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1、EuropeanIVD MarketStatisticsReport2022 MEDTECH EUROPE EUROPEAN IVD MARKET STATISTICS REPORT 20221OverviewMedTech Europe is pleased to publish the market estimates of the In vitro diagnostic(IVD)industry in Europe.The MedTech Europe figures include market size and dynamics information,based on 2021 a
2、nd 2020 data.Macroeconomic and healthcare data are also included for the EU27-member states plus the European Free Trade Association members(EFTA)Switzerland,Norway and Iceland,and Switzerland,as well as for the United Kingdom and Turkey.In vitro diagnostics(IVDs)are an essential part of todays heal
3、thcare.Results of in vitro testing influence as many as 70%of clinical decisions,while IVDs account for just 1%of total healthcare expenditure in the EU-27,UK and EFTA.They play a vital role in in the response to COVID-19.A critical element for combatting the COVID-19 pandemic is to have suitable di
4、agnostic tests available.Furthermore,IVDs are used to diagnose,monitor,screen and assess predispositions to diseases,thereby contributing to the available medical information regarding a patient.By allowing earlier and more targeted treatments,IVDs help to reduce hospital stays and convalescences,re
5、sulting in healthier populations,reduced costs,and economic growth in the long run.Since 2013,the IVD market has been stagnant with slight growth.In 2020,however,due to the COVID-19 pandemic and the high demands for SARS-Cov-2 testing,the IVD market has experienced an increase of+25,4%.In 2021,we wi
6、tness an unprecedented record growth of 41.2%.Overall revenues across EU-27,UK and EFTA reached 20,670 million.When looking beyond the COVID-19 related diagnostics and comparing to 2020,there have been clear signs of recovery in most tests in the other IVD segments such as clinical chemistry,immunol
7、ogy,and haematology across the countries.The differences in total healthcare expenditure,both in relative terms to GDP and absolute amounts,demonstrate the wide variation in access to healthcare across the thirty-one countries in this report.Relative to GDP Germany is the leading country at 13.2%,fo
8、llowed by the UK,Austria,Switzerland and Sweden.In absolute amounts the healthcare expenditure per capita Switzerland is in first position,followed by Germany,Austria,Slovakia,Denmark,Norway and Iceland.The IVD per capita expenditure also shows a wide variation from a low of 7.2 in Bulgaria to 88.9
9、in Switzerland,which remains also the leading country.-10%-5%0%5%10%15%20%25%30%35%40%45%05,00010,00015,00020,00025,00010.94310.60310.54910.58010.73610.75810.96511.10211.20001920202021Revenues(million)Growth Rate0,9%-3,1%-0,5%0,3%1,5%0,2%1,9%1,2%0,4%29,1%41,2%14.3842
10、0.670The European IVD MarketMEDTECH EUROPE EUROPEAN IVD MARKET STATISTICS REPORT 20222CountriesPopulation2021GDP 2021GDP/capita 2021THE 2021 (or latest availiable)THE/capita THE as%GDPIVD mkt.2021IVD mkt.2020IVD market growth rate 21-20IVD market /THE 2021IVD mkt/capita 20211000Mio Mio%Mio Mio%Sourc
11、e:EurostatSource:OECDSource MedTech EuropeGermany83.1553.601.75043.290457.2325.49912,7%6.3013.051106,5%1,4%75,8France167.6572.500.87036.660307.7854.54911,2%2.6102.14022,0%0,8%38,6Italy59.2361.782.05030.150167.8552.8349,4%2.0711.78016,3%1,2%35,0Spain47.3991.206.84225.500120.2032.53610,0%1.7271.51414,
12、1%1,4%36,4Netherlands17.475856.35648.84096.4985.52210,4%50436538,2%0,5%28,8Greece10.679181.67517.01015.7201.4728,7%41225462,1%2,6%38,6Portugal10.298214.47120.84023.6862.30011,0%49140122,6%2,1%47,7Belgium11.555502.31243.34049.2934.2669,8%42837214,8%0,9%37,0Sweden10.379537.31051.59060.6695.84511,3%253
