1、European IVD MarketStatistics Report11,10011,20011,30011,26511,40011,00010,90010,80010,70010,60010,50020092010201120122013201420152016201720182019EUROPEAN IVD MARKET REVENUES(MILLION)OverviewMedTech Europe is pleased to publish the market estimates of the In vitro diagnostic(IVD)industry in Europe.T

2、he MedTech Europe figures include market size and dynamics information,based on 2019 and 2018 data.Macroeconomic and healthcare data are also included for all 28 EU-member states plus the European Free Trade Association members(EFTA)Switzerland,Norway and Iceland.In vitro diagnostics(IVDs)are an ess

3、ential part of todays healthcare.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,result

4、ing in healthier populations,reduced costs and economic growth in the long run.Three out of the five largest European IVD markets France,Spain and UK are showing slight to moderate growth in 2019 and overall revenues across EU-28 plus EFTA reached 11,265 million,an increase of+1.5%.If changes in the

5、 value of non-Euro currencies,are considered the overall change in the Euro value of the European IVD market from 2018 to 2019 is+1.3%.The IVD revenues in Germany stagnated(-0.4%),further market decrease was seen in the reagents market(-1.2%).In Italy,the IVD market decreased(-2%),with decreased rev

6、enues in both clinical chemistry,(-7.6%)and haematology,(-2.7%).From the largest five markets,the UK is experienced the highest increase of+3.1%,largely due to increase in instruments and consumables,infectious disease testing,and nucleic acid testing systems.In Spain,the IVD market increased by+2.8

7、%due to growth in immunochemistry,micro and infectious diseases segments.After stagnation in 2015 and 2016,the French IVD market registered a third year of slight growth of+0.3%.The changes in revenues do not necessarily reflect changes in test volumes,and there is evidence in many countries that vo

8、lumes have increased significantly without increased revenues.The Greek market marked an increase of+3.7%,the highest growth since 2008.On the other hand,Portugal reported a-1.5%decrease in IVD expenditure.In the newer EU member states,IVD expenditure averaged 1.2%of total healthcare expenditure(THE

9、),significantly higher than the 0.63%seen in older member states(EU-15),but in absolute terms the new member states spend only 11.3 per capita compared to 23 in the EU-15.Growth in those states is at+6.4%compares to+0.8%in the EU-15 states.11,10011,20011,30011,26511,40011,00010,90010,80010,70010,600

10、10,50020092010201120122013201420152016201720182019EUROPEAN IVD MARKET REVENUES(MILLION)OverviewCountrySpecificDataCountriesPopulation GDPGDP/capita THETHE/capita THE as%GDPIVD mkt.2019IVD mkt.2018IVD mkt.growth rate 19-18IVD mkt./THEIVD mkt./capita1000Mio Mio%Mio Mio%Germany83.0193.449.05041.545383.

11、6364.62711,5%2.1612.170-0,4%0,6%26,0France 167.0132.425.70836.198265.7643.96911,3%1.6231.6190,3%0,6%24,2UK 266.6472.522.71337.852242.3003.64610,0%1.0421.0113,1%0,4%15,6Italy60.3601.789.74729.651153.0852.5348,7%1.5561.588-2,0%1,0%25,8Spain46.9371.244.77226.520108.1102.3109,0%1.0331.0042,8%0,9%22,0Net

12、herlands17.282810.24746.88377.2024.48010,0%2942862,7%0,4%17,0Greece10.725183.41417.10214.2511.3287,7%2131987,5%1,4%19,8Portugal10.277213.30120.75619.3031.8779,5%226229-1,5%1,2%22,0Belgium11.456476.20341.57047.4174.15010,3%3993863,3%0,8%34,8Sweden10.230474.46846.37951.2965.04110,9%1871794,5%0,3%18,2A

13、ustria8.859397.57544.87939.7914.50110,3%2682622,3%0,7%30,3Denmark5.806312.74753.86530.4505.25610,1%1551512,8%0,5%26,7Finland5.518240.55643.59521.1173.8299,0%119120-1,2%0,6%21,5Ireland4.904356.05172.60122.4524.6136,9%1261223,7%0,5%25,7Luxembourg61463.516103.4653.1745.2215,3%19190,0%0,6%30,9EU-15409.6

