Vaccines' Contribution to Europes Future

www.evm-vaccines.org

EuropeanVaccineManufacturers

Vaccines’contributionto Europe’s future

March 2010

Vaccines make an invaluable contribution toEurope’s public health. Since their introduction twocenturies ago, vaccines have eradicated smallpoxworldwide, eliminated endemic polio in Europe, andmany other once common infectious diseases arenow rare.

While vaccines’ medical importance is clear, thebroader strategic value offered by the vaccineindustry is not always recognised. EVM’s researchinto the sector provides an insight into its broadercontribution to Europe. The research also revealstrends that may be relevant for sustaining Europe’sleadership position in the vaccines field.

Discovering, developing and introducing newvaccines involves major risk and requires significantinvestment over long periods of time. Majormanufacturers are committed to innovating toenhance public health, and have launched a numberof new vaccines in recent years. This innovation, aswell as resulting in new products, boosts scientificresearch and supports high quality employment.This is particularly true for Europe, where much ofthe vaccine industry’s research and developmentis based.

3V A C C I N E S ’ C O N T R I B U T I O N T O E U R O P E ’ S F U T U R E

1In

novatin

gfo

rp

ub

lichealth

As a result of decades of industry innovation, a widerange of vaccines is now available. In recent years,producers have added to this and have introducednew vaccines, with a number targeting diseases forwhich none previously existed. In addition, several newcombination vaccines offer practical advantages thatcan boost vaccine uptake, thereby further improvingpublic health.

Of the new vaccines introduced since 2003, over 60%are based on new antigens. Of these:

– Two target human papilloma virus strains that areresponsible for causing approximately 70% ofcervical cancers.

– Two protect against rotavirus infection, which cancause severe gastroenteritis, hospitalisation and evendeath, particularly in young children.

– Two target invasive pneumococcal disease causedby Streptococcus pneumoniae bacteria; infectionssuch as meningitis and bacteraemia caused by thesebacteria are potentially life-threatening.

4

Vaccine development is a lengthy process taking manyyears and requiring significant resources and expertise.The process to develop and introduce a new medicinetakes on average 12 -13 years, with the cost of R&Destimated at over €1 billion in 2006[source: EFPIA, ‘The Pharmaceutical Industry in Figures, 2009 update’].

Given the extensive requirements of research anddevelopment, manufacturers make a long-termcommitment to the process of vaccine innovation.This dedication is borne out by the results of the EVMsurvey. In 2008, major producers had 122 ongoingR&D projects spread throughout the key stages ofdevelopment. Of the ongoing studies, 29 were in thefinal phase of development (phase III), meaning manynew vaccines targeting a range of diseases maybecome available in the relatively near future.

A further 22 projects were in phase IV clinical studies.Phase IV studies provide further information on vaccineperformance post-licensure, such as in specialpopulations who may not have been included inearlier trials.

5

Manufacturers concentrate their R&D on highlyinnovative new vaccines. While a small number ofprojects address technological improvements andother advances, approximately 70% focus on thedevelopment on new vaccines.

The EVM survey demonstrates that vaccine industrydevelopment efforts are focused on new vaccines,and of these nearly 90% are based on new antigens(new active ingredients). These could lead to innovativevaccines that result in new medical breakthroughs.

6

Vaccine R&D consumes significant amounts of capital,the vast majority of which is provided by privateindustry. In 2008, major manufacturers committedover €2 billion to the development of new vaccines.This has increased by nearly 40% since 2002, whenindustry investment amounted to approximately€1.5 billion.

Given the importance of vaccines for public health,the public sector plays a key partnership role throughinvestment in fundamental scientific research.However, of the total invested in 2008 in vaccine R&D,under 4% came from public sources. Throughout theEVM survey period (2002 – 2008), public funds haveconsistently accounted for only a small proportion(approximately 2 – 4%) of vaccine industryR&D investment.

7

Research and development forms the foundations onwhich the vaccine industry is based. Discovering anddeveloping new vaccines is highly resource intensive,with producers investing over €2 billion in R&Dduring 2008.

To maintain this significant level of investment,manufacturers commit a major portion of theirrevenues to research and development activities.Within Europe, this high rate of investment is matchedonly by pharmaceutical and biotechnology companies.With investment amounting to over 15% of revenuesthese life science industries have an “R&D intensity”that is 50% greater than the next closest Europeanindustrial sector (software and computer services).