13、2395,7%0,4%24,4Austria8.933406.14945.37049.0245.48812,1%56848018,3%1,2%63,6Denmark5.840336.71957.52036.4116.23510,8%33317590,1%0,9%57,0Finland5.534251.36745.36022.6854.0999,0%15913220,7%0,7%28,7Ireland5.006426.28384.94028.3615.6656,7%23215153,6%0,8%46,3Luxembourg63572.295112.7803.6835.8025,1%302145,
14、0%0,8%48,0Poland37.840574.77215.06037.8791.0016,6%49344211,6%1,3%13,0Romania19.202240.15412.56013.4967035,6%24021810,0%1,8%12,5Czechia10.702238.23822.27020.5261.9188,6%26717849,5%1,3%24,9Hungary9.731153.75915.8409.7661.0046,4%1078132,6%1,1%11,0Bulgaria6.91771.07710.3305.2117537,3%503541,1%1,0%7,2Slo
15、vakia5.46098.52318.1106.6861.2256,8%33597244,9%5,0%61,3Croatia4.03658.25415.0203.9019676,7%836725,0%2,1%20,7Lithuania2.79656.17920.0004.3491.5557,7%583755,8%1,3%20,6Latvia1.89333.69617.8902.1681.1456,4%493637,7%2,3%25,9Slovenia2.10952.20824.7704.7622.2588,6%1006260,8%2,1%47,3Estonia1.33031.44522.580
16、2.2891.7217,3%402651,5%1,7%30,1Cyprus89624.01926.6801.7501.9537,3%151045,0%0,9%16,9Malta51614.68128.3101.2552.4328,5%8645,0%0,6%15,5EU27447.20714.523.453912.6101.553.14380.74710,5%17.96312.37045,2%1,2%40,2Switzerland8.670676.77577.75077.1878.90311,4%77151449,9%1,0%88,9Norway5.391407.53375.36041.1207
17、.62710,1%29016872,7%0,7%53,8Iceland36921.65358.1302.0795.6389,6%181247,3%0,9%48,3EFTA14.4301.105.962211.240120.38722.16810,9%1.07969455,4%0,9%74,7UK267.2812.555.06537.976321.5054.77912,6%1.6281.31923,4%0,5%24,2TOTAL(EU27,EFTA,UK)528.91918.184.4801.161.8261.995.036107.69310,8%20.67014.38443,7%1,0%39,
18、1Turkey 83.614689.5478.24722.7192723,3%71249743,4%3,1%8,5TOTAL(EU27,EFTA,UK,Turkey)612.53318.874.0261.170.0732.017.755107.96510,5%21.38214.88043,7%1,1%34,9The applied exchange rates are the 2021 annual average exchange rates published by The European Central Bank.Applying a single exchange rate to b
19、oth 2021 and 2020 sales data eliminates possible fluctuations of market size and market growth due to exchange variations.The impact of these fluctuations is shown in the table below.During the collection of 2021 years figures,the 2020 market size was re-estimated at the same time.That,together with
20、 the use of a single exchange rate,explains why some countries show different revenues compared to the figures presented in last years report for 2020.The growth rate between 2021 and 2020 has been calculated using the re-estimated figures.The 2021 data regarding population and GDP are the latest av
21、ailable from Eurostat.The figures regarding healthcare expenditure are the latest available from OECD.1)France data includes only the Central Laboratory IVD Market.2)UK data reflects the consolidated sales of the participating companies in GDMS,plus the figures published by NHS England for glucose t
22、est strip sales adjusted to represent the whole of the UK.CountryCurrency2021Exchange Rate2020 Exchange RateIVD market 2021IVD market 2020IVD market 2021IVD market 2020IVD market growthrate 21-20AverageAverageMio LCMio LCMio Mio%PolandPLN0,21910,22522.249 2.015 493 454 8,6%RomaniaRON0,20320,20671.18
23、1 1.054 240 218 10,2%Czech RepCZK0,039010,037836.837 4.574 267 173 54,1%HungaryHUF0,002790,00284938.392 29.106 107 83 29,2%EU27EURN/A17.96312.37945,1%UKGBP1,16221,12481.401 1.135 1.628 1.277 27,5%TOTAL(EU27,EFTA,UK)EURN/A20.67014.35044,0%TurkeyTRL0,097480,126237.307 5.094 712 643 10,8%TOTAL(EU27,EFT
24、A,UK,Turkey)EURN/A21.38314.99342,6%IVD Market Size in EUR(using actual exchange rates)IVD Market StatisticsMEDTECH EUROPE EUROPEAN IVD MARKET STATISTICS REPORT 20223 8 Malta 15 Cyprus 18 Iceland 30 Luxembourg 40 Estonia 49 Latvia 50 Bulgaria 58 Lithuania 83 Croatia 100 Slovenia 107 Hungary 159 Finla