14、4614.960.06936.5201.479.3493.6119,9%9.4199.3430,8%0,6%23,0Poland37.973532.32914.01931.5028306,3%3943774,4%1,2%10,4Romania19.414223.33711.50411.3715845,6%1951808,1%1,6%10,0Czech Rep10.650223.94521.02815.8721.4937,7%18215815,0%1,0%17,1Hungary9.773146.06214.9468.9649176,7%82795,1%0,9%8,4Bulgaria7.00061

15、.2408.7484.1215877,4%3032-7,4%0,8%4,3Slovakia5.45093.86517.2225.9911.1006,7%77761,9%1,3%14,2Croatia4.07654.23813.3063.5248626,8%67654,4%1,8%16,5Lithuania2.79448.79717.4642.9731.0616,6%31299,3%1,0%11,3Latvia1.92030.46315.8671.8049366,2%302424,3%1,3%15,5Slovenia2.08148.39323.2563.7971.8318,3%52520,1%1

16、,4%25,0Estonia1.32528.11221.2201.7351.3126,7%2121-0,8%1,2%16,1Cyprus87622.28725.4451.4311.6456,8%10105,3%0,7%11,4Malta49413.46227.2761.1102.2909,0%550,0%0,5%10,1New MS103.8261.526.53114.70394.1949076,2%1.1771.1086,3%1,2%11,3EU-28(EU-15+new MS)513.47216.486.60032.1081.573.5433.0659,5%10.59610.4511,4%

17、0,7%20,6Switzerland8.545653.47176.47870.9028.32711,9%4734622,2%0,7%55,3Norway5.328360.30167.62136.9716.96010,1%1851783,8%0,5%34,7Iceland35721.63560.6041.8625.2808,5%11110,0%0,6%30,8EFTA14.2301.035.40772.764109.7357.71210,6%6686512,6%0,6%47,0TOTAL(EU-28+EFTA)527.70117.522.00733.2041.683.2783.1909,6%1

18、1.26511.1021,5%0,7%21,3Turkey 82.004679.5108.28627.7013384,1%N/A645N/A2,3%N/ATOTAL(EU-28+EFTA+Turkey)609.70518.201.51829.8531.710.9792.8069,4%N/A11.748N/A0,7%N/AEurostat 2019Eurostat 2018Source MedTech EuropeUKGBP1,13991,1304914 887 1.042 1.002 3,9%SwedenSEK0,094460,097521.975 1.891 187 184 1,2%Denm

19、arkDKK0,1339390,1341711.159 1.128 155 151 2,5%EU-15EURN/AN/A9.419 9.341 0,8%PolandPLN0,23270,23471.678 1.608 390 377 3,5%RomaniaRON0,21070,2149906 840 191 180 5,7%Czech RepCZK0,038960,038994.664 4.057 182 158 15%HungaryHUF0,0030750,00313726.739 25.681 82 81 2,1%BulgariaBGN0,5113050,51130560 64 30 32

20、 -7,4%CroatiaHRK0,1340,134502 481 67 65 4,4%New MSEURN/AN/A1.169 1.110 5,3%EU-28(EU-15+new MS)EURN/AN/A10.588 10.451 1,3%CountryCurrency2019 average Exchange Rate2018 average Exchange RateIVD mkt.2019 Mio LCIVD mkt.2018Mio IVD mkt.growth rate 19-18IVD mkt.2018 Mio LCIVD mkt.2019Mio IVD Market Statis

21、ticsThe applied exchange rates are the 2019 annual average exchange rates published by The European Central Bank.Applying a single exchange rate to both 2019 and 2018 sales data eliminates possible fluctuations of market size and market growth due to exchange variations.The impact of these fluctuati

22、ons is shown in the table below.During the collection of 2019 years figures,the 2018 market size was re-estimated at the same time.That,together with the use of a single exchange rate,explains why some countries show different revenues compared to the figures presented in last years report for 2018.

