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1、TheEuropeanMedicalTechnologyIndustryin figures2022What is Medical Technology?3Regulations 7Innovation 11Employment 15Companies 19Table of contentsExpenditure on Medical Technology 21MedTech Market in Europe 25Trade in Europe 33About MedTech Europe 39What is MedicalTechnology?Medical technologies are
2、 products,services or solutions used to save and improve peoples lives.In their many forms,they are with you from prevention to diagnosis and cure.There are three main categories of medical technologies:Medical devices(MDs)are products,services or solutions that prevent,diagnose,monitor,treat and ca
3、re for people.In vitro diagnostics(IVDs)are non-invasive tests used on biological samples(for example blood,urine or tissues)to determine the status of a persons health.Digital health are tools and services that use information and communication technologies(ICTs)to improve prevention,diagnosis,trea
4、tment,monitoring and management of a persons health and lifestyle.This document addresses only medical devices and in vitro diagnostics.4There are more than 500,000 medical technologies available in hospitals,community care settings and at home.Medical technologies can be everyday objects such as st
5、icking plasters,syringes,surgical masks,and latex gloves,as well as spectacles,wheelchairs,COVID-19 tests and medical apps.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 m
6、ay not always notice medical technologies,but they are always there for you.5Medical 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 ca
7、re,and the efficiency and sustainability of healthcare systems.6RegulationsIn the European Union,medical technologies are tightly regulated by laws that govern the safety and performance of devices across their lifetime,before and after they are placed on the market.The European medical technology s
8、ector is currently transitioning from being regulated under the EU medical devices and IVD directives to two new regulations.8DCBAHigh public health riske.g.blood safety/high risk infectious diseases4%Percentage of devices by class1IVD Regulation classification systemHigh risk for individual patient
9、se.g.cancer markers,dangerous infectious diseases,etc.Medium risk for individual patientse.g.blood chemistry,pregnancy tests,etc.Low risk for individual patients e.g.instruments,accessories,specimen collection systems,etc.26%49%21%Classification of In Vitro Diagnostic Medical Devices The In Vitro Di
10、agnostic(IVD)sector is regulated by the Regulation 2017/746/EU.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 generally reflects the risk of an incorrect result from th
11、e test.Under the IVD Regulation,all IVDs are 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 result of an incorrect test result.All IVDs are classified as class A,B,C or D,with class D being the highes
12、t risk class.9Classification of Medical Devices Since 26 May 2021,the medical device(MD)sector has been covered by Regulation(EU)2017/745,the so-calledMedical Devices Regulation(MDR),which has come into full application.Classification of medical devices drives many pre-and post-market requirements.D
13、ue to the large variety ofproducts,the level of control made by a third-party(the“notified body”)before placing them on the marketdepends on the level of impact on the human body that their use might imply.The same notified body isinvolved post-market to ensure the continued safety and performance o
14、f medical devices.Under the MD Regulation,MDs are classified into 4 classes following a risk-based classification system,which links the class of the device to the potential risk posed to the publics or individuals health as a result of a fault of performance.All MDs are classified as class I,IIA,II
15、B or III,with class III being the highest risk class.10Class I(e.g.simple bandages or woundcare products)Class IIa(e.g.syringes forpump infusion)Class IIb(e.g.anaesthesiamachines)Class III(e.g.pacemakers)InnovationEPO countries(including EU27,NO,CH,UK)United StatesOther countries41%38%21%Medical tec
16、hnology 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 users.The average global R&D investment rate(R&D spend as a percentage of sales)is estimated to be around 8%in the medical t
17、echnology sector2.Products typically have a lifecycle of only 18-24 months before an improved product becomes available.In 2021,more than 15,300 patent applications were filed with the European Patent Office(EPO)in the field of medical technology,representing a 0.8%growth in patent applications comp
18、ared to the previous year3.The medical technology field accounts for 8.1%of the total number of applications,the 2nd highest among all industrial sectors in Europe.41%of these patent applications were filed from EPO countries(including EU27,UK,Norway and Switzerland),38%from the US and the remaining