25、nd 232 Ireland 240 Romania 253 Sweden 267 Czechia 290 Norway 333 Denmark 335 Slovakia 412 Greece 428 Belgium 491 Portugal 493 Poland 504 Netherlands 568 Austria 712 Turkey 771 Switzerland1,628UK1,727Spain2,071Italy2,610France6,301Germany1,0002,0003,0004,0005,0006,0007,000IVD Market Size 2021(million
26、 EUR)20,0040,0060,0080,00100,00 7,2 Bulgaria 8,5 Turkey 11,0 Hungary 12,5 Romania 13,0 Poland 15,5 Malta 16,9 Cyprus 20,6 Lithuania 20,7 Croatia 24,2 UK 24,4 Sweden 24,9 Czechia 25,9 Latvia 28,7 Finland 28,8 Netherlands 30,1 Estonia 35,0 Italy 36,4 Spain 37,0 Belgium 38,6 Greece 38,6 France 39,9 EU2
27、7 46,3 Ireland 47,3 Slovenia 47,7 Portugal 48,0 Luxembourg 48,3 Iceland 53,8 Norway 57,0 Denmark 61,3 Slovakia 63,6 Austria 75,8 Germany 88,9 SwitzerlandIVD Market per Capita 2021(EUR)MEDTECH EUROPE EUROPEAN IVD MARKET STATISTICS REPORT 20224CountryTotal Tests 2021Total Tests 2020Growth rate 21-20So
28、urce:ECDC;*Our World in DataUnited Kingdom*343.554.199 48.972.436 602%France148.436.784 33.651.450 341%Austria115.889.875 3.747.074 2993%Italy114.406.110 20.887.600 448%Greece104.759.764 3.432.711 2952%Denmark95.106.382 10.576.739 799%Turkey*94.520.585 24.464.277 286%Germany57.414.318 36.088.129 59%
29、Spain46.894.218 21.486.152 118%Czechia41.832.831 4.736.765 783%Netherlands29.968.706 8.372.650 258%Portugal20.937.405 5.724.026 266%Poland20.019.974 7.886.328 154%Cyprus16.727.060 939.253 1681%Romania12.391.363 1.940.112 539%Slovenia12.068.113 755.813 1497%Switzerland*11.090.167 3.288.431 237%Slovak
30、ia11.053.154 1.256.833 779%Sweden10.737.369 4.093.604 162%Norway10.052.849 3.069.032 228%Ireland7.625.591 2.472.349 208%Belgium6.324.519 7.010.457-10%Bulgaria6.276.243 1.093.797 474%Finland6.255.010 2.512.145 149%Croatia5.194.645 1.084.453 379%Lithuania2.916.002 1.577.134 85%Hungary2.798.321 1.799.5
31、26 56%Luxembourg2.168.275 1.656.550 31%Estonia1.881.816 550.121 242%Latvia1.114.303 475.460 134%Malta1.023.883 527.375 94%Iceland944.683 429.819 120%Total1.362.384.517 266.558.601 411%SARS-Cov-2 Tests:Volumes ITALY IVD MARKET 2,071 mEUR+16.3%“The IVD Italian market,in 2021 recorded an increase of 16
32、.3%.The growth,for almost the totality,is to be attributed to the COVID-19 diagnostics.Looking at the market data,excluding COVID-19 diagnostics and glucose tests,we record an even higher growth of 19.4%.In addition to the increase in COVID-19 related turnover,this market growth is due to the the gr
33、adual reopening of all health services which allowed Laboratory Diagnostics to resume its normal activities(hospital and territorial)after almost a year of total closure.In addition,in 2021,laboratory activities began to recover the enormous accumulation of health services not provided in the previo
34、us year.The latter will certainly further affect overall growth.The year 2020 is certainly not comparable with any other year.The serious economic crisis due to the almost total closure of all activities,has in fact generated,in 2021,a“rebound effect”that has led to the results achieved.If we compar
35、e the results of 2021 to 2019(pre-pandemic),the overall result(excluding COVID-19 diagnostics)would certainly be more truthful than the country system and in this specific case of Laboratory Diagnostics(+1.7%).“Confindustria Dispositivi Medici,Italian IVD industry associationUNITED KINGDOM IVD MARKE
36、T 1,628 mEUR+23.4%“In the UK,dramatic reductions in non-Covid testing activity were evidenced in 2020 by reductions in revenue,such as-20%for Clinical Chemistry excluding Rapid Tests,this activity has recovered significantly in 2021(+20%).Nucleic Acid Testing and Immunoassay are strongly boosted by