23、The growth rate between 2019 and 2018 has been calculated using the re-estimated figures.The data regarding population,GDP and healthcare expenditure are the latest available from Eurostat.IVD Market Size in EUR(using actual exchange rates)1 France data includes only the Central Laboratory IVD Marke

24、t.2 UK data reflects the consolidated sales of the participating companies in GDMS,plus the figures published by NHS England for glucose test strip sales adjusted to represent the whole of the UK.CountrySpecificDataAlthough there are variations in healthcare systems,reimbursement policies etc.from c

25、ountry to country,healthcare cost containment is a constant across the various countries in this report.Besides budget restrictions,greater centralization both in the public and private laboratory sectors has increased the power of purchasing organizations.The overall situation with Sales Outstandin

26、g(DSO)in 2019 remains unsatisfactory.2019 IVDMarket Sizein mEUR2019 IVDMarket/Capitain EURSwitzerland 55Belgium 35Norway 35Luxembourg 31Iceland 31Austria 30Germany 26Italy 26Ireland 26Slovenia 25France 24Spain 22Portugal 22Finland 22Greece 20Sweden 18Czech Republic 17Netherlands 17Estonia 16Croatia

27、17UK 16Latvia 15Slovakia 14Cyprus 11Lithuania 11Poland 10Malta 10Romania 10Hungary 8Bulgaria 4Denmark 27The 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 re

28、port.Relative to GDP Switzerland is the leading country at 11.9%,followed by Germany,France and Sweden.In absolute amounts the healthcare expenditure per capita Switzerland remains in first position,followed by Norway,Iceland,Denmark,Luxemburg,and Sweden.The IVD per capita expenditure also shows a w

29、ide variation from a low of 4.2 in Bulgaria to 55.2 in Switzerland,which remains also the leading country.Germany -0.4%IVD MARKET 2161 M EUR “The German IVD market continues with a slight decrease.The total IVD market 2019 is estimated at 2.161 billion euros.This represents a market decline of 0.4%c

30、ompared to the previous year.The reagents market fell by 1.2%,while the market for instruments(including services,spare parts and supporting software)grew by 4.2%.Looking at the different market segments the laboratory market(reagents and instruments)grew by 2.0%.Some of the effects of the 2018 labo

31、ratory reform are now probably priced in.This reform essentially involved stricter budgeting by office-based physicians.After leaving this through immunochemistry,microbiology and infectious immunology were the growth drivers in 2019.In contrast,the rapid test market shows a decline of 5.6%.The gap

32、in growth in these market segments has widened in 2019.Again,the decline in the market for blood glucose test strips(-6.4%)dominates the entire rapid test market.However,this should be offset by significant growth in sensor-based glucose measurement(FGM,CGM)which cannot be shown in the data.From 202

33、0,the total IVD market will additionally be reported without the diabetes self-management segment.This further increases the informative value of the data reports.”-VDGH,German IVD industry associationItaly -2.0%IVD MARKET 1556 M EUR Italian IVD market remains almost unchanged with slight decline of

34、 2%during 2019 and only 0.5%if we exclude glucose tests.Compared to the previous year,the 2019 clinical chemistry sales decreased by 7.6%,mainly due to contraction of the public healthcare expenditure.Public buyers followed harsh cost containment strategies,and an ongoing reorganisation taking place

35、 in the public labs.The immunochemistry market grew by 3.9%,caused largely by increased testing in hormone and cardiac markers,as well as tests for autoimmune diseases and cancer.The haematology segment decreased by 2.7%.,while a 6.9%drop of sales occurred in microbiology,infectious diseases,and gen

36、etic testing.In 2019,strategies by the Regions continued to be focused on controlling public expenditure for IVDs.The lines of these policies were:(i)usually many biddings were equal as in the previous years;(ii)many Regions approved laws to reduce the number of tests in private labs(in many cases,a

37、 patient could have tests taken in a private labs but still reimbursed by the NHS),and such tests have to be done by only public labs(usually with long queues);(iii)the Government was not able to design its own governance strategies on medical devices and IVD,and the goal was to reduce it.Confindust

38、ria Dispositivi Medici,Italian IVD industry associationSpain +2.8%IVD MARKET 1033 M EUR“Mainly price-driven market and mild growth thanks to innovative tests.Growth in immunochemistry,micro and infectious diseases.Aggregated purchasing for the region and consolidation of laboratories remains a stron

