The European Medical Technology Industry in Figures

The European Medical
Technology Industry
in Figures
What is Medical Technology?
Medical technology is a collective noun for medical devices,
in vitro diagnostics, medical imaging equipment and e-health
solutions. Billions of patients worldwide depend on medical
technology at home, at the doctor’s, at hospital and nursing
homes. Wheelchairs, pacemakers, blood-glucose monitors,
orthopaedic shoes, spectacles and contact lenses, insulin
pens, hip prostheses, condoms, oxygen masks, HIV-tests,
dental floss, MRI scanners, pregnancy tests, surgical
instruments, bandages, syringes, life-supporting machines:
more than 500,000 products (20,000 generic groups) are
available today.
Medical technology is used to ensure health in individuals
suffering from a wide range of conditions. It extends
life and brings healthy life years, reduces symptoms and
prevents disease progression, thus playing an essential role in
healthcare. Good health is a prerequisite for well-being and
economic prosperity. Medical technology helps people live
healthier, more productive, social active, independent lives
and reinforces employability. Moreover, continuous medical
technology innovation enhances the quality and effectiveness
of care. In doing so, it contributes to steering healthcare onto
a sustainable path.
Diversity of Medical Technology
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T h e E u r o p e a n M e d i ca l T ec h n o lo gy I n d u st ry i n F i g u r es
Despite this high diversity, the MedTech industry’s common
goal is to develop medical technology of the highest quality
and offering the greatest benefit to patients. Products
need to meet stringent quality criteria and their clinical
performance is evaluated to ensure they work as designed.
Moreover, each technology comes with strict instructions for
use and industry continuously invests in hands-on training
for physicians. At the same time, clinical investigations
comprised of thousands of patients, and interviews with
physicians and patients help the medical technology industry
to improve its products ever more.
Also, after a product has been made available to patient
industry has a permanent monitoring system (vigilance)
in place to ensure that any serious adverse event can be
addressed quickly and appropriately.
There are more than 500,000 technologies, in 20,000 generic groups.
These fall within 16 categories of products, as determined by the Global Medical Devices Nomenclature (GMDN) Agency.1
Code
Classification
01
Active implantable technology
02
Anaesthetic and respiratory technologyOxygen mask, gas delivery unit, anaesthesia
breathing circuit
03
Dental technology
Dentistry tools, alloys, resins, floss, brushes
04
Electromechanical medical technology
X-ray machine, laser, scanner
05
Hospital hardware
Hospital bed
06
In vitro diagnostic technology
Pregnancy test, genetic test, glucose strip
07
Non-active implantable technology
Hip or knee joint replacement, cardiac stent
08
Ophthalmic and optical technologySpectacles, contact lenses, intraocular lenses,
ophthalmoscope
09
Reusable instrumentsSurgical instruments, rigid endoscopes, blood pressure
cuffs, stethoscopes, skin electrodes
10
Single use technology
Syringes, needles, latex gloves, balloon catheters
11
Technical aids for disabled
Wheelchairs, walking frames, hearing aids
12 Diagnostic and therapeutic radiation technology
Example
Cardiac pacemakers, neurostimulators
Radiotherapy units
13
Complementary therapy devicesAcupuncture needles/devices, bio-energy mapping
systems/software, magnets, moxibustion devices,
suction cups
14
Biological-derived devices
Biological heart valves
15 Healthcare facility products and adaptations
Gas delivery systems
Most IVD which are not reagents
16
Laboratory equipment
3
Innovation
Medical technology is characterised by a constant flow of
innovations, which are the result of a high level of research
and development within the industry, and of close cooperation with the users. Products typically have a lifecycle
of only 18-24 months before an improved product becomes
available. In 2012, more than 10,000 patent applications were
filed with the European Patent Office (EPO) in the field of
medical technology – equivalent to 7 % of the total number
of applications – more than any other technical field. 38% of
these patent applications were filed from European countries.
In comparison, around 5,400 applications were filed in the
pharmaceutical field and 5,300 in the field of biotechnology.
