Spain - Commercial Guide
Medical Equipment & Devices

This is a best prospect industry sector for this country. Includes a market overview and trade data.

Last published date: 2020-08-07

This is a best prospect industry sector for Spain, including a market overview and trade data.  

Overview 

Medical Equipment (USD millions)

2017

2018

2019

2020*

Total Market Size

6,678

6,366

6,287

6,597

Total Exports

 1,720

1,842

1,759

n.a.

Total Local Production

 3,723

3,170

2,919

n.a.

Total Imports

4,675

5,038

5,127

n.a.

Exchange rate - Euro 1.00: USD 1.00

1.1297

1.1810

1.1195

1.1812

Total Market Size = (Total Local Production + Total Imports) – (Total Exports) 
Data sources:  Unofficial estimates based on input from sector sources and research firms.

*Estimate prior to onset of international health crisis.

**Given the magnitude of the unforeseen international health crisis, estimates for 2020/21 are currently unavailable. 

 

With a population of over 47 million, and the fourth largest economy in the EU, Spain is an important market for medical products. Public healthcare institutions are the main purchasers of medical equipment and supplies and currently represent 75-80 percent of the market. These entities include public hospitals, health centers, research institutes, etc.  The private healthcare sector currently accounts for approximately 20 percent of the market, although this share may well increase given the need for greater public/private collaboration, particularly as a result of the current healthcare crisis.  Comprehensive medical attention is available to all Spaniards, while more than 10 million Spaniards also have private health insurance. The regions of Madrid and Catalonia account for over 80 percent of medical equipment sales. 

Small and medium sized companies make up 90 percent of the market and account for more than 40 percent of the sales.  Large companies account for only 8 percent of the market but they generate approximately 60 percent of the sales.  The majority of the large U.S. names are well-established in Spain. 

Spain underwent a severe prolonged economic crisis from 2007 through 2013.  One of measures taken by the Government to offset the crisis was a reduction in the healthcare budget.  This reduction was felt at all levels, including procurement which, at one stage fell below 2007 levels.  Despite budget increases over the past several years, the pace of recovery in this area has been relatively slow.   According to a report released in December 2019 by the country’s healthcare technology federation, FENIN, Spain continues to have a major problem with obsolete equipment. While the situation in the area of diagnostic imaging equipment has improved due to a substantial private sector donation, the report, nonetheless indicates that approximately 50 percent of the equipment in many areas including surgical and intensive care, is approximately 10 years old, if not more.   The Spanish Ministry of Health, Consumer Affairs and Social Services, announced in October 2019 a centralized acquisition over a period of two years, with a possible one-year extension of cardiovascular devices (pacemakers, defibrillators and electrodes.  The total acquisition was valued at USD 39 million, however, as in so many other areas, the impact of the health crisis on undisbursed funding will be substantial.    

According to Spanish Ministry of Health, Consumer Affairs and Social Services, total (public and private) healthcare expenditure in 2019 was  (USD 117.5 billion)  which represents 9 percent of the country’s GDP.  The average per capita expenditure (public and private) is reported at USD 2,524 (USD 1,904–public, USD 741- private).  Each of the 17 regional governments administers its respective healthcare budget authorized by the Central Government.  Consequently, per capita expenditures vary from region to region, with public expenditures ranging from USD 1, 376 in the region of Andalusia with a population of more than 10.4 million to USD 1,993 in the Basque Country where the population is 3.7 million. 

Official statistics for the sector are not available.  The above figures are not all-inclusive but reflect market trends.  Estimates for the rest of 2020 are currently unavailable due to the magnitude of the current healthcare crisis and the inordinate amount of resources utilized by the government to date. Despite the demand for equipment and supplies to meet the current health situation, overall the market for medical devices will be slow in the coming months due to the drain on resources and the contraction of the economy, estimated at between minus 9 – 13 percent in 2020. Spain is the fifth largest market in Western Europe for medical devices and, as the economy starts to slowly recover, the value of technological renovation and digital transformation that became so apparent during the health crisis will result in these areas becoming the object of prime attention.  An ageing population and the prevalence of chronic diseases are also factors that will generate a demand in the future. 

