The European Medical Technology Industry - in figures 2020
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
The European Medical Technology Industry in figures 2020
Table of contents What is Medical Technology? 3 Regulations 7 Innovation 11 Employment 15 Companies 19
Expenditure on Medical Technology 21 MedTech Market in Europe 25 Trade in Europe 33 About MedTech Europe 39
What is Medical Technology?
Medical technologies are products, services or solutions used to save and improve people’s lives.
In their many forms, they are with you all the time, from prevention, to diagnosis to cure.
There are three main categories of medical technologies:
• Medical devices (MDs) are products, services or solutions that prevent, diagnose, monitor, treat and
care for human beings by physical means.
• In vitro diagnostics (IVDs) are non-invasive tests used on biological samples (for example blood, urine
or tissues) to determine the status of one’s health.
• Digital health and care refers to tools and services that use information and communication technologies
(ICTs) to improve prevention, diagnosis, treatment, monitoring and management of health and lifestyle.
For the sake of this document, medical technology refers to medical devices and in vitro diagnostics.
4
There are more than 500,000 medical technologies available in hospitals, community-care settings and at home.
Medical technology can be everyday objects such as sticking plasters, syringes, screening tests, or latex gloves.
It could also be spectacles, wheelchairs, pregnancy tests or hearing aids.
Medical technologies also include total body scanners, gene mutation tests, implantable devices such as
heart valves and pacemakers, and replacement joints for knees and hips.
You may not always notice medical technologies, but they are always there for you.
5
Medical technologies provide value in different ways. They allow people to live longer and better lives, thus
empowering them to contribute to society for longer. At the same time, medical technologies improve the
quality of care, and the efficiency and sustainability of healthcare systems.
6
Regulations
In the European Union, medical technologies are tightly regulated
by laws that govern the safety and performance of devices across their lifetime, pre- and post-market. Over
the next few years, the European medical technology sector will transition from being regulated under the
current medical devices directives to two new regulations.
8
Classification of In Vitro Diagnostic Medical Devices
Today, the in vitro diagnostic (IVD) sector is regulated by Directive 98/79/EC. From 26 May 2022, the new
Regulation 2017/746/EU will fully apply. Until this date, manufacturers can choose to comply with either the
Directive or the Regulation.
Classification of IVDs is important as it determines the level of involvement by a third party (the “notified
body”) in assessing IVDs both pre- and post-market. This level of control is generally relative to the risk of an
erroneous result from the assay.
Under the IVD Directive, IVDs are classified into four classes following a positive list approach:
Annex II Annex II Devices for Self-declared
List A List B self-testing devices
(e.g. ABO blood- (e.g. blood glucose (e.g. pregnancy (e.g. clinical
typing) monitoring) tests) chemistry analyser)
Under the IVD Regulation, all IVDs will be classified under a new risk-based classification system according to
the risk the device poses to the health of the public and or an individual as a result of an incorrect test result.
All IVDs will be classified under class A, B, C or D, with class D being the highest risk class.
9Classification of Medical Devices
The medical device (MD) sector is regulated by Directives 93/42/EC and 90/385/EEC. From 26 May 2021, the
new Regulation 2017/745/EU will fully apply. Until this date, manufacturers can choose to comply with either
the Directives or the Regulation.
Classification of medical devices (estimated to be more than 500,000) drives many pre- and post-market
requirements. Due to the large variety of products, the level of control made by a third-party (the “notified
body”) before placing them on the market depends on the level of impact on the human body that their
use might imply. The same notified body, together with the Competent National Authorities, is involved
post-market to ensure the continued safety and performance of medical devices.
Under the MD Directive, MDs are classified into 4 classes following a risk-based classification system:
Class I Class IIa Class IIb Class III
(e.g. simple (e.g. syringes for (e.g. anaesthesia (e.g. stents)
bandages or wound pump infusion) machines)
care products)
Under the new MD Regulation, the risk-based classification system contained in the current Directives has been
maintained, although some changes/additions have been introduced. The principle is the same: to link the class
of the device to the potential risk posed to the health of the public and an individual as a result of fault in the
functioning. All MDs are classified under class I, IIa, IIb or III, with class III being the highest risk class.
10Innovation
Medical technology is characterised by a constant flow of innovations,
which are the results of a high level of research and development within the industry, and of close co-
operation with the users. The average global R&D investment rate (R&D spending as a percentage of sales)
is estimated to be around 8% in the medical technology sector1. Products typically have a lifecycle of only
18-24 months before an improved product becomes available.
