MedTech FactsFigures2016 FINAL 20160105 Layout 1 · 1/5/2016 · EUROPEAN MEDICAL DEVICE MARKET BY...
Transcript of MedTech FactsFigures2016 FINAL 20160105 Layout 1 · 1/5/2016 · EUROPEAN MEDICAL DEVICE MARKET BY...
The European Medical TechnologyIndustry – in figures
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What is Medical Technology? 4
Innovation 10
Employment 14
Companies 18
Table of contents
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Expenditure on Medical Technology 20
MedTech Market in Europe 24
Trade in Europe 32
About MedTech Europe 38
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What is MedicalTechnology?
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Medical technology is any technology used to save lives in individuals suffering from a widerange of conditions. In its many forms, medical technology is already diagnosing, monitoring andtreating virtually every disease or condition that affects us.
Medical technology can be familiar, everyday objects such as sticking plasters, syringes or latexgloves. Alternatively, it can also be pregnancy tests, spectacles, wheelchairs and hearing aids.Meanwhile, at the high tech end of the scale, medical technology includes total body scanners,blood glucose monitoring devices, ultrasounds, life-supporting machines, implantable devicessuch as heart valves and pacemakers, neurostimulators and replacement joints for knees andhips. There are more than 500,000 medical technologies currently available and they all share acommon purpose: improving, extending and transforming people’s lives.
The common thread through all applications of medical technology is the beneficial impact onhealth, quality of life and society as a whole. Medical technologies all contribute to living longerand better, and empower citizens to contribute to society for longer. In so doing, they improvethe quality of care and the efficacy, efficiency and sustainability of healthcare systems.
What is Medical Technology? 5
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Visual 1: Diversity and classification of medical technology Medical Devices In Vitro Diagnostics
DIVERSITY AND CLASSIFICATION OF MEDICAL TECHNOLOGY
6 What is Medical Technology?
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Code Classification Example
01 Active implantable technology Cardiac pacemakers, neurostimulators
02 Anesthetic respiratory technology Oxygen mask, gas delivery unit, anesthesia 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 diagnostics technology Pregnancy test, genetic test, glucose strip
07 Non-active implantable technology Hip or knee joint replacement, cardiac stent
08 Ophthalmic and optical technology Spectacles, contact lenses, intraocular lenses, ophthalmoscope
09 Reusable instruments Surgical 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 Radiotherapy units
13 Complementary therapy devices Acupuncture needles/devices, bio-energy mapping systems/software, magnets, moxibustion devices, suction cups
14 Biological-derived devices Biological hearth valves
15 Healthcare facility products and adaptations Gas delivery systems
16 Laboratory equipment Most IVD which are not reagents
What is Medical Technology? 7
There are more than 500,000 medical technologies registered. These fall within 16 categoriesof products, as determined by the Global Medical Devices Nomenclature (GMDN) Agency3.
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8 What is Medical Technology?
The risk classification ensures that appropriate testing and quality checks are put in place toensure the safety of a product before it becomes available. It also guarantees that permanentmonitoring during the lifetime of high risk devices is conducted by specialised institutions. Thenumber of medical devices receiving CE marking in 2015 is estimated to be around 4,500, around500 of which were class III devices4.
Moreover, each technology comes with strict instructions for use and industry continuously investsin hands-on training for healthcare professionals. At the same time, clinical investigations com-prised of thousands of patients and interviews with physicians and patients enable the medicaltechnology industry to continuously enhance its technology and provide increased value formoney.
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What is Medical Technology? 9
■ MEDICAL DEVICE
Any instrument, apparatus, appliance, software, material or other article, whether used alone orin combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by themanufacturer to be used for human being for the purpose of:
• diagnosis, prevention, monitoring, treatment or alleviation of disease;
• diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;
• investigation, replacement or modification of the anatomy or of a physiological process;
• control of conception;
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its functionby such means5.
■ IN VITRO DIAGNOSTICS (IVD)
Any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination, intendedby the manufacturer to be used in vitro for the examination of specimens, including blood andtissue donations, derived from the human body, solely or principally for the purpose of providinginformation:
• concerning a physiological or patho logical state;
• or concerning a congenital abnormality;
• or to determine the safety and compatibility with potential recipients; or to monitor therapeuticmeasures5.
Definitions
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Innovation
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Medical technology is characterised by a constant flow of innovations, which are the resultsof a high level of research and development within the industry, and of close co-operation withthe users. Products typically have a lifecycle of only 18-24 months before an improved productbecomes available.
