Executive Summary
Market Entry
Current Market Trends
Best Prospects
Market Size
Main Competitors
Current Demand
Registration Process
Reimbursement
Barriers
Procurement & Tenders
FAQs
U.S. Commercial Service Contact Information
Tab Options
Executive Summary
Market Entry
Current Market Trends
Best Prospects
Market Size
Main Competitors
Current Demand
Registration Process
Reimbursement
Barriers
Procurement & Tenders
FAQs
U.S. Commercial Service Contact Information
Executive 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.
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.
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.
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 more details can be found at this website: https://www.trade.gov/knowledge-product/european-union-selling-government .
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 $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.
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.
Market Size
Healthcare Spending (Including Investment)
…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
… of which spent on investments
N/A
… of which spent on outpatient services
N/A
Hospitals, Procedures, Healthcare Professionals (Source: Albanian Institute of Statistics)
Number of Hospitals
965
… Public
487
… Private
478
Number of Hospital Beds
205,229
… available beds per 1000
3.5
… of which in general hospitals
131,213
… of which in specialized clinics and rehab centers
62,852
Number of Surgical Procedures
11,183,000
Physicians
245,514
… of which surgeons
59,830
… of which pediatricians
17,711
Dentists
44,993
Demographics (Source: Albanian Institute of Statistics)
Population
60.5 million
Life expectancy men/women
81.1/85.2
Infant mortality
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.
Main Competitors
Medical equipment and devices:
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.
Current Demand
Medical Devices
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
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.
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) .
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.
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.
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.
FAQs
1. Is the CE mark enough to export a medical device to Italy?
2. What is the custom import health clearance (nulla osta sanitario )?
3. What are the major sales channels in Italy?
U.S. Commercial Service Contact Information
Name: Kira Migliorini Kira.Migliorini@trade.gov
