Italy - Medical Devices and TechnologyItaly - Medical Devices & Technology
Overview
Unit: USD Millions
| 2017 | 2018 (Estimated) | 2019 (Estimated) | 2020 (Estimated) | |
| 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 US | 371 | 374 | 380 | 385 |
| Total Market Size | 9,728 | 9,873 | 10,021 | 10,170 |
Italy is a mature market for medical equipment, and its high per capita income and sophisticated healthcare system translate 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 3,957 companies (including 42% distributors, 53% producers and 5% service providers) and a workforce of 76,400. 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 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 percent of medical device sales, with the remaining 25 percent of sales to the private sector. Despite having a considerable local manufacturing industry, the domestic market for medical equipment is highly dependent on imports. Major suppliers include 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. medical device imports to Italy include diagnostic imaging, dental and patient aids.
Budgetary pressures and escalating costs 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.
The manufacturing sector in Italy is heterogeneous, made up of a broad network of small and micro businesses and technological start-ups, which account for 3,605 production plants. The local market is strong in the production of diagnostic imaging equipment, contrast media for imaging, cardiology equipment, sterilizers, implantable pacemakers, hospital furniture, anesthesia equipment, respiratory apparatus, dialysis equipment and dental products ranging from instruments to dental chairs. The highest concentration of medical devices companies is in Northern Italy, primarily in the regions of Lombardy, Veneto, and Emilia Romagna, which is an important hub for major medical device companies.
A significant number of U.S. manufacturers of medical equipment are 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 United States or from plants in other foreign countries. There are also a considerable number of U.S. companies represented by local importers and distributors. Since U.S. technology and standards are highly regarded and recognized, we believe that U.S. companies will maintain their excellent market position in the future.
Leading Sub-Sectors
The strongest sales potential for U.S. manufactured medical equipment exists 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 as well as therapeutic equipment and products.
With increasing attention on reforming and improving healthcare management, medical devices companies providing services and solutions as add-ons to their products will also find strong opportunities in the Italian market. The services enhance the value proposition of existing products for patients (ex: services to identify the appropriate patients for the use of a device, training for nurses on new procedures and products, partnerships with hospitals to increase efficiency, etc).
E-Health
The European e-Health market has an estimated value of $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 expenditure in healthcare in 2018 was $1.6 billion corresponding to 1.4% of the total healthcare expenditures, which is less than many other developed countries which average 2.5-3%. Despite the 7% increase compared to 2017 expenditures the adoption of digital instruments in healthcare remains fragmented.
| EHEALTH 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) are the areas of digital innovation that collect the highest budgets, respectively $114 and $59 million. Experts expect to see investments over the next three years in electronic health records, cloud computing, administrative management, digital management of drugs, ePrescription, mobile health and business intelligence and clinical governance.
Requirements
The Italian government issues regulations governing the procurement of medical equipment. Recently the healthcare procurement system has been re-organized into 33 procurements centers. Most purchases are made by public tender and are open to both domestic and foreign companies. Announcements of tenders on public procurements are available on the National Procurement Center, CONSIP (www.consip.it).
It is unrealistic for a foreign firm to believe they can navigate the cumbersome bureaucratic procedure of public procurement without having a base in Italy or a strategic Italian partner. Companies wishing to participate in public tenders must first qualify by submitting adequate evidence of their business experience and professional expertise.
In April 2017, two new Regulations on medical devices were adopted by the European Commission, which entered into force in May 2017. These replace the existing three Directives: Active Implantable Medical Devices Directive (90/385/EEC), Medical Devices Directive (93/42/EEC) and In Vitro Diagnostic Medical Device Directive (98/79/EEC). The new rules will only apply after a transitional period: three years after entry into force for the Regulation on medical devices in spring 2020 and five years after entry into force in spring 2022 for the Regulation on in vitro diagnostic medical devices. All medical devices marketed in the EU must bear the CE mark to certify conformity with EU law. Information on the new regulations can be found on the European Commission website: http://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework/revision_it
The designated competent authority for medical devices in Italy is the Directorate General of Medical Devices and Pharmaceutical Services at the Ministry of Health. New-to-market medical devices must be registered and have a unique identification number in the National Health System directory (Repertorio). U.S. companies should designate a third party in Italy to register their products with the Minister of Health. The online registration can be found on the Ministry of Health website:
http://www.salute.gov.it/portale/temi/p2_6.jsp?lingua=italiano&id=395&area=dispositivi-medici&menu=registrazione
Web Resources
MINISTERO DELLA SALUTE (Ministry of Health)
www.salute.gov.it
CONFINDUSTRIA DISPOSITIVI MEDICI (Italian Association of Medical Equipment Manufacturers)
www.confindustriadm.it
AIOP (Italian Associazione of Private Hospitals)
www.aiop.it
U.S. Commercial Service Contact:
Kira Migliorini, Healthcare Technologies Specialist
U.S. Commercial Service, U.S. Embassy Rome
Tel: +39 064674 2202
E-mail:Kira.Migliorini@trade.gov
http://export.gov/italy