Research and development investment plays astrategically important role in boosting Europe’seconomy, enhancing competitiveness and providinghigh quality jobs. The vaccine industry makes a majora contribution to each of these areas.

8

While major vaccine manufacturers are global innature, many of their operations are based in Europe.This is the case for much of the vaccine industry’sresearch and development, which is concentrated inthe region.

Of the 144 R&D projects ongoing in 2008 (including22 in phase IV development), nearly 60% (84) werebased in Europe. This is nearly 60% greater than thenumber based in North America (53), with otherterritories home to under 5% of the total.

Research and development employment is also highlyconcentrated in Europe. Of the nearly 6,000 R&Dspecialists employed by major manufacturers,68% (approximately 4,000) are based in the region.This employment supports Europe’s science base,providing high quality work in a broad range oftechnological and scientific disciplines.

9

Since their first introduction over two centuries ago,vaccines have greatly enhanced public health, andnow save the lives of 3 million people each year[source: WHO Europe]. Thanks to vaccines, smallpox,which used to kill 5 million people annually, has beeneradicated, and by 2002 endemic polio was eliminatedfrom Europe [source: WHO Europe].

Although vaccines are now available against a rangeof infections, many disease targets still exist. Equally,the emergence of SARS in 2003 and H1N1 pandemicinfluenza in 2009 demonstrates that new threats canarise at any time. As a consequence, it is imperativethat R&D efforts are sustained to combat future healthchallenges.

The vaccine industry is committed to the developmentof new vaccines to further enhance public health.Europe is at the centre of this global effort, with themajority of the industry’s 122 R&D projects and 6,000R&D employees based in the region. With investmentrates substantially higher than any other Europeansector outside the field of life sciences, Europe’svaccine industry is a strategic asset.

10

As well as concentrating its R&D activities in Europe,the global vaccine industry bases many of its otheroperations in the region. This is particularly true ofvaccine manufacturing. Major manufacturers producenearly all of their vaccines in Europe and export themajority of these important products worldwide. Thisexport success story is in sharp contrast with recentindustrial trends, in which a number of sectors havemoved production outside of the European Union.

As a research-based, high-technology, high-growthindustrial sector, vaccines are an importantcontributor to Europe’s global competitiveness.This largely European-based industry provideshigh quality employment, boosts the region’seconomy and contributes to social andeconomic development.


2Boostin

gEu

rop

e'sco

mp

etitiveness

Europe has a long history of vaccine manufacturing,and benefits from a strong industrial infrastructure.Of major producers’ 32 production facilities aroundthe world, over 60% are in Europe. Thirteen Europeancountries are home to these vaccine manufacturingsites. In contrast only 5 countries across the rest of theworld have plants operated by major producers, andof these the vast majority are in North America.

Throughout the EVM survey period (2002 – 2008), thetotal number of production facilities in the continenthas increased slightly, emphasising manufacturers’commitment to the region.

12

With Europe home to much of the world’s vaccineR&D activities and most of its production facilities, itfollows that the majority of the industry’s employeesare based in the region also. The EVM survey showsthat Europe accounts for over 60% of industry’s totalemployment, with the region’s more than 20,000workers amounting to nearly two-and-a-half timesthe number based in North America.

Vaccine industry employment is important as it offersmany of the qualities required to maintain successfuleconomies. Many of the jobs are highly skilled andinvolve a range of high technology and scientificdisciplines. These positions offer the prospect oflong-term career and skills development in anexpanding and successful sector. Consequently,the vaccine industry helps contribute to social aswell as economic development.

13

From their 20 production sites located in Europe, theworld’s major vaccine manufacturers produced morethan 4.7 billion doses in 2008. This amounted to over90% of their global output, and was nine times morethan the number of doses they manufactured inNorth America.

Throughout the EVM survey period both the overallvolume of vaccine industry production has grown,as well as the proportion manufactured in Europeanplants. In 2002, major manufacturers produced3.9 billion doses, which grew by approximately34% to reach 5.2 billion in 2008. During this periodEuropean production increased slightly more rapidlythan the overall upward trend, with the 3.5 billiondoses manufactured in 2002 increasing 36% to4.7 billion in 2008.

European manufacturing success stories on this scalemay appear rare in recent times. However, in the caseof vaccines, production by major manufacturers hascontinued to be concentrated in Europe.

14

Of the 4.7 billion doses of vaccines produced inEurope in 2008, approximately 80% were exportedaround the world. Of these a small proportion weredestined for North America (227 million doses), whileover a third (approximately 1.4 billion doses) weredistributed to developing countries via specificagencies and international organisations such asUNICEF: Europe plays a particularly important role insupplying large quantities of vaccines for the globalinitiative to eradicate polio.