In 2015, more than 12,400 patent applications were filed with the European Patent Office (EPO)in the field of medical technology – 7.8% of the total number of applications –, still more thanany other sector in Europe. 40% of these patent applications were filed from European countries(EU28, Norway and Switzerland) and 60% from other countries, with the majority of applicationsfiled from the US (41%).
In comparison, around 5,900 applications were filed in the pharmaceutical field and 6,000 in thefield of biotechnology. While over the last decade the number of EPO filings in the field of medicaltechnology has doubled, pharma and biotech patent applications were relatively stagnant6.
PATENT APPLICATION IN MEDICAL TECHNOLOGY FIELDFILLED WITH EPO IN 2015
40%
60%
EU28, Norwayand Switzerland
Other countries
Innovation 11
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TOP 10 TECHNICAL FIELDS IN PATENT APPLICATIONS.
NUMBER OF PATENT APPLICATIONS FILED WITH EPO, 2015 (REF. 6)
MEDICAL TECHNOLOGY
DIGITAL COMMUNICATION
COMPUTER COMMUNICATION
ELECTRICAL MACHINERY, APPARATUS, ENERGY
TRANSPORT
MEASUREMENT
ORGANIC FINE CHEMISTRY
ENGINES, PUMPS, TURBINES
BIOTECHNOLOGY
PHARMACEUTICALS
12.474
10.762
10.549
10.198
7.802
7.727
6.414
6.374
6.048
5.884
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EVOLUTION OF EUROPEAN PATENT APPLICATIONS BY TECHNICAL FIELD (REF. 6)
14.000
12.000
10.000
8.000
4.000
2.000
Medical technology
Bioechnology
Pharmaceuticals
0
2006
6.000
2007 2008 2011 2012 2013 2014 20152009 2010
Innovation 13
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Employment
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Employment 15
The European medical technology industry employs more than 650,000 people. Germany had the highest absolute number of people employed in the medical technology sector,while the number of medtech employees per capita is highest in Switzerland and Ireland. Thishigh level of employment shows that the medical technology industry is an important player inthe European economy.
In comparison, the European pharmaceutical industry employs more than 700,000 people7.
Europe refers to EU 28, Norway and Switzerland unless specified otherwise.
650,000 employees 8
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Germany
195.000UnitedKingdom
71.000
68.000
France
90.000Switzerland
54.000
ItalySpain
23.000
16 MedTech Market in Europe
TOP 6 COUNTRIES WITH HIGHEST EMPLOYMENT IN THE MEDICAL TECHNOLOGY INDUSTRY (REF. 8)
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Switzerland
66
NUMBER OF PEOPLE EMPLOYED IN THE MEDICAL TECHNOLOGY INDUSTRY PER 10,000 INHABITANTS (REF. 8)
Ireland
58Germany
24France
14Italy
11Netherlands
9Spain
5Portugal
4Sweden
23Belgium
16Denmark
36UK
11
Employment 17
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Companies
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Companies 19
There are approximately 26,000 medical technology companies in Europe. Mostof them are based in Germany, followed by the UK, Italy, Switzerland, Spain and France. Smalland 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)8.
*An enterprise is considered to be a SME if it employs fewer than 250 personsand has an annual turnover not exceeding €50 million (small company- employsfewer than 50 persons and has a turnover of less than €10 million).
95% SMEs
26,000medical technology
companies in Europe
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Expenditureon MedicalTechnology
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Expenditure on Medical Technology 21
In Europe, an average of 10% of gross domestic product (GDP) is spent on health-care. Of this figure, around 7.3% is attributed to medical technologies, i.e. less than 1% of GDP.The spending on medical technology is estimated to vary significantly across European countries,ranging from around 5% to 10% of the total healthcare expenditure9. Expenditure on medicaltechnology per capita in Europe is at around €197 (weighted average).
¤197Expenditure on
medical technologyper capita in Europe
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BREAKDOWN OF TOTAL HEALTHCARE EXPENDITURE IN EUROPE (REF. 10)
In vitro diagnostics
Medical devices(incl. imaging)
6,5%
7,3%Medical technology
Phamaceuticals& other medicalnon-durables
16,1%
0,8%
Inpatient & outpatient care,other
76,6%
22 Expenditure on Medical Technology
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Expenditure on Medical Technology 23
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MedTech Marketin Europe
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MedTech Market in Europe 25
The European medical technology market in 2015 is estimated at roughly €110 billion11.
Based upon manufacturer prices the European medical technology market is estimated to makeup 28% of the world market. It is the second largest medical technology market after the US(approximately 40%).