39、g tendency but there is not too much extra-room for consolidation.Most laboratories have already consolidated and are looking for economies of scale and homogenization of the regions procedures and technologies.Customers are looking for new contracts based on risk sharing or value based consideratio

40、ns but the implementation of this kind of contracts is still only testimonial.Costs are increasing for automation and digitalization that reach almost every lab.Very automated market.Introduction of innovative technology or new tests remains slow due to a very heterogeneous market with 17 autonomous

41、 regions with different technology incorporation processes and purchase approaches.There is no central process to incorporate new technologies.Innovation is accepted but in a scenario where prices remains blocked and cost increases are seldom accepted.Continuous monitoring of Glucose is reimbursed i

42、n all regions subject to individual approval.Other glucose test strips suffers a commoditization approach.Evolution of POC lacking of a clear model of reimbursement and we dont see a significant improvement in the near future.”FENIN,Spanish IVD industry associationFrance+0.3%IVD MARKET 1624 M EUR “T

43、he Central Laboratory IVD French market is estimated at 1.624 billion,with a growth of+0.3%compared to 2018.The Central Laboratory IVD French market has been in stagnation since 2014 with continuous non-significant growth of less than 1%.”SIDIV,French IVD industry associationPoland +4.4%IVD MARKET 3

44、94 M EUR“Compared to the previous year,the Polish market observed an increase of+4.4%.”MedTech Polska,Polish IVD industry associationUnited Kingdom +3.1%IVD MARKET 1042 M EUR“The UK IVD market grew by 3.1%during 2019,of which a significant component was instruments and consumables.This could be in p

45、art due to increased reporting of these groups.Reagent revenues increased by 1.1%and there was particularly strong growth in Infectious Disease testing revenues.It is difficult to avoid commenting on 2019 without mentioning the current situation in the midst of the 2020 Covid-19 epidemic,but as the

46、Influenza season was mild,it may have contributed to a lack of preparedness for mass testing later.At the time,however,the major concern was still Brexit and its likely impact on supply chains and market access.As expected,nucleic acid testing systems continue to grow strongly,by about 12m(17%)over

47、2018,and multiple target NAT infectious disease systems grew by 32%.Some individual tests declined surprisingly,such as Vitamin D,while allergy and autoimmune testing saw double digit percentage growth.Overall,the UK still spends a very low amount per capita on IVD testing.”-BIVDA,British IVD indust

48、ry associationPortugal 1.5%IVD MARKET 226 M EUR“IVD market in Portugal has been quite stable,showing a negative development of-1.5%when compared with 2018.The market excluding glucose strips,has been stable,with a growth of 0.4%.The cause of the-1.5%market growthis that we are seeing a shift towards

49、 new technologies.In 2019,test strips declined around 4%.Short term tendering and contracts adding to political measures to contain costs in Healthcare,specifically with Medical Devices,leads to high pressure on prices.Slight market positive development from organic growth(higher life expectancy and

50、 increase in elderly population)is being compensated by market value decrease with cost measures and aggressive competitive pressure.Public funding is leaning towards more cost-effective and integrated care,with and increasing role of insurance companies.Health insurance continues to gain relevance

51、with 25%of population insured(growth 4.5%)and a growing number of private hospitals competing aggressively to gain MS.Lab consolidation seen in the past has slowed down with stabilization of number of labs in the country.Weve been witnessing increasing patient empowerment and education,with a shift

52、of disease management from reactive to preventive.Public policies are focused at improving screening and integrating hospitals and primary care.NHS purchasing centralization continuous to be discussed although not yet applied to IVD.Discussions are arising on new models of funding healthcare,like va

53、lue-based purchasing and payments over results in health.”APIFARMA,Portuguese IVD industry associationGreece+7.5%IVD MARKET 213 M EUR“2019 was the first full year during which the Greek Government was able to define its fiscal policy outside the fiscal adjustment programmes since 2010.The Greek econ