For many years producers have provided vaccines atreduced prices for use in the developing world. As aresult, the 1.4 billion doses supplied to lower-incomecountries account for 36% of exports and 26% of totalproduction, but less than 3% of revenues.

The success of Europe’s vaccine exports has a dualimportance. As well as supporting public healthinitiatives around the world, it demonstrates thecompetitiveness of a European industry sectorthat contributes positively to the region’s economy.

15

Throughout the EVM survey period majormanufacturers have introduced new vaccines andsubstantially increased production. Similarly Europeanmanufacturing has grown significantly, along withexports from the region which rose by over 30%(increasing from 2.8 billion doses in 2002 to 3.7 billionin 2008).

In parallel with this growth, vaccine industry revenueshave also increased. As a result, manufacturers cancontinue to invest heavily in R&D activities, which inturn support Europe’s knowledge-based economyand science base. As a rapidly growing sector, theEuropean vaccine industry also contributes to thecontinent’s broader economy, provides quality jobsand enhances the region’s competitiveness. Overall,vaccines represent a strategically important industryfor Europe.

16

Mirroring its growing product range, productionoutput, exports and revenues, Europe’s vaccineindustry has also increased its workforce dramaticallyin recent years.

While the EVM survey completed in 2008 may notcapture the full impact of the ongoing global recession,the long-term upward trend in vaccine industryemployment is clear. Each biennial survey has showna consistent increase in European employment from2002 through to 2008. The total growth during thisperiod stands at over 75%, outstripping thecorresponding increase in North America whereemployment grew by 69% to reach 8,870 workersin 2008 (vs 21,257 in Europe).

This general upward trend is largely mirrored in R&Demployment also. Throughout the survey period,employment of research and development workersbased in Europe has grown at each time point except2004, with a total increase of 58% between 2002and 2008.

17

Vaccines have been developed in Europe for centuries,and EVM surveys show that the continent continues itslong tradition in the field:

– The global vaccine industry employs over 60% ofits workers in Europe, and over 2/3rds of its R&Dspecialists.

– Major manufacturers produce over 90% of theirvaccines in the region, of which 80% are exportedaround the world.

– European R&D and vaccine production enhancespublic health in all regions of the globe, includingin the developing world, provides high qualityemployment, supports Europe’s knowledgeeconomy and boosts the region’s competitiveness.

Unlike some other major industrial sectors, includingpharmaceuticals, Europe’s vaccine producers remainat the heart of the global industry. This regionalconcentration of operations provides a range ofimportant economic and social benefits.

18

Over a period of time, thepharmaceutical industry hasundergone a shift in its centreof gravity. For many years Europeenjoyed its position as a leadingcentre of pharmaceuticaldevelopment and production.However, with more rapid growth,greater R&D spending andincreased relative competitivenessNorth America has increased inimportance, and the region noweclipses Europe on a number ofkey measures. This situation isagain in flux, with a number ofexperts believing Asia will be thefuture centre of the global marketfor the pharmaceutical sector.

[Sources: DG Enterprise and Industry:Pharmaceutical Industry Policy - Introduction(13/8/08); Commission staff workingdocument ‘European industry in a changingworld updated sectoral overview 2009’;PricewaterhouseCoopers: Gearing up fora global gravity shift (2007).]

In recent years, the vaccinesindustry has experiencedsignificant growth andreinvigoration. Europe hasbenefited from this success, andthe region continues to enjoy itsplace at the heart of the globalindustry. However, analysis ofEVM surveys over the last six yearsreveals an increase in opportunitiesin other regions of the world,particularly North America.

The early signs of a potential futuretrend are perhaps most noticeablein R&D, which is at the beginningof the cycle of new vaccinecreation and commercialisation.

Given the importance of vaccineinnovation, experts from theEuropean Academies ScienceAdvisory Council (EASAC), a high-level advisory group composedof members from EU MemberStates’ scientific academies, haveproposed a number of supportivepolicies. These may help sustainthe region’s global lead in the field,and the industry’s importantcontribution to Europe’s socialand economic development.


3Su

stainin

gEu

rop

e’slead

inth

evaccin

esfield

During the 20th Century, the development of vaccinesprogressed steadily for many years, and importantpublic health improvements were made when theywere introduced. In particular, the second half of thecentury witnessed a rapid acceleration in researchand development, and many new vaccines becameavailable during this period.