¤110billion market
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EUROPEAN MEDICAL DEVICE MARKET BY COUNTRY, BASED UPON MANUFACTURER PRICES, 2015 (REF. 11)
The biggest medtech markets in Europe are Germany, France, theUnited Kingdom, Italy and Spain11. The same countries form thetop 5 IVD markets in Europe12.
GERMANY
28%
FRANCE
15%
UK
13%
ITALY
10%
SWEDEN
2%
SWITZERLAND
4%
NETHERLANDS
4%
SPAIN
6%
BELGIUM
3%
AUSTRIA
2%
OTHER
14%
26 MedTech Market in Europe
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EUROPEAN IVD MARKET BY COUNTRY, 2015 (REF. 12)
GERMANY
21%
FRANCE
13%
ITALY
16%
SPAIN
9%
UK
8%
NETHERLANDS
3%
BELGIUM
3%
SWITZERLAND
3%
POLAND
3%
AUSTRIA
2%
OTHERS
17%
MedTech Market in Europe 27
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WORLD MEDICAL DEVICE MARKET BY REGION BASED UPON MANUFACTURER PRICES, 2015 (REF. 11)
USA
42% 29% 8% 6%
2% 11%2% 1%
EUROPE JAPAN CHINA
CANADA BRAZIL OTHERRUSSIA
28 MedTech Market in Europe
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WORLD MEDICAL TECHNOLOGY MARKET BY AREA AND SALES GROWTH, 2015-2022 (REF. 13)
Note: Size of Bubble = WW Sales in 2022
Source: EvaluateMedTech®
September 2016
WW Market Share in 2022
% Sales Growth: CAGR 2015-22
2%
4%
6%
8%
10%
12%
14%
16%
18%
0%
+3.0% +3.5% +4.0% +4.5% +5.0% +5.5% +6.0% +6.5% +7.0% +7.5%
Ophthalmics
Cardiology
Drugdelivery
Wound management
General & Plastic Surgery
Orthopedics
Diagnosticimaging
DentalEndoscopy
In Vitro Diagnostics
(IVD)
Medical technology offers solutions for many disease areas. On a worldwide perspective,in vitro diagnostics are the largest sector, followed by cardiology and diagnostic imaging13.
MedTech Market in Europe 29
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EUROPEAN MEDICAL DEVICE MARKET GROWTH RATES, BASED UPON MANUFACTURER PRICES, 2008-2015 (REF. 11)
The European medical technology market has been growing on average by4,6% per annum over the past 8 years. Demand fell in 2009 due to the economic crisis, resulting in a growth rate of only 1%. The market recoveredin 2010, but growth rates fell back in 2011 .
5%
10%
15%
-5%
0%
2008 2009 2010 2011 2012 2013 2014 2015
30 MedTech Market in Europe
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EUROPEAN IN VITRO DIAGNOSTICS MARKET GROWTH RATES, BASED UPON MANUFACTURER PRICES, 2008-2015 (REF. 12)
The European IVD market growth has been slowing down until 2013, while annualgrowth rates in the pre-crisis period were at around 2-4%. In 2013 the Europeanmarket started to recover and the annual growth rate in 2015 was around 0.6%.
* Market size estimated in manufacturers’ prices, not includingmargins, such as value added in the wholesaling and retailing,transportation costs, some taxes included in the final price, etc.
1%
0%
-1%
4%
3%
2%
5%
-4%
-3%
-2%
2008 2009 2010 2011 2012 2013 2014 2015
MedTech Market in Europe 31
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Trade in Europe
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Trade in Europe 33
Europe has a positive medical technology trade* balance of 14.1 billion (2015)and this still represents a twofold increase since 2006. In comparison, the US medical technologytrade surplus is at €5 billion. Compared to 2012, the main European medtech trade partners remain the same: the US, China and Japan (Ref 11).
*Trade section does not include in vitro diagnostics in the figures for medical technology.
¤14.1 billion
Estimation of Europe’strade surplus in 2015
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TOP EUROPEAN MEDICAL DEVICE EXPORT DESTINATIONS, 2015 (REF. 11)
USA
37%
Brazil1,7%
India1,9%
China10,3%
Russia2,9%
Japan8,1%
34 Trade in Europe
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TOP SUPPLIERS TO EUROPEAN MEDICAL DEVICE MARKET (IMPORTS), 2015 (REF. 11)
USA
58,9%
Canada1%
Australia2%
India0,8%
China10,2%
Japan6,1%
Trade in Europe 35
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EXPORT AND IMPORTS OF MEDICAL DEVICE BY COUNTRY 2015 (INCLUDING INTRA-COMMUNITY TRADE, MILLION EUROS) (REF. 11)
5000
10.000
15.000
20.000
25.000
0
GERM
ANY
24.4
7615
.900
15.1
4012
.381
15.1
409.