37、Coronavirus testing,as is Rapid Testing(mainly antigen tests for current infection).Coronavirus testing has grown from zero in 2019 to almost one quarter of the total UK IVD market in 2021,without counting non-participant company supply via government contracts,for which we have no reliable estimate
38、s.Core laboratory reagents,instruments&consumables market revenues recovered a further 66m(+16%).Microbiology revenues decreased by 12m.The decrease was due mainly to a drop of-11m due to transport media,as PCR testing requirements stabilised.”BIVDA,British IVD industry associationMEDTECH EUROPE EUR
39、OPEAN IVD MARKET STATISTICS REPORT 20225GERMANYIVD MARKET 6,301 mEUR+106.5%“For the second time in a row,the German IVD market has reached record volumes.The background is the ongoing COVID-19 pandemic.Comprehensive testing is a central component of the German governments health policy strategy to c
40、ombat the pandemic and protect vulnerable groups from infection.In this respect,the German IVD market has become to a large extent a political market in 2021.The IVD market in 2021 is estimated to have a total volume of 6.3 billion euros.Of this,4.1 billion euros(65%)will be accounted for by Coronav
41、irus testing and 2.2 billion euros(35%)by other diagnostics.The market volume doubled compared to 2020(+106.5%).While growth for all Coronavirus testing was extremely dynamic(+367%),other diagnostics developed flat(+1.2%).The biggest growth driver in 2021 was Coronavirus rapid testing.With a volume
42、of 3.67 billion,this market segment alone is significantly larger than the entire pre-pandemic IVD market.As a result of the slowdown in infections,declining trends for 2022 are already clearly discernible.In non-Covid diagnostics,the area of clinical chemistry has recovered.The same applies to haem
43、atology/histology/cytology.Microbiology,on the other hand,recorded market declines for the second time in a row.The development of blood glucose self-testing is also dampening.This market lost 7.2 per cent compared to the previous year,but the decline in sales has slowed down.The shift to sensor-bas
44、ed measurement systems continues to play a decisive role here.”VDGH,German IVD industry associationFRANCE IVD MARKET 2,610 mEUR+22%“The Central Laboratory IVD French market(excluding diabetes)is estimated at 2,610 million Euro,with a growth of+22%compared to 2020.This increase(14.4%)is driven by SAR
45、S-CoV-2 products and to recovery of pre-Covid lab activity(+7.6%).”SIDIV,French IVD industry associationPOLANDIVD MARKET 493 mEUR+11.6%“The year 2020 was a critical one for the Polish healthcare system.Closing hospital wards,postponing treatments,and creating more beds for COVID-19 patients was pivo
46、tal.In 2021,the pandemic is slowly being brought under control and delays in overdue services are being compensated.Market increase has been shown in clinical chemistry,immunology,haematology and microbiology.Virology research is at its peak in 2021.”MedTech Polska,Polish IVD industry association BE
47、LGIUMIVD MARKET 428 mEUR+14.8%“The IVD market in Belgium reached 428 million EUR with a growth of 14.8%compared to 2020.In 2021,the expenses in the hospitals and ambulant setting have increased vs.2020(in 2020 Covid had a major impact)with more hospitalisations and consultations,therefore more IVD t
48、ests were done.”beMedTech,Belgian IVD industry association.PORTUGALIVD MARKET 491 mEUR+22.6%“COVID-19 had a big impact on the IVD market,according to our estimation the Sars-CoV-2 reagents represented around 45%of the total IVD sales in Portugal in 2021.In 2020,the country focus was on the COVID-19