In 2019, nearly 14,000 patent applications were filed with the European Patent Office (EPO) in the field of
medical technology representing a 0.9% growth in patent applications compared to the previous year.2 The
medical technology field accounts for 7.7% of the total number of applications, second highest among all
the sectors in Europe. In comparison, around 7,700 applications were filed in the pharmaceutical field and
around 6,800 in the field of biotechnology. (Figure 2)
39% of all patent applications were filed from EPO countries (including EU27, UK, Norway and Switzerland)
and 61% from other countries, out of which with the majority of applications filed from the US (40%).
Figure 1. Medical technology patent applications filed
with EPO in 2019
39%
EPO countries
(including EU27,
NO, CH, UK)
61%
Other countries
12Figure 2 – Top 10 technical fields in patent applications
Number of patent applications filed with EPO, 2019 (ref. 2)
Digital communication 14,175
Medical technology 13,833
Computer technology 12,774
Electrical machinery, apparatus, energy 11,255
Transport 9,635
Measurement 9,045
Pharmaceuticals 7,697
Biotechnology 6,801
Other special machines 6,436
Organic fine chemistry 6,167
THOUSAND SEPARATORS 0 2,000 4,000 6,000 8,000 10,000 12,000 14,000 16,000While over the last decade the number of EPO filings in the field of medical technology has doubled, pharma
and biotech patent applications were relatively stagnant. Furthermore, the ratio of granted patents to patent
applications in the medtech sector has been continuously growing in the past years reaching 76% in 2019.
In comparison, this ratio is around 50% in the pharmaceutical and biotechnology field. (Figure 3)
Figure 3 – Evolution of European patents by technical field
(ref 2.)
16,000 80%
14,000 70%
12,000 60%
10,000 50%
Granted Patents
Applications
8,000 40%
6,000 30%
4,000 20%
2,000 10%
0 0%
2010 2011 2012 2013 2014 2015 2016 2017 2018 2019
MedTech Applications Pharma Applications BioTech Applications
MedTech Granted Pharma Granted BioTech GrantedEmployment
730,000
The European medical technology industry employs directly more
than 730,000 people3. Germany had the highest absolute number of people employed in the
medical technology sector, while the number of medical technology employees per capita is highest in Ireland
and Switzerland. In comparison, the European pharmaceutical industry employs around 765,000 people4.
The jobs created by the medical technology industry account for around 0.3% of total employment in
Europe.5 These jobs are also highly productive, as the value added per employee is estimated to reach
€160,000 per employee. These indicators show that the medical technology industry has an important
economic and societal impact in Europe.
16Figure 4 – Top 10 European countries with highest
medtech employment
Direct employment in the medical technology industry in 2018, or latest year available (ref. 3)
Denmark
16,500
Sweden
Belgium 27,000
17,800 Germany
United Kingdom
97,600 227,700
Ireland
Switzerland
40,000
58,500
France
89,130
Spain
25,500
Italy
76,400Figure 5 – Number of people directly employed in the
medical technology industry per 10,000 inhabitants
2018 or latest year available (ref. 3)
nd
la
Ire
nd
la
er
itz
Sw
k
y
ar
en
an
m
ed
m
en
er
Sw
D
G
s
nd
um
rla
ry
e
ia
i
ga
he
nc
lg
tr
ly
K
Be
un
et
a
us
Ita
U
Fr
N
A
H
ia
al
ia
d
an
e
ug
ak
n
ec
n
la
m
ai
ov
rt
re
n
Ro
Sp
Po
Sl
Fi
G
83 69 29 28 27 16 15 13 13 12 10 9 7 5 5 4 3 3Companies
32,000
medical technology
companies in Europe
95%
SMEs
There are more than 32,000 medical technology companies in Europe.
The highest number of them are based in Germany, followed by Italy, the UK, France and Switzerland. Small
and medium-sized companies (SMEs) make up around 95% of the medical technology industry, the majority
of which employ less than 50 people (small and micro-sized companies)3.
20Expenditure on Medical Technology
225
Expenditure on
medical technology
per capita
in Europe
In Europe, an average of approximately
10% of gross domestic product (GDP) is spent
on healthcare. Of this figure, around 7.4% is attributed to medical 10%
technologies, i.e. less than 1% of GDP. The spending on medical of GDP spent
technology is estimated to vary significantly across European
on healthcare
countries, ranging from around 5% to 12% of the total
healthcare expenditure. Expenditure on medical technology
per capita in Europe is at around €225 (weighted average).*
* Medtech Europe calculation based on sources 4-8.