19、 21%originated from other countries.In comparison,around 9,000 applications were filed in the pharmaceutical field and around 7,600 in the field of biotechnology.While over the last two decades the number of EPO filings in the field of medical technology has almost tripled,pharma and biotech patent
20、applications remained relatively stagnant.Furthermore,the ratio of granted patents to patent applications stands at 55%in 2021.In contrast,the same ratio is 33%in both the pharmaceutical and biotechnology field(Graph 2).12Patent applications in medical technology field filed with EPO in 202102,0004,
21、0006,0008,00010,00012,00014,00016,000Medical technologyDigital communicationComputer technologyElectrical machinery,apparatus,energyTransportPharmaceuticalsMeasurementBiotechnologyOther special machinesOrganic fine chemistry15,40015,32114,67112,0549,3999,1679,0267,6116,4505,923Graph 1 Top 10 technic
22、al fields in patent applicationsNumber of patent applications filed with EPO,2021(ref.3)201116,00014,00012,00010,0008,0006,0004,0002,00002000021MedTech ApplicationsPharma ApplicationsBioTech ApplicationsMedTech GrantedPharma GrantedBioTech Granted41%30%36%44%33%38%45
23、%39%40%44%43%41%48%36%46%68%53%57%65%48%58%68%47%54%75%46%52%69%42%45%55%33%33%Graph 2 Evolution of European patent applications and granted patents by technical field2021(ref 3.)Employment800,000+employees4The European medical technology industry employs directly more than 800,000 people4.Germany h
24、ad 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 840,000 people5.The jobs created by the medical techn
25、ology industry account for around 0.3%of total employment in Europe.6 These jobs are also highly productive,as the value added per employee is estimated to reach around 184,000 per employee.These indicators show that the medical technology industry has an important economic and societal impact in Eu
26、rope.16Germany 235,000UK 106,500France 88,000Switzerland 63,000Ireland 42,000Spain 29,000Sweden 27,000Belgium 17,800Denmark 16,500Italy 112,534Graph 3 Top 10 countries in Europe with highest direct employment in the medical technology industry2021 or latest year available(ref.4)Denmark29Germany28Ita
27、ly19UK16Switzerland7484IrelandSweden27France13Finland7Portugal4Romania3Belgium16Greece5Slovakia4Austria10Norway9Netherlands9Spain6Hungary12Graph 4 Number of people directly employed in the medical technology industry per 10,000 inhabitants 2021 or latest year available (ref.4)Companies 34,000 medica
28、l technology companies in Europe95%SMEsThere are more than 34,000 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 majo
29、rity of which employ less than 50 people(small and micro-sized companies)4.20Expenditure onMedical Technology7.6%of totalhealthcare expenditureis spent on medicaltechnologies 284 expenditure on medical technology per capita in EuropeIn Europe,an average of approximately 11%of gross domestic product(
30、GDP)is spent on healthcare.Of this figure,around 7.6%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 12%of the total healthcare expenditure.Expenditure on medical tec
31、hnology per capita in Europe is at around 284.*22*MedTech Europe calculation based on sources 5-9.77.5%Inpatient&outpatient care,other 7.6%Medical Technology15%Pharmaceuticals&other medical non-durables0.9%diagnostics6.7%Medical devices(incl.imaging)Graph 5 Breakdown of total healthcare expenditure
32、in Europe2021(ref.59)24MedTech Marketin Europe 150 billion market27.3%of the worldmarket2ndlargest marketafter USThe European medical technology market is estimated at roughly 150 billion in 2021.8,9 The top five biggest markets are Germany,France,the United Kingdom,Italy,and Spain.Based upon manufa
33、cturer prices,the European medical device market is estimated to make up 27.3%of the world market.It is the second largest medical device market after the US(43.5%).9 2625.8%Germany14.3%France10.4%UK9.0%Italy6.4%Netherlands6.1%Spain3.6%Switzerland 3.4%Belgium2.6%Austria2.4%Sweden16.1%OthersGraph 6 E
34、uropean medical device market by country2021(ref.9)19.6%Germany16.8%Other2.6%Netherlands2.7%Belgium 3.2%Poland12.7%Italy 3.3%Austria3.8%Switzerland9.1%UK15.3%France10.8%SpainGraph 7 European IVD market by country2020(ref.8)43.5%US27.3%Europe7.2%China5.6%Japan1.9%Canada1.7%South Korea1.5%Russia11.3%O
35、thersGraph 8 Europe in the world medical device market2021(ref.9)3043%27%7%6%13%2%1%1%EuropeJapanChinaCanadaBrazilRussiaOthersUSA5%10%15%-5%0%2009200016 200202021Graph 9 European medical device market growth rates2009-2021 (ref.9)The European medical device market ha
36、s been growing on average by 4.8%per year over the past 10 years.Demand fell in 2009 due to the economic crisis,resulting in a growth rate of only 1%(the lowest in 13 years).The market regained its momentum in 2010,and since then the annual growth rate has varied between 2.4%(2017)and 9.3%(2015),sta
37、nding at 2.9%in 2021.9The European medical device market has been growing on average by 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.