842
9.68
54.
048
1.97
8
8.15
31.
644
7.83
85.
614
5.25
53.
352
6.84
5
NETHER
LANDS
BELGIU
M
SWITZ
ERLA
ND
IREL
AND
FRANCE
UNITED K
INGDOM
DENM
ARK
AUSTRIA
SWED
EN
FINLA
NDSP
AIN
POLA
ND
CZECH R
EPUBLIC
ITALY
9.43
6
1.19
3
1.76
51.
726
1.53
71.
534
1.53
380
0 1.41
93.
628
1.30
71.
585
989
1011
MILLIONS
36 Trade in Europe
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MEDICAL DEVICE TRADE BALANCE BY COUNTRY (INCLUDING INTRA-COMMUNITYTRADE, MILLION EUROS) , 2015 (REF. 11)
2000
4000
6000
10.000
MILLIONS
8000
-2000
-4000
0%
GERM
ANY
IREL
AND
SWITZ
ERLA
ND
NETHER
LANDS
BELGIU
M
DENM
ARK
FINLA
ND
HUNGARY
AUSTRIA
LITHUANIA
ESTO
NIA
SWED
EN
CZECH
LATV
IA
SLOVEN
IA
BULGARIA
CROATIA
SLOVAKIA
POLA
ND
ROMANIA
PORTU
GAL
GREECE
NORWAY
ITALY
SPAIN
UK FRANCE
8.57
6
6.50
9
5.63
7
2.75
9
1.72
4
785
734
-278
-290
-348
-423
-605
-1.9
04
-2.2
09
-2.2
23
-2.5
91
Trade in Europe 37
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About MedTechEurope
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About MedTech Europe 39
MedTech Europe is the European trade association representing the medicaltechnology industry from diagnosis to cure. We represent In-Vitro 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 promotes a balanced policy environment that helps the medical technology industry meet Europe’s growing healthcare needs and expectations. We also promote medicaltechnology’s value for Europe through our five-year industry strategy, which focuses on value-based innovations that support more sustainable healthcare systems.
We use economic research to show the benefits of medical technology and we organise manyinitiatives to explain the value we bring to Europe. We bring stakeholders together to discusstrends, issues and opportunities. Each year we also organise the European MedTech Forum, thelargest health and industry policy conference in Europe, to engage with stakeholders on commontopics of interest.
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References
1 European Commission. The classification of medical devices is a ‘risk based’ system based on the vulnerability of the humanbody taking into account of the potential risks associated with the devices. The classification rules are based on differentcriteria such as the duration of contact with the patient, the degree of invasiveness and the part of the body affected bythe use of the device.
2 European Commission. IVD classification is based on the degree of health risk posed to an individual and public, and isrelated to the risk of an incorrect result arising from the use of the IVD.
3 Global Medical Devices Nomenclature (GMDN) Agency, 2010.
4 The European Association for Medical Devices of Notified Bodies- Medical Device Survey 2015: data from 25 Notified Bodies.CE mark is a verification that a device meets all regulatory requirements of the Directives which apply to it.
5 Guidelines on the qualification and classification of stand alone software used in healthcare within the regulatory frameworkof medical devices – January 2012.
6 European Patent Office, Eucomed calculations. Medical technology as defined by World Intellectual Property Organization(based on the WIPO IPC-Technology concordance as revised in August 2015). European countries refer to EU + Norway,Switzerland. Patents are attributed by the country of residence of the applicant.
7 EFPIA – The Pharmaceutical Industry in Figures. Key Data 2015. Europe refers to EU + Norway, Switzerland.
8 Eucomed calculation based on the data obtained from National Associations of 15 countries for the latest year available.Europe refers to EU + Norway, Switzerland.
9 WHO Global Health expenditure Database, Eurostat, 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. Europerefers to EU + Norway, Switzerland.
10 WHO, Eurostat, EFPIA, EDMA, Eucomed calculations. Europe refers to EU + Norway, Switzerland.
11 Espicom, Eucomed calculations. Manufacturer prices. Medical technology excluding in vitro diagnostics. Europe.
12 EDMA- European IVD Market Statistics Report 2015.
13 EvaluateMedTech® World Preview 2016, Outlook to 2022 (October 2016) http://www.evaluategroup.com/public/Reports/EvaluateMedTech-World-Preview-2016.aspx
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© MedTech Europe, 2016Printed in Belgium
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www.medtecheurope.org
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