22Figure 6 – Breakdown of total healthcare expenditure in Europe
2018 (ref. 4–8)
16% Pharmaceuticals &
other medical non-durables
7.4%
Medical Technology
0.7% In vitro diagnostics
6.7% Medical devices
(incl. imaging)
76.6% Inpatient &
outpatient care, other24
MedTech Market in Europe
120
billion market
The European medical technology market is
estimated at roughly €120 billion in 2018. 7,8
The biggest medical device markets in Europe are Germany, France,
the United Kingdom, Italy and Spain. The same group of countries
27%
form the top 5 IVD markets in Europe. (Figures 7 and 8) of the world
market
Based upon manufacturer prices the European medical device
2
market is estimated to make up 27% of the world market. nd
It is the second largest medical device market after the US
(around 43%).8 largest market
after US
26Figure 7 – European medical device market by country
2018 (ref. 8)
27.1% Germany
14.6% France
11% UK
10.1% Italy
6.3% Spain
4.2% Netherlands
3.7% Switzerland
2.7% Belgium
2.6% Poland
2.5% Austria
15% OthersFigure 8 – European IVD market by country
2018 (ref. 7)
19.4% Germany
14.5% Italy
14.5% France
9.0% Spain
8.8% UK
4.2% Switzerland
3.6% Poland
3.5% Belgium
2.6% Netherlands
2.4% Austria
17.5% OtherFigure 9 – Europe in the global medical device market 2018 (ref. 8) 6% China 7% Japan 17% Rest of the world 27% Europe 43% US
Figure 10 – World medical technology market by
area and sales growth
2017-2024 (ref. 1)
18%
16%
In–Vitro
Diagnostics
(IVD)
14%
WW Market Share % in 2024
12%
Diagnostic
Imaging
10%
Source: Evaluate, September 2018
Cardiology
8%
Ophtalmics General &
Plastic Surgery
Drug Delivery
6%
Orthopedics
4%
Endoscopy
2%
Dental
Diabetic Care
0%
+3.0% +4.0% +5.0% +6.0% +7.0% +8.0% +9.0%
% Sales Growth: CAGR 2017-24
Medical technology offers solutions for many disease areas. On a worldwide perspective, in vitro diagnostics (IVD)
are the largest sector, followed by cardiology and diagnostic imaging.1
30Figure 11 – European medical device market growth rates
2009-2018 (ref. 8)
15%
10%
USA Europe Japan China
5% 43% 27% 7% 6%
0%
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018
Canada Brazil Russia Others
2% 1% 1% 13%
-5%
The European medical device market has been growing on average by 4.2% per annum over the past 10
years. Demand fell in 2009 due to the economic crisis, resulting in a growth rate of only 1%. The market
recovered in 2010, since then the annual growth rate has varied between 2.6 and 9.3% in the European
medical device market.7Figure 12 – European IVD market growth rates
2009-2018 (ref. 7)
5%
4%
3%
2%
1%
0%
2013 2014 2015 2016 2017 2018
-1%
-2%
-3%
-4%
The European IVD market growth has been slowing down until 2013, while annual growth rates in the pre-crisis
period were at around 2-4%. In 2013 the European market started to recover and the annual growth rate in 2018
was around 1%.Trade in Europe
billion
Estimation of Europes ’
trade surplus in 2018
Europe has a positive medical devices trade balance of €11.7 billion (2018).
Compared to the previous years, the main European medical device trade partners remain the same: the US,
China, Japan and Mexico.9
Medical devices trade balance of individual countries varies a lot across Europe as shown in
Figures 15 and 16. Based on export and import values including European intra-community
trade, the international trade balance indicator is highest in Ireland and Germany followed
by Switzerland and the Netherlands.