49、pandemic,and we had a decrease on the routine testing with around-8%.In 2021,mainly during the second half of the year,the routine lab testing recovered,and the patients had the possibility to start again visits to the health institutions.The focus of care was not only COVID-19 and due to this fact,
50、the turnover for the other IVD segments was aligned with 2019 figures.”APIFARMA,Portuguese IVD industry associationMEDTECH EUROPE EUROPEAN IVD MARKET STATISTICS REPORT 20226SPAIN IVD MARKET 1,727 mEUR+14.1%“In 2021,the Spanish market is still under the strong influence of COVID-19 and the related te
51、sts.Development of biomarkers and molecular test(not only PCR)for other parameters has also been observed.The centralisation trend for public and private labs remains high but there is not a lot of room for further centralisation.Furthermore,big tenders covering whole region and centralised per prov
52、inces and with very long execution periods superior to six years has been registered.Declining or stagnating point of care testing is seen due to the lack of reimbursement except for diabetes testing.In certain cases,type 2 insulin dependent patients could be candidates for continuous glucose monito
53、ring.We witness that robotisation is reaching not only the very big labs but also many medium size ones.IVDs are now recognized as a key player in medicine both for public and politicians.There has been major investment in human resources and instrumentation in most laboratories but there is uncerta
54、inty regarding the future of IVD market once the pandemic is now under control.The best perception of added value is of microbiology and anatomic pathology departments contribution.”FENIN,Spanish IVD industry associationAUSTRIAIVD MARKET 568 mEUR+18.3%“The market dynamic,in 2021,was again determined
55、 mostly by SARS-CoV-2 Testing(PCR and Antigen testing)due to the very extensive testing strategy by the government.Many companies,not participating to the market statistics programmes entered the market.Thus,making it difficult to estimate the total COVID-19 related market.The classical laboratory m
56、arket recovered and went basically back to the pre-pandemic level with a small increase.“AUSTROMED,Austrian IVD industry association GREECEIVD MARKET 412 mEUR+62.1%“After a substantial decrease in GDP in 2020 due to the COVID-19 pandemic(-9.0%based on latest data),in 2021 Greece is again on a growth
57、 trajectory,with a+8.3%increase in GDP year-on-year.In 2021,the total IVD Market grew by 62.1%compared to 2019,mainly driven by SARS-CoV-2 revenues of 180M Euro compared to 50M Euro in 2020.The Greek IVD Market,excluding coronavirus testing,grew by 13.7%,driven by growth across all the traditional I
58、VD categories-clinical chemistry,haematology,immunology excluding coronavirus testing.“SEIV,Greek IVD industry association.CZECH REPUBLIC IVD MARKET 267 mEUR+49.5%“The market growth observed in 2021 in the Czech Republic has been driven by infectious disease testing+39.8%,due to the COVID-19 pandemi
59、c,as well as related increased revenues in services+15,6%and instruments+2.4%compared to 2020.Furthermore,market recovery is shown also in in microbiology 14%,clinical chemistry 6.3%,and haematology 8.1%segments.”CZEDMA,Czech IVD industry association.SWITZERLAND IVD MARKET 771 mEUR+49.9%“After a neg
60、ative growth(-3.7%)of the IVD market excluding SARS-COV-2 testing in 2020 vs 2019,we observed a recovery in 2021 with a growth of 6.5%.All Coronavirus testing experienced strong expected growth of almost 50%vs.2020.”SVDI,Swiss IVD industry Association.MEDTECH EUROPE EUROPEAN IVD MARKET STATISTICS RE
