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Recent developments onclinical trials in Belgium
March 17th 2011, Brussels
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PwC
Outline
1. Trends in clinical trials globally
2. Status and evolution of clinical trials in Belgium
3. Belgium’s clinical trial situation within Europe
4. Conclusions and recommendations
2
Trends in clinical trialsglobally
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PwC
Trends in clinical trials globallyClinical trials will be highly affected in the coming years
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Change drivers
Pressure on Pharma R&Dspend
• R&D spend is directly linked to the budget allocated to clinical trials.• R&D spend historically exhibited continuous, long-term growth. However,
as from 2009 R&D productivity declined.
Increased diseaseprevalence
• Forecasted trends in disease prevalence and death causes, may indicatetherapeutic areas where demand for drugs, and thus clinical trials,will increase.
Blockbuster patent expirywill reduce clinical trialsspending
• The leading pharmaceutical companies will be exposed to revenuedeclines as a result of patent expiries. This will likely have an impact onnew clinical trial launches.
Patient empowerment willincrease
• Patients and patient groups will have more influence on recruiting,protocol and information sharing through a networked community.
• Ethical pressures will continue to increase.
Treatment personalization& Pay for performance
• Personalization of treatment requires specific clinical trial design.• Life licensing: cumulative testing and release of the drug throughout its
lifecycle.• Outcome focussed clinical trial designs.
Source: Clinical trials – key challenges, November 2010, PwC
PwC
Trends in clinical trials globallyGlobal Pharma R&D spend declined in 2009 for the firsttime, while the number of registered clinical trials remainedstable
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Source: Federal Trade Commission, PwC analysis
* For 2010, data until the end of June 2010 are included.
*
PwC
Trends in clinical trials globallyThe leading pharmaceutical companies see between 14% and41% of their existing revenues impacted by patent expiries
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Source: PwC Analysis, AXA Framlington
*Estimate of global sales in 12 months prior to patent signing;**Value of products losing patent protection as a percentage of total company sales over next five years
• Revenue pressure will most likely resultin cost-cutting initiatives and clinicalresearch expenditure might benegatively impacted.
• Additionally, as the innovativepharmaceutical market consolidationprogresses, small R&D orientedcompanies are acquired by largerplayers. As a result, pressure forefficiency and searching forsynergies may decrease the overallnet R&D spend.
• However, this might be favourable forlow cost CROs, which could benefit fromincreased outsourcing of clinicalresearch activities – as outsourcing isbelieved to provide more cost flexibility.
Status and evolution ofclinical trials in Belgium
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Status and evolution of clinical trials in BelgiumThe purpose of this study is to understand if Belgium canmaintain its unique position in the clinical trials market
• Study requested by:
– “The initiative to promote clinical trials inBelgium”(www.theinitiative.be)
• Study goals and scope:
– Understand the market forcesimpacting clinical trials
– Understand how Belgium performsin terms of clinical trials and if it iscapable of upholding its uniqueposition of the last years
– Formulate policyrecommendations allowing tostrengthen the Belgian clinical trialsposition where necessary
– Study time frame: Jan 2006- Dec 2010
• Basis of this study:
– CTA FAGG-database
– Pharma.be input
– PwC clinical trial reports
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PwC
Status and evolution of clinical trials in BelgiumIn 2009 there is an overall decrease in number of clinicaltrials, as from 2010 this trend stagnates
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• The number of clinical trials has decreasedwith 15% in 2009
• There is stagnation in 2010
Source: CTA FAGG-database
• In 2010, there is a decline in Phase 2clinical trials (- 25%), but more adaptivetrials are applied (Phase 1 & 2 combined)
• Phase 3 stagnates, which is in contrastwith the global trend
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Status and evolution of clinical trials in BelgiumAlthough the total number of clinical trials is decreasing, thetotal number of amendments is increasing
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• Belgium with 15% academic trials is below EUaverage of 22%.
• For academic as well as commercial clinical trials, thenumber of amendments is increasing: increase ofapprox. 7% in the total number of amendments per clinicaltrial for the period 2009-2010.
• Although the commercial trials represent approx. 85%of the total number of clinical trials, they account forapprox. 95% of the total number of amendments.
• The increase in total number of amendments mightbecome difficult to manage.
Source: CTA FAGG-database
PwC
Status and evolution of clinical trials in BelgiumCompetent authority approval times for Phase 2, 3 & 4 trialscontinue to decrease, for Phase 1 they remain roughly stable
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• The officially stated approval timesare:
• Phase 1: 15 days• Phase 2, 3 & 4: 28 days
• The FAGG approval timecorresponds to complete filesubmission until the final approval ofthe dossier. The time for providingadditional information in order tocomplete the dossier and the time torespond to objections ("clock-stopperiod"), has been excluded from thiscalculation.
The approval times are respected for all phases.
Source: CTA FAGG-database
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Status and evolution of clinical trials in BelgiumFor the top 5 pharmaceutical companies, there is a slowtrend towards concentration, while for the top 5 academicinstitutions, de-concentration is noticed
• In 2010, The top 5pharmaceuticalcompanies account for43,7.9% of initiated industrytrials, which is an increaseof 2,8%.
• In 2010, the top 5academic institutionsaccount for 61,5% ofinitiated academic trials,which is a decrease of8,2%.