The sector continues to rely heavily (approximately over 70 percent) on imports.  Germany accounts for approximately 50 percent of the imports, while the United States accounts for another 25 percent, some of which comes through other European ports. Most of the well-known U.S. brands are well-established in the Spanish market.  

Spanish manufacturers have stepped up their international activities since the previous economic crisis. Medical device exports from Spain increased over 30 percent between 2012-2017.  Exports have since slowed down.  The European Union continues to be the principal destination for Spanish exports in this sector, with more than 60 percent of exports going to Germany, Portugal, Belgium, France and Italy.   

A revised Medical Device Regulation (MDR) was approved in May 2017 and was scheduled to be fully implemeted by May 2020.  In order to avoid shortages of medical devices during the ongoing COVID-19 pandemic due the limited capacity of national competent authorities or notified bodies to implement the Regulation, the European Parliament and the Council of the EU adopted a proposal in April 2020 to extend the transitional period of the Medical Devices Regulation by one year - until 26 May 2021.  

Medical products and devices must have the CE mark and need to be imported by a company that has the corresponding authorization to handle medical products.  This permit is issued by

the Spanish Agency for Medicine and Health Products. As a result of the development and expansion of the EU market and the requirement for the CE Mark, many U.S. companies have been centralizing their manufacturing and import operations into one single EU country from which they register and distribute their products to the rest of the EU.  

Official tenders are used for most public healthcare sector purchases. There is a pre-selection process among the competing companies prior to the open bid.  During pre-selection, supplying companies present the hospital with descriptions of their products and their prices.  After reviewing the proposals, the hospital chooses the companies considered the most suitable.   Tenders are not used in the private sector.  Normally, private hospitals select a small number of suppliers from whom they make direct purchases. Non-EU and U.S. companies need to have either a Spanish distributor or their own branch in Spain in order to participate in official tenders and to avail of other market opportunities, as also to provide the after-care service required by law.  

Refurbished medical equipment can be imported, but both public and private medical providers in Spain have traditionally shown interest only in new equipment. As is the case for new equipment, refurbished equipment must follow CE mark and registration with the Ministry of Health requirements.

Leading Sub-Sectors 

While the increased demand for products related directly to the current health crisis  (personal protection equipment, consumables, infection control, etc.) will help drive the market in 2020, the demand for other products will decline due to the pressure on healthcare resources and the severe contraction in the economy.  Nonetheless, according as the economy improves, and despite the cost containment measures that will be imposed in order to balance the budget, as Spain is heavily reliant on imports there will be an increased demand for e-health products as well as innovative and efficient cardiology, respiratory/anesthesia, neurology, orthopedic, MRA, ETP, CT, etc. The area of personalized medicine will continue to prosper. Minimally invasive technologies, primarily in the areas of cardiology and robotics, are growing more popular as well, due to the lower cost of treatment. As a result of the aging population, the demand for orthopedics and prosthetics, patient aids, home care and hospice products will continue.    

 While there is a good demand for disposables, Asia has become the dominant supplier in recent years because of greater cost control.  In light of the current situation, it remains to be seen what impact the need to guarantee national requirements will have on trade and supply chains, although pricing will continue to be a major component of the decision process.  Likewise, budgetary considerations will drive   other changes in the sector, one of which may well be more centralized procurement, more emphasis on cost/benefit of equipment, increased tax on products.  

Opportunities 

As a result of the healthcare crisis, there will be increased healthcare expenditure in the immediate future.  Increased resources will be used to cover diverse areas including increased personnel and infrastructure, improved primary assistance, personal protection equipment, increased public-private partnerships, increased collaboration between the central government and the 17 regional governments, swifter transition towards greater digitalization, big data etc. 

Traditionally, the MEDICA trade fair that takes place every November in Düsseldorf, Germany, is by far the most important venue for Spanish professionals, both manufacturers and distributors on an international level.  ICEX, the Spanish Institute for Foreign Trade  in collaboration with FENIN organizes a large pavilion at the fair.  Many of the Spanish exhibitors at the fair also import products.  Irrespective of the final format for the November 2019 edition, CS Madrid will actively promote the event to professionals in the Spanish healthcare sector.   

U.S. Commercial Service Spain: 
Healthcare Sector Specialist: Helen Crowley 

Tel: +34 91 308 1548 
e-mail: Helen.Crowley@trade.gov