54、omy grew for the third consecutive year,with 1.9%GDP growth compared to 2018.The Greek IVD market grew by 7.5%in 2019,for the fourth consecutive time since 2008,reaching a size of 213M.This growth is driven mainly from the public sector,which represents 67%of the Greek IVD market.The remaining 33%co

55、rresponds to the private sector.Finally,for the total IVD Market,DSO were approximately 230 days during 2019.”SEIV,Greek IVD industry associationSlovenia+0.1%IVD MARKET 52 M EUR“The market stayed at last years level,only+0.1%growth.The reason is mainly the decline of the Rapid testing and Diabetes C

56、are market by almost-4%and slowing down of the Laboratory market growth.Reagents sales were declining approximately-2%due to Clin Chemistry(-3%),Haematology/Haemostasis(-4%),and a big drop in Infect.Immunology(-14%),all being partially compensated by Immunology Reagents sales by+6%.To last years out

57、standing contribution of the Instruments sales to the market value,the trend continued by+8%growth in 2019(importantly by Immunochemistry&Infectious Immunology Instruments)and after-sales Service.As the public procurement system is still very much based on price,no significant increase in the market

58、 value is expected.”SIEDMA,Slovenian IVD industry associationAustria+2.3%IVD MARKET 268 M EUR“In 2019,the Austrian IVD market grew by 2.3%,reaching a market size of 268 M Euros.”AUSTROMED,Austrian IVD industry association Slovakia+1.9%IVD MARKET 77 M EUR“IVD market in Slovakia has been quite stable,

59、showing a growth of 1.9%when compared with 2018,mainly caused by NAT testing in Blood Banks.”SEDMA,Slovakian IVD industry associationDataGatheringParticipating in the GDMS programmeNot participating in the GDMS programmeThe results presented above are based on individual 2019 estimates made for 28 c

60、ountries,comprising of the EU countries,EFTA countries and Turkey:13 countries are participating in the Global Diagnostic Market Statistics(GDMS,former EDMS)programme:Austria,Belgium,Czech Republic,France,Germany,Italy,the Netherlands,Poland,Portugal,Slovakia,Spain,Switzerland,and the UK.The Nationa

61、l Association Members of MedTech Europe and the MedTech Europes Market Research Committee have estimated the IVD market in 17 other countries not participating in the GDMS programme:Bulgaria,Croatia,Cyprus,Denmark,Estonia,Finland,Greece,Hungary,Iceland,Ireland,Latvia,Lithuania,Malta,Norway,Romania,S

62、lovenia,Sweden.The figures per country are compiled from the Global Diagnostic Market Statistics(GDMS)programme,through which companies report invoiced sales of reagents,instruments and consumables to an independent auditor,CIP,as based on the Global IVD Classification(GIVD).This is done in associat

63、ion with the MedTech Europes Market Research Committee and the National Association Members.More than 85%of the market is covered in major countries by GDMS,ensuring the reliability and objectiveness of the information provided by MedTech Europe and its members.MedTech Europe encourages all IVD supp

64、liers 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 understanding and predicting market trends.About In Vitro Diagnostics In vitro diagnostics are non-invasive tests performed on biological

65、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.They are used for diagnosis,prognosis,risk stratification,screening and therapeutic monitoring of diseases.IVDs have a broad scope r

66、anging from sophisticated technologies performed in clinical laboratories to simple self-tests,such as those for pregnancy and glucose monitoring.About MedTech Europe MedTech Europe is the European trade association for the medical technology industry including diagnostics,medical devices and digita

67、l health.Our members are national,European and multinational companies as well as a network of national medical technology associations who research,develop,manufacture,distribute and supply health-related technologies,services and solutions.MedTech Europes mission is to make innovative medical tech

68、nology available to more people,while helping 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 innov

69、ation and stakeholder relations,using economic research and data,communications,industry events and training sessions.The European in vitro diagnostic industry is a market worth around 11 billion.Driven by research and development,95%of the industry is comprised of small and medium size enterprises

70、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,visit www.medtecheurope.org.For more informationTeodora Angelova Market Data ManagerEmail:t.angelovamedtecheurope.orgwww.medtecheurope.orgPhone:+32 2 777 02 74www.medtecheurope.org