Source: CTA FAGG-database
Pharmaceuticalcompanies
Academicinstitutions
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Status and evolution of clinical trials in Belgium73% of the studies are evaluated by the top 5 ethiccommittees
• In 2010, 73% of the studies are evaluated by the top 5 ethic committees
• Certain ethic committees are polyvalent, while others are more specialised (e.g. inphase 1)
Source: CTA FAGG-database
% single opinions of top 5 ethiccommittees on total single opinions
Number of single opinions per leading 5 ethic committees
PwC
Status and evolution of clinical trials in BelgiumThe spread of clinical trials over the different therapeuticareas remains stable
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There is no significant shift in the spread of clinical trials over the different therapeuticdomains
Clinical trials per therapeutic domain 2010Clinical trials per therapeutic domain 2008
* Phase I research (all therapeutic domains) is reported separately due to the specificity and importance
*
Ph
ase
2,
3&
4
Source: CTA FAGG-database
Belgium’s clinical trialsituation within Europe
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Belgium’s clinical trial situation within EuropeClinical trials in Europe are threatened by EmergingCountries and the US
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• US– The gap on R&D spending between US & EU is getting wider:
• Emerging Countries– Emerging countries are attracting a growing number of large-scale
clinical trials as they have access to large patient populations requiredto run these trials.
– The costs of running clinical trials is lower.– The shift to the “rest of the world” has increased markedly in recent
years and the trend looks set to continue, ultimately leading to a drop inclinical research activities in EU and US.
Source: pharma.be
2005 2008
US EU US EU
R&D spending(million)
30,969 $ 21,949 € 38,428 $ 27,200 €
PwC
Belgium’s clinical trial situation within EuropeOverall, Belgium is scoring well on the average cost ofclinical trials, but there is a threat from the Easterncountries
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Based on a PwC analysis performed in 2010, Belgium is scoring well compared to the other EUcountries & US, but the cost to perform clinical trials is still 10% more compared toPoland and more than 20% compared to China & Russia.As a consequence, it can be expected that by 2012, the clinical trial market for CRO’s willincrease by 15% for Eastern Europe, compared to only 8,5% for Western Europe.
Source: PwC analysis, November 2010Source: “Pharmaceutical Outsourcing Strategies” by Business Insight; ESCP-EAP Analysis, 2008
Total world wide clinical marketsize and distribution
PwC
Belgium’s clinical trial situation within EuropeBelgium is one of the countries with the highestparticipation rate for clinical trials in Europe
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When comparing the number of patientsparticipating in clinical trials, Belgiumranks lower (with an average of 54 patients),due to its relatively limited patient population.
Source: EMA
Belgium
However, when these figures are expressed inper capita terms, Belgium emerges asone of the countries with the highestparticipation rate in Europe.
PwC
Belgium’s clinical trial situation within EuropeFor Belgium the total number of planned children & teensparticipating in clinical trials is declining, while onEuropean level, an upward trend is noticed
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•Over the last 2 years, the total number of planned children & teens participating in clinical trials hasdecreased by approx. 44% in Belgium.
•After a drop in the number of planned children & teens participating in clinical trials in 2009, anupward trend can be noticed for the year 2010 on European level.
•On European level, the participation rate of Belgian children & teens in clinical trials has beendecreasing as from 2010.
Source: CTA FAGG-database
Number of planned children & teens participating in clinicaltrials
Spread of the number of planned children & teensparticipating in clinical trials between Belgium & EU
Conclusions andrecommendations
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Conclusions and recommendationsThe economic impact of clinical trials
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Source: Clinical trials – key challenges, November 2010, PwC
• Clinical trials imply a number of tangible and intangible benefits to the hosteconomy
• Clinical research market impacts a number of stakeholders and many of thembenefit from clinical trials as an additional source of cash flow
• More than one-fourth of revenue earned on clinical trials by sponsors ends up as adirectly paid tax contribution to the state budget
• Clinical trials can provide early access to innovative treatments
PwC
Conclusions and recommendationsFocusing on transparency, structure, cooperation andcommunication can keep Belgium on the map
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• In 2009 there is an overall decreasein number of clinical trials, as from2010 this trend stagnates.
• The total number of amendments isincreasing
• On European level, theparticipation rate of Belgianchildren & teens in clinical trials isdecreasing
• Belgium is scoring well on theaverage cost of clinical trials, butthere is a threat from the Easterncountries
• Clinical development needs tobecome more flexible and willrequire a structure that is more“agile”
• Good communication practices andtransparency to patients and healthcare providers (e.g. informationsharing, transparency, developingawareness and positive attitude ofgeneral public)
• One-stop-shop idea• Creating a link between different
key-databases (e.g. database ofhealth technology assessmentbodies)
• Creating a framework todetermine a standard cost forclinical trials
Turning around the market decline and maximizing the potential benefits to theeconomy is possible providing that a flexible framework is provided, transparency isenhanced, a responsive structure is implemented and that cooperation &communication are encouraged.
PwC
Conclusions and recommendationsIn the light of these market forces, research organizations /companies will need to focus on shorter drug developmentpaths, process efficiency and higher trial flexibility
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Companies need to focus on strategies that:
Shorter and morefocussed drugdevelopment paths(less trial & error)
• The future drug development process is expectedto be more refined, as more emphasis will be puton fundamental research (translationalresearch).
Increased focus onprocess efficiency
• Sponsors seek for increased operational (andcost) efficiency, primarily by outsourcing trials toCROs and considering new locations for researchprojects.
Higher developmentflexibility
• Personalized drugs and shorter developmentpaths as well as focus on efficiency will result inrequirements for higher trial flexibility.
• Adaptive trials and smaller trials with highercomplexity will be managed, but recruitingpatients that correspond to all criteria andtimings will become more challenging.
• Life licensing: step-wise approvals.
Source: Clinical trials – key challenges, November 2010, PwC
Change drivers
Pressure on Pharma R&Dspend
Increased diseaseprevalence
Blockbuster patent expirywill reduce clinical trialsspending
Patient empowerment willincrease
Treatment personalization& Pay for performance
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More info can be found in our reportsor on our website
Coming soon
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Thank you!
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