In recent years vaccines have entered an excitingnew era. Dramatic advances in immunology, genetics,molecular biology and bioinformatics are enablingscientists to target a wide range of diseases for whichvaccines were previously unavailable. Vaccines havebecome important players in the ‘biotechnologyrevolution’, and the pace of new product introductionshas increased substantially in the last 10 years.

Currently 28 diseases are vaccine preventable; in therelatively near future this number is likely to expandconsiderably.

By harnessing the power of a range of newtechnologies, vaccine development continues toaccelerate. A large number of candidates are indevelopment, targeting nosocomial infections, malaria,dengue fever, tuberculosis and other health threats(such as SARS and bioterrorism). In future, vaccinesmay address not only infectious diseases butAlzheimer’s, various cancers and addictions.

20

EVM surveys over the period 2002 – 2008 showthat the current era of technological advance andaccelerating vaccine development is creating manynew R&D opportunities. The surveys demonstratethat at each biennial checkpoint Europe consistentlyremains home to the majority of vaccine industry R&Dprojects. Indeed, in 2006 it appeared Europe may beconsolidating its R&D lead.

However, the most recent research from 2008 paintsa different picture. A rapid shift of power during thetwo-year period from 2006 has seen the gap betweenEurope and North America narrow. The differencebetween the proportion of total R&D projects locatedin Europe vs North America decreased from 43% in2006 to just 21% in 2008. This move means that thetwo regions are now more evenly matched, and thetrend over the entire survey period reveals a potentialdecline in Europe’s dominance, with a correspondingrise in North America’s importance.

21

Deeper analysis of the EVM survey data shows thatthe recent trend in the movement of R&D projectsappears to be mirrored in those projects based onnew antigens (active ingredients). As these antigenshave the potential to form the basis of innovative newvaccines they may represent a fundamental measureof R&D quality and overall commercial potential, givingtrends in their development an added poignancy.

From 2002 - 2006, Europe maintained its positionas the leading centre for new antigen developmentprogrammes, and while the location of these projectschanged repeatedly this did not follow a clear trend.However, the addition of the 2008 EVM data revealsan early trend of movement away from Europetowards North America. The difference between theproportion of new antigen R&D projects located inEurope vs North America decreased from 28% in2006 to just 7% in 2008. This narrowing of the gapbetween the regions is similar to the changes seen inoverall R&D projects during the same two-year period.

22

The 2008 EVM survey results highlight further objectivemeasures that demonstrate the strength of R&Dopportunities outside Europe. Analysis of R&Dinvestment and the location of research anddevelopment sites shows the importance of NorthAmerica, mirroring the new emphasis on the region inboth overall R&D and projects based on new antigens.

– Of the €2 billion committed to vaccine R&D by theindustry in 2008, slightly over €1 billion was investedin Europe and a similar sum in North America:Europe received just €34 million greater investmentthan North America.

– This even investment split between the two regions ismirrored in the location of research and developmentsites. While Europe was home to 22 such facilities, asimilar number were based in North America (20).

23

Although public funding accounts for a very smallpercentage of total vaccine industry R&D investment(under 4%), it may be seen as an indicator of theenvironment and support offered by thecontributing region.

In this regard, analysis of the EVM surveys isinformative, showing steadily growing support fromNorth America. In the last two years, contributionsfrom other regions have increased dramatically toa level approaching those from North America.

This is in sharp contrast with European funding.Throughout the survey period, and most notablyduring the last three surveys, very limited fundingwas taken up by major manufacturers from Europeangovernments or the Commission. In 2008, majorproducers did not receive any funding from theCommission at all.

24

Clinical trials play an essential role in the developmentof new vaccines. Reflecting this importance, the mostrecent EVM survey shows that in 2008 majormanufacturers were conducting 572 such studies.

Conducting clinical trials is a complex undertaking,requiring skilled local personnel, consistently highquality standards and robust regulatory oversight.As a result, many factors influence the location ofclinical studies. These include the necessity to conductclinical trials in specific regions when targeting region-specific diseases (e.g. malaria and dengue in Africa).Furthermore, regulatory authorities tend to requestcompanies conduct additional clinical trials in localpopulations prior to authorisation.

While the factors supporting the location of clinicaltrials may be complex, the EVM survey of such alarge number of studies can provide an insight intothe relative importance of different regions. In 2008,Europe accounted for almost exactly 1/3rd of vaccineclinical studies undertaken by major producers, whileNorth America was home to a similar number (over1/4 of the total). This fairly even split between the tworegions is in line with the now more evenly balancedlocation of R&D projects, as well as research anddevelopment investment and R&D sites.