61、PORT 20227Data Gathering The results presented above are based on individual 2021 estimates made for 27 countries,comprising of the EU countries,EFTA countries,the UK and Turkey:13 countries are participating in the Global Diagnostic Market Statistics(GDMS,former EDMS)programme:Austria,Belgium,Czech
62、 Republic,France,Germany,Italy,the Netherlands,Poland,Portugal,Slovakia,Spain,Switzerland,and the UK.The National Association Members of MedTech Europe and the MedTech Europes Market Research Committee have estimated the IVD market in 18 other countries not participating in the GDMS programme:Bulgar
63、ia,Croatia,Cyprus,Denmark,Estonia,Finland,Greece,Hungary,Iceland,Ireland,Latvia,Lithuania,Malta,Norway,Romania,Slovenia,Sweden,and Turkey.The figures per country are compiled from the Global Diagnostic Market Statistics(GDMS)programme,through which companies report invoiced sales of reagents,instrum
64、ents and consumables to an independent auditor,CIP,as based on the Global IVD Classification(GIVD).This is done in association with the MedTech Europes Market Research Committee and the National Association Members.Although most of the molecular tests for Coronavirus have been captured in the progra
65、mmes as they are supplied by participating companies,there are revenues on Rapid Tests purchased directly through national government arrangements from non-participant companies which might not be all captured in this report.More than 85%of the market is covered in major countries by GDMS,ensuring t
66、he reliability and objectiveness of the information provided by MedTech Europe and its members.MedTech Europe encourages all IVD suppliers and countries to participate in the GDMS programme,which is the largest In vitro diagnostic audit in Europe and the most accurate source of information for under
67、standing and predicting market trends.About In Vitro Diagnostics In vitro diagnostics are non-invasive tests performed on biological samples(for example blood,urine or tissues)to diagnose or exclude a disease.IVDs provide valuable information about how the body is functioning and its state of health
68、.They are used for diagnosis,prognosis,risk stratification,screening and therapeutic monitoring of diseases.IVDs have a broad scope ranging from sophisticated technologies performed in clinical laboratories to simple self-tests,such as those for pregnancy and glucose monitoring.About MedTech Europe
69、MedTech Europe is the European trade association for the medical technology industry including diagnostics,medical devices and digital health.Our members are national,European and multinational companies as well as a network of national medical technology associations who research,develop,manufactur
70、e,distribute and supply health-related technologies,services and solutions.MedTech Europes 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 in
71、dustry meet Europes growing healthcare needs and expectations.It also promotes medical technologys value for Europe focusing on innovation and stakeholder relations,using economic research and data,communications,industry events and training sessions.The European in vitro diagnostic industry is driv
72、en by research and development.Almost 95%of the industry is comprised of small and medium size enterprises and approximately 1 billion euros per year is reinvested in R&D.Developed by MedTech Europe,the Global Diagnostic Market Statistics(GDMS)and Management Information System(MIS)programmes provide a comprehensive overview of the latest market trends based on the Global IVD Product Classification(GIVD).For more information Teodora Angelova Senior Manager Market DataEmail:t.angelovamedtecheurope.orgPhone:+32 2 777 02 74