While over the last decade the number of EPO filings in
the field of medical technology has doubled, biotech and
pharma patent applications were relatively stagnant.2
Top technical fields in patent applications. Number of patent applications filed with EPO, 20122
Medical technology
10.412
9.799
Electrical machinery, apparatus, energy
Digital communication
9.592
Computer technology
8.288
Transport
6.633
Measurement
6.428
Organic fine chemistry
6.002
Engines, pumps, turbines
5.668
Pharmaceuticals
5.364
Biotechnology
5.309
Distribution of health technology fields by patent applications filed with EPO, 20122
Pharmaceuticals
5,309
Biotechnology
38%
10,412
Medical technology
62%
Applications filed from EU28, Norway
and Switzerland
5,364
Applications filed from other countries
Biotechnology
Number of patent applications
filed with EPO
Evolution of European patent applications by technical field2
12 000
10 000
8 000
6 000
Pharmaceuticals
Medical technology
4
4 000
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
T h e E u r o p e a n M e d i ca l T ec h n o lo gy I n d u st ry i n F i g u r es
Employment in Europe
The European medical technology industry employs more
than 575,000 people. Germany has the largest share of
total employment, while the number of medical technology
employees per capita is highest in Switzerland and Ireland.3
This high level of employment shows that the medical
technology industry is an important player in the European
economy. In comparison, the US medical technology
industry employs around 520.000 people4 while the
European pharmaceutical industry employs 675.000
people5.
Number of people employed in the medical technology industry3
200 000
70
Number of employees
150 000
Number of employees
per 10 000 inhabitants
60
50
40
100 000
30
20
50 000
10
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Companies in Europe
There are almost 25,000 medical technology companies
in Europe. Most of them are based in Germany, followed
by the UK, Italy, Switzerland, Spain and France. Small
and medium-sized companies (SMEs*) make up almost
95% of the medical technology industry, the majority of
which employ less than 50 people (small and micro-sized
companies).6
95% SMEs
*An enterprise is considered to be an SME if it employs fewer than
250 persons and has an annual turnover not exceeding €50 million
(Small company - employs fewer than 50 persons and has a turnover
of less than €10 million).
5
€100 bn
European Market
The European medical technology market is estimated at roughly €100 billion7.
Medical technology offers solutions for many disease areas. On a worldwide
perspective, in vitro diagnostics are the largest segment, followed by cardiology
and diagnostic imaging.
% WW Market Share in 2012
Medical technology market estimates by area and sales growth, World, 2012-20188
16%
In vitro diagnostics
14%
Cardiology
Diagnostic imaging
12%
10%
Orthopedics
Ophthalmics
8%
Endoscopy
6%
Drug
delivery
Dental
4%
General &
plastic surgery
2%
Wound management
0%
2,0%
2,5%
3,0%
3,5%
4,0%
4,5%
5,0%
Note: Bubble size = WW Sales in 2012
5,5%
6,0%
6,5%
% Sales growth: CAGR 2012-2018
Based upon manufacturer prices the European medical technology market* is estimated to comprise around 30%9 of the
world market. It is the second largest medical technology market after US (40%9).
World medical technology market*
by region, based upon manufacturer
prices, 20129
12%
European medical technology market*
by region, based upon manufacturer
prices, 20129
39%
2%
2%
2%
US
Europe
Japan
5%
China
Russia
10%
Germany
14%
Canada
Brazil
Other
27%
Italy
3%
3%
Spain
Netherlands
4%
Switzerland
4%
Sweden
5%
16%
10%
28%
6
France
United Kingdom
3%
Belgium
Austria
Other
11%
T h e E u r o p e a n M e d i ca l T ec h n o lo gy I n d u st ry i n F i g u r es
The European market has been growing on average by 4%10 per annum over the past 6 years.
European medical technology market* growth rates, based upon manufacturer
prices, 2008-201310
10%
8%
6%
4%
Annual growth rate
2%
Trend
0%
2008
2009
2010
2011
2012
2013
*Market size estimated in manufacturers’ prices, not including margins, such as value added in the wholesaling and retailing, transportation costs, some
taxes included in the final price, etc. Medical technology not including in vitro diagnostics. IVD specific information is available at European IVD Market
Statistics Report11.
Trade
Europe has a positive medical technology* trade balance of €15.5 billion (2012), more than a twofold increase since 2006.
In comparison, US medical technology* trade surplus is at €5.3 billion.9
Exports and imports of medical technology* by country, 2012
(including European intra-trade)9
Germany
Netherlands
Belgium
Switzerland
Ireland
France
United Kingdom
Italy
Sweden
Denmark
Austria
Finland
Spain
Export
Import
Czech Republic
Poland
Billion EUR
0
5
10
15
20
25
7
Top European medical technology* export destinations, 20129
Russia
5.5%
Canada
3%
US
41%
China
9.5%
Brazil
2.5%
Japan
10%
Australia
4%
Top suppliers to European medical technology* market (imports), 20129
US
65%
China
10.5%
Japan
7%
Singapore
2%
Australia
2%
Medical technology* trade balance by country, 20129
8
7
6
5
4
3
2
1
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*Medical technology not including in vitro diagnostics.