34Figure 13 – Top export destinations of the European
medical devices market
2018 (ref. 9)
Russia
Canada 3.8%
1.9%
Japan
USA 6.5%
South Korea
41.5% Turkey
1.9%
China
2.3%
Saudi Arabia
1.9% 10.2%
India
2.1%
Australia
3.1%Figure 14 – Top import suppliers to the European
medical devices market
2018 (ref. 9)
USA Japan
6.0%
50.4% South Korea
Mexico
Israel China 1.5%
6.6%
1.5%
12.7%
Costa Rica Malaysia
2.1%
3.7%
Singapore
3.7%
Australia
1.6%Figure 15 – Export and import of medical devices by country
Including intra-community trade, million euros, 2018 (ref. 9)
GERMANY 26,604
17,217
20,677
NETHERLANDS 15,384
IRELAND 11,599
2,083
BELGIUM 10,401
9,146
SWITZERLAND 9,915
4,154
FRANCE 7,352
9,607
5,861
UK
7,600
ITALY 3,816
5,737
POLAND 2,596
2,186
AUSTRIA 2,031
2,055
DENMARK 1,880
1,303
FINLAND 1,822
931
SPAIN 1,560
4,242
SWEDEN 1,414
1,673
CZECH REPUBLIC 1,161
1,100
0 5,000 10,000 15,000 20,000 25,000 30,000
Export ImportFigure 16 – Medical devices trade balance by country
Including intra-community trade, million euros, 2018 (ref. 9)
IRELAND 9,516
GERMANY 9,386
SWITZERLAND 5,761
NETHERLANDS 5,293
BELGIUM 1,255
FINLAND 891
HUNGARY 577
DENMARK 576
POLAND 410
CZECH REPUBLIC 61
LITHUANIA 45
MALTA 22
ESTONIA 8
-19 SLOVENIA
-23 AUSTRIA
-34 BULGARIA
-51 LATVIA
-60 CYPRUS
-93 LUXEMBOURG
-168 SLOVAKIA
-235 CROATIA
-259 SWEDEN
-359 ROMANIA
-586 GREECE
-674 PORTUGAL
-684 NORWAY
-1,740 UK
-1,921 ITALY
-2,255 FRANCE
-2,681 SPAIN
-4,000 -2,000 0 2,000 4,000 6,000 8,000 10,000About MedTech Europe
MedTech Europe is the European trade association representing the
medical technology industries, from diagnosis to cure.
We represent diagnostics and medical devices manufacturers operating in Europe.
MedTech Europe’s mission is to make innovative medical technology available to more people while helping
healthcare systems move towards a sustainable path. MedTech Europe encourages policies that help the medical
technology industry meet Europe’s growing healthcare needs and expectations. It also promotes medical
technology’s value for Europe focusing on innovation and stakeholder relations, using economic research and
data, communications, industry events and training sessions.
MedTech Europe’s Facts & Figures publication is an annually updated report with robust industry data compiled
from multiple sources. The publication is used as the quintessential source of data by international stakeholders
seeking an up-to-date view of industry innovation and employment, SME activity, expenditure on medical
technology, trade and market size in Europe.
40Scope of this report
• In this report Europe refers to EU27, Norway, Switzerland and the United Kingdom, unless specified otherwise.
• The Innovation chapter defines medical technology following the methodology of the World Intellectual Property Orga-
nization (based on the WIPO IPC-Technology concordance as revised in August 2014).
Patents are attributed by the country of residence of the applicant. EPO countries refer to the 38 member states of the
European Patent Organisation.
• The Employment and Companies chapters are based on data from the 2019 survey carried out among MedTech Europe’s
National Associations. Figures refer to 2018 or the latest year available.
An enterprise is considered to be a SME if it employs fewer than 250 persons and has an annual turnover not exceeding €50
million (small and micro-sized companies employ fewer than 50 persons and have a turnover of less than €10 million).
• The Expenditures on Medical Technology chapter is based on MedTech Europe calculations using healthcare statistics
from the following sources: EFPIA, Eurostat, Fitch Solutions, WHO.
• The MedTech Market in Europe chapter is based on manufacturers’ sales (revenue) not including margins, such as value
added in the wholesaling and retailing, transportation costs, some taxes included in the final price, etc.
• The Trade in Europe chapter data refers to the medical technology products in the following categories, excluding in
vitro diagnostics: orthopaedics & prosthetics, patient aids, dental products, diagnostics imaging, consumables, other
medical devices (incl. wheelchairs, ophthalmic instruments, hospital furniture, medical & surgical sterilisers, ultra-violet
or infra-red ray apparatus, blood pressure monitors, endoscopy apparatus, dialysis apparatus, transfusion apparatus,
anaesthetic apparatus & instruments).
References
1 Evaluate MedTech, 2018, World Preview 2018, Outlook to 2024.
2 European Patent Office (EPO), 2020, Patent Index 2019.
3 MedTech Europe, 2019, National Associations Survey.
4 EFPIA, 2019, The Pharmaceutical Industry in figures.
5 Eurostat, 2020, Employment and Population Statistics.
6 WHO, 2019, Global Health Expenditure Database.
7 MedTech Europe, 2019, European IVD Market Statistics Report 2019.
8 Fitch Solutions, 2019, Worldwide Medical Devices Market Factbook.
9 International Trade Centre, 2020, International Trade Statistics – MedTech Europe calculations.
41www.medtecheurope.org
You can also read
