Overview   

Table: Total Market size for Medical Equipment & Devices

Medical Devices (USD millions)	2019	2020	2021 (estimate)	2022 (forecast)
Total Exports	1,741	1,864	2,145	2,984
Total Local Production	3,025	2,827	3,274	4,778
Total Imports	5,114	5,587	6,295	6,317
Average Exchange Rate: Euro 1.00: USD 1.00	1.119	1.142	1.183	1.12

Total Market Size = (Total Local Production + Total Imports) – (Total Exports)

Data sources:  Fitch Solutions and other market sources. 

With a population of over 47 million, and the fourth largest economy in the EU, Spain is an important market for medical products. Comprehensive medical attention is available to all Spaniards. Public healthcare institutions currently represent approximately 70 percent of the healthcare sector and are the main purchasers of medical equipment and supplies. These entities include public hospitals, health centers, and research institutes, etc. The weight of the private healthcare sector continues to increase given the need for greater public/private collaboration, particularly in view of the strain put on the system by COVID. According to official figures, the private healthcare sector accounts for 2.7 percent of GDP, while the public sector accounts for 6.6 percent. 

The public health budget for 2021 was USD 96.7 billion, representing approximately 6.6 percent of GDP.  According to the Spanish Ministry of Health, Consumer Affairs and Social Services, total (public and private) healthcare expenditure in 2021 was USD 136.5 billion (115.48 billion euros), which represents 9.3 percent of the country’s GDP.  Each of the country’s 17 regional governments administers its respective healthcare budget as authorized by the Central Government.

The average per capita expenditure (public and private) is reported at USD 2,450 (USD 2,050–public, USD 850- private). Public per capita expenditures vary from region to region, with public expenditures ranging from USD 1,642 in the region of Andalusia with a population of more than 10.4 million, to USD 2,355 in the Basque Country where the population is 3.7 million.  Per capita expenditure continues to lag behind that of other leading economies in Europe.

Official statistics for the sector are not available. The figures in the chart above are not all-inclusive but reflect market trends. In the absence of local data for 2021, the statistics in the chart provided only include medical devices.  When available, local figures include a broader range of categories.

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 10 percent of the market and generate approximately 60 percent of the sales. Most of the large U.S. and European names are well-established in Spain, with only 6 percent manufacturing locally.

Spain still had not fully recovered from the severe impact of the 2007-2013 economic crisis at the onset of COVID-19 in 2020. According to the country’s healthcare technology federation, FENIN, Spain has a major problem with obsolete equipment. It is anticipated that part of the EU relief funding will be used to start renovating the equipment.

The sector continues to rely heavily on imports. In the absence of statistics, a breakdown is currently not available.  Prior to COVID, the bulk of the imports came from Europe, with Germany accounting for approximately 50 percent of total imports. Most well-known U.S. brands are well-established in the Spanish market.  Imports from the United States are estimated to be in the 15-20 percent range although it is difficult to confirm the U.S. market share as a portion of imports arrive in Spain through various other European ports and/or from the U.S. firms’ European production facilities.  The European Union (EU) 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. 

Medical products and devices must have the CE mark and must be imported by a company that has the corresponding authorization to handle medical products. This permit is issued by the Spanish Agency of Medicine and Medical Devices (AEMPA). 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 country markets.

A revised EU Medical Device Regulation (EU) 2017/745, (MDR) came into effect on May 26, 2021. This MDR replaces Directives 93/42/EC and 90/385/EEC meaning that medical devices can no longer be certified under the old directives.  Manufacturers are strongly advised to review the new regulation to ensure compliance with new requirements.

Official tenders are used for most public healthcare sector acquisitions. Non-EU and U.S. companies need to have either a Spanish distributor or their own branch in Spain to participate in official tenders and to avail themselves of other market opportunities, as also to provide the after-care service required by law. There is a pre-selection process among the competing companies prior to the open bid. During pre-selection, the companies present the hospital with descriptions of the products and 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.

Leading Sub-Sectors

While the need for products related directly to COVID-19 (personal protection equipment, consumables, infection control, etc.) has dominated the market for the past two years and strained resources to the limits, the slow return to regular activities and the need to remedy the highest waitlist for surgery in a decade, will drive demand for other supplies and equipment.  Given the country’s reliance on imports, and despite cost containment measures to balance the budget, the sector should see an increased demand in almost all areas, with orthopedics and consumables in high demand.

The strain of meeting the challenges of these past two years has brought to the surface the need for a deep restructuring of the healthcare system in terms of scope and operation:

• Increased automation.
• The renewal of the obsolete equipment (cardiology, respiratory/anesthesia, neurology, orthopedic, MRA, ETP, CT, etc.).
• Reinforcement of personnel and infrastructure.

Opportunities

Areas of focus will be on replacing/upgrading high-tech equipment and infrastructure, swifter transition towards greater digitalization, big data, and increased public-private partnerships, etc. This focus will be spread out over several years and, for the most part, funding will be administered by the 17 regional governments.  This latter fact may well mean that the pace and nature of the procurements will vary from region to region.

Other areas of interest include:

• An ageing population and the prevalence of chronic diseases are also factors that will generate demand in the future, i.e., orthopedics, prosthetics, patient aids, home care, hospice products, etc.  

• The lower cost of treatment will continue to drive the increased interest in minimally invasive technologies, primarily in the areas of cardiology and robotics.
• The demand for reputable e-health technology will continue.

• Consumables*. Asia had become the dominant supplier in recent years, mainly because of greater cost control.  It is interesting to note that consumables are one of the more dynamic local sectors although much of this production is earmarked for export.
  • *Medical consumables and equipment include syringes, needles, sutures, staples, packaging, tubing, catheters, medical gloves, gowns, masks, adhesives and sealants for wound dressing and a whole host of other devices and tools used with a hospital or surgical environment.

Pricing will continue to be a major component of the decision process. Likewise, budgetary considerations will drive other changes in the sector, which may well include more centralized procurement, as well as ongoing, if not greater emphasis on the cost/benefit of equipment, increased tax on products, etc.

It should be noted, however, that apart from competitive pricing, sector professionals tend to prefer products with a proven track record and, if possible, in use in other European markets. Competition is stiff not only from in-country companies but also from most well-known international suppliers, including numerous U.S. names, that are well-established in the Spanish market.

Traditionally, the MEDICA trade fair that takes place every November in Düsseldorf, Germany, has been by far the most important venue for Spanish professionals, for 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. CS Madrid will actively promote the event to professionals in the Spanish healthcare sector. 

Resources

• Ministry of Health
• Spanish Healthcare Technology Federation - FENIN

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

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