8
T h e E u r o p e a n M e d i ca l T ec h n o lo gy I n d u st ry i n F i g u r es
Expenditure on Medical
Technology
In Europe, an average of 10.4% of gross domestic product
is spent on healthcare. Of this figure, around 7.5% is
attributed to medical technologies. The spending on
medical technology varies significantly across European
countries, ranging from around 5% to 10% of the total
healthcare expenditure.7
Expenditure on medical technology per capita in Europe is
at around €1957 (weighted average), compared with €380
in the US 12.
Breakdown of total healthcare expenditure in Europe13
17%
Inpatient & outpatient care, other
0.8%
Phamaceuticals & other medical non-durables
7.5%
Medical technology
6.7%
75.5%
Medical devices (incl. imaging)
In vitro diagnostics
Per capita spending on various fields, in EUR, latest year available7
1600
Education
Environmental protection
560
Pharmaceuticals
450
Medical technology
195
0
500
1000
1500
2000
9
T h e E u r o p e a n M e d i ca l T ec h n o lo gy I n d u st ry i n F i g u r es
References
1
Global Medical Devices Nomenclature (GMDN) Agency, 2010.
2
E uropean Patent Office, Eucomed calculations. Medical technology as defined by World Intellectual Property Organization (based
on the WIPO IPC-Technology concordance as revised in August 2012). European countries refer to EU + Norway, Switzerland.
Patents are attributed by the country of residence of the applicant.
3
E urostat, Eucomed calculations based on the data obtained from National Associations of 15 countries for the latest year available.
Countries with (partially) provided data: Belgium, Czech Republic, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands,
Poland, Portugal, Spain, Sweden, UK, Switzerland. Europe refers to EU + Norway, Switzerland.
4
S . Tripp, M. Grueber, R. Helwig - The Economic Impact of the U.S. Advanced Medical Technology Industry, Battelle Technology
Partnership Practice, March 2012.
5
EFPIA – The Pharmaceutical Industry in Figures. Key Data 2013. Europe refers to EU + Norway, Switzerland.
6
E ucomed calculations based on the data obtained from National Associations of 15 countries for the latest year available. Europe
refers to EU + Norway, Switzerland.
7
HO Global Health Expenditure Database, Eurostat, Eucomed calculations based on the data obtained from National Associations
W
of 15 countries for the latest year available. Countries with (partially) provided data: Belgium, Czech Republic, Denmark, France,
Germany, Greece, Ireland, Italy, Netherlands, Poland, Portugal, Spain, Sweden, UK, Switzerland. Europe refers to EU + Norway,
Switzerland.
8
orld Preview 2013, Outlook to 2018: The Future of Medtech, EvaluateMedTech™, September 2013.www.evaluategroup.com/
W
MedTechWP2013.
9
E spicom, Eucomed calculations. Manufacturer prices. Medical devices and Imaging excluding in vitro diagnostics. Europe refers to
EU (excluding Cyprus, Luxembourg, Malta) + Norway, Switzerland.
10
E spicom, Eucomed calculations. Average growth rate over 2008-2013 years. Manufacturer prices. Medical Devices and Imaging
excluding in vitro diagnostics. Europe refers to EU (excluding Cyprus, Luxembourg, Malta) + Norway, Switzerland.
11
http://www.edma-ivd.eu/uploads/Market%20Intelligence/2011_EU_IVD_Market_Statistics_Report-2.pdf
12
WHO; G. Donahoe and G.King - Estimates of Medical Device Spending in the United States, F.S.A., M.A.A.A. AdvaMed, 2012.
13
WHO, Eurostat, EFPIA, EDMA, Eucomed calculations.
10
About MedTech Europe
MedTech Europe is an Alliance of European medical technology
industry associations. The Alliance was founded in October 2012 and
currently has two members being EDMA, representing the European
in vitro diagnostic industry, and Eucomed, representing the European
medical devices industry.
The Alliance was established to represent the common policy interests
of its members more effectively and efficiently. Its mission is to make
value-based, innovative medical technology available to more people,
while supporting the transformation of healthcare systems onto
a sustainable path. As such, the medical devices and in vitro diagnostics
industries are jointly executing their industry strategy.
In 2012 MedTech Europe published the “Contract for a Healthy Future”,
the medtech industry’s 5-year strategy, and “Creating Value in European
Healthcare”. “Contract for a Healthy Future” details the role of Europe’s
medical technology industry in steering healthcare systems onto
a sustainable path, while the “Creating Value in European Healthcare”publication explains how Europe's medical technology industry is
delivering on the promise of the “Contract”. Both publications are
available at www.reforminghealthcare.eu
www.edma-ivd.eu
www.eucomed.org
www.medtecheurope.org
www.reforminghealthcare.eu
12
2013