23

2017

1,715,832

6.70

113,786

1,436

1.26

2018

1,764,755

6.60

115,154

1,489

1.29

2019

1,818,438

6.50

117,469

1,556

1.32

2020

1,870,204

6.37

119,214

1,617

1.36

*Censis – Impresa Lavoro

According to data, the Italian eHealth expenditures over the public healthcare expenditures will likely reach 1.36% in 2020. Strategic areas which will see investments over the next three years include electronic health records, cloud computing, administrative management, digital management of drugs, ePrescription, mobile health and business intelligence and clinical governance.

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 Ministry of Health.

All new–to-market medical devices must go through an on-line device registration process with the Italian Ministry of Health to be placed in the Italian market. Information on registration procedures is available on the Ministry of Health’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

Reimbursement

In October 2012, the Ministry of Health determined the maximum reimbursement rates for the compensation of services provided in the hospital sector and in the 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 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 faced in the past long payment delays from the public healthcare institutions. In the last years, the average time to pay is gradually being reduced. According to Assobiomedica (the Italian trade association for medical devices), the average payment time was 166 days in September 2015.

 

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 Electro technical 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.

 

Procurement & Tenders

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

 

Trade Events

 

EXPOSANITA’

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

April 21, 2018

Bologna, Italy

http://www.senaf.it/Expo-Sanita/107/en

 

U.S. Commercial Service Contact Information

Name: Kira Migliorini

Position: Commercial Specialist

Email: Kira.Migliorini@trade.gov

Phone: +39 06 4674 2204          

Available Market Research/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 on demand.
  • Telemedicine and eHealth are slowly developing but will be on demand in the near future.
  • Focus on preventive care will increase demand for POC diagnostic products.

Market Size 2015

Healthcare spending (including investment)

USD 155.4 bn

... as percent of GDP

8.7 %

... 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

1,111

…Public

601

…Private

510

Number of hospital beds

194,065

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

3.9

...of which in general hospitals

131,213

...of which in specialized clinics and rehabilitation centers

62,852

Number of surgical procedures

8,352,000

...of which [Cataract surgery]

526,974

...of which [Caesarean section]

171,403

Physicians

240,481

...of which surgeons

59,830

...of which pediatricians

17,711

Dentists

47,098

Demographics

Population

61 million

Life expectancy men/women

80.4/85

Infant mortality (000 live births)

3.1

Percent of population older than 65

22.4%

...projection, 2030

26.1%

Annual deaths

605,600

...caused by [cardiovascular diseases]

220,200

...caused by [cancer]

177,301

Data sources: BMI, Istat, OECD Stat.


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