25

Europe has much to benefit from its position at theheart of the global vaccine industry. In recognition ofthe importance of supporting new vaccine innovationin the EU, the European Academies Science AdvisoryCouncil (EASAC) 2006 report, ‘Vaccines: innovationand human health’, made a series ofrecommendations to incentivise and facilitate R&Dand promote vaccine uptake.

The report identifies ‘a series of matters that have tobe tackled at European level to exploit the potentialof vaccines in the fight against infectious diseases’.Its comprehensive recommendations focus onstrengthening support for vaccine R&D, reducingimpediments and increasing vaccine usage to furtherenhance public health.

The Commission in its 2009 update on Europeanindustrial sectors identified several issues for the widerpharmaceutical industry that demonstrate the impactof structural change. Of particular note is the relativedecline of EU competitiveness and R&D investmentin comparison with the US.

By learning from the experience of the broaderpharmaceutical industry in recent decades, concertedefforts by all stakeholders, including policy makersand industry, can help sustain Europe’s lead in thevaccine field.

26

In conclusion, EVM surveys conducted over the last6 years clearly demonstrate the strategic value ofEurope’s vaccine industry.

– Vaccines are of great importance for public health,and Europe leads the world in their research,development and production. As a result, theEuropean industry is a global partner in the fightagainst infectious disease and the improvementof public health around the world.

– Vaccine producers are leading innovators,committing a greater proportion of revenues toR&D than any other major industrial sector inEurope outside the life sciences field. Thisinvestment is reaping rewards with several newvaccines introduced recently and many others in

development, against existing infections, emerginghealth threats, cancers and addictions.

–With the majority of the global vaccine industry’sR&D, employment and manufacturing based inEurope, the region’s competitiveness, science baseand knowledge economy all gain. The ongoingsuccess and growth of the vaccine sector isimportant for both public health and Europe’ssocial and economic development. However,early trends suggest that Europe’s R&D dominancemay be lessening, with the gap between the regionand North America narrowing. Consequently, itis important that Europe fosters a positiveenvironment and supportive policies to sustainits lead in the vaccines field.


Sum

mary:

Vaccin

es’co

ntrib

utio

nto

Euro

pe’s

futu

re

NotesImmunisation’s key role in improving public healthin Europe and around the world is well recognised.However, the contributions vaccine producers maketo Europe’s knowledge economy, science base, exportperformance and skills development are perhaps lesswell understood. To promote broader understandingof this strategically important industry, the EuropeanVaccine Manufacturers (EVM) group conducts biennialsurveys to capture a range of objective social andeconomic data.

EVM’s research, now conducted four times over thelast six years, provides an insight into the innovation,research and development, employment andmanufacturing undertaken by the industry in Europe.With information collected every two years over theperiod 2002 – 2008, the EVM database revealsindustrial trends that can assist policy makers andother stakeholders concerned with Europe’s socialand economic development.

28

NotesThe EVM research includes information from all themajor vaccine companies operating in Europe toensure the data is as complete as possible.

The vaccine producers covered by the survey arenot only major regional manufacturers. Due to thedominance of Europe within the global vaccineindustry, these companies are also leading producerson a worldwide basis.

The global role of the manufacturers included in theresearch is clearly demonstrated by the survey results:surveyed producers account for the vast majority ofworldwide vaccine production and revenues.

29

NotesTo ensure consistency the survey uses a number ofstandard definitions.

– Based on the worldwide significance of thecompanies included in the research, they aretaken as representing on a global scale thevaccine ‘industry’, vaccine ‘producers’ and vaccine‘manufacturers’. Consequently, these terms areused interchangeably when referring to the surveyrespondents.

– The EVM surveys define Europe on a political ratherthan geographic basis. As a result, the surveyincludes the 27 European Union countries andfour EFTA members.

– For the purposes of quantifying vaccine productionand distribution, one dose is defined as targetingone disease. Consequently, a combination vaccinetargeting several diseases will account for severaldoses. Similarly, the active ingredients in vaccines,termed ‘antigens’, differ for each targeted disease.Therefore, for the purposes of the survey, one dose= one antigen.

30

For further information please contact

EuropeanVaccineManufacturers

Vaccines' Contribution to Europes Future

Documents

Transcript of Vaccines' Contribution to Europes Future