38、3%7-5%0%5%10%15%20%25%30%200920000192020Growth in the European IVD market was in decline for several years until 2013.Since then,the annual growth rate for the European IVD market has been 2.7%on average,hitting the record 25%in 2020.Graph 10 European IVD market grow
39、th rates2010-2020(ref.8)Orthopaedics&prosthetics growthDental products growthConsumables growthPatient aids growthOther medical devices growthDiagnostic imaging growth-10%-5#%0%5%10%15%20%25%200202021Graph 11-European medical technology growth rates by sectors2017-2021(ref.9)COVID-19 affe
40、cted the medical technology industry in several ways.Postponement of elective surgeries across EU countries in 2020 led to deferred patient care within the Orthopaedics and Dental fields.On the other end of the spectrum,sales of IVDs(e.g.PCR tests),patient aids(artificial respiration apparatus such
41、as ventilators)and consumables(e.g.nasal cannulae,syringes,surgical gloves)increased significantly in 2020 as these medical technologies were essential to the special care that severe COVID-19 patients require.Trade in Europe 6 billionEstimation of Europestrade surplus in 2021Europe has a positive m
42、edical devices trade balance of 6 billion(2021).The main European medical device trade partners remain the same as in previous years:the US,China,Japan and Mexico.1034Canada2.1%Russia4.2%India2.2%USA40.3%Australia3.3%China12.0%Japan6.0%South Korea2.3%Turkey1.8%Saudi Arabia1.7%Graph 12-Top European m
43、edical technology export destinations2021(ref.10)Malaysia5.8%USA42.4%Australia1.7%Costa Rica2.6%Mexico7.9%Singapore3.3%Israel1.6%China17.6%Japan4.9%South Korea1.6%Graph 13 Top import suppliers to the European medical devices market2021(ref.10)5,00010,00015,00020,00025,00030,0000GERMANYNETHERLANDSIRE
44、LANDBELGIUMSWITZERLANDFRANCEUKITALYDENMARKPOLANDAUSTRIASWEDENHUNGARYExportImportFINLANDSPAIN 31,006 27,619 21,532 19,909 12,640 10,902 2,632 9,940 10,530 4,529 7,220 11,724 6,447 8,677 4,602 6,610 3,622 2,903 2,396 2,602 2,048 1,780 1,786 5,293 1,586 782 1,483 1,967 1,747 1,074 Graph 14 Export and i
45、mport of medical devices by countryIncluding intra-community trade,million euros,2021(ref.10)2,0004,0006,00010,0008,000-2,000-4,0000 10,008 9,474 7,710 6,002 963 804 719 673 268 103 59 12-34-205-45-49-83-93-108-272-303-484-585-705-766-990-2,008-2,230-3,508-4,504IRELANDGERMANYNETHERLANDSSWITZERLANDBE
46、LGIUMHUNGARYPOLANDFINLANDDENMARKLITHUANIABULGARIAMALTAESTONIASLOVENIALATVIACZECH REPUBLICCYPRUSLUXEMBOURGAUSTRIACROATIASLOVAKIASWEDENROMANIAGREECEPORTUGALNORWAYITALYUKSPAINFRANCEGraph 15 Medical devices trade balance by countryIncluding intra-community trade,million euros,2021(ref.10)About MedTech E
47、uropeMedTech 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 Europes mission is to make innovative medical technology available to more people while h
48、elping healthcare systems move towards a sustainable path.MedTech Europe encourages policies that help the medical technology industry meet Europes growing healthcare needs and expectations.It also promotes medical technologys value for Europe focusing on innovation and stakeholder relations,using e
49、conomic research and data,communications,industry events and training sessions.MedTech Europes Facts&Figures publication is an annually updated report with robust industry data compiled from multiple sources.It is an essential source of data for international stakeholders seeking an up-to-date view
50、of industry innovation and employment,SME activity,expenditure on medical technology,trade flows 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 technolog
51、y following the methodology of the World Intellectual Property Organization(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
52、Employment and Companies chapters are based on data from the annual surveys MedTech Europe carries out among its member National Associations.The most recent survey was finalized in March 2022.Figures refer to the latest year available.An enterprise is considered to be a SME if it employs fewer than
53、 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 follo
54、wing 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 chapter data refers to the
55、 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
56、infra-red ray apparatus,blood pressure monitors,endoscopy apparatus,dialysis apparatus,transfusion apparatus,anaesthetic apparatus&instruments).41References1 MedTech Europe Survey Report analysing the availability of In vitro Diagnostic Medical Devices(IVDs)in May 2022 when the new EU IVD Regulation
57、 applies.2 Evaluate MedTech,2018,World Preview 2018,Outlook to 2024.3 European Patent Office(EPO),2022,Patent Index 2021.4 MedTech Europe,2021,National Associations Survey.5 EFPIA,2022,The Pharmaceutical Industry in figures.6 Eurostat,2022,Employment and Population Statistics.7 WHO,2019,Global Healt
58、h Expenditure Database.8 MedTech Europe,2021,European IVD Market Statistics Report 2021.2021 IVD market size data is preliminary and is based on MedTech Europe Statistics Programmes 9 Fitch Solutions,2022,Worldwide Medical Devices Market Factbook 2021.10 International Trade Centre,2022,International Trade Statistics MedTech Europe calculations.42www